diff --git a/NEWS.md b/NEWS.md index 4201d5a..2cba711 100644 --- a/NEWS.md +++ b/NEWS.md @@ -1,11 +1,15 @@ # pharmaverseadam (development version) ## New features - - - Refreshed `{pharmaverseadam}` datasets using `{admiral}` 1.1.1.9027 (development version). (#91) + + - Refreshed `{pharmaverseadam}` datasets using `{admiral}` 1.1.1.9019 (development version) `{admiralophtha}` 1.2.0.9001 (development version), `{admiralonco}` 1.2.0, `{admiralvaccine}` 0.4.0, `{pharmaversesdtm}` 1.2.0 (development version). (#103) ## Documentation +- Added more details to README "Documentation Process" section. (#103) + +- Improved reference page so that dataset labels are displayed under each dataset name. (#103) +
Developer Notes diff --git a/R/adae.R b/R/adae.R index d63a9dc..e26f5c0 100644 --- a/R/adae.R +++ b/R/adae.R @@ -1,8 +1,9 @@ -#' adae -#' -#' Adverse Events Analysis +# This file is automatically generated by data-raw/create_adams_data.R. +# For updating it please edit inst/extdata/adams-specs.xlsx and rerun create_adams_data.R. +# Manual edits are not recommended, as changes may be overwritten. #' #' @name adae +#' @title Adverse Events Analysis #' @docType data #' @format A data frame with 105 columns: #' \describe{ diff --git a/R/adbcva_ophtha.R b/R/adbcva_ophtha.R index 2dc4486..a37912a 100644 --- a/R/adbcva_ophtha.R +++ b/R/adbcva_ophtha.R @@ -1,10 +1,11 @@ -#' adbcva_ophtha -#' -#' Best Corrected Visual Acuity Analysis +# This file is automatically generated by data-raw/create_adams_data.R. +# For updating it please edit inst/extdata/adams-specs.xlsx and rerun create_adams_data.R. +# Manual edits are not recommended, as changes may be overwritten. #' #' @name adbcva_ophtha +#' @title Best Corrected Visual Acuity Analysis #' @docType data -#' @format A data frame with 120 columns: +#' @format A data frame with 71 columns: #' \describe{ #' \item{ STUDYID }{Study Identifier} #' \item{ DOMAIN }{Domain Abbreviation} @@ -59,71 +60,22 @@ #' \item{ BASEC }{Baseline Value (C)} #' \item{ CHG }{Change from Baseline} #' \item{ PCHG }{Percent Change from Baseline} -#' \item{ ASEQ }{Analysis Sequence Number} -#' \item{ SUBJID }{Subject Identifier for the Study} -#' \item{ RFSTDTC }{Subject Reference Start Date/Time} -#' \item{ RFENDTC }{Subject Reference End Date/Time} -#' \item{ RFXSTDTC }{Date/Time of First Study Treatment} -#' \item{ RFXENDTC }{Date/Time of Last Study Treatment} -#' \item{ RFICDTC }{Date/Time of Informed Consent} -#' \item{ RFPENDTC }{Date/Time of End of Participation} -#' \item{ DTHDTC }{Date/Time of Death} -#' \item{ DTHFL }{Subject Death Flag} -#' \item{ SITEID }{Study Site Identifier} -#' \item{ AGE }{Age} -#' \item{ AGEU }{Age Units} -#' \item{ SEX }{Sex} -#' \item{ RACE }{Race} -#' \item{ ETHNIC }{Ethnicity} -#' \item{ ARMCD }{Planned Arm Code} -#' \item{ ARM }{Description of Planned Arm} -#' \item{ ACTARMCD }{Actual Arm Code} -#' \item{ ACTARM }{Description of Actual Arm} -#' \item{ COUNTRY }{Country/Region} -#' \item{ DMDTC }{Date/Time of Collection} -#' \item{ DMDY }{Study Day of Collection} -#' \item{ TRTSDTM }{Datetime of First Exposure to Treatment} -#' \item{ TRTSTMF }{Time of First Exposure Imput. Flag} -#' \item{ TRTEDTM }{Datetime of Last Exposure to Treatment} -#' \item{ TRTETMF }{Time of Last Exposure Imput. Flag} -#' \item{ TRTDURD }{Total Treatment Duration (Days)} -#' \item{ SCRFDT }{Screen Failure Date} -#' \item{ EOSDT }{End of Study Date} -#' \item{ EOSSTT }{End of Study Status} -#' \item{ FRVDT }{Final Retrievel Visit Date} -#' \item{ RANDDT }{Date of Randomization} -#' \item{ DTHDT }{Date of Death} -#' \item{ DTHDTF }{undocumented field} -#' \item{ DTHADY }{Relative Day of Death} -#' \item{ LDDTHELD }{Elapsed Days from Last Dose to Death} -#' \item{ DTHCAUS }{undocumented field} -#' \item{ DTHDOM }{undocumented field} -#' \item{ DTHCGR1 }{undocumented field} -#' \item{ LSTALVDT }{Date Last Known Alive} -#' \item{ SAFFL }{Safety Population Flag} -#' \item{ RACEGR1 }{Pooled Race Group 1} -#' \item{ AGEGR1 }{Pooled Age Group 1} -#' \item{ REGION1 }{Geographic Region 1} -#' \item{ LDDTHGR1 }{Last Dose to Death - Days Elapsed Grp 1} -#' \item{ DTH30FL }{Death Within 30 Days of Last Trt Flag} -#' \item{ DTHA30FL }{Death After 30 Days from Last Trt Flag} -#' \item{ DTHB30FL }{Death Within 30 Days of First Trt Flag} -#' \item{ CRIT1 }{Analysis Criterion 1} #' \item{ CRIT1FL }{Criterion 1 Evaluation Result Flag} -#' \item{ CRIT2 }{Analysis Criterion 2} +#' \item{ CRIT1 }{Analysis Criterion 1} #' \item{ CRIT2FL }{Criterion 2 Evaluation Result Flag} -#' \item{ CRIT3 }{Analysis Criterion 3} +#' \item{ CRIT2 }{Analysis Criterion 2} #' \item{ CRIT3FL }{Criterion 3 Evaluation Result Flag} -#' \item{ CRIT4 }{Analysis Criterion 4} +#' \item{ CRIT3 }{Analysis Criterion 3} #' \item{ CRIT4FL }{Criterion 4 Evaluation Result Flag} -#' \item{ CRIT5 }{Analysis Criterion 5} +#' \item{ CRIT4 }{Analysis Criterion 4} #' \item{ CRIT5FL }{Criterion 5 Evaluation Result Flag} -#' \item{ CRIT6 }{Analysis Criterion 6} +#' \item{ CRIT5 }{Analysis Criterion 5} #' \item{ CRIT6FL }{Criterion 6 Evaluation Result Flag} -#' \item{ CRIT7 }{Analysis Criterion 7} +#' \item{ CRIT6 }{Analysis Criterion 6} #' \item{ CRIT7FL }{Criterion 7 Evaluation Result Flag} -#' \item{ CRIT8 }{Analysis Criterion 8} +#' \item{ CRIT7 }{Analysis Criterion 7} #' \item{ CRIT8FL }{Criterion 8 Evaluation Result Flag} +#' \item{ CRIT8 }{Analysis Criterion 8} #' \item{ AVALCA1N }{Analysis Value Category 1 (N)} #' \item{ AVALCAT1 }{Analysis Value Category 1} #' } diff --git a/R/adce_vaccine.R b/R/adce_vaccine.R index 1404a7c..436c3a9 100644 --- a/R/adce_vaccine.R +++ b/R/adce_vaccine.R @@ -1,8 +1,9 @@ -#' adce_vaccine -#' -#' Clinical Events Analysis for Vaccine +# This file is automatically generated by data-raw/create_adams_data.R. +# For updating it please edit inst/extdata/adams-specs.xlsx and rerun create_adams_data.R. +# Manual edits are not recommended, as changes may be overwritten. #' #' @name adce_vaccine +#' @title Clinical Events Analysis for Vaccine #' @docType data #' @format A data frame with 56 columns: #' \describe{ diff --git a/R/adcm.R b/R/adcm.R index 67956cc..4c6220f 100644 --- a/R/adcm.R +++ b/R/adcm.R @@ -1,8 +1,9 @@ -#' adcm -#' -#' Concomitant Medications Analysis +# This file is automatically generated by data-raw/create_adams_data.R. +# For updating it please edit inst/extdata/adams-specs.xlsx and rerun create_adams_data.R. +# Manual edits are not recommended, as changes may be overwritten. #' #' @name adcm +#' @title Concomitant Medications Analysis #' @docType data #' @format A data frame with 95 columns: #' \describe{ diff --git a/R/adeg.R b/R/adeg.R index 4599cb5..c9c7f15 100644 --- a/R/adeg.R +++ b/R/adeg.R @@ -1,8 +1,9 @@ -#' adeg -#' -#' Electrocardiogram Tests Analysis +# This file is automatically generated by data-raw/create_adams_data.R. +# For updating it please edit inst/extdata/adams-specs.xlsx and rerun create_adams_data.R. +# Manual edits are not recommended, as changes may be overwritten. #' #' @name adeg +#' @title Electrocardiogram Tests Analysis #' @docType data #' @format A data frame with 108 columns: #' \describe{ diff --git a/R/adex.R b/R/adex.R index e5c73ad..14b9bee 100644 --- a/R/adex.R +++ b/R/adex.R @@ -1,8 +1,9 @@ -#' adex -#' -#' Exposure Analysis +# This file is automatically generated by data-raw/create_adams_data.R. +# For updating it please edit inst/extdata/adams-specs.xlsx and rerun create_adams_data.R. +# Manual edits are not recommended, as changes may be overwritten. #' #' @name adex +#' @title Exposure Analysis #' @docType data #' @format A data frame with 92 columns: #' \describe{ diff --git a/R/adface_vaccine.R b/R/adface_vaccine.R index 80dbaf0..ac26c61 100644 --- a/R/adface_vaccine.R +++ b/R/adface_vaccine.R @@ -1,8 +1,9 @@ -#' adface_vaccine -#' -#' Findings About Clinical Events Analysis +# This file is automatically generated by data-raw/create_adams_data.R. +# For updating it please edit inst/extdata/adams-specs.xlsx and rerun create_adams_data.R. +# Manual edits are not recommended, as changes may be overwritten. #' #' @name adface_vaccine +#' @title Findings About Clinical Events Analysis #' @docType data #' @format A data frame with 61 columns: #' \describe{ diff --git a/R/adis_vaccine.R b/R/adis_vaccine.R index db584f8..2697312 100644 --- a/R/adis_vaccine.R +++ b/R/adis_vaccine.R @@ -1,8 +1,9 @@ -#' adis_vaccine -#' -#' Immunogenicity Specimen Assessments +# This file is automatically generated by data-raw/create_adams_data.R. +# For updating it please edit inst/extdata/adams-specs.xlsx and rerun create_adams_data.R. +# Manual edits are not recommended, as changes may be overwritten. #' #' @name adis_vaccine +#' @title Immunogenicity Specimen Assessments #' @docType data #' @format A data frame with 102 columns: #' \describe{ diff --git a/R/adlb.R b/R/adlb.R index 7ccc927..1e62d10 100644 --- a/R/adlb.R +++ b/R/adlb.R @@ -1,8 +1,9 @@ -#' adlb -#' -#' Laboratory Analysis +# This file is automatically generated by data-raw/create_adams_data.R. +# For updating it please edit inst/extdata/adams-specs.xlsx and rerun create_adams_data.R. +# Manual edits are not recommended, as changes may be overwritten. #' #' @name adlb +#' @title Laboratory Analysis #' @docType data #' @format A data frame with 115 columns: #' \describe{ diff --git a/R/adlbhy.R b/R/adlbhy.R index 75e6569..bb7e748 100644 --- a/R/adlbhy.R +++ b/R/adlbhy.R @@ -1,8 +1,9 @@ -#' adlbhy -#' -#' Analysis of Lab Hy's Law +# This file is automatically generated by data-raw/create_adams_data.R. +# For updating it please edit inst/extdata/adams-specs.xlsx and rerun create_adams_data.R. +# Manual edits are not recommended, as changes may be overwritten. #' #' @name adlbhy +#' @title Analysis of Lab Hy's Law #' @docType data #' @format A data frame with 14 columns: #' \describe{ diff --git a/R/admh.R b/R/admh.R index 67bb841..52a1196 100644 --- a/R/admh.R +++ b/R/admh.R @@ -1,8 +1,9 @@ -#' admh -#' -#' Medical History Analysis +# This file is automatically generated by data-raw/create_adams_data.R. +# For updating it please edit inst/extdata/adams-specs.xlsx and rerun create_adams_data.R. +# Manual edits are not recommended, as changes may be overwritten. #' #' @name admh +#' @title Medical History Analysis #' @docType data #' @format A data frame with 114 columns: #' \describe{ diff --git a/R/adoe_ophtha.R b/R/adoe_ophtha.R index 2ec783c..2a5368c 100644 --- a/R/adoe_ophtha.R +++ b/R/adoe_ophtha.R @@ -1,8 +1,9 @@ -#' adoe_ophtha -#' -#' Exam Analysis for Ophthalmology +# This file is automatically generated by data-raw/create_adams_data.R. +# For updating it please edit inst/extdata/adams-specs.xlsx and rerun create_adams_data.R. +# Manual edits are not recommended, as changes may be overwritten. #' #' @name adoe_ophtha +#' @title Exam Analysis for Ophthalmology #' @docType data #' @format A data frame with 102 columns: #' \describe{ diff --git a/R/adpc.R b/R/adpc.R index 8a24482..448b136 100644 --- a/R/adpc.R +++ b/R/adpc.R @@ -1,8 +1,9 @@ -#' adpc -#' -#' Pharmacokinetic Concentrations +# This file is automatically generated by data-raw/create_adams_data.R. +# For updating it please edit inst/extdata/adams-specs.xlsx and rerun create_adams_data.R. +# Manual edits are not recommended, as changes may be overwritten. #' #' @name adpc +#' @title Pharmacokinetic Concentrations #' @docType data #' @format A data frame with 127 columns: #' \describe{ @@ -55,7 +56,6 @@ #' \item{ ATPTN }{Analysis Timepoint (N)} #' \item{ ATPT }{Analysis Timepoint} #' \item{ ATPTREF }{Analysis Timepoint Reference} -#' \item{ ABLFL }{Baseline Record Flag} #' \item{ BASETYPE }{Baseline Type} #' \item{ DOSEA }{Actual Treatment Dose} #' \item{ DOSEP }{Planned Treatment Dose} @@ -71,6 +71,7 @@ #' \item{ SRCVAR }{Source Variable} #' \item{ SRCSEQ }{Source Sequence Number} #' \item{ DTYPE }{Derivation Type} +#' \item{ ABLFL }{Baseline Record Flag} #' \item{ MRRLT }{Modified Rel. Time from Ref. Dose} #' \item{ ANL01FL }{Analysis Flag 01} #' \item{ ANL02FL }{Analysis Flag 02} diff --git a/R/adpp.R b/R/adpp.R index 13563a3..1f98dc4 100644 --- a/R/adpp.R +++ b/R/adpp.R @@ -1,8 +1,9 @@ -#' adpp -#' -#' Pharmacokinetic Parameters +# This file is automatically generated by data-raw/create_adams_data.R. +# For updating it please edit inst/extdata/adams-specs.xlsx and rerun create_adams_data.R. +# Manual edits are not recommended, as changes may be overwritten. #' #' @name adpp +#' @title Pharmacokinetic Parameters #' @docType data #' @format A data frame with 79 columns: #' \describe{ diff --git a/R/adppk.R b/R/adppk.R index ea07c93..624edfd 100644 --- a/R/adppk.R +++ b/R/adppk.R @@ -1,8 +1,9 @@ -#' adppk -#' -#' Population Pharmacokinetic +# This file is automatically generated by data-raw/create_adams_data.R. +# For updating it please edit inst/extdata/adams-specs.xlsx and rerun create_adams_data.R. +# Manual edits are not recommended, as changes may be overwritten. #' #' @name adppk +#' @title Population Pharmacokinetic #' @docType data #' @format A data frame with 61 columns: #' \describe{ diff --git a/R/adrs_onco.R b/R/adrs_onco.R index 1d44de5..ba670fe 100644 --- a/R/adrs_onco.R +++ b/R/adrs_onco.R @@ -1,8 +1,9 @@ -#' adrs_onco -#' -#' Tumor Response Analysis +# This file is automatically generated by data-raw/create_adams_data.R. +# For updating it please edit inst/extdata/adams-specs.xlsx and rerun create_adams_data.R. +# Manual edits are not recommended, as changes may be overwritten. #' #' @name adrs_onco +#' @title Tumor Response Analysis #' @docType data #' @format A data frame with 79 columns: #' \describe{ diff --git a/R/adsl.R b/R/adsl.R index 7e3a02f..831c1bb 100644 --- a/R/adsl.R +++ b/R/adsl.R @@ -1,8 +1,9 @@ -#' adsl -#' -#' Subject Level Analysis +# This file is automatically generated by data-raw/create_adams_data.R. +# For updating it please edit inst/extdata/adams-specs.xlsx and rerun create_adams_data.R. +# Manual edits are not recommended, as changes may be overwritten. #' #' @name adsl +#' @title Subject Level Analysis #' @docType data #' @format A data frame with 54 columns: #' \describe{ diff --git a/R/adsl_vaccine.R b/R/adsl_vaccine.R index 58344c1..e9a9208 100644 --- a/R/adsl_vaccine.R +++ b/R/adsl_vaccine.R @@ -1,8 +1,9 @@ -#' adsl_vaccine -#' -#' Subject Level Analysis for Vaccine +# This file is automatically generated by data-raw/create_adams_data.R. +# For updating it please edit inst/extdata/adams-specs.xlsx and rerun create_adams_data.R. +# Manual edits are not recommended, as changes may be overwritten. #' #' @name adsl_vaccine +#' @title Subject Level Analysis for Vaccine #' @docType data #' @format A data frame with 46 columns: #' \describe{ diff --git a/R/adtr_onco.R b/R/adtr_onco.R index 6153071..4822dcc 100644 --- a/R/adtr_onco.R +++ b/R/adtr_onco.R @@ -1,8 +1,9 @@ -#' adtr_onco -#' -#' Tumor Results Analysis for Oncology +# This file is automatically generated by data-raw/create_adams_data.R. +# For updating it please edit inst/extdata/adams-specs.xlsx and rerun create_adams_data.R. +# Manual edits are not recommended, as changes may be overwritten. #' #' @name adtr_onco +#' @title Tumor Results Analysis for Oncology #' @docType data #' @format A data frame with 99 columns: #' \describe{ diff --git a/R/adtte_onco.R b/R/adtte_onco.R index d7f9e4f..9df24a8 100644 --- a/R/adtte_onco.R +++ b/R/adtte_onco.R @@ -1,8 +1,9 @@ -#' adtte_onco -#' -#' Time to Event Analysis for Oncology +# This file is automatically generated by data-raw/create_adams_data.R. +# For updating it please edit inst/extdata/adams-specs.xlsx and rerun create_adams_data.R. +# Manual edits are not recommended, as changes may be overwritten. #' #' @name adtte_onco +#' @title Time to Event Analysis for Oncology #' @docType data #' @format A data frame with 20 columns: #' \describe{ diff --git a/R/advfq_ophtha.R b/R/advfq_ophtha.R index c6cebf7..040202b 100644 --- a/R/advfq_ophtha.R +++ b/R/advfq_ophtha.R @@ -1,8 +1,9 @@ -#' advfq_ophtha -#' -#' Visual Function Questionnaire Analysis +# This file is automatically generated by data-raw/create_adams_data.R. +# For updating it please edit inst/extdata/adams-specs.xlsx and rerun create_adams_data.R. +# Manual edits are not recommended, as changes may be overwritten. #' #' @name advfq_ophtha +#' @title Visual Function Questionnaire Analysis #' @docType data #' @format A data frame with 89 columns: #' \describe{ diff --git a/R/advs.R b/R/advs.R index d962294..27e9e43 100644 --- a/R/advs.R +++ b/R/advs.R @@ -1,8 +1,9 @@ -#' advs -#' -#' Vital Signs Analysis +# This file is automatically generated by data-raw/create_adams_data.R. +# For updating it please edit inst/extdata/adams-specs.xlsx and rerun create_adams_data.R. +# Manual edits are not recommended, as changes may be overwritten. #' #' @name advs +#' @title Vital Signs Analysis #' @docType data #' @format A data frame with 105 columns: #' \describe{ diff --git a/R/advs_peds.R b/R/advs_peds.R index e12e707..37803d3 100644 --- a/R/advs_peds.R +++ b/R/advs_peds.R @@ -1,8 +1,9 @@ -#' advs_peds -#' -#' Vital Signs Analysis for Pediatrics +# This file is automatically generated by data-raw/create_adams_data.R. +# For updating it please edit inst/extdata/adams-specs.xlsx and rerun create_adams_data.R. +# Manual edits are not recommended, as changes may be overwritten. #' #' @name advs_peds +#' @title Vital Signs Analysis for Pediatrics #' @docType data #' @format A data frame with 80 columns: #' \describe{ diff --git a/README.md b/README.md index ea5a384..7523872 100644 --- a/README.md +++ b/README.md @@ -9,17 +9,20 @@ Test data (ADaM) for the pharmaverse family of packages -# Purpose +## Purpose To provide a one-stop-shop for ADaM test data in the pharmaverse family of packages. -# Package Contents +## Package Contents -The ADaM contents of this package is populated by an action that executes the `{admiral}`, `{admiralonco}`, `{admiralophtha}`, `{admiralvaccine}` and `{admiralpeds}` templates and saves the resulting datasets here. This action can be triggered manually by the package maintainers in two scenarios: -- Regularly, upon new releases of these packages; -- Ad-hoc, whenever templates in the above packages have been updated but releases are far away in the calendar. In this case, the ADaM datasets are created using the development version of the templates. +The ADaM contents of this package is populated by an script that executes the `{admiral}`, `{admiralonco}`, `{admiralophtha}`, `{admiralvaccine}` and `{admiralpeds}` templates and saves the resulting datasets here. This script can be executed by the package maintainers in two scenarios: -# Installation +* Regularly, upon new releases of these packages; +* Ad-hoc, whenever templates in the above packages have been updated but releases are far away in the calendar. In this case, the ADaM datasets are created using a development version of the templates. + +Please check the [Changelog](https://pharmaverse.github.io/pharmaverseadam/news/index.html) to see the versions of the packages used to generate the ADaM datasets in current or past version of `{pharmaverseadam}`. Please see the [Dataset Creation and Documentation Process](#doc) for details on the script. + +## Installation The package is available from CRAN and can be installed by running `install.packages("pharmaverseadam")`. To install the latest development version of the package directly from GitHub use the following code: @@ -31,16 +34,39 @@ if (!requireNamespace("remotes", quietly = TRUE)) { remotes::install_github("pharmaverse/pharmaverseadam", ref = "main") ``` -# Documentation Process +## Dataset Creation and Documentation Process {#doc} + +The execution of the ADaM templates and creation of the package documentation in `{pharmaverseadam}` is semi-automated for consistency and ease of maintenance. Metadata for each dataset such as names, labels, descriptions, authors, and sources, is managed in a centralized XLSX file (`inst/extdata/adams-specs.xlsx`) and used to generate `.R` documentation files. These are then used to populate the [reference pages](https://pharmaverse.github.io/pharmaverseadam/reference/index.html) in the package documentation. + +The workflow consists of two main steps: + +### 1. Metadata Preparation + +Firstly, the user reviews `inst/extdata/adams-specs.xlsx` and ensures its contents is up-to-date. If a new template has been added to an existing package, or if a new extension package has been created whose ADaM templates they wish to execute in `{pharmaverseadam}`, then the user should update `adams-specs.xlsx` with specifications for the new dataset(s). Note that any missing metadata fields will be set by default to "No label/description/source available." + +### 2. Execute `create_adams_data` + +Secondly, the user runs `data-raw/create_adams_data.R`. This script handles the installation of each package, the execution of the templates, the saving of the ADaM datasets and the creation of the documentation pages. + +#### Script steps + +1. **Installs Required Packages** + Installs the following packages: + - `{admiral}` + - `{admiralonco}` + - `{admiralophtha}` + - `{admiralvaccine}` + - `{admiralpeds}` + - `{pharmaversesdtm}` + By default, the latest development versions of each package will be used, but the user can also select a different version instead (e.g. a released version) with which to refresh `{pharmaverseadam}`. The user may also deselect some packages whose templates they do not wish to run. If a new extension package has been created, this should be added to the script in each relevant section (see the script itself for more details). -The documentation process in `{pharmaverseadam}` is automated for consistency and ease of maintenance. Metadata for each dataset, such as names, labels, descriptions, authors, and sources, is managed in a centralized XLSX file (`inst/extdata/adams-specs.xlsx`) and used to generate `.R` documentation files. +2. **Executes Templates from Each Package** -## Workflow +3. **Processes and Saves Datasets into {pharmaverseadam}** -1. **Metadata Preparation**: - - Ensure `adams-specs.xlsx` contains up-to-date metadata for all datasets. - - Missing fields default to "No label/description/source available." -2. **Run Script**: - - The `data-raw/create_adams_data.R` script dynamically retrieves metadata, enriches it with dataset attributes, and generates `.R` files in the `R/` directory. -3. **Generate Documentation**: - - Use `roxygen2::roxygenize()` to update `.Rd` files in the `man/` directory. +4. **Generates Dataset Documentation** + For every dataset, a matching `.R` file is created in the `R/` folder containing: + - Dataset name and title, + - Variable-level documentation (names and labels), + - Source information indicating which template and package generated it, + - Example usage with `data("")`. diff --git a/data-raw/create_adams_data.R b/data-raw/create_adams_data.R index baeb248..9e5c297 100644 --- a/data-raw/create_adams_data.R +++ b/data-raw/create_adams_data.R @@ -34,13 +34,12 @@ write_doc <- function(data, dataset_name, dataset_label, pkg, template_name) { # TODO: use metatools/metacore for doc ? dataset_label <- str_replace(dataset_label, "Hys Law", "Hy's Law") doc_string <- paste( - sprintf("# This file is automatically generated."), - sprintf("# Manual edits are not recommended, as changes may be overwritten."), - sprintf("#' %s", dataset_name), - "#'", - sprintf("#' %s", dataset_label), + "# This file is automatically generated by data-raw/create_adams_data.R.", + "# For updating it please edit inst/extdata/adams-specs.xlsx and rerun create_adams_data.R.", + "# Manual edits are not recommended, as changes may be overwritten.", "#'", sprintf("#' @name %s", dataset_name), + sprintf("#' @title %s", dataset_label), "#' @docType data", sprintf("#' @format A data frame with %s columns:", ncol(data)), "#' \\describe{", @@ -139,8 +138,8 @@ if (update_pkg) { # dict to match admiral xlsx specs suffixes suffixes_dict <- list("_ophtha" = "_P", "_onco" = "_O", "_vaccine" = "_V", "_peds" = "_E") mc <- metacore::spec_to_metacore("inst/extdata/adams-specs.xlsx", - where_sep_sheet = FALSE, - quiet = TRUE + where_sep_sheet = FALSE, + quiet = TRUE ) packages_list <- c("admiral", "admiralonco", "admiralophtha", "admiralvaccine", "admiralpeds") @@ -152,12 +151,12 @@ for (pkg in packages_list) { if (update_pkg) { # TODO: replace by main once done remotes::install_github(sprintf("pharmaverse/%s", pkg), - ref = "main", auth_token = if (github_pat == "") { - NULL - } else { - github_pat - }, - upgrade = "always", force = TRUE + ref = "main", auth_token = if (github_pat == "") { + NULL + } else { + github_pat + }, + upgrade = "always", force = TRUE ) } # get templates scripts diff --git a/data/adbcva_ophtha.rda b/data/adbcva_ophtha.rda index 31ee069..7db9f45 100644 Binary files a/data/adbcva_ophtha.rda and b/data/adbcva_ophtha.rda differ diff --git a/data/adeg.rda b/data/adeg.rda index b279692..8cbb70d 100644 Binary files a/data/adeg.rda and b/data/adeg.rda differ diff --git a/data/adoe_ophtha.rda b/data/adoe_ophtha.rda index 2e4e4af..97595c8 100644 Binary files a/data/adoe_ophtha.rda and b/data/adoe_ophtha.rda differ diff --git a/data/adpc.rda b/data/adpc.rda index a3a33c2..20046be 100644 Binary files a/data/adpc.rda and b/data/adpc.rda differ diff --git a/data/advs_peds.rda b/data/advs_peds.rda index 702bdae..c6831bd 100644 Binary files a/data/advs_peds.rda and b/data/advs_peds.rda differ diff --git a/inst/WORDLIST b/inst/WORDLIST index 016998e..737eaad 100644 --- a/inst/WORDLIST +++ b/inst/WORDLIST @@ -205,3 +205,5 @@ XLSX WORD CRANstatus tibble +Changelog +README diff --git a/inst/extdata/adams-specs.json b/inst/extdata/adams-specs.json new file mode 100644 index 0000000..e137bff --- /dev/null +++ b/inst/extdata/adams-specs.json @@ -0,0 +1,19925 @@ +{ + "Define": [ + { + "Attribute": "StudyName" + }, + { + "Attribute": "StudyDescription" + }, + { + "Attribute": "ProtocolName" + }, + { + "Attribute": "StandardName", + "Value": "ADaM-IG" + }, + { + "Attribute": "StandardVersion", + "Value": "1.1" + }, + { + "Attribute": "Language", + "Value": "en" + }, + { + "Attribute": "Legend", + "Value": "Highlighted cells are required for Define-XML 2.1 and can be ignored for prior versions." + }, + { + "Value": "Highlighted cells are used by ADaM only and can be left empty otherwise." + } + ], + "Datasets": [ + { + "Dataset": "ADAE", + "Label": "Adverse Events Analysis", + "Class": "OCCURRENCE DATA STRUCTURE", + "Structure": "One record per subject per adverse event", + "Key Variables": "STUDYID, USUBJID", + "Standard": "ADaM-IG 1.1", + "Has No Data": "No", + "Repeating": "Yes", + "Reference Data": "No" + }, + { + "Dataset": "ADBCVA_P", + "Label": "Best Corrected Visual Acuity Analysis", + "Class": "BASIC DATA STRUCTURE", + "Structure": "One or more records per subject per analysis parameter per analysis timepoint", + "Key Variables": "STUDYID, USUBJID, PARAM, PARAMCD, AVAL", + "Standard": "ADaM-IG 1.1", + "Has No Data": "No", + "Repeating": "Yes", + "Reference Data": "No" + }, + { + "Dataset": "ADCE_V", + "Label": "Clinical Events Analysis for Vaccine", + "Standard": "ADaM-IG 1.1", + "Has No Data": "No", + "Repeating": "Yes", + "Reference Data": "No" + }, + { + "Dataset": "ADCM", + "Label": "Concomitant Medications Analysis", + "Standard": "ADaM-IG 1.1", + "Has No Data": "No", + "Repeating": "Yes", + "Reference Data": "No" + }, + { + "Dataset": "ADEG", + "Label": "Electrocardiogram Tests Analysis", + "Class": "BASIC DATA STRUCTURE", + "Structure": "One or more records per subject per analysis parameter per analysis timepoint", + "Key Variables": "STUDYID, USUBJID, PARAM, PARAMCD, AVAL", + "Standard": "ADaM-IG 1.1", + "Has No Data": "No", + "Repeating": "Yes", + "Reference Data": "No" + }, + { + "Dataset": "ADEX", + "Label": "Exposure Analysis ", + "Class": "BASIC DATA STRUCTURE", + "Structure": "One or more records per subject per analysis parameter per analysis timepoint", + "Key Variables": "STUDYID, USUBJID, PARAM, PARAMCD, AVAL", + "Standard": "ADaM-IG 1.1", + "Has No Data": "No", + "Repeating": "Yes", + "Reference Data": "No" + }, + { + "Dataset": "ADFACE_V", + "Label": "Findings About Clinical Events Analysis", + "Class": "BASIC DATA STRUCTURE", + "Structure": "One or more records per subject per analysis parameter per analysis timepoint", + "Key Variables": "STUDYID, USUBJID, PARAM, PARAMCD, AVAL", + "Standard": "ADaM-IG 1.1", + "Has No Data": "No", + "Repeating": "Yes", + "Reference Data": "No" + }, + { + "Dataset": "ADIS_V", + "Label": "Immunogenicity Specimen Assessments", + "Class": "BASIC DATA STRUCTURE", + "Structure": "One or more records per subject per analysis parameter per analysis timepoint", + "Key Variables": "STUDYID, USUBJID, PARAM, PARAMCD, AVAL", + "Standard": "ADaM-IG 1.1", + "Has No Data": "No", + "Repeating": "Yes", + "Reference Data": "No" + }, + { + "Dataset": "ADLB", + "Label": "Laboratory Analysis", + "Class": "BASIC DATA STRUCTURE", + "Structure": "One or more records per subject per analysis parameter per analysis timepoint", + "Key Variables": "STUDYID, USUBJID, PARAM, PARAMCD, AVAL", + "Standard": "ADaM-IG 1.1", + "Has No Data": "No", + "Repeating": "Yes", + "Reference Data": "No" + }, + { + "Dataset": "ADLBHY", + "Label": "Analysis of Lab Hys Law", + "Class": "BASIC DATA STRUCTURE", + "Structure": "One or more records per subject per analysis parameter per analysis timepoint", + "Key Variables": "STUDYID, USUBJID, PARAM, PARAMCD, AVAL", + "Standard": "ADaM-IG 1.1", + "Has No Data": "No", + "Repeating": "Yes", + "Reference Data": "No" + }, + { + "Dataset": "ADMH", + "Label": "Medical History Analysis", + "Standard": "ADaM-IG 1.1", + "Has No Data": "No", + "Repeating": "Yes", + "Reference Data": "No" + }, + { + "Dataset": "ADOE_P", + "Label": "Exam Analysis for Ophthalmology", + "Class": "BASIC DATA STRUCTURE", + "Structure": "One or more records per subject per analysis parameter per analysis timepoint", + "Key Variables": "STUDYID, USUBJID, PARAM, PARAMCD, AVAL", + "Standard": "ADaM-IG 1.1", + "Has No Data": "No", + "Repeating": "Yes", + "Reference Data": "No" + }, + { + "Dataset": "ADPC", + "Label": "Pharmacokinetic Concentrations", + "Class": "BASIC DATA STRUCTURE", + "Structure": "One or more records per subject per analysis parameter per analysis timepoint", + "Key Variables": "STUDYID, USUBJID, PARAM, PARAMCD, AVAL", + "Standard": "ADaM-IG 1.1", + "Has No Data": "No", + "Repeating": "Yes", + "Reference Data": "No" + }, + { + "Dataset": "ADPP", + "Label": " Pharmacokinetic Parameters", + "Class": "BASIC DATA STRUCTURE", + "Structure": "One or more records per subject per analysis parameter per analysis timepoint", + "Key Variables": "STUDYID, USUBJID, PARAMCD, AVAL", + "Standard": "ADaM-IG 1.1", + "Has No Data": "No", + "Repeating": "Yes", + "Reference Data": "No" + }, + { + "Dataset": "ADPPK", + "Label": "Population Pharmacokinetic", + "Standard": "ADaM-IG 1.1", + "Has No Data": "No", + "Repeating": "Yes", + "Reference Data": "No" + }, + { + "Dataset": "ADRS_O", + "Label": "Tumor Response Analysis", + "Class": "BASIC DATA STRUCTURE", + "Structure": "One or more records per subject per analysis parameter per analysis timepoint", + "Key Variables": "STUDYID, USUBJID, PARAM, PARAMCD, AVAL", + "Standard": "ADaM-IG 1.1", + "Has No Data": "No", + "Repeating": "Yes", + "Reference Data": "No" + }, + { + "Dataset": "ADSL", + "Label": "Subject Level Analysis ", + "Class": "SUBJECT LEVEL ANALYSIS DATASET", + "Structure": "One record per subject", + "Key Variables": "STUDYID, USUBJID", + "Standard": "ADaM-IG 1.1", + "Has No Data": "No", + "Repeating": "Yes", + "Reference Data": "No" + }, + { + "Dataset": "ADSL_V", + "Label": "Subject Level Analysis for Vaccine", + "Standard": "ADaM-IG 1.1", + "Has No Data": "No", + "Repeating": "Yes", + "Reference Data": "No" + }, + { + "Dataset": "ADTR_O", + "Label": "Tumor Results Analysis for Oncology", + "Class": "BASIC DATA STRUCTURE", + "Structure": "One or more records per subject per analysis parameter per analysis timepoint", + "Key Variables": "STUDYID, USUBJID, PARAM, PARAMCD, AVAL", + "Standard": "ADaM-IG 1.1", + "Has No Data": "No", + "Repeating": "Yes", + "Reference Data": "No" + }, + { + "Dataset": "ADTTE_O", + "Label": "Time to Event Analysis for Oncology", + "Class": "BASIC DATA STRUCTURE", + "Structure": "One or more records per subject per analysis parameter per analysis timepoint", + "Key Variables": "STUDYID, USUBJID, PARAM, PARAMCD, AVAL", + "Standard": "ADaM-IG 1.1", + "Has No Data": "No", + "Repeating": "Yes", + "Reference Data": "No" + }, + { + "Dataset": "ADVFQ_P", + "Label": "Visual Function Questionnaire Analysis", + "Class": "BASIC DATA STRUCTURE", + "Structure": "One or more records per subject per analysis parameter per analysis timepoint", + "Key Variables": "STUDYID, USUBJID, PARAM, PARAMCD, AVAL", + "Standard": "ADaM-IG 1.1", + "Has No Data": "No", + "Repeating": "Yes", + "Reference Data": "No" + }, + { + "Dataset": "ADVS", + "Label": "Vital Signs Analysis", + "Class": "BASIC DATA STRUCTURE", + "Structure": "One or more records per subject per analysis parameter per analysis timepoint", + "Key Variables": "STUDYID, USUBJID, PARAM, PARAMCD, AVAL", + "Standard": "ADaM-IG 1.1", + "Has No Data": "No", + "Repeating": "Yes", + "Reference Data": "No" + }, + { + "Dataset": "ADVS_E", + "Label": "Vital Signs Analysis for Pediatrics", + "Class": "BASIC DATA STRUCTURE", + "Structure": "One or more records per subject per analysis parameter per analysis timepoint", + "Key Variables": "STUDYID, USUBJID, PARAM, PARAMCD, AVAL", + "Standard": "ADaM-IG 1.1", + "Has No Data": "No", + "Repeating": "Yes", + "Reference Data": "No" + } + ], + "Variables": [ + { + "Order": "1", + "Dataset": "ADAE", + "Variable": "STUDYID", + "Label": "Study Identifier", + "Data Type": "text", + "Length": "12", + "Mandatory": "Yes", + "Role": "OCCDS Identifier Variables", + "Has No Data": "No" + }, + { + "Order": "2", + "Dataset": "ADAE", + "Variable": "DOMAIN", + "Label": "Domain Abbreviation", + "Data Type": "text", + "Length": "2", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "3", + "Dataset": "ADAE", + "Variable": "USUBJID", + "Label": "Unique Subject Identifier", + "Data Type": "text", + "Length": "11", + "Mandatory": "Yes", + "Role": "OCCDS Identifier Variables", + "Has No Data": "No" + }, + { + "Order": "4", + "Dataset": "ADAE", + "Variable": "AESEQ", + "Label": "Sequence Number", + "Data Type": "integer", + "Length": "8", + "Mandatory": "Yes", + "Role": "OCCDS Identifier Variables", + "Has No Data": "No" + }, + { + "Order": "5", + "Dataset": "ADAE", + "Variable": "AESPID", + "Label": "Sponsor-Defined Identifier", + "Data Type": "text", + "Length": "3", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "6", + "Dataset": "ADAE", + "Variable": "AETERM", + "Label": "Reported Term for the Adverse Event", + "Data Type": "text", + "Length": "46", + "Mandatory": "Yes", + "Role": "MedDRA Dictionary Coding Variables", + "Has No Data": "No" + }, + { + "Order": "7", + "Dataset": "ADAE", + "Variable": "AELLT", + "Label": "Lowest Level Term", + "Data Type": "text", + "Length": "46", + "Mandatory": "No", + "Role": "MedDRA Dictionary Coding Variables", + "Has No Data": "No" + }, + { + "Order": "8", + "Dataset": "ADAE", + "Variable": "AELLTCD", + "Label": "Lowest Level Term Code", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "MedDRA Dictionary Coding Variables", + "Has No Data": "No" + }, + { + "Order": "9", + "Dataset": "ADAE", + "Variable": "AEDECOD", + "Label": "Dictionary-Derived Term", + "Data Type": "text", + "Length": "46", + "Mandatory": "No", + "Role": "MedDRA Dictionary Coding Variables", + "Has No Data": "No" + }, + { + "Order": "10", + "Dataset": "ADAE", + "Variable": "AEPTCD", + "Label": "Preferred Term Code", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "MedDRA Dictionary Coding Variables", + "Has No Data": "No" + }, + { + "Order": "11", + "Dataset": "ADAE", + "Variable": "AEHLT", + "Label": "High Level Term", + "Data Type": "text", + "Length": "8", + "Mandatory": "No", + "Role": "MedDRA Dictionary Coding Variables", + "Has No Data": "No" + }, + { + "Order": "12", + "Dataset": "ADAE", + "Variable": "AEHLTCD", + "Label": "High Level Term Code", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "MedDRA Dictionary Coding Variables", + "Has No Data": "No" + }, + { + "Order": "13", + "Dataset": "ADAE", + "Variable": "AEHLGT", + "Label": "High Level Group Term", + "Data Type": "text", + "Length": "9", + "Mandatory": "No", + "Role": "MedDRA Dictionary Coding Variables", + "Has No Data": "No" + }, + { + "Order": "14", + "Dataset": "ADAE", + "Variable": "AEHLGTCD", + "Label": "High Level Group Term Code", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "MedDRA Dictionary Coding Variables", + "Has No Data": "No" + }, + { + "Order": "15", + "Dataset": "ADAE", + "Variable": "AEBODSYS", + "Label": "Body System or Organ Class", + "Data Type": "text", + "Length": "67", + "Mandatory": "No", + "Role": "MedDRA Dictionary Coding Variables", + "Has No Data": "No" + }, + { + "Order": "16", + "Dataset": "ADAE", + "Variable": "AEBDSYCD", + "Label": "Body System or Organ Class Code", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "MedDRA Dictionary Coding Variables", + "Has No Data": "No" + }, + { + "Order": "17", + "Dataset": "ADAE", + "Variable": "AESOC", + "Label": "Primary System Organ Class", + "Data Type": "text", + "Length": "67", + "Mandatory": "No", + "Role": "MedDRA Dictionary Coding Variables", + "Has No Data": "No" + }, + { + "Order": "18", + "Dataset": "ADAE", + "Variable": "AESOCCD", + "Label": "Primary System Organ Class Code", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "MedDRA Dictionary Coding Variables", + "Has No Data": "No" + }, + { + "Order": "19", + "Dataset": "ADAE", + "Variable": "AESEV", + "Label": "Severity/Intensity", + "Data Type": "text", + "Length": "8", + "Mandatory": "No", + "Role": "Adverse Event Descriptive Variables", + "Has No Data": "No" + }, + { + "Order": "20", + "Dataset": "ADAE", + "Variable": "AESER", + "Label": "Serious Event", + "Data Type": "text", + "Length": "1", + "Mandatory": "Yes", + "Role": "Adverse Event Descriptive Variables", + "Has No Data": "No" + }, + { + "Order": "21", + "Dataset": "ADAE", + "Variable": "AEACN", + "Label": "Action Taken with Study Treatment", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "Adverse Event Descriptive Variables", + "Has No Data": "No" + }, + { + "Order": "22", + "Dataset": "ADAE", + "Variable": "AEREL", + "Label": "Causality", + "Data Type": "text", + "Length": "8", + "Mandatory": "No", + "Role": "Adverse Event Descriptive Variables", + "Has No Data": "No" + }, + { + "Order": "23", + "Dataset": "ADAE", + "Variable": "AEOUT", + "Label": "Outcome of Adverse Event", + "Data Type": "text", + "Length": "26", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "24", + "Dataset": "ADAE", + "Variable": "AESCAN", + "Label": "Involves Cancer", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "25", + "Dataset": "ADAE", + "Variable": "AESCONG", + "Label": "Congenital Anomaly or Birth Defect", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "26", + "Dataset": "ADAE", + "Variable": "AESDISAB", + "Label": "Persist or Signif Disability/Incapacity", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "27", + "Dataset": "ADAE", + "Variable": "AESDTH", + "Label": "Results in Death", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "28", + "Dataset": "ADAE", + "Variable": "AESHOSP", + "Label": "Requires or Prolongs Hospitalization", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "29", + "Dataset": "ADAE", + "Variable": "AESLIFE", + "Label": "Is Life Threatening", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "30", + "Dataset": "ADAE", + "Variable": "AESOD", + "Label": "Occurred with Overdose", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "31", + "Dataset": "ADAE", + "Variable": "AEDTC", + "Label": "Date/Time of Collection", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "32", + "Dataset": "ADAE", + "Variable": "AESTDTC", + "Label": "Start Date/Time of Adverse Event", + "Data Type": "datetime", + "Mandatory": "No", + "Role": "Timing Variables", + "Has No Data": "No" + }, + { + "Order": "33", + "Dataset": "ADAE", + "Variable": "AEENDTC", + "Label": "End Date/Time of Adverse Event", + "Data Type": "datetime", + "Mandatory": "No", + "Role": "Timing Variables", + "Has No Data": "No" + }, + { + "Order": "34", + "Dataset": "ADAE", + "Variable": "AESTDY", + "Label": "Study Day of Start of Adverse Event", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Timing Variables", + "Has No Data": "No" + }, + { + "Order": "35", + "Dataset": "ADAE", + "Variable": "AEENDY", + "Label": "Study Day of End of Adverse Event", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Timing Variables", + "Has No Data": "No" + }, + { + "Order": "36", + "Dataset": "ADAE", + "Variable": "TRTSDT", + "Label": "Date of First Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "37", + "Dataset": "ADAE", + "Variable": "TRTEDT", + "Label": "Date of Last Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "38", + "Dataset": "ADAE", + "Variable": "DTHDT", + "Label": "Date of Death", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "39", + "Dataset": "ADAE", + "Variable": "EOSDT", + "Label": "End of Study Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "40", + "Dataset": "ADAE", + "Variable": "ASTDTM", + "Label": "Analysis Start Date/Time", + "Data Type": "integer", + "Length": "8", + "Format": "DATETIME", + "Mandatory": "No", + "Role": "Timing Variables", + "Has No Data": "No" + }, + { + "Order": "41", + "Dataset": "ADAE", + "Variable": "ASTDTF", + "Label": "Analysis Start Date Imputation Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "Timing Variables", + "Has No Data": "No" + }, + { + "Order": "42", + "Dataset": "ADAE", + "Variable": "ASTTMF", + "Label": "Analysis Start Time Imputation Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "Timing Variables", + "Has No Data": "No" + }, + { + "Order": "43", + "Dataset": "ADAE", + "Variable": "AENDTM", + "Label": "Analysis End Date/Time", + "Data Type": "integer", + "Length": "8", + "Format": "DATETIME", + "Mandatory": "No", + "Role": "Timing Variables", + "Has No Data": "No" + }, + { + "Order": "44", + "Dataset": "ADAE", + "Variable": "AENDTF", + "Label": "Analysis End Date Imputation Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "Timing Variables", + "Has No Data": "No" + }, + { + "Order": "45", + "Dataset": "ADAE", + "Variable": "AENTMF", + "Label": "Analysis End Time Imputation Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "Timing Variables", + "Has No Data": "No" + }, + { + "Order": "46", + "Dataset": "ADAE", + "Variable": "ASTDT", + "Label": "Analysis Start Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "Timing Variables", + "Has No Data": "No" + }, + { + "Order": "47", + "Dataset": "ADAE", + "Variable": "AENDT", + "Label": "Analysis End Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "Timing Variables", + "Has No Data": "No" + }, + { + "Order": "48", + "Dataset": "ADAE", + "Variable": "ASTDY", + "Label": "Analysis Start Relative Day", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Timing Variables", + "Has No Data": "No" + }, + { + "Order": "49", + "Dataset": "ADAE", + "Variable": "AENDY", + "Label": "Analysis End Relative Day", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Timing Variables", + "Has No Data": "No" + }, + { + "Order": "50", + "Dataset": "ADAE", + "Variable": "ADURN", + "Label": "Analysis Duration (N)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Timing Variables", + "Has No Data": "No" + }, + { + "Order": "51", + "Dataset": "ADAE", + "Variable": "ADURU", + "Label": "Analysis Duration Units", + "Data Type": "text", + "Length": "4", + "Mandatory": "No", + "Role": "Timing Variables", + "Has No Data": "No" + }, + { + "Order": "52", + "Dataset": "ADAE", + "Variable": "LDOSEDTM", + "Label": "End Date/Time of Last Dose", + "Data Type": "integer", + "Length": "8", + "Format": "DATETIME", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "53", + "Dataset": "ADAE", + "Variable": "ASEV", + "Label": "Analysis Severity/Intensity", + "Data Type": "text", + "Length": "8", + "Mandatory": "No", + "Role": "Adverse Event Descriptive Variables", + "Has No Data": "No" + }, + { + "Order": "54", + "Dataset": "ADAE", + "Variable": "AREL", + "Label": "Analysis Causality", + "Data Type": "text", + "Length": "8", + "Mandatory": "No", + "Role": "Adverse Event Descriptive Variables", + "Has No Data": "No" + }, + { + "Order": "55", + "Dataset": "ADAE", + "Variable": "TRTEMFL", + "Label": "Treatment Emergent Analysis Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "Adverse Events Indicator Variables", + "Has No Data": "No" + }, + { + "Order": "56", + "Dataset": "ADAE", + "Variable": "ASEVN", + "Label": "Analysis Severity/Intensity (N)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Adverse Event Descriptive Variables", + "Has No Data": "No" + }, + { + "Order": "57", + "Dataset": "ADAE", + "Variable": "AOCCIFL", + "Label": "1st Max Sev./Int. Occurrence Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "OCCDS Occurrence Flag Variables", + "Has No Data": "No" + }, + { + "Order": "58", + "Dataset": "ADAE", + "Variable": "SUBJID", + "Label": "Subject Identifier for the Study", + "Data Type": "text", + "Length": "4", + "Mandatory": "No", + "Role": "OCCDS Identifier Variables", + "Has No Data": "No" + }, + { + "Order": "59", + "Dataset": "ADAE", + "Variable": "RFSTDTC", + "Label": "Subject Reference Start Date/Time", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "60", + "Dataset": "ADAE", + "Variable": "RFENDTC", + "Label": "Subject Reference End Date/Time", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "61", + "Dataset": "ADAE", + "Variable": "RFXSTDTC", + "Label": "Date/Time of First Study Treatment", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "62", + "Dataset": "ADAE", + "Variable": "RFXENDTC", + "Label": "Date/Time of Last Study Treatment", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "63", + "Dataset": "ADAE", + "Variable": "RFICDTC", + "Label": "Date/Time of Informed Consent", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "64", + "Dataset": "ADAE", + "Variable": "RFPENDTC", + "Label": "Date/Time of End of Participation", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "65", + "Dataset": "ADAE", + "Variable": "DTHDTC", + "Label": "Date/Time of Death", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "66", + "Dataset": "ADAE", + "Variable": "DTHFL", + "Label": "Subject Death Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "67", + "Dataset": "ADAE", + "Variable": "SITEID", + "Label": "Study Site Identifier", + "Data Type": "text", + "Length": "3", + "Mandatory": "No", + "Role": "OCCDS Identifier Variables", + "Has No Data": "No" + }, + { + "Order": "68", + "Dataset": "ADAE", + "Variable": "AGE", + "Label": "Age", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "ADSL Subject Demographics Variables", + "Has No Data": "No" + }, + { + "Order": "69", + "Dataset": "ADAE", + "Variable": "AGEU", + "Label": "Age Units", + "Data Type": "text", + "Length": "5", + "Mandatory": "No", + "Role": "ADSL Subject Demographics Variables", + "Has No Data": "No" + }, + { + "Order": "70", + "Dataset": "ADAE", + "Variable": "SEX", + "Label": "Sex", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "ADSL Subject Demographics Variables", + "Has No Data": "No" + }, + { + "Order": "71", + "Dataset": "ADAE", + "Variable": "RACE", + "Label": "Race", + "Data Type": "text", + "Length": "32", + "Mandatory": "No", + "Role": "ADSL Subject Demographics Variables", + "Has No Data": "No" + }, + { + "Order": "72", + "Dataset": "ADAE", + "Variable": "ETHNIC", + "Label": "Ethnicity", + "Data Type": "text", + "Length": "22", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "73", + "Dataset": "ADAE", + "Variable": "ARMCD", + "Label": "Planned Arm Code", + "Data Type": "text", + "Length": "6", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "74", + "Dataset": "ADAE", + "Variable": "ARM", + "Label": "Description of Planned Arm", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Role": "ADSL Treatment Variables", + "Has No Data": "No" + }, + { + "Order": "75", + "Dataset": "ADAE", + "Variable": "ACTARMCD", + "Label": "Actual Arm Code", + "Data Type": "text", + "Length": "6", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "76", + "Dataset": "ADAE", + "Variable": "ACTARM", + "Label": "Description of Actual Arm", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Role": "ADSL Treatment Variables", + "Has No Data": "No" + }, + { + "Order": "77", + "Dataset": "ADAE", + "Variable": "COUNTRY", + "Label": "Country", + "Data Type": "text", + "Length": "3", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "78", + "Dataset": "ADAE", + "Variable": "DMDTC", + "Label": "Date/Time of Collection", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "79", + "Dataset": "ADAE", + "Variable": "DMDY", + "Label": "Study Day of Collection", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "80", + "Dataset": "ADAE", + "Variable": "TRT01P", + "Label": "Planned Treatment for Period 01", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "81", + "Dataset": "ADAE", + "Variable": "TRT01A", + "Label": "Actual Treatment for Period 01", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "82", + "Dataset": "ADAE", + "Variable": "TRTSDTM", + "Label": "Datetime of First Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATETIME", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "83", + "Dataset": "ADAE", + "Variable": "TRTSTMF", + "Label": "Time of First Exposure Imput. Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "84", + "Dataset": "ADAE", + "Variable": "TRTEDTM", + "Label": "Datetime of Last Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATETIME", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "85", + "Dataset": "ADAE", + "Variable": "TRTETMF", + "Label": "Time of Last Exposure Imput. Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "86", + "Dataset": "ADAE", + "Variable": "TRTDURD", + "Label": "Total Treatment Duration (Days)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "87", + "Dataset": "ADAE", + "Variable": "SCRFDT", + "Label": "Screen Failure Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "88", + "Dataset": "ADAE", + "Variable": "EOSSTT", + "Label": "End of Study Status", + "Data Type": "text", + "Length": "12", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "89", + "Dataset": "ADAE", + "Variable": "FRVDT", + "Label": "Final Retrievel Visit Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "90", + "Dataset": "ADAE", + "Variable": "RANDDT", + "Label": "Date of Randomization", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "91", + "Dataset": "ADAE", + "Variable": "DTHADY", + "Label": "Relative Day of Death", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "92", + "Dataset": "ADAE", + "Variable": "LDDTHELD", + "Label": "Elapsed Days from Last Dose to Death", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "93", + "Dataset": "ADAE", + "Variable": "LSTALVDT", + "Label": "Date Last Known Alive", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "94", + "Dataset": "ADAE", + "Variable": "AGEGR1", + "Label": "Pooled Age Group 1", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "95", + "Dataset": "ADAE", + "Variable": "SAFFL", + "Label": "Safety Population Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "ADSL Population Indicator Variables", + "Has No Data": "No" + }, + { + "Order": "96", + "Dataset": "ADAE", + "Variable": "RACEGR1", + "Label": "Pooled Race Group 1", + "Data Type": "text", + "Length": "9", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "97", + "Dataset": "ADAE", + "Variable": "REGION1", + "Label": "Geographic Region 1", + "Data Type": "text", + "Length": "2", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "98", + "Dataset": "ADAE", + "Variable": "LDDTHGR1", + "Label": "Last Dose to Death - Days Elapsed Grp 1", + "Data Type": "text", + "Length": "5", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "99", + "Dataset": "ADAE", + "Variable": "DTH30FL", + "Label": "Death Within 30 Days of Last Trt Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "100", + "Dataset": "ADAE", + "Variable": "DTHA30FL", + "Label": "Death After 30 Days from Last Trt Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "101", + "Dataset": "ADAE", + "Variable": "DTHB30FL", + "Label": "Death Within 30 Days of First Trt Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "1", + "Dataset": "ADBCVA_P", + "Variable": "STUDYID", + "Label": "Study Identifier", + "Data Type": "text", + "Length": "12", + "Mandatory": "Yes", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "2", + "Dataset": "ADBCVA_P", + "Variable": "DOMAIN", + "Label": "Domain Abbreviation", + "Data Type": "text", + "Length": "2", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "3", + "Dataset": "ADBCVA_P", + "Variable": "USUBJID", + "Label": "Unique Subject Identifier", + "Data Type": "text", + "Length": "11", + "Mandatory": "Yes", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "4", + "Dataset": "ADBCVA_P", + "Variable": "OESEQ", + "Label": "Sequence Number", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "5", + "Dataset": "ADBCVA_P", + "Variable": "OECAT", + "Label": "Category for Ophthalmic Test or Exam", + "Data Type": "text", + "Length": "28", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "6", + "Dataset": "ADBCVA_P", + "Variable": "OESCAT", + "Label": "Subcategory for Ophthalmic Test or Exam", + "Data Type": "text", + "Length": "18", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "7", + "Dataset": "ADBCVA_P", + "Variable": "OEDTC", + "Label": "Date/Time of Collection", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "8", + "Dataset": "ADBCVA_P", + "Variable": "VISIT", + "Label": "Visit Name", + "Data Type": "text", + "Length": "11", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "9", + "Dataset": "ADBCVA_P", + "Variable": "VISITNUM", + "Label": "Visit Number", + "Data Type": "float", + "Length": "3", + "Significant Digits": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "10", + "Dataset": "ADBCVA_P", + "Variable": "VISITDY", + "Label": "Planned Study Day of Visit", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "11", + "Dataset": "ADBCVA_P", + "Variable": "OESTRESN", + "Label": "Numeric Result/Finding in Standard Units", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "12", + "Dataset": "ADBCVA_P", + "Variable": "OESTRESC", + "Label": "Character Result/Finding in Std Format", + "Data Type": "text", + "Length": "3", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "13", + "Dataset": "ADBCVA_P", + "Variable": "OEORRES", + "Label": "Result or Finding in Original Units", + "Data Type": "text", + "Length": "3", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "14", + "Dataset": "ADBCVA_P", + "Variable": "OETEST", + "Label": "Name of Ophthalmic Test or Exam", + "Data Type": "text", + "Length": "19", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "15", + "Dataset": "ADBCVA_P", + "Variable": "OETESTCD", + "Label": "Short Name of Ophthalmic Test or Exam", + "Data Type": "text", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "16", + "Dataset": "ADBCVA_P", + "Variable": "OETSTDTL", + "Label": "Ophthalmic Test or Exam Detail", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "17", + "Dataset": "ADBCVA_P", + "Variable": "OELAT", + "Label": "Laterality", + "Data Type": "text", + "Length": "5", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "18", + "Dataset": "ADBCVA_P", + "Variable": "OELOC", + "Label": "Location Used for the Measurement", + "Data Type": "text", + "Length": "3", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "19", + "Dataset": "ADBCVA_P", + "Variable": "OEDY", + "Label": "Study Day of Visit/Collection/Exam", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "20", + "Dataset": "ADBCVA_P", + "Variable": "OEMETHOD", + "Label": "Method of Test or Examination", + "Data Type": "text", + "Length": "15", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "21", + "Dataset": "ADBCVA_P", + "Variable": "OEORRESU", + "Label": "Original Units", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "22", + "Dataset": "ADBCVA_P", + "Variable": "OESTRESU", + "Label": "Standard Units", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "23", + "Dataset": "ADBCVA_P", + "Variable": "OESTAT", + "Label": "Completion Status", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "24", + "Dataset": "ADBCVA_P", + "Variable": "OETPT", + "Label": "Planned Time Point Name", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "25", + "Dataset": "ADBCVA_P", + "Variable": "OETPTNUM", + "Label": "Planned Time Point Number", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "26", + "Dataset": "ADBCVA_P", + "Variable": "TRTSDT", + "Label": "Date of First Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "27", + "Dataset": "ADBCVA_P", + "Variable": "TRTEDT", + "Label": "Date of Last Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "28", + "Dataset": "ADBCVA_P", + "Variable": "TRT01A", + "Label": "Actual Treatment for Period 01", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "29", + "Dataset": "ADBCVA_P", + "Variable": "TRT01P", + "Label": "Planned Treatment for Period 01", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "30", + "Dataset": "ADBCVA_P", + "Variable": "STUDYEYE", + "Label": "Study Eye Location", + "Data Type": "text", + "Length": "5", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "31", + "Dataset": "ADBCVA_P", + "Variable": "AVAL", + "Label": "Analysis Value", + "Data Type": "float", + "Length": "4", + "Significant Digits": "2", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "32", + "Dataset": "ADBCVA_P", + "Variable": "AVALU", + "Label": "Analysis Value Unit", + "Data Type": "text", + "Length": "7", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "33", + "Dataset": "ADBCVA_P", + "Variable": "DTYPE", + "Label": "Derivation Type", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "Analysis Descriptor Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "34", + "Dataset": "ADBCVA_P", + "Variable": "AFEYE", + "Label": "Affected Eye", + "Data Type": "text", + "Length": "10", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "35", + "Dataset": "ADBCVA_P", + "Variable": "PARAM", + "Label": "Parameter", + "Data Type": "text", + "Length": "40", + "Mandatory": "Yes", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "36", + "Dataset": "ADBCVA_P", + "Variable": "PARAMCD", + "Label": "Parameter Code", + "Data Type": "text", + "Length": "8", + "Mandatory": "Yes", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "37", + "Dataset": "ADBCVA_P", + "Variable": "AVALC", + "Label": "Analysis Value (C)", + "Data Type": "text", + "Length": "19", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "38", + "Dataset": "ADBCVA_P", + "Variable": "ADT", + "Label": "Analysis Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "39", + "Dataset": "ADBCVA_P", + "Variable": "ADY", + "Label": "Analysis Relative Day", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "40", + "Dataset": "ADBCVA_P", + "Variable": "ATPTN", + "Label": "Analysis Timepoint (N)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "41", + "Dataset": "ADBCVA_P", + "Variable": "ATPT", + "Label": "Analysis Timepoint", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "42", + "Dataset": "ADBCVA_P", + "Variable": "AVISIT", + "Label": "Analysis Visit", + "Data Type": "text", + "Length": "11", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "43", + "Dataset": "ADBCVA_P", + "Variable": "AVISITN", + "Label": "Analysis Visit (N)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "44", + "Dataset": "ADBCVA_P", + "Variable": "BASETYPE", + "Label": "Baseline Type", + "Data Type": "text", + "Length": "4", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "45", + "Dataset": "ADBCVA_P", + "Variable": "ONTRTFL", + "Label": "On Treatment Record Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "Flag Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "46", + "Dataset": "ADBCVA_P", + "Variable": "ABLFL", + "Label": "Baseline Record Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "Flag Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "47", + "Dataset": "ADBCVA_P", + "Variable": "ANL01FL", + "Label": "Analysis Flag 01", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "48", + "Dataset": "ADBCVA_P", + "Variable": "ANL02FL", + "Label": "Analysis Flag 02", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "49", + "Dataset": "ADBCVA_P", + "Variable": "WORS01FL", + "Label": "Worst Post Baseline Obs", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "50", + "Dataset": "ADBCVA_P", + "Variable": "BASE", + "Label": "Baseline Value", + "Data Type": "float", + "Length": "4", + "Significant Digits": "2", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "51", + "Dataset": "ADBCVA_P", + "Variable": "BASEC", + "Label": "Baseline Value (C)", + "Data Type": "text", + "Length": "19", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "52", + "Dataset": "ADBCVA_P", + "Variable": "CHG", + "Label": "Change from Baseline", + "Data Type": "float", + "Length": "4", + "Significant Digits": "2", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "53", + "Dataset": "ADBCVA_P", + "Variable": "PCHG", + "Label": "Percent Change from Baseline", + "Data Type": "float", + "Length": "13", + "Significant Digits": "8", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "54", + "Dataset": "ADBCVA_P", + "Variable": "ASEQ", + "Label": "Analysis Sequence Number", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "55", + "Dataset": "ADBCVA_P", + "Variable": "SUBJID", + "Label": "Subject Identifier for the Study", + "Data Type": "text", + "Length": "4", + "Mandatory": "No", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "56", + "Dataset": "ADBCVA_P", + "Variable": "RFSTDTC", + "Label": "Subject Reference Start Date/Time", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "57", + "Dataset": "ADBCVA_P", + "Variable": "RFENDTC", + "Label": "Subject Reference End Date/Time", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "58", + "Dataset": "ADBCVA_P", + "Variable": "RFXSTDTC", + "Label": "Date/Time of First Study Treatment", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "59", + "Dataset": "ADBCVA_P", + "Variable": "RFXENDTC", + "Label": "Date/Time of Last Study Treatment", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "60", + "Dataset": "ADBCVA_P", + "Variable": "RFICDTC", + "Label": "Date/Time of Informed Consent", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "61", + "Dataset": "ADBCVA_P", + "Variable": "RFPENDTC", + "Label": "Date/Time of End of Participation", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "62", + "Dataset": "ADBCVA_P", + "Variable": "DTHDTC", + "Label": "Date/Time of Death", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "63", + "Dataset": "ADBCVA_P", + "Variable": "DTHFL", + "Label": "Subject Death Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "64", + "Dataset": "ADBCVA_P", + "Variable": "SITEID", + "Label": "Study Site Identifier", + "Data Type": "text", + "Length": "3", + "Mandatory": "No", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "65", + "Dataset": "ADBCVA_P", + "Variable": "AGE", + "Label": "Age", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "ADSL Subject Demographics Variables", + "Has No Data": "No" + }, + { + "Order": "66", + "Dataset": "ADBCVA_P", + "Variable": "AGEU", + "Label": "Age Units", + "Data Type": "text", + "Length": "5", + "Mandatory": "No", + "Role": "ADSL Subject Demographics Variables", + "Has No Data": "No" + }, + { + "Order": "67", + "Dataset": "ADBCVA_P", + "Variable": "SEX", + "Label": "Sex", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "ADSL Subject Demographics Variables", + "Has No Data": "No" + }, + { + "Order": "68", + "Dataset": "ADBCVA_P", + "Variable": "RACE", + "Label": "Race", + "Data Type": "text", + "Length": "32", + "Mandatory": "No", + "Role": "ADSL Subject Demographics Variables", + "Has No Data": "No" + }, + { + "Order": "69", + "Dataset": "ADBCVA_P", + "Variable": "ETHNIC", + "Label": "Ethnicity", + "Data Type": "text", + "Length": "22", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "70", + "Dataset": "ADBCVA_P", + "Variable": "ARMCD", + "Label": "Planned Arm Code", + "Data Type": "text", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "71", + "Dataset": "ADBCVA_P", + "Variable": "ARM", + "Label": "Description of Planned Arm", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Role": "ADSL Treatment Variables", + "Has No Data": "No" + }, + { + "Order": "72", + "Dataset": "ADBCVA_P", + "Variable": "ACTARMCD", + "Label": "Actual Arm Code", + "Data Type": "text", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "73", + "Dataset": "ADBCVA_P", + "Variable": "ACTARM", + "Label": "Description of Actual Arm", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Role": "ADSL Treatment Variables", + "Has No Data": "No" + }, + { + "Order": "74", + "Dataset": "ADBCVA_P", + "Variable": "COUNTRY", + "Label": "Country/Region", + "Data Type": "text", + "Length": "3", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "75", + "Dataset": "ADBCVA_P", + "Variable": "DMDTC", + "Label": "Date/Time of Collection", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "76", + "Dataset": "ADBCVA_P", + "Variable": "DMDY", + "Label": "Study Day of Collection", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "77", + "Dataset": "ADBCVA_P", + "Variable": "TRTSDTM", + "Label": "Datetime of First Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATETIME", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "78", + "Dataset": "ADBCVA_P", + "Variable": "TRTSTMF", + "Label": "Time of First Exposure Imput. Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "79", + "Dataset": "ADBCVA_P", + "Variable": "TRTEDTM", + "Label": "Datetime of Last Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATETIME", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "80", + "Dataset": "ADBCVA_P", + "Variable": "TRTETMF", + "Label": "Time of Last Exposure Imput. Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "81", + "Dataset": "ADBCVA_P", + "Variable": "TRTDURD", + "Label": "Total Treatment Duration (Days)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "82", + "Dataset": "ADBCVA_P", + "Variable": "SCRFDT", + "Label": "Screen Failure Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "83", + "Dataset": "ADBCVA_P", + "Variable": "EOSDT", + "Label": "End of Study Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "84", + "Dataset": "ADBCVA_P", + "Variable": "EOSSTT", + "Label": "End of Study Status", + "Data Type": "text", + "Length": "12", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "85", + "Dataset": "ADBCVA_P", + "Variable": "FRVDT", + "Label": "Final Retrievel Visit Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "86", + "Dataset": "ADBCVA_P", + "Variable": "RANDDT", + "Label": "Date of Randomization", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "87", + "Dataset": "ADBCVA_P", + "Variable": "DTHDT", + "Label": "Date of Death", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "88", + "Dataset": "ADBCVA_P", + "Variable": "DTHADY", + "Label": "Relative Day of Death", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "89", + "Dataset": "ADBCVA_P", + "Variable": "LDDTHELD", + "Label": "Elapsed Days from Last Dose to Death", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "90", + "Dataset": "ADBCVA_P", + "Variable": "LSTALVDT", + "Label": "Date Last Known Alive", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "91", + "Dataset": "ADBCVA_P", + "Variable": "AGEGR1", + "Label": "Pooled Age Group 1", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "92", + "Dataset": "ADBCVA_P", + "Variable": "SAFFL", + "Label": "Safety Population Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "ADSL Population Indicator Variables", + "Has No Data": "No" + }, + { + "Order": "93", + "Dataset": "ADBCVA_P", + "Variable": "RACEGR1", + "Label": "Pooled Race Group 1", + "Data Type": "text", + "Length": "9", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "94", + "Dataset": "ADBCVA_P", + "Variable": "REGION1", + "Label": "Geographic Region 1", + "Data Type": "text", + "Length": "2", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "95", + "Dataset": "ADBCVA_P", + "Variable": "LDDTHGR1", + "Label": "Last Dose to Death - Days Elapsed Grp 1", + "Data Type": "text", + "Length": "5", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "96", + "Dataset": "ADBCVA_P", + "Variable": "DTH30FL", + "Label": "Death Within 30 Days of Last Trt Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "97", + "Dataset": "ADBCVA_P", + "Variable": "DTHA30FL", + "Label": "Death After 30 Days from Last Trt Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "98", + "Dataset": "ADBCVA_P", + "Variable": "DTHB30FL", + "Label": "Death Within 30 Days of First Trt Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "99", + "Dataset": "ADBCVA_P", + "Variable": "CRIT1", + "Label": "Analysis Criterion 1", + "Data Type": "text", + "Length": "13", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "100", + "Dataset": "ADBCVA_P", + "Variable": "CRIT1FL", + "Label": "Criterion 1 Evaluation Result Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "101", + "Dataset": "ADBCVA_P", + "Variable": "CRIT2", + "Label": "Analysis Criterion 2", + "Data Type": "text", + "Length": "15", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "102", + "Dataset": "ADBCVA_P", + "Variable": "CRIT2FL", + "Label": "Criterion 2 Evaluation Result Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "103", + "Dataset": "ADBCVA_P", + "Variable": "CRIT3", + "Label": "Analysis Criterion 3", + "Data Type": "text", + "Length": "15", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "104", + "Dataset": "ADBCVA_P", + "Variable": "CRIT3FL", + "Label": "Criterion 3 Evaluation Result Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "105", + "Dataset": "ADBCVA_P", + "Variable": "CRIT4", + "Label": "Analysis Criterion 4", + "Data Type": "text", + "Length": "10", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "106", + "Dataset": "ADBCVA_P", + "Variable": "CRIT4FL", + "Label": "Criterion 4 Evaluation Result Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "107", + "Dataset": "ADBCVA_P", + "Variable": "CRIT5", + "Label": "Analysis Criterion 5", + "Data Type": "text", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "108", + "Dataset": "ADBCVA_P", + "Variable": "CRIT5FL", + "Label": "Criterion 5 Evaluation Result Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "109", + "Dataset": "ADBCVA_P", + "Variable": "CRIT6", + "Label": "Analysis Criterion 6", + "Data Type": "text", + "Length": "9", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "110", + "Dataset": "ADBCVA_P", + "Variable": "CRIT6FL", + "Label": "Criterion 6 Evaluation Result Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "111", + "Dataset": "ADBCVA_P", + "Variable": "CRIT7", + "Label": "Analysis Criterion 7", + "Data Type": "text", + "Length": "10", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "112", + "Dataset": "ADBCVA_P", + "Variable": "CRIT7FL", + "Label": "Criterion 7 Evaluation Result Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "113", + "Dataset": "ADBCVA_P", + "Variable": "CRIT8", + "Label": "Analysis Criterion 8", + "Data Type": "text", + "Length": "9", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "114", + "Dataset": "ADBCVA_P", + "Variable": "CRIT8FL", + "Label": "Criterion 8 Evaluation Result Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "115", + "Dataset": "ADBCVA_P", + "Variable": "AVALCA1N", + "Label": "Analysis Value Category 1 (N)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "116", + "Dataset": "ADBCVA_P", + "Variable": "AVALCAT1", + "Label": "Analysis Value Category 1", + "Data Type": "text", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "1", + "Dataset": "ADCE_V", + "Variable": "STUDYID", + "Label": "Study Identifier", + "Data Type": "text", + "Length": "3", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "2", + "Dataset": "ADCE_V", + "Variable": "DOMAIN", + "Label": "Domain Abbreviation", + "Data Type": "text", + "Length": "2", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "3", + "Dataset": "ADCE_V", + "Variable": "USUBJID", + "Label": "Unique Subject Identifier", + "Data Type": "text", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "4", + "Dataset": "ADCE_V", + "Variable": "CESEQ", + "Label": "Sequence Number", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "5", + "Dataset": "ADCE_V", + "Variable": "CELNKID", + "Label": "Link ID", + "Data Type": "text", + "Length": "56", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "6", + "Dataset": "ADCE_V", + "Variable": "CELNKGRP", + "Label": "Link Group ID", + "Data Type": "text", + "Length": "43", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "7", + "Dataset": "ADCE_V", + "Variable": "CETERM", + "Label": "Reported Term for the Clinical Event", + "Data Type": "text", + "Length": "27", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "8", + "Dataset": "ADCE_V", + "Variable": "CEDECOD", + "Label": "Dictionary-Derived Term", + "Data Type": "text", + "Length": "19", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "9", + "Dataset": "ADCE_V", + "Variable": "CELAT", + "Label": "Laterality", + "Data Type": "text", + "Length": "4", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "10", + "Dataset": "ADCE_V", + "Variable": "CELOC", + "Label": "Location of Event", + "Data Type": "text", + "Length": "14", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "11", + "Dataset": "ADCE_V", + "Variable": "CECAT", + "Label": "Category for the Clinical Event", + "Data Type": "text", + "Length": "14", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "12", + "Dataset": "ADCE_V", + "Variable": "CESCAT", + "Label": "Subcategory for the Clinical Event", + "Data Type": "text", + "Length": "19", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "13", + "Dataset": "ADCE_V", + "Variable": "CEPRESP", + "Label": "Clinical Event Pre-specified", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "14", + "Dataset": "ADCE_V", + "Variable": "CEOCCUR", + "Label": "Clinical Event Occurrence", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "15", + "Dataset": "ADCE_V", + "Variable": "CESEV", + "Label": "Severity/Intensity", + "Data Type": "text", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "16", + "Dataset": "ADCE_V", + "Variable": "CEREL", + "Label": "Causality", + "Data Type": "text", + "Length": "7", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "17", + "Dataset": "ADCE_V", + "Variable": "CEOUT", + "Label": "Outcome of Event", + "Data Type": "text", + "Length": "18", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "18", + "Dataset": "ADCE_V", + "Variable": "EPOCH", + "Label": "Epoch", + "Data Type": "text", + "Length": "13", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "19", + "Dataset": "ADCE_V", + "Variable": "CEDTC", + "Label": "Date/Time of Event Collection", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "20", + "Dataset": "ADCE_V", + "Variable": "CESTDTC", + "Label": "Start Date/Time of Clinical Event", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "21", + "Dataset": "ADCE_V", + "Variable": "CEENDTC", + "Label": "End Date/Time of Clinical Event", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "22", + "Dataset": "ADCE_V", + "Variable": "CEDUR", + "Label": "Duration of Clinical Event", + "Data Type": "text", + "Length": "3", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "23", + "Dataset": "ADCE_V", + "Variable": "CETPT", + "Label": "Planned Time Point Name", + "Data Type": "text", + "Length": "5", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "24", + "Dataset": "ADCE_V", + "Variable": "CETPTNUM", + "Label": "Planned Time Point Number", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "25", + "Dataset": "ADCE_V", + "Variable": "CETPTREF", + "Label": "Time Point Reference", + "Data Type": "text", + "Length": "13", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "26", + "Dataset": "ADCE_V", + "Variable": "CERFTDTC", + "Label": "Date/Time of Reference Time Point", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "27", + "Dataset": "ADCE_V", + "Variable": "CEEVINTX", + "Label": "Evaluation Interval Text", + "Data Type": "text", + "Length": "17", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "28", + "Dataset": "ADCE_V", + "Variable": "CESTAT", + "Label": "Completion Status", + "Data Type": "text", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "29", + "Dataset": "ADCE_V", + "Variable": "CEREASND", + "Label": "Reason Clinical Event Not Collected", + "Data Type": "text", + "Length": "41", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "30", + "Dataset": "ADCE_V", + "Variable": "TRTSDT", + "Label": "Date of First Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "31", + "Dataset": "ADCE_V", + "Variable": "TRTEDT", + "Label": "Date of Last Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "32", + "Dataset": "ADCE_V", + "Variable": "ASTDT", + "Label": "Analysis Start Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "33", + "Dataset": "ADCE_V", + "Variable": "AENDT", + "Label": "Analysis End Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "34", + "Dataset": "ADCE_V", + "Variable": "ASTDY", + "Label": "Analysis Start Relative Day", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "35", + "Dataset": "ADCE_V", + "Variable": "AENDY", + "Label": "Analysis End Relative Day", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "36", + "Dataset": "ADCE_V", + "Variable": "APERIOD", + "Label": "Period", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "37", + "Dataset": "ADCE_V", + "Variable": "APERSDT", + "Label": "Period Start Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "38", + "Dataset": "ADCE_V", + "Variable": "APEREDT", + "Label": "Period End Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "39", + "Dataset": "ADCE_V", + "Variable": "APERSTDY", + "Label": "Analysis Sub-period Start Relative Day ", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "40", + "Dataset": "ADCE_V", + "Variable": "AREL", + "Label": "Analysis Causality", + "Data Type": "text", + "Length": "7", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "41", + "Dataset": "ADCE_V", + "Variable": "ASEV", + "Label": "Analysis Severity/Intensity", + "Data Type": "text", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "42", + "Dataset": "ADCE_V", + "Variable": "ASEVN", + "Label": "Analysis Severity/Intensity (N)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "43", + "Dataset": "ADCE_V", + "Variable": "AOCC01FL", + "Label": "Event Occurrence Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "44", + "Dataset": "ADCE_V", + "Variable": "ASEQ", + "Label": "Analysis Sequence Number", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "45", + "Dataset": "ADCE_V", + "Variable": "ADURN", + "Label": "Analysis Duration (N)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "46", + "Dataset": "ADCE_V", + "Variable": "ADURU", + "Label": "Analysis Duration Units", + "Data Type": "text", + "Length": "4", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "47", + "Dataset": "ADCE_V", + "Variable": "TRT01A", + "Label": "Actual Treatment for Period 01", + "Data Type": "text", + "Length": "9", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "48", + "Dataset": "ADCE_V", + "Variable": "TRT01P", + "Label": "Planned Treatment for Period 01", + "Data Type": "text", + "Length": "9", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "49", + "Dataset": "ADCE_V", + "Variable": "AGE", + "Label": "Age", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "50", + "Dataset": "ADCE_V", + "Variable": "AGEU", + "Label": "Age Units", + "Data Type": "text", + "Length": "5", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "51", + "Dataset": "ADCE_V", + "Variable": "SEX", + "Label": "Sex", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "52", + "Dataset": "ADCE_V", + "Variable": "RACE", + "Label": "Race", + "Data Type": "text", + "Length": "25", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "53", + "Dataset": "ADCE_V", + "Variable": "COUNTRY", + "Label": "Country", + "Data Type": "text", + "Length": "3", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "54", + "Dataset": "ADCE_V", + "Variable": "ETHNIC", + "Label": "Ethnicity", + "Data Type": "text", + "Length": "22", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "55", + "Dataset": "ADCE_V", + "Variable": "SITEID", + "Label": "Study Site Identifier", + "Data Type": "text", + "Length": "4", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "56", + "Dataset": "ADCE_V", + "Variable": "SUBJID", + "Label": "Subject Identifier for the Study", + "Data Type": "text", + "Length": "4", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "1", + "Dataset": "ADCM", + "Variable": "STUDYID", + "Label": "Study Identifier", + "Data Type": "text", + "Length": "12", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "2", + "Dataset": "ADCM", + "Variable": "DOMAIN", + "Label": "Domain Abbreviation", + "Data Type": "text", + "Length": "2", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "3", + "Dataset": "ADCM", + "Variable": "USUBJID", + "Label": "Unique Subject Identifier", + "Data Type": "text", + "Length": "11", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "4", + "Dataset": "ADCM", + "Variable": "CMSEQ", + "Label": "Sequence Number", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "5", + "Dataset": "ADCM", + "Variable": "CMSPID", + "Label": "Sponsor-Defined Identifier", + "Data Type": "text", + "Length": "2", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "6", + "Dataset": "ADCM", + "Variable": "CMTRT", + "Label": "Reported Name of Drug, Med, or Therapy", + "Data Type": "text", + "Length": "44", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "7", + "Dataset": "ADCM", + "Variable": "CMDECOD", + "Label": "Standardized Medication Name", + "Data Type": "text", + "Length": "24", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "8", + "Dataset": "ADCM", + "Variable": "CMINDC", + "Label": "Indication", + "Data Type": "text", + "Length": "34", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "9", + "Dataset": "ADCM", + "Variable": "CMCLAS", + "Label": "Medication Class", + "Data Type": "text", + "Length": "42", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "10", + "Dataset": "ADCM", + "Variable": "CMDOSE", + "Label": "Dose per Administration", + "Data Type": "float", + "Length": "7", + "Significant Digits": "3", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "11", + "Dataset": "ADCM", + "Variable": "CMDOSU", + "Label": "Dose Units", + "Data Type": "text", + "Length": "7", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "12", + "Dataset": "ADCM", + "Variable": "CMDOSFRQ", + "Label": "Dosing Frequency per Interval", + "Data Type": "text", + "Length": "13", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "13", + "Dataset": "ADCM", + "Variable": "CMROUTE", + "Label": "Route of Administration", + "Data Type": "text", + "Length": "24", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "14", + "Dataset": "ADCM", + "Variable": "VISITNUM", + "Label": "Visit Number", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "15", + "Dataset": "ADCM", + "Variable": "VISIT", + "Label": "Visit Name", + "Data Type": "text", + "Length": "17", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "16", + "Dataset": "ADCM", + "Variable": "VISITDY", + "Label": "Planned Study Day of Visit", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "17", + "Dataset": "ADCM", + "Variable": "CMDTC", + "Label": "Date/Time of Collection", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "18", + "Dataset": "ADCM", + "Variable": "CMSTDTC", + "Label": "Start Date/Time of Medication", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "19", + "Dataset": "ADCM", + "Variable": "CMENDTC", + "Label": "End Date/Time of Medication", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "20", + "Dataset": "ADCM", + "Variable": "CMSTDY", + "Label": "Study Day of Start of Medication", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "21", + "Dataset": "ADCM", + "Variable": "CMENDY", + "Label": "Study Day of End of Medication", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "22", + "Dataset": "ADCM", + "Variable": "TRTSDT", + "Label": "Date of First Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "23", + "Dataset": "ADCM", + "Variable": "TRTEDT", + "Label": "Date of Last Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "24", + "Dataset": "ADCM", + "Variable": "DTHDT", + "Label": "Date of Death", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "25", + "Dataset": "ADCM", + "Variable": "EOSDT", + "Label": "End of Study Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "26", + "Dataset": "ADCM", + "Variable": "TRT01P", + "Label": "Planned Treatment for Period 01", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "27", + "Dataset": "ADCM", + "Variable": "TRT01A", + "Label": "Actual Treatment for Period 01", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "28", + "Dataset": "ADCM", + "Variable": "ASTDTM", + "Label": "Analysis Start Date/Time", + "Data Type": "integer", + "Length": "8", + "Format": "DATETIME", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "29", + "Dataset": "ADCM", + "Variable": "ASTDTF", + "Label": "Analysis Start Date Imputation Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "30", + "Dataset": "ADCM", + "Variable": "ASTTMF", + "Label": "Analysis Start Time Imputation Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "31", + "Dataset": "ADCM", + "Variable": "AENDTM", + "Label": "Analysis End Date/Time", + "Data Type": "integer", + "Length": "8", + "Format": "DATETIME", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "32", + "Dataset": "ADCM", + "Variable": "AENDTF", + "Label": "Analysis End Date Imputation Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "33", + "Dataset": "ADCM", + "Variable": "AENTMF", + "Label": "Analysis End Time Imputation Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "34", + "Dataset": "ADCM", + "Variable": "ASTDT", + "Label": "Analysis Start Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "35", + "Dataset": "ADCM", + "Variable": "AENDT", + "Label": "Analysis End Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "36", + "Dataset": "ADCM", + "Variable": "ASTDY", + "Label": "Analysis Start Relative Day", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "37", + "Dataset": "ADCM", + "Variable": "AENDY", + "Label": "Analysis End Relative Day", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "38", + "Dataset": "ADCM", + "Variable": "ADURN", + "Label": "Analysis Duration (N)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "39", + "Dataset": "ADCM", + "Variable": "ADURU", + "Label": "Analysis Duration Units", + "Data Type": "text", + "Length": "4", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "40", + "Dataset": "ADCM", + "Variable": "ONTRTFL", + "Label": "On Treatment Record Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "41", + "Dataset": "ADCM", + "Variable": "PREFL", + "Label": "Pre-treatment Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "42", + "Dataset": "ADCM", + "Variable": "FUPFL", + "Label": "Follow-up Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "43", + "Dataset": "ADCM", + "Variable": "ANL01FL", + "Label": "Analysis Flag 01", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "44", + "Dataset": "ADCM", + "Variable": "AOCCPFL", + "Label": "1st Occurrence of Preferred Term Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "45", + "Dataset": "ADCM", + "Variable": "APHASE", + "Label": "Phase", + "Data Type": "text", + "Length": "13", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "46", + "Dataset": "ADCM", + "Variable": "APHASEN", + "Label": "Description of Phase N", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "47", + "Dataset": "ADCM", + "Variable": "TRTP", + "Label": "Planned Treatment", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "48", + "Dataset": "ADCM", + "Variable": "TRTA", + "Label": "Actual Treatment", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "49", + "Dataset": "ADCM", + "Variable": "SUBJID", + "Label": "Subject Identifier for the Study", + "Data Type": "text", + "Length": "4", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "50", + "Dataset": "ADCM", + "Variable": "RFSTDTC", + "Label": "Subject Reference Start Date/Time", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "51", + "Dataset": "ADCM", + "Variable": "RFENDTC", + "Label": "Subject Reference End Date/Time", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "52", + "Dataset": "ADCM", + "Variable": "RFXSTDTC", + "Label": "Date/Time of First Study Treatment", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "53", + "Dataset": "ADCM", + "Variable": "RFXENDTC", + "Label": "Date/Time of Last Study Treatment", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "54", + "Dataset": "ADCM", + "Variable": "RFICDTC", + "Label": "Date/Time of Informed Consent", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "55", + "Dataset": "ADCM", + "Variable": "RFPENDTC", + "Label": "Date/Time of End of Participation", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "56", + "Dataset": "ADCM", + "Variable": "DTHDTC", + "Label": "Date/Time of Death", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "57", + "Dataset": "ADCM", + "Variable": "DTHFL", + "Label": "Subject Death Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "58", + "Dataset": "ADCM", + "Variable": "SITEID", + "Label": "Study Site Identifier", + "Data Type": "text", + "Length": "3", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "59", + "Dataset": "ADCM", + "Variable": "AGE", + "Label": "Age", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "60", + "Dataset": "ADCM", + "Variable": "AGEU", + "Label": "Age Units", + "Data Type": "text", + "Length": "5", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "61", + "Dataset": "ADCM", + "Variable": "SEX", + "Label": "Sex", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "62", + "Dataset": "ADCM", + "Variable": "RACE", + "Label": "Race", + "Data Type": "text", + "Length": "32", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "63", + "Dataset": "ADCM", + "Variable": "ETHNIC", + "Label": "Ethnicity", + "Data Type": "text", + "Length": "22", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "64", + "Dataset": "ADCM", + "Variable": "ARMCD", + "Label": "Planned Arm Code", + "Data Type": "text", + "Length": "6", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "65", + "Dataset": "ADCM", + "Variable": "ARM", + "Label": "Description of Planned Arm", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "66", + "Dataset": "ADCM", + "Variable": "ACTARMCD", + "Label": "Actual Arm Code", + "Data Type": "text", + "Length": "6", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "67", + "Dataset": "ADCM", + "Variable": "ACTARM", + "Label": "Description of Actual Arm", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "68", + "Dataset": "ADCM", + "Variable": "COUNTRY", + "Label": "Country", + "Data Type": "text", + "Length": "3", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "69", + "Dataset": "ADCM", + "Variable": "DMDTC", + "Label": "Date/Time of Collection", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "70", + "Dataset": "ADCM", + "Variable": "DMDY", + "Label": "Study Day of Collection", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "71", + "Dataset": "ADCM", + "Variable": "TRTSDTM", + "Label": "Datetime of First Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATETIME", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "72", + "Dataset": "ADCM", + "Variable": "TRTSTMF", + "Label": "Time of First Exposure Imput. Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "73", + "Dataset": "ADCM", + "Variable": "TRTEDTM", + "Label": "Datetime of Last Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATETIME", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "74", + "Dataset": "ADCM", + "Variable": "TRTETMF", + "Label": "Treatment End Datetime Imput Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "75", + "Dataset": "ADCM", + "Variable": "TRTDURD", + "Label": "Total Treatment Duration (Days)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "76", + "Dataset": "ADCM", + "Variable": "SCRFDT", + "Label": "Screen Failure Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "77", + "Dataset": "ADCM", + "Variable": "EOSSTT", + "Label": "End of Study Status", + "Data Type": "text", + "Length": "12", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "78", + "Dataset": "ADCM", + "Variable": "FRVDT", + "Label": "Final Retrievel Visit Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "79", + "Dataset": "ADCM", + "Variable": "RANDDT", + "Label": "Date of Randomization", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "80", + "Dataset": "ADCM", + "Variable": "DTHADY", + "Label": "Relative Day of Death", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "81", + "Dataset": "ADCM", + "Variable": "LDDTHELD", + "Label": "Elapsed Days from Last Dose to Death", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "82", + "Dataset": "ADCM", + "Variable": "LSTALVDT", + "Label": "Date Last Known Alive", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "83", + "Dataset": "ADCM", + "Variable": "AGEGR1", + "Label": "Pooled Age Group 1", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "84", + "Dataset": "ADCM", + "Variable": "SAFFL", + "Label": "Safety Population Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "85", + "Dataset": "ADCM", + "Variable": "RACEGR1", + "Label": "Pooled Race Group 1", + "Data Type": "text", + "Length": "9", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "86", + "Dataset": "ADCM", + "Variable": "REGION1", + "Label": "Geographic Region 1", + "Data Type": "text", + "Length": "2", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "87", + "Dataset": "ADCM", + "Variable": "LDDTHGR1", + "Label": "Last Dose to Death - Days Elapsed Grp 1", + "Data Type": "text", + "Length": "5", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "88", + "Dataset": "ADCM", + "Variable": "DTH30FL", + "Label": "Death Within 30 Days of Last Trt Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "89", + "Dataset": "ADCM", + "Variable": "DTHA30FL", + "Label": "Death After 30 Days from Last Trt Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "90", + "Dataset": "ADCM", + "Variable": "DTHB30FL", + "Label": "Death Within 30 Days of First Trt Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "1", + "Dataset": "ADEG", + "Variable": "STUDYID", + "Label": "Study Identifier", + "Data Type": "text", + "Length": "12", + "Mandatory": "Yes", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "2", + "Dataset": "ADEG", + "Variable": "DOMAIN", + "Label": "Domain Abbreviation", + "Data Type": "text", + "Length": "2", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "3", + "Dataset": "ADEG", + "Variable": "USUBJID", + "Label": "Unique Subject Identifier", + "Data Type": "text", + "Length": "11", + "Mandatory": "Yes", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "4", + "Dataset": "ADEG", + "Variable": "EGSEQ", + "Label": "Sequence Number", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "5", + "Dataset": "ADEG", + "Variable": "EGTESTCD", + "Label": "ECG Test or Examination Short Name", + "Data Type": "text", + "Length": "6", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "6", + "Dataset": "ADEG", + "Variable": "EGTEST", + "Label": "ECG Test or Examination Name", + "Data Type": "text", + "Length": "18", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "7", + "Dataset": "ADEG", + "Variable": "EGORRES", + "Label": "Result or Finding in Original Units", + "Data Type": "text", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "8", + "Dataset": "ADEG", + "Variable": "EGORRESU", + "Label": "Original Units", + "Data Type": "text", + "Length": "9", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "9", + "Dataset": "ADEG", + "Variable": "EGSTRESC", + "Label": "Character Result/Finding in Std Format", + "Data Type": "text", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "10", + "Dataset": "ADEG", + "Variable": "EGSTRESN", + "Label": "Numeric Result/Finding in Standard Units", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "11", + "Dataset": "ADEG", + "Variable": "EGSTRESU", + "Label": "Standard Units", + "Data Type": "text", + "Length": "9", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "12", + "Dataset": "ADEG", + "Variable": "EGSTAT", + "Label": "Completion Status", + "Data Type": "text", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "13", + "Dataset": "ADEG", + "Variable": "EGLOC", + "Label": "Lead Location Used for Measurement", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "14", + "Dataset": "ADEG", + "Variable": "EGBLFL", + "Label": "Baseline Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "15", + "Dataset": "ADEG", + "Variable": "VISITNUM", + "Label": "Visit Number", + "Data Type": "float", + "Length": "4", + "Significant Digits": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "16", + "Dataset": "ADEG", + "Variable": "VISIT", + "Label": "Visit Name", + "Data Type": "text", + "Length": "19", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "17", + "Dataset": "ADEG", + "Variable": "VISITDY", + "Label": "Planned Study Day of Visit", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "18", + "Dataset": "ADEG", + "Variable": "EGDTC", + "Label": "Date/Time of ECG", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "19", + "Dataset": "ADEG", + "Variable": "EGDY", + "Label": "Study Day of ECG", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "20", + "Dataset": "ADEG", + "Variable": "EGTPT", + "Label": "Planned Time Point Name", + "Data Type": "text", + "Length": "30", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "21", + "Dataset": "ADEG", + "Variable": "EGTPTNUM", + "Label": "Planned Time Point Number", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "22", + "Dataset": "ADEG", + "Variable": "EGELTM", + "Label": "Planned Elapsed Time from Time Point Ref", + "Data Type": "text", + "Length": "4", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "23", + "Dataset": "ADEG", + "Variable": "EGTPTREF", + "Label": "Time Point Reference", + "Data Type": "text", + "Length": "16", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "24", + "Dataset": "ADEG", + "Variable": "TEMP", + "Label": "Temp", + "Data Type": "text", + "Length": "3", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "25", + "Dataset": "ADEG", + "Variable": "TRTSDT", + "Label": "Date of First Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "26", + "Dataset": "ADEG", + "Variable": "TRTEDT", + "Label": "Date of Last Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "27", + "Dataset": "ADEG", + "Variable": "TRT01A", + "Label": "Actual Treatment for Period 01", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "28", + "Dataset": "ADEG", + "Variable": "TRT01P", + "Label": "Planned Treatment for Period 01", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "29", + "Dataset": "ADEG", + "Variable": "ADTM", + "Label": "Analysis Datetime", + "Data Type": "integer", + "Length": "8", + "Format": "DATETIME", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "30", + "Dataset": "ADEG", + "Variable": "ATMF", + "Label": "Analysis Time Imputation Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "31", + "Dataset": "ADEG", + "Variable": "ADY", + "Label": "Analysis Relative Day", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "32", + "Dataset": "ADEG", + "Variable": "PARAMCD", + "Label": "Parameter Code", + "Data Type": "text", + "Length": "6", + "Mandatory": "Yes", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "33", + "Dataset": "ADEG", + "Variable": "AVAL", + "Label": "Analysis Value", + "Data Type": "float", + "Length": "12", + "Significant Digits": "8", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "34", + "Dataset": "ADEG", + "Variable": "AVALC", + "Label": "Analysis Value (C)", + "Data Type": "text", + "Length": "8", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "35", + "Dataset": "ADEG", + "Variable": "ADT", + "Label": "Analysis Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "36", + "Dataset": "ADEG", + "Variable": "ATPTN", + "Label": "Analysis Timepoint (N)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "37", + "Dataset": "ADEG", + "Variable": "ATPT", + "Label": "Analysis Timepoint", + "Data Type": "text", + "Length": "30", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "38", + "Dataset": "ADEG", + "Variable": "AVISIT", + "Label": "Analysis Visit", + "Data Type": "text", + "Length": "8", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "39", + "Dataset": "ADEG", + "Variable": "AVISITN", + "Label": "Analysis Visit (N)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "40", + "Dataset": "ADEG", + "Variable": "DTYPE", + "Label": "Derivation Type", + "Data Type": "text", + "Length": "7", + "Mandatory": "No", + "Role": "Analysis Descriptor Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "41", + "Dataset": "ADEG", + "Variable": "ONTRTFL", + "Label": "On Treatment Record Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "Flag Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "42", + "Dataset": "ADEG", + "Variable": "ANRLO", + "Label": "Analysis Normal Range Lower Limit", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Toxicity and Range Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "43", + "Dataset": "ADEG", + "Variable": "ANRHI", + "Label": "Analysis Normal Range Upper Limit", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Toxicity and Range Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "44", + "Dataset": "ADEG", + "Variable": "ANRIND", + "Label": "Analysis Reference Range Indicator", + "Data Type": "text", + "Length": "6", + "Mandatory": "No", + "Role": "Toxicity and Range Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "45", + "Dataset": "ADEG", + "Variable": "BASETYPE", + "Label": "Baseline Type", + "Data Type": "text", + "Length": "36", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "46", + "Dataset": "ADEG", + "Variable": "ABLFL", + "Label": "Baseline Record Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "Flag Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "47", + "Dataset": "ADEG", + "Variable": "BASE", + "Label": "Baseline Value", + "Data Type": "float", + "Length": "12", + "Significant Digits": "8", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "48", + "Dataset": "ADEG", + "Variable": "BASEC", + "Label": "Baseline Value (C)", + "Data Type": "text", + "Length": "3", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "49", + "Dataset": "ADEG", + "Variable": "BNRIND", + "Label": "Baseline Reference Range Indicator", + "Data Type": "text", + "Length": "6", + "Mandatory": "No", + "Role": "Toxicity and Range Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "50", + "Dataset": "ADEG", + "Variable": "CHG", + "Label": "Change from Baseline", + "Data Type": "float", + "Length": "12", + "Significant Digits": "8", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "51", + "Dataset": "ADEG", + "Variable": "PCHG", + "Label": "Percent Change from Baseline", + "Data Type": "float", + "Length": "11", + "Significant Digits": "8", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "52", + "Dataset": "ADEG", + "Variable": "ANL01FL", + "Label": "Analysis Flag 01", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "53", + "Dataset": "ADEG", + "Variable": "TRTP", + "Label": "Planned Treatment", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Role": "Record-Level Treatment Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "54", + "Dataset": "ADEG", + "Variable": "TRTA", + "Label": "Actual Treatment", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Role": "Record-Level Treatment Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "55", + "Dataset": "ADEG", + "Variable": "ASEQ", + "Label": "Analysis Sequence Number", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "56", + "Dataset": "ADEG", + "Variable": "AVALCA1N", + "Label": "Analysis Value Category 1 (N)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "57", + "Dataset": "ADEG", + "Variable": "AVALCAT1", + "Label": "Analysis Value Category 1", + "Data Type": "text", + "Length": "14", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "58", + "Dataset": "ADEG", + "Variable": "CHGCAT1N", + "Label": "Change from Baseline Category 1 (N)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "59", + "Dataset": "ADEG", + "Variable": "CHGCAT1", + "Label": "Change from Baseline Category 1", + "Data Type": "text", + "Length": "12", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "60", + "Dataset": "ADEG", + "Variable": "PARAM", + "Label": "Parameter", + "Data Type": "text", + "Length": "55", + "Mandatory": "Yes", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "61", + "Dataset": "ADEG", + "Variable": "PARAMN", + "Label": "Parameter (N)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "62", + "Dataset": "ADEG", + "Variable": "SUBJID", + "Label": "Subject Identifier for the Study", + "Data Type": "text", + "Length": "4", + "Mandatory": "No", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "63", + "Dataset": "ADEG", + "Variable": "RFSTDTC", + "Label": "Subject Reference Start Date/Time", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "64", + "Dataset": "ADEG", + "Variable": "RFENDTC", + "Label": "Subject Reference End Date/Time", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "65", + "Dataset": "ADEG", + "Variable": "RFXSTDTC", + "Label": "Date/Time of First Study Treatment", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "66", + "Dataset": "ADEG", + "Variable": "RFXENDTC", + "Label": "Date/Time of Last Study Treatment", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "67", + "Dataset": "ADEG", + "Variable": "RFICDTC", + "Label": "Date/Time of Informed Consent", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "68", + "Dataset": "ADEG", + "Variable": "RFPENDTC", + "Label": "Date/Time of End of Participation", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "69", + "Dataset": "ADEG", + "Variable": "DTHDTC", + "Label": "Date/Time of Death", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "70", + "Dataset": "ADEG", + "Variable": "DTHFL", + "Label": "Subject Death Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "71", + "Dataset": "ADEG", + "Variable": "SITEID", + "Label": "Study Site Identifier", + "Data Type": "text", + "Length": "3", + "Mandatory": "No", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "72", + "Dataset": "ADEG", + "Variable": "AGE", + "Label": "Age", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "ADSL Subject Demographics Variables", + "Has No Data": "No" + }, + { + "Order": "73", + "Dataset": "ADEG", + "Variable": "AGEU", + "Label": "Age Units", + "Data Type": "text", + "Length": "5", + "Mandatory": "No", + "Role": "ADSL Subject Demographics Variables", + "Has No Data": "No" + }, + { + "Order": "74", + "Dataset": "ADEG", + "Variable": "SEX", + "Label": "Sex", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "ADSL Subject Demographics Variables", + "Has No Data": "No" + }, + { + "Order": "75", + "Dataset": "ADEG", + "Variable": "RACE", + "Label": "Race", + "Data Type": "text", + "Length": "32", + "Mandatory": "No", + "Role": "ADSL Subject Demographics Variables", + "Has No Data": "No" + }, + { + "Order": "76", + "Dataset": "ADEG", + "Variable": "ETHNIC", + "Label": "Ethnicity", + "Data Type": "text", + "Length": "22", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "77", + "Dataset": "ADEG", + "Variable": "ARMCD", + "Label": "Planned Arm Code", + "Data Type": "text", + "Length": "6", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "78", + "Dataset": "ADEG", + "Variable": "ARM", + "Label": "Description of Planned Arm", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Role": "ADSL Treatment Variables", + "Has No Data": "No" + }, + { + "Order": "79", + "Dataset": "ADEG", + "Variable": "ACTARMCD", + "Label": "Actual Arm Code", + "Data Type": "text", + "Length": "6", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "80", + "Dataset": "ADEG", + "Variable": "ACTARM", + "Label": "Description of Actual Arm", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Role": "ADSL Treatment Variables", + "Has No Data": "No" + }, + { + "Order": "81", + "Dataset": "ADEG", + "Variable": "COUNTRY", + "Label": "Country", + "Data Type": "text", + "Length": "3", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "82", + "Dataset": "ADEG", + "Variable": "DMDTC", + "Label": "Date/Time of Collection", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "83", + "Dataset": "ADEG", + "Variable": "DMDY", + "Label": "Study Day of Collection", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "84", + "Dataset": "ADEG", + "Variable": "TRTSDTM", + "Label": "Datetime of First Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATETIME", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "85", + "Dataset": "ADEG", + "Variable": "TRTSTMF", + "Label": "Time of First Exposure Imput. Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "86", + "Dataset": "ADEG", + "Variable": "TRTEDTM", + "Label": "Datetime of Last Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATETIME", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "87", + "Dataset": "ADEG", + "Variable": "TRTETMF", + "Label": "Time of Last Exposure Imput. Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "88", + "Dataset": "ADEG", + "Variable": "TRTDURD", + "Label": "Total Treatment Duration (Days)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "89", + "Dataset": "ADEG", + "Variable": "SCRFDT", + "Label": "Screen Failure Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "90", + "Dataset": "ADEG", + "Variable": "EOSDT", + "Label": "End of Study Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "91", + "Dataset": "ADEG", + "Variable": "EOSSTT", + "Label": "End of Study Status", + "Data Type": "text", + "Length": "12", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "92", + "Dataset": "ADEG", + "Variable": "FRVDT", + "Label": "Final Retrievel Visit Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "93", + "Dataset": "ADEG", + "Variable": "RANDDT", + "Label": "Date of Randomization", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "94", + "Dataset": "ADEG", + "Variable": "DTHDT", + "Label": "Date of Death", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "95", + "Dataset": "ADEG", + "Variable": "DTHADY", + "Label": "Relative Day of Death", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "96", + "Dataset": "ADEG", + "Variable": "LDDTHELD", + "Label": "Elapsed Days from Last Dose to Death", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "97", + "Dataset": "ADEG", + "Variable": "LSTALVDT", + "Label": "Date Last Known Alive", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "98", + "Dataset": "ADEG", + "Variable": "AGEGR1", + "Label": "Pooled Age Group 1", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "99", + "Dataset": "ADEG", + "Variable": "SAFFL", + "Label": "Safety Population Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "ADSL Population Indicator Variables", + "Has No Data": "No" + }, + { + "Order": "100", + "Dataset": "ADEG", + "Variable": "RACEGR1", + "Label": "Pooled Race Group 1", + "Data Type": "text", + "Length": "9", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "101", + "Dataset": "ADEG", + "Variable": "REGION1", + "Label": "Geographic Region 1", + "Data Type": "text", + "Length": "2", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "102", + "Dataset": "ADEG", + "Variable": "LDDTHGR1", + "Label": "Last Dose to Death - Days Elapsed Grp 1", + "Data Type": "text", + "Length": "5", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "103", + "Dataset": "ADEG", + "Variable": "DTH30FL", + "Label": "Death Within 30 Days of Last Trt Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "104", + "Dataset": "ADEG", + "Variable": "DTHA30FL", + "Label": "Death After 30 Days from Last Trt Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "105", + "Dataset": "ADEG", + "Variable": "DTHB30FL", + "Label": "Death Within 30 Days of First Trt Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "1", + "Dataset": "ADEX", + "Variable": "STUDYID", + "Label": "Study Identifier", + "Data Type": "text", + "Length": "12", + "Mandatory": "Yes", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "2", + "Dataset": "ADEX", + "Variable": "DOMAIN", + "Label": "Domain Abbreviation", + "Data Type": "text", + "Length": "2", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "3", + "Dataset": "ADEX", + "Variable": "USUBJID", + "Label": "Unique Subject Identifier", + "Data Type": "text", + "Length": "11", + "Mandatory": "Yes", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "4", + "Dataset": "ADEX", + "Variable": "EXSEQ", + "Label": "Sequence Number", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "5", + "Dataset": "ADEX", + "Variable": "EXTRT", + "Label": "Name of Treatment", + "Data Type": "text", + "Length": "10", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "6", + "Dataset": "ADEX", + "Variable": "EXDOSE", + "Label": "Dose", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "7", + "Dataset": "ADEX", + "Variable": "EXDOSU", + "Label": "Dose Units", + "Data Type": "text", + "Length": "2", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "8", + "Dataset": "ADEX", + "Variable": "EXDOSFRM", + "Label": "Dose Form", + "Data Type": "text", + "Length": "5", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "9", + "Dataset": "ADEX", + "Variable": "EXDOSFRQ", + "Label": "Dosing Frequency per Interval", + "Data Type": "text", + "Length": "2", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "10", + "Dataset": "ADEX", + "Variable": "EXROUTE", + "Label": "Route of Administration", + "Data Type": "text", + "Length": "11", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "11", + "Dataset": "ADEX", + "Variable": "VISITNUM", + "Label": "Visit Number", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "12", + "Dataset": "ADEX", + "Variable": "VISIT", + "Label": "Visit Name", + "Data Type": "text", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "13", + "Dataset": "ADEX", + "Variable": "VISITDY", + "Label": "Planned Study Day of Visit", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "14", + "Dataset": "ADEX", + "Variable": "EXSTDTC", + "Label": "Start Date/Time of Treatment", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "15", + "Dataset": "ADEX", + "Variable": "EXENDTC", + "Label": "End Date/Time of Treatment", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "16", + "Dataset": "ADEX", + "Variable": "EXSTDY", + "Label": "Study Day of Start of Treatment", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "17", + "Dataset": "ADEX", + "Variable": "EXENDY", + "Label": "Study Day of End of Treatment", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "18", + "Dataset": "ADEX", + "Variable": "EXADJ", + "Label": "Reason for Dose Adjustment", + "Data Type": "text", + "Length": "16", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "19", + "Dataset": "ADEX", + "Variable": "EXPLDOS", + "Label": "Planned Dose", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "20", + "Dataset": "ADEX", + "Variable": "TRTSDT", + "Label": "Date of First Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "21", + "Dataset": "ADEX", + "Variable": "TRTSDTM", + "Label": "Datetime of First Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATETIME", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "22", + "Dataset": "ADEX", + "Variable": "TRTEDTM", + "Label": "Datetime of Last Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATETIME", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "23", + "Dataset": "ADEX", + "Variable": "ASTDTM", + "Label": "Analysis Start Datetime", + "Data Type": "integer", + "Length": "8", + "Format": "DATETIME", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "24", + "Dataset": "ADEX", + "Variable": "ASTDTF", + "Label": "Analysis Start Date Imputation Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "25", + "Dataset": "ADEX", + "Variable": "ASTTMF", + "Label": "Analysis Start Time Imputation Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "26", + "Dataset": "ADEX", + "Variable": "AENDTM", + "Label": "Analysis End Datetime", + "Data Type": "integer", + "Length": "8", + "Format": "DATETIME", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "27", + "Dataset": "ADEX", + "Variable": "AENDTF", + "Label": "Analysis End Date Imputation Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "28", + "Dataset": "ADEX", + "Variable": "AENTMF", + "Label": "Analysis End Time Imputation Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "29", + "Dataset": "ADEX", + "Variable": "ASTDY", + "Label": "Analysis Start Relative Day", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "30", + "Dataset": "ADEX", + "Variable": "AENDY", + "Label": "Analysis End Relative Day", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "31", + "Dataset": "ADEX", + "Variable": "EXDURD", + "Label": "Duration of Treatment (Days)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "32", + "Dataset": "ADEX", + "Variable": "ASTDT", + "Label": "Analysis Start Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "33", + "Dataset": "ADEX", + "Variable": "AENDT", + "Label": "Analysis End Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "34", + "Dataset": "ADEX", + "Variable": "DOSEO", + "Label": "Dose O", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "35", + "Dataset": "ADEX", + "Variable": "PDOSEO", + "Label": "PDose O", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "36", + "Dataset": "ADEX", + "Variable": "PARAMCD", + "Label": "Parameter Code", + "Data Type": "text", + "Length": "7", + "Mandatory": "Yes", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "37", + "Dataset": "ADEX", + "Variable": "AVAL", + "Label": "Analysis Value", + "Data Type": "float", + "Length": "13", + "Significant Digits": "8", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "38", + "Dataset": "ADEX", + "Variable": "AVALC", + "Label": "Analysis Value (C)", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "39", + "Dataset": "ADEX", + "Variable": "PARCAT1", + "Label": "Parameter Category 1", + "Data Type": "text", + "Length": "10", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "40", + "Dataset": "ADEX", + "Variable": "PARAM", + "Label": "Parameter", + "Data Type": "text", + "Length": "58", + "Mandatory": "Yes", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "41", + "Dataset": "ADEX", + "Variable": "PARAMN", + "Label": "Parameter (N)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "42", + "Dataset": "ADEX", + "Variable": "AVALCAT1", + "Label": "Analysis Value Category 1", + "Data Type": "text", + "Length": "19", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "43", + "Dataset": "ADEX", + "Variable": "ASEQ", + "Label": "Analysis Sequence Number", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "44", + "Dataset": "ADEX", + "Variable": "SUBJID", + "Label": "Subject Identifier for the Study", + "Data Type": "text", + "Length": "4", + "Mandatory": "No", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "45", + "Dataset": "ADEX", + "Variable": "RFSTDTC", + "Label": "Subject Reference Start Date/Time", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "46", + "Dataset": "ADEX", + "Variable": "RFENDTC", + "Label": "Subject Reference End Date/Time", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "47", + "Dataset": "ADEX", + "Variable": "RFXSTDTC", + "Label": "Date/Time of First Study Treatment", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "48", + "Dataset": "ADEX", + "Variable": "RFXENDTC", + "Label": "Date/Time of Last Study Treatment", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "49", + "Dataset": "ADEX", + "Variable": "RFICDTC", + "Label": "Date/Time of Informed Consent", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "50", + "Dataset": "ADEX", + "Variable": "RFPENDTC", + "Label": "Date/Time of End of Participation", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "51", + "Dataset": "ADEX", + "Variable": "DTHDTC", + "Label": "Date/Time of Death", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "52", + "Dataset": "ADEX", + "Variable": "DTHFL", + "Label": "Subject Death Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "53", + "Dataset": "ADEX", + "Variable": "SITEID", + "Label": "Study Site Identifier", + "Data Type": "text", + "Length": "3", + "Mandatory": "No", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "54", + "Dataset": "ADEX", + "Variable": "AGE", + "Label": "Age", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "ADSL Subject Demographics Variables", + "Has No Data": "No" + }, + { + "Order": "55", + "Dataset": "ADEX", + "Variable": "AGEU", + "Label": "Age Units", + "Data Type": "text", + "Length": "5", + "Mandatory": "No", + "Role": "ADSL Subject Demographics Variables", + "Has No Data": "No" + }, + { + "Order": "56", + "Dataset": "ADEX", + "Variable": "SEX", + "Label": "Sex", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "ADSL Subject Demographics Variables", + "Has No Data": "No" + }, + { + "Order": "57", + "Dataset": "ADEX", + "Variable": "RACE", + "Label": "Race", + "Data Type": "text", + "Length": "32", + "Mandatory": "No", + "Role": "ADSL Subject Demographics Variables", + "Has No Data": "No" + }, + { + "Order": "58", + "Dataset": "ADEX", + "Variable": "ETHNIC", + "Label": "Ethnicity", + "Data Type": "text", + "Length": "22", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "59", + "Dataset": "ADEX", + "Variable": "ARMCD", + "Label": "Planned Arm Code", + "Data Type": "text", + "Length": "6", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "60", + "Dataset": "ADEX", + "Variable": "ARM", + "Label": "Description of Planned Arm", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Role": "ADSL Treatment Variables", + "Has No Data": "No" + }, + { + "Order": "61", + "Dataset": "ADEX", + "Variable": "ACTARMCD", + "Label": "Actual Arm Code", + "Data Type": "text", + "Length": "6", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "62", + "Dataset": "ADEX", + "Variable": "ACTARM", + "Label": "Description of Actual Arm", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Role": "ADSL Treatment Variables", + "Has No Data": "No" + }, + { + "Order": "63", + "Dataset": "ADEX", + "Variable": "COUNTRY", + "Label": "Country", + "Data Type": "text", + "Length": "3", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "64", + "Dataset": "ADEX", + "Variable": "DMDTC", + "Label": "Date/Time of Collection", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "65", + "Dataset": "ADEX", + "Variable": "DMDY", + "Label": "Study Day of Collection", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "66", + "Dataset": "ADEX", + "Variable": "TRT01P", + "Label": "Planned Treatment for Period 01", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "67", + "Dataset": "ADEX", + "Variable": "TRT01A", + "Label": "Actual Treatment for Period 01", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "68", + "Dataset": "ADEX", + "Variable": "TRTSTMF", + "Label": "Time of First Exposure Imput. Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "69", + "Dataset": "ADEX", + "Variable": "TRTETMF", + "Label": "Time of Last Exposure Imput. Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "70", + "Dataset": "ADEX", + "Variable": "TRTEDT", + "Label": "Date of Last Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "71", + "Dataset": "ADEX", + "Variable": "TRTDURD", + "Label": "Total Treatment Duration (Days)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "72", + "Dataset": "ADEX", + "Variable": "SCRFDT", + "Label": "Screen Failure Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "73", + "Dataset": "ADEX", + "Variable": "EOSDT", + "Label": "End of Study Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "74", + "Dataset": "ADEX", + "Variable": "EOSSTT", + "Label": "End of Study Status", + "Data Type": "text", + "Length": "12", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "75", + "Dataset": "ADEX", + "Variable": "FRVDT", + "Label": "Final Retrievel Visit Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "76", + "Dataset": "ADEX", + "Variable": "RANDDT", + "Label": "Date of Randomization", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "77", + "Dataset": "ADEX", + "Variable": "DTHDT", + "Label": "Date of Death", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "78", + "Dataset": "ADEX", + "Variable": "DTHADY", + "Label": "Relative Day of Death", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "79", + "Dataset": "ADEX", + "Variable": "LDDTHELD", + "Label": "Elapsed Days from Last Dose to Death", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "80", + "Dataset": "ADEX", + "Variable": "LSTALVDT", + "Label": "Date Last Known Alive", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "81", + "Dataset": "ADEX", + "Variable": "AGEGR1", + "Label": "Pooled Age Group 1", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "82", + "Dataset": "ADEX", + "Variable": "SAFFL", + "Label": "Safety Population Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "ADSL Population Indicator Variables", + "Has No Data": "No" + }, + { + "Order": "83", + "Dataset": "ADEX", + "Variable": "RACEGR1", + "Label": "Pooled Race Group 1", + "Data Type": "text", + "Length": "9", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "84", + "Dataset": "ADEX", + "Variable": "REGION1", + "Label": "Geographic Region 1", + "Data Type": "text", + "Length": "2", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "85", + "Dataset": "ADEX", + "Variable": "LDDTHGR1", + "Label": "Last Dose to Death - Days Elapsed Grp 1", + "Data Type": "text", + "Length": "5", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "86", + "Dataset": "ADEX", + "Variable": "DTH30FL", + "Label": "Death Within 30 Days of Last Trt Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "87", + "Dataset": "ADEX", + "Variable": "DTHA30FL", + "Label": "Death After 30 Days from Last Trt Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "88", + "Dataset": "ADEX", + "Variable": "DTHB30FL", + "Label": "Death Within 30 Days of First Trt Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "1", + "Dataset": "ADFACE_V", + "Variable": "STUDYID", + "Label": "Study Identifier", + "Data Type": "text", + "Length": "3", + "Mandatory": "Yes", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "2", + "Dataset": "ADFACE_V", + "Variable": "USUBJID", + "Label": "Unique Subject Identifier", + "Data Type": "text", + "Length": "8", + "Mandatory": "Yes", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "3", + "Dataset": "ADFACE_V", + "Variable": "SUBJID", + "Label": "Subject Identifier for the Study", + "Data Type": "text", + "Length": "4", + "Mandatory": "No", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "4", + "Dataset": "ADFACE_V", + "Variable": "SITEID", + "Label": "Study Site Identifier", + "Data Type": "text", + "Length": "4", + "Mandatory": "No", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "5", + "Dataset": "ADFACE_V", + "Variable": "AGE", + "Label": "Age", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "ADSL Subject Demographics Variables", + "Has No Data": "No" + }, + { + "Order": "6", + "Dataset": "ADFACE_V", + "Variable": "AGEU", + "Label": "Age Units", + "Data Type": "text", + "Length": "5", + "Mandatory": "No", + "Role": "ADSL Subject Demographics Variables", + "Has No Data": "No" + }, + { + "Order": "7", + "Dataset": "ADFACE_V", + "Variable": "SEX", + "Label": "Sex", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "ADSL Subject Demographics Variables", + "Has No Data": "No" + }, + { + "Order": "8", + "Dataset": "ADFACE_V", + "Variable": "RACE", + "Label": "Race", + "Data Type": "text", + "Length": "25", + "Mandatory": "No", + "Role": "ADSL Subject Demographics Variables", + "Has No Data": "No" + }, + { + "Order": "9", + "Dataset": "ADFACE_V", + "Variable": "SAFFL", + "Label": "Safety Population Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "ADSL Population Indicator Variables", + "Has No Data": "No" + }, + { + "Order": "10", + "Dataset": "ADFACE_V", + "Variable": "ARM", + "Label": "Description of Planned Arm", + "Data Type": "text", + "Length": "19", + "Mandatory": "No", + "Role": "ADSL Treatment Variables", + "Has No Data": "No" + }, + { + "Order": "11", + "Dataset": "ADFACE_V", + "Variable": "ARMCD", + "Label": "Planned Arm Code", + "Data Type": "text", + "Length": "5", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "12", + "Dataset": "ADFACE_V", + "Variable": "ACTARM", + "Label": "Description of Actual Arm", + "Data Type": "text", + "Length": "19", + "Mandatory": "No", + "Role": "ADSL Treatment Variables", + "Has No Data": "No" + }, + { + "Order": "13", + "Dataset": "ADFACE_V", + "Variable": "ACTARMCD", + "Label": "Actual Arm Code", + "Data Type": "text", + "Length": "5", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "14", + "Dataset": "ADFACE_V", + "Variable": "TRTSDT", + "Label": "Date of First Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "15", + "Dataset": "ADFACE_V", + "Variable": "TRTSDTM", + "Label": "Datetime of First Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATETIME", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "16", + "Dataset": "ADFACE_V", + "Variable": "TRTEDT", + "Label": "Date of Last Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "17", + "Dataset": "ADFACE_V", + "Variable": "TRTEDTM", + "Label": "Datetime of Last Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATETIME", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "18", + "Dataset": "ADFACE_V", + "Variable": "FATEST", + "Label": "Findings About Test Name", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "19", + "Dataset": "ADFACE_V", + "Variable": "FALNKID", + "Label": "Link ID", + "Data Type": "text", + "Length": "62", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "20", + "Dataset": "ADFACE_V", + "Variable": "FALNKGRP", + "Label": "Link Group ID", + "Data Type": "text", + "Length": "56", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "21", + "Dataset": "ADFACE_V", + "Variable": "FATESTCD", + "Label": "Findings About Test Short Name", + "Data Type": "text", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "22", + "Dataset": "ADFACE_V", + "Variable": "PARAMCD", + "Label": "Parameter Code", + "Data Type": "text", + "Length": "8", + "Mandatory": "Yes", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "23", + "Dataset": "ADFACE_V", + "Variable": "PARAM", + "Label": "Parameter", + "Data Type": "text", + "Length": "63", + "Mandatory": "Yes", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "24", + "Dataset": "ADFACE_V", + "Variable": "PARAMN", + "Label": "Parameter (N)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "25", + "Dataset": "ADFACE_V", + "Variable": "FAOBJ", + "Label": "Object of the Observation", + "Data Type": "text", + "Length": "27", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "26", + "Dataset": "ADFACE_V", + "Variable": "PARCAT1", + "Label": "Parameter Category 1", + "Data Type": "text", + "Length": "14", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "27", + "Dataset": "ADFACE_V", + "Variable": "PARCAT2", + "Label": "Parameter Category 2", + "Data Type": "text", + "Length": "19", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "28", + "Dataset": "ADFACE_V", + "Variable": "AVALC", + "Label": "Analysis Value (C)", + "Data Type": "text", + "Length": "8", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "29", + "Dataset": "ADFACE_V", + "Variable": "AVAL", + "Label": "Analysis Value", + "Data Type": "float", + "Length": "2", + "Significant Digits": "1", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "30", + "Dataset": "ADFACE_V", + "Variable": "FASTAT", + "Label": "Completion Status", + "Data Type": "text", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "31", + "Dataset": "ADFACE_V", + "Variable": "FAREASND", + "Label": "Reason Not Performed", + "Data Type": "text", + "Length": "41", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "32", + "Dataset": "ADFACE_V", + "Variable": "FAEVAL", + "Label": "Evaluator", + "Data Type": "text", + "Length": "13", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "33", + "Dataset": "ADFACE_V", + "Variable": "EPOCH", + "Label": "Epoch", + "Data Type": "text", + "Length": "13", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "34", + "Dataset": "ADFACE_V", + "Variable": "ADT", + "Label": "Analysis Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "35", + "Dataset": "ADFACE_V", + "Variable": "ADTM", + "Label": "Analysis Datetime", + "Data Type": "integer", + "Length": "8", + "Format": "DATETIME", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "36", + "Dataset": "ADFACE_V", + "Variable": "FAEVINTX", + "Label": "Evaluation Interval Text", + "Data Type": "text", + "Length": "17", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "37", + "Dataset": "ADFACE_V", + "Variable": "ADY", + "Label": "Analysis Relative Day", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "38", + "Dataset": "ADFACE_V", + "Variable": "ATPT", + "Label": "Analysis Timepoint", + "Data Type": "text", + "Length": "5", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "39", + "Dataset": "ADFACE_V", + "Variable": "ATPTN", + "Label": "Analysis Timepoint (N)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "40", + "Dataset": "ADFACE_V", + "Variable": "ATPTREF", + "Label": "Analysis Timepoint Reference", + "Data Type": "text", + "Length": "13", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "41", + "Dataset": "ADFACE_V", + "Variable": "EXDOSE", + "Label": "Dose", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "42", + "Dataset": "ADFACE_V", + "Variable": "EXTRT", + "Label": "Name of Treatment", + "Data Type": "text", + "Length": "9", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "43", + "Dataset": "ADFACE_V", + "Variable": "EXSTDTC", + "Label": "Start Date/Time of Treatment", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "44", + "Dataset": "ADFACE_V", + "Variable": "EXENDTC", + "Label": "End Date/Time of Treatment", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "45", + "Dataset": "ADFACE_V", + "Variable": "TRTA", + "Label": "Actual Treatment", + "Data Type": "text", + "Length": "9", + "Mandatory": "No", + "Role": "Record-Level Treatment Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "46", + "Dataset": "ADFACE_V", + "Variable": "TRTP", + "Label": "Planned Treatment", + "Data Type": "text", + "Length": "9", + "Mandatory": "No", + "Role": "Record-Level Treatment Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "47", + "Dataset": "ADFACE_V", + "Variable": "APERIOD", + "Label": "Period", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "48", + "Dataset": "ADFACE_V", + "Variable": "APERSDT", + "Label": "Period Start Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "Period, Subperiod, and Phase Start and End Timing Variables", + "Has No Data": "No" + }, + { + "Order": "49", + "Dataset": "ADFACE_V", + "Variable": "APEREDT", + "Label": "Period End Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "Period, Subperiod, and Phase Start and End Timing Variables", + "Has No Data": "No" + }, + { + "Order": "50", + "Dataset": "ADFACE_V", + "Variable": "FAORRES", + "Label": "Result