Endpoints and assessment
death, disability or dysfunction, congenital malformation, birth defect, Tumors, TRAEs, Cancer
ADVERSE EVENT, ADVERSE EVENTS, ADVERSE EVENT, EVENT, TUMORS, EVENTS, CANCER
The primary endpoints were safety, ORR and DCR assessed by investigators. Secondary endpoints included progression-free survival (PFS) and overall survival (OS). Adverse events (AEs) were recorded during the study period and until 28 days after the last dose of BPI-9016M, and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. AEs referred to treatment-emergent adverse events (TEAEs) and TRAEs were assessed by investigators. Serious adverse events (SAEs) referred to AEs meeting at least one of the following criteria: event leading to death; life-threatening event; event requiring hospitalization or extension of hospital stay; event leading to persistent or evident disability or dysfunction; event leading to congenital malformation or birth defect or event which might lead to injury or that need medical treatment to avoid the above mentioned important medical events. Response was evaluated according to the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 [Efficacy was analyzed in full analysis set (FAS) which included patients with at least one dose of BPI-9016M. The safety was analyzed in safety set (SS) which included patients with at least one dose of BPI-9016M with safety assessment. ORR was defined as the proportion of patients with CR or PR. DCR was defined as the proportion of patients with CR, PR or SD. PFS was defined as the time from the initiation of BPI-9016M treatment to radiographic progression or death of any cause, whichever occurred first. OS was defined as the time from the initiation of BPI-9016M treatment to death of any cause.