Synthetic CDISC ADaM Subject Level (ADSL) dataset from fictional study TFRM-2024-001, a 24-week randomized, double-blind, placebo-controlled trial of Zomerane (a fictional anti-cholinesterase inhibitor) in mild-to-moderate Alzheimer's Disease.
Contains one row per subject (N = 135). Used for:
Demographics table (Table 14.1.1): age, sex, race, BMI by treatment arm
Disposition table (Table 14.1.3): completion, discontinuation reasons
Variable names follow the CDISC ADaM Implementation Guide v1.3.
Format
A data frame with 135 rows and 31 variables:
- STUDYID
Study identifier (
"TFRM-2024-001")- USUBJID
Unique subject identifier (
"TFR-NNN-NNNN")- SUBJID
Subject identifier within study
- SITEID
Site identifier (
"001"to"005")- ARM
Planned treatment arm:
"Placebo","Zomerane 50mg", or"Zomerane 100mg"- TRT01P
Planned treatment (same as
ARM)- TRT01PN
Planned treatment numeric code:
0,50, or100- TRT01A
Actual treatment (same as
TRT01P— no switches)- TRT01AN
Actual treatment numeric code
- TRTSDT
Treatment start date
- TRTEDT
Treatment end date
- TRTDURD
Treatment duration in days
- AGE
Age in years at randomization (55–88)
- AGEGR1
Age group:
"<65","65-80", or">80"- AGEGR1N
Age group numeric: 1, 2, or 3
- AGEU
Age units (
"YEARS")- SEX
Sex:
"F"(Female) or"M"(Male)- RACE
Race (CDISC controlled terminology):
"WHITE","BLACK OR AFRICAN AMERICAN","ASIAN","AMERICAN INDIAN OR ALASKA NATIVE"- ETHNIC
Ethnicity:
"HISPANIC OR LATINO"or"NOT HISPANIC OR LATINO"- COUNTRY
Country of enrolment:
"USA","GBR","CAN","DEU", or"FRA"- HEIGHTBL
Baseline height (cm)
- WEIGHTBL
Baseline weight (kg)
- BMIBL
Baseline BMI (kg/m squared)
- MMSEBL
Baseline Mini-Mental State Examination score (10–26); lower scores indicate greater cognitive impairment
- DURDIS
Disease duration at baseline (months)
- DURDSGR1
Disease duration group:
"<12"or">=12"months- SAFFL
Safety population flag:
"Y"(all randomized subjects)- ITTFL
Intent-to-treat population flag:
"Y"(all randomized)- EFFFL
Efficacy population flag:
"Y"if treatment duration >= 14 days- EOSSTT
End of study status:
"COMPLETED"or"DISCONTINUED"- DCSREAS
Discontinuation reason (NA if completed):
"Adverse Event","Withdrew Consent","Lost to Follow-up","Lack of Efficacy", or"Physician Decision"
Source
Synthetic data generated in data-raw/create_adam_datasets.R.
No real patient data. Follows CDISC ADaM ADSL specifications.
Examples
# Quick look
head(adsl)
#> STUDYID USUBJID SUBJID SITEID ARM TRT01P TRT01PN TRT01A
#> 1 TFRM-2024-001 TFR-001-0001 0001 001 Placebo Placebo 0 Placebo
#> 2 TFRM-2024-001 TFR-005-0002 0002 005 Placebo Placebo 0 Placebo
#> 3 TFRM-2024-001 TFR-001-0003 0003 001 Placebo Placebo 0 Placebo
#> 4 TFRM-2024-001 TFR-005-0004 0004 005 Placebo Placebo 0 Placebo
#> 5 TFRM-2024-001 TFR-003-0005 0005 003 Placebo Placebo 0 Placebo
#> 6 TFRM-2024-001 TFR-003-0006 0006 003 Placebo Placebo 0 Placebo
#> TRT01AN TRTSDT TRTEDT TRTDURD AGE AGEGR1 AGEGR1N AGEU SEX RACE
#> 1 0 2020-12-24 2021-06-09 168 72 65-80 2 YEARS M WHITE
#> 2 0 2020-01-25 2020-07-10 168 79 65-80 2 YEARS F ASIAN