or Finding in Original Units", + "Data Type": "text", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "51", + "Dataset": "ADFACE_V", + "Variable": "TRT01P", + "Label": "Planned Treatment for Period 01", + "Data Type": "text", + "Length": "9", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "52", + "Dataset": "ADFACE_V", + "Variable": "TRT02P", + "Label": "Planned Treatment for Period 02", + "Data Type": "text", + "Length": "9", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "53", + "Dataset": "ADFACE_V", + "Variable": "TRT01A", + "Label": "Actual Treatment for Period 01", + "Data Type": "text", + "Length": "9", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "54", + "Dataset": "ADFACE_V", + "Variable": "TRT02A", + "Label": "Actual Treatment for Period 02", + "Data Type": "text", + "Length": "9", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "55", + "Dataset": "ADFACE_V", + "Variable": "VAX01DT", + "Label": "Vaccination Date 01", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "56", + "Dataset": "ADFACE_V", + "Variable": "VAX02DT", + "Label": "Vaccination Date 02", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "57", + "Dataset": "ADFACE_V", + "Variable": "EVENTFL", + "Label": "Event Value Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "58", + "Dataset": "ADFACE_V", + "Variable": "EVENTDFL", + "Label": "Day Event Value Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "59", + "Dataset": "ADFACE_V", + "Variable": "ANL01FL", + "Label": "Analysis Flag 01", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "60", + "Dataset": "ADFACE_V", + "Variable": "ANL02FL", + "Label": "Analysis Flag 02", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "1", + "Dataset": "ADIS_V", + "Variable": "STUDYID", + "Label": "Study Identifier", + "Data Type": "text", + "Length": "3", + "Mandatory": "Yes", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "2", + "Dataset": "ADIS_V", + "Variable": "DOMAIN", + "Label": "Domain Abbreviation", + "Data Type": "text", + "Length": "2", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "3", + "Dataset": "ADIS_V", + "Variable": "USUBJID", + "Label": "Unique Subject Identifier", + "Data Type": "text", + "Length": "8", + "Mandatory": "Yes", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "4", + "Dataset": "ADIS_V", + "Variable": "ISSEQ", + "Label": "Sequence Number", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "5", + "Dataset": "ADIS_V", + "Variable": "ISTESTCD", + "Label": "Immunogenicity Test/Exam Short Name", + "Data Type": "text", + "Length": "7", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "6", + "Dataset": "ADIS_V", + "Variable": "ISTEST", + "Label": "Immunogenicity Test or Examination Name", + "Data Type": "text", + "Length": "16", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "7", + "Dataset": "ADIS_V", + "Variable": "ISCAT", + "Label": "Category for Immunogenicity Test", + "Data Type": "text", + "Length": "10", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "8", + "Dataset": "ADIS_V", + "Variable": "ISORRES", + "Label": "Results or Findings in Original Units", + "Data Type": "text", + "Length": "5", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "9", + "Dataset": "ADIS_V", + "Variable": "ISORRESU", + "Label": "Original Units", + "Data Type": "text", + "Length": "5", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "10", + "Dataset": "ADIS_V", + "Variable": "ISSTRESC", + "Label": "Character Result/Finding in Std Format", + "Data Type": "text", + "Length": "5", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "11", + "Dataset": "ADIS_V", + "Variable": "ISSTRESN", + "Label": "Numeric Results/Findings in Std. Units", + "Data Type": "float", + "Length": "4", + "Significant Digits": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "12", + "Dataset": "ADIS_V", + "Variable": "ISSTRESU", + "Label": "Standard Units", + "Data Type": "text", + "Length": "5", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "13", + "Dataset": "ADIS_V", + "Variable": "ISSTAT", + "Label": "Completion Status", + "Data Type": "text", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "14", + "Dataset": "ADIS_V", + "Variable": "ISREASND", + "Label": "Reason Not Done", + "Data Type": "text", + "Length": "14", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "15", + "Dataset": "ADIS_V", + "Variable": "ISNAM", + "Label": "Vendor Name", + "Data Type": "text", + "Length": "7", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "16", + "Dataset": "ADIS_V", + "Variable": "ISSPEC", + "Label": "Specimen Type", + "Data Type": "text", + "Length": "5", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "17", + "Dataset": "ADIS_V", + "Variable": "ISMETHOD", + "Label": "Method of Test or Examination", + "Data Type": "text", + "Length": "10", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "18", + "Dataset": "ADIS_V", + "Variable": "ISBLFL", + "Label": "Baseline Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "19", + "Dataset": "ADIS_V", + "Variable": "ISLLOQ", + "Label": "Lower Limit of Quantitation", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "20", + "Dataset": "ADIS_V", + "Variable": "VISITNUM", + "Label": "Visit Number", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "21", + "Dataset": "ADIS_V", + "Variable": "EPOCH", + "Label": "Epoch", + "Data Type": "text", + "Length": "16", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "22", + "Dataset": "ADIS_V", + "Variable": "ISDTC", + "Label": "Date/Time of Collection", + "Data Type": "text", + "Length": "7", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "23", + "Dataset": "ADIS_V", + "Variable": "ISDY", + "Label": "Study Day of Visit/Collection/Exam", + "Data Type": "text", + "Length": "2", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "24", + "Dataset": "ADIS_V", + "Variable": "ISULOQ", + "Label": "Upper Limit of Quantitation", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "25", + "Dataset": "ADIS_V", + "Variable": "LOD", + "Label": "Limit of Detection", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "26", + "Dataset": "ADIS_V", + "Variable": "AVISITN", + "Label": "Analysis Visit (N)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "27", + "Dataset": "ADIS_V", + "Variable": "AVISIT", + "Label": "Analysis Visit", + "Data Type": "text", + "Length": "7", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "28", + "Dataset": "ADIS_V", + "Variable": "ATPTN", + "Label": "Analysis Timepoint (N)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "29", + "Dataset": "ADIS_V", + "Variable": "ATPT", + "Label": "Analysis Timepoint", + "Data Type": "text", + "Length": "16", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "30", + "Dataset": "ADIS_V", + "Variable": "ATPTREF", + "Label": "Analysis Timepoint Reference", + "Data Type": "text", + "Length": "16", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "31", + "Dataset": "ADIS_V", + "Variable": "ADT", + "Label": "Analysis Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "32", + "Dataset": "ADIS_V", + "Variable": "RFSTDTC", + "Label": "Subject Reference Start Date/Time", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "33", + "Dataset": "ADIS_V", + "Variable": "PPROTFL", + "Label": "Per-Protocol Population Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "ADSL Population Indicator Variables", + "Has No Data": "No" + }, + { + "Order": "34", + "Dataset": "ADIS_V", + "Variable": "ADY", + "Label": "Analysis Relative Day", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "35", + "Dataset": "ADIS_V", + "Variable": "PARAMCD", + "Label": "Parameter Code", + "Data Type": "text", + "Length": "8", + "Mandatory": "Yes", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "36", + "Dataset": "ADIS_V", + "Variable": "PARAM", + "Label": "Parameter", + "Data Type": "text", + "Length": "30", + "Mandatory": "Yes", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "37", + "Dataset": "ADIS_V", + "Variable": "PARAMN", + "Label": "Parameter (N)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "38", + "Dataset": "ADIS_V", + "Variable": "PARCAT1", + "Label": "Parameter Category 1", + "Data Type": "text", + "Length": "10", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "39", + "Dataset": "ADIS_V", + "Variable": "CUTOFF02", + "Label": "First Cutoff Value", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "40", + "Dataset": "ADIS_V", + "Variable": "CUTOFF03", + "Label": "Second Cutoff Value", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "41", + "Dataset": "ADIS_V", + "Variable": "AVAL", + "Label": "Analysis Value", + "Data Type": "float", + "Length": "5", + "Significant Digits": "2", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "42", + "Dataset": "ADIS_V", + "Variable": "AVALU", + "Label": "Analysis Value Unit", + "Data Type": "text", + "Length": "5", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "43", + "Dataset": "ADIS_V", + "Variable": "SERCAT1", + "Label": "Pre-vaccination seropositivity status", + "Data Type": "text", + "Length": "7", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "44", + "Dataset": "ADIS_V", + "Variable": "SERCAT1N", + "Label": "Pre-vaccination sero status (n)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "45", + "Dataset": "ADIS_V", + "Variable": "DTYPE", + "Label": "Derivation Type", + "Data Type": "text", + "Length": "8", + "Mandatory": "No", + "Role": "Analysis Descriptor Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "46", + "Dataset": "ADIS_V", + "Variable": "BASETYPE", + "Label": "Baseline Type", + "Data Type": "text", + "Length": "7", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "47", + "Dataset": "ADIS_V", + "Variable": "BASE", + "Label": "Baseline Value", + "Data Type": "float", + "Length": "8", + "Significant Digits": "2", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "48", + "Dataset": "ADIS_V", + "Variable": "ABLFL", + "Label": "Baseline Record Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "Flag Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "49", + "Dataset": "ADIS_V", + "Variable": "BASECAT1", + "Label": "Baseline Category 1", + "Data Type": "text", + "Length": "19", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "50", + "Dataset": "ADIS_V", + "Variable": "CHG", + "Label": "Change from Baseline", + "Data Type": "float", + "Length": "8", + "Significant Digits": "2", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "51", + "Dataset": "ADIS_V", + "Variable": "R2BASE", + "Label": "Ratio to Baseline", + "Data Type": "float", + "Length": "11", + "Significant Digits": "8", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "52", + "Dataset": "ADIS_V", + "Variable": "CRIT1FL", + "Label": "Criterion 1 Evaluation Result Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "53", + "Dataset": "ADIS_V", + "Variable": "CRIT1FN", + "Label": "Criterion 1 Evaluation Result Flag (N)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "54", + "Dataset": "ADIS_V", + "Variable": "CRIT1", + "Label": "Analysis Criterion 1", + "Data Type": "text", + "Length": "15", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "55", + "Dataset": "ADIS_V", + "Variable": "APERIOD", + "Label": "Period", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "56", + "Dataset": "ADIS_V", + "Variable": "APERSDT", + "Label": "Period Start Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "Period, Subperiod, and Phase Start and End Timing Variables", + "Has No Data": "No" + }, + { + "Order": "57", + "Dataset": "ADIS_V", + "Variable": "APEREDT", + "Label": "Period End Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "Period, Subperiod, and Phase Start and End Timing Variables", + "Has No Data": "No" + }, + { + "Order": "58", + "Dataset": "ADIS_V", + "Variable": "TRTA", + "Label": "Actual Treatment", + "Data Type": "text", + "Length": "9", + "Mandatory": "No", + "Role": "Record-Level Treatment Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "59", + "Dataset": "ADIS_V", + "Variable": "TRTP", + "Label": "Planned Treatment", + "Data Type": "text", + "Length": "9", + "Mandatory": "No", + "Role": "Record-Level Treatment Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "60", + "Dataset": "ADIS_V", + "Variable": "PPSRFL", + "Label": "Per-Protocol Record-Level Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "61", + "Dataset": "ADIS_V", + "Variable": "SUBJID", + "Label": "Subject Identifier for the Study", + "Data Type": "text", + "Length": "4", + "Mandatory": "No", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "62", + "Dataset": "ADIS_V", + "Variable": "RFENDTC", + "Label": "Subject Reference End Date/Time", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "63", + "Dataset": "ADIS_V", + "Variable": "RFXSTDTC", + "Label": "Date/Time of First Study Treatment", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "64", + "Dataset": "ADIS_V", + "Variable": "RFXENDTC", + "Label": "Date/Time of Last Study Treatment", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "65", + "Dataset": "ADIS_V", + "Variable": "RFICDTC", + "Label": "Date/Time of Informed Consent", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "66", + "Dataset": "ADIS_V", + "Variable": "RFPENDTC", + "Label": "Date/Time of End of Participation", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "67", + "Dataset": "ADIS_V", + "Variable": "DTHDTC", + "Label": "Date/Time of Death", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "68", + "Dataset": "ADIS_V", + "Variable": "DTHFL", + "Label": "Subject Death Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "69", + "Dataset": "ADIS_V", + "Variable": "SITEID", + "Label": "Study Site Identifier", + "Data Type": "text", + "Length": "4", + "Mandatory": "No", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "70", + "Dataset": "ADIS_V", + "Variable": "INVID", + "Label": "Investigator Identifier", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "71", + "Dataset": "ADIS_V", + "Variable": "INVNAM", + "Label": "Investigator Name", + "Data Type": "text", + "Length": "13", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "72", + "Dataset": "ADIS_V", + "Variable": "BRTHDTC", + "Label": "Date/Time of Birth", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "73", + "Dataset": "ADIS_V", + "Variable": "AGE", + "Label": "Age", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "ADSL Subject Demographics Variables", + "Has No Data": "No" + }, + { + "Order": "74", + "Dataset": "ADIS_V", + "Variable": "AGEU", + "Label": "Age Units", + "Data Type": "text", + "Length": "5", + "Mandatory": "No", + "Role": "ADSL Subject Demographics Variables", + "Has No Data": "No" + }, + { + "Order": "75", + "Dataset": "ADIS_V", + "Variable": "SEX", + "Label": "Sex", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "ADSL Subject Demographics Variables", + "Has No Data": "No" + }, + { + "Order": "76", + "Dataset": "ADIS_V", + "Variable": "RACE", + "Label": "Race", + "Data Type": "text", + "Length": "25", + "Mandatory": "No", + "Role": "ADSL Subject Demographics Variables", + "Has No Data": "No" + }, + { + "Order": "77", + "Dataset": "ADIS_V", + "Variable": "ETHNIC", + "Label": "Ethnicity", + "Data Type": "text", + "Length": "22", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "78", + "Dataset": "ADIS_V", + "Variable": "ARMCD", + "Label": "Planned Arm Code", + "Data Type": "text", + "Length": "5", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "79", + "Dataset": "ADIS_V", + "Variable": "ARM", + "Label": "Description of Planned Arm", + "Data Type": "text", + "Length": "19", + "Mandatory": "No", + "Role": "ADSL Treatment Variables", + "Has No Data": "No" + }, + { + "Order": "80", + "Dataset": "ADIS_V", + "Variable": "ACTARMCD", + "Label": "Actual Arm Code", + "Data Type": "text", + "Length": "5", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "81", + "Dataset": "ADIS_V", + "Variable": "ACTARM", + "Label": "Description of Actual Arm", + "Data Type": "text", + "Length": "19", + "Mandatory": "No", + "Role": "ADSL Treatment Variables", + "Has No Data": "No" + }, + { + "Order": "82", + "Dataset": "ADIS_V", + "Variable": "COUNTRY", + "Label": "Country", + "Data Type": "text", + "Length": "3", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "83", + "Dataset": "ADIS_V", + "Variable": "DMDTC", + "Label": "Date/Time of Collection", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "84", + "Dataset": "ADIS_V", + "Variable": "DMDY", + "Label": "Study Day of Collection", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "85", + "Dataset": "ADIS_V", + "Variable": "TRT01P", + "Label": "Planned Treatment for Period 01", + "Data Type": "text", + "Length": "9", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "86", + "Dataset": "ADIS_V", + "Variable": "TRT02P", + "Label": "Planned Treatment for Period 02", + "Data Type": "text", + "Length": "9", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "87", + "Dataset": "ADIS_V", + "Variable": "TRT01A", + "Label": "Actual Treatment for Period 01", + "Data Type": "text", + "Length": "9", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "88", + "Dataset": "ADIS_V", + "Variable": "TRT02A", + "Label": "Actual Treatment for Period 02", + "Data Type": "text", + "Length": "9", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "89", + "Dataset": "ADIS_V", + "Variable": "TRTSDTM", + "Label": "Datetime of First Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATETIME", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "90", + "Dataset": "ADIS_V", + "Variable": "TRTEDTM", + "Label": "Datetime of Last Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATETIME", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "91", + "Dataset": "ADIS_V", + "Variable": "TRTSDT", + "Label": "Date of First Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "92", + "Dataset": "ADIS_V", + "Variable": "TRTEDT", + "Label": "Date of Last Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "93", + "Dataset": "ADIS_V", + "Variable": "TRTDURD", + "Label": "Total Treatment Duration (Days)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "94", + "Dataset": "ADIS_V", + "Variable": "SAFFL", + "Label": "Safety Population Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "ADSL Population Indicator Variables", + "Has No Data": "No" + }, + { + "Order": "95", + "Dataset": "ADIS_V", + "Variable": "RACEGR1", + "Label": "Pooled Race Group 1", + "Data Type": "text", + "Length": "9", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "96", + "Dataset": "ADIS_V", + "Variable": "AGEGR1", + "Label": "Pooled Age Group 1", + "Data Type": "text", + "Length": "3", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "97", + "Dataset": "ADIS_V", + "Variable": "REGION1", + "Label": "Geographic Region 1", + "Data Type": "text", + "Length": "2", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "98", + "Dataset": "ADIS_V", + "Variable": "VAX01DT", + "Label": "Vaccination Date 01", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "99", + "Dataset": "ADIS_V", + "Variable": "VAX02DT", + "Label": "Vaccination Date 02", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "100", + "Dataset": "ADIS_V", + "Variable": "AP01SDT", + "Label": "Period 01 Start Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "101", + "Dataset": "ADIS_V", + "Variable": "AP01EDT", + "Label": "Period 01 End Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "102", + "Dataset": "ADIS_V", + "Variable": "AP02SDT", + "Label": "Period 02 Start Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "103", + "Dataset": "ADIS_V", + "Variable": "AP02EDT", + "Label": "Period 02 End Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "1", + "Dataset": "ADLB", + "Variable": "STUDYID", + "Label": "Study Identifier", + "Data Type": "text", + "Length": "12", + "Mandatory": "Yes", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "2", + "Dataset": "ADLB", + "Variable": "DOMAIN", + "Label": "Domain Abbreviation", + "Data Type": "text", + "Length": "2", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "3", + "Dataset": "ADLB", + "Variable": "USUBJID", + "Label": "Unique Subject Identifier", + "Data Type": "text", + "Length": "11", + "Mandatory": "Yes", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "4", + "Dataset": "ADLB", + "Variable": "LBSEQ", + "Label": "Sequence Number", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "5", + "Dataset": "ADLB", + "Variable": "LBTESTCD", + "Label": "Lab Test or Examination Short Name", + "Data Type": "text", + "Length": "7", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "6", + "Dataset": "ADLB", + "Variable": "LBTEST", + "Label": "Lab Test or Examination Name", + "Data Type": "text", + "Length": "39", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "7", + "Dataset": "ADLB", + "Variable": "LBCAT", + "Label": "Category for Lab Test", + "Data Type": "text", + "Length": "10", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "8", + "Dataset": "ADLB", + "Variable": "LBORRES", + "Label": "Result or Finding in Original Units", + "Data Type": "text", + "Length": "5", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "9", + "Dataset": "ADLB", + "Variable": "LBORRESU", + "Label": "Original Units", + "Data Type": "text", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "10", + "Dataset": "ADLB", + "Variable": "LBORNRLO", + "Label": "Reference Range Lower Limit in Orig Unit", + "Data Type": "text", + "Length": "5", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "11", + "Dataset": "ADLB", + "Variable": "LBORNRHI", + "Label": "Reference Range Upper Limit in Orig Unit", + "Data Type": "text", + "Length": "5", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "12", + "Dataset": "ADLB", + "Variable": "LBSTRESC", + "Label": "Character Result/Finding in Std Format", + "Data Type": "text", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "13", + "Dataset": "ADLB", + "Variable": "LBSTRESN", + "Label": "Numeric Result/Finding in Standard Units", + "Data Type": "float", + "Length": "9", + "Significant Digits": "5", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "14", + "Dataset": "ADLB", + "Variable": "LBSTRESU", + "Label": "Standard Units", + "Data Type": "text", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "15", + "Dataset": "ADLB", + "Variable": "LBSTNRLO", + "Label": "Reference Range Lower Limit-Std Units", + "Data Type": "float", + "Length": "6", + "Significant Digits": "3", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "16", + "Dataset": "ADLB", + "Variable": "LBSTNRHI", + "Label": "Reference Range Upper Limit-Std Units", + "Data Type": "float", + "Length": "6", + "Significant Digits": "3", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "17", + "Dataset": "ADLB", + "Variable": "LBNRIND", + "Label": "Reference Range Indicator", + "Data Type": "text", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "18", + "Dataset": "ADLB", + "Variable": "LBBLFL", + "Label": "Baseline Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "19", + "Dataset": "ADLB", + "Variable": "VISITNUM", + "Label": "Visit Number", + "Data Type": "float", + "Length": "4", + "Significant Digits": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "20", + "Dataset": "ADLB", + "Variable": "VISIT", + "Label": "Visit Name", + "Data Type": "text", + "Length": "19", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "21", + "Dataset": "ADLB", + "Variable": "VISITDY", + "Label": "Planned Study Day of Visit", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "22", + "Dataset": "ADLB", + "Variable": "LBDTC", + "Label": "Date/Time of Specimen Collection", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "23", + "Dataset": "ADLB", + "Variable": "LBDY", + "Label": "Study Day of Specimen Collection", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "24", + "Dataset": "ADLB", + "Variable": "TRTSDT", + "Label": "Date of First Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "25", + "Dataset": "ADLB", + "Variable": "TRTEDT", + "Label": "Date of Last Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "26", + "Dataset": "ADLB", + "Variable": "TRT01A", + "Label": "Actual Treatment for Period 01", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "27", + "Dataset": "ADLB", + "Variable": "TRT01P", + "Label": "Planned Treatment for Period 01", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "28", + "Dataset": "ADLB", + "Variable": "ADT", + "Label": "Analysis Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "29", + "Dataset": "ADLB", + "Variable": "ADY", + "Label": "Analysis Relative Day", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "30", + "Dataset": "ADLB", + "Variable": "PARAMCD", + "Label": "Parameter Code", + "Data Type": "text", + "Length": "7", + "Mandatory": "Yes", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "31", + "Dataset": "ADLB", + "Variable": "PARAM", + "Label": "Parameter", + "Data Type": "text", + "Length": "48", + "Mandatory": "Yes", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "32", + "Dataset": "ADLB", + "Variable": "PARAMN", + "Label": "Parameter (N)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "33", + "Dataset": "ADLB", + "Variable": "PARCAT1", + "Label": "Parameter Category 1", + "Data Type": "text", + "Length": "10", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "34", + "Dataset": "ADLB", + "Variable": "AVAL", + "Label": "Analysis Value", + "Data Type": "float", + "Length": "9", + "Significant Digits": "5", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "35", + "Dataset": "ADLB", + "Variable": "AVALC", + "Label": "Analysis Value (C)", + "Data Type": "text", + "Length": "8", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "36", + "Dataset": "ADLB", + "Variable": "ANRLO", + "Label": "Analysis Normal Range Lower Limit", + "Data Type": "float", + "Length": "6", + "Significant Digits": "3", + "Mandatory": "No", + "Role": "Toxicity and Range Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "37", + "Dataset": "ADLB", + "Variable": "ANRHI", + "Label": "Analysis Normal Range Upper Limit", + "Data Type": "float", + "Length": "6", + "Significant Digits": "3", + "Mandatory": "No", + "Role": "Toxicity and Range Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "38", + "Dataset": "ADLB", + "Variable": "DTYPE", + "Label": "Derivation Type", + "Data Type": "text", + "Length": "11", + "Mandatory": "No", + "Role": "Analysis Descriptor Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "39", + "Dataset": "ADLB", + "Variable": "AVISIT", + "Label": "Analysis Visit", + "Data Type": "text", + "Length": "21", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "40", + "Dataset": "ADLB", + "Variable": "AVISITN", + "Label": "Analysis Visit (N)", + "Data Type": "float", + "Length": "5", + "Significant Digits": "1", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "41", + "Dataset": "ADLB", + "Variable": "ONTRTFL", + "Label": "On Treatment Record Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "Flag Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "42", + "Dataset": "ADLB", + "Variable": "ANRIND", + "Label": "Analysis Reference Range Indicator", + "Data Type": "text", + "Length": "6", + "Mandatory": "No", + "Role": "Toxicity and Range Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "43", + "Dataset": "ADLB", + "Variable": "BASETYPE", + "Label": "Baseline Type", + "Data Type": "text", + "Length": "4", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "44", + "Dataset": "ADLB", + "Variable": "ABLFL", + "Label": "Baseline Record Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "Flag Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "45", + "Dataset": "ADLB", + "Variable": "BASE", + "Label": "Baseline Value", + "Data Type": "float", + "Length": "9", + "Significant Digits": "5", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "46", + "Dataset": "ADLB", + "Variable": "BASEC", + "Label": "Baseline Value (C)", + "Data Type": "text", + "Length": "8", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "47", + "Dataset": "ADLB", + "Variable": "BNRIND", + "Label": "Baseline Reference Range Indicator", + "Data Type": "text", + "Length": "6", + "Mandatory": "No", + "Role": "Toxicity and Range Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "48", + "Dataset": "ADLB", + "Variable": "CHG", + "Label": "Change from Baseline", + "Data Type": "float", + "Length": "9", + "Significant Digits": "5", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "49", + "Dataset": "ADLB", + "Variable": "PCHG", + "Label": "Percent Change from Baseline", + "Data Type": "float", + "Length": "12", + "Significant Digits": "8", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "50", + "Dataset": "ADLB", + "Variable": "ATOXDSCL", + "Label": "Analysis Toxicity Description Low", + "Data Type": "text", + "Length": "26", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "51", + "Dataset": "ADLB", + "Variable": "ATOXDSCH", + "Label": "Analysis Toxicity Description High", + "Data Type": "text", + "Length": "36", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "52", + "Dataset": "ADLB", + "Variable": "ATOXGRL", + "Label": "Analysis Toxicity Grade Low", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "53", + "Dataset": "ADLB", + "Variable": "ATOXGRH", + "Label": "Analysis Toxicity Grade High", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "54", + "Dataset": "ADLB", + "Variable": "ATOXGR", + "Label": "Analysis Toxicity Grade", + "Data Type": "text", + "Length": "2", + "Mandatory": "No", + "Role": "Toxicity and Range Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "55", + "Dataset": "ADLB", + "Variable": "BTOXGRL", + "Label": "Baseline Toxicity Grade Low", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "56", + "Dataset": "ADLB", + "Variable": "BTOXGRH", + "Label": "Baseline Toxicity Grade High", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "57", + "Dataset": "ADLB", + "Variable": "BTOXGR", + "Label": "Baseline Toxicity Grade", + "Data Type": "text", + "Length": "2", + "Mandatory": "No", + "Role": "Toxicity and Range Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "58", + "Dataset": "ADLB", + "Variable": "R2BASE", + "Label": "Ratio to Baseline", + "Data Type": "float", + "Length": "10", + "Significant Digits": "8", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "59", + "Dataset": "ADLB", + "Variable": "R2ANRLO", + "Label": "Ratio of Analysis Val compared to ANRLO", + "Data Type": "float", + "Length": "10", + "Significant Digits": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "60", + "Dataset": "ADLB", + "Variable": "R2ANRHI", + "Label": "Ratio of Analysis Val compared to ANRHI", + "Data Type": "float", + "Length": "10", + "Significant Digits": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "61", + "Dataset": "ADLB", + "Variable": "SHIFT1", + "Label": "Shift from Baseline to Analysis Value", + "Data Type": "text", + "Length": "16", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "62", + "Dataset": "ADLB", + "Variable": "SHIFT2", + "Label": "Shift from Baseline to Overall Grade", + "Data Type": "text", + "Length": "12", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "63", + "Dataset": "ADLB", + "Variable": "ANL01FL", + "Label": "Analysis Flag 01", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "64", + "Dataset": "ADLB", + "Variable": "LVOTFL", + "Label": "Last Value On Treatment Record Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "Flag Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "65", + "Dataset": "ADLB", + "Variable": "TRTP", + "Label": "Planned Treatment", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Role": "Record-Level Treatment Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "66", + "Dataset": "ADLB", + "Variable": "TRTA", + "Label": "Actual Treatment", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Role": "Record-Level Treatment Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "67", + "Dataset": "ADLB", + "Variable": "ASEQ", + "Label": "Analysis Sequence Number", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "68", + "Dataset": "ADLB", + "Variable": "SUBJID", + "Label": "Subject Identifier for the Study", + "Data Type": "text", + "Length": "4", + "Mandatory": "No", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "69", + "Dataset": "ADLB", + "Variable": "RFSTDTC", + "Label": "Subject Reference Start Date/Time", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "70", + "Dataset": "ADLB", + "Variable": "RFENDTC", + "Label": "Subject Reference End Date/Time", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "71", + "Dataset": "ADLB", + "Variable": "RFXSTDTC", + "Label": "Date/Time of First Study Treatment", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "72", + "Dataset": "ADLB", + "Variable": "RFXENDTC", + "Label": "Date/Time of Last Study Treatment", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "73", + "Dataset": "ADLB", + "Variable": "RFICDTC", + "Label": "Date/Time of Informed Consent", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "74", + "Dataset": "ADLB", + "Variable": "RFPENDTC", + "Label": "Date/Time of End of Participation", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "75", + "Dataset": "ADLB", + "Variable": "DTHDTC", + "Label": "Date/Time of Death", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "76", + "Dataset": "ADLB", + "Variable": "DTHFL", + "Label": "Subject Death Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "77", + "Dataset": "ADLB", + "Variable": "SITEID", + "Label": "Study Site Identifier", + "Data Type": "text", + "Length": "3", + "Mandatory": "No", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "78", + "Dataset": "ADLB", + "Variable": "AGE", + "Label": "Age", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "ADSL Subject Demographics Variables", + "Has No Data": "No" + }, + { + "Order": "79", + "Dataset": "ADLB", + "Variable": "AGEU", + "Label": "Age Units", + "Data Type": "text", + "Length": "5", + "Mandatory": "No", + "Role": "ADSL Subject Demographics Variables", + "Has No Data": "No" + }, + { + "Order": "80", + "Dataset": "ADLB", + "Variable": "SEX", + "Label": "Sex", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "ADSL Subject Demographics Variables", + "Has No Data": "No" + }, + { + "Order": "81", + "Dataset": "ADLB", + "Variable": "RACE", + "Label": "Race", + "Data Type": "text", + "Length": "32", + "Mandatory": "No", + "Role": "ADSL Subject Demographics Variables", + "Has No Data": "No" + }, + { + "Order": "82", + "Dataset": "ADLB", + "Variable": "ETHNIC", + "Label": "Ethnicity", + "Data Type": "text", + "Length": "22", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "83", + "Dataset": "ADLB", + "Variable": "ARMCD", + "Label": "Planned Arm Code", + "Data Type": "text", + "Length": "6", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "84", + "Dataset": "ADLB", + "Variable": "ARM", + "Label": "Description of Planned Arm", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Role": "ADSL Treatment Variables", + "Has No Data": "No" + }, + { + "Order": "85", + "Dataset": "ADLB", + "Variable": "ACTARMCD", + "Label": "Actual Arm Code", + "Data Type": "text", + "Length": "6", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "86", + "Dataset": "ADLB", + "Variable": "ACTARM", + "Label": "Description of Actual Arm", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Role": "ADSL Treatment Variables", + "Has No Data": "No" + }, + { + "Order": "87", + "Dataset": "ADLB", + "Variable": "COUNTRY", + "Label": "Country", + "Data Type": "text", + "Length": "3", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "88", + "Dataset": "ADLB", + "Variable": "DMDTC", + "Label": "Date/Time of Collection", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "89", + "Dataset": "ADLB", + "Variable": "DMDY", + "Label": "Study Day of Collection", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "90", + "Dataset": "ADLB", + "Variable": "TRTSDTM", + "Label": "Datetime of First Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATETIME", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "91", + "Dataset": "ADLB", + "Variable": "TRTSTMF", + "Label": "Time of First Exposure Imput. Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "92", + "Dataset": "ADLB", + "Variable": "TRTEDTM", + "Label": "Datetime of Last Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATETIME", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "93", + "Dataset": "ADLB", + "Variable": "TRTETMF", + "Label": "Time of Last Exposure Imput. Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "94", + "Dataset": "ADLB", + "Variable": "TRTDURD", + "Label": "Total Treatment Duration (Days)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "95", + "Dataset": "ADLB", + "Variable": "SCRFDT", + "Label": "Screen Failure Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "96", + "Dataset": "ADLB", + "Variable": "EOSDT", + "Label": "End of Study Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "97", + "Dataset": "ADLB", + "Variable": "EOSSTT", + "Label": "End of Study Status", + "Data Type": "text", + "Length": "12", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "98", + "Dataset": "ADLB", + "Variable": "FRVDT", + "Label": "Final Retrievel Visit Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "99", + "Dataset": "ADLB", + "Variable": "RANDDT", + "Label": "Date of Randomization", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "100", + "Dataset": "ADLB", + "Variable": "DTHDT", + "Label": "Date of Death", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "101", + "Dataset": "ADLB", + "Variable": "DTHADY", + "Label": "Relative Day of Death", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "102", + "Dataset": "ADLB", + "Variable": "LDDTHELD", + "Label": "Elapsed Days from Last Dose to Death", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "103", + "Dataset": "ADLB", + "Variable": "LSTALVDT", + "Label": "Date Last Known Alive", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "104", + "Dataset": "ADLB", + "Variable": "AGEGR1", + "Label": "Pooled Age Group 1", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "105", + "Dataset": "ADLB", + "Variable": "SAFFL", + "Label": "Safety Population Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "ADSL Population Indicator Variables", + "Has No Data": "No" + }, + { + "Order": "106", + "Dataset": "ADLB", + "Variable": "RACEGR1", + "Label": "Pooled Race Group 1", + "Data Type": "text", + "Length": "9", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "107", + "Dataset": "ADLB", + "Variable": "REGION1", + "Label": "Geographic Region 1", + "Data Type": "text", + "Length": "2", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "108", + "Dataset": "ADLB", + "Variable": "LDDTHGR1", + "Label": "Last Dose to Death - Days Elapsed Grp 1", + "Data Type": "text", + "Length": "5", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "109", + "Dataset": "ADLB", + "Variable": "DTH30FL", + "Label": "Death Within 30 Days of Last Trt Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "110", + "Dataset": "ADLB", + "Variable": "DTHA30FL", + "Label": "Death After 30 Days from Last Trt Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "111", + "Dataset": "ADLB", + "Variable": "DTHB30FL", + "Label": "Death Within 30 Days of First Trt Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "1", + "Dataset": "ADLBHY", + "Variable": "STUDYID", + "Label": "Study Identifier", + "Data Type": "text", + "Length": "12", + "Mandatory": "Yes", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "2", + "Dataset": "ADLBHY", + "Variable": "USUBJID", + "Label": "Unique Subject Identifier", + "Data Type": "text", + "Length": "11", + "Mandatory": "Yes", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "3", + "Dataset": "ADLBHY", + "Variable": "TRT01A", + "Label": "Actual Treatment for Period 01", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "4", + "Dataset": "ADLBHY", + "Variable": "PARAMCD", + "Label": "Parameter Code", + "Data Type": "text", + "Length": "6", + "Mandatory": "Yes", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "5", + "Dataset": "ADLBHY", + "Variable": "LBSEQ", + "Label": "Sequence Number", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "6", + "Dataset": "ADLBHY", + "Variable": "ADT", + "Label": "Analysis Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "7", + "Dataset": "ADLBHY", + "Variable": "AVISIT", + "Label": "Analysis Visit", + "Data Type": "text", + "Length": "15", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "8", + "Dataset": "ADLBHY", + "Variable": "ADY", + "Label": "Analysis Relative Day", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "9", + "Dataset": "ADLBHY", + "Variable": "AVAL", + "Label": "Analysis Value", + "Data Type": "float", + "Length": "5", + "Significant Digits": "2", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "10", + "Dataset": "ADLBHY", + "Variable": "ANRHI", + "Label": "Analysis Normal Range Upper Limit", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Toxicity and Range Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "11", + "Dataset": "ADLBHY", + "Variable": "CRIT1", + "Label": "Analysis Criterion 1", + "Data Type": "text", + "Length": "12", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "12", + "Dataset": "ADLBHY", + "Variable": "CRIT1FL", + "Label": "Criterion 1 Evaluation Result Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "13", + "Dataset": "ADLBHY", + "Variable": "AVALC", + "Label": "Analysis Value (C)", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "14", + "Dataset": "ADLBHY", + "Variable": "PARAM", + "Label": "Parameter", + "Data Type": "text", + "Length": "34", + "Mandatory": "Yes", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "1", + "Dataset": "ADMH", + "Variable": "STUDYID", + "Label": "Study Identifier", + "Data Type": "text", + "Length": "12", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "2", + "Dataset": "ADMH", + "Variable": "DOMAIN", + "Label": "Domain Abbreviation", + "Data Type": "text", + "Length": "2", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "3", + "Dataset": "ADMH", + "Variable": "USUBJID", + "Label": "Unique Subject Identifier", + "Data Type": "text", + "Length": "11", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "4", + "Dataset": "ADMH", + "Variable": "MHSEQ", + "Label": "Sequence Number", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "5", + "Dataset": "ADMH", + "Variable": "MHSPID", + "Label": "Sponsor-Defined Identifier", + "Data Type": "text", + "Length": "3", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "6", + "Dataset": "ADMH", + "Variable": "MHTERM", + "Label": "Reported Term for the Medical History", + "Data Type": "text", + "Length": "19", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "7", + "Dataset": "ADMH", + "Variable": "MHLLT", + "Label": "Lowest Level Term", + "Data Type": "text", + "Length": "60", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "8", + "Dataset": "ADMH", + "Variable": "MHDECOD", + "Label": "Dictionary-Derived Term", + "Data Type": "text", + "Length": "44", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "9", + "Dataset": "ADMH", + "Variable": "MHHLT", + "Label": "High Level Term", + "Data Type": "text", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "10", + "Dataset": "ADMH", + "Variable": "MHHLGT", + "Label": "High Level Group Term", + "Data Type": "text", + "Length": "9", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "11", + "Dataset": "ADMH", + "Variable": "MHCAT", + "Label": "Category for Medical History", + "Data Type": "text", + "Length": "34", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "12", + "Dataset": "ADMH", + "Variable": "MHBODSYS", + "Label": "Body System or Organ Class", + "Data Type": "text", + "Length": "67", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "13", + "Dataset": "ADMH", + "Variable": "MHSEV", + "Label": "Severity/Intensity", + "Data Type": "text", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "14", + "Dataset": "ADMH", + "Variable": "VISITNUM", + "Label": "Visit Number", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "15", + "Dataset": "ADMH", + "Variable": "VISIT", + "Label": "Visit Name", + "Data Type": "text", + "Length": "11", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "16", + "Dataset": "ADMH", + "Variable": "VISITDY", + "Label": "Planned Study Day of Visit", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "17", + "Dataset": "ADMH", + "Variable": "MHDTC", + "Label": "Date/Time of History Collection", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "18", + "Dataset": "ADMH", + "Variable": "MHSTDTC", + "Label": "Start Date/Time of Medical History Event", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "19", + "Dataset": "ADMH", + "Variable": "MHDY", + "Label": "Study Day of History Collection", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "20", + "Dataset": "ADMH", + "Variable": "MHENDTC", + "Label": "End Date/Time of Medical History Event", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "21", + "Dataset": "ADMH", + "Variable": "MHPRESP", + "Label": "Medical History Event Pre-Specified", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "22", + "Dataset": "ADMH", + "Variable": "MHOCCUR", + "Label": "Medical History Occurrence", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "23", + "Dataset": "ADMH", + "Variable": "MHSTRTPT", + "Label": "Start Relative to Reference Time