From 1bea27e359cedccda902aae367f6c489bff91fc3 Mon Sep 17 00:00:00 2001 From: Edoardo Mancini Date: Mon, 12 May 2025 09:49:53 +0000 Subject: [PATCH 1/3] #100 add labels, save specs as JSON, improve readme --- DESCRIPTION | 3 +- NEWS.md | 2 + R/adae.R | 8 +- R/adcm.R | 10 +- R/adeg.R | 8 +- R/adex.R | 8 +- R/adface_vaccine.R | 2 +- R/adlb.R | 8 +- R/admh.R | 8 +- R/adoe_ophtha.R | 8 +- R/adpc.R | 8 +- R/adpp.R | 8 +- R/adsl.R | 6 +- R/advfq_ophtha.R | 8 +- R/advs.R | 8 +- README.md | 16 +- data-raw/create_adams_data.R | 17 +- data/adae.rda | Bin 54038 -> 54074 bytes data/adbcva_ophtha.rda | Bin 129083 -> 129064 bytes data/adcm.rda | Bin 86628 -> 86931 bytes data/adeg.rda | Bin 1098926 -> 1099060 bytes data/adex.rda | Bin 60003 -> 60200 bytes data/adface_vaccine.rda | Bin 5642 -> 5622 bytes data/adlb.rda | Bin 1243555 -> 1243827 bytes data/admh.rda | Bin 64211 -> 64112 bytes data/adoe_ophtha.rda | Bin 137156 -> 137061 bytes data/adpc.rda | Bin 136728 -> 136787 bytes data/adpp.rda | Bin 36655 -> 36704 bytes data/adsl.rda | Bin 12814 -> 12850 bytes data/advfq_ophtha.rda | Bin 174336 -> 174455 bytes data/advs.rda | Bin 486693 -> 486860 bytes inst/WORDLIST | 3 + inst/extdata/adams-specs.json | 19956 +------------------------------- inst/extdata/adams-specs.xlsx | Bin 197070 -> 204985 bytes man/adae.Rd | 8 +- man/adcm.Rd | 10 +- man/adeg.Rd | 8 +- man/adex.Rd | 8 +- man/adface_vaccine.Rd | 2 +- man/adlb.Rd | 8 +- man/admh.Rd | 8 +- man/adoe_ophtha.Rd | 8 +- man/adpc.Rd | 8 +- man/adpp.Rd | 8 +- man/adsl.Rd | 6 +- man/advfq_ophtha.Rd | 8 +- man/advs.Rd | 8 +- 47 files changed, 161 insertions(+), 20032 deletions(-) diff --git a/DESCRIPTION b/DESCRIPTION index 84949ab..2832815 100644 --- a/DESCRIPTION +++ b/DESCRIPTION @@ -44,7 +44,8 @@ Suggests: roxygen2, spelling, testthat (>= 3.0.0), - usethis + usethis, + jsonlite Config/testthat/edition: 3 Encoding: UTF-8 Language: en-US diff --git a/NEWS.md b/NEWS.md index 2cba711..3620ab8 100644 --- a/NEWS.md +++ b/NEWS.md @@ -10,6 +10,8 @@ - Improved reference page so that dataset labels are displayed under each dataset name. (#103) +- Added labels to variables within datasets that were missing them. (#100) +
Developer Notes diff --git a/R/adae.R b/R/adae.R index e26f5c0..a595b6e 100644 --- a/R/adae.R +++ b/R/adae.R @@ -97,12 +97,12 @@ #' \item{ EOSSTT }{End of Study Status} #' \item{ FRVDT }{Final Retrievel Visit Date} #' \item{ RANDDT }{Date of Randomization} -#' \item{ DTHDTF }{undocumented field} +#' \item{ DTHDTF }{Date of Death Imputation Flag} #' \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{ DTHCAUS }{Cause of Death} +#' \item{ DTHDOM }{Domain for Date of Death Collection} +#' \item{ DTHCGR1 }{Cause of Death Reason 1} #' \item{ LSTALVDT }{Date Last Known Alive} #' \item{ SAFFL }{Safety Population Flag} #' \item{ RACEGR1 }{Pooled Race Group 1} diff --git a/R/adcm.R b/R/adcm.R index 4c6220f..cbe6f87 100644 --- a/R/adcm.R +++ b/R/adcm.R @@ -28,7 +28,7 @@ #' \item{ CMENDTC }{End Date/Time of Medication} #' \item{ CMSTDY }{Study Day of Start of Medication} #' \item{ CMENDY }{Study Day of End of Medication} -#' \item{ CMENRTPT }{undocumented field} +#' \item{ CMENRTPT }{End Relative to Reference Time Point} #' \item{ TRTSDT }{Date of First Exposure to Treatment} #' \item{ TRTEDT }{Date of Last Exposure to Treatment} #' \item{ DTHDT }{Date of Death} @@ -87,12 +87,12 @@ #' \item{ EOSSTT }{End of Study Status} #' \item{ FRVDT }{Final Retrievel Visit Date} #' \item{ RANDDT }{Date of Randomization} -#' \item{ DTHDTF }{undocumented field} +#' \item{ DTHDTF }{Date of Death Imputation Flag} #' \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{ DTHCAUS }{Cause of Death} +#' \item{ DTHDOM }{Domain for Date of Death Collection} +#' \item{ DTHCGR1 }{Cause of Death Reason 1} #' \item{ LSTALVDT }{Date Last Known Alive} #' \item{ SAFFL }{Safety Population Flag} #' \item{ RACEGR1 }{Pooled Race Group 1} diff --git a/R/adeg.R b/R/adeg.R index c9c7f15..78c23da 100644 --- a/R/adeg.R +++ b/R/adeg.R @@ -100,12 +100,12 @@ #' \item{ FRVDT }{Final Retrievel Visit Date} #' \item{ RANDDT }{Date of Randomization} #' \item{ DTHDT }{Date of Death} -#' \item{ DTHDTF }{undocumented field} +#' \item{ DTHDTF }{Date of Death Imputation Flag} #' \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{ DTHCAUS }{Cause of Death} +#' \item{ DTHDOM }{Domain for Date of Death Collection} +#' \item{ DTHCGR1 }{Cause of Death Reason 1} #' \item{ LSTALVDT }{Date Last Known Alive} #' \item{ SAFFL }{Safety Population Flag} #' \item{ RACEGR1 }{Pooled Race Group 1} diff --git a/R/adex.R b/R/adex.R index 14b9bee..935a202 100644 --- a/R/adex.R +++ b/R/adex.R @@ -84,12 +84,12 @@ #' \item{ FRVDT }{Final Retrievel Visit Date} #' \item{ RANDDT }{Date of Randomization} #' \item{ DTHDT }{Date of Death} -#' \item{ DTHDTF }{undocumented field} +#' \item{ DTHDTF }{Date of Death Imputation Flag} #' \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{ DTHCAUS }{Cause of Death} +#' \item{ DTHDOM }{Domain for Date of Death Collection} +#' \item{ DTHCGR1 }{Cause of Death Reason 1} #' \item{ LSTALVDT }{Date Last Known Alive} #' \item{ SAFFL }{Safety Population Flag} #' \item{ RACEGR1 }{Pooled Race Group 1} diff --git