Statistical analyses
toxicities, DLTs
The intent-to-treat population included all patients who received at least one dose of the study drug and formed the population assessed in the safety and efficacy analyses. Dose-limiting toxicities (DLTs) were determined from the DLT-evaluable population for BGB-A333 monotherapy, which included patients who received at least two-thirds of the assigned dose of BGB-A333 during the DLT observation period (i.e. within 21 days of the first dose of BGB-A333) and had sufficient safety evaluation, or patients who experienced a DLT within the DLT observation period. DLTs were assessed among evaluable patients within 21 days after the first dose of BGB-A333. The PK analysis population included all patients with valid PK sampling after treatment with the study drug. Missing data were not imputed unless specified. SAS v.9.3 or higher was used for statistical analyses. Descriptive statistics were used to summarise all study data. Median time and 95% confidence interval (CI) for PFS were estimated by the Kaplan–Meier method.