Point", + "Data Type": "text", + "Length": "6", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "24", + "Dataset": "ADMH", + "Variable": "MHENRTPT", + "Label": "End Relative to Reference Time Point", + "Data Type": "text", + "Length": "7", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "25", + "Dataset": "ADMH", + "Variable": "MHSTTPT", + "Label": "Start Reference Time Point", + "Data Type": "text", + "Length": "9", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "26", + "Dataset": "ADMH", + "Variable": "MHENTPT", + "Label": "End Reference Time Point", + "Data Type": "text", + "Length": "24", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "27", + "Dataset": "ADMH", + "Variable": "MHENRF", + "Label": "End Relative to Reference Period", + "Data Type": "text", + "Length": "6", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "28", + "Dataset": "ADMH", + "Variable": "MHSTAT", + "Label": "Completion Status", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "29", + "Dataset": "ADMH", + "Variable": "TRTSDT", + "Label": "Date of First Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "30", + "Dataset": "ADMH", + "Variable": "TRTEDT", + "Label": "Date of Last Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "31", + "Dataset": "ADMH", + "Variable": "TRT01A", + "Label": "Actual Treatment for Period 01", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "32", + "Dataset": "ADMH", + "Variable": "TRT01P", + "Label": "Planned Treatment for Period 01", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "33", + "Dataset": "ADMH", + "Variable": "DTHDT", + "Label": "Date of Death", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "34", + "Dataset": "ADMH", + "Variable": "EOSDT", + "Label": "End of Study Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "35", + "Dataset": "ADMH", + "Variable": "ASTDT", + "Label": "Analysis Start Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "36", + "Dataset": "ADMH", + "Variable": "AENDT", + "Label": "Analysis End Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "37", + "Dataset": "ADMH", + "Variable": "ASTDY", + "Label": "Analysis Start Relative Day", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "38", + "Dataset": "ADMH", + "Variable": "AENDY", + "Label": "Analysis End Relative Day", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "39", + "Dataset": "ADMH", + "Variable": "ADT", + "Label": "Analysis Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "40", + "Dataset": "ADMH", + "Variable": "ADY", + "Label": "Analysis Relative Day", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "41", + "Dataset": "ADMH", + "Variable": "SMQ02NAM", + "Label": "SMQ 02 Name", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "42", + "Dataset": "ADMH", + "Variable": "SMQ02CD", + "Label": "SMQ 02 Code", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "43", + "Dataset": "ADMH", + "Variable": "SMQ02SC", + "Label": "SMQ 02 Scope", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "44", + "Dataset": "ADMH", + "Variable": "SMQ02SCN", + "Label": "SMQ 02 Scope (N)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "45", + "Dataset": "ADMH", + "Variable": "SMQ03NAM", + "Label": "SMQ 03 Name", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "46", + "Dataset": "ADMH", + "Variable": "SMQ03CD", + "Label": "SMQ 03 Code", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "47", + "Dataset": "ADMH", + "Variable": "SMQ03SC", + "Label": "SMQ 03 Scope", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "48", + "Dataset": "ADMH", + "Variable": "SMQ03SCN", + "Label": "SMQ 03 Scope (N)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "49", + "Dataset": "ADMH", + "Variable": "SMQ05NAM", + "Label": "SMQ 05 Name", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "50", + "Dataset": "ADMH", + "Variable": "SMQ05CD", + "Label": "SMQ 05 Code", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "51", + "Dataset": "ADMH", + "Variable": "SMQ05SC", + "Label": "SMQ 05 Scope", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "52", + "Dataset": "ADMH", + "Variable": "SMQ05SCN", + "Label": "SMQ 05 Scope (N)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "53", + "Dataset": "ADMH", + "Variable": "CQ01NAM", + "Label": "Customized Query 01 Name", + "Data Type": "text", + "Length": "19", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "54", + "Dataset": "ADMH", + "Variable": "CQ04NAM", + "Label": "Customized Query 04 Name", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "55", + "Dataset": "ADMH", + "Variable": "CQ04CD", + "Label": "Customized Query 04 Code", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "56", + "Dataset": "ADMH", + "Variable": "AHIST", + "Label": "Response of Med Hx (past or current)", + "Data Type": "text", + "Length": "7", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "57", + "Dataset": "ADMH", + "Variable": "AOCCFL", + "Label": "1st Occurrence within Subject Flag\t", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "58", + "Dataset": "ADMH", + "Variable": "AOCCSFL", + "Label": "1st Occurrence of SOC Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "59", + "Dataset": "ADMH", + "Variable": "AOCCPFL", + "Label": "1st Occurrence of Preferred Term Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "60", + "Dataset": "ADMH", + "Variable": "AOCPFL", + "Label": "1st Occur w/in Trt Prd FL", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "61", + "Dataset": "ADMH", + "Variable": "AOCPSFL", + "Label": "1st Occur of SOC w/in Trt Prd FL", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "62", + "Dataset": "ADMH", + "Variable": "AOCPPFL", + "Label": "1st Occur of PT w/in Trt Prd FL", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "63", + "Dataset": "ADMH", + "Variable": "ANL01FL", + "Label": "Analysis Flag 01", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "64", + "Dataset": "ADMH", + "Variable": "TRTP", + "Label": "Planned Treatment", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "65", + "Dataset": "ADMH", + "Variable": "TRTA", + "Label": "Actual Treatment", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "66", + "Dataset": "ADMH", + "Variable": "APHASE", + "Label": "Phase", + "Data Type": "text", + "Length": "9", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "67", + "Dataset": "ADMH", + "Variable": "APHASEN", + "Label": "Description of Phase N", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "68", + "Dataset": "ADMH", + "Variable": "MHTERMN", + "Label": "Medical History Term (N)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "69", + "Dataset": "ADMH", + "Variable": "SUBJID", + "Label": "Subject Identifier for the Study", + "Data Type": "text", + "Length": "4", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "70", + "Dataset": "ADMH", + "Variable": "RFSTDTC", + "Label": "Subject Reference Start Date/Time", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "71", + "Dataset": "ADMH", + "Variable": "RFENDTC", + "Label": "Subject Reference End Date/Time", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "72", + "Dataset": "ADMH", + "Variable": "RFXSTDTC", + "Label": "Date/Time of First Study Treatment", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "73", + "Dataset": "ADMH", + "Variable": "RFXENDTC", + "Label": "Date/Time of Last Study Treatment", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "74", + "Dataset": "ADMH", + "Variable": "RFICDTC", + "Label": "Date/Time of Informed Consent", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "75", + "Dataset": "ADMH", + "Variable": "RFPENDTC", + "Label": "Date/Time of End of Participation", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "76", + "Dataset": "ADMH", + "Variable": "DTHDTC", + "Label": "Date/Time of Death", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "77", + "Dataset": "ADMH", + "Variable": "DTHFL", + "Label": "Subject Death Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "78", + "Dataset": "ADMH", + "Variable": "SITEID", + "Label": "Study Site Identifier", + "Data Type": "text", + "Length": "3", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "79", + "Dataset": "ADMH", + "Variable": "AGE", + "Label": "Age", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "80", + "Dataset": "ADMH", + "Variable": "AGEU", + "Label": "Age Units", + "Data Type": "text", + "Length": "5", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "81", + "Dataset": "ADMH", + "Variable": "SEX", + "Label": "Sex", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "82", + "Dataset": "ADMH", + "Variable": "RACE", + "Label": "Race", + "Data Type": "text", + "Length": "32", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "83", + "Dataset": "ADMH", + "Variable": "ETHNIC", + "Label": "Ethnicity", + "Data Type": "text", + "Length": "22", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "84", + "Dataset": "ADMH", + "Variable": "ARMCD", + "Label": "Planned Arm Code", + "Data Type": "text", + "Length": "6", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "85", + "Dataset": "ADMH", + "Variable": "ARM", + "Label": "Description of Planned Arm", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "86", + "Dataset": "ADMH", + "Variable": "ACTARMCD", + "Label": "Actual Arm Code", + "Data Type": "text", + "Length": "6", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "87", + "Dataset": "ADMH", + "Variable": "ACTARM", + "Label": "Description of Actual Arm", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "88", + "Dataset": "ADMH", + "Variable": "COUNTRY", + "Label": "Country", + "Data Type": "text", + "Length": "3", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "89", + "Dataset": "ADMH", + "Variable": "DMDTC", + "Label": "Date/Time of Collection", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "90", + "Dataset": "ADMH", + "Variable": "DMDY", + "Label": "Study Day of Collection", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "91", + "Dataset": "ADMH", + "Variable": "TRTSDTM", + "Label": "Datetime of First Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATETIME", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "92", + "Dataset": "ADMH", + "Variable": "TRTSTMF", + "Label": "Time of First Exposure Imput. Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "93", + "Dataset": "ADMH", + "Variable": "TRTEDTM", + "Label": "Datetime of Last Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATETIME", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "94", + "Dataset": "ADMH", + "Variable": "TRTETMF", + "Label": "Treatment End Datetime Imput Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "95", + "Dataset": "ADMH", + "Variable": "TRTDURD", + "Label": "Total Treatment Duration (Days)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "96", + "Dataset": "ADMH", + "Variable": "SCRFDT", + "Label": "Screen Failure Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "97", + "Dataset": "ADMH", + "Variable": "EOSSTT", + "Label": "End of Study Status", + "Data Type": "text", + "Length": "12", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "98", + "Dataset": "ADMH", + "Variable": "FRVDT", + "Label": "Final Retrievel Visit Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "99", + "Dataset": "ADMH", + "Variable": "RANDDT", + "Label": "Date of Randomization", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "100", + "Dataset": "ADMH", + "Variable": "DTHADY", + "Label": "Relative Day of Death", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "101", + "Dataset": "ADMH", + "Variable": "LDDTHELD", + "Label": "Elapsed Days from Last Dose to Death", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "102", + "Dataset": "ADMH", + "Variable": "LSTALVDT", + "Label": "Date Last Known Alive", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "103", + "Dataset": "ADMH", + "Variable": "AGEGR1", + "Label": "Pooled Age Group 1", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "104", + "Dataset": "ADMH", + "Variable": "SAFFL", + "Label": "Safety Population Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "105", + "Dataset": "ADMH", + "Variable": "RACEGR1", + "Label": "Pooled Race Group 1", + "Data Type": "text", + "Length": "9", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "106", + "Dataset": "ADMH", + "Variable": "REGION1", + "Label": "Geographic Region 1", + "Data Type": "text", + "Length": "2", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "107", + "Dataset": "ADMH", + "Variable": "LDDTHGR1", + "Label": "Last Dose to Death - Days Elapsed Grp 1", + "Data Type": "text", + "Length": "5", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "108", + "Dataset": "ADMH", + "Variable": "DTH30FL", + "Label": "Death Within 30 Days of Last Trt Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "109", + "Dataset": "ADMH", + "Variable": "DTHA30FL", + "Label": "Death After 30 Days from Last Trt Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "110", + "Dataset": "ADMH", + "Variable": "DTHB30FL", + "Label": "Death Within 30 Days of First Trt Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "1", + "Dataset": "ADOE_P", + "Variable": "STUDYID", + "Label": "Study Identifier", + "Data Type": "text", + "Length": "12", + "Mandatory": "Yes", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "2", + "Dataset": "ADOE_P", + "Variable": "DOMAIN", + "Label": "Domain Abbreviation", + "Data Type": "text", + "Length": "2", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "3", + "Dataset": "ADOE_P", + "Variable": "USUBJID", + "Label": "Unique Subject Identifier", + "Data Type": "text", + "Length": "11", + "Mandatory": "Yes", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "4", + "Dataset": "ADOE_P", + "Variable": "OESEQ", + "Label": "Sequence Number", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "5", + "Dataset": "ADOE_P", + "Variable": "OECAT", + "Label": "Category for Ophthalmic Test or Exam", + "Data Type": "text", + "Length": "22", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "6", + "Dataset": "ADOE_P", + "Variable": "OESCAT", + "Label": "Subcategory for Ophthalmic Test or Exam", + "Data Type": "text", + "Length": "33", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "7", + "Dataset": "ADOE_P", + "Variable": "OEDTC", + "Label": "Date/Time of Collection", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "8", + "Dataset": "ADOE_P", + "Variable": "VISIT", + "Label": "Visit Name", + "Data Type": "text", + "Length": "11", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "9", + "Dataset": "ADOE_P", + "Variable": "VISITNUM", + "Label": "Visit Number", + "Data Type": "float", + "Length": "3", + "Significant Digits": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "10", + "Dataset": "ADOE_P", + "Variable": "VISITDY", + "Label": "Planned Study Day of Visit", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "11", + "Dataset": "ADOE_P", + "Variable": "OESTRESN", + "Label": "Numeric Result/Finding in Standard Units", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "12", + "Dataset": "ADOE_P", + "Variable": "OESTRESC", + "Label": "Character Result/Finding in Std Format", + "Data Type": "text", + "Length": "14", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "13", + "Dataset": "ADOE_P", + "Variable": "OEORRES", + "Label": "Result or Finding in Original Units", + "Data Type": "text", + "Length": "14", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "14", + "Dataset": "ADOE_P", + "Variable": "OETEST", + "Label": "Name of Ophthalmic Test or Exam", + "Data Type": "text", + "Length": "37", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "15", + "Dataset": "ADOE_P", + "Variable": "OETESTCD", + "Label": "Short Name of Ophthalmic Test or Exam", + "Data Type": "text", + "Length": "6", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "16", + "Dataset": "ADOE_P", + "Variable": "OETSTDTL", + "Label": "Ophthalmic Test or Exam Detail", + "Data Type": "text", + "Length": "62", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "17", + "Dataset": "ADOE_P", + "Variable": "OELAT", + "Label": "Laterality", + "Data Type": "text", + "Length": "5", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "18", + "Dataset": "ADOE_P", + "Variable": "OELOC", + "Label": "Location Used for the Measurement", + "Data Type": "text", + "Length": "6", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "19", + "Dataset": "ADOE_P", + "Variable": "OEDY", + "Label": "Study Day of Visit/Collection/Exam", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "20", + "Dataset": "ADOE_P", + "Variable": "OEMETHOD", + "Label": "Method of Test or Examination", + "Data Type": "text", + "Length": "23", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "21", + "Dataset": "ADOE_P", + "Variable": "OEORRESU", + "Label": "Original Units", + "Data Type": "text", + "Length": "2", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "22", + "Dataset": "ADOE_P", + "Variable": "OESTRESU", + "Label": "Standard Units", + "Data Type": "text", + "Length": "2", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "23", + "Dataset": "ADOE_P", + "Variable": "OESTAT", + "Label": "Completion Status", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "24", + "Dataset": "ADOE_P", + "Variable": "OETPT", + "Label": "Planned Time Point Name", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "25", + "Dataset": "ADOE_P", + "Variable": "OETPTNUM", + "Label": "Planned Time Point Number", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "26", + "Dataset": "ADOE_P", + "Variable": "TRTSDT", + "Label": "Date of First Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "27", + "Dataset": "ADOE_P", + "Variable": "TRTEDT", + "Label": "Date of Last Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "28", + "Dataset": "ADOE_P", + "Variable": "TRT01A", + "Label": "Actual Treatment for Period 01", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "29", + "Dataset": "ADOE_P", + "Variable": "TRT01P", + "Label": "Planned Treatment for Period 01", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "30", + "Dataset": "ADOE_P", + "Variable": "STUDYEYE", + "Label": "Study Eye Location", + "Data Type": "text", + "Length": "5", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "31", + "Dataset": "ADOE_P", + "Variable": "AVAL", + "Label": "Analysis Value", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "32", + "Dataset": "ADOE_P", + "Variable": "AVALC", + "Label": "Analysis Value (C)", + "Data Type": "text", + "Length": "14", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "33", + "Dataset": "ADOE_P", + "Variable": "AVALU", + "Label": "Analysis Value Unit", + "Data Type": "text", + "Length": "2", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "34", + "Dataset": "ADOE_P", + "Variable": "DTYPE", + "Label": "Derivation Type", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "Analysis Descriptor Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "35", + "Dataset": "ADOE_P", + "Variable": "AFEYE", + "Label": "Affected Eye", + "Data Type": "text", + "Length": "10", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "36", + "Dataset": "ADOE_P", + "Variable": "PARAM", + "Label": "Parameter", + "Data Type": "text", + "Length": "41", + "Mandatory": "Yes", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "37", + "Dataset": "ADOE_P", + "Variable": "PARAMCD", + "Label": "Parameter Code", + "Data Type": "text", + "Length": "7", + "Mandatory": "Yes", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "38", + "Dataset": "ADOE_P", + "Variable": "ADT", + "Label": "Analysis Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "39", + "Dataset": "ADOE_P", + "Variable": "ADY", + "Label": "Analysis Relative Day", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "40", + "Dataset": "ADOE_P", + "Variable": "ATPTN", + "Label": "Analysis Timepoint (N)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "41", + "Dataset": "ADOE_P", + "Variable": "ATPT", + "Label": "Analysis Timepoint", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "42", + "Dataset": "ADOE_P", + "Variable": "AVISIT", + "Label": "Analysis Visit", + "Data Type": "text", + "Length": "11", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "43", + "Dataset": "ADOE_P", + "Variable": "AVISITN", + "Label": "Analysis Visit (N)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "44", + "Dataset": "ADOE_P", + "Variable": "BASETYPE", + "Label": "Baseline Type", + "Data Type": "text", + "Length": "4", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "45", + "Dataset": "ADOE_P", + "Variable": "ONTRTFL", + "Label": "On Treatment Record Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "Flag Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "46", + "Dataset": "ADOE_P", + "Variable": "ABLFL", + "Label": "Baseline Record Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "Flag Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "47", + "Dataset": "ADOE_P", + "Variable": "ANL01FL", + "Label": "Analysis Flag 01", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "48", + "Dataset": "ADOE_P", + "Variable": "ANL02FL", + "Label": "Analysis Flag 02", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "49", + "Dataset": "ADOE_P", + "Variable": "WORS01FL", + "Label": "Worst Post Baseline Obs", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "50", + "Dataset": "ADOE_P", + "Variable": "BASE", + "Label": "Baseline Value", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "51", + "Dataset": "ADOE_P", + "Variable": "BASEC", + "Label": "Baseline Value (C)", + "Data Type": "text", + "Length": "3", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "52", + "Dataset": "ADOE_P", + "Variable": "CHG", + "Label": "Change from Baseline", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "53", + "Dataset": "ADOE_P", + "Variable": "PCHG", + "Label": "Percent Change from Baseline", + "Data Type": "float", + "Length": "13", + "Significant Digits": "8", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "54", + "Dataset": "ADOE_P", + "Variable": "ASEQ", + "Label": "Analysis Sequence Number", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "55", + "Dataset": "ADOE_P", + "Variable": "SUBJID", + "Label": "Subject Identifier for the Study", + "Data Type": "text", + "Length": "4", + "Mandatory": "No", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "56", + "Dataset": "ADOE_P", + "Variable": "RFSTDTC", + "Label": "Subject Reference Start Date/Time", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "57", + "Dataset": "ADOE_P", + "Variable": "RFENDTC", + "Label": "Subject Reference End Date/Time", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "58", + "Dataset": "ADOE_P", + "Variable": "RFXSTDTC", + "Label": "Date/Time of First Study Treatment", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "59", + "Dataset": "ADOE_P", + "Variable": "RFXENDTC", + "Label": "Date/Time of Last Study Treatment", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "60", + "Dataset": "ADOE_P", + "Variable": "RFICDTC", + "Label": "Date/Time of Informed Consent", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "61", + "Dataset": "ADOE_P", + "Variable": "RFPENDTC", + "Label": "Date/Time of End of Participation", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "62", + "Dataset": "ADOE_P", + "Variable": "DTHDTC", + "Label": "Date/Time of Death", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "63", + "Dataset": "ADOE_P", + "Variable": "DTHFL", + "Label": "Subject Death Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "64", + "Dataset": "ADOE_P", + "Variable": "SITEID", + "Label": "Study Site Identifier", + "Data Type": "text", + "Length": "3", + "Mandatory": "No", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "65", + "Dataset": "ADOE_P", + "Variable": "AGE", + "Label": "Age", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "ADSL Subject Demographics Variables", + "Has No Data": "No" + }, + { + "Order": "66", + "Dataset": "ADOE_P", + "Variable": "AGEU", + "Label": "Age Units", + "Data Type": "text", + "Length": "5", + "Mandatory": "No", + "Role": "ADSL Subject Demographics Variables", + "Has No Data": "No" + }, + { + "Order": "67", + "Dataset": "ADOE_P", + "Variable": "SEX", + "Label": "Sex", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "ADSL Subject Demographics Variables", + "Has No Data": "No" + }, + { + "Order": "68", + "Dataset": "ADOE_P", + "Variable": "RACE", + "Label": "Race", + "Data Type": "text", + "Length": "32", + "Mandatory": "No", + "Role": "ADSL Subject Demographics Variables", + "Has No Data": "No" + }, + { + "Order": "69", + "Dataset": "ADOE_P", + "Variable": "ETHNIC", + "Label": "Ethnicity", + "Data Type": "text", + "Length": "22", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "70", + "Dataset": "ADOE_P", + "Variable": "ARMCD", + "Label": "Planned Arm Code", + "Data Type": "text", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "71", + "Dataset": "ADOE_P", + "Variable": "ARM", + "Label": "Description of Planned Arm", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Role": "ADSL Treatment Variables", + "Has No Data": "No" + }, + { + "Order": "72", + "Dataset": "ADOE_P", + "Variable": "ACTARMCD", + "Label": "Actual Arm Code", + "Data Type": "text", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "73", + "Dataset": "ADOE_P", + "Variable": "ACTARM", + "Label": "Description of Actual Arm", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Role": "ADSL Treatment Variables", + "Has No Data": "No" + }, + { + "Order": "74", + "Dataset": "ADOE_P", + "Variable": "COUNTRY", + "Label": "Country", + "Data Type": "text", + "Length": "3", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "75", + "Dataset": "ADOE_P", + "Variable": "DMDTC", + "Label": "Date/Time of Collection", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "76", + "Dataset": "ADOE_P", + "Variable": "DMDY", + "Label": "Study Day of Collection", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "77", + "Dataset": "ADOE_P", + "Variable": "TRTSDTM", + "Label": "Datetime of First Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATETIME", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "78", + "Dataset": "ADOE_P", + "Variable": "TRTSTMF", + "Label": "Time of First Exposure Imput. Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "79", + "Dataset": "ADOE_P", + "Variable": "TRTEDTM", + "Label": "Datetime of Last Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATETIME", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "80", + "Dataset": "ADOE_P", + "Variable": "TRTETMF", + "Label": "Time of Last Exposure Imput. Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "81", + "Dataset": "ADOE_P", + "Variable": "TRTDURD", + "Label": "Total Treatment Duration (Days)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "82", + "Dataset": "ADOE_P", + "Variable": "SCRFDT", + "Label": "Screen Failure Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "83", + "Dataset": "ADOE_P", + "Variable": "EOSDT", + "Label": "End of Study Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "84", + "Dataset": "ADOE_P", + "Variable": "EOSSTT", + "Label": "End of Study Status", + "Data Type": "text", + "Length": "12", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "85", + "Dataset": "ADOE_P", + "Variable": "FRVDT", + "Label": "Final Retrievel Visit Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "86", + "Dataset": "ADOE_P", + "Variable": "RANDDT", + "Label": "Date of Randomization", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "87", + "Dataset": "ADOE_P", + "Variable": "DTHDT", + "Label": "Date of Death", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "88", + "Dataset": "ADOE_P", + "Variable": "DTHADY", + "Label": "Relative Day of Death", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "89", + "Dataset": "ADOE_P", + "Variable": "LDDTHELD", + "Label": "Elapsed Days from Last Dose to Death", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "90", + "Dataset": "ADOE_P", + "Variable": "LSTALVDT", + "Label": "Date Last Known Alive", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "91", + "Dataset": "ADOE_P", + "Variable": "AGEGR1", + "Label": "Pooled Age Group 1", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "92", + "Dataset": "ADOE_P", + "Variable": "SAFFL", + "Label": "Safety Population Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "ADSL Population Indicator Variables", + "Has No Data": "No" + }, + { + "Order": "93", + "Dataset": "ADOE_P", + "Variable": "RACEGR1", + "Label": "Pooled Race Group 1", + "Data Type": "text", + "Length": "9", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "94", + "Dataset": "ADOE_P", + "Variable": "REGION1", + "Label": "Geographic Region 1", + "Data Type": "text", + "Length": "2", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "95", + "Dataset": "ADOE_P", + "Variable": "LDDTHGR1", + "Label": "Last Dose to Death - Days Elapsed Grp 1", + "Data Type": "text", + "Length": "5", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "96", + "Dataset": "ADOE_P", + "Variable": "DTH30FL", + "Label": "Death Within 30 Days of Last Trt Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "97", + "Dataset": "ADOE_P", + "Variable": "DTHA30FL", + "Label": "Death After 30 Days from Last Trt Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "98", + "Dataset": "ADOE_P", + "Variable": "DTHB30FL", + "Label": "Death Within 30 Days of First Trt Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "1", + "Dataset": "ADPC", + "Variable": "STUDYID", + "Label": "Study Identifier", + "Data Type": "text", + "Length": "12", + "Mandatory": "Yes", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "2", + "Dataset": "ADPC", + "Variable": "USUBJID", + "Label": "Unique Subject Identifier", + "Data Type": "text", + "Length": "11", + "Mandatory": "Yes", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "3", + "Dataset": "ADPC", + "Variable": "NFRLT", + "Label": "Nom. Rel. Time from Analyte First Dose", + "Data Type": "float", + "Length": "4", + "Significant Digits": "2", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "4", + "Dataset": "ADPC", + "Variable": "PCTESTCD", + "Label": "Pharmacokinetic Test Short Name", + "Data Type": "text", + "Length": "3", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "5", + "Dataset": "ADPC", + "Variable": "PCTEST", + "Label": "Pharmacokinetic Test Name", + "Data Type": "text", + "Length": "10", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "6", + "Dataset": "ADPC", + "Variable": "PCORRES", + "Label": "Result or Finding in Original Units", + "Data Type": "text", + "Length": "18", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "7", + "Dataset": "ADPC", + "Variable": "PCORRESU", + "Label": "Original Units", + "Data Type": "text", + "Length": "5", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "8", + "Dataset": "ADPC", + "Variable": "PCSTRESC", + "Label": "Character Result/Finding in Std Format", + "Data Type": "text", + "Length": "18", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "9", + "Dataset": "ADPC", + "Variable": "PCSTRESN", + "Label": "Numeric Result/Finding in Standard Units", + "Data Type": "float", + "Length": "9", + "Significant Digits": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "10", + "Dataset": "ADPC", + "Variable": "PCSTRESU", + "Label": "Standard Units", + "Data Type": "text", + "Length": "5", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "11", + "Dataset": "ADPC", + "Variable": "PCNAM", + "Label": "Vendor Name", + "Data Type": "text", + "Length": "14", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "12", + "Dataset": "ADPC", + "Variable": "PCSPEC", + "Label": "Specimen Material Type", + "Data Type": "text", + "Length": "6", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "13", + "Dataset": "ADPC", + "Variable": "PCLLOQ", + "Label": "Lower Limit of Quantitation", + "Data Type": "float", + "Length": "3", + "Significant Digits": "2", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "14", + "Dataset": "ADPC", + "Variable": "VISIT", + "Label": "Visit Name", + "Data Type": "text", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "15", + "Dataset": "ADPC", + "Variable": "VISITNUM", + "Label": "Visit Number", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "16", + "Dataset": "ADPC", + "Variable": "PCDTC", + "Label": "Date/Time of Specimen Collection", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "17", + "Dataset": "ADPC", + "Variable": "PCDY", + "Label": "Actual Study Day of Specimen Collection", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "18", + "Dataset": "ADPC", + "Variable": "PCTPT", + "Label": "Planned Time Point Name", + "Data Type": "text", + "Length": "16", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "19", + "Dataset": "ADPC", + "Variable": "PCTPTNUM", + "Label": "Planned Time Point Number", + "Data Type": "float", + "Length": "4", + "Significant Digits": "2", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "20", + "Dataset": "ADPC", + "Variable": "TRTSDT", + "Label": "Date of First Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "21", + "Dataset": "ADPC", + "Variable": "TRTSDTM", + "Label": "Datetime of First Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATETIME", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "22", + "Dataset": "ADPC", + "Variable": "TRT01P", + "Label": "Planned Treatment for Period 01", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "23", + "Dataset": "ADPC", + "Variable": "TRT01A", + "Label": "Actual Treatment for Period 01", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "24", + "Dataset": "ADPC", + "Variable": "ADTM", + "Label": "Analysis Datetime", + "Data Type": "integer", + "Length": "8", + "Format": "DATETIME", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "25", + "Dataset": "ADPC", + "Variable": "ATMF", + "Label": "Analysis Time Imputation Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "26", + "Dataset": "ADPC", + "Variable": "ADT", + "Label": "Analysis Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "27", + "Dataset": "ADPC", + "Variable": "ATM", + "Label": "Analysis Time", + "Data Type": "integer", + "Length": "8", + "Format": "TIME", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "28", + "Dataset": "ADPC", + "Variable": "ADY", + "Label": "Analysis Relative Day", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "29", + "Dataset": "ADPC", + "Variable": "FANLDTM", + "Label": "First Datetime of Dose for Analyte", + "Data Type": "integer", + "Length": "8", + "Format": "DATETIME", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "30", + "Dataset": "ADPC", + "Variable": "AVISITN", + "Label": "Analysis Visit (N)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "31", + "Dataset": "ADPC", + "Variable": "AVISIT", + "Label": "Analysis Visit", + "Data Type": "text", + "Length": "5", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "32", + "Dataset": "ADPC", + "Variable": "ASTDT", + "Label": "Analysis Start Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "33", + "Dataset": "ADPC", + "Variable": "ASTDTM", + "Label": "Analysis Start Datetime", + "Data Type": "integer", + "Length": "8", + "Format": "DATETIME", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "34", + "Dataset": "ADPC", + "Variable": "AENDT", + "Label": "Analysis End Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "35", + "Dataset": "ADPC", + "Variable": "AENDTM", + "Label": "Analysis End Datetime", + "Data Type": "integer", + "Length": "8", + "Format": "DATETIME", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "36", + "Dataset": "ADPC", + "Variable": "ASTTM", + "Label": "Analysis Start Time", + "Data Type": "integer", + "Length": "8", + "Format": "TIME", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "37", + "Dataset": "ADPC", + "Variable": "AENTM", + "Label": "Analysis End Time", + "Data Type": "integer", + "Length": "8", + "Format": "TIME", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "38", + "Dataset": "ADPC", + "Variable": "AFRLT", + "Label": "Act. Rel. Time from Analyte First Dose", + "Data Type": "float", + "Length": "10", + "Significant Digits": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "39", + "Dataset": "ADPC", + "Variable": "ARRLT", + "Label": "Actual Rel. Time from Ref. Dose", + "Data Type": "float", + "Length": "10", + "Significant Digits": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "40", + "Dataset": "ADPC", + "Variable": "PCRFTDTM", + "Label": "Reference Datetime of Dose for Analyte", + "Data Type": "integer", + "Length": "8", + "Format": "DATETIME", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "41", + "Dataset": "ADPC", + "Variable": "FANLDT", + "Label": "First Date of Dose for Analyte", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "42", + "Dataset": "ADPC", + "Variable": "FANLTM", + "Label": "First Time of Dose for Analyte", + "Data Type": "integer", + "Length": "8", + "Format": "TIME", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "43", + "Dataset": "ADPC", + "Variable": "PCRFTDT", + "Label": "Reference Date of Dose for Analyte", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "44", + "Dataset": "ADPC", + "Variable": "PCRFTTM", + "Label": "Reference Time of Dose for Analyte", + "Data Type": "integer", + "Length": "8", + "Format": "TIME", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "45", + "Dataset": "ADPC", + "Variable": "NRRLT", + "Label": "Nominal Rel. Time from Ref. Dose", + "Data Type": "float", + "Length": "4", + "Significant Digits": "2", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "46", + "Dataset": "ADPC", + "Variable": "ATPTN", + "Label": "Analysis Timepoint (N)", + "Data Type": "float", + "Length": "4", + "Significant Digits": "2", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "47", + "Dataset": "ADPC", + "Variable": "ATPT", + "Label": "Analysis Timepoint", + "Data Type": "text", + "Length": "16", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "48", + "Dataset": "ADPC", + "Variable": "ATPTREF", + "Label": "Analysis Timepoint Reference", + "Data Type": "text", + "Length": "5", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "49", + "Dataset": "ADPC", + "Variable": "ABLFL", + "Label": "Baseline Record Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "Flag Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "50", + "Dataset": "ADPC", + "Variable": "BASETYPE", + "Label": "Baseline Type", + "Data Type": "text", + "Length": "14", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "51", + "Dataset": "ADPC", + "Variable": "DOSEA", + "Label": "Actual Treatment Dose", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Record-Level Dose Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "52", + "Dataset": "ADPC", + "Variable": "DOSEP", + "Label": "Planned Treatment Dose", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Record-Level Dose Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "53", + "Dataset": "ADPC", + "Variable": "DOSEU", + "Label": "Treatment Dose Units", + "Data Type": "text", + "Length": "2", + "Mandatory": "No", + "Role": "Record-Level Dose Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "54", + "Dataset": "ADPC", + "Variable": "FRLTU", + "Label": "Rel. Time from First Dose Unit", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "55", + "Dataset": "ADPC", + "Variable": "RRLTU", + "Label": "Rel. Time from Ref. Dose Unit", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "56", + "Dataset": "ADPC", + "Variable": "PARAMCD", + "Label": "Parameter Code", + "Data Type": "text", + "Length": "4", + "Mandatory": "Yes", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "57", + "Dataset": "ADPC", + "Variable": "ALLOQ", + "Label": "Analysis Lower Limit of Quantitation", + "Data Type": "float", + "Length": "3", + "Significant Digits": "2", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "58", + "Dataset": "ADPC", + "Variable": "AVAL", + "Label": "Analysis Value", + "Data Type": "float", + "Length": "10", + "Significant Digits": "8", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "59", + "Dataset": "ADPC", + "Variable": "AVALU", + "Label": "Analysis Value Unit", + "Data Type": "text", + "Length": "5", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "60", + "Dataset": "ADPC", + "Variable": "AVALCAT1", + "Label": "Analysis Value Category 1", + "Data Type": "text", + "Length": "6", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "61", + "Dataset": "ADPC", + "Variable": "SRCDOM", + "Label": "Source Data", + "Data Type": "text", + "Length": "2", + "Mandatory": "No", + "Role": "Datapoint Traceability Variables", + "Has No Data": "No" + }, + { + "Order": "62", + "Dataset": "ADPC", + "Variable": "SRCVAR", + "Label": "Source Variable", + "Data Type": "text", + "Length": "3", + "Mandatory": "No", + "Role": "Datapoint Traceability Variables", + "Has No Data": "No" + }, + { + "Order": "63", + "Dataset": "ADPC", + "Variable": "SRCSEQ", + "Label": "Source Sequence Number", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Datapoint Traceability Variables", + "Has No Data": "No" + }, + { + "Order": "64", + "Dataset": "ADPC", + "Variable": "DTYPE", + "Label": "Derivation Type", + "Data Type": "text", + "Length": "4", + "Mandatory": "No", + "Role": "Analysis Descriptor Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "65", + "Dataset": "ADPC", + "Variable": "MRRLT", + "Label": "Modified Rel. Time from Ref. Dose ", + "Data Type": "float", + "Length": "10", + "Significant Digits": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "66", + "Dataset": "ADPC", + "Variable": "ANL01FL", + "Label": "Analysis Flag 01", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "67", + "Dataset": "ADPC", + "Variable": "ANL02FL", + "Label": "Analysis Flag 02", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "68", + "Dataset": "ADPC", + "Variable": "BASE", + "Label": "Baseline Value", + "Data Type": "float", + "Length": "9", + "Significant Digits": "8", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "69", + "Dataset": "ADPC", + "Variable": "CHG", + "Label": "Change from Baseline", + "Data Type": "float", + "Length": "10", + "Significant Digits": "8", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "70", + "Dataset": "ADPC", + "Variable": "ASEQ", + "Label": "Analysis Sequence Number", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "71", + "Dataset": "ADPC", + "Variable": "PARAM", + "Label": "Parameter", + "Data Type": "text", + "Length": "43", + "Mandatory": "Yes", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "72", + "Dataset": "ADPC", + "Variable": "PARAMN", + "Label": "Parameter (N)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "73", + "Dataset": "ADPC", + "Variable": "HTBL", + "Label": "Numeric Result/Finding in Standard Units", + "Data Type": "float", + "Length": "5", + "Significant Digits": "2", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "74", + "Dataset": "ADPC", + "Variable": "HTBLU", + "Label": "Standard Units", + "Data Type": "text", + "Length": "2", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "75", + "Dataset": "ADPC", + "Variable": "WTBL", + "Label": "Numeric Result/Finding in Standard Units", + "Data Type": "float", + "Length": "5", + "Significant Digits": "2", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "76", + "Dataset": "ADPC", + "Variable": "WTBLU", + "Label": "Standard Units", + "Data Type": "text", + "Length": "2", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "77", + "Dataset": "ADPC", + "Variable": "BMIBL", + "Label": "Baseline Body Mass Index (kg/m2)", + "Data Type": "float", + "Length": "10", + "Significant Digits": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "78", + "Dataset": "ADPC", + "Variable": "BMIBLU", + "Label": "BMI at Baseline (Unit)", + "Data Type": "text", + "Length": "6", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "79", + "Dataset": "ADPC", + "Variable": "SUBJID", + "Label": "Subject Identifier for the Study", + "Data Type": "text", + "Length": "4", + "Mandatory": "No", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "80", + "Dataset": "ADPC", + "Variable": "RFSTDTC", + "Label": "Subject Reference Start Date/Time", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "81", + "Dataset": "ADPC", + "Variable": "RFENDTC", + "Label": "Subject Reference End Date/Time", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "82", + "Dataset": "ADPC", + "Variable": "RFXSTDTC", + "Label": "Date/Time of First Study Treatment", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "83", + "Dataset": "ADPC", + "Variable": "RFXENDTC", + "Label": "Date/Time of Last Study Treatment", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "84", + "Dataset": "ADPC", + "Variable": "RFICDTC", + "Label": "Date/Time of Informed Consent", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "85", + "Dataset": "ADPC", + "Variable": "RFPENDTC", + "Label": "Date/Time of End of Participation", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "86", + "Dataset": "ADPC", + "Variable": "DTHDTC", + "Label": "Date/Time of Death", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "87", + "Dataset": "ADPC", + "Variable": "DTHFL", + "Label": "Subject Death Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "88", + "Dataset": "ADPC", + "Variable": "SITEID", + "Label": "Study Site Identifier", + "Data Type": "text", + "Length": "3", + "Mandatory": "No", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "89", + "Dataset": "ADPC", + "Variable": "AGE", + "Label": "Age", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "ADSL Subject Demographics Variables", + "Has No Data": "No" + }, + { + "Order": "90", + "Dataset": "ADPC", + "Variable": "AGEU", + "Label": "Age Units", + "Data Type": "text", + "Length": "5", + "Mandatory": "No", + "Role": "ADSL Subject Demographics Variables", + "Has No Data": "No" + }, + { + "Order": "91", + "Dataset": "ADPC", + "Variable": "SEX", + "Label": "Sex", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "ADSL Subject Demographics Variables", + "Has No Data": "No" + }, + { + "Order": "92", + "Dataset": "ADPC", + "Variable": "RACE", + "Label": "Race", + "Data Type": "text", + "Length": "32", + "Mandatory": "No", + "Role": "ADSL Subject Demographics Variables", + "Has No Data": "No" + }, + { + "Order": "93", + "Dataset": "ADPC", + "Variable": "ETHNIC", + "Label": "Ethnicity", + "Data Type": "text", + "Length": "22", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "94", + "Dataset": "ADPC", + "Variable": "ARMCD", + "Label": "Planned Arm Code", + "Data Type": "text", + "Length": "6", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "95", + "Dataset": "ADPC", + "Variable": "ARM", + "Label": "Description of Planned Arm", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Role": "ADSL Treatment Variables", + "Has No Data": "No" + }, + { + "Order": "96", + "Dataset": "ADPC", + "Variable": "ACTARMCD", + "Label": "Actual Arm Code", + "Data Type": "text", + "Length": "6", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "97", + "Dataset": "ADPC", + "Variable": "ACTARM", + "Label": "Description of Actual Arm", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Role": "ADSL Treatment Variables", + "Has No Data": "No" + }, + { + "Order": "98", + "Dataset": "ADPC", + "Variable": "COUNTRY", + "Label": "Country", + "Data Type": "text", + "Length": "3", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "99", + "Dataset": "ADPC", + "Variable": "DMDTC", + "Label": "Date/Time of Collection", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "100", + "Dataset": "ADPC", + "Variable": "DMDY", + "Label": "Study Day of Collection", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "101", + "Dataset": "ADPC", + "Variable": "TRTSTMF", + "Label": "Time of First Exposure Imput. Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "102", + "Dataset": "ADPC", + "Variable": "TRTEDTM", + "Label": "Datetime of Last Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATETIME", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "103", + "Dataset": "ADPC", + "Variable": "TRTETMF", + "Label": "Time of Last Exposure Imput. Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "104", + "Dataset": "ADPC", + "Variable": "TRTEDT", + "Label": "Date of Last Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "105", + "Dataset": "ADPC", + "Variable": "TRTDURD", + "Label": "Total Treatment Duration (Days)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "106", + "Dataset": "ADPC", + "Variable": "SCRFDT", + "Label": "Screen Failure Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "107", + "Dataset": "ADPC", + "Variable": "EOSDT", + "Label": "End of Study Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "108", + "Dataset": "ADPC", + "Variable": "EOSSTT", + "Label": "End of Study Status", + "Data Type": "text", + "Length": "12", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "109", + "Dataset": "ADPC", + "Variable": "FRVDT", + "Label": "Final Retrievel Visit Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "110", + "Dataset": "ADPC", + "Variable": "RANDDT", + "Label": "Date of Randomization", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "111", + "Dataset": "ADPC", + "Variable": "DTHDT", + "Label": "Date of Death", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "112", + "Dataset": "ADPC", + "Variable": "DTHADY", + "Label": "Relative Day of Death", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "113", + "Dataset": "ADPC", + "Variable": "LDDTHELD", + "Label": "Elapsed Days from Last Dose to Death", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "114", + "Dataset": "ADPC", + "Variable": "LSTALVDT", + "Label": "Date Last Known Alive", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "115", + "Dataset": "ADPC", + "Variable": "AGEGR1", + "Label": "Pooled Age Group 1", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "116", + "Dataset": "ADPC", + "Variable": "SAFFL", + "Label": "Safety Population Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "ADSL Population Indicator Variables", + "Has No Data": "No" + }, + { + "Order": "117", + "Dataset": "ADPC", + "Variable": "RACEGR1", + "Label": "Pooled Race Group 1", + "Data Type": "text", + "Length": "9", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "118", + "Dataset": "ADPC", + "Variable": "REGION1", + "Label": "Geographic Region 1", + "Data Type": "text", + "Length": "2", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "119", + "Dataset": "ADPC", + "Variable": "LDDTHGR1", + "Label": "Last Dose to Death - Days Elapsed Grp 1", + "Data Type": "text", + "Length": "5", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "120", + "Dataset": "ADPC", + "Variable": "DTH30FL", + "Label": "Under 30 Group", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "121", + "Dataset": "ADPC", + "Variable": "DTHA30FL", + "Label": "Over 30 Group", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "122", + "Dataset": "ADPC", + "Variable": "DTHB30FL", + "Label": "Over 30 plus 30 days Group", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "123", + "Dataset": "ADPC", + "Variable": "PARCAT1", + "Label": "Parameter Category 1", + "Data Type": "text", + "Length": "40", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "1", + "Dataset": "ADPP", + "Variable": "STUDYID", + "Label": "Study Identifier", + "Data Type": "text", + "Length": "12", + "Mandatory": "Yes", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "2", + "Dataset": "ADPP", + "Variable": "USUBJID", + "Label": "Unique Subject Identifier", + "Data Type": "text", + "Length": "11", + "Mandatory": "Yes", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "3", + "Dataset": "ADPP", + "Variable": "PPTESTCD", + "Label": "Parameter Short Name", + "Data Type": "text", + "Length": "7", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "4", + "Dataset": "ADPP", + "Variable": "PPTEST", + "Label": "Parameter Name", + "Data Type": "text", + "Length": "29", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "5", + "Dataset": "ADPP", + "Variable": "PPCAT", + "Label": "Parameter Category", + "Data Type": "text", + "Length": "13", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "6", + "Dataset": "ADPP", + "Variable": "PPORRES", + "Label": "Result or Finding in Original Units", + "Data Type": "float", + "Length": "10", + "Significant Digits": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "7", + "Dataset": "ADPP", + "Variable": "PPORRESU", + "Label": "Original Units", + "Data Type": "text", + "Length": "7", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "8", + "Dataset": "ADPP", + "Variable": "PPSTRESU", + "Label": "Standard Units", + "Data Type": "text", + "Length": "7", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "9", + "Dataset": "ADPP", + "Variable": "PPSPEC", + "Label": "Specimen Material Type", + "Data Type": "text", + "Length": "6", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "10", + "Dataset": "ADPP", + "Variable": "PPRFDTC", + "Label": "Date/Time of Reference Point", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "11", + "Dataset": "ADPP", + "Variable": "TRTSDT", + "Label": "Date of First Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "12", + "Dataset": "ADPP", + "Variable": "TRTEDT", + "Label": "Date of Last Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "13", + "Dataset": "ADPP", + "Variable": "DTHDT", + "Label": "Date of Death", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "14", + "Dataset": "ADPP", + "Variable": "EOSDT", + "Label": "End of Study Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "15", + "Dataset": "ADPP", + "Variable": "TRT01P", + "Label": "Planned Treatment for Period 01", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "16", + "Dataset": "ADPP", + "Variable": "TRT01A", + "Label": "Actual Treatment for Period 01", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "17", + "Dataset": "ADPP", + "Variable": "ADT", + "Label": "Analysis Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "18", + "Dataset": "ADPP", + "Variable": "ADY", + "Label": "Analysis Relative Day", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "19", + "Dataset": "ADPP", + "Variable": "PARAMCD", + "Label": "Parameter Code", + "Data Type": "text", + "Length": "7", + "Mandatory": "Yes", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "20", + "Dataset": "ADPP", + "Variable": "AVAL", + "Label": "Numeric Result/Finding in Standard Units", + "Data Type": "float", + "Length": "10", + "Significant Digits": "8", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "21", + "Dataset": "ADPP", + "Variable": "AVALC", + "Label": "Character Result/Finding in Std Format", + "Data Type": "float", + "Length": "10", + "Significant Digits": "8", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "22", + "Dataset": "ADPP", + "Variable": "SRCDOM", + "Label": "Domain Abbreviation", + "Data Type": "text", + "Length": "2", + "Mandatory": "No", + "Role": "Datapoint Traceability Variables", + "Has No Data": "No" + }, + { + "Order": "23", + "Dataset": "ADPP", + "Variable": "SRCVAR", + "Label": "Source Variable", + "Data Type": "text", + "Length": "3", + "Mandatory": "No", + "Role": "Datapoint Traceability Variables", + "Has No Data": "No" + }, + { + "Order": "24", + "Dataset": "ADPP", + "Variable": "SRCSEQ", + "Label": "Sequence Number", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Datapoint Traceability Variables", + "Has No Data": "No" + }, + { + "Order": "25", + "Dataset": "ADPP", + "Variable": "VISIT", + "Label": "Visit Name", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "26", + "Dataset": "ADPP", + "Variable": "VISITNUM", + "Label": "Visit Number", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "27", + "Dataset": "ADPP", + "Variable": "AVISIT", + "Label": "Analysis Visit", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "28", + "Dataset": "ADPP", + "Variable": "AVISITN", + "Label": "Analysis Visit (N)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "29", + "Dataset": "ADPP", + "Variable": "TRTP", + "Label": "Planned Treatment", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Role": "Record-Level Treatment Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "30", + "Dataset": "ADPP", + "Variable": "TRTA", + "Label": "Actual Treatment", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Role": "Record-Level Treatment Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "31", + "Dataset": "ADPP", + "Variable": "AVALCA1N", + "Label": "Analysis Value Category 1 (N)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "32", + "Dataset": "ADPP", + "Variable": "AVALCAT1", + "Label": "Analysis Value Category 1", + "Data Type": "text", + "Length": "5", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "33", + "Dataset": "ADPP", + "Variable": "SUBJID", + "Label": "Subject Identifier for the Study", + "Data Type": "text", + "Length": "4", + "Mandatory": "No", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "34", + "Dataset": "ADPP", + "Variable": "RFSTDTC", + "Label": "Subject Reference Start Date/Time", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "35", + "Dataset": "ADPP", + "Variable": "RFENDTC", + "Label": "Subject Reference End Date/Time", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "36", + "Dataset": "ADPP", + "Variable": "RFXSTDTC", + "Label": "Date/Time of First Study Treatment", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "37", + "Dataset": "ADPP", + "Variable": "RFXENDTC", + "Label": "Date/Time of Last Study Treatment", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "38", + "Dataset": "ADPP", + "Variable": "RFICDTC", + "Label": "Date/Time of Informed Consent", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "39", + "Dataset": "ADPP", + "Variable": "RFPENDTC", + "Label": "Date/Time of End of Participation", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "40", + "Dataset": "ADPP", + "Variable": "DTHDTC", + "Label": "Date/Time of Death", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "41", + "Dataset": "ADPP", + "Variable": "DTHFL", + "Label": "Subject Death Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "42", + "Dataset": "ADPP", + "Variable": "SITEID", + "Label": "Study Site Identifier", + "Data Type": "text", + "Length": "3", + "Mandatory": "No", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "43", + "Dataset": "ADPP", + "Variable": "AGE", + "Label": "Age", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "ADSL Subject Demographics Variables", + "Has No Data": "No" + }, + { + "Order": "44", + "Dataset": "ADPP", + "Variable": "AGEU", + "Label": "Age Units", + "Data Type": "text", + "Length": "5", + "Mandatory": "No", + "Role": "ADSL Subject Demographics Variables", + "Has No Data": "No" + }, + { + "Order": "45", + "Dataset": "ADPP", + "Variable": "SEX", + "Label": "Sex", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "ADSL Subject Demographics Variables", + "Has No Data": "No" + }, + { + "Order": "46", + "Dataset": "ADPP", + "Variable": "RACE", + "Label": "Race", + "Data Type": "text", + "Length": "32", + "Mandatory": "No", + "Role": "ADSL Subject Demographics Variables", + "Has No Data": "No" + }, + { + "Order": "47", + "Dataset": "ADPP", + "Variable": "ETHNIC", + "Label": "Ethnicity", + "Data Type": "text", + "Length": "22", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "48", + "Dataset": "ADPP", + "Variable": "ARMCD", + "Label": "Planned Arm Code", + "Data Type": "text", + "Length": "6", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "49", + "Dataset": "ADPP", + "Variable": "ARM", + "Label": "Description of Planned Arm", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Role": "ADSL Treatment Variables", + "Has No Data": "No" + }, + { + "Order": "50", + "Dataset": "ADPP", + "Variable": "ACTARMCD", + "Label": "Actual Arm Code", + "Data Type": "text", + "Length": "6", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "51", + "Dataset": "ADPP", + "Variable": "ACTARM", + "Label": "Description of Actual Arm", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Role": "ADSL Treatment Variables", + "Has No Data": "No" + }, + { + "Order": "52", + "Dataset": "ADPP", + "Variable": "COUNTRY", + "Label": "Country", + "Data Type": "text", + "Length": "3", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "53", + "Dataset": "ADPP", + "Variable": "DMDTC", + "Label": "Date/Time of Collection", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "54", + "Dataset": "ADPP", + "Variable": "DMDY", + "Label": "Study Day of Collection", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "55", + "Dataset": "ADPP", + "Variable": "TRTSDTM", + "Label": "Datetime of First Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATETIME", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "56", + "Dataset": "ADPP", + "Variable": "TRTSTMF", + "Label": "Time of First Exposure Imput. Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "57", + "Dataset": "ADPP", + "Variable": "TRTEDTM", + "Label": "Datetime of Last Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATETIME", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "58", + "Dataset": "ADPP", + "Variable": "TRTETMF", + "Label": "Time of Last Exposure Imput. Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "59", + "Dataset": "ADPP", + "Variable": "TRTDURD", + "Label": "Total Treatment Duration (Days)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "60", + "Dataset": "ADPP", + "Variable": "SCRFDT", + "Label": "Screen Failure Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "61", + "Dataset": "ADPP", + "Variable": "EOSSTT", + "Label": "End of Study Status", + "Data Type": "text", + "Length": "12", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "62", + "Dataset": "ADPP", + "Variable": "FRVDT", + "Label": "Final Retrievel Visit Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "63", + "Dataset": "ADPP", + "Variable": "RANDDT", + "Label": "Date of Randomization", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "64", + "Dataset": "ADPP", + "Variable": "DTHADY", + "Label": "Relative Day of Death", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "65", + "Dataset": "ADPP", + "Variable": "LDDTHELD", + "Label": "Elapsed Days from Last Dose to Death", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "66", + "Dataset": "ADPP", + "Variable": "LSTALVDT", + "Label": "Date Last Known Alive", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "67", + "Dataset": "ADPP", + "Variable": "AGEGR1", + "Label": "Pooled Age Group 1", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "68", + "Dataset": "ADPP", + "Variable": "SAFFL", + "Label": "Safety Population Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "ADSL Population Indicator Variables", + "Has No Data": "No" + }, + { + "Order": "69", + "Dataset": "ADPP", + "Variable": "RACEGR1", + "Label": "Pooled Race Group 1", + "Data Type": "text", + "Length": "9", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "70", + "Dataset": "ADPP", + "Variable": "REGION1", + "Label": "Geographic Region 1", + "Data Type": "text", + "Length": "2", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "71", + "Dataset": "ADPP", + "Variable": "LDDTHGR1", + "Label": "Last Dose to Death - Days Elapsed Grp 1", + "Data Type": "text", + "Length": "5", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "72", + "Dataset": "ADPP", + "Variable": "DTH30FL", + "Label": "Death Within 30 Days of Last Trt Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "73", + "Dataset": "ADPP", + "Variable": "DTHA30FL", + "Label": "Death After 30 Days from Last Trt Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "74", + "Dataset": "ADPP", + "Variable": "DTHB30FL", + "Label": "Death Within 30 Days of First Trt Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "1", + "Dataset": "ADPPK", + "Variable": "STUDYID", + "Label": "Study Identifier", + "Data Type": "text", + "Length": "12", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "2", + "Dataset": "ADPPK", + "Variable": "USUBJID", + "Label": "Unique Subject Identifier", + "Data Type": "text", + "Length": "11", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "3", + "Dataset": "ADPPK", + "Variable": "EVID", + "Label": "Event ID", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "4", + "Dataset": "ADPPK", + "Variable": "NFRLT", + "Label": "Nom. Rel. Time from Analyte First Dose", + "Data Type": "float", + "Length": "4", + "Significant Digits": "2", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "5", + "Dataset": "ADPPK", + "Variable": "AFRLT", + "Label": "Act. Rel. Time from Analyte First Dose", + "Data Type": "float", + "Length": "10", + "Significant Digits": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "6", + "Dataset": "ADPPK", + "Variable": "APRLT", + "Label": "Actual Rel Time from Previous Dose", + "Data Type": "float", + "Length": "10", + "Significant Digits": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "7", + "Dataset": "ADPPK", + "Variable": "NPRLT", + "Label": "Nominal Rel Time from Previous Dose", + "Data Type": "float", + "Length": "4", + "Significant Digits": "2", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "8", + "Dataset": "ADPPK", + "Variable": "DOSEA", + "Label": "Actual Treatment Dose", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "9", + "Dataset": "ADPPK", + "Variable": "DOSEP", + "Label": "Planned Treatment Dose", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "10", + "Dataset": "ADPPK", + "Variable": "ALLOQ", + "Label": "Analysis Lower Limit of Quantitation", + "Data Type": "float", + "Length": "3", + "Significant Digits": "2", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "11", + "Dataset": "ADPPK", + "Variable": "CMT", + "Label": "Compartment", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "12", + "Dataset": "ADPPK", + "Variable": "BLQFL", + "Label": "Below Lower Limit of Quant Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "13", + "Dataset": "ADPPK", + "Variable": "BLQFN", + "Label": "Below Lower Limit of Quant Flag (N)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "14", + "Dataset": "ADPPK", + "Variable": "AMT", + "Label": "Actual Amount of Dose Received (unit)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "15", + "Dataset": "ADPPK", + "Variable": "DV", + "Label": "Dependent Variable Result", + "Data Type": "float", + "Length": "9", + "Significant Digits": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "16", + "Dataset": "ADPPK", + "Variable": "AVAL", + "Label": "Analysis Value", + "Data Type": "float", + "Length": "9", + "Significant Digits": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "17", + "Dataset": "ADPPK", + "Variable": "DVL", + "Label": "Log DV", + "Data Type": "float", + "Length": "10", + "Significant Digits": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "18", + "Dataset": "ADPPK", + "Variable": "MDV", + "Label": "Missing Dependent Variable Result", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "19", + "Dataset": "ADPPK", + "Variable": "AVALU", + "Label": "Analysis Value Unit", + "Data Type": "text", + "Length": "5", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "20", + "Dataset": "ADPPK", + "Variable": "UDTC", + "Label": "Date/Time", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "21", + "Dataset": "ADPPK", + "Variable": "II", + "Label": "Dosing Interval (unit)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "22", + "Dataset": "ADPPK", + "Variable": "SS", + "Label": "Steady State", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "23", + "Dataset": "ADPPK", + "Variable": "ASEQ", + "Label": "Analysis Sequence Number", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "24", + "Dataset": "ADPPK", + "Variable": "PROJID", + "Label": "Project Identifier", + "Data Type": "text", + "Length": "10", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "25", + "Dataset": "ADPPK", + "Variable": "PROJIDN", + "Label": "Project Identifier (N)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "26", + "Dataset": "ADPPK", + "Variable": "STUDYIDN", + "Label": "Study Identifier (N)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "27", + "Dataset": "ADPPK", + "Variable": "SITEID", + "Label": "Study Site Identifier", + "Data Type": "text", + "Length": "3", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "28", + "Dataset": "ADPPK", + "Variable": "SITEIDN", + "Label": "Study Site Identifier (N)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "29", + "Dataset": "ADPPK", + "Variable": "USUBJIDN", + "Label": "Unique Subject Identifier (N)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "30", + "Dataset": "ADPPK", + "Variable": "SUBJID", + "Label": "Subject Identifier for the Study", + "Data Type": "text", + "Length": "4", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "31", + "Dataset": "ADPPK", + "Variable": "SUBJIDN", + "Label": "Subject Identifier for the Study (N)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "32", + "Dataset": "ADPPK", + "Variable": "AGE", + "Label": "Age", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "33", + "Dataset": "ADPPK", + "Variable": "SEX", + "Label": "Sex", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "34", + "Dataset": "ADPPK", + "Variable": "SEXN", + "Label": "Sex (N)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "35", + "Dataset": "ADPPK", + "Variable": "COHORT", + "Label": "Cohort Subject Enrolled Into", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "36", + "Dataset": "ADPPK", + "Variable": "COHORTC", + "Label": "Description of Planned Arm", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "37", + "Dataset": "ADPPK", + "Variable": "ROUTE", + "Label": "Route of Administration", + "Data Type": "text", + "Length": "11", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "38", + "Dataset": "ADPPK", + "Variable": "ROUTEN", + "Label": "Route of Administration (N)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "39", + "Dataset": "ADPPK", + "Variable": "RACE", + "Label": "Race", + "Data Type": "text", + "Length": "32", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "40", + "Dataset": "ADPPK", + "Variable": "RACEN", + "Label": "Race (N)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "41", + "Dataset": "ADPPK", + "Variable": "ETHNIC", + "Label": "Ethnicity", + "Data Type": "text", + "Length": "22", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "42", + "Dataset": "ADPPK", + "Variable": "ETHNICN", + "Label": "Ethnicity (N)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "43", + "Dataset": "ADPPK", + "Variable": "FORM", + "Label": "Drug Formulation", + "Data Type": "text", + "Length": "5", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "44", + "Dataset": "ADPPK", + "Variable": "FORMN", + "Label": "Drug Formulation (N)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "45", + "Dataset": "ADPPK", + "Variable": "COUNTRY", + "Label": "Country", + "Data Type": "text", + "Length": "3", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "46", + "Dataset": "ADPPK", + "Variable": "COUNTRYN", + "Label": "Country (N)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "47", + "Dataset": "ADPPK", + "Variable": "REGION1", + "Label": "Geographic Region 1", + "Data Type": "text", + "Length": "2", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "48", + "Dataset": "ADPPK", + "Variable": "REGION1N", + "Label": "Geographic Region 1 (N)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "49", + "Dataset": "ADPPK", + "Variable": "HTBL", + "Label": "Numeric Result/Finding in Standard Units", + "Data Type": "float", + "Length": "5", + "Significant Digits": "2", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "50", + "Dataset": "ADPPK", + "Variable": "WTBL", + "Label": "Numeric Result/Finding in Standard Units", + "Data Type": "float", + "Length": "5", + "Significant Digits": "2", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "51", + "Dataset": "ADPPK", + "Variable": "ALTBL", + "Label": "Numeric Result/Finding in Standard Units", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "52", + "Dataset": "ADPPK", + "Variable": "ASTBL", + "Label": "Numeric Result/Finding in Standard Units", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "53", + "Dataset": "ADPPK", + "Variable": "TBILBL", + "Label": "Numeric Result/Finding in Standard Units", + "Data Type": "float", + "Length": "4", + "Significant Digits": "2", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "54", + "Dataset": "ADPPK", + "Variable": "CREATBL", + "Label": "Numeric Result/Finding in Standard Units", + "Data Type": "float", + "Length": "5", + "Significant Digits": "2", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "55", + "Dataset": "ADPPK", + "Variable": "BMIBL", + "Label": "Baseline Body Mass Index (kg/m2)", + "Data Type": "float", + "Length": "10", + "Significant Digits": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "56", + "Dataset": "ADPPK", + "Variable": "BSABL", + "Label": "Numeric Result/Finding in Standard Units", + "Data Type": "float", + "Length": "9", + "Significant Digits": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "57", + "Dataset": "ADPPK", + "Variable": "CRCLBL", + "Label": "Baseline Creatinine Clearance", + "Data Type": "float", + "Length": "11", + "Significant Digits": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "58", + "Dataset": "ADPPK", + "Variable": "EGFRBL", + "Label": "Age", + "Data Type": "float", + "Length": "10", + "Significant Digits": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "59", + "Dataset": "ADPPK", + "Variable": "RECSEQ", + "Label": "Record Sequence", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "60", + "Dataset": "ADPPK", + "Variable": "PARAMCD", + "Label": "Parameter Code", + "Data Type": "text", + "Length": "40", + "Significant Digits": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "61", + "Dataset": "ADPPK", + "Variable": "PARAM", + "Label": "Parameter", + "Data Type": "text", + "Length": "40", + "Significant Digits": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "62", + "Dataset": "ADPPK", + "Variable": "PARAMN", + "Label": "Parameter (N)", + "Data Type": "integer", + "Length": "8", + "Significant Digits": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "63", + "Dataset": "ADPPK", + "Variable": "COUNTRYL", + "Label": "Country Name", + "Data Type": "text", + "Length": "20", + "Significant Digits": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "1", + "Dataset": "ADRS_O", + "Variable": "DOMAIN", + "Label": "Domain Abbreviation", + "Data Type": "text", + "Length": "2", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "2", + "Dataset": "ADRS_O", + "Variable": "STUDYID", + "Label": "Study Identifier", + "Data Type": "text", + "Length": "12", + "Mandatory": "Yes", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "3", + "Dataset": "ADRS_O", + "Variable": "USUBJID", + "Label": "Unique Subject Identifier", + "Data Type": "text", + "Length": "11", + "Mandatory": "Yes", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "4", + "Dataset": "ADRS_O", + "Variable": "VISITNUM", + "Label": "Visit Number", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "5", + "Dataset": "ADRS_O", + "Variable": "VISIT", + "Label": "Visit Name", + "Data Type": "text", + "Length": "7", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "6", + "Dataset": "ADRS_O", + "Variable": "RSTESTCD", + "Label": "Assessment Short Name", + "Data Type": "text", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "7", + "Dataset": "ADRS_O", + "Variable": "RSTEST", + "Label": "Assessment Name", + "Data Type": "text", + "Length": "16", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "8", + "Dataset": "ADRS_O", + "Variable": "RSORRES", + "Label": "Result or Finding in Original Units", + "Data Type": "text", + "Length": "13", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "9", + "Dataset": "ADRS_O", + "Variable": "RSSTRESC", + "Label": "Character Result/Finding in Std Format", + "Data Type": "text", + "Length": "13", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "10", + "Dataset": "ADRS_O", + "Variable": "RSEVAL", + "Label": "Evaluator", + "Data Type": "text", + "Length": "12", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "11", + "Dataset": "ADRS_O", + "Variable": "RSEVALID", + "Label": "Evaluator Identifier", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "12", + "Dataset": "ADRS_O", + "Variable": "RSACPTFL", + "Label": "Accepted Record Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "13", + "Dataset": "ADRS_O", + "Variable": "RSDTC", + "Label": "Date/Time of Assessment", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "14", + "Dataset": "ADRS_O", + "Variable": "RSSEQ", + "Label": "Sequence Number", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "15", + "Dataset": "ADRS_O", + "Variable": "RANDDT", + "Label": "Date of Randomization", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "16", + "Dataset": "ADRS_O", + "Variable": "PARAMCD", + "Label": "Parameter Code", + "Data Type": "text", + "Length": "5", + "Mandatory": "Yes", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "17", + "Dataset": "ADRS_O", + "Variable": "PARAM", + "Label": "Parameter", + "Data Type": "text", + "Length": "74", + "Mandatory": "Yes", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "18", + "Dataset": "ADRS_O", + "Variable": "PARCAT1", + "Label": "Parameter Category 1", + "Data Type": "text", + "Length": "15", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "19", + "Dataset": "ADRS_O", + "Variable": "PARCAT2", + "Label": "Parameter Category 2", + "Data Type": "text", + "Length": "12", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "20", + "Dataset": "ADRS_O", + "Variable": "PARCAT3", + "Label": "Parameter Category 3", + "Data Type": "text", + "Length": "10", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "21", + "Dataset": "ADRS_O", + "Variable": "ADT", + "Label": "Analysis Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "22", + "Dataset": "ADRS_O", + "Variable": "ADTF", + "Label": "Analysis Date Imputation Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "23", + "Dataset": "ADRS_O", + "Variable": "AVISIT", + "Label": "Analysis Visit", + "Data Type": "text", + "Length": "7", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "24", + "Dataset": "ADRS_O", + "Variable": "AVALC", + "Label": "Analysis Value (C)", + "Data Type": "text", + "Length": "13", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "25", + "Dataset": "ADRS_O", + "Variable": "AVAL", + "Label": "Analysis Value", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "26", + "Dataset": "ADRS_O", + "Variable": "ANL01FL", + "Label": "Analysis Flag 01", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "27", + "Dataset": "ADRS_O", + "Variable": "ANL02FL", + "Label": "Analysis Flag 02", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "28", + "Dataset": "ADRS_O", + "Variable": "ASEQ", + "Label": "Analysis Sequence Number", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "29", + "Dataset": "ADRS_O", + "Variable": "SUBJID", + "Label": "Subject Identifier for the Study", + "Data Type": "text", + "Length": "4", + "Mandatory": "No", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "30", + "Dataset": "ADRS_O", + "Variable": "RFSTDTC", + "Label": "Subject Reference Start Date/Time", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "31", + "Dataset": "ADRS_O", + "Variable": "RFENDTC", + "Label": "Subject Reference End Date/Time", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "32", + "Dataset": "ADRS_O", + "Variable": "RFXSTDTC", + "Label": "Date/Time of First Study Treatment", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "33", + "Dataset": "ADRS_O", + "Variable": "RFXENDTC", + "Label": "Date/Time of Last Study Treatment", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "34", + "Dataset": "ADRS_O", + "Variable": "RFICDTC", + "Label": "Date/Time of Informed Consent", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "35", + "Dataset": "ADRS_O", + "Variable": "RFPENDTC", + "Label": "Date/Time of End of Participation", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "36", + "Dataset": "ADRS_O", + "Variable": "DTHDTC", + "Label": "Date/Time of Death", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "37", + "Dataset": "ADRS_O", + "Variable": "DTHFL", + "Label": "Subject Death Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "38", + "Dataset": "ADRS_O", + "Variable": "SITEID", + "Label": "Study Site Identifier", + "Data Type": "text", + "Length": "3", + "Mandatory": "No", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "39", + "Dataset": "ADRS_O", + "Variable": "AGE", + "Label": "Age", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "ADSL Subject Demographics Variables", + "Has No Data": "No" + }, + { + "Order": "40", + "Dataset": "ADRS_O", + "Variable": "AGEU", + "Label": "Age Units", + "Data Type": "text", + "Length": "5", + "Mandatory": "No", + "Role": "ADSL Subject Demographics Variables", + "Has No Data": "No" + }, + { + "Order": "41", + "Dataset": "ADRS_O", + "Variable": "SEX", + "Label": "Sex", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "ADSL Subject Demographics Variables", + "Has No Data": "No" + }, + { + "Order": "42", + "Dataset": "ADRS_O", + "Variable": "RACE", + "Label": "Race", + "Data Type": "text", + "Length": "32", + "Mandatory": "No", + "Role": "ADSL Subject Demographics Variables", + "Has No Data": "No" + }, + { + "Order": "43", + "Dataset": "ADRS_O", + "Variable": "ETHNIC", + "Label": "Ethnicity", + "Data Type": "text", + "Length": "22", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "44", + "Dataset": "ADRS_O", + "Variable": "ARMCD", + "Label": "Planned Arm Code", + "Data Type": "text", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "45", + "Dataset": "ADRS_O", + "Variable": "ARM", + "Label": "Description of Planned Arm", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Role": "ADSL Treatment Variables", + "Has No Data": "No" + }, + { + "Order": "46", + "Dataset": "ADRS_O", + "Variable": "ACTARMCD", + "Label": "Actual Arm Code", + "Data Type": "text", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "47", + "Dataset": "ADRS_O", + "Variable": "ACTARM", + "Label": "Description of Actual Arm", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Role": "ADSL Treatment Variables", + "Has No Data": "No" + }, + { + "Order": "48", + "Dataset": "ADRS_O", + "Variable": "COUNTRY", + "Label": "Country", + "Data Type": "text", + "Length": "3", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "49", + "Dataset": "ADRS_O", + "Variable": "DMDTC", + "Label": "Date/Time of Collection", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "50", + "Dataset": "ADRS_O", + "Variable": "DMDY", + "Label": "Study Day of Collection", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "51", + "Dataset": "ADRS_O", + "Variable": "TRT01P", + "Label": "Planned Treatment for Period 01", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "52", + "Dataset": "ADRS_O", + "Variable": "TRT01A", + "Label": "Actual Treatment for Period 01", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "53", + "Dataset": "ADRS_O", + "Variable": "TRTSDTM", + "Label": "Datetime of First Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATETIME", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "54", + "Dataset": "ADRS_O", + "Variable": "TRTSTMF", + "Label": "Time of First Exposure Imput. Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "55", + "Dataset": "ADRS_O", + "Variable": "TRTEDTM", + "Label": "Datetime of Last Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATETIME", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "56", + "Dataset": "ADRS_O", + "Variable": "TRTETMF", + "Label": "Time of Last Exposure Imput. Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "57", + "Dataset": "ADRS_O", + "Variable": "TRTSDT", + "Label": "Date of First Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "58", + "Dataset": "ADRS_O", + "Variable": "TRTEDT", + "Label": "Date of Last Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "59", + "Dataset": "ADRS_O", + "Variable": "TRTDURD", + "Label": "Total Treatment Duration (Days)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "60", + "Dataset": "ADRS_O", + "Variable": "SCRFDT", + "Label": "Screen Failure Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "61", + "Dataset": "ADRS_O", + "Variable": "EOSDT", + "Label": "End of Study Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "62", + "Dataset": "ADRS_O", + "Variable": "EOSSTT", + "Label": "End of Study Status", + "Data Type": "text", + "Length": "12", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "63", + "Dataset": "ADRS_O", + "Variable": "FRVDT", + "Label": "Final Retrievel Visit Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "64", + "Dataset": "ADRS_O", + "Variable": "DTHDT", + "Label": "Date of Death", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "65", + "Dataset": "ADRS_O", + "Variable": "DTHADY", + "Label": "Relative Day of Death", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "66", + "Dataset": "ADRS_O", + "Variable": "LDDTHELD", + "Label": "Elapsed Days from Last Dose to Death", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "67", + "Dataset": "ADRS_O", + "Variable": "LSTALVDT", + "Label": "Date Last Known Alive", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "68", + "Dataset": "ADRS_O", + "Variable": "AGEGR1", + "Label": "Pooled Age Group 1", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "69", + "Dataset": "ADRS_O", + "Variable": "SAFFL", + "Label": "Safety Population Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "ADSL Population Indicator Variables", + "Has No Data": "No" + }, + { + "Order": "70", + "Dataset": "ADRS_O", + "Variable": "RACEGR1", + "Label": "Pooled Race Group 1", + "Data Type": "text", + "Length": "9", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "71", + "Dataset": "ADRS_O", + "Variable": "REGION1", + "Label": "Geographic Region 1", + "Data Type": "text", + "Length": "2", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "72", + "Dataset": "ADRS_O", + "Variable": "LDDTHGR1", + "Label": "Last Dose to Death - Days Elapsed Grp 1", + "Data Type": "text", + "Length": "5", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "73", + "Dataset": "ADRS_O", + "Variable": "DTH30FL", + "Label": "Death Within 30 Days of Last Trt Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "74", + "Dataset": "ADRS_O", + "Variable": "DTHA30FL", + "Label": "Death After 30 Days from Last Trt Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "75", + "Dataset": "ADRS_O", + "Variable": "DTHB30FL", + "Label": "Death Within 30 Days of First Trt Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "76", + "Dataset": "ADRS_O", + "Variable": "DTHCAUS", + "Label": "Cause of Death", + "Data Type": "text", + "Length": "200", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "77", + "Dataset": "ADRS_O", + "Variable": "DTHDOM", + "Label": "Domain for Date of Death Collection", + "Data Type": "text", + "Length": "200", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "78", + "Dataset": "ADRS_O", + "Variable": "DTHCGR1", + "Label": "Cause of Death Reason 1", + "Data Type": "text", + "Length": "200", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "1", + "Dataset": "ADSL", + "Variable": "STUDYID", + "Label": "Study Identifier", + "Data Type": "text", + "Length": "12", + "Mandatory": "Yes", + "Role": "ADSL Identifier Variables", + "Has No Data": "No" + }, + { + "Order": "2", + "Dataset": "ADSL", + "Variable": "USUBJID", + "Label": "Unique Subject Identifier", + "Data Type": "text", + "Length": "11", + "Mandatory": "Yes", + "Role": "ADSL Identifier Variables", + "Has No Data": "No" + }, + { + "Order": "3", + "Dataset": "ADSL", + "Variable": "SUBJID", + "Label": "Subject Identifier for the Study", + "Data Type": "text", + "Length": "4", + "Mandatory": "Yes", + "Role": "ADSL Identifier Variables", + "Has No Data": "No" + }, + { + "Order": "4", + "Dataset": "ADSL", + "Variable": "RFSTDTC", + "Label": "Subject Reference Start Date/Time", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "5", + "Dataset": "ADSL", + "Variable": "RFENDTC", + "Label": "Subject Reference End Date/Time", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "6", + "Dataset": "ADSL", + "Variable": "RFXSTDTC", + "Label": "Date/Time of First Study Treatment", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "7", + "Dataset": "ADSL", + "Variable": "RFXENDTC", + "Label": "Date/Time of Last Study Treatment", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "8", + "Dataset": "ADSL", + "Variable": "RFICDTC", + "Label": "Date/Time of Informed Consent", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "9", + "Dataset": "ADSL", + "Variable": "RFPENDTC", + "Label": "Date/Time of End of Participation", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "10", + "Dataset": "ADSL", + "Variable": "DTHDTC", + "Label": "Date/Time of Death", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "11", + "Dataset": "ADSL", + "Variable": "DTHFL", + "Label": "Subject Death Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "12", + "Dataset": "ADSL", + "Variable": "SITEID", + "Label": "Study Site Identifier", + "Data Type": "text", + "Length": "3", + "Mandatory": "Yes", + "Role": "ADSL Identifier Variables", + "Has No Data": "No" + }, + { + "Order": "13", + "Dataset": "ADSL", + "Variable": "AGE", + "Label": "Age", + "Data Type": "integer", + "Length": "8", + "Mandatory": "Yes", + "Role": "ADSL Subject Demographics Variables", + "Has No Data": "No" + }, + { + "Order": "14", + "Dataset": "ADSL", + "Variable": "AGEU", + "Label": "Age Units", + "Data Type": "text", + "Length": "5", + "Mandatory": "Yes", + "Role": "ADSL Subject Demographics Variables", + "Has No Data": "No" + }, + { + "Order": "15", + "Dataset": "ADSL", + "Variable": "SEX", + "Label": "Sex", + "Data Type": "text", + "Length": "1", + "Mandatory": "Yes", + "Role": "ADSL Subject Demographics Variables", + "Has No Data": "No" + }, + { + "Order": "16", + "Dataset": "ADSL", + "Variable": "RACE", + "Label": "Race", + "Data Type": "text", + "Length": "32", + "Mandatory": "Yes", + "Role": "ADSL Subject Demographics Variables", + "Has No Data": "No" + }, + { + "Order": "17", + "Dataset": "ADSL", + "Variable": "ETHNIC", + "Label": "Ethnicity", + "Data Type": "text", + "Length": "22", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "18", + "Dataset": "ADSL", + "Variable": "ARMCD", + "Label": "Planned Arm Code", + "Data Type": "text", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "19", + "Dataset": "ADSL", + "Variable": "ARM", + "Label": "Description of Planned Arm", + "Data Type": "text", + "Length": "20", + "Mandatory": "Yes", + "Role": "ADSL Treatment Variables", + "Has No Data": "No" + }, + { + "Order": "20", + "Dataset": "ADSL", + "Variable": "ACTARMCD", + "Label": "Actual Arm Code", + "Data Type": "text", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "21", + "Dataset": "ADSL", + "Variable": "ACTARM", + "Label": "Description of Actual Arm", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Role": "ADSL Treatment Variables", + "Has No Data": "No" + }, + { + "Order": "22", + "Dataset": "ADSL", + "Variable": "COUNTRY", + "Label": "Country", + "Data Type": "text", + "Length": "3", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "23", + "Dataset": "ADSL", + "Variable": "DMDTC", + "Label": "Date/Time of Collection", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "24", + "Dataset": "ADSL", + "Variable": "DMDY", + "Label": "Study Day of Collection", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "25", + "Dataset": "ADSL", + "Variable": "TRT01P", + "Label": "Planned Treatment for Period 01", + "Data Type": "text", + "Length": "20", + "Mandatory": "Yes", + "Role": "ADSL Treatment Variables", + "Has No Data": "No" + }, + { + "Order": "26", + "Dataset": "ADSL", + "Variable": "TRT01A", + "Label": "Actual Treatment for Period 01", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "27", + "Dataset": "ADSL", + "Variable": "TRTSDTM", + "Label": "Datetime of First Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATETIME", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "28", + "Dataset": "ADSL", + "Variable": "TRTSTMF", + "Label": "Time of First Exposure Imput. Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "29", + "Dataset": "ADSL", + "Variable": "TRTEDTM", + "Label": "Datetime of Last Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATETIME", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "30", + "Dataset": "ADSL", + "Variable": "TRTETMF", + "Label": "Time of Last Exposure Imput. Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "31", + "Dataset": "ADSL", + "Variable": "TRTSDT", + "Label": "Date of First Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "32", + "Dataset": "ADSL", + "Variable": "TRTEDT", + "Label": "Date of Last Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "33", + "Dataset": "ADSL", + "Variable": "TRTDURD", + "Label": "Total Treatment Duration (Days)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "34", + "Dataset": "ADSL", + "Variable": "SCRFDT", + "Label": "Screen Failure Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "35", + "Dataset": "ADSL", + "Variable": "EOSDT", + "Label": "End of Study Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "36", + "Dataset": "ADSL", + "Variable": "EOSSTT", + "Label": "End of Study Status", + "Data Type": "text", + "Length": "12", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "37", + "Dataset": "ADSL", + "Variable": "FRVDT", + "Label": "Final Retrievel Visit Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "38", + "Dataset": "ADSL", + "Variable": "RANDDT", + "Label": "Date of Randomization", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "39", + "Dataset": "ADSL", + "Variable": "DTHDT", + "Label": "Date of Death", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "40", + "Dataset": "ADSL", + "Variable": "DTHDTF", + "Label": "Date of Death Imputation Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "41", + "Dataset": "ADSL", + "Variable": "DTHADY", + "Label": "Relative Day of Death", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "42", + "Dataset": "ADSL", + "Variable": "LDDTHELD", + "Label": "Elapsed Days from Last Dose to Death", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "43", + "Dataset": "ADSL", + "Variable": "LSTALVDT", + "Label": "Date Last Known Alive", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "44", + "Dataset": "ADSL", + "Variable": "SAFFL", + "Label": "Safety Population Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "ADSL Population Indicator Variables", + "Has No Data": "No" + }, + { + "Order": "45", + "Dataset": "ADSL", + "Variable": "RACEGR1", + "Label": "Pooled Race Group 1", + "Data Type": "text", + "Length": "9", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "46", + "Dataset": "ADSL", + "Variable": "AGEGR1", + "Label": "Pooled Age Group 1", + "Data Type": "text", + "Length": "5", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "47", + "Dataset": "ADSL", + "Variable": "REGION1", + "Label": "Geographic Region 1", + "Data Type": "text", + "Length": "2", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "48", + "Dataset": "ADSL", + "Variable": "LDDTHGR1", + "Label": "Last Dose to Death - Days Elapsed Grp 1", + "Data Type": "text", + "Length": "5", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "49", + "Dataset": "ADSL", + "Variable": "DTH30FL", + "Label": "Death Within 30 Days of Last Trt Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "50", + "Dataset": "ADSL", + "Variable": "DTHA30FL", + "Label": "Death After 30 Days from Last Trt Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "51", + "Dataset": "ADSL", + "Variable": "DTHB30FL", + "Label": "Death Within 30 Days of First Trt Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "1", + "Dataset": "ADSL_V", + "Variable": "STUDYID", + "Label": "Study Identifier", + "Data Type": "text", + "Length": "3", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "2", + "Dataset": "ADSL_V", + "Variable": "USUBJID", + "Label": "Unique Subject Identifier", + "Data Type": "text", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "3", + "Dataset": "ADSL_V", + "Variable": "SUBJID", + "Label": "Subject Identifier for the Study", + "Data Type": "text", + "Length": "4", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "4", + "Dataset": "ADSL_V", + "Variable": "RFSTDTC", + "Label": "Subject Reference Start Date/Time", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "5", + "Dataset": "ADSL_V", + "Variable": "RFENDTC", + "Label": "Subject Reference End Date/Time", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "6", + "Dataset": "ADSL_V", + "Variable": "RFXSTDTC", + "Label": "Date/Time of First Study Treatment", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "7", + "Dataset": "ADSL_V", + "Variable": "RFXENDTC", + "Label": "Date/Time of Last Study Treatment", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "8", + "Dataset": "ADSL_V", + "Variable": "RFICDTC", + "Label": "Date/Time of Informed Consent", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "9", + "Dataset": "ADSL_V", + "Variable": "RFPENDTC", + "Label": "Date/Time of End of Participation", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "10", + "Dataset": "ADSL_V", + "Variable": "DTHDTC", + "Label": "Date/Time of Death", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "11", + "Dataset": "ADSL_V", + "Variable": "DTHFL", + "Label": "Subject Death Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "12", + "Dataset": "ADSL_V", + "Variable": "SITEID", + "Label": "Study Site Identifier", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "13", + "Dataset": "ADSL_V", + "Variable": "INVID", + "Label": "Investigator Identifier", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "14", + "Dataset": "ADSL_V", + "Variable": "INVNAM", + "Label": "Investigator Name", + "Data Type": "text", + "Length": "13", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "15", + "Dataset": "ADSL_V", + "Variable": "BRTHDTC", + "Label": "Date/Time of Birth", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "16", + "Dataset": "ADSL_V", + "Variable": "AGE", + "Label": "Age", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "17", + "Dataset": "ADSL_V", + "Variable": "AGEU", + "Label": "Age Units", + "Data Type": "text", + "Length": "5", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "18", + "Dataset": "ADSL_V", + "Variable": "SEX", + "Label": "Sex", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "19", + "Dataset": "ADSL_V", + "Variable": "RACE", + "Label": "Race", + "Data Type": "text", + "Length": "25", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "20", + "Dataset": "ADSL_V", + "Variable": "ETHNIC", + "Label": "Ethnicity", + "Data Type": "text", + "Length": "22", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "21", + "Dataset": "ADSL_V", + "Variable": "ARMCD", + "Label": "Planned Arm Code", + "Data Type": "text", + "Length": "5", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "22", + "Dataset": "ADSL_V", + "Variable": "ARM", + "Label": "Description of Planned Arm", + "Data Type": "text", + "Length": "19", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "23", + "Dataset": "ADSL_V", + "Variable": "ACTARMCD", + "Label": "Actual Arm Code", + "Data Type": "text", + "Length": "5", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "24", + "Dataset": "ADSL_V", + "Variable": "ACTARM", + "Label": "Description of Actual Arm", + "Data Type": "text", + "Length": "19", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "25", + "Dataset": "ADSL_V", + "Variable": "COUNTRY", + "Label": "Country/Region", + "Data Type": "text", + "Length": "3", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "26", + "Dataset": "ADSL_V", + "Variable": "DMDTC", + "Label": "Date/Time of Collection", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "27", + "Dataset": "ADSL_V", + "Variable": "DMDY", + "Label": "Study Day of Collection", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "28", + "Dataset": "ADSL_V", + "Variable": "TRT01P", + "Label": "Planned Treatment for Period 01", + "Data Type": "text", + "Length": "9", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "29", + "Dataset": "ADSL_V", + "Variable": "TRT02P", + "Label": "Planned Treatment for Period 02", + "Data Type": "text", + "Length": "9", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "30", + "Dataset": "ADSL_V", + "Variable": "TRT01A", + "Label": "Actual Treatment for Period 01", + "Data Type": "text", + "Length": "9", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "31", + "Dataset": "ADSL_V", + "Variable": "TRT02A", + "Label": "Actual Treatment for Period 02", + "Data Type": "text", + "Length": "9", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "32", + "Dataset": "ADSL_V", + "Variable": "TRTSDTM", + "Label": "Datetime of First Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATETIME", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "33", + "Dataset": "ADSL_V", + "Variable": "TRTEDTM", + "Label": "Datetime of Last Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATETIME", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "34", + "Dataset": "ADSL_V", + "Variable": "TRTSDT", + "Label": "Date of First Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "35", + "Dataset": "ADSL_V", + "Variable": "TRTEDT", + "Label": "Date of Last Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "36", + "Dataset": "ADSL_V", + "Variable": "SAFFL", + "Label": "Safety Population Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "37", + "Dataset": "ADSL_V", + "Variable": "PPROTFL", + "Label": "Per-Protocol Population Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "38", + "Dataset": "ADSL_V", + "Variable": "RACEGR1", + "Label": "Pooled Race Group 1", + "Data Type": "text", + "Length": "9", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "39", + "Dataset": "ADSL_V", + "Variable": "AGEGR1", + "Label": "Pooled Age Group 1", + "Data Type": "text", + "Length": "3", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "40", + "Dataset": "ADSL_V", + "Variable": "REGION1", + "Label": "Geographic Region 1", + "Data Type": "text", + "Length": "2", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "41", + "Dataset": "ADSL_V", + "Variable": "VAX01DT", + "Label": "Vaccination Date 01", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "42", + "Dataset": "ADSL_V", + "Variable": "VAX02DT", + "Label": "Vaccination Date 02", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "43", + "Dataset": "ADSL_V", + "Variable": "AP01SDT", + "Label": "Period 01 Start Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "44", + "Dataset": "ADSL_V", + "Variable": "AP01EDT", + "Label": "Period 01 End Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "45", + "Dataset": "ADSL_V", + "Variable": "AP02SDT", + "Label": "Period 02 Start Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "46", + "Dataset": "ADSL_V", + "Variable": "AP02EDT", + "Label": "Period 02 End Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "1", + "Dataset": "ADTR_O", + "Variable": "STUDYID", + "Label": "Study Identifier", + "Data Type": "text", + "Length": "12", + "Mandatory": "Yes", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "2", + "Dataset": "ADTR_O", + "Variable": "DOMAIN", + "Label": "Domain Abbreviation", + "Data Type": "text", + "Length": "2", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "3", + "Dataset": "ADTR_O", + "Variable": "USUBJID", + "Label": "Unique Subject Identifier", + "Data Type": "text", + "Length": "11", + "Mandatory": "Yes", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "4", + "Dataset": "ADTR_O", + "Variable": "TRSEQ", + "Label": "Sequence Number", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "5", + "Dataset": "ADTR_O", + "Variable": "TRGRPID", + "Label": "Group ID", + "Data Type": "text", + "Length": "6", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "6", + "Dataset": "ADTR_O", + "Variable": "TRLNKGRP", + "Label": "Link Group", + "Data Type": "text", + "Length": "2", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "7", + "Dataset": "ADTR_O", + "Variable": "TRLNKID", + "Label": "Link ID", + "Data Type": "text", + "Length": "3", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "8", + "Dataset": "ADTR_O", + "Variable": "TRTESTCD", + "Label": "Tumor/Lesion Assessment Short Name", + "Data Type": "text", + "Length": "5", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "9", + "Dataset": "ADTR_O", + "Variable": "TRTEST", + "Label": "Tumor/Lesion Assessment Test Name", + "Data Type": "text", + "Length": "21", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "10", + "Dataset": "ADTR_O", + "Variable": "TRORRES", + "Label": "Result or Finding in Original Units", + "Data Type": "text", + "Length": "4", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "11", + "Dataset": "ADTR_O", + "Variable": "TRORRESU", + "Label": "Original Units", + "Data Type": "text", + "Length": "2", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "12", + "Dataset": "ADTR_O", + "Variable": "TRSTRESC", + "Label": "Character Result/Finding in Std Format", + "Data Type": "text", + "Length": "4", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "13", + "Dataset": "ADTR_O", + "Variable": "TRSTRESN", + "Label": "Numeric Result/Finding in Standard Units", + "Data Type": "float", + "Length": "3", + "Significant Digits": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "14", + "Dataset": "ADTR_O", + "Variable": "TRSTRESU", + "Label": "Standard Units", + "Data Type": "text", + "Length": "2", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "15", + "Dataset": "ADTR_O", + "Variable": "TRSTAT", + "Label": "Completion Status", + "Data Type": "text", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "16", + "Dataset": "ADTR_O", + "Variable": "TRREASND", + "Label": "Reason Not Done", + "Data Type": "text", + "Length": "30", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "17", + "Dataset": "ADTR_O", + "Variable": "TRMETHOD", + "Label": "Method Used to Identify the Tumor/Lesion", + "Data Type": "text", + "Length": "7", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "18", + "Dataset": "ADTR_O", + "Variable": "TREVAL", + "Label": "Evaluator", + "Data Type": "text", + "Length": "12", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "19", + "Dataset": "ADTR_O", + "Variable": "TREVALID", + "Label": "Evaluator Identifier", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "20", + "Dataset": "ADTR_O", + "Variable": "TRACPTFL", + "Label": "Accepted Record Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "21", + "Dataset": "ADTR_O", + "Variable": "VISITNUM", + "Label": "Visit Number", + "Data Type": "float", + "Length": "3", + "Significant Digits": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "22", + "Dataset": "ADTR_O", + "Variable": "VISIT", + "Label": "Visit Name", + "Data Type": "text", + "Length": "15", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "23", + "Dataset": "ADTR_O", + "Variable": "TRDTC", + "Label": "Date/Time of Tumor/Lesion Measurement", + "Data Type": "text", + "Length": "10", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "24", + "Dataset": "ADTR_O", + "Variable": "TRDY", + "Label": "Study Day of Tumor/Lesion Measurement", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "25", + "Dataset": "ADTR_O", + "Variable": "RANDDT", + "Label": "Date of Randomization", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "26", + "Dataset": "ADTR_O", + "Variable": "TULOC", + "Label": "Location of the Tumor/Lesion", + "Data Type": "text", + "Length": "16", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "27", + "Dataset": "ADTR_O", + "Variable": "TULOCGR1", + "Label": "Tumor Site Group 1", + "Data Type": "text", + "Length": "9", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "28", + "Dataset": "ADTR_O", + "Variable": "LSEXP", + "Label": "Lesion IDs Expected", + "Data Type": "text", + "Length": "23", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "29", + "Dataset": "ADTR_O", + "Variable": "LSASS", + "Label": "Lesion IDs Assessed", + "Data Type": "text", + "Length": "48", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "30", + "Dataset": "ADTR_O", + "Variable": "ADT", + "Label": "Analysis Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "31", + "Dataset": "ADTR_O", + "Variable": "ADTF", + "Label": "Analysis Date Imputation Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "32", + "Dataset": "ADTR_O", + "Variable": "ADY", + "Label": "Analysis Relative Day", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "33", + "Dataset": "ADTR_O", + "Variable": "AVISIT", + "Label": "Analysis Visit", + "Data Type": "text", + "Length": "15", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "34", + "Dataset": "ADTR_O", + "Variable": "AVISITN", + "Label": "Analysis Visit (N)", + "Data Type": "float", + "Length": "3", + "Significant Digits": "1", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "35", + "Dataset": "ADTR_O", + "Variable": "PARAMCD", + "Label": "Parameter Code", + "Data Type": "text", + "Length": "7", + "Mandatory": "Yes", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "36", + "Dataset": "ADTR_O", + "Variable": "PARAM", + "Label": "Parameter", + "Data Type": "text", + "Length": "47", + "Mandatory": "Yes", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "37", + "Dataset": "ADTR_O", + "Variable": "PARCAT1", + "Label": "Parameter Category 1", + "Data Type": "text", + "Length": "16", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "38", + "Dataset": "ADTR_O", + "Variable": "PARCAT2", + "Label": "Parameter Category 2", + "Data Type": "text", + "Length": "12", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "39", + "Dataset": "ADTR_O", + "Variable": "PARCAT3", + "Label": "Parameter Category 3", + "Data Type": "text", + "Length": "10", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "40", + "Dataset": "ADTR_O", + "Variable": "AVAL", + "Label": "Analysis Value", + "Data Type": "float", + "Length": "3", + "Significant Digits": "1", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "41", + "Dataset": "ADTR_O", + "Variable": "ANL01FL", + "Label": "Analysis Flag 01", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "42", + "Dataset": "ADTR_O", + "Variable": "ABLFL", + "Label": "Baseline Record Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "Flag Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "43", + "Dataset": "ADTR_O", + "Variable": "BASE", + "Label": "Baseline Value", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "44", + "Dataset": "ADTR_O", + "Variable": "NADIR", + "Label": "NADIR", + "Data Type": "float", + "Length": "8", + "Significant Digits": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "45", + "Dataset": "ADTR_O", + "Variable": "CHG", + "Label": "Change from Baseline", + "Data Type": "float", + "Length": "8", + "Significant Digits": "1", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "46", + "Dataset": "ADTR_O", + "Variable": "PCHG", + "Label": "Percent Change from Baseline", + "Data Type": "float", + "Length": "12", + "Significant Digits": "8", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "47", + "Dataset": "ADTR_O", + "Variable": "CHGNAD", + "Label": "Change from NADIR", + "Data Type": "float", + "Length": "8", + "Significant Digits": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "48", + "Dataset": "ADTR_O", + "Variable": "PCHGNAD", + "Label": "Percent Change from NADIR", + "Data Type": "float", + "Length": "12", + "Significant Digits": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "49", + "Dataset": "ADTR_O", + "Variable": "PDFL", + "Label": "Pharmacodynamic Analysis Set Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "50", + "Dataset": "ADTR_O", + "Variable": "ANL02FL", + "Label": "Analysis Flag 02", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "51", + "Dataset": "ADTR_O", + "Variable": "ANL03FL", + "Label": "Analysis Flag 03", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "52", + "Dataset": "ADTR_O", + "Variable": "ANL04FL", + "Label": "Analysis Flag 04", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "53", + "Dataset": "ADTR_O", + "Variable": "ASEQ", + "Label": "Analysis Sequence Number", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "54", + "Dataset": "ADTR_O", + "Variable": "SUBJID", + "Label": "Subject Identifier for the Study", + "Data Type": "text", + "Length": "4", + "Mandatory": "No", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "55", + "Dataset": "ADTR_O", + "Variable": "RFSTDTC", + "Label": "Subject Reference Start Date/Time", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "56", + "Dataset": "ADTR_O", + "Variable": "RFENDTC", + "Label": "Subject Reference End Date/Time", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "57", + "Dataset": "ADTR_O", + "Variable": "RFXSTDTC", + "Label": "Date/Time of First Study Treatment", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "58", + "Dataset": "ADTR_O", + "Variable": "RFXENDTC", + "Label": "Date/Time of Last Study Treatment", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "59", + "Dataset": "ADTR_O", + "Variable": "RFICDTC", + "Label": "Date/Time of Informed Consent", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "60", + "Dataset": "ADTR_O", + "Variable": "RFPENDTC", + "Label": "Date/Time of End of Participation", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "61", + "Dataset": "ADTR_O", + "Variable": "DTHDTC", + "Label": "Date/Time of Death", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "62", + "Dataset": "ADTR_O", + "Variable": "DTHFL", + "Label": "Subject Death Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "63", + "Dataset": "ADTR_O", + "Variable": "SITEID", + "Label": "Study Site Identifier", + "Data Type": "text", + "Length": "3", + "Mandatory": "No", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "64", + "Dataset": "ADTR_O", + "Variable": "AGE", + "Label": "Age", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "ADSL Subject Demographics Variables", + "Has No Data": "No" + }, + { + "Order": "65", + "Dataset": "ADTR_O", + "Variable": "AGEU", + "Label": "Age Units", + "Data Type": "text", + "Length": "5", + "Mandatory": "No", + "Role": "ADSL Subject Demographics Variables", + "Has No Data": "No" + }, + { + "Order": "66", + "Dataset": "ADTR_O", + "Variable": "SEX", + "Label": "Sex", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "ADSL Subject Demographics Variables", + "Has No Data": "No" + }, + { + "Order": "67", + "Dataset": "ADTR_O", + "Variable": "RACE", + "Label": "Race", + "Data Type": "text", + "Length": "32", + "Mandatory": "No", + "Role": "ADSL Subject Demographics Variables", + "Has No Data": "No" + }, + { + "Order": "68", + "Dataset": "ADTR_O", + "Variable": "ETHNIC", + "Label": "Ethnicity", + "Data Type": "text", + "Length": "22", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "69", + "Dataset": "ADTR_O", + "Variable": "ARMCD", + "Label": "Planned Arm Code", + "Data Type": "text", + "Length": "6", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "70", + "Dataset": "ADTR_O", + "Variable": "ARM", + "Label": "Description of Planned Arm", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Role": "ADSL Treatment Variables", + "Has No Data": "No" + }, + { + "Order": "71", + "Dataset": "ADTR_O", + "Variable": "ACTARMCD", + "Label": "Actual Arm Code", + "Data Type": "text", + "Length": "6", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "72", + "Dataset": "ADTR_O", + "Variable": "ACTARM", + "Label": "Description of Actual Arm", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Role": "ADSL Treatment Variables", + "Has No Data": "No" + }, + { + "Order": "73", + "Dataset": "ADTR_O", + "Variable": "COUNTRY", + "Label": "Country", + "Data Type": "text", + "Length": "3", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "74", + "Dataset": "ADTR_O", + "Variable": "DMDTC", + "Label": "Date/Time of Collection", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "75", + "Dataset": "ADTR_O", + "Variable": "DMDY", + "Label": "Study Day of Collection", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "76", + "Dataset": "ADTR_O", + "Variable": "TRT01P", + "Label": "Planned Treatment for Period 01", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "77", + "Dataset": "ADTR_O", + "Variable": "TRT01A", + "Label": "Actual Treatment for Period 01", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "78", + "Dataset": "ADTR_O", + "Variable": "TRTSDTM", + "Label": "Datetime of First Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATETIME", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "79", + "Dataset": "ADTR_O", + "Variable": "TRTSTMF", + "Label": "Time of First Exposure Imput. Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "80", + "Dataset": "ADTR_O", + "Variable": "TRTEDTM", + "Label": "Datetime of Last Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATETIME", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "81", + "Dataset": "ADTR_O", + "Variable": "TRTETMF", + "Label": "Time of Last Exposure Imput. Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "82", + "Dataset": "ADTR_O", + "Variable": "TRTSDT", + "Label": "Date of First Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "83", + "Dataset": "ADTR_O", + "Variable": "TRTEDT", + "Label": "Date of Last Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "84", + "Dataset": "ADTR_O", + "Variable": "TRTDURD", + "Label": "Total Treatment Duration (Days)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "85", + "Dataset": "ADTR_O", + "Variable": "SCRFDT", + "Label": "Screen Failure Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "86", + "Dataset": "ADTR_O", + "Variable": "EOSDT", + "Label": "End of Study Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "87", + "Dataset": "ADTR_O", + "Variable": "EOSSTT", + "Label": "End of Study Status", + "Data Type": "text", + "Length": "12", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "88", + "Dataset": "ADTR_O", + "Variable": "FRVDT", + "Label": "Final Retrievel Visit Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "89", + "Dataset": "ADTR_O", + "Variable": "DTHDT", + "Label": "Date of Death", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "90", + "Dataset": "ADTR_O", + "Variable": "DTHADY", + "Label": "Relative Day of Death", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "91", + "Dataset": "ADTR_O", + "Variable": "LDDTHELD", + "Label": "Elapsed Days from Last Dose to Death", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "92", + "Dataset": "ADTR_O", + "Variable": "LSTALVDT", + "Label": "Date Last Known Alive", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "93", + "Dataset": "ADTR_O", + "Variable": "AGEGR1", + "Label": "Pooled Age Group 1", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "94", + "Dataset": "ADTR_O", + "Variable": "SAFFL", + "Label": "Safety Population Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "ADSL Population Indicator Variables", + "Has No Data": "No" + }, + { + "Order": "95", + "Dataset": "ADTR_O", + "Variable": "RACEGR1", + "Label": "Pooled Race Group 1", + "Data Type": "text", + "Length": "9", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "96", + "Dataset": "ADTR_O", + "Variable": "REGION1", + "Label": "Geographic Region 1", + "Data Type": "text", + "Length": "2", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "97", + "Dataset": "ADTR_O", + "Variable": "LDDTHGR1", + "Label": "Last Dose to Death - Days Elapsed Grp 1", + "Data Type": "text", + "Length": "5", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "98", + "Dataset": "ADTR_O", + "Variable": "DTH30FL", + "Label": "Death Within 30 Days of Last Trt Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "99", + "Dataset": "ADTR_O", + "Variable": "DTHA30FL", + "Label": "Death After 30 Days from Last Trt Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "100", + "Dataset": "ADTR_O", + "Variable": "DTHB30FL", + "Label": "Death Within 30 Days of First Trt Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "101", + "Dataset": "ADTR_O", + "Variable": "DTHCAUS", + "Label": "Cause of Death", + "Data Type": "text", + "Length": "200", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "102", + "Dataset": "ADTR_O", + "Variable": "DTHDOM", + "Label": "Domain for Date of Death Collection", + "Data Type": "text", + "Length": "200", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "103", + "Dataset": "ADTR_O", + "Variable": "DTHCGR1", + "Label": "Cause of Death Reason 1", + "Data Type": "text", + "Length": "200", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "1", + "Dataset": "ADTTE_O", + "Variable": "STUDYID", + "Label": "Study Identifier", + "Data Type": "text", + "Length": "12", + "Mandatory": "Yes", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "2", + "Dataset": "ADTTE_O", + "Variable": "USUBJID", + "Label": "Unique Subject Identifier", + "Data Type": "text", + "Length": "11", + "Mandatory": "Yes", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "3", + "Dataset": "ADTTE_O", + "Variable": "EVNTDESC", + "Label": "Event or Censoring Description", + "Data Type": "text", + "Length": "21", + "Mandatory": "No", + "Role": "Time-to-Event Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "4", + "Dataset": "ADTTE_O", + "Variable": "SRCDOM", + "Label": "Source Data", + "Data Type": "text", + "Length": "4", + "Mandatory": "No", + "Role": "Datapoint Traceability Variables", + "Has No Data": "No" + }, + { + "Order": "5", + "Dataset": "ADTTE_O", + "Variable": "SRCVAR", + "Label": "Source Variable", + "Data Type": "text", + "Length": "8", + "Mandatory": "No", + "Role": "Datapoint Traceability Variables", + "Has No Data": "No" + }, + { + "Order": "6", + "Dataset": "ADTTE_O", + "Variable": "SRCSEQ", + "Label": "Source Sequence Number", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Datapoint Traceability Variables", + "Has No Data": "No" + }, + { + "Order": "7", + "Dataset": "ADTTE_O", + "Variable": "CNSR", + "Label": "Censor", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Time-to-Event Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "8", + "Dataset": "ADTTE_O", + "Variable": "ADT", + "Label": "Analysis Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "9", + "Dataset": "ADTTE_O", + "Variable": "CNSDTDSC", + "Label": "Censor Date Description", + "Data Type": "text", + "Length": "21", + "Mandatory": "No", + "Role": "Time-to-Event Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "10", + "Dataset": "ADTTE_O", + "Variable": "STARTDT", + "Label": "Time-to-Event Origin Date for Subject", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "Time-to-Event Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "11", + "Dataset": "ADTTE_O", + "Variable": "PARAMCD", + "Label": "Parameter Code", + "Data Type": "text", + "Length": "3", + "Mandatory": "Yes", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "12", + "Dataset": "ADTTE_O", + "Variable": "PARAM", + "Label": "Parameter", + "Data Type": "text", + "Length": "25", + "Mandatory": "Yes", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "13", + "Dataset": "ADTTE_O", + "Variable": "AVAL", + "Label": "Analysis Value", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "14", + "Dataset": "ADTTE_O", + "Variable": "ASEQ", + "Label": "Analysis Sequence Number", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "15", + "Dataset": "ADTTE_O", + "Variable": "ARMCD", + "Label": "Planned Arm Code", + "Data Type": "text", + "Length": "6", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "16", + "Dataset": "ADTTE_O", + "Variable": "ARM", + "Label": "Description of Planned Arm", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Role": "ADSL Treatment Variables", + "Has No Data": "No" + }, + { + "Order": "17", + "Dataset": "ADTTE_O", + "Variable": "ACTARMCD", + "Label": "Actual Arm Code", + "Data Type": "text", + "Length": "6", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "18", + "Dataset": "ADTTE_O", + "Variable": "ACTARM", + "Label": "Description of Actual Arm", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Role": "ADSL Treatment Variables", + "Has No Data": "No" + }, + { + "Order": "19", + "Dataset": "ADTTE_O", + "Variable": "AGE", + "Label": "Age", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "ADSL Subject Demographics Variables", + "Has No Data": "No" + }, + { + "Order": "20", + "Dataset": "ADTTE_O", + "Variable": "SEX", + "Label": "Sex", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "ADSL Subject Demographics Variables", + "Has No Data": "No" + }, + { + "Order": "1", + "Dataset": "ADVFQ_P", + "Variable": "STUDYID", + "Label": "Study Identifier", + "Data Type": "text", + "Length": "12", + "Mandatory": "Yes", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "2", + "Dataset": "ADVFQ_P", + "Variable": "DOMAIN", + "Label": "Domain Abbreviation", + "Data Type": "text", + "Length": "2", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "3", + "Dataset": "ADVFQ_P", + "Variable": "USUBJID", + "Label": "Unique Subject Identifier", + "Data Type": "text", + "Length": "11", + "Mandatory": "Yes", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "4", + "Dataset": "ADVFQ_P", + "Variable": "QSSEQ", + "Label": "Sequence Number", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "5", + "Dataset": "ADVFQ_P", + "Variable": "QSTESTCD", + "Label": "Question Short Name", + "Data Type": "text", + "Length": "4", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "6", + "Dataset": "ADVFQ_P", + "Variable": "QSTEST", + "Label": "Question Name", + "Data Type": "text", + "Length": "34", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "7", + "Dataset": "ADVFQ_P", + "Variable": "QSCAT", + "Label": "Category of Question", + "Data Type": "text", + "Length": "10", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "8", + "Dataset": "ADVFQ_P", + "Variable": "QSSCAT", + "Label": "Subcategory for Question", + "Data Type": "text", + "Length": "17", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "9", + "Dataset": "ADVFQ_P", + "Variable": "QSORRES", + "Label": "Finding in Original Units", + "Data Type": "text", + "Length": "10", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "10", + "Dataset": "ADVFQ_P", + "Variable": "QSORRESU", + "Label": "Original Units", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "11", + "Dataset": "ADVFQ_P", + "Variable": "QSSTRESC", + "Label": "Character Result/Finding in Std Format", + "Data Type": "text", + "Length": "10", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "12", + "Dataset": "ADVFQ_P", + "Variable": "QSSTRESN", + "Label": "Numeric Finding in Standard Units", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "13", + "Dataset": "ADVFQ_P", + "Variable": "QSSTRESU", + "Label": "Standard Units", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "14", + "Dataset": "ADVFQ_P", + "Variable": "QSBLFL", + "Label": "Baseline Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "15", + "Dataset": "ADVFQ_P", + "Variable": "QSDRVFL", + "Label": "Derived Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "16", + "Dataset": "ADVFQ_P", + "Variable": "VISITNUM", + "Label": "Visit Number", + "Data Type": "float", + "Length": "4", + "Significant Digits": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "17", + "Dataset": "ADVFQ_P", + "Variable": "VISIT", + "Label": "Visit Name", + "Data Type": "text", + "Length": "17", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "18", + "Dataset": "ADVFQ_P", + "Variable": "VISITDY", + "Label": "Planned Study Day of Visit", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "19", + "Dataset": "ADVFQ_P", + "Variable": "QSDTC", + "Label": "Date/Time of Finding", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "20", + "Dataset": "ADVFQ_P", + "Variable": "QSDY", + "Label": "Study Day of Finding", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "21", + "Dataset": "ADVFQ_P", + "Variable": "TRTSDT", + "Label": "Date of First Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "22", + "Dataset": "ADVFQ_P", + "Variable": "TRTEDT", + "Label": "Date of Last Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "23", + "Dataset": "ADVFQ_P", + "Variable": "TRT01A", + "Label": "Actual Treatment for Period 01", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "24", + "Dataset": "ADVFQ_P", + "Variable": "TRT01P", + "Label": "Planned Treatment for Period 01", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "25", + "Dataset": "ADVFQ_P", + "Variable": "ADT", + "Label": "Analysis Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "26", + "Dataset": "ADVFQ_P", + "Variable": "ADY", + "Label": "Analysis Relative Day", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "27", + "Dataset": "ADVFQ_P", + "Variable": "PARAMCD", + "Label": "Parameter Code", + "Data Type": "text", + "Length": "8", + "Mandatory": "Yes", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "28", + "Dataset": "ADVFQ_P", + "Variable": "AVAL", + "Label": "Analysis Value", + "Data Type": "float", + "Length": "4", + "Significant Digits": "1", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "29", + "Dataset": "ADVFQ_P", + "Variable": "AVALC", + "Label": "Analysis Value (C)", + "Data Type": "text", + "Length": "10", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "30", + "Dataset": "ADVFQ_P", + "Variable": "AVISIT", + "Label": "Analysis Visit", + "Data Type": "text", + "Length": "11", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "31", + "Dataset": "ADVFQ_P", + "Variable": "AVISITN", + "Label": "Analysis Visit (N)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "32", + "Dataset": "ADVFQ_P", + "Variable": "ONTRTFL", + "Label": "On Treatment Record Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "Flag Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "33", + "Dataset": "ADVFQ_P", + "Variable": "ABLFL", + "Label": "Baseline Record Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "Flag Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "34", + "Dataset": "ADVFQ_P", + "Variable": "BASE", + "Label": "Baseline Value", + "Data Type": "float", + "Length": "4", + "Significant Digits": "1", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "35", + "Dataset": "ADVFQ_P", + "Variable": "CHG", + "Label": "Change from Baseline", + "Data Type": "float", + "Length": "5", + "Significant Digits": "1", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "36", + "Dataset": "ADVFQ_P", + "Variable": "PCHG", + "Label": "Percent Change from Baseline", + "Data Type": "float", + "Length": "12", + "Significant Digits": "8", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "37", + "Dataset": "ADVFQ_P", + "Variable": "ANL01FL", + "Label": "Analysis Flag 01", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "38", + "Dataset": "ADVFQ_P", + "Variable": "ASEQ", + "Label": "Analysis Sequence Number", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "39", + "Dataset": "ADVFQ_P", + "Variable": "PARAM", + "Label": "Parameter", + "Data Type": "text", + "Length": "23", + "Mandatory": "Yes", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "40", + "Dataset": "ADVFQ_P", + "Variable": "PARCAT1", + "Label": "Parameter Category 1", + "Data Type": "text", + "Length": "10", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "41", + "Dataset": "ADVFQ_P", + "Variable": "PARCAT2", + "Label": "Parameter Category 2", + "Data Type": "text", + "Length": "17", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "42", + "Dataset": "ADVFQ_P", + "Variable": "SUBJID", + "Label": "Subject Identifier for the Study", + "Data Type": "text", + "Length": "4", + "Mandatory": "No", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "43", + "Dataset": "ADVFQ_P", + "Variable": "RFSTDTC", + "Label": "Subject Reference Start Date/Time", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "44", + "Dataset": "ADVFQ_P", + "Variable": "RFENDTC", + "Label": "Subject Reference End Date/Time", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "45", + "Dataset": "ADVFQ_P", + "Variable": "RFXSTDTC", + "Label": "Date/Time of First Study Treatment", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "46", + "Dataset": "ADVFQ_P", + "Variable": "RFXENDTC", + "Label": "Date/Time of Last Study Treatment", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "47", + "Dataset": "ADVFQ_P", + "Variable": "RFICDTC", + "Label": "Date/Time of Informed Consent", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "48", + "Dataset": "ADVFQ_P", + "Variable": "RFPENDTC", + "Label": "Date/Time of End of Participation", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "49", + "Dataset": "ADVFQ_P", + "Variable": "DTHDTC", + "Label": "Date/Time of Death", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "50", + "Dataset": "ADVFQ_P", + "Variable": "DTHFL", + "Label": "Subject Death Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "51", + "Dataset": "ADVFQ_P", + "Variable": "SITEID", + "Label": "Study Site Identifier", + "Data Type": "text", + "Length": "3", + "Mandatory": "No", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "52", + "Dataset": "ADVFQ_P", + "Variable": "AGE", + "Label": "Age", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "ADSL Subject Demographics Variables", + "Has No Data": "No" + }, + { + "Order": "53", + "Dataset": "ADVFQ_P", + "Variable": "AGEU", + "Label": "Age Units", + "Data Type": "text", + "Length": "5", + "Mandatory": "No", + "Role": "ADSL Subject Demographics Variables", + "Has No Data": "No" + }, + { + "Order": "54", + "Dataset": "ADVFQ_P", + "Variable": "SEX", + "Label": "Sex", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "ADSL Subject Demographics Variables", + "Has No Data": "No" + }, + { + "Order": "55", + "Dataset": "ADVFQ_P", + "Variable": "RACE", + "Label": "Race", + "Data Type": "text", + "Length": "32", + "Mandatory": "No", + "Role": "ADSL Subject Demographics Variables", + "Has No Data": "No" + }, + { + "Order": "56", + "Dataset": "ADVFQ_P", + "Variable": "ETHNIC", + "Label": "Ethnicity", + "Data Type": "text", + "Length": "22", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "57", + "Dataset": "ADVFQ_P", + "Variable": "ARMCD", + "Label": "Planned Arm Code", + "Data Type": "text", + "Length": "6", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "58", + "Dataset": "ADVFQ_P", + "Variable": "ARM", + "Label": "Description of Planned Arm", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Role": "ADSL Treatment Variables", + "Has No Data": "No" + }, + { + "Order": "59", + "Dataset": "ADVFQ_P", + "Variable": "ACTARMCD", + "Label": "Actual Arm Code", + "Data Type": "text", + "Length": "6", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "60", + "Dataset": "ADVFQ_P", + "Variable": "ACTARM", + "Label": "Description of Actual Arm", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Role": "ADSL Treatment Variables", + "Has No Data": "No" + }, + { + "Order": "61", + "Dataset": "ADVFQ_P", + "Variable": "COUNTRY", + "Label": "Country", + "Data Type": "text", + "Length": "3", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "62", + "Dataset": "ADVFQ_P", + "Variable": "DMDTC", + "Label": "Date/Time of Collection", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "63", + "Dataset": "ADVFQ_P", + "Variable": "DMDY", + "Label": "Study Day of Collection", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "64", + "Dataset": "ADVFQ_P", + "Variable": "TRTSDTM", + "Label": "Datetime of First Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATETIME", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "65", + "Dataset": "ADVFQ_P", + "Variable": "TRTSTMF", + "Label": "Time of First Exposure Imput. Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "66", + "Dataset": "ADVFQ_P", + "Variable": "TRTEDTM", + "Label": "Datetime of Last Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATETIME", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "67", + "Dataset": "ADVFQ_P", + "Variable": "TRTETMF", + "Label": "Time of Last Exposure Imput. Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "68", + "Dataset": "ADVFQ_P", + "Variable": "TRTDURD", + "Label": "Total Treatment Duration (Days)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "69", + "Dataset": "ADVFQ_P", + "Variable": "SCRFDT", + "Label": "Screen Failure Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "70", + "Dataset": "ADVFQ_P", + "Variable": "EOSDT", + "Label": "End of Study Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "71", + "Dataset": "ADVFQ_P", + "Variable": "EOSSTT", + "Label": "End of Study Status", + "Data Type": "text", + "Length": "12", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "72", + "Dataset": "ADVFQ_P", + "Variable": "FRVDT", + "Label": "Final Retrievel Visit Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "73", + "Dataset": "ADVFQ_P", + "Variable": "RANDDT", + "Label": "Date of Randomization", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "74", + "Dataset": "ADVFQ_P", + "Variable": "DTHDT", + "Label": "Date of Death", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "75", + "Dataset": "ADVFQ_P", + "Variable": "DTHADY", + "Label": "Relative Day of Death", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "76", + "Dataset": "ADVFQ_P", + "Variable": "LDDTHELD", + "Label": "Elapsed Days from Last Dose to Death", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "77", + "Dataset": "ADVFQ_P", + "Variable": "LSTALVDT", + "Label": "Date Last Known Alive", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "78", + "Dataset": "ADVFQ_P", + "Variable": "AGEGR1", + "Label": "Pooled Age Group 1", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "79", + "Dataset": "ADVFQ_P", + "Variable": "SAFFL", + "Label": "Safety Population Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "ADSL Population Indicator Variables", + "Has No Data": "No" + }, + { + "Order": "80", + "Dataset": "ADVFQ_P", + "Variable": "RACEGR1", + "Label": "Pooled Race Group 1", + "Data Type": "text", + "Length": "9", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "81", + "Dataset": "ADVFQ_P", + "Variable": "REGION1", + "Label": "Geographic Region 1", + "Data Type": "text", + "Length": "2", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "82", + "Dataset": "ADVFQ_P", + "Variable": "LDDTHGR1", + "Label": "Last Dose to Death - Days Elapsed Grp 1", + "Data Type": "text", + "Length": "5", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "83", + "Dataset": "ADVFQ_P", + "Variable": "DTH30FL", + "Label": "Death Within 30 Days of Last Trt Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "84", + "Dataset": "ADVFQ_P", + "Variable": "DTHA30FL", + "Label": "Death After 30 Days from Last Trt Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "85", + "Dataset": "ADVFQ_P", + "Variable": "DTHB30FL", + "Label": "Death Within 30 Days of First Trt Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "1", + "Dataset": "ADVS", + "Variable": "STUDYID", + "Label": "Study Identifier", + "Data Type": "text", + "Length": "12", + "Mandatory": "Yes", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "2", + "Dataset": "ADVS", + "Variable": "DOMAIN", + "Label": "Domain Abbreviation", + "Data Type": "text", + "Length": "2", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "3", + "Dataset": "ADVS", + "Variable": "USUBJID", + "Label": "Unique Subject Identifier", + "Data Type": "text", + "Length": "11", + "Mandatory": "Yes", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "4", + "Dataset": "ADVS", + "Variable": "VSSEQ", + "Label": "Sequence Number", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "5", + "Dataset": "ADVS", + "Variable": "VSTESTCD", + "Label": "Vital Signs Test Short Name", + "Data Type": "text", + "Length": "6", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "6", + "Dataset": "ADVS", + "Variable": "VSTEST", + "Label": "Vital Signs Test Name", + "Data Type": "text", + "Length": "24", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "7", + "Dataset": "ADVS", + "Variable": "VSPOS", + "Label": "Vital Signs Position of Subject", + "Data Type": "text", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "8", + "Dataset": "ADVS", + "Variable": "VSORRES", + "Label": "Result or Finding in Original Units", + "Data Type": "text", + "Length": "5", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "9", + "Dataset": "ADVS", + "Variable": "VSORRESU", + "Label": "Original Units", + "Data Type": "text", + "Length": "9", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "10", + "Dataset": "ADVS", + "Variable": "VSSTRESC", + "Label": "Character Result/Finding in Std Format", + "Data Type": "text", + "Length": "6", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "11", + "Dataset": "ADVS", + "Variable": "VSSTRESN", + "Label": "Numeric Result/Finding in Standard Units", + "Data Type": "float", + "Length": "8", + "Significant Digits": "2", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "12", + "Dataset": "ADVS", + "Variable": "VSSTRESU", + "Label": "Standard Units", + "Data Type": "text", + "Length": "9", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "13", + "Dataset": "ADVS", + "Variable": "VSSTAT", + "Label": "Completion Status", + "Data Type": "text", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "14", + "Dataset": "ADVS", + "Variable": "VSLOC", + "Label": "Location of Vital Signs Measurement", + "Data Type": "text", + "Length": "11", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "15", + "Dataset": "ADVS", + "Variable": "VSBLFL", + "Label": "Baseline Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "16", + "Dataset": "ADVS", + "Variable": "VISITNUM", + "Label": "Visit Number", + "Data Type": "float", + "Length": "4", + "Significant Digits": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "17", + "Dataset": "ADVS", + "Variable": "VISIT", + "Label": "Visit Name", + "Data Type": "text", + "Length": "19", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "18", + "Dataset": "ADVS", + "Variable": "VISITDY", + "Label": "Planned Study Day of Visit", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "19", + "Dataset": "ADVS", + "Variable": "VSDTC", + "Label": "Date/Time of Measurements", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "20", + "Dataset": "ADVS", + "Variable": "VSDY", + "Label": "Study Day of Vital Signs", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "21", + "Dataset": "ADVS", + "Variable": "VSTPT", + "Label": "Planned Time Point Name", + "Data Type": "text", + "Length": "30", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "22", + "Dataset": "ADVS", + "Variable": "VSTPTNUM", + "Label": "Planned Time Point Number", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "23", + "Dataset": "ADVS", + "Variable": "VSELTM", + "Label": "Planned Elapsed Time from Time Point Ref", + "Data Type": "text", + "Length": "4", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "24", + "Dataset": "ADVS", + "Variable": "VSTPTREF", + "Label": "Time Point Reference", + "Data Type": "text", + "Length": "16", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "25", + "Dataset": "ADVS", + "Variable": "TRTSDT", + "Label": "Date of First Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "26", + "Dataset": "ADVS", + "Variable": "TRTEDT", + "Label": "Date of Last Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "27", + "Dataset": "ADVS", + "Variable": "TRT01A", + "Label": "Actual Treatment for Period 01", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "28", + "Dataset": "ADVS", + "Variable": "TRT01P", + "Label": "Planned Treatment for Period 01", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "29", + "Dataset": "ADVS", + "Variable": "ADT", + "Label": "Analysis Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "30", + "Dataset": "ADVS", + "Variable": "ADY", + "Label": "Analysis Relative Day", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "31", + "Dataset": "ADVS", + "Variable": "PARAMCD", + "Label": "Parameter Code", + "Data Type": "text", + "Length": "6", + "Mandatory": "Yes", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "32", + "Dataset": "ADVS", + "Variable": "AVAL", + "Label": "Analysis Value", + "Data Type": "float", + "Length": "11", + "Significant Digits": "8", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "33", + "Dataset": "ADVS", + "Variable": "AVALC", + "Label": "Analysis Value (C)", + "Data Type": "text", + "Length": "6", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "34", + "Dataset": "ADVS", + "Variable": "ATPTN", + "Label": "Analysis Timepoint (N)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "35", + "Dataset": "ADVS", + "Variable": "ATPT", + "Label": "Analysis Timepoint", + "Data Type": "text", + "Length": "30", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "36", + "Dataset": "ADVS", + "Variable": "AVISIT", + "Label": "Analysis Visit", + "Data Type": "text", + "Length": "16", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "37", + "Dataset": "ADVS", + "Variable": "AVISITN", + "Label": "Analysis Visit (N)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "38", + "Dataset": "ADVS", + "Variable": "DTYPE", + "Label": "Derivation Type", + "Data Type": "text", + "Length": "7", + "Mandatory": "No", + "Role": "Analysis Descriptor Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "39", + "Dataset": "ADVS", + "Variable": "ONTRTFL", + "Label": "On Treatment Record Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "Flag Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "40", + "Dataset": "ADVS", + "Variable": "ANRLO", + "Label": "Analysis Normal Range Lower Limit", + "Data Type": "float", + "Length": "8", + "Significant Digits": "1", + "Mandatory": "No", + "Role": "Toxicity and Range Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "41", + "Dataset": "ADVS", + "Variable": "ANRHI", + "Label": "Analysis Normal Range Upper Limit", + "Data Type": "float", + "Length": "8", + "Significant Digits": "1", + "Mandatory": "No", + "Role": "Toxicity and Range Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "42", + "Dataset": "ADVS", + "Variable": "A1LO", + "Label": "Analysis Range 1 Lower Limit", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "43", + "Dataset": "ADVS", + "Variable": "A1HI", + "Label": "Analysis Range 1 Upper Limit", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "44", + "Dataset": "ADVS", + "Variable": "ANRIND", + "Label": "Analysis Reference Range Indicator", + "Data Type": "text", + "Length": "6", + "Mandatory": "No", + "Role": "Toxicity and Range Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "45", + "Dataset": "ADVS", + "Variable": "BASETYPE", + "Label": "Baseline Type", + "Data Type": "text", + "Length": "36", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "46", + "Dataset": "ADVS", + "Variable": "ABLFL", + "Label": "Baseline Record Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "Flag Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "47", + "Dataset": "ADVS", + "Variable": "BASE", + "Label": "Baseline Value", + "Data Type": "float", + "Length": "11", + "Significant Digits": "8", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "48", + "Dataset": "ADVS", + "Variable": "BASEC", + "Label": "Baseline Value (C)", + "Data Type": "text", + "Length": "6", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "49", + "Dataset": "ADVS", + "Variable": "BNRIND", + "Label": "Baseline Reference Range Indicator", + "Data Type": "text", + "Length": "6", + "Mandatory": "No", + "Role": "Toxicity and Range Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "50", + "Dataset": "ADVS", + "Variable": "CHG", + "Label": "Change from Baseline", + "Data Type": "float", + "Length": "11", + "Significant Digits": "8", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "51", + "Dataset": "ADVS", + "Variable": "PCHG", + "Label": "Percent Change from Baseline", + "Data Type": "float", + "Length": "11", + "Significant Digits": "8", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "52", + "Dataset": "ADVS", + "Variable": "ANL01FL", + "Label": "Analysis Flag 01", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "53", + "Dataset": "ADVS", + "Variable": "TRTP", + "Label": "Planned Treatment", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Role": "Record-Level Treatment Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "54", + "Dataset": "ADVS", + "Variable": "TRTA", + "Label": "Actual Treatment", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Role": "Record-Level Treatment Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "55", + "Dataset": "ADVS", + "Variable": "ASEQ", + "Label": "Analysis Sequence Number", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "56", + "Dataset": "ADVS", + "Variable": "AVALCA1N", + "Label": "Analysis Value Category 1 (N)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "57", + "Dataset": "ADVS", + "Variable": "AVALCAT1", + "Label": "Analysis Value Category 1", + "Data Type": "text", + "Length": "9", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "58", + "Dataset": "ADVS", + "Variable": "PARAM", + "Label": "Parameter", + "Data Type": "text", + "Length": "31", + "Mandatory": "Yes", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "59", + "Dataset": "ADVS", + "Variable": "PARAMN", + "Label": "Parameter (N)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "60", + "Dataset": "ADVS", + "Variable": "SUBJID", + "Label": "Subject Identifier for the Study", + "Data Type": "text", + "Length": "4", + "Mandatory": "No", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "61", + "Dataset": "ADVS", + "Variable": "RFSTDTC", + "Label": "Subject Reference Start Date/Time", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "62", + "Dataset": "ADVS", + "Variable": "RFENDTC", + "Label": "Subject Reference End Date/Time", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "63", + "Dataset": "ADVS", + "Variable": "RFXSTDTC", + "Label": "Date/Time of First Study Treatment", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "64", + "Dataset": "ADVS", + "Variable": "RFXENDTC", + "Label": "Date/Time of Last Study Treatment", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "65", + "Dataset": "ADVS", + "Variable": "RFICDTC", + "Label": "Date/Time of Informed Consent", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "66", + "Dataset": "ADVS", + "Variable": "RFPENDTC", + "Label": "Date/Time of End of Participation", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "67", + "Dataset": "ADVS", + "Variable": "DTHDTC", + "Label": "Date/Time of Death", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "68", + "Dataset": "ADVS", + "Variable": "DTHFL", + "Label": "Subject Death Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "69", + "Dataset": "ADVS", + "Variable": "SITEID", + "Label": "Study Site Identifier", + "Data Type": "text", + "Length": "3", + "Mandatory": "No", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "70", + "Dataset": "ADVS", + "Variable": "AGE", + "Label": "Age", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "ADSL Subject Demographics Variables", + "Has No Data": "No" + }, + { + "Order": "71", + "Dataset": "ADVS", + "Variable": "AGEU", + "Label": "Age Units", + "Data Type": "text", + "Length": "5", + "Mandatory": "No", + "Role": "ADSL Subject Demographics Variables", + "Has No Data": "No" + }, + { + "Order": "72", + "Dataset": "ADVS", + "Variable": "SEX", + "Label": "Sex", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "ADSL Subject Demographics Variables", + "Has No Data": "No" + }, + { + "Order": "73", + "Dataset": "ADVS", + "Variable": "RACE", + "Label": "Race", + "Data Type": "text", + "Length": "32", + "Mandatory": "No", + "Role": "ADSL Subject Demographics Variables", + "Has No Data": "No" + }, + { + "Order": "74", + "Dataset": "ADVS", + "Variable": "ETHNIC", + "Label": "Ethnicity", + "Data Type": "text", + "Length": "22", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "75", + "Dataset": "ADVS", + "Variable": "ARMCD", + "Label": "Planned Arm Code", + "Data Type": "text", + "Length": "6", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "76", + "Dataset": "ADVS", + "Variable": "ARM", + "Label": "Description of Planned Arm", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Role": "ADSL Treatment Variables", + "Has No Data": "No" + }, + { + "Order": "77", + "Dataset": "ADVS", + "Variable": "ACTARMCD", + "Label": "Actual Arm Code", + "Data Type": "text", + "Length": "6", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "78", + "Dataset": "ADVS", + "Variable": "ACTARM", + "Label": "Description of Actual Arm", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Role": "ADSL Treatment Variables", + "Has No Data": "No" + }, + { + "Order": "79", + "Dataset": "ADVS", + "Variable": "COUNTRY", + "Label": "Country", + "Data Type": "text", + "Length": "3", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "80", + "Dataset": "ADVS", + "Variable": "DMDTC", + "Label": "Date/Time of Collection", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "81", + "Dataset": "ADVS", + "Variable": "DMDY", + "Label": "Study Day of Collection", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "82", + "Dataset": "ADVS", + "Variable": "TRTSDTM", + "Label": "Datetime of First Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATETIME", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "83", + "Dataset": "ADVS", + "Variable": "TRTSTMF", + "Label": "Time of First Exposure Imput. Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "84", + "Dataset": "ADVS", + "Variable": "TRTEDTM", + "Label": "Datetime of Last Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATETIME", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "85", + "Dataset": "ADVS", + "Variable": "TRTETMF", + "Label": "Time of Last Exposure Imput. Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "86", + "Dataset": "ADVS", + "Variable": "TRTDURD", + "Label": "Total Treatment Duration (Days)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "87", + "Dataset": "ADVS", + "Variable": "SCRFDT", + "Label": "Screen Failure Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "88", + "Dataset": "ADVS", + "Variable": "EOSDT", + "Label": "End of Study Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "89", + "Dataset": "ADVS", + "Variable": "EOSSTT", + "Label": "End of Study Status", + "Data Type": "text", + "Length": "12", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "90", + "Dataset": "ADVS", + "Variable": "FRVDT", + "Label": "Final Retrievel Visit Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "91", + "Dataset": "ADVS", + "Variable": "RANDDT", + "Label": "Date of Randomization", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "92", + "Dataset": "ADVS", + "Variable": "DTHDT", + "Label": "Date of Death", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "93", + "Dataset": "ADVS", + "Variable": "DTHADY", + "Label": "Relative Day of Death", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "94", + "Dataset": "ADVS", + "Variable": "LDDTHELD", + "Label": "Elapsed Days from Last Dose to Death", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "95", + "Dataset": "ADVS", + "Variable": "LSTALVDT", + "Label": "Date Last Known Alive", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "96", + "Dataset": "ADVS", + "Variable": "AGEGR1", + "Label": "Pooled Age Group 1", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "97", + "Dataset": "ADVS", + "Variable": "SAFFL", + "Label": "Safety Population Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "ADSL Population Indicator Variables", + "Has No Data": "No" + }, + { + "Order": "98", + "Dataset": "ADVS", + "Variable": "RACEGR1", + "Label": "Pooled Race Group 1", + "Data Type": "text", + "Length": "9", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "99", + "Dataset": "ADVS", + "Variable": "REGION1", + "Label": "Geographic Region 1", + "Data Type": "text", + "Length": "2", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "100", + "Dataset": "ADVS", + "Variable": "LDDTHGR1", + "Label": "Last Dose to Death - Days Elapsed Grp 1", + "Data Type": "text", + "Length": "5", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "101", + "Dataset": "ADVS", + "Variable": "DTH30FL", + "Label": "Death Within 30 Days of Last Trt Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "102", + "Dataset": "ADVS", + "Variable": "DTHA30FL", + "Label": "Death After 30 Days from Last Trt Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "103", + "Dataset": "ADVS", + "Variable": "DTHB30FL", + "Label": "Death Within 30 Days of First Trt Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "1", + "Dataset": "ADVS_E", + "Variable": "STUDYID", + "Label": "Study Identifier", + "Data Type": "text", + "Length": "12", + "Mandatory": "Yes", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "2", + "Dataset": "ADVS_E", + "Variable": "DOMAIN", + "Label": "Domain Abbreviation", + "Data Type": "text", + "Length": "2", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "3", + "Dataset": "ADVS_E", + "Variable": "USUBJID", + "Label": "Unique Subject Identifier", + "Data Type": "text", + "Length": "11", + "Mandatory": "Yes", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "4", + "Dataset": "ADVS_E", + "Variable": "EPOCH", + "Label": "Epoch", + "Data Type": "text", + "Length": "40", + "Mandatory": "No" + }, + { + "Order": "5", + "Dataset": "ADVS_E", + "Variable": "VSEVAL", + "Label": "Evaluator", + "Data Type": "text", + "Length": "41", + "Mandatory": "No" + }, + { + "Order": "6", + "Dataset": "ADVS_E", + "Variable": "VSSEQ", + "Label": "Sequence Number", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "7", + "Dataset": "ADVS_E", + "Variable": "VSTESTCD", + "Label": "Vital Signs Test Short Name", + "Data Type": "text", + "Length": "6", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "8", + "Dataset": "ADVS_E", + "Variable": "VSTEST", + "Label": "Vital Signs Test Name", + "Data Type": "text", + "Length": "24", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "9", + "Dataset": "ADVS_E", + "Variable": "VSPOS", + "Label": "Vital Signs Position of Subject", + "Data Type": "text", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "10", + "Dataset": "ADVS_E", + "Variable": "VSORRES", + "Label": "Result or Finding in Original Units", + "Data Type": "text", + "Length": "5", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "11", + "Dataset": "ADVS_E", + "Variable": "VSORRESU", + "Label": "Original Units", + "Data Type": "text", + "Length": "9", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "12", + "Dataset": "ADVS_E", + "Variable": "VSSTRESC", + "Label": "Character Result/Finding in Std Format", + "Data Type": "text", + "Length": "6", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "13", + "Dataset": "ADVS_E", + "Variable": "VSSTRESN", + "Label": "Numeric Result/Finding in Standard Units", + "Data Type": "float", + "Length": "8", + "Significant Digits": "2", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "14", + "Dataset": "ADVS_E", + "Variable": "VSSTRESU", + "Label": "Standard Units", + "Data Type": "text", + "Length": "9", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "15", + "Dataset": "ADVS_E", + "Variable": "VSSTAT", + "Label": "Completion Status", + "Data Type": "text", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "16", + "Dataset": "ADVS_E", + "Variable": "VSLOC", + "Label": "Location of Vital Signs Measurement", + "Data Type": "text", + "Length": "11", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "17", + "Dataset": "ADVS_E", + "Variable": "VSBLFL", + "Label": "Baseline Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "18", + "Dataset": "ADVS_E", + "Variable": "VISITNUM", + "Label": "Visit Number", + "Data Type": "float", + "Length": "4", + "Significant Digits": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "19", + "Dataset": "ADVS_E", + "Variable": "VISIT", + "Label": "Visit Name", + "Data Type": "text", + "Length": "19", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "20", + "Dataset": "ADVS_E", + "Variable": "VISITDY", + "Label": "Planned Study Day of Visit", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "21", + "Dataset": "ADVS_E", + "Variable": "VSDTC", + "Label": "Date/Time of Measurements", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "22", + "Dataset": "ADVS_E", + "Variable": "VSDY", + "Label": "Study Day of Vital Signs", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "23", + "Dataset": "ADVS_E", + "Variable": "VSTPT", + "Label": "Planned Time Point Name", + "Data Type": "text", + "Length": "30", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "24", + "Dataset": "ADVS_E", + "Variable": "VSTPTNUM", + "Label": "Planned Time Point Number", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "25", + "Dataset": "ADVS_E", + "Variable": "VSELTM", + "Label": "Planned Elapsed Time from Time Point Ref", + "Data Type": "text", + "Length": "4", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "26", + "Dataset": "ADVS_E", + "Variable": "BRTHDT", + "Label": "Date/Time of Birth", + "Data Type": "datetime", + "Mandatory": "No" + }, + { + "Order": "27", + "Dataset": "ADVS_E", + "Variable": "BRTHDTC", + "Label": "Date/Time of Birth (Character)", + "Data Type": "text", + "Length": "20", + "Mandatory": "No" + }, + { + "Order": "28", + "Dataset": "ADVS_E", + "Variable": "VSTPTREF", + "Label": "Time Point Reference", + "Data Type": "text", + "Length": "16", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "29", + "Dataset": "ADVS_E", + "Variable": "TRTSDT", + "Label": "Date of First Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "30", + "Dataset": "ADVS_E", + "Variable": "TRTEDT", + "Label": "Date of Last Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "31", + "Dataset": "ADVS_E", + "Variable": "TRT01A", + "Label": "Actual Treatment for Period 01", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "32", + "Dataset": "ADVS_E", + "Variable": "TRT01P", + "Label": "Planned Treatment for Period 01", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "33", + "Dataset": "ADVS_E", + "Variable": "ADT", + "Label": "Analysis Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "34", + "Dataset": "ADVS_E", + "Variable": "ADY", + "Label": "Analysis Relative Day", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "35", + "Dataset": "ADVS_E", + "Variable": "PARAMCD", + "Label": "Parameter Code", + "Data Type": "text", + "Length": "6", + "Mandatory": "Yes", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "36", + "Dataset": "ADVS_E", + "Variable": "AVAL", + "Label": "Analysis Value", + "Data Type": "float", + "Length": "11", + "Significant Digits": "8", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "37", + "Dataset": "ADVS_E", + "Variable": "ATPTN", + "Label": "Analysis Timepoint (N)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "38", + "Dataset": "ADVS_E", + "Variable": "ATPT", + "Label": "Analysis Timepoint", + "Data Type": "text", + "Length": "30", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "39", + "Dataset": "ADVS_E", + "Variable": "AVISIT", + "Label": "Analysis Visit", + "Data Type": "text", + "Length": "16", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "40", + "Dataset": "ADVS_E", + "Variable": "AVISITN", + "Label": "Analysis Visit (N)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Timing Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "41", + "Dataset": "ADVS_E", + "Variable": "ONTRTFL", + "Label": "On Treatment Record Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "Flag Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "42", + "Dataset": "ADVS_E", + "Variable": "ABLFL", + "Label": "Baseline Record Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "Flag Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "43", + "Dataset": "ADVS_E", + "Variable": "BASE", + "Label": "Baseline Value", + "Data Type": "float", + "Length": "11", + "Significant Digits": "8", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "44", + "Dataset": "ADVS_E", + "Variable": "CHG", + "Label": "Change from Baseline", + "Data Type": "float", + "Length": "11", + "Significant Digits": "8", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "45", + "Dataset": "ADVS_E", + "Variable": "PCHG", + "Label": "Percent Change from Baseline", + "Data Type": "float", + "Length": "11", + "Significant Digits": "8", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "46", + "Dataset": "ADVS_E", + "Variable": "ANL01FL", + "Label": "Analysis Flag 01", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "47", + "Dataset": "ADVS_E", + "Variable": "ASEQ", + "Label": "Analysis Sequence Number", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "48", + "Dataset": "ADVS_E", + "Variable": "PARAM", + "Label": "Parameter", + "Data Type": "text", + "Length": "31", + "Mandatory": "Yes", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "49", + "Dataset": "ADVS_E", + "Variable": "PARAMN", + "Label": "Parameter (N)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "Analysis Parameter Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "50", + "Dataset": "ADVS_E", + "Variable": "SUBJID", + "Label": "Subject Identifier for the Study", + "Data Type": "text", + "Length": "4", + "Mandatory": "No", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "51", + "Dataset": "ADVS_E", + "Variable": "RFSTDTC", + "Label": "Subject Reference Start Date/Time", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "52", + "Dataset": "ADVS_E", + "Variable": "RFENDTC", + "Label": "Subject Reference End Date/Time", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "53", + "Dataset": "ADVS_E", + "Variable": "RFXSTDTC", + "Label": "Date/Time of First Study Treatment", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "54", + "Dataset": "ADVS_E", + "Variable": "RFXENDTC", + "Label": "Date/Time of Last Study Treatment", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "55", + "Dataset": "ADVS_E", + "Variable": "RFICDTC", + "Label": "Date/Time of Informed Consent", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "56", + "Dataset": "ADVS_E", + "Variable": "RFPENDTC", + "Label": "Date/Time of End of Participation", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "57", + "Dataset": "ADVS_E", + "Variable": "DTHDTC", + "Label": "Date/Time of Death", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "58", + "Dataset": "ADVS_E", + "Variable": "DTHFL", + "Label": "Subject Death Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "59", + "Dataset": "ADVS_E", + "Variable": "SITEID", + "Label": "Study Site Identifier", + "Data Type": "text", + "Length": "3", + "Mandatory": "No", + "Role": "Identifier Variables for BDS Datasets", + "Has No Data": "No" + }, + { + "Order": "60", + "Dataset": "ADVS_E", + "Variable": "AGE", + "Label": "Age", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "ADSL Subject Demographics Variables", + "Has No Data": "No" + }, + { + "Order": "61", + "Dataset": "ADVS_E", + "Variable": "AGEU", + "Label": "Age Units", + "Data Type": "text", + "Length": "5", + "Mandatory": "No", + "Role": "ADSL Subject Demographics Variables", + "Has No Data": "No" + }, + { + "Order": "62", + "Dataset": "ADVS_E", + "Variable": "SEX", + "Label": "Sex", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "ADSL Subject Demographics Variables", + "Has No Data": "No" + }, + { + "Order": "63", + "Dataset": "ADVS_E", + "Variable": "RACE", + "Label": "Race", + "Data Type": "text", + "Length": "32", + "Mandatory": "No", + "Role": "ADSL Subject Demographics Variables", + "Has No Data": "No" + }, + { + "Order": "64", + "Dataset": "ADVS_E", + "Variable": "ETHNIC", + "Label": "Ethnicity", + "Data Type": "text", + "Length": "22", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "65", + "Dataset": "ADVS_E", + "Variable": "ARMCD", + "Label": "Planned Arm Code", + "Data Type": "text", + "Length": "6", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "66", + "Dataset": "ADVS_E", + "Variable": "ARM", + "Label": "Description of Planned Arm", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Role": "ADSL Treatment Variables", + "Has No Data": "No" + }, + { + "Order": "67", + "Dataset": "ADVS_E", + "Variable": "ACTARMCD", + "Label": "Actual Arm Code", + "Data Type": "text", + "Length": "6", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "68", + "Dataset": "ADVS_E", + "Variable": "ACTARM", + "Label": "Description of Actual Arm", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Role": "ADSL Treatment Variables", + "Has No Data": "No" + }, + { + "Order": "69", + "Dataset": "ADVS_E", + "Variable": "COUNTRY", + "Label": "Country", + "Data Type": "text", + "Length": "3", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "70", + "Dataset": "ADVS_E", + "Variable": "DMDTC", + "Label": "Date/Time of Collection", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "71", + "Dataset": "ADVS_E", + "Variable": "DMDY", + "Label": "Study Day of Collection", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "72", + "Dataset": "ADVS_E", + "Variable": "TRTSDTM", + "Label": "Datetime of First Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATETIME", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "73", + "Dataset": "ADVS_E", + "Variable": "TRTSTMF", + "Label": "Time of First Exposure Imput. Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "74", + "Dataset": "ADVS_E", + "Variable": "TRTEDTM", + "Label": "Datetime of Last Exposure to Treatment", + "Data Type": "integer", + "Length": "8", + "Format": "DATETIME", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "75", + "Dataset": "ADVS_E", + "Variable": "TRTETMF", + "Label": "Time of Last Exposure Imput. Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Role": "ADSL Treatment Timing Variables", + "Has No Data": "No" + }, + { + "Order": "76", + "Dataset": "ADVS_E", + "Variable": "TRTDURD", + "Label": "Total Treatment Duration (Days)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Role": "ADSL Subject-Level Trial Experience Variables", + "Has No Data": "No" + }, + { + "Order": "77", + "Dataset": "ADVS_E", + "Variable": "AAGECUR", + "Label": "Current Analysis Age (Days)", + "Data Type": "integer", + "Length": "9", + "Mandatory": "No" + }, + { + "Order": "78", + "Dataset": "ADVS_E", + "Variable": "AAGECURU", + "Label": "Current Analysis Age Units", + "Data Type": "text", + "Length": "20", + "Mandatory": "No" + }, + { + "Order": "79", + "Dataset": "ADVS_E", + "Variable": "HGTTMP", + "Label": "Temporary Height at Timepoint", + "Data Type": "integer", + "Length": "9", + "Mandatory": "No" + }, + { + "Order": "80", + "Dataset": "ADVS_E", + "Variable": "HGTTMPU", + "Label": "Temporary Height at Timepoint Units", + "Data Type": "text", + "Length": "20", + "Mandatory": "No" + } + ], + "ValueLevel": [], + "Codelists": [], + "Dictionaries": [], + "Methods": [], + "Comments": [], + "Documents": [], + "Analysis Displays": [], + "Analysis Results": [] +} \ No newline at end of file diff --git a/man/adae.Rd b/man/adae.Rd index 71240ef..b83ca1d 100644 --- a/man/adae.Rd +++ b/man/adae.Rd @@ -3,7 +3,7 @@ \docType{data} \name{adae} \alias{adae} -\title{adae} +\title{Adverse Events Analysis} \format{ A data frame with 105 columns: \describe{ diff --git a/man/adbcva_ophtha.Rd b/man/adbcva_ophtha.Rd index d2c4504..e10c44e 100644 --- a/man/adbcva_ophtha.Rd +++ b/man/adbcva_ophtha.Rd @@ -3,9 +3,9 @@ \docType{data} \name{adbcva_ophtha} \alias{adbcva_ophtha} -\title{adbcva_ophtha} +\title{Best Corrected Visual Acuity Analysis} \format{ -A data frame with 120 columns: +A data frame with 71 columns: \describe{ \item{ STUDYID }{Study Identifier} \item{ DOMAIN }{Domain Abbreviation} @@ -60,71 +60,22 @@ A data frame with 120 columns: \item{ BASEC }{Baseline Value (C)} \item{ CHG }{Change from Baseline} \item{ PCHG }{Percent Change from Baseline} -\item{ ASEQ }{Analysis Sequence Number} -\item{ SUBJID }{Subject Identifier for the Study} -\item{ RFSTDTC }{Subject Reference Start Date/Time} -\item{ RFENDTC }{Subject Reference End Date/Time} -\item{ RFXSTDTC }{Date/Time of First Study Treatment} -\item{ RFXENDTC }{Date/Time of Last Study Treatment} -\item{ RFICDTC }{Date/Time of Informed Consent} -\item{ RFPENDTC }{Date/Time of End of Participation} -\item{ DTHDTC }{Date/Time of Death} -\item{ DTHFL }{Subject Death Flag} -\item{ SITEID }{Study Site Identifier} -\item{ AGE }{Age} -\item{ AGEU }{Age Units} -\item{ SEX }{Sex} -\item{ RACE }{Race} -\item{ ETHNIC }{Ethnicity} -\item{ ARMCD }{Planned Arm Code} -\item{ ARM }{Description of Planned Arm} -\item{ ACTARMCD }{Actual Arm Code} -\item{ ACTARM }{Description of Actual Arm} -\item{ COUNTRY }{Country/Region} -\item{ DMDTC }{Date/Time of Collection} -\item{ DMDY }{Study Day of Collection} -\item{ TRTSDTM }{Datetime of First Exposure to Treatment} -\item{ TRTSTMF }{Time of First Exposure Imput. Flag} -\item{ TRTEDTM }{Datetime of Last Exposure to Treatment} -\item{ TRTETMF }{Time of Last Exposure Imput. Flag} -\item{ TRTDURD }{Total Treatment Duration (Days)} -\item{ SCRFDT }{Screen Failure Date} -\item{ EOSDT }{End of Study Date} -\item{ EOSSTT }{End of Study Status} -\item{ FRVDT }{Final Retrievel Visit Date} -\item{ RANDDT }{Date of Randomization} -\item{ DTHDT }{Date of Death} -\item{ DTHDTF }{undocumented field} -\item{ DTHADY }{Relative Day of Death} -\item{ LDDTHELD }{Elapsed Days from Last Dose to Death} -\item{ DTHCAUS }{undocumented field} -\item{ DTHDOM }{undocumented field} -\item{ DTHCGR1 }{undocumented field} -\item{ LSTALVDT }{Date Last Known Alive} -\item{ SAFFL }{Safety Population Flag} -\item{ RACEGR1 }{Pooled Race Group 1} -\item{ AGEGR1 }{Pooled Age Group 1} -\item{ REGION1 }{Geographic Region 1} -\item{ LDDTHGR1 }{Last Dose to Death - Days Elapsed Grp 1} -\item{ DTH30FL }{Death Within 30 Days of Last Trt Flag} -\item{ DTHA30FL }{Death After 30 Days from Last Trt Flag} -\item{ DTHB30FL }{Death Within 30 Days of First Trt Flag} -\item{ CRIT1 }{Analysis Criterion 1} \item{ CRIT1FL }{Criterion 1 Evaluation Result Flag} -\item{ CRIT2 }{Analysis Criterion 2} +\item{ CRIT1 }{Analysis Criterion 1} \item{ CRIT2FL }{Criterion 2 Evaluation Result Flag} -\item{ CRIT3 }{Analysis Criterion 3} +\item{ CRIT2 }{Analysis Criterion 2} \item{ CRIT3FL }{Criterion 3 Evaluation Result Flag} -\item{ CRIT4 }{Analysis Criterion 4} +\item{ CRIT3 }{Analysis Criterion 3} \item{ CRIT4FL }{Criterion 4 Evaluation Result Flag} -\item{ CRIT5 }{Analysis Criterion 5} +\item{ CRIT4 }{Analysis Criterion 4} \item{ CRIT5FL }{Criterion 5 Evaluation Result Flag} -\item{ CRIT6 }{Analysis Criterion 6} +\item{ CRIT5 }{Analysis Criterion 5} \item{ CRIT6FL }{Criterion 6 Evaluation Result Flag} -\item{ CRIT7 }{Analysis Criterion 7} +\item{ CRIT6 }{Analysis Criterion 6} \item{ CRIT7FL }{Criterion 7 Evaluation Result Flag} -\item{ CRIT8 }{Analysis Criterion 8} +\item{ CRIT7 }{Analysis Criterion 7} \item{ CRIT8FL }{Criterion 8 Evaluation Result Flag} +\item{ CRIT8 }{Analysis Criterion 8} \item{ AVALCA1N }{Analysis Value Category 1 (N)} \item{ AVALCAT1 }{Analysis Value Category 1} } diff --git a/man/adce_vaccine.Rd b/man/adce_vaccine.Rd index 3e100ef..4b8a83a 100644 --- a/man/adce_vaccine.Rd +++ b/man/adce_vaccine.Rd @@ -3,7 +3,7 @@ \docType{data} \name{adce_vaccine} \alias{adce_vaccine} -\title{adce_vaccine} +\title{Clinical Events Analysis for Vaccine} \format{ A data frame with 56 columns: \describe{ diff --git a/man/adcm.Rd b/man/adcm.Rd index 796d086..5d9a088 100644 --- a/man/adcm.Rd +++ b/man/adcm.Rd @@ -3,7 +3,7 @@ \docType{data} \name{adcm} \alias{adcm} -\title{adcm} +\title{Concomitant Medications Analysis} \format{ A data frame with 95 columns: \describe{ diff --git a/man/adeg.Rd b/man/adeg.Rd index 0a4fd6d..9ef164a 100644 --- a/man/adeg.Rd +++ b/man/adeg.Rd @@ -3,7 +3,7 @@ \docType{data} \name{adeg} \alias{adeg} -\title{adeg} +\title{Electrocardiogram Tests Analysis} \format{ A data frame with 108 columns: \describe{ diff --git a/man/adex.Rd b/man/adex.Rd index 14ca839..409f223 100644 --- a/man/adex.Rd +++ b/man/adex.Rd @@ -3,7 +3,7 @@ \docType{data} \name{adex} \alias{adex} -\title{adex} +\title{Exposure Analysis} \format{ A data frame with 92 columns: \describe{ diff --git a/man/adface_vaccine.Rd b/man/adface_vaccine.Rd index b601b80..1c23e49 100644 --- a/man/adface_vaccine.Rd +++ b/man/adface_vaccine.Rd @@ -3,7 +3,7 @@ \docType{data} \name{adface_vaccine} \alias{adface_vaccine} -\title{adface_vaccine} +\title{Findings About Clinical Events Analysis} \format{ A data frame with 61 columns: \describe{ diff --git a/man/adis_vaccine.Rd b/man/adis_vaccine.Rd index 2e2b681..db776ec 100644 --- a/man/adis_vaccine.Rd +++ b/man/adis_vaccine.Rd @@ -3,7 +3,7 @@ \docType{data} \name{adis_vaccine} \alias{adis_vaccine} -\title{adis_vaccine} +\title{Immunogenicity Specimen Assessments} \format{ A data frame with 102 columns: \describe{ diff --git a/man/adlb.Rd b/man/adlb.Rd index 22e728e..ae84513 100644 --- a/man/adlb.Rd +++ b/man/adlb.Rd @@ -3,7 +3,7 @@ \docType{data} \name{adlb} \alias{adlb} -\title{adlb} +\title{Laboratory Analysis} \format{ A data frame with 115 columns: \describe{ diff --git a/man/adlbhy.Rd b/man/adlbhy.Rd index 8548fc3..2ffd116 100644 --- a/man/adlbhy.Rd +++ b/man/adlbhy.Rd @@ -3,7 +3,7 @@ \docType{data} \name{adlbhy} \alias{adlbhy} -\title{adlbhy} +\title{Analysis of Lab Hy's Law} \format{ A data frame with 14 columns: \describe{ diff --git a/man/admh.Rd b/man/admh.Rd index a78a861..ac55305 100644 --- a/man/admh.Rd +++ b/man/admh.Rd @@ -3,7 +3,7 @@ \docType{data} \name{admh} \alias{admh} -\title{admh} +\title{Medical History Analysis} \format{ A data frame with 114 columns: \describe{ diff --git a/man/adoe_ophtha.Rd b/man/adoe_ophtha.Rd index 93d12f6..91eb1e6 100644 --- a/man/adoe_ophtha.Rd +++ b/man/adoe_ophtha.Rd @@ -3,7 +3,7 @@ \docType{data} \name{adoe_ophtha} \alias{adoe_ophtha} -\title{adoe_ophtha} +\title{Exam Analysis for Ophthalmology} \format{ A data frame with 102 columns: \describe{ diff --git a/man/adpc.Rd b/man/adpc.Rd index 0b179a2..453d5bf 100644 --- a/man/adpc.Rd +++ b/man/adpc.Rd @@ -3,7 +3,7 @@ \docType{data} \name{adpc} \alias{adpc} -\title{adpc} +\title{Pharmacokinetic Concentrations} \format{ A data frame with 127 columns: \describe{ @@ -56,7 +56,6 @@ A data frame with 127 columns: \item{ ATPTN }{Analysis Timepoint (N)} \item{ ATPT }{Analysis Timepoint} \item{ ATPTREF }{Analysis Timepoint Reference} -\item{ ABLFL }{Baseline Record Flag} \item{ BASETYPE }{Baseline Type} \item{ DOSEA }{Actual Treatment Dose} \item{ DOSEP }{Planned Treatment Dose} @@ -72,6 +71,7 @@ A data frame with 127 columns: \item{ SRCVAR }{Source Variable} \item{ SRCSEQ }{Source Sequence Number} \item{ DTYPE }{Derivation Type} +\item{ ABLFL }{Baseline Record Flag} \item{ MRRLT }{Modified Rel. Time from Ref. Dose} \item{ ANL01FL }{Analysis Flag 01} \item{ ANL02FL }{Analysis Flag 02} diff --git a/man/adpp.Rd b/man/adpp.Rd index acad6da..b8fe3ee 100644 --- a/man/adpp.Rd +++ b/man/adpp.Rd @@ -3,7 +3,7 @@ \docType{data} \name{adpp} \alias{adpp} -\title{adpp} +\title{Pharmacokinetic Parameters} \format{ A data frame with 79 columns: \describe{ diff --git a/man/adppk.Rd b/man/adppk.Rd index a35f56e..5dde978 100644 --- a/man/adppk.Rd +++ b/man/adppk.Rd @@ -3,7 +3,7 @@ \docType{data} \name{adppk} \alias{adppk} -\title{adppk} +\title{Population Pharmacokinetic} \format{ A data frame with 61 columns: \describe{ diff --git a/man/adrs_onco.Rd b/man/adrs_onco.Rd index e1255eb..65b0516 100644 --- a/man/adrs_onco.Rd +++ b/man/adrs_onco.Rd @@ -3,7 +3,7 @@ \docType{data} \name{adrs_onco} \alias{adrs_onco} -\title{adrs_onco} +\title{Tumor Response Analysis} \format{ A data frame with 79 columns: \describe{ diff --git a/man/adsl.Rd b/man/adsl.Rd index 2c8b431..c95a6a2 100644 --- a/man/adsl.Rd +++ b/man/adsl.Rd @@ -3,7 +3,7 @@ \docType{data} \name{adsl} \alias{adsl} -\title{adsl} +\title{Subject Level Analysis} \format{ A data frame with 54 columns: \describe{ diff --git a/man/adsl_vaccine.Rd b/man/adsl_vaccine.Rd index 735adb7..0ad3d9b 100644 --- a/man/adsl_vaccine.Rd +++ b/man/adsl_vaccine.Rd @@ -3,7 +3,7 @@ \docType{data} \name{adsl_vaccine} \alias{adsl_vaccine} -\title{adsl_vaccine} +\title{Subject Level Analysis for Vaccine} \format{ A data frame with 46 columns: \describe{ diff --git a/man/adtr_onco.Rd b/man/adtr_onco.Rd index e31e35f..9638c6e 100644 --- a/man/adtr_onco.Rd +++ b/man/adtr_onco.Rd @@ -3,7 +3,7 @@ \docType{data} \name{adtr_onco} \alias{adtr_onco} -\title{adtr_onco} +\title{Tumor Results Analysis for Oncology} \format{ A data frame with 99 columns: \describe{ diff --git a/man/adtte_onco.Rd b/man/adtte_onco.Rd index be0427c..a4670a6 100644 --- a/man/adtte_onco.Rd +++ b/man/adtte_onco.Rd @@ -3,7 +3,7 @@ \docType{data} \name{adtte_onco} \alias{adtte_onco} -\title{adtte_onco} +\title{Time to Event Analysis for Oncology} \format{ A data frame with 20 columns: \describe{ diff --git a/man/advfq_ophtha.Rd b/man/advfq_ophtha.Rd index 1fa4161..70a19bd 100644 --- a/man/advfq_ophtha.Rd +++ b/man/advfq_ophtha.Rd @@ -3,7 +3,7 @@ \docType{data} \name{advfq_ophtha} \alias{advfq_ophtha} -\title{advfq_ophtha} +\title{Visual Function Questionnaire Analysis} \format{ A data frame with 89 columns: \describe{ diff --git a/man/advs.Rd b/man/advs.Rd index e7bd05e..84671e8 100644 --- a/man/advs.Rd +++ b/man/advs.Rd @@ -3,7 +3,7 @@ \docType{data} \name{advs} \alias{advs} -\title{advs} +\title{Vital Signs Analysis} \format{ A data frame with 105 columns: \describe{ diff --git a/man/advs_peds.Rd b/man/advs_peds.Rd index 435524a..d2b0b68 100644 --- a/man/advs_peds.Rd +++ b/man/advs_peds.Rd @@ -3,7 +3,7 @@ \docType{data} \name{advs_peds} \alias{advs_peds} -\title{advs_peds} +\title{Vital Signs Analysis for Pediatrics} \format{ A data frame with 80 columns: \describe{