a/R/adface_vaccine.R b/R/adface_vaccine.R index ac26c61..d7b89ad 100644 --- a/R/adface_vaccine.R +++ b/R/adface_vaccine.R @@ -67,7 +67,7 @@ #' \item{ EVENTDFL }{Day Event Value Flag} #' \item{ ANL01FL }{Analysis Flag 01} #' \item{ ANL02FL }{Analysis Flag 02} -#' \item{ ANL03FL }{undocumented field} +#' \item{ ANL03FL }{Analysis Flag 03} #' } #' #' @source Generated from admiralvaccine package (template ad_adface.R). diff --git a/R/adlb.R b/R/adlb.R index 1e62d10..cdd76c6 100644 --- a/R/adlb.R +++ b/R/adlb.R @@ -107,12 +107,12 @@ #' \item{ FRVDT }{Final Retrievel Visit Date} #' \item{ RANDDT }{Date of Randomization} #' \item{ DTHDT }{Date of Death} -#' \item{ DTHDTF }{undocumented field} +#' \item{ DTHDTF }{Date of Death Imputation Flag} #' \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{ DTHCAUS }{Cause of Death} +#' \item{ DTHDOM }{Domain for Date of Death Collection} +#' \item{ DTHCGR1 }{Cause of Death Reason 1} #' \item{ LSTALVDT }{Date Last Known Alive} #' \item{ SAFFL }{Safety Population Flag} #' \item{ RACEGR1 }{Pooled Race Group 1} diff --git a/R/admh.R b/R/admh.R index 52a1196..949e8f7 100644 --- a/R/admh.R +++ b/R/admh.R @@ -106,12 +106,12 @@ #' \item{ EOSSTT }{End of Study Status} #' \item{ FRVDT }{Final Retrievel Visit Date} #' \item{ RANDDT }{Date of Randomization} -#' \item{ DTHDTF }{undocumented field} +#' \item{ DTHDTF }{Date of Death Imputation Flag} #' \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{ DTHCAUS }{Cause of Death} +#' \item{ DTHDOM }{Domain for Date of Death Collection} +#' \item{ DTHCGR1 }{Cause of Death Reason 1} #' \item{ LSTALVDT }{Date Last Known Alive} #' \item{ SAFFL }{Safety Population Flag} #' \item{ RACEGR1 }{Pooled Race Group 1} diff --git a/R/adoe_ophtha.R b/R/adoe_ophtha.R index 2a5368c..305da18 100644 --- a/R/adoe_ophtha.R +++ b/R/adoe_ophtha.R @@ -94,12 +94,12 @@ #' \item{ FRVDT }{Final Retrievel Visit Date} #' \item{ RANDDT }{Date of Randomization} #' \item{ DTHDT }{Date of Death} -#' \item{ DTHDTF }{undocumented field} +#' \item{ DTHDTF }{Date of Death Imputation Flag} #' \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{ DTHCAUS }{Cause of Death} +#' \item{ DTHDOM }{Domain for Date of Death Collection} +#' \item{ DTHCGR1 }{Cause of Death Reason 1} #' \item{ LSTALVDT }{Date Last Known Alive} #' \item{ SAFFL }{Safety Population Flag} #' \item{ RACEGR1 }{Pooled Race Group 1} diff --git a/R/adpc.R b/R/adpc.R index 448b136..1cf138e 100644 --- a/R/adpc.R +++ b/R/adpc.R @@ -119,12 +119,12 @@ #' \item{ FRVDT }{Final Retrievel Visit Date} #' \item{ RANDDT }{Date of Randomization} #' \item{ DTHDT }{Date of Death} -#' \item{ DTHDTF }{undocumented field} +#' \item{ DTHDTF }{Date of Death Imputation Flag} #' \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{ DTHCAUS }{Cause of Death} +#' \item{ DTHDOM }{Domain for Date of Death Collection} +#' \item{ DTHCGR1 }{Cause of Death Reason 1} #' \item{ LSTALVDT }{Date Last Known Alive} #' \item{ SAFFL }{Safety Population Flag} #' \item{ RACEGR1 }{Pooled Race Group 1} diff --git a/R/adpp.R b/R/adpp.R index 1f98dc4..c631397 100644 --- a/R/adpp.R +++ b/R/adpp.R @@ -71,12 +71,12 @@ #' \item{ EOSSTT }{End of Study Status} #' \item{ FRVDT }{Final Retrievel Visit Date} #' \item{ RANDDT }{Date of Randomization} -#' \item{ DTHDTF }{undocumented field} +#' \item{ DTHDTF }{Date of Death Imputation Flag} #' \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{ DTHCAUS }{Cause of Death} +#' \item{ DTHDOM }{Domain for Date of Death Collection} +#' \item{ DTHCGR1 }{Cause of Death Reason 1} #' \item{ LSTALVDT }{Date Last Known Alive} #' \item{ SAFFL }{Safety Population Flag} #' \item{ RACEGR1 }{Pooled Race Group 1} diff --git a/R/adsl.R b/R/adsl.R index 831c1bb..100f096 100644 --- a/R/adsl.R +++ b/R/adsl.R @@ -49,9 +49,9 @@ #' \item{ DTHDTF }{Date of Death Imputation Flag} #' \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{ DTHCAUS }{Cause of Death} +#' \item{ DTHDOM }{Domain for Date of Death Collection} +#' \item{ DTHCGR1 }{Cause of Death Reason 1} #' \item{ LSTALVDT }{Date Last Known Alive} #' \item{ SAFFL }{Safety Population Flag} #' \item{ RACEGR1 }{Pooled Race Group 1} diff --git a/R/advfq_ophtha.R b/R/advfq_ophtha.R index 040202b..95e8944 100644 --- a/R/advfq_ophtha.R +++ b/R/advfq_ophtha.R @@ -81,12 +81,12 @@ #' \item{ FRVDT }{Final Retrievel Visit Date} #' \item{ RANDDT }{Date of Randomization} #' \item{ DTHDT }{Date of Death} -#' \item{ DTHDTF }{undocumented field} +#' \item{ DTHDTF }{Date of Death Imputation Flag} #' \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{ DTHCAUS }{Cause of Death} +#' \item{ DTHDOM }{Domain for Date of Death Collection} +#' \item{ DTHCGR1 }{Cause of Death Reason 1} #' \item{ LSTALVDT }{Date Last Known Alive} #' \item{ SAFFL }{Safety Population Flag} #' \item{ RACEGR1 }{Pooled Race Group 1} diff --git a/R/advs.R b/R/advs.R index 27e9e43..cc4384b 100644 --- a/R/advs.R +++ b/R/advs.R @@ -97,12 +97,12 @@ #' \item{ FRVDT }{Final Retrievel Visit Date} #' \item{ RANDDT }{Date of Randomization} #' \item{ DTHDT }{Date of Death} -#' \item{ DTHDTF }{undocumented field} +#' \item{ DTHDTF }{Date of Death Imputation Flag} #' \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{ DTHCAUS }{Cause of Death} +#' \item{ DTHDOM }{Domain for Date of Death Collection} +#' \item{ DTHCGR1 }{Cause of Death Reason 1} #' \item{ LSTALVDT }{Date Last Known Alive} #' \item{ SAFFL }{Safety Population Flag} #' \item{ RACEGR1 }{Pooled Race Group 1} diff --git a/README.md b/README.md index 7523872..fb7ed49 100644 --- a/README.md +++ b/README.md @@ -44,14 +44,18 @@ The workflow consists of two main steps: 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` +### 2. Execute `create_adams_data.R` 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: +1. **Save specs as JSON** + The script saves the specs stored in `inst/extdata/adams-specs.xlsx` as a JSON file located here: `inst/extdata/adams-specs.json`. + This is so that the specs themselves, as well as any diffs across commits, are easily viewable on Github and R Studio. + +2. **Installs Required Packages** + The script installs the following packages: - `{admiral}` - `{admiralonco}` - `{admiralophtha}` @@ -60,11 +64,11 @@ Secondly, the user runs `data-raw/create_adams_data.R`. This script handles the - `{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). -2. **Executes Templates from Each Package** +3. **Executes Templates from Each Package** -3. **Processes and Saves Datasets into {pharmaverseadam}** +4. **Processes and Saves Datasets into {pharmaverseadam}** -4. **Generates Dataset Documentation** +5. **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), diff --git a/data-raw/create_adams_data.R b/data-raw/create_adams_data.R index 9e5c297..5eaaf69 100644 --- a/data-raw/create_adams_data.R +++ b/data-raw/create_adams_data.R @@ -1,4 +1,16 @@ -# ensure every packages are installed +# Save specs as JSON file for traceability of changes ---- + +library(readxl) +library(jsonlite) + +# Read the .xlsx file +specs_xlsx <- readxl::read_excel("inst/extdata/adams-specs.xlsx") + +specs_json <- toJSON(specs_xlsx, pretty = TRUE) + +write(json_data, "inst/extdata/adams-specs.json") + +# Ensure all packages are installed ---- library(stringr) update_pkg <- TRUE ignore_templates <- list( @@ -29,6 +41,7 @@ get_attr <- function(data, col_name) { return(att) } +# Create documentation ---- write_doc <- function(data, dataset_name, dataset_label, pkg, template_name) { # create documentation for the current dataset # TODO: use metatools/metacore for doc ? @@ -187,5 +200,5 @@ for (res in all_results) { } } -# Generate the documentation +# Generate the documentation ---- roxygen2::roxygenize(".", roclets = c("rd", "collate", "namespace")) diff --git a/data/adae.rda b/data/adae.rda index fdbecda5f28586e1c66d4c60374e19a4efb53ab7..994b0f56c9e0a703bf18a5c90612dc84be240f30 100644 GIT binary patch delta 14806 zcmV;{IVr}LrUSaB1F+hd2PN@MCxBIfli`>of2--a>OGvNfB*`jw{EheKJBmo8@m7j z@KBFUc`GRm0{4Ib000000PetG0q0&l+33%mjMhUdD~02sUr 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"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", - 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zyt#xU?gxwBM<2*+x!ed# znb`q^Nu13*Dt~Yw>>KK(k?(-=uu#&^%20O)qig<%k-gR{dT1(O1|)XuJ~$l?UJ7 zK8*NIV10)Kw|l6++{u9Fui^)cBHrUF8nigh!Fkd(I2seThL|&|661j#YF=0zlstSS z@o0|$QQEg-eBZoElblNfyH7jF|6Jo@IB@pxAK>zuAR}oUGzQL6f}lgdvF=&T?3+TtIKGuTQ;h8BGA*i+^wo-w~Gp9l9MT2AR?!q+~h*;5roT1+Hg`S zG(-x{Ku4WaOR}^a>n9u@lZp+0br!c^uBhdW+;u0w)HZUw{SMK1k_Ec}em(07W#RMZ zP}-1Ok6^7l3n?cAF<_18WQ!U?23N|n$>&drb61uM{VUgQ<^tEtdb%*eo@WDXJg*-x-ntDlN!gr z&YlAn8M%E#A4``wSIqBn*PghMCkq1$8p^i@;yt*0H6n4-H z!WVx#cj+$*GfCbqnO4V_Pm`OC(lN;Nw&Zm-d4|vxeI>3Z2zJe$-tVNhE@!qJeQ-v= zE`;y<7^^_%ZcE{4z|&*B8(F3dqaGP*ZvP2TRH;;wTxw)Y83%*pB>jIQ-M@VO-0sCt z#lF5WnJ+cO=|lA%u4+gnGA%}E%{Wj8qh7f9z?e2b(w6tAqZEBkmvx6jJJ1S_^Hu|p zcuhM#uPa%-dhopESy^Xr!Y+r8LUepi3$9Ubp3Ro^ zF1VF;p+|)-b+#!$X`qx;^MnTZ>u%9)$ z|6*l;$g^{%OU$gWkv!a@RhL)}j8xJ{&NNwD(6V)YBetoxwrOw2Ktf|&JLnQreQBxR zR3!Bfs1kSL5^ldr=p>ceLuomRYJgA*`j<<$Kk5+MeqVd6OhA> zznOHXasnIH%8I&`eUG>$2&3+cO^vX`*6#~iD{+onx}&st+NooU{R;Y@B_8tp3P_9~ zKBz8xkL-{W)N@e9H;r*P{zKzf%SaS-7-S5zMl2FHEH9>|w83UQxwJ~Pc)5kXDwM+~ 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    ZcVQqU+yWt{y)vmjJxZuc76l06Pa(W}r)_>+(- z645K>qET@E{!Fu(aq4$m3j2%?GeIMIWsUm4x&ii{N6 zF3Dn>kj*q+p0+hcR8ZqJl0V*duI`76Adiw*}+Q`gzDW-Lw5 zpGLu`w7UbVcgNAYnlqSP5TY;vtYwrn+pTzQ!A2S;{xQoLh@sXOSMfOKl#gD2rtR;B zalW-n`_V`oR6TX@^=P+tQdRwMelN^-;DW(RYl zsLyBkVX6@3&IFvMWTlx!!cgq1b9|@v<`m`EZAYM;Qaq^OeuCOxJ*jeg%8iSg`X-bt zCo3&((&1fOn49RMLx4T8{O=yw@pnOEa1mj8oBWZd6eBk}qC*Ay9|h!K$8lt+^lM$O2VCPe?+)BipQ-d>9GcM$~2bM^z*wcaypL(~xO1Y!@6GpsYy66$C#H{O$TcN0_wX5aJ~9y~`6vHA zjqur#2nzQ%|JwX|l0FjvM!;o{988-usb;uCe3k88{$!_>w3!90*pfpk8Px968kW#qwt%r8 zVp#h9eIJ5;fxi(Ht*y?m@HVt&DP0H;BxD4QbGxp*Ft6Yzv;Ay1ui)#!)ql{*IH6Pt zWrtR)CQD(3%Dy(YC8jzJ>;%4v_5+Omc~yBj8G4~!*V3{es>@(y97lNO@r+%Z4Buxg z=vse|_Q`dV;KW9e7ZKF0OS;1K3XoiLW4Q4SDb_XeDEs)PVlZQlXY$pvS>Bb2 zN?_88d&~1tLA=c zM1rRUgYR6X({H-_-S|9#l1LLHkzzTFPMYnumhJA;B@ab}oJaJ0h-!#bOI>v3@jMN|IpI<>j6*(uwCj{TAN1+8MAi2nzj^el%+ zobM$jSd$UBHwsnc{JpqSP^Z@d-!0!i;Q7^{Li8NE6q=vcDJ0b)qVyri;)>n-P*O4* z1(;*Y_7*GBDMaI+{ zY--*R2)h{_OaKR8qOym_-$MEx%moVs|F9rH0x6rwWQzIQuAp#MlUP@L`}neYf}r&5 zWjEQ@lkMvu42|UXf;VeRfS1ev2v1sOYT$t4W<1evi>)I~Nzs&`k_*=1WM*M;Dd#9h zt&EyAAw(qbN@&DefM4M&;fP{d3nb;fL_ZjaW)I?haT8f408{YM27@$fKsIT^u?9?W+yl;X*~R`t)VO|teU~}0uX?=ZJLYRP z$EnJ(Z+icX6rjU=+O8?Vyjo40TYpkQy~yOBOn`3ZLYr!