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..14ea77d 100644 --- a/data-raw/create_adams_data.R +++ b/data-raw/create_adams_data.R @@ -1,4 +1,26 @@ -# ensure every packages are installed +# Save specs as JSON file for traceability of changes ---- + +library(readxl) +library(jsonlite) + +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) + +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) update_pkg <- TRUE ignore_templates <- list( @@ -29,6 +51,7 @@ 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 ? @@ -138,8 +161,8 @@ 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") @@ -151,12 +174,12 @@ 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 @@ -187,5 +210,5 @@ 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 fdbecda..994b0f5 100644 Binary files a/data/adae.rda and b/data/adae.rda differ diff --git a/data/adbcva_ophtha.rda b/data/adbcva_ophtha.rda index 7db9f45..36f8274 100644 Binary files a/data/adbcva_ophtha.rda and b/data/adbcva_ophtha.rda differ diff --git a/data/adcm.rda b/data/adcm.rda index 70e0502..db3cb13 100644 Binary files a/data/adcm.rda and b/data/adcm.rda differ diff --git a/data/adeg.rda b/data/adeg.rda index 8cbb70d..ea9f5ed 100644 Binary files a/data/adeg.rda and b/data/adeg.rda differ diff --git a/data/adex.rda b/data/adex.rda index 19fe314..573fe8b 100644 Binary files a/data/adex.rda and b/data/adex.rda differ diff --git a/data/adface_vaccine.rda b/data/adface_vaccine.rda index d128bae..0e53c70 100644 Binary files a/data/adface_vaccine.rda and b/data/adface_vaccine.rda differ diff --git a/data/adlb.rda b/data/adlb.rda index 7f17397..6eebbf7 100644 Binary files a/data/adlb.rda and b/data/adlb.rda differ diff --git a/data/admh.rda b/data/admh.rda index 2a0cb74..0665ce9 100644 Binary files a/data/admh.rda and b/data/admh.rda differ diff --git a/data/adoe_ophtha.rda b/data/adoe_ophtha.rda index 97595c8..475eecf 100644 Binary files a/data/adoe_ophtha.rda and b/data/adoe_ophtha.rda differ diff --git a/data/adpc.rda b/data/adpc.rda index 20046be..65c50ce 100644 Binary files a/data/adpc.rda and b/data/adpc.rda differ diff --git a/data/adpp.rda b/data/adpp.rda index df51f22..580048c 100644 Binary files a/data/adpp.rda and b/data/adpp.rda differ diff --git a/data/adsl.rda b/data/adsl.rda index d6bc307..0e59829 100644 Binary files a/data/adsl.rda and b/data/adsl.rda differ diff --git a/data/advfq_ophtha.rda b/data/advfq_ophtha.rda index 22acdb1..10a5df9 100644 Binary files a/data/advfq_ophtha.rda and b/data/advfq_ophtha.rda differ diff --git a/data/advs.rda b/data/advs.rda index f4a3d63..20cb205 100644 Binary files a/data/advs.rda and b/data/advs.rda differ diff --git a/inst/WORDLIST b/inst/WORDLIST index 737eaad..7cd4da0 100644 --- a/inst/WORDLIST +++ b/inst/WORDLIST @@ -207,3 +207,7 @@ CRANstatus tibble Changelog README +viewable +diffs +JSON +Github diff --git a/inst/extdata/adams-specs.json b/inst/extdata/adams-specs.json index e137bff..76036e9 100644 --- a/inst/extdata/adams-specs.json +++ b/inst/extdata/adams-specs.json @@ -21,6 +21,7 @@ "Attribute": "Language", "Value": "en" }, + {}, { "Attribute": "Legend", "Value": "Highlighted cells are required for Define-XML 2.1 and can be ignored for prior versions." @@ -81,7 +82,7 @@ }, { "Dataset": "ADEX", - "Label": "Exposure Analysis ", + "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", @@ -166,7 +167,7 @@ }, { "Dataset": "ADPP", - "Label": " Pharmacokinetic Parameters", + "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", @@ -196,7 +197,7 @@ }, { "Dataset": "ADSL", - "Label": "Subject Level Analysis ", + "Label": "Subject Level Analysis", "Class": "SUBJECT LEVEL ANALYSIS DATASET", "Structure": "One record per subject", "Key Variables": "STUDYID, USUBJID", @@ -1347,6 +1348,47 @@ "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", @@ -2943,7 +2985,7 @@ "Order": "39", "Dataset": "ADCE_V", "Variable": "APERSTDY", - "Label": "Analysis Sub-period Start Relative Day ", + "Label": "Analysis Sub-period Start Relative Day", "Data Type": "integer", "Length": "8", "Mandatory": "No", @@ -3243,6 +3285,16 @@ { "Order": "13", "Dataset": "ADCM", + "Variable": "CMENRTPT", + "Label": "End Relative to Reference Time Point", + "Data Type": "text", + "Length": "20", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "14", + "Dataset": "ADCM", "Variable": "CMROUTE", "Label": "Route of Administration", "Data Type": "text", @@ -3251,7 +3303,7 @@ "Has No Data": "No" }, { - "Order": "14", + "Order": "15", "Dataset": "ADCM", "Variable": "VISITNUM", "Label": "Visit Number", @@ -3261,7 +3313,7 @@ "Has No Data": "No" }, { - "Order": "15", + "Order": "16", "Dataset": "ADCM", "Variable": "VISIT", "Label": "Visit Name", @@ -3271,7 +3323,7 @@ "Has No Data": "No" }, { - "Order": "16", + "Order": "17", "Dataset": "ADCM", "Variable": "VISITDY", "Label": "Planned Study Day of Visit", @@ -3281,7 +3333,7 @@ "Has No Data": "No" }, { - "Order": "17", + "Order": "18", "Dataset": "ADCM", "Variable": "CMDTC", "Label": "Date/Time of Collection", @@ -3290,7 +3342,7 @@ "Has No Data": "No" }, { - "Order": "18", + "Order": "19", "Dataset": "ADCM", "Variable": "CMSTDTC", "Label": "Start Date/Time of Medication", @@ -3299,7 +3351,7 @@ "Has No Data": "No" }, { - "Order": "19", + "Order": "20", "Dataset": "ADCM", "Variable": "CMENDTC", "Label": "End Date/Time of Medication", @@ -3308,7 +3360,7 @@ "Has No Data": "No" }, { - "Order": "20", + "Order": "21", "Dataset": "ADCM", "Variable": "CMSTDY", "Label": "Study Day of Start of Medication", @@ -3318,7 +3370,7 @@ "Has No Data": "No" }, { - "Order": "21", + "Order": "22", "Dataset": "ADCM", "Variable": "CMENDY", "Label": "Study Day of End of Medication", @@ -3328,7 +3380,7 @@ "Has No Data": "No" }, { - "Order": "22", + "Order": "23", "Dataset": "ADCM", "Variable": "TRTSDT", "Label": "Date of First Exposure to Treatment", @@ -3339,7 +3391,7 @@ "Has No Data": "No" }, { - "Order": "23", + "Order": "24", "Dataset": "ADCM", "Variable": "TRTEDT", "Label": "Date of Last Exposure to Treatment", @@ -3350,7 +3402,7 @@ "Has No Data": "No" }, { - "Order": "24", + "Order": "25", "Dataset": "ADCM", "Variable": "DTHDT", "Label": "Date of Death", @@ -3361,7 +3413,7 @@ "Has No Data": "No" }, { - "Order": "25", + "Order": "26", "Dataset": "ADCM", "Variable": "EOSDT", "Label": "End of Study Date", @@ -3372,7 +3424,7 @@ "Has No Data": "No" }, { - "Order": "26", + "Order": "27", "Dataset": "ADCM", "Variable": "TRT01P", "Label": "Planned Treatment for Period 01", @@ -3382,7 +3434,7 @@ "Has No Data": "No" }, { - "Order": "27", + "Order": "28", "Dataset": "ADCM", "Variable": "TRT01A", "Label": "Actual Treatment for Period 01", @@ -3392,7 +3444,7 @@ "Has No Data": "No" }, { - "Order": "28", + "Order": "29", "Dataset": "ADCM", "Variable": "ASTDTM", "Label": "Analysis Start Date/Time", @@ -3403,7 +3455,7 @@ "Has No Data": "No" }, { - "Order": "29", + "Order": "30", "Dataset": "ADCM", "Variable": "ASTDTF", "Label": "Analysis Start Date Imputation Flag", @@ -3413,7 +3465,7 @@ "Has No Data": "No" }, { - "Order": "30", + "Order": "31", "Dataset": "ADCM", "Variable": "ASTTMF", "Label": "Analysis Start Time Imputation Flag", @@ -3423,7 +3475,7 @@ "Has No Data": "No" }, { - "Order": "31", + "Order": "32", "Dataset": "ADCM", "Variable": "AENDTM", "Label": "Analysis End Date/Time", @@ -3434,7 +3486,7 @@ "Has No Data": "No" }, { - "Order": "32", + "Order": "33", "Dataset": "ADCM", "Variable": "AENDTF", "Label": "Analysis End Date Imputation Flag", @@ -3444,7 +3496,7 @@ "Has No Data": "No" }, { - "Order": "33", + "Order": "34", "Dataset": "ADCM", "Variable": "AENTMF", "Label": "Analysis End Time Imputation Flag", @@ -3454,7 +3506,7 @@ "Has No Data": "No" }, { - "Order": "34", + "Order": "35", "Dataset": "ADCM", "Variable": "ASTDT", "Label": "Analysis Start Date", @@ -3465,7 +3517,7 @@ "Has No Data": "No" }, { - "Order": "35", + "Order": "36", "Dataset": "ADCM", "Variable": "AENDT", "Label": "Analysis End Date", @@ -3476,7 +3528,7 @@ "Has No Data": "No" }, { - "Order": "36", + "Order": "37", "Dataset": "ADCM", "Variable": "ASTDY", "Label": "Analysis Start Relative Day", @@ -3486,7 +3538,7 @@ "Has No Data": "No" }, { - "Order": "37", + "Order": "38", "Dataset": "ADCM", "Variable": "AENDY", "Label": "Analysis End Relative Day", @@ -3496,7 +3548,7 @@ "Has No Data": "No" }, { - "Order": "38", + "Order": "39", "Dataset": "ADCM", "Variable": "ADURN", "Label": "Analysis Duration (N)", @@ -3506,7 +3558,7 @@ "Has No Data": "No" }, { - "Order": "39", + "Order": "40", "Dataset": "ADCM", "Variable": "ADURU", "Label": "Analysis Duration Units", @@ -3516,7 +3568,7 @@ "Has No Data": "No" }, { - "Order": "40", + "Order": "41", "Dataset": "ADCM", "Variable": "ONTRTFL", "Label": "On Treatment Record Flag", @@ -3526,7 +3578,7 @@ "Has No Data": "No" }, { - "Order": "41", + "Order": "42", "Dataset": "ADCM", "Variable": "PREFL", "Label": "Pre-treatment Flag", @@ -3536,7 +3588,7 @@ "Has No Data": "No" }, { - "Order": "42", + "Order": "43", "Dataset": "ADCM", "Variable": "FUPFL", "Label": "Follow-up Flag", @@ -3546,7 +3598,7 @@ "Has No Data": "No" }, { - "Order": "43", + "Order": "44", "Dataset": "ADCM", "Variable": "ANL01FL", "Label": "Analysis Flag 01", @@ -3556,7 +3608,7 @@ "Has No Data": "No" }, { - "Order": "44", + "Order": "45", "Dataset": "ADCM", "Variable": "AOCCPFL", "Label": "1st Occurrence of Preferred Term Flag", @@ -3566,7 +3618,7 @@ "Has No Data": "No" }, { - "Order": "45", + "Order": "46", "Dataset": "ADCM", "Variable": "APHASE", "Label": "Phase", @@ -3576,7 +3628,7 @@ "Has No Data": "No" }, { - "Order": "46", + "Order": "47", "Dataset": "ADCM", "Variable": "APHASEN", "Label": "Description of Phase N", @@ -3586,7 +3638,7 @@ "Has No Data": "No" }, { - "Order": "47", + "Order": "48", "Dataset": "ADCM", "Variable": "TRTP", "Label": "Planned Treatment", @@ -3596,7 +3648,7 @@ "Has No Data": "No" }, { - "Order": "48", + "Order": "49", "Dataset": "ADCM", "Variable": "TRTA", "Label": "Actual Treatment", @@ -3606,7 +3658,7 @@ "Has No Data": "No" }, { - "Order": "49", + "Order": "50", "Dataset": "ADCM", "Variable": "SUBJID", "Label": "Subject Identifier for the Study", @@ -3616,7 +3668,7 @@ "Has No Data": "No" }, { - "Order": "50", + "Order": "51", "Dataset": "ADCM", "Variable": "RFSTDTC", "Label": "Subject Reference Start Date/Time", @@ -3625,7 +3677,7 @@ "Has No Data": "No" }, { - "Order": "51", + "Order": "52", "Dataset": "ADCM", "Variable": "RFENDTC", "Label": "Subject Reference End Date/Time", @@ -3634,7 +3686,7 @@ "Has