Endpoints and assessments
treatment-emergent adverse events, tumor, death, Cancer
ADVERSE EVENT, TUMOR, DISEASE, SECONDARY, ADVERSE EVENT, BLOOD, APPENDIX, CANCER
The safety analysis set consisted of all patients who received at least one dose of pamiparib. The efficacy analysis set consisted of all patients in the safety population who had measurable disease at baseline per RECIST v1.1 and had at least one evaluable post-baseline tumor assessment by independent review committee (IRC) unless they discontinued treatment due to clinical progression or death prior to tumor assessment.The primary endpoint of this study was ORR by IRC per RECIST v1.1 in the efficacy analysis set. The key secondary endpoint was duration of response (DoR) per RECIST v1.1 by IRC and investigator. Other secondary endpoints included ORR by investigator, best overall response, disease control rate, and clinical benefit rate by IRC and investigator in the efficacy analysis set, and PFS and OS in the safety analysis set.Blood samples collected during the pre-screening phase were analysed in a qualified central laboratory to confirm Safety and tolerability were assessed throughout the study and up to 30 days after the last dose of pamiparib by monitoring the incidence and severity of treatment-emergent adverse events (TEAEs) and serious TEAEs (graded according to National Cancer Institute Common Terminology Criteria for Adverse Events [v4.03]). A TEAE was defined as an adverse event (AE) with an onset date on or after the first dose of study drug up to 30 days following treatment discontinuation. A complete list of study endpoints is provided in the Supplementary Appendix.