|nP3dhQ5^o6-m9WGabd`( zSw{rgy?1{mIcb&3heac|VP;M>G;KWV2(AEf_WTx5A*R~2;=`2B7*;#$r1kRvzDIP`_DWz?my6%`yY@5B^UiyNl5fh z*;w{pF#QiGSN|7E{{sQ_|Ao{4z;N?_fs+`_3fgJ^FZ@e}#R?|<2})&!g0NG$2*4PG z|9@!Z|6bR(q101iFbU!RjavBu1B3m)&Hri&lc{thU{Ub9Gf*l79ZZ=TM*^k?BcFp( zF(F{u)EyEq2E+d>FjyEEcn}N>=Ks^1;tB*~?r5gs;^^ecV&>>#k;+B@#!lrV1>=L0 bZa}H3q+kJX-aRNamK02hkofd(0GR&+HGgF& diff --git a/man/adae.Rd b/man/adae.Rd index b83ca1d..3524b11 100644 --- a/man/adae.Rd +++ b/man/adae.Rd @@ -97,12 +97,12 @@ A data frame with 105 columns: \item{ EOSSTT }{End of Study Status} \item{ FRVDT }{Final Retrievel Visit Date} \item{ RANDDT }{Date of Randomization} -\item{ DTHDTF }{undocumented field} +\item{ DTHDTF }{Date of Death Imputation Flag} \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{ DTHCAUS }{Cause of Death} +\item{ DTHDOM }{Domain for Date of Death Collection} +\item{ DTHCGR1 }{Cause of Death Reason 1} \item{ LSTALVDT }{Date Last Known Alive} \item{ SAFFL }{Safety Population Flag} \item{ RACEGR1 }{Pooled Race Group 1} diff --git a/man/adcm.Rd b/man/adcm.Rd index 5d9a088..284644d 100644 --- a/man/adcm.Rd +++ b/man/adcm.Rd @@ -28,7 +28,7 @@ A data frame with 95 columns: \item{ CMENDTC }{End Date/Time of Medication} \item{ CMSTDY }{Study Day of Start of Medication} \item{ CMENDY }{Study Day of End of Medication} -\item{ CMENRTPT }{undocumented field} +\item{ CMENRTPT }{End Relative to Reference Time Point} \item{ TRTSDT }{Date of First Exposure to Treatment} \item{ TRTEDT }{Date of Last Exposure to Treatment} \item{ DTHDT }{Date of Death} @@ -87,12 +87,12 @@ A data frame with 95 columns: \item{ EOSSTT }{End of Study Status} \item{ FRVDT }{Final Retrievel Visit Date} \item{ RANDDT }{Date of Randomization} -\item{ DTHDTF }{undocumented field} +\item{ DTHDTF }{Date of Death Imputation Flag} \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{ DTHCAUS }{Cause of Death} +\item{ DTHDOM }{Domain for Date of Death Collection} +\item{ DTHCGR1 }{Cause of Death Reason 1} \item{ LSTALVDT }{Date Last Known Alive} \item{ SAFFL }{Safety Population Flag} \item{ RACEGR1 }{Pooled Race Group 1} diff --git a/man/adeg.Rd b/man/adeg.Rd index 9ef164a..23b8cbd 100644 --- a/man/adeg.Rd +++ b/man/adeg.Rd @@ -100,12 +100,12 @@ A data frame with 108 columns: \item{ FRVDT }{Final Retrievel Visit Date} \item{ RANDDT }{Date of Randomization} \item{ DTHDT }{Date of Death} -\item{ DTHDTF }{undocumented field} +\item{ DTHDTF }{Date of Death Imputation Flag} \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{ DTHCAUS }{Cause of Death} +\item{ DTHDOM }{Domain for Date of Death Collection} +\item{ DTHCGR1 }{Cause of Death Reason 1} \item{ LSTALVDT }{Date Last Known Alive} \item{ SAFFL }{Safety Population Flag} \item{ RACEGR1 }{Pooled Race Group 1} diff --git a/man/adex.Rd b/man/adex.Rd index 409f223..689be06 100644 --- a/man/adex.Rd +++ b/man/adex.Rd @@ -84,12 +84,12 @@ A data frame with 92 columns: \item{ FRVDT }{Final Retrievel Visit Date} \item{ RANDDT }{Date of Randomization} \item{ DTHDT }{Date of Death} -\item{ DTHDTF }{undocumented field} +\item{ DTHDTF }{Date of Death Imputation Flag} \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{ DTHCAUS }{Cause of Death} +\item{ DTHDOM }{Domain for Date of Death Collection} +\item{ DTHCGR1 }{Cause of Death Reason 1} \item{ LSTALVDT }{Date Last Known Alive} \item{ SAFFL }{Safety Population Flag} \item{ RACEGR1 }{Pooled Race Group 1} diff --git a/man/adface_vaccine.Rd b/man/adface_vaccine.Rd index 1c23e49..8ebb73e 100644 --- a/man/adface_vaccine.Rd +++ b/man/adface_vaccine.Rd @@ -67,7 +67,7 @@ A data frame with 61 columns: \item{ EVENTDFL }{Day Event Value Flag} \item{ ANL01FL }{Analysis Flag 01} \item{ ANL02FL }{Analysis Flag 02} -\item{ ANL03FL }{undocumented field} +\item{ ANL03FL }{Analysis Flag 03} } } \source{ diff --git a/man/adlb.Rd b/man/adlb.Rd index ae84513..358e668 100644 --- a/man/adlb.Rd +++ b/man/adlb.Rd @@ -107,12 +107,12 @@ A data frame with 115 columns: \item{ FRVDT }{Final Retrievel Visit Date} \item{ RANDDT }{Date of Randomization} \item{ DTHDT }{Date of Death} -\item{ DTHDTF }{undocumented field} +\item{ DTHDTF }{Date of Death Imputation Flag} \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{ DTHCAUS }{Cause of Death} +\item{ DTHDOM }{Domain for Date of Death Collection} +\item{ DTHCGR1 }{Cause of Death Reason 1} \item{ LSTALVDT }{Date Last Known Alive} \item{ SAFFL }{Safety Population Flag} \item{ RACEGR1 }{Pooled Race Group 1} diff --git a/man/admh.Rd b/man/admh.Rd index ac55305..944a831 100644 --- a/man/admh.Rd +++ b/man/admh.Rd @@ -106,12 +106,12 @@ A data frame with 114 columns: \item{ EOSSTT }{End of Study Status} \item{ FRVDT }{Final Retrievel Visit Date} \item{ RANDDT }{Date of Randomization} -\item{ DTHDTF }{undocumented field} +\item{ DTHDTF }{Date of Death Imputation Flag} \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{ DTHCAUS }{Cause of Death} +\item{ DTHDOM }{Domain for Date of Death Collection} +\item{ DTHCGR1 }{Cause of Death Reason 1} \item{ LSTALVDT }{Date Last Known Alive} \item{ SAFFL }{Safety Population Flag} \item{ RACEGR1 }{Pooled Race Group 1} diff --git a/man/adoe_ophtha.Rd b/man/adoe_ophtha.Rd index 91eb1e6..0567575 100644 --- a/man/adoe_ophtha.Rd +++ b/man/adoe_ophtha.Rd @@ -94,12 +94,12 @@ A data frame with 102 columns: \item{ FRVDT }{Final Retrievel Visit Date} \item{ RANDDT }{Date of Randomization} \item{ DTHDT }{Date of Death} -\item{ DTHDTF }{undocumented field} +\item{ DTHDTF }{Date of Death Imputation Flag} \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{ DTHCAUS }{Cause of Death} +\item{ DTHDOM }{Domain for Date of Death Collection} +\item{ DTHCGR1 }{Cause of Death Reason 1} \item{ LSTALVDT }{Date Last Known Alive} \item{ SAFFL }{Safety Population Flag} \item{ RACEGR1 }{Pooled Race Group 1} diff --git a/man/adpc.Rd b/man/adpc.Rd index 453d5bf..1f60fcf 100644 --- a/man/adpc.Rd +++ b/man/adpc.Rd @@ -119,12 +119,12 @@ A data frame with 127 columns: \item{ FRVDT }{Final Retrievel Visit Date} \item{ RANDDT }{Date of Randomization} \item{ DTHDT }{Date of Death} -\item{ DTHDTF }{undocumented field} +\item{ DTHDTF }{Date of Death Imputation Flag} \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{ DTHCAUS }{Cause of Death} +\item{ DTHDOM }{Domain for Date of Death Collection} +\item{ DTHCGR1 }{Cause of Death Reason 1} \item{ LSTALVDT }{Date Last Known Alive} \item{ SAFFL }{Safety Population Flag} \item{ RACEGR1 }{Pooled Race Group 1} diff --git a/man/adpp.Rd b/man/adpp.Rd index b8fe3ee..e189a71 100644 --- a/man/adpp.Rd +++ b/man/adpp.Rd @@ -71,12 +71,12 @@ A data frame with 79 columns: \item{ EOSSTT }{End of Study Status} \item{ FRVDT }{Final Retrievel Visit Date} \item{ RANDDT }{Date of Randomization} -\item{ DTHDTF }{undocumented field} +\item{ DTHDTF }{Date of Death Imputation Flag} \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{ DTHCAUS }{Cause of Death} +\item{ DTHDOM }{Domain for Date of Death Collection} +\item{ DTHCGR1 }{Cause of Death Reason 1} \item{ LSTALVDT }{Date Last Known Alive} \item{ SAFFL }{Safety Population Flag} \item{ RACEGR1 }{Pooled Race Group 1} diff --git a/man/adsl.Rd b/man/adsl.Rd index c95a6a2..edeabe5 100644 --- a/man/adsl.Rd +++ b/man/adsl.Rd @@ -49,9 +49,9 @@ A data frame with 54 columns: \item{ DTHDTF }{Date of Death Imputation Flag} \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{ DTHCAUS }{Cause of Death} +\item{ DTHDOM }{Domain for Date of Death Collection} +\item{ DTHCGR1 }{Cause of Death Reason 1} \item{ LSTALVDT }{Date Last Known Alive} \item{ SAFFL }{Safety Population Flag} \item{ RACEGR1 }{Pooled Race Group 1} diff --git a/man/advfq_ophtha.Rd b/man/advfq_ophtha.Rd index 70a19bd..03f4f4b 100644 --- a/man/advfq_ophtha.Rd +++ b/man/advfq_ophtha.Rd @@ -81,12 +81,12 @@ A data frame with 89 columns: \item{ FRVDT }{Final Retrievel Visit Date} \item{ RANDDT }{Date of Randomization} \item{ DTHDT }{Date of Death} -\item{ DTHDTF }{undocumented field} +\item{ DTHDTF }{Date of Death Imputation Flag} \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{ DTHCAUS }{Cause of Death} +\item{ DTHDOM }{Domain for Date of Death Collection} +\item{ DTHCGR1 }{Cause of Death Reason 1} \item{ LSTALVDT }{Date Last Known Alive} \item{ SAFFL }{Safety Population Flag} \item{ RACEGR1 }{Pooled Race Group 1} diff --git a/man/advs.Rd b/man/advs.Rd index 84671e8..75eefc7 100644 --- a/man/advs.Rd +++ b/man/advs.Rd @@ -97,12 +97,12 @@ A data frame with 105 columns: \item{ FRVDT }{Final Retrievel Visit Date} \item{ RANDDT }{Date of Randomization} \item{ DTHDT }{Date of Death} -\item{ DTHDTF }{undocumented field} +\item{ DTHDTF }{Date of Death Imputation Flag} \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{ DTHCAUS }{Cause of Death} +\item{ DTHDOM }{Domain for Date of Death Collection} +\item{ DTHCGR1 }{Cause of Death Reason 1} \item{ LSTALVDT }{Date Last Known Alive} \item{ SAFFL }{Safety Population Flag} \item{ RACEGR1 }{Pooled Race Group 1} From 02cf115aac8e9c59aeb851ae7f26d691bc444962 Mon Sep 17 00:00:00 2001 From: Edoardo Mancini Date: Mon, 12 May 2025 09:53:04 +0000 Subject: [PATCH 2/3] #100 chore: checks --- data-raw/create_adams_data.R | 16 ++++++++-------- inst/WORDLIST | 1 + 2 files changed, 9 insertions(+), 8 deletions(-) diff --git a/data-raw/create_adams_data.R b/data-raw/create_adams_data.R index 5eaaf69..f9197a2 100644 --- a/data-raw/create_adams_data.R +++ b/data-raw/create_adams_data.R @@ -151,8 +151,8 @@ 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") @@ -164,12 +164,12 @@ 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/inst/WORDLIST b/inst/WORDLIST index 9a4c2a3..7cd4da0 100644 --- a/inst/WORDLIST +++ b/inst/WORDLIST @@ -210,3 +210,4 @@ README viewable diffs JSON +Github From b173e3aed6b522c245a442b64ded56759f12fe72 Mon Sep 17 00:00:00 2001 From: Edoardo Mancini Date: Mon, 12 May 2025 11:09:50 +0000 Subject: [PATCH 3/3] #100 update for qc comments --- data-raw/create_adams_data.R | 16 +- inst/extdata/adams-specs.json | 20458 +++++++++++++++++++++++++++++++- 2 files changed, 20440 insertions(+), 34 deletions(-) diff --git a/data-raw/create_adams_data.R b/data-raw/create_adams_data.R index f9197a2..14ea77d 100644 --- a/data-raw/create_adams_data.R +++ b/data-raw/create_adams_data.R @@ -3,12 +3,22 @@ library(readxl) library(jsonlite) -# Read the .xlsx file -specs_xlsx <- readxl::read_excel("inst/extdata/adams-specs.xlsx") +json_file <- "inst/extdata/adams-specs.json" +excel_file <- "inst/extdata/adams-specs.xlsx" +specs_xlsx <- readxl::read_excel(excel_file) specs_json <- toJSON(specs_xlsx, pretty = TRUE) -write(json_data, "inst/extdata/adams-specs.json") +sheet_names <- excel_sheets(excel_file) + +all_sheets <- lapply(sheet_names, function(sheet) { + read_excel(excel_file, sheet = sheet) +}) + +names(all_sheets) <- sheet_names +json_data <- toJSON(all_sheets, pretty = TRUE) + +write(json_data, file = json_file) # Ensure all packages are installed ---- library(stringr) diff --git a/inst/extdata/adams-specs.json b/inst/extdata/adams-specs.json index 2ae609b..76036e9 100644 --- a/inst/extdata/adams-specs.json +++ b/inst/extdata/adams-specs.json @@ -1,31 +1,20427 @@ -[ - { - "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." - } -] +{ + "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": 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"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 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"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. 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"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": "102", + "Dataset": "ADAE", + "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": "103", + "Dataset": "ADAE", + "Variable": "DTHCAUS", + "Label": "Cause of Death", + "Data Type": "text", + "Length": "200", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "104", + "Dataset": "ADAE", + "Variable": "DTHDOM", + "Label": "Domain for Date of Death Collection", + "Data Type": "text", + "Length": "200", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "105", + "Dataset": "ADAE", + "Variable": "DTHCGR1", + "Label": "Cause of Death Reason 1", + "Data Type": "text", + "Length": "200", + "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", + 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"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", + 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"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": 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"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": 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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 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"Label": "Planned Treatment for Period 01", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "28", + "Dataset": "ADCM", + "Variable": "TRT01A", + "Label": "Actual Treatment for Period 01", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "29", + "Dataset": "ADCM", + "Variable": "ASTDTM", + "Label": "Analysis Start Date/Time", + "Data Type": "integer", + "Length": "8", + "Format": "DATETIME", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "30", + "Dataset": "ADCM", + "Variable": "ASTDTF", + "Label": "Analysis Start Date Imputation Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "31", + "Dataset": "ADCM", + "Variable": "ASTTMF", + "Label": "Analysis Start Time Imputation Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "32", + "Dataset": "ADCM", + "Variable": "AENDTM", + "Label": "Analysis End Date/Time", + "Data Type": "integer", + "Length": "8", + "Format": "DATETIME", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "33", + "Dataset": "ADCM", + "Variable": "AENDTF", + "Label": "Analysis End Date Imputation Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "34", + "Dataset": "ADCM", + "Variable": "AENTMF", + "Label": "Analysis End Time Imputation Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "35", + "Dataset": "ADCM", + "Variable": "ASTDT", + "Label": "Analysis Start Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "36", + "Dataset": "ADCM", + "Variable": "AENDT", + "Label": "Analysis End Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "37", + "Dataset": "ADCM", + "Variable": "ASTDY", + "Label": "Analysis Start Relative Day", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "38", + "Dataset": "ADCM", + "Variable": "AENDY", + "Label": "Analysis End Relative Day", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "39", + "Dataset": "ADCM", + "Variable": "ADURN", + "Label": "Analysis Duration (N)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "40", + "Dataset": "ADCM", + "Variable": "ADURU", + "Label": "Analysis Duration Units", + "Data Type": "text", + "Length": "4", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "41", + "Dataset": "ADCM", + "Variable": "ONTRTFL", + "Label": "On Treatment Record Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "42", + "Dataset": "ADCM", + "Variable": "PREFL", + "Label": "Pre-treatment Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "43", + "Dataset": "ADCM", + "Variable": "FUPFL", + "Label": "Follow-up Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "44", + "Dataset": "ADCM", + "Variable": "ANL01FL", + "Label": "Analysis Flag 01", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "45", + "Dataset": "ADCM", + "Variable": "AOCCPFL", + "Label": "1st Occurrence of Preferred Term Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "46", + "Dataset": "ADCM", + "Variable": "APHASE", + "Label": "Phase", + "Data