No Data": "No" }, { - "Order": "52", + "Order": "53", "Dataset": "ADCM", "Variable": "RFXSTDTC", "Label": "Date/Time of First Study Treatment", @@ -3643,7 +3695,7 @@ "Has No Data": "No" }, { - "Order": "53", + "Order": "54", "Dataset": "ADCM", "Variable": "RFXENDTC", "Label": "Date/Time of Last Study Treatment", @@ -3652,7 +3704,7 @@ "Has No Data": "No" }, { - "Order": "54", + "Order": "55", "Dataset": "ADCM", "Variable": "RFICDTC", "Label": "Date/Time of Informed Consent", @@ -3662,7 +3714,7 @@ "Has No Data": "No" }, { - "Order": "55", + "Order": "56", "Dataset": "ADCM", "Variable": "RFPENDTC", "Label": "Date/Time of End of Participation", @@ -3671,7 +3723,7 @@ "Has No Data": "No" }, { - "Order": "56", + "Order": "57", "Dataset": "ADCM", "Variable": "DTHDTC", "Label": "Date/Time of Death", @@ -3680,7 +3732,7 @@ "Has No Data": "No" }, { - "Order": "57", + "Order": "58", "Dataset": "ADCM", "Variable": "DTHFL", "Label": "Subject Death Flag", @@ -3690,7 +3742,7 @@ "Has No Data": "No" }, { - "Order": "58", + "Order": "59", "Dataset": "ADCM", "Variable": "SITEID", "Label": "Study Site Identifier", @@ -3700,7 +3752,7 @@ "Has No Data": "No" }, { - "Order": "59", + "Order": "60", "Dataset": "ADCM", "Variable": "AGE", "Label": "Age", @@ -3710,7 +3762,7 @@ "Has No Data": "No" }, { - "Order": "60", + "Order": "61", "Dataset": "ADCM", "Variable": "AGEU", "Label": "Age Units", @@ -3720,7 +3772,7 @@ "Has No Data": "No" }, { - "Order": "61", + "Order": "62", "Dataset": "ADCM", "Variable": "SEX", "Label": "Sex", @@ -3730,7 +3782,7 @@ "Has No Data": "No" }, { - "Order": "62", + "Order": "63", "Dataset": "ADCM", "Variable": "RACE", "Label": "Race", @@ -3740,7 +3792,7 @@ "Has No Data": "No" }, { - "Order": "63", + "Order": "64", "Dataset": "ADCM", "Variable": "ETHNIC", "Label": "Ethnicity", @@ -3750,7 +3802,7 @@ "Has No Data": "No" }, { - "Order": "64", + "Order": "65", "Dataset": "ADCM", "Variable": "ARMCD", "Label": "Planned Arm Code", @@ -3760,7 +3812,7 @@ "Has No Data": "No" }, { - "Order": "65", + "Order": "66", "Dataset": "ADCM", "Variable": "ARM", "Label": "Description of Planned Arm", @@ -3770,7 +3822,7 @@ "Has No Data": "No" }, { - "Order": "66", + "Order": "67", "Dataset": "ADCM", "Variable": "ACTARMCD", "Label": "Actual Arm Code", @@ -3780,7 +3832,7 @@ "Has No Data": "No" }, { - "Order": "67", + "Order": "68", "Dataset": "ADCM", "Variable": "ACTARM", "Label": "Description of Actual Arm", @@ -3790,7 +3842,7 @@ "Has No Data": "No" }, { - "Order": "68", + "Order": "69", "Dataset": "ADCM", "Variable": "COUNTRY", "Label": "Country", @@ -3800,7 +3852,7 @@ "Has No Data": "No" }, { - "Order": "69", + "Order": "70", "Dataset": "ADCM", "Variable": "DMDTC", "Label": "Date/Time of Collection", @@ -3809,7 +3861,7 @@ "Has No Data": "No" }, { - "Order": "70", + "Order": "71", "Dataset": "ADCM", "Variable": "DMDY", "Label": "Study Day of Collection", @@ -3819,7 +3871,7 @@ "Has No Data": "No" }, { - "Order": "71", + "Order": "72", "Dataset": "ADCM", "Variable": "TRTSDTM", "Label": "Datetime of First Exposure to Treatment", @@ -3830,7 +3882,7 @@ "Has No Data": "No" }, { - "Order": "72", + "Order": "73", "Dataset": "ADCM", "Variable": "TRTSTMF", "Label": "Time of First Exposure Imput. Flag", @@ -3840,7 +3892,7 @@ "Has No Data": "No" }, { - "Order": "73", + "Order": "74", "Dataset": "ADCM", "Variable": "TRTEDTM", "Label": "Datetime of Last Exposure to Treatment", @@ -3851,7 +3903,7 @@ "Has No Data": "No" }, { - "Order": "74", + "Order": "75", "Dataset": "ADCM", "Variable": "TRTETMF", "Label": "Treatment