14.1.1 · Demographics
Tracker — programs, TLFs & datasets
OutputRoles
ADSL · Subject-level analysis
14.1.2 · Baseline characteristics
14.2.1 · Primary endpoint — ORR
ADTTE · Time-to-event
14.3.2 · Kaplan–Meier overall survival
14.2.3 · Objective response rate and duration of response by BICR assessment — full analysis set (FAS)
ADAE · Adverse events analysis
14.3.1 · Adverse events — overview
14.3.8 · Concomitant medications
14.3.1.1 · Treatment-emergent adverse events by System Organ Class and Preferred Term (Safety analysis set)
14.3.1.2 · Serious adverse events by System Organ Class, Preferred Term, and relationship to study drug
14.3.1.3 · Adverse events leading to permanent discontinuation of study treatment — by Preferred Term
14.3.1.4 · Grade 3 or higher treatment-emergent adverse events by System Organ Class and Preferred Term
14.3.1.5 · Adverse events of special interest (AESI): immune-mediated events, infusion reactions, and hepatic toxicity
14.3.1.6 · Time to first Grade ≥3 treatment-emergent adverse event — Kaplan–Meier summary (Safety)
14.3.2.1 · Listing of serious adverse events with onset, duration, outcome, and action taken with study drug
14.3.2.2 · Listing of deaths and adverse events with fatal outcome (including primary cause of death)
14.3.3 · Adverse events by maximum severity grade (CTCAE v5.0) and System Organ Class — Safety analysis set
14.3.4 · Common adverse events (≥5% in any treatment arm) by Preferred Term — descending frequency
14.3.5 · Laboratory — chemistry shifts
14.3.5.1 · Laboratory chemistry shifts from baseline to worst post-baseline grade (CTCAE) — Safety analysis set
14.3.5.2 · Hematology parameters: change from baseline over time (mean ± SE) — Safety analysis set
Job status (from Tracker)
| Job | Programs | Started | Status |
|---|---|---|---|
| JOB-1842 | adam_adae.sas · tfl_14_1_1… | Today · 9:48 AM ET | |
| JOB-1839 | adam_adsl.sas | Today · 8:02 AM ET | |
| JOB-1831 | tfl_14_2_1_orr.R | Yesterday · 5:40 PM ET |