Study drug exposure of the simulated study XYZ-ONC-01 (see adsl): one
dose every 21 days from the first to the last dose; a reduced dose
follows a related grade >= 3 adverse event (AEACN = "DOSE REDUCED" in
adae).
Format
adex: a data frame, one row per dose and four summary rows per
treated subject, with the subject keys (STUDYID, USUBJID, TRT01P,
TRT01PN, TRT01A, TRT01AN, SAFFL) and
- PARAMCD, PARAM
DOSE(each administration, mg),TRTDURD(days),NCYCLE,CUMDOSE(mg),RDI(relative dose intensity, %)- AVISIT, AVISITN
cycle (
OVERALLfor the summaries)- AVAL, AVALU
value and unit
- EXPLDOS, EXDOSRFL
planned dose; dose reduced flag
- ASTDT, AENDT
dates