Adverse events of the simulated study XYZ-ONC-01 (see adsl), coded
with a small MedDRA-like dictionary (31 preferred terms in 12 system
organ classes) and graded by CTCAE. Treatment-emergent events start
from the first dose to 30 days after the last; a few start between
randomisation and the first dose (TRTEMFL = "N"). A death before
progression on treatment is a grade 5 event on the date of death.
Format
adae: a data frame, one row per event, with the subject keys
(as in adex) and
- AESEQ, AETERM, AEDECOD, AEBODSYS, AESOC
the event and its coding
- AETOXGR, ATOXGR, AESEV
CTCAE grade (1-5); severity
- AESER, AEREL, AEACN, AEOUT, AESDTH
serious, causality, action with the study drug, outcome, results in death
- ASTDT, AENDT, ASTDY, AENDY
start / end dates and study days
- TRTEMFL
treatment-emergent flag