End Datetime Imput Flag", @@ -3861,7 +3913,7 @@ "Has No Data": "No" }, { - "Order": "75", + "Order": "76", "Dataset": "ADCM", "Variable": "TRTDURD", "Label": "Total Treatment Duration (Days)", @@ -3871,7 +3923,7 @@ "Has No Data": "No" }, { - "Order": "76", + "Order": "77", "Dataset": "ADCM", "Variable": "SCRFDT", "Label": "Screen Failure Date", @@ -3882,7 +3934,7 @@ "Has No Data": "No" }, { - "Order": "77", + "Order": "78", "Dataset": "ADCM", "Variable": "EOSSTT", "Label": "End of Study Status", @@ -3892,7 +3944,7 @@ "Has No Data": "No" }, { - "Order": "78", + "Order": "79", "Dataset": "ADCM", "Variable": "FRVDT", "Label": "Final Retrievel Visit Date", @@ -3903,7 +3955,7 @@ "Has No Data": "No" }, { - "Order": "79", + "Order": "80", "Dataset": "ADCM", "Variable": "RANDDT", "Label": "Date of Randomization", @@ -3914,7 +3966,7 @@ "Has No Data": "No" }, { - "Order": "80", + "Order": "81", "Dataset": "ADCM", "Variable": "DTHADY", "Label": "Relative Day of Death", @@ -3924,7 +3976,7 @@ "Has No Data": "No" }, { - "Order": "81", + "Order": "82", "Dataset": "ADCM", "Variable": "LDDTHELD", "Label": "Elapsed Days from Last Dose to Death", @@ -3934,7 +3986,7 @@ "Has No Data": "No" }, { - "Order": "82", + "Order": "83", "Dataset": "ADCM", "Variable": "LSTALVDT", "Label": "Date Last Known Alive", @@ -3945,7 +3997,7 @@ "Has No Data": "No" }, { - "Order": "83", + "Order": "84", "Dataset": "ADCM", "Variable": "AGEGR1", "Label": "Pooled Age Group 1", @@ -3955,7 +4007,7 @@ "Has No Data": "No" }, { - "Order": "84", + "Order": "85", "Dataset": "ADCM", "Variable": "SAFFL", "Label": "Safety Population Flag", @@ -3965,7 +4017,7 @@ "Has No Data": "No" }, { - "Order": "85", + "Order": "86", "Dataset": "ADCM", "Variable": "RACEGR1", "Label": "Pooled Race Group 1", @@ -3975,7 +4027,7 @@ "Has No Data": "No" }, { - "Order": "86", + "Order": "87", "Dataset": "ADCM", "Variable": "REGION1", "Label": "Geographic Region 1", @@ -3985,7 +4037,7 @@ "Has No Data": "No" }, { - "Order": "87", + "Order": "88", "Dataset": "ADCM", "Variable": "LDDTHGR1", "Label": "Last Dose to Death - Days Elapsed Grp 1", @@ -3995,7 +4047,7 @@ "Has No Data": "No" }, { - "Order": "88", + "Order": "89", "Dataset": "ADCM", "Variable": "DTH30FL", "Label": "Death Within 30 Days of Last Trt Flag", @@ -4005,7 +4057,7 @@ "Has No Data": "No" }, { - "Order": "89", + "Order": "90", "Dataset": "ADCM", "Variable": "DTHA30FL", "Label": "Death After 30 Days from Last Trt Flag", @@ -4015,7 +4067,48 @@ "Has No Data": "No" }, { - "Order": "90", + "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", @@ -5134,6 +5227,47 @@ "Mandatory": "No", "Has No Data": "No" }, + { + "Order": "106", + "Dataset": "ADEG", + "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": "107", + "Dataset": "ADEG", + "Variable": "DTHCAUS", + "Label": "Cause of Death", + "Data Type": "text", + "Length": "200", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "108", + "Dataset": "ADEG", + "Variable": "DTHDOM", + "Label": "Domain for Date of Death Collection", + "Data Type": "text", + "Length": "200", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "109", + "Dataset": "ADEG", + "Variable": "DTHCGR1", + "Label": "Cause of Death Reason 1", + "Data Type": "text", + "Length": "200", + "Mandatory": "No", + "Has No Data": "No" + }, { "Order": "1", "Dataset": "ADEX", @@ -6059,6 +6193,47 @@ "Mandatory": "No", "Has No