Statistical Analysis
tumor
DISEASE PROGRESSION, TUMOR PROGRESSION, TUMOR
The trial was powered to assess PFS between the 2 different dose schedules of Efficacy analyses were performed in the full analysis set (FAS) population who had received at least one dose of the study drug. For the primary analysis of PFS, data for patients who were alive and did not have disease progression, lost to follow up, or received non-study antitumor treatment before gaining evidence of objective tumor progression were censored to exclude the effects of maintenance therapy on PFS. To consider the impact of maintenance therapy in the sensitivity analysis of PFS, data from patients who were alive and did not have disease progression or who were lost to follow up were censored at the time of the last tumor assessment. For the analysis of OS, data from patients who were alive or lost to follow up were censored at the time of the last follow-up. The Kaplan-Meier method generated time-to-event curves, from which median values were calculated. A stratified log-rank test was used to compare the treatment groups, with an estimation of the HR and 95% CIs (CIs) from the log-rank test statistics. The relative dose intensity (RDI) was calculated as the actual dose intensity divided by the planned dose intensity during treatment. All statistical tests were 2-sided, with significance at 