RECIST 1.1 responses of the simulated study XYZ-ONC-01 (see adsl):
the investigator's overall response at each assessment (OVR: CR when
the sum of diameters is 0 mm, PR at least 30% below baseline, PD at
least 20% and 5 mm above the nadir or a new lesion, else SD) and the
best confirmed overall response (BOR: CR / PR confirmed by the next
assessment; NE without a post-baseline assessment), one per subject.
Format
adrs: a data frame with the subject keys (STUDYID, USUBJID,
TRT01P, TRT01PN, TRT01A, TRT01AN, ITTFL, SAFFL, EFFFL) and
- PARAMCD, PARAM
OVRorBOR- AVISIT, AVISITN, ADT, ADY
visit (
WEEK 6, ...;OVERALLfor BOR), date, study day- AVALC, AVAL
response (CR, PR, SD, PD, NE) and its code 1-5
- ANL01FL
analysis flag