#> 3 0 2020-10-30 2021-04-15 168 69 65-80 2 YEARS F WHITE
#> 4 0 2020-05-24 2020-11-07 168 85 >80 3 YEARS F WHITE
#> 5 0 2020-12-21 2021-06-06 168 69 65-80 2 YEARS F WHITE
#> 6 0 2020-04-03 2020-09-17 168 85 >80 3 YEARS F WHITE
#> ETHNIC COUNTRY HEIGHTBL WEIGHTBL BMIBL MMSEBL DURDIS DURDSGR1
#> 1 HISPANIC OR LATINO USA 175 80.9 26.4 15 29 >=12
#> 2 NOT HISPANIC OR LATINO USA 176 64.6 20.9 22 24 >=12
#> 3 HISPANIC OR LATINO USA 161 48.8 18.8 14 45 >=12
#> 4 NOT HISPANIC OR LATINO DEU 171 68.8 23.5 21 26 >=12
#> 5 NOT HISPANIC OR LATINO USA 159 71.9 28.4 20 37 >=12
#> 6 NOT HISPANIC OR LATINO USA 162 69.8 26.6 16 15 >=12
#> SAFFL ITTFL EFFFL EOSSTT DCSREAS
#> 1 Y Y Y COMPLETED <NA>
#> 2 Y Y Y COMPLETED <NA>
#> 3 Y Y Y COMPLETED <NA>
#> 4 Y Y Y COMPLETED <NA>
#> 5 Y Y Y COMPLETED <NA>
#> 6 Y Y Y COMPLETED <NA>
table(adsl$ARM)
#>
#> Placebo Zomerane 100mg Zomerane 50mg
#> 45 45 45
table(adsl$EOSSTT, adsl$ARM)
#>
#> Placebo Zomerane 100mg Zomerane 50mg
#> COMPLETED 44 37 41
#> DISCONTINUED 1 8 4
# Demographics table input
subset(adsl, SAFFL == "Y", select = c(ARM, AGE, SEX, RACE, BMIBL))
#> ARM AGE SEX RACE BMIBL
#> 1 Placebo 72 M WHITE 26.4
#> 2 Placebo 79 F ASIAN 20.9
#> 3 Placebo 69 F WHITE 18.8
#> 4 Placebo 85 F WHITE 23.5
#> 5 Placebo 69 F WHITE 28.4
#> 6 Placebo 85 F WHITE 26.6
#> 7 Placebo 83 M WHITE 20.0
#> 8 Placebo 78 F WHITE 20.2
#> 9 Placebo 78 F WHITE 33.9
#> 10 Placebo 80 F WHITE 30.0
#> 11 Placebo 65 M WHITE 25.8
#> 12 Placebo 80 M WHITE 29.9
#> 13 Placebo 71 F ASIAN 21.4
#> 14 Placebo 69 F WHITE 28.8
#> 15 Placebo 65 F WHITE 30.2
#> 16 Placebo 86 M WHITE 24.1
#> 17 Placebo 78 F WHITE 42.3
#> 18 Placebo 65 F WHITE 30.4
#> 19 Placebo 78 M WHITE 24.1
#> 20 Placebo 72 F WHITE 30.4
#> 21 Placebo 72 M WHITE 20.2
#> 22 Placebo 77 F WHITE 30.5
#> 23 Placebo 75 F WHITE 30.2
#> 24 Placebo 82 M WHITE 25.8
#> 25 Placebo 70 M ASIAN 27.8
#> 26 Placebo 70 M ASIAN 30.3
#> 27 Placebo 88 F WHITE 31.8
#> 28 Placebo 88 M WHITE 29.3
#> 29 Placebo 67 M WHITE 30.8
#> 30 Placebo 74 F ASIAN 31.8
#> 31 Placebo 70 F WHITE 28.3
#> 32 Placebo 88 M WHITE 29.2
#> 33 Placebo 69 F WHITE 22.5
#> 34 Placebo 83 F WHITE 22.7
#> 35 Placebo 67 F WHITE 26.9
#> 36 Placebo 69 F WHITE 23.7
#> 37 Placebo 78 M ASIAN 30.5
#> 38 Placebo 67 F WHITE 25.6
#> 39 Placebo 71 M BLACK OR AFRICAN AMERICAN 32.3
#> 40 Placebo 78 F WHITE 23.3
#> 41 Placebo 75 M WHITE 18.7
#> 42 Placebo 73 M WHITE 24.5
#> 43 Placebo 74 M WHITE 24.4
#> 44 Placebo 67 F WHITE 34.2
#> 45 Placebo 74 F WHITE 28.6
#> 46 Zomerane 50mg 70 F WHITE 25.3
#> 47 Zomerane 50mg 65 F WHITE 32.2
#> 48 Zomerane 50mg 81 M WHITE 25.1
#> 49 Zomerane 50mg 80 M WHITE 24.1
#> 50 Zomerane 50mg 80 M WHITE 22.9
#> 51 Zomerane 50mg 88 M WHITE 26.0
#> 52 Zomerane 50mg 69 F WHITE 29.1
#> 53 Zomerane 50mg 68 F WHITE 25.3
#> 54 Zomerane 50mg 75 M ASIAN 20.3
#> 55 Zomerane 50mg 71 F WHITE 28.4
#> 56 Zomerane 50mg 74 M AMERICAN INDIAN OR ALASKA NATIVE 25.2
#> 57 Zomerane 50mg 74 M BLACK OR AFRICAN AMERICAN 30.6
#> 58 Zomerane 50mg 69 M ASIAN 20.1
#> 59 Zomerane 50mg 77 M WHITE 22.4