Type": "text", + "Length": "13", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "47", + "Dataset": "ADCM", + "Variable": "APHASEN", + "Label": "Description of Phase N", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "48", + "Dataset": "ADCM", + "Variable": "TRTP", + "Label": "Planned Treatment", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "49", + "Dataset": "ADCM", + "Variable": "TRTA", + "Label": "Actual Treatment", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "50", + "Dataset": "ADCM", + "Variable": "SUBJID", + "Label": "Subject Identifier for the Study", + "Data Type": "text", + "Length": "4", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "51", + "Dataset": "ADCM", + "Variable": "RFSTDTC", + "Label": "Subject Reference Start Date/Time", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "52", + "Dataset": "ADCM", + "Variable": "RFENDTC", + "Label": "Subject Reference End Date/Time", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "53", + "Dataset": "ADCM", + "Variable": "RFXSTDTC", + "Label": "Date/Time of First Study Treatment", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "54", + "Dataset": "ADCM", + "Variable": "RFXENDTC", + "Label": "Date/Time of Last Study Treatment", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "55", + "Dataset": "ADCM", + "Variable": "RFICDTC", + "Label": "Date/Time of Informed Consent", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "56", + "Dataset": "ADCM", + "Variable": "RFPENDTC", + "Label": "Date/Time of End of Participation", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "57", + "Dataset": "ADCM", + "Variable": "DTHDTC", + "Label": "Date/Time of Death", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "58", + "Dataset": "ADCM", + "Variable": "DTHFL", + "Label": "Subject Death Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "59", + "Dataset": "ADCM", + "Variable": "SITEID", + "Label": "Study Site Identifier", + "Data Type": "text", + "Length": "3", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "60", + "Dataset": "ADCM", + "Variable": "AGE", + "Label": "Age", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "61", + "Dataset": "ADCM", + "Variable": "AGEU", + "Label": "Age Units", + "Data Type": "text", + "Length": "5", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "62", + "Dataset": "ADCM", + "Variable": "SEX", + "Label": "Sex", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "63", + "Dataset": "ADCM", + "Variable": "RACE", + "Label": "Race", + "Data Type": "text", + "Length": "32", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "64", + "Dataset": "ADCM", + "Variable": "ETHNIC", + "Label": "Ethnicity", + "Data Type": "text", + "Length": "22", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "65", + "Dataset": "ADCM", + "Variable": "ARMCD", + "Label": "Planned Arm Code", + "Data Type": "text", + "Length": "6", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "66", + "Dataset": "ADCM", + "Variable": "ARM", + "Label": "Description of Planned Arm", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "67", + "Dataset": "ADCM", + "Variable": "ACTARMCD", + "Label": "Actual Arm Code", + "Data Type": "text", + "Length": "6", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "68", + "Dataset": "ADCM", + "Variable": "ACTARM", + "Label": "Description of Actual Arm", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "69", + "Dataset": "ADCM", + "Variable": "COUNTRY", + "Label": "Country", + "Data Type": "text", + "Length": "3", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "70", + "Dataset": "ADCM", + "Variable": "DMDTC", + "Label": "Date/Time of Collection", + "Data Type": "datetime", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "71", + "Dataset": "ADCM", + "Variable": "DMDY", + "Label": "Study Day of Collection", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "72", + "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": "73", + "Dataset": "ADCM", + "Variable": "TRTSTMF", + "Label": "Time of First Exposure Imput. Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "74", + "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": "75", + "Dataset": "ADCM", + "Variable": "TRTETMF", + "Label": "Treatment End Datetime Imput Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "76", + "Dataset": "ADCM", + "Variable": "TRTDURD", + "Label": "Total Treatment Duration (Days)", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "77", + "Dataset": "ADCM", + "Variable": "SCRFDT", + "Label": "Screen Failure Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "78", + "Dataset": "ADCM", + "Variable": "EOSSTT", + "Label": "End of Study Status", + "Data Type": "text", + "Length": "12", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "79", + "Dataset": "ADCM", + "Variable": "FRVDT", + "Label": "Final Retrievel Visit Date", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "80", + "Dataset": "ADCM", + "Variable": "RANDDT", + "Label": "Date of Randomization", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "81", + "Dataset": "ADCM", + "Variable": "DTHADY", + "Label": "Relative Day of Death", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "82", + "Dataset": "ADCM", + "Variable": "LDDTHELD", + "Label": "Elapsed