Statistical Analysis
RCC
RCC
The planned sample size was 414 participants (207 per treatment group) for comparing the primary endpoint of LCQ change from baseline in total score at Week 12, assuming a pooled SD of 3.5 points. These assumptions were based on a phase 2 study in participants with RCC or UCC [The primary efficacy analyses were based on the Full Analysis Set (FAS) and were conducted based on the observed data only with no imputation for missing diaries or missing questionnaire items. The pattern of missingness was assumed to be missing at random. The primary efficacy endpoint of this study is the change from baseline in LCQ total score and the primary analysis approach used a longitudinal ANCOVA model. In this model, the response vector consisted of the change from baseline in LCQ total score at each post-baseline visit. The model included factors for intervention group, visit, interaction of treatment by visit, gender, and the baseline LCQ score. The model used all available LCQ data at Weeks 6 and 12. Contrasts were constructed to compare the gefapixant arm to the placebo arm and least squares (LS) mean change from baseline with associated standard errors were calculated for each intervention group. Overall estimated treatment differences (gefapixant − placebo) were assessed along with corresponding 