Table 2.
Summary of Adverse Events Reported in Adults and Pediatric Patients Naïve to C5i Treatment up to 2 Years (Safety Analysis Set)
| Adults Naïve to C5i Treatment (n=58) |
Pediatric Patients Naïve to C5i Treatment (n=24) |
|||
|---|---|---|---|---|
| n (%) | Events | n (%) | Events | |
| Patients with any AE | 58 (100%) | 1153 | 23 (96%) | 473 |
| AE severity | ||||
| Grade 1 | 56 (97%) | 621 | 22 (92%) | 299 |
| Grade 2 | 49 (85%) | 327 | 18 (75%) | 135 |
| Grade 3 | 34 (59%) | 172 | 12 (50%) | 38 |
| Grade 4 | 15 (26%) | 29 | 1 (4%) | 1 |
| Grade 5 | 3 (5%) | 3 | 0 (0%) | 0 |
| Patients with any SAE | 36 (62%) | 120 | 16 (67%) | 42 |
| Patients with any treatment-related AE | 21 (36%) | 74 | 12 (50%) | 47 |
| Study discontinuation because of AE | 3 (5%) | 3 | 2 (8%) | 3 |
| Death because of AEa | 3 (5%) | 3 | 0 (0%) | 0 |
| Meningococcal infections | 0 (0%) | 0 | 0 (0%) | 0 |
Abbreviations: AE, adverse event; C5i, complement C5 inhibitor; SAE, serious adverse event.
a
Septic shock (n=2 events); cerebral hemorrhage (n=1 event).18