Data Analysis and Statistics

Patient-reported outcomes data were summarized descriptively by group for each scale, and mean scores were compared. The data are presented as frequencies and proportions, and as means with standard deviation and range.

Proportions were compared using the chi-square test. Continuous variables were compared using the Student t-test. Calculations were performed in the IBM SPSS Statistics software application (version 21: IBM, Armonk, NY, U.S.A.). Two-tailed p values less than 0.05 were considered statistically significant.

■ Data analysis focused on the differences in mean qol scores between the ftd/tpi-treated cohort and the bsc-treated cohort. Endpoints were analyzed as follows:

■ Differences between the study groups in overall qol, including physical symptom distress, activity level, psychological distress, and overall valuation of life (measured using the rscl)

■ Difference between the study groups in crc symptoms (measured using the fcsi)

■ Difference between the study groups with respect to pain (measured using the vas for pain)