Statistical analyses
tumor, dyspnea, TTD, pain, lung cancer, PD, hemoptysis, PD‐L1
LUNG CANCER, DISEASE, PERIPHERAL NEUROPATHY, TUMOR
The PRO analyses consisted of all patients who were randomized and received at least one dose of the study drug and completed at least one assessment of HRQoL. The analysis included HRQoL assessments up to point of investigator‐assessed progressive disease (PD), as patients had the option to receive additional therapy following the assessment. If patients completed at least one item on a PRO instrument, they were deemed to have completed one HRQoL assessment. Compliance with the PRO assessments was determined as the proportion of questionnaires that were actually received out of the expected number (i.e., number of patients on treatment and are alive).A longitudinal analysis of covariance was conducted to evaluate differences between the arms regarding mean score changes from baseline to week 12 and week 18 in the PRO endpoints. In line with the missing at random assumption, the response variable was the PRO score, while the covariates were treatment, study visit, treatment by study visit interaction, and randomization stratification factors (PD‐L1 expression in tumor cells and disease stage). Between‐group comparisons were reported as differences in the least square (LS) mean change from baseline with the 95% confidence interval (CI) and nominal Time to deterioration (TTD) was examined using the QLQ‐LC13 symptom index scale, and the most relevant lung cancer symptoms of dyspnea, coughing, peripheral neuropathy, pain in chest, pain in arm or shoulder, and hemoptysis symptoms. TTD threshold was defined as time to first onset of ≥10‐points