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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.

Usage

adrs

Format

adrs: a data frame with the subject keys (STUDYID, USUBJID, TRT01P, TRT01PN, TRT01A, TRT01AN, ITTFL, SAFFL, EFFFL) and

PARAMCD, PARAM

OVR or BOR

AVISIT, AVISITN, ADT, ADY

visit (WEEK 6, ...; OVERALL for BOR), date, study day

AVALC, AVAL

response (CR, PR, SD, PD, NE) and its code 1-5

ANL01FL

analysis flag

Source

Simulated by data-raw/gen_onco.R in the package's source, seed 20261016; not real patient data.

See also

Other oncology sample data: adae, adex, adlb, adsl, adtr, adtte, advs