Progression-free survival, overall survival and duration of response of the simulated study XYZ-ONC-01 (see adsl), in months; and a safety endpoint, the time to the first treatment-emergent skin and subcutaneous tissue disorder, in days. PFS: to progression or death, censored at the last tumour assessment; OS: to death, censored at the cut-off; DOR: from the first confirmed CR / PR; TTSKIN: the safety set, from the first dose, censored at the end of the treatment-emergent period (30 days after the last dose, death or the cut-off).
Format
adtte: a data frame, one row per subject and parameter, with
the subject keys (as in adrs), the subgroups of a forest plot
(AGEGR1, SEX, RACE, ECOGBL, REGION1, STRATA1) and
- PARAMCD, PARAM, PARAMN
PFS,OS,DOR,TTSKIN- STARTDT, ADT, ADY
origin and event / censoring dates
- AVAL, AVALU
time (
MONTHS;DAYSforTTSKIN)- CNSR, EVNTDESC, CNSDTDSC
censor (1) or event (0) and why
Source
Simulated by data-raw/gen_onco.R in the package's source,
seed 20261016; not real patient data.
Examples
pfs <- adtte[adtte$PARAMCD == "PFS", ]
tapply(pfs$CNSR == 0, pfs$TRT01P, sum)
#> Drug X Control
#> 77 78