Table 2

Primary efficacy endpoints analysed in two patient populations

(A) Analysis conducted using data from all participants
 Primary efficacy endpointsPlacebo (n=123)MethylcobalaminCrude p value
(comparison with placebo)
Adjusted p value
(comparison with placebo)
25 mg (n=124)50 mg (n=123)50 mgMethylcobalamin50 mgMethylcobalamin
Time to the primary event*, day
 Median (95% CI)880 (678 to 12171147 (819 to –)954 (777 to –)0.33†0.20†0.15†0.13†
 First quartile (25%) (95% CI)465 (363 to 538)499 (392 to 610)503 (377 to 627)
 Third quartile (75%) (95% CI)–‡–‡
 HR vs the placebo group in each active group (95% CI)0.83 (0.58 to 1.20)0.92 (0.65 to 1.32)
 HR vs the placebo group in total active group (95% CI)0.88 (0.64 to 1.20)
Change in ALSFRS-R score
 Patients, n123124122
 Median (min, max)−24.0 (−42, −1)−22.0 (−42, 2)−21.0 (−39, 1)0.15§0.09§0.18§0.19§
 First quartile (25%)−30.0−30.5−27.0
 Third quartile (75%)−16.0−12.5−10.0