An ADSL-flavored clinical trial toy dataset

This tibble contains artificial data for 182 subjects of the GT01 study. Each row corresponds to demographic characteristics of a single trial participant. Two out of 182 study participants were screen failures and thus not treated, the rest of the study population was randomized with a 1:1 ratio to receive either "Placebo" (as comparator) or "Drug 1". The dataset entails subject level demographics such as age, age group, sex, ethnicity, and body mass index (BMI) at baseline, as well as an event flag, indicating whether the subject experienced a specific event throughout the course of the study or not.

Although the data was intentionally created to mimic a typical clinical trial dataset following the CDISC format, it might not strictly comply with CDISC ADaM rules. The intent is to showcase the workflow for clinical table creation rather than creating a fully CDISC-compliant ADaM dataset.

Usage

rx_adsl

Format

A tibble with 182 rows and 14 variables:

STUDYID, STUDYIDN: The unique study identifier and its numeric version.
USUBJID: The unique subject identifier.
TRTA, TRTAN: The study intervention and its numeric version, which is either "Placebo" (1), "Drug 1" (2) or NA (3), missing for screen failures).
ITTFL: Intent-to-Treat (ITT) population flag, where "Y" indicates a subject belongs to the ITT population and "N" indicates a subject is not in the ITT population.
RANDFL: Randomization flag, where "Y" indicates a subject was randomized to receive either "Placebo" or "Drug 1" and "N" indicates a subject was not randomized at all.
SCRFREAS: The reason for screen failure. This is either missing ("") for non-screen failure subjects or indicates the reason for screen failure
AGE: The age of a subject at baseline in years.
AAGEGR1: The analysis age group, indicating if a subject was strictly younger than 40 years at baseline or older.
SEX: Sex of a subject. Can be either "Male", "Female" or "Undifferentiated".
ETHNIC: Ethnicity of a subject. Can be either "Hispanic or Latino", "Not Hispanic or Latino" or missing ("").
BLBMI: Body Mass Index (BMI) of a subject at baseline in kg/m2.
EVNTFL: Event Flag. Indicates whether the subject experienced a specific event during the course of the study or not. Can be either "Y" (if if the subject had the event) or "N".

Examples

Here is a glimpse at the data available in rx_adsl.

dplyr::glimpse(rx_adsl)
#> Rows: 182
#> Columns: 14
#> $ STUDYID  <chr> "GT01", "GT01", "GT01", "GT01", "GT01", "GT01", "GT01", "GT01~
#> $ STUDYIDN <chr> "4001", "4001", "4001", "4001", "4001", "4001", "4001", "4001~
#> $ USUBJID  <chr> "GT1000", "GT1001", "GT1002", "GT1003", "GT1004", "GT1005", "~
#> $ TRTA     <fct> NA, Placebo, Placebo, Placebo, Placebo, Placebo, Placebo, Pla~
#> $ TRTAN    <dbl> 3, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1~
#> $ ITTFL    <chr> "N", "Y", "Y", "Y", "Y", "Y", "Y", "Y", "Y", "Y", "Y", "Y", "~
#> $ RANDFL   <chr> "N", "Y", "Y", "Y", "Y", "Y", "Y", "Y", "Y", "Y", "Y", "Y", "~
#> $ SCRFREAS <chr> "WITHDRAWAL BY SUBJECT", "", "", "", "", "", "", "", "", "", ~
#> $ AGE      <int> 37, 41, 39, 38, 45, 35, 42, 35, 42, 38, 48, 36, 46, 34, 44, 4~
#> $ AAGEGR1  <fct> <40, >=40, <40, <40, >=40, <40, >=40, <40, >=40, <40, >=40, <~
#> $ SEX      <fct> Male, Male, Female, Male, Male, Female, Female, Male, Male, F~
#> $ ETHNIC   <fct> Hispanic or Latino, Not Hispanic or Latino, Not Hispanic or L~
#> $ BLBMI    <dbl> 33.76723, 33.35073, 30.45862, 22.85986, 23.89713, 29.09856, 2~
#> $ EVNTFL   <chr> "", "Y", "Y", "N", "Y", "Y", "N", "N", "N", "N", "N", "N", "Y~

Dataset ID and Badge

DATA-12

Dataset Introduced

v0.9.0 (Mar 31, 2023)