Table 2 TEAEs by intensity in the first period and overall period
Category of TEAE and intensity | First period | Overall period | ||||
|---|---|---|---|---|---|---|
IVIg (n = 52a) | Placebo (N = 48) | All IVIg (N = 95) | ||||
No. of pts (%) | No. of events (%) | No. of pts (%) | No. of events (%) | No. of pts (%) | No. of events (%) | |
All TEAEs | ||||||
Mild | 39 (75.0%) | 142 (72.4%) | 28 (58.3%) | 102 (75.6%) | 79 (83.2%) | 405 (74.3%) |
Moderate | 20 (38.5%) | 48 (24.5%) | 10 (20.8%) | 33 (24.4%) | 39 (41.1%) | 118 (21.7%) |
Severe | 4 (7.7%) | 6 (3.1%) | 0 (0.0%) | 0 (0.0%) | 10 (10.5%) | 22 (4.0%) |
TEAEs relatedb to study drug | ||||||
Mild | 28 (53.8%) | 82 (72.6%) | 9 (18.8%) | 24 (63.2%) | 55 (57.9%) | 207 (73.4%) |
Moderate | 13 (25.0%) | 28 (24.8%) | 5 (10.4%) | 14 (36.8%) | 25 (26.3%) | 66 (23.4%) |
Severe | 2 (3.8%) | 3 (2.7%) | 0 (0.0%) | 0 (0.0%) | 5 (5.3%) | 9 (3.2%) |