Table 3

Adjudicated MS relationship for the 81 observed deaths in the different randomised treatment-allocation groups.

IFNβ-1b
Placebo50 µg250 µgTotal
Total number of deaths*37 (45.7%)22 (27.2%)22 (27.2%)81 (100%)
MS relationship indeterminate5 (6.2%)5 (6.2%)2 (2.5%)12 (14.8%)
Total MS relationship known32 (46.4%)17 (24.6%)20 (29.0%)69 (100%)
MS related26 (37.7%)12 (17.4%)16 (23.2%)54 (78.3%)
Not MS related6 (8.7%)5 (7.2%)4 (5.8%)15 (21.7%)
Expected in null condition33 (33.3%)33 (33.3%)33 (33.3%)69 (100%)
MS related18 (26.1%)18 (26.1%)18 (26.1%)54 (78.3%)
Not MS related5 (7.2%)5 (7.2%)5 (7.2%)15 (21.7%)
  • *Numbers represent the number of patients in each category. Numbers in parentheses represent the percentage of the total deaths (81) in each category for each treatment group separately. Total represents the combined numbers for all treatment arms.

  • †Numbers represent the number of patients in each category. Numbers in parentheses represent the percentage of the total deaths where MS relationship known (69) in each category for each treatment group separately. Total represents the combined numbers for all treatment arms.

  • ‡The null condition represents the number of deaths expected in each of the three treatment groups if the 69 observed deaths (54 MS related; 15 not MS related) had been distributed evenly between groups. In the circumstances of the present study, there were nine more deaths than expected in the placebo-treated group (eight MS related and one not MS related) and, similarly, nine fewer deaths than expected in the two treated groups combined.

  • IFNβ-1b, interferon β-1b; MS, multiple sclerosis.