Adverse events
| Variable . | Ravulizumab (N = 125) . | Eculizumab (N = 121) . |
|---|---|---|
| Patients with AEs, n (%) | 110 (88.0) | 105 (86.8) |
| Most common AEs (≥5% of patients in either treatment group), n (%) | ||
| Headache | 45 (36.0) | 40 (33.1) |
| Nasopharyngitis | 11 (8.8) | 18 (14.9) |
| Nausea | 11 (8.8) | 10 (8.3) |
| Upper respiratory tract infection | 13 (10.4) | 7 (5.8) |
| Pyrexia | 6 (4.8) | 13 (10.7) |
| Viral upper respiratory tract infection | 9 (7.2) | 10 (8.3) |
| Arthralgia | 8 (6.4) | 8 (6.6) |
| Dizziness | 9 (7.2) | 7 (5.8) |
| Pain in extremity | 9 (7.2) | 7 (5.8) |
| Diarrhea | 10 (8.0) | 5 (4.1) |
| Myalgia | 7 (5.6) | 9 (7.4) |
| Abdominal pain | 7 (5.6) | 7 (5.8) |
| Oropharyngeal pain | 8 (6.4) | 6 (5.0) |
| Back pain | 7 (5.6) | 6 (5.0) |
| Cough | 4 (3.2) | 8 (6.6) |
| Hypokalemia | 6 (4.8) | 6 (5.0) |
| Dyspepsia | 4 (3.2) | 6 (5.0) |
| Insomnia | 2 (1.6) | 6 (5.0) |
| Patients with serious AEs, n (%)* | 11 (8.8) | 9 (7.4) |
| Meningococcal infections, n (%) | 0 | 0 |
| Death, n (%) | 0 | 1 (0.8)† |
| Patients with AEs leading to withdrawal of study drug, n (%) | 0 | 1 (0.8)† |
| Patients with serious AEs leading to withdrawal of study drug, n (%) | 0 | 1 (0.8) |
| Variable . | Ravulizumab (N = 125) . | Eculizumab (N = 121) . |
|---|---|---|
| Patients with AEs, n (%) | 110 (88.0) | 105 (86.8) |
| Most common AEs (≥5% of patients in either treatment group), n (%) | ||
| Headache | 45 (36.0) | 40 (33.1) |
| Nasopharyngitis | 11 (8.8) | 18 (14.9) |
| Nausea | 11 (8.8) | 10 (8.3) |
| Upper respiratory tract infection | 13 (10.4) | 7 (5.8) |
| Pyrexia | 6 (4.8) | 13 (10.7) |
| Viral upper respiratory tract infection | 9 (7.2) | 10 (8.3) |
| Arthralgia | 8 (6.4) | 8 (6.6) |
| Dizziness | 9 (7.2) | 7 (5.8) |
| Pain in extremity | 9 (7.2) | 7 (5.8) |
| Diarrhea | 10 (8.0) | 5 (4.1) |
| Myalgia | 7 (5.6) | 9 (7.4) |
| Abdominal pain | 7 (5.6) | 7 (5.8) |
| Oropharyngeal pain | 8 (6.4) | 6 (5.0) |
| Back pain | 7 (5.6) | 6 (5.0) |
| Cough | 4 (3.2) | 8 (6.6) |
| Hypokalemia | 6 (4.8) | 6 (5.0) |
| Dyspepsia | 4 (3.2) | 6 (5.0) |
| Insomnia | 2 (1.6) | 6 (5.0) |
| Patients with serious AEs, n (%)* | 11 (8.8) | 9 (7.4) |
| Meningococcal infections, n (%) | 0 | 0 |
| Death, n (%) | 0 | 1 (0.8)† |
| Patients with AEs leading to withdrawal of study drug, n (%) | 0 | 1 (0.8)† |
| Patients with serious AEs leading to withdrawal of study drug, n (%) | 0 | 1 (0.8) |
Serious AEs in the ravulizumab group included: anemia, aplastic anemia, neutropenia, thrombocytopenia, left ventricular failure, myocardial ischemia, pyrexia, leptospirosis, systemic infection, laceration, uterine leiomyoma, renal colic, and deep vein thrombosis (n = 1 patient each). Serious AEs in the eculizumab group included: pyrexia (n = 2 patients), ileus, neutropenic colitis, limb abscess, cellulitis, infection, pneumonia, viral upper respiratory tract infection, adenocarcinoma of colon, lung adenocarcinoma, and paroxysmal nocturnal hemoglobinuria (n = 1 patient each).
One patient in the eculizumab arm died of lung cancer (unrelated to treatment) during the extension phase of the study.