Data": "No" }, + { + "Order": "89", + "Dataset": "ADEX", + "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": "90", + "Dataset": "ADEX", + "Variable": "DTHCAUS", + "Label": "Cause of Death", + "Data Type": "text", + "Length": "200", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "91", + "Dataset": "ADEX", + "Variable": "DTHDOM", + "Label": "Domain for Date of Death Collection", + "Data Type": "text", + "Length": "200", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "92", + "Dataset": "ADEX", + "Variable": "DTHCGR1", + "Label": "Cause of Death Reason 1", + "Data Type": "text", + "Length": "200", + "Mandatory": "No", + "Has No Data": "No" + }, { "Order": "1", "Dataset": "ADFACE_V", @@ -6699,6 +6874,16 @@ "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", @@ -8957,6 +9142,47 @@ "Mandatory": "No", "Has No Data": "No" }, + { + "Order": "112", + "Dataset": "ADLB", + "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": "113", + "Dataset": "ADLB", + "Variable": "DTHCAUS", + "Label": "Cause of Death", + "Data Type": "text", + "Length": "200", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "114", + "Dataset": "ADLB", + "Variable": "DTHDOM", + "Label": "Domain for Date of Death Collection", + "Data Type": "text", + "Length": "200", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "115", + "Dataset": "ADLB", + "Variable": "DTHCGR1", + "Label": "Cause of Death Reason 1", + "Data Type": "text", + "Length": "200", + "Mandatory": "No", + "Has No Data": "No" + }, { "Order": "1", "Dataset": "ADLBHY", @@ -9677,7 +9903,7 @@ "Order": "57", "Dataset": "ADMH", "Variable": "AOCCFL", - "Label": "1st Occurrence within Subject Flag\t", + "Label": "1st Occurrence within Subject Flag", "Data Type": "text", "Length": "1", "Mandatory": "No", @@ -10183,32 +10409,73 @@ "Has No Data": "No" }, { - "Order": "108", + "Order": "108", + "Dataset": "ADMH", + "Variable": "DTH30FL", + "Label": "Death Within 30 Days of Last Trt Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "109", + "Dataset": "ADMH", + "Variable": "DTHB30FL", + "Label": "Death Within 30 Days of First Trt Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "110", + "Dataset": "ADMH", + "Variable": "DTHA30FL", + "Label": "Death After 30 Days from Last Trt Flag", + "Data Type": "text", + "Length": "1", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "111", + "Dataset": "ADMH", + "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": "112", "Dataset": "ADMH", - "Variable": "DTH30FL", - "Label": "Death Within 30 Days of Last Trt Flag", + "Variable": "DTHCAUS", + "Label": "Cause of Death", "Data Type": "text", - "Length": "1", + "Length": "200", "Mandatory": "No", "Has No Data": "No" }, { - "Order": "109", + "Order": "113", "Dataset": "ADMH", - "Variable": "DTHA30FL", - "Label": "Death After 30 Days from Last Trt Flag", + "Variable": "DTHDOM", + "Label": "Domain for Date of Death Collection", "Data Type": "text", - "Length": "1", + "Length": "200", "Mandatory": "No", "Has No Data": "No" }, { - "Order": "110", + "Order": "114", "Dataset": "ADMH", - "Variable": "DTHB30FL", - "Label": "Death Within 30 Days of First Trt Flag", + "Variable": "DTHCGR1", + "Label": "Cause of Death Reason 1", "Data Type": "text", - "Length": "1", + "Length": "200", "Mandatory": "No", "Has No Data": "No" }, @@ -11239,6 +11506,47 @@ "Mandatory": "No", "Has No Data": "No" }, + { + "Order": "99", + "Dataset": "ADOE_P", + "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": "100", + "Dataset": "ADOE_P", + "Variable": "DTHCAUS", + "Label": "Cause of