Statistical analysis methods
death
SENSITIVITY
Overall survival analysis was conducted for 1:1 propensity score–matched individuals from the PRO‐ACT external control group and the CENTAUR PB and TURSO group. Overall survival (time to death) was defined as the time from date of randomization to date of death due to any cause. Median overall survival and IQRs were estimated for the two cohorts using the Kaplan–Meier method. The HR between the two groups was estimated from a Cox proportional hazards model. The treatment difference in overall survival between the two groups was declared significant if the two‐sided Sensitivity analyses were performed with different caliper widths for the propensity score matching (0.1, 0.2, and 0.6, in addition to the prespecified caliper width of 0.4), on the full eligible PRO‐ACT analysis set without propensity score matching, and on the full eligible PRO‐ACT analysis set with propensity score inverse probability treatment weighting (IPTW). In addition, change in ALSFRS‐R total score from baseline through 24 weeks was assessed in the propensity score–matched PRO‐ACT external control group with an aim of evaluating the comparability of change in this functional end point to that in the placebo group from the randomized phase of CENTAUR.