Outcomes
Tumors, death, Cancer
DISEASE PROGRESSION, ADVERSE EVENT, EVENT, TUMORS, CANCER
The primary end point of the study was PFS (time from randomization to the date of objective disease progression or death from any cause in the absence of progression). Secondary end points included OS (time from the date of randomization to the date of death event by any cause), ORR (the proportion with radiologically confirmed partial response and complete response), according to Response Evaluation Criteria in Solid Tumors version 1.1, frequency and extent of AEs. AEs were graded in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. PFS and ORR were both assessed by blinded independent central review.