Most common TEAEs throughout the study
| Most common TEAEs by organ class (≥2 patients) . | Eculizumab-naive (n = 5) . | Eculizumab-experienced (n = 8) . | Total (N = 13) . | |||
|---|---|---|---|---|---|---|
| n (%) . | E . | n (%) . | E . | n (%) . | E . | |
| Total patient-years of exposure to ravulizumab, y | 11.9 | 22.4 | 34.3 | |||
| All TEAEs | 5 (100) | 28 | 8 (100) | 92 | 13 (100) | 120 |
| Blood and lymphatic system | ||||||
| Anemia | 0 (0) | 0 | 2 (25.0) | 5 | 2 (15.4) | 5 |
| Gastrointestinal | ||||||
| Abdominal pain | 0 (0) | 0 | 3 (37.5) | 3 | 3 (23.1) | 3 |
| Upper abdominal pain | 0 (0) | 0 | 3 (37.5) | 3 | 3 (23.1) | 3 |
| Nausea | 0 (0) | 0 | 3 (37.5) | 3 | 3 (23.1) | 3 |
| Constipation | 0 (0) | 0 | 2 (25.0) | 2 | 2 (15.4) | 2 |
| Diarrhea | 0 (0) | 0 | 2 (25.0) | 2 | 2 (15.4) | 2 |
| General | ||||||
| Fatigue | 0 (0) | 0 | 2 (25.0) | 2 | 2 (15.4) | 2 |
| Pyrexia | 1 (20.0) | 1 | 1 (12.5) | 1 | 2 (15.4) | 2 |
| Infections | ||||||
| COVID-19 | 2 (40.0) | 2 | 1 (12.5) | 1 | 3 (23.1) | 3 |
| Nasopharyngitis | 1 (20.0) | 1 | 2 (25.0) | 2 | 3 (23.1) | 3 |
| Upper respiratory tract infection | 0 (0) | 0 | 2 (25.0) | 3 | 2 (15.4) | 3 |
| Urinary tract infection | 0 (0) | 0 | 2 (25.0) | 2 | 2 (15.4) | 2 |
| Viral upper respiratory tract infection | 0 (0) | 0 | 2 (25.0) | 2 | 2 (15.4) | 2 |
| Musculoskeletal and connective tissue | ||||||
| Pain in extremity | 0 (0) | 0 | 2 (25.0) | 2 | 2 (15.4) | 2 |
| Nervous system | ||||||
| Headache | 1 (20.0) | 1 | 2 (25.0) | 3 | 3 (23.1) | 4 |
| Respiratory, thoracic, and mediastinal | ||||||
| Oropharyngeal pain | 0 (0) | 0 | 2 (25.0) | 2 | 2 (15.4) | 2 |
| Most common TEAEs by organ class (≥2 patients) . | Eculizumab-naive (n = 5) . | Eculizumab-experienced (n = 8) . | Total (N = 13) . | |||
|---|---|---|---|---|---|---|
| n (%) . | E . | n (%) . | E . | n (%) . | E . | |
| Total patient-years of exposure to ravulizumab, y | 11.9 | 22.4 | 34.3 | |||
| All TEAEs | 5 (100) | 28 | 8 (100) | 92 | 13 (100) | 120 |
| Blood and lymphatic system | ||||||
| Anemia | 0 (0) | 0 | 2 (25.0) | 5 | 2 (15.4) | 5 |
| Gastrointestinal | ||||||
| Abdominal pain | 0 (0) | 0 | 3 (37.5) | 3 | 3 (23.1) | 3 |
| Upper abdominal pain | 0 (0) | 0 | 3 (37.5) | 3 | 3 (23.1) | 3 |
| Nausea | 0 (0) | 0 | 3 (37.5) | 3 | 3 (23.1) | 3 |
| Constipation | 0 (0) | 0 | 2 (25.0) | 2 | 2 (15.4) | 2 |
| Diarrhea | 0 (0) | 0 | 2 (25.0) | 2 | 2 (15.4) | 2 |
| General | ||||||
| Fatigue | 0 (0) | 0 | 2 (25.0) | 2 | 2 (15.4) | 2 |
| Pyrexia | 1 (20.0) | 1 | 1 (12.5) | 1 | 2 (15.4) | 2 |
| Infections | ||||||
| COVID-19 | 2 (40.0) | 2 | 1 (12.5) | 1 | 3 (23.1) | 3 |
| Nasopharyngitis | 1 (20.0) | 1 | 2 (25.0) | 2 | 3 (23.1) | 3 |
| Upper respiratory tract infection | 0 (0) | 0 | 2 (25.0) | 3 | 2 (15.4) | 3 |
| Urinary tract infection | 0 (0) | 0 | 2 (25.0) | 2 | 2 (15.4) | 2 |
| Viral upper respiratory tract infection | 0 (0) | 0 | 2 (25.0) | 2 | 2 (15.4) | 2 |
| Musculoskeletal and connective tissue | ||||||
| Pain in extremity | 0 (0) | 0 | 2 (25.0) | 2 | 2 (15.4) | 2 |
| Nervous system | ||||||
| Headache | 1 (20.0) | 1 | 2 (25.0) | 3 | 3 (23.1) | 4 |
| Respiratory, thoracic, and mediastinal | ||||||
| Oropharyngeal pain | 0 (0) | 0 | 2 (25.0) | 