Six laboratory parameters of the simulated study XYZ-ONC-01 (see adsl) on day 1 of each cycle (cycle 1 is the baseline): ALT, AST, bilirubin, haemoglobin, neutrophils, platelets, with normal ranges and CTCAE grades for shift tables.
Format
adlb: a data frame, one row per subject, parameter and visit,
with the subject keys (as in adex) and
- PARAMCD, PARAM, PARCAT1
ALT,AST,BILI,HGB,NEUT,PLAT; chemistry or haematology- AVISIT, AVISITN, ADT, ADY
visit, date, study day
- AVAL, BASE, CHG, PCHG
value, baseline, change, percent change
- ANRLO, ANRHI, ANRIND, BNRIND
normal range and indicator (and at baseline)
- ATOXGR, BTOXGR
CTCAE grade (and at baseline)
- ABLFL, ONTRTFL
baseline and on-treatment record flags