Days from Last Dose to Death", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "83", + "Dataset": "ADCM", + "Variable": "LSTALVDT", + "Label": "Date Last Known Alive", + "Data Type": "integer", + "Length": "8", + "Format": "DATE", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "84", + "Dataset": "ADCM", + "Variable": "AGEGR1", + "Label": "Pooled Age Group 1", + "Data Type": "integer", + "Length": "8", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "85", + "Dataset": "ADCM", + "Variable": "SAFFL", + "Label": "Safety Population Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "86", + "Dataset": "ADCM", + "Variable": "RACEGR1", + "Label": "Pooled Race Group 1", + "Data Type": "text", + "Length": "9", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "87", + "Dataset": "ADCM", + "Variable": "REGION1", + "Label": "Geographic Region 1", + "Data Type": "text", + "Length": "2", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "88", + "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": "89", + "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": "90", + "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": "91", + "Dataset": "ADCM", + "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": "92", + "Dataset": "ADCM", + "Variable": "DTHCAUS", + "Label": "Cause of Death", + "Data Type": "text", + "Length": "200", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "93", + "Dataset": "ADCM", + "Variable": "DTHDOM", + "Label": "Domain for Date of Death Collection", + "Data Type": "text", + "Length": "200", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "94", + "Dataset": "ADCM", + "Variable": "DTHCGR1", + "Label": "Cause of Death Reason 1", + "Data Type": "text", + "Length": "200", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "95", + "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", + 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"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 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"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 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"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": "61", + "Dataset": "ADFACE_V", + "Variable": "ANL03FL", + "Label": "Analysis Flag 03", + "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. 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"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 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"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" + }, + { 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"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 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"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", 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"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" + 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"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": 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"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. 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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": "75", + "Dataset": "ADPP", + "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": "76", + "Dataset": "ADPP", + "Variable": "DTHCAUS", + "Label": "Cause of Death", + "Data Type": "text", + "Length": "200", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "77", + "Dataset": "ADPP", + "Variable": "DTHDOM", + "Label": "Domain for Date of Death Collection", + "Data Type": "text", + "Length": "200", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "78", + "Dataset": "ADPP", + "Variable": "DTHCGR1", + "Label": "Cause of Death Reason 1", + "Data Type": "text", + "Length": "200", + "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. 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"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": 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+ "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", 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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": "104", + "Dataset": "ADVS", + "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": "105", + "Dataset": "ADVS", + "Variable": "DTHCAUS", + "Label": "Cause of Death", + "Data Type": "text", + "Length": "200", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "106", + "Dataset": "ADVS", + "Variable": "DTHDOM", + "Label": "Domain for Date of Death Collection", + "Data Type": "text", + "Length": "200", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "107", + "Dataset": "ADVS", + "Variable": "DTHCGR1", + "Label": "Cause of Death Reason 1", + "Data Type": "text", + "Length": "200", + "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": 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"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", + 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"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": 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"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": [] +}