Statistical analysis
EVENTS
Based on the results from previous studies [Based on recommendations from an independent data monitoring committee (IDMC) when evaluating the phase II part of the study, an interim analysis for futility, wherein the primary endpoint was OS in the phase III study, was planned and represented as Cox proportional hazards and Bayesian prediction probability. The IDMC comprehensively evaluated whether the study was to be continued.Time-dependent events were estimated using the Kaplan–Meier method. HRs and their confidence intervals (CIs) were calculated using the stratified Cox proportional hazards model. The stratified factors were as follows: patients with a The analysis groups comprised FAS (all randomised patients except those with serious protocol violations or who withdrew consent to participate), safety analysis set (all patients in FAS who received ≥1 dose of the study drug in their assigned treatment group), and QoL analysis set (all patients in FAS from whom QoL questionnaires were collected before the initiation of study treatment and ≥1 timepoint after treatment initiation). All statistical analyses were performed using SAS