Table 4.

Adverse events

VariableRavulizumab (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 (%)
 Headache45 (36.0)40 (33.1)
 Nasopharyngitis11 (8.8)18 (14.9)
 Nausea11 (8.8)10 (8.3)
 Upper respiratory tract infection13 (10.4)7 (5.8)
 Pyrexia6 (4.8)13 (10.7)
 Viral upper respiratory tract infection9 (7.2)10 (8.3)
 Arthralgia8 (6.4)8 (6.6)
 Dizziness9 (7.2)7 (5.8)
 Pain in extremity9 (7.2)7 (5.8)
 Diarrhea10 (8.0)5 (4.1)
 Myalgia7 (5.6)9 (7.4)
 Abdominal pain7 (5.6)7 (5.8)
 Oropharyngeal pain8 (6.4)6 (5.0)
 Back pain7 (5.6)6 (5.0)
 Cough4 (3.2)8 (6.6)
 Hypokalemia6 (4.8)6 (5.0)
 Dyspepsia4 (3.2)6 (5.0)
 Insomnia2 (1.6)6 (5.0)
Patients with serious AEs, n (%)*11 (8.8)9 (7.4)
Meningococcal infections, n (%)00
Death, n (%)01 (0.8)
Patients with AEs leading to withdrawal of study drug, n (%)01 (0.8)
Patients with serious AEs leading to withdrawal of study drug, n (%)01 (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.