Endpoints
bleeding, death, Tumor, cardiac toxicity, proteinuria, hepatotoxicity, Tumors, Cancer
ADVERSE EVENT, BLEEDING, TUMOR, ADVERSE EVENTS, ADVERSE EVENT, DISEASE, TUMORS, SECONDARY, TUMOR PROGRESSION, HAND-FOOT SYNDROME, EVENTS, HYPERTENSION, CANCER
The primary endpoint was safety, assessed by the incidence and severity of adverse events, especially TRAEs. Adverse events of special interest were evaluated, including hypertension, proteinuria, hand-foot syndrome, bleeding events, hepatotoxicity, and cardiac toxicity. All adverse events were codified and summarized per the Medical Dictionary for Regular Activities (MedDRA) version 22.0 and graded according to the National Cancer Institute Common Terminology Criteria Adverse Events (NCI-CTCAE) version 4.0 up to 30 days after the last dose of apatinib.The secondary endpoint was efficacy, including OS, progression-free survival (PFS), objective response rate (ORR), and disease control rate (DCR). OS was defined as the interval between enrollment and death from any cause or data censoring. PFS was defined as the interval between enrollment and tumor progression or death from any cause or data censoring. Tumor response was assessed per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigators.