Study assessments
tumor, death
DISEASE PROGRESSION, DISEASE, TUMOR
Safety was assessed through the evaluation of AEs (NCI CTCAE v5.0), changes in laboratory test results and changes in vital signs and electrocardiograms, and included all patients who received at least one dose of both study drugs. Attribution of AEs to study drug was determined by the investigator. For each AE requiring a dose modification, only one action taken with study drug was selected according to the following hierarchy: withdrawal, reduction and interruption. Preliminary antitumor activity was determined by the investigator according to RECIST v1.1. Confirmed ORR was defined as the proportion of patients with measurable disease at baseline with CR or PR on two consecutive tumor assessments at least 4 weeks apart, while the best response did not require a confirmatory assessment. PFS was defined as the time from first treatment to the first occurrence of disease progression or death from any cause during the study (whichever occurred first).