#> 60 Zomerane 50mg 70 F WHITE 33.9
#> 61 Zomerane 50mg 74 F WHITE 23.6
#> 62 Zomerane 50mg 57 M WHITE 23.8
#> 63 Zomerane 50mg 70 F WHITE 29.3
#> 64 Zomerane 50mg 74 F WHITE 22.3
#> 65 Zomerane 50mg 55 M WHITE 21.2
#> 66 Zomerane 50mg 55 F ASIAN 26.0
#> 67 Zomerane 50mg 77 F ASIAN 25.9
#> 68 Zomerane 50mg 74 F BLACK OR AFRICAN AMERICAN 24.1
#> 69 Zomerane 50mg 88 M BLACK OR AFRICAN AMERICAN 24.1
#> 70 Zomerane 50mg 82 F WHITE 18.9
#> 71 Zomerane 50mg 88 F BLACK OR AFRICAN AMERICAN 26.1
#> 72 Zomerane 50mg 61 F WHITE 36.2
#> 73 Zomerane 50mg 70 F WHITE 22.2
#> 74 Zomerane 50mg 81 F ASIAN 23.8
#> 75 Zomerane 50mg 69 M BLACK OR AFRICAN AMERICAN 25.7
#> 76 Zomerane 50mg 75 F ASIAN 31.8
#> 77 Zomerane 50mg 83 F WHITE 36.5
#> 78 Zomerane 50mg 64 F WHITE 25.9
#> 79 Zomerane 50mg 60 M WHITE 29.5
#> 80 Zomerane 50mg 86 M WHITE 32.9
#> 81 Zomerane 50mg 74 F WHITE 19.2
#> 82 Zomerane 50mg 60 F WHITE 29.0
#> 83 Zomerane 50mg 75 F WHITE 27.9
#> 84 Zomerane 50mg 68 F WHITE 31.4
#> 85 Zomerane 50mg 78 F WHITE 30.4
#> 86 Zomerane 50mg 77 F WHITE 25.2
#> 87 Zomerane 50mg 79 F WHITE 34.6
#> 88 Zomerane 50mg 81 M WHITE 28.0
#> 89 Zomerane 50mg 74 F WHITE 26.9
#> 90 Zomerane 50mg 69 M AMERICAN INDIAN OR ALASKA NATIVE 17.3
#> 91 Zomerane 100mg 83 F WHITE 27.3
#> 92 Zomerane 100mg 66 F BLACK OR AFRICAN AMERICAN 33.8
#> 93 Zomerane 100mg 69 F WHITE 18.9
#> 94 Zomerane 100mg 72 M WHITE 23.9
#> 95 Zomerane 100mg 73 M WHITE 26.2
#> 96 Zomerane 100mg 74 F WHITE 24.6
#> 97 Zomerane 100mg 55 F WHITE 24.0
#> 98 Zomerane 100mg 85 M WHITE 21.0
#> 99 Zomerane 100mg 68 F ASIAN 18.6
#> 100 Zomerane 100mg 67 M WHITE 20.8
#> 101 Zomerane 100mg 77 M BLACK OR AFRICAN AMERICAN 16.7
#> 102 Zomerane 100mg 67 M WHITE 29.8
#> 103 Zomerane 100mg 83 M WHITE 18.5
#> 104 Zomerane 100mg 83 M WHITE 21.9
#> 105 Zomerane 100mg 88 F WHITE 32.4
#> 106 Zomerane 100mg 73 F WHITE 29.7
#> 107 Zomerane 100mg 80 M WHITE 19.1
#> 108 Zomerane 100mg 88 F WHITE 19.3
#> 109 Zomerane 100mg 77 F WHITE 26.9
#> 110 Zomerane 100mg 67 M WHITE 25.0
#> 111 Zomerane 100mg 84 F WHITE 28.5
#> 112 Zomerane 100mg 83 M WHITE 16.8
#> 113 Zomerane 100mg 81 M WHITE 20.2
#> 114 Zomerane 100mg 81 M WHITE 14.2
#> 115 Zomerane 100mg 75 M BLACK OR AFRICAN AMERICAN 20.8
#> 116 Zomerane 100mg 81 M BLACK OR AFRICAN AMERICAN 28.5
#> 117 Zomerane 100mg 88 M WHITE 29.9
#> 118 Zomerane 100mg 71 F WHITE 20.9
#> 119 Zomerane 100mg 78 F ASIAN 24.6
#> 120 Zomerane 100mg 68 F WHITE 29.2
#> 121 Zomerane 100mg 72 F WHITE 26.6
#> 122 Zomerane 100mg 73 F WHITE 33.0
#> 123 Zomerane 100mg 82 F WHITE 24.8
#> 124 Zomerane 100mg 71 M WHITE 19.9
#> 125 Zomerane 100mg 71 M ASIAN 35.3
#> 126 Zomerane 100mg 73 M WHITE 27.8
#> 127 Zomerane 100mg 73 M ASIAN 20.7
#> 128 Zomerane 100mg 76 M WHITE 21.9
#> 129 Zomerane 100mg 65 F ASIAN 44.5
#> 130 Zomerane 100mg 73 M WHITE 26.2
#> 131 Zomerane 100mg 78 F BLACK OR AFRICAN AMERICAN 24.7
#> 132 Zomerane 100mg 71 M WHITE 23.7
#> 133 Zomerane 100mg 73 F WHITE 32.4
#> 134 Zomerane 100mg 80 M WHITE 21.4
#> 135 Zomerane 100mg 71 M WHITE 24.6