Statistical analyses
tumor
DISEASE, TUMOR
The safety analysis was performed in all patients who received ≥1 dose of study treatment. The efficacy analysis was performed in the response evaluable set, which included all patients who received ≥1 dose of study treatment who had a tumor assessment and measurable disease at baseline.Data are summarized with descriptive statistics. Continuous variables were summarized by the number of observations and median with upper and lower quartiles, range or 95% confidence interval (CI). Categorical values were summarized by frequency and percentage. Kaplan–Meier methods were used to estimate the median, 95% CIs, and upper and lower quartile ranges for DoR, PFS, and OS. No inferential analyses were performed based on statistical tests. Data are presented for Part A and Part B separately and in combination.