Statistical analysis
tumor, death
FAP, DISEASE PROGRESSION, DISEASE, TUMOR
All patients who received at least one partial or complete dose of study drug were included in the full analysis population (FAP), and all of these patients who had at least one post-baseline safety assessment were included in the safety population. Separate efficacy-evaluable populations (EEPs) were defined for both cohorts. The EEPs were (1) all patients with progressive disease who had completed at least cycle 1 and who had at least one on-study tumor assessment or radiological assessment, and (2) patients with stable disease, partial response, or complete response at the end of cycle 2, who had received at least four doses of study drug in the first two cycles. The objective response rate was the proportion of patients responding, i.e., with a best observed objective response of complete or partial response. The disease control rate was the proportion of patients with controlled disease (complete or partial response or stable disease) after two and four treatment cycles, and at the end of treatment. Progression-free survival (PFS) was defined as the interval between the date of first infusion and the earliest date of objective disease progression, investigator-confirmed clinical progression, or death due to any cause. Percentages and 95% confidence intervals (CIs) were calculated. Background, demographic and safety data were analyzed using descriptive statistics or contingency tables. Safety assessments included the frequency of AEs and laboratory abnormalities in the safety population. Statistical analyses were performed using SAS® Version 9.3 or higher (SAS Institute, Cary, North Carolina, USA).