Table 1 Overview of adverse events
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 | |
TEAEs | 42 (80.8%) | 196 | 28 (58.3%) | 135 | 84 (88.4%) | 545 |
Infusional TEAEs | 34 (65.4%) | 139 | 19 (39.6%) | 65 | 76 (80.0%) | 351 |
Serious TEAEs | 3 (5.8%) | 5 | 2 (4.2%) | 4 | 14 (14.7%) | 22 |
TEAEs related to study drug | 30 (57.7%) | 113 | 11 (22.9%) | 38 | 62 (65.3%) | 282 |
TEAEs leading to discontinuation of study drug | 3 (5.8%) | 8 | 0 (0.0%) | 0 | 13 (13.7%) | 25 |
TEEs | 1 (1.9%) | 2 | 0 (0.0%) | 0 | 6 (6.3%) | 8 |
Relatedb TEEs | 0 (0.0%) | 0 | 0 (0.0%) | 0 | 5 (5.3%) | 6 |
HTRs | 0 (0.0%) | 0 | 0 (0.0%) | 0 | 0 (0.0%) | 0 |
Deaths | 0 (0.0%) | 0 | 0 (0.0%) | 0 | 0 (0.0%) | 0 |