Oncology sample study XYZ-ONC-01: subject level (ADSL)

One of the eight ADaM datasets of a simulated oncology study: Drug X vs Control, randomised 1:1 (stratified by baseline ECOG and region), RECIST 1.1 every 6 weeks, data cut-off 30 June 2026; 200 subjects screened, 160 randomised. The datasets agree with one another: they are made from one set of simulated subject histories, so a confirmed CR/PR has its tumour sizes at least 30% below baseline, nothing is assessed after progression, the PFS and OS events are the progressions and the deaths, and doses stop at progression, toxicity, death or the cut-off. TRT01P, TRT01A and ARM are factors with Drug X first.

Usage

adsl

Format

adsl: a data frame, one row per screened subject (200 rows), with

STUDYID, USUBJID, SUBJID, SITEID

identifiers

COUNTRY, REGION1

country; region (North America, Europe, Asia)

AGE, AGEGR1, SEX, RACE, ETHNIC

demographics (AGEGR1: <65, >=65)

ECOGBL, STRATA1

baseline ECOG (0, 1; 2 in some screen failures); randomisation stratum

ARM, TRT01P, TRT01A

planned / actual treatment (factors, Drug X first; TRT01A is NA for the subjects never treated, all three for the screen failures)

ARMCD, ACTARM, ACTARMCD, ARMNRS

arm codes; why an arm is null (SCREEN FAILURE, ASSIGNED, NOT TREATED)

TRT01PN, TRT01AN

their numeric codes (1 Drug X, 2 Control)

RFICDT, RANDDT, TRTSDT, TRTEDT, TRTDURD

informed consent, randomisation, first and last dose dates, treatment duration (days)

ENRLFL, ITTFL, SAFFL, EFFFL

enrolled (randomised), intent-to-treat, safety and efficacy evaluable population flags

EOTSTT, DCTREAS

end of treatment status and reason

EOSSTT, EOSDT, DCSREAS, DCSREASP

end of study status (ONGOING in follow-up at the cut-off, DISCONTINUED), its date, reason (DEATH, SCREEN FAILURE) and the screen failure's reason

DTHFL, DTHDT, DTHCAUS, LSTALVDT, DCUTDT

death; date last known alive; data cut-off date

BSLD

baseline sum of diameters of target lesions (mm)

Source

Simulated by data-raw/gen_onco.R in the package's source, seed 20261016; not real patient data.

Details

ADSL holds every screened subject: the 160 randomised (ENRLFL, ITTFL) and 40 screen failures, who have no arm (ARM, TRT01P ... NA, ARMNRS "SCREEN FAILURE", as SDTMIG 3.3 has it) and no records in the other datasets. An analysis of the randomised subjects selects them (ITTFL == "Y", or SAFFL / EFFFL).

The study's mini SAP (populations, endpoints, a display list) and CRF outline are installed with the package: system.file("sample", "onco", "SAP.md", package = "tflspec") and "CRF.md". Variables carry CDISC labels (attr(x, "label")).

See also

The other datasets of the study: adex, adae, adlb, advs, adrs, adtr, adtte; the study's SAP and CRF outline, system.file("sample", "onco", package = "tflspec").

Other oncology sample data: adae, adex, adlb, adrs, adtr, adtte, advs

Examples

table(adsl$ARMNRS, useNA = "ifany")
#> 
#> ASSIGNED, NOT TREATED        SCREEN FAILURE                  <NA> 
#>                     2                    40                   158 
itt <- adsl[adsl$ITTFL == "Y", ]
table(itt$TRT01P, itt$DTHFL)
#>          
#>            N  Y
#>   Drug X  40 42
#>   Control 27 51