Table 5. Adverse events and suspected adverse drug reactions (SID patients).
| All patients | All SID patients | SID patients with IVIG before NIS | SID patients without IVIG before NIS | |||||
|---|---|---|---|---|---|---|---|---|
| (N = 2,195) | (N = 1,644) | (N = 595) | (N = 1,049) | |||||
| No. of IVIG infusions | 81,033 | 58,187 | 25,205 | 32,982 | ||||
| nP | nE | nP | nE | nP | nE | nP | nE | |
| Adverse events: any | 723 (32.9%) | 2,999 | 607 (36.9%) | 2,618 | 253 (42.5%) | 1,158 | 354 (33.7%) | 1,460 |
| Temporally associateda | 321 (14.6%) | 656 | 264 (16.1%) | 522 | 115 (19.3%) | 234 | 149 (14.2%) | 288 |
| Serious | 411 (18.7%) | 1,427 | 360 (21.9%) | 1,300 | 151 (25.4%) | 561 | 209 (19.9%) | 739 |
| Fatal | 107 (4.9%) | 190 | 56 (3.4%) | 98 | 22 (3.7%) | 32 | 34 (3.2%) | 66 |
| Adverse drug reactions: any | 304 (13.8%) | 608 | 251 (15.3%) | 479 | 105 (17.6%) | 201 | 146 (13.9%) | 278 |
| Serious | 20 (0.9%) | 54 | 16 (1.0%) | 40 | 4 (0.7%) | 14 | 12 (1.1%) | 26 |
| Fatal | – | – | – | – | – | – | – | – |
Total N = 2,195 and 1,644 with SID. nP = number of patients (percentage based on N); nE = number of events. a≤ 72 hours after start of infusion. SID = secondary immunodeficiency; NIS = large-scale non-interventional study.