Death", + "Data Type": "text", + "Length": "200", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "101", + "Dataset": "ADOE_P", + "Variable": "DTHDOM", + "Label": "Domain for Date of Death Collection", + "Data Type": "text", + "Length": "200", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "102", + "Dataset": "ADOE_P", + "Variable": "DTHCGR1", + "Label": "Cause of Death Reason 1", + "Data Type": "text", + "Length": "200", + "Mandatory": "No", + "Has No Data": "No" + }, { "Order": "1", "Dataset": "ADPC", @@ -11940,7 +12248,7 @@ "Order": "65", "Dataset": "ADPC", "Variable": "MRRLT", - "Label": "Modified Rel. Time from Ref. Dose ", + "Label": "Modified Rel. Time from Ref. Dose", "Data Type": "float", "Length": "10", "Significant Digits": "8", @@ -12557,6 +12865,47 @@ "Mandatory": "No", "Has No Data": "No" }, + { + "Order": "124", + "Dataset": "ADPC", + "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": "125", + "Dataset": "ADPC", + "Variable": "DTHCAUS", + "Label": "Cause of Death", + "Data Type": "text", + "Length": "200", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "126", + "Dataset": "ADPC", + "Variable": "DTHDOM", + "Label": "Domain for Date of Death Collection", + "Data Type": "text", + "Length": "200", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "127", + "Dataset": "ADPC", + "Variable": "DTHCGR1", + "Label": "Cause of Death Reason 1", + "Data Type": "text", + "Length": "200", + "Mandatory": "No", + "Has No Data": "No" + }, { "Order": "1", "Dataset": "ADPP", @@ -13338,6 +13687,47 @@ "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", @@ -15339,6 +15729,36 @@ "Mandatory": "No", "Has No Data": "No" }, + { + "Order": "52", + "Dataset": "ADSL", + "Variable": "DTHCAUS", + "Label": "Cause of Death", + "Data Type": "text", + "Length": "200", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "53", + "Dataset": "ADSL", + "Variable": "DTHDOM", + "Label": "Domain for Date of Death Collection", + "Data Type": "text", + "Length": "200", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "54", + "Dataset": "ADSL", + "Variable": "DTHCGR1", + "Label": "Cause of Death Reason 1", + "Data Type": "text", + "Length": "200", + "Mandatory": "No", + "Has No Data": "No" + }, { "Order": "1", "Dataset": "ADSL_V", @@ -17996,6 +18416,47 @@ "Mandatory": "No", "Has No Data": "No" }, + { + "Order": "86", + "Dataset": "ADVFQ_P", + "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": "87", + "Dataset": "ADVFQ_P", + "Variable": "DTHCAUS", + "Label": "Cause of Death", + "Data Type": "text", + "Length": "200", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "88", + "Dataset": "ADVFQ_P", + "Variable": "DTHDOM", + "Label": "Domain for Date of Death Collection", + "Data Type": "text", + "Length": "200", + "Mandatory": "No", + "Has No Data": "No" + }, + { + "Order": "89", + "Dataset": "ADVFQ_P", + "Variable": "DTHCGR1", + "Label": "Cause of Death Reason 1", + "Data Type": "text", + "Length": "200", + "Mandatory": "No", + "Has No Data": "No" + }, { "Order": "1", "Dataset": "ADVS", @@ -19086,6 +19547,47 @@ "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", @@ -19922,4 +20424,4 @@ "Documents": [], "Analysis Displays": [], "Analysis Results": [] -} \ No newline at end of file +} diff --git a/inst/extdata/adams-specs.xlsx b/inst/extdata/adams-specs.xlsx index af535b8..c919622 100644 Binary files a/inst/extdata/adams-specs.xlsx and b/inst/extdata/adams-specs.xlsx differ 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}