Statistical analysis
Musoro, death
On the basis of rates of treatment completion from a previous study and literature review, the current study was planned to include 230 patients. Prior data indicated that the rate of treatment cessation among controls was 50% [The proportion of patients experiencing early treatment cessation, hospitalization or dose reduction was compared between arms using Fisher’s exact test. OS was defined as time from inclusion in the study to death from any cause. The survival curves were calculated using the Kaplan–Meier estimator and compared between arms using the log-rank test. Median OS (mOS) was computed based on the estimated survival curves. The Cox proportional hazards model was used to estimate hazard ratios and corresponding 95% CIs. Variables with possible effect on survival were included in the analyses. Differences between arms in QoL was assessed using linear mixed effects models with time and group as fixed effects allowing for interaction, and patient as a random effect. Minimal important differences (MID) for interpreting EORTC QLQ-C30 were applied according to Musoro et al. and a MID of 10 point was applied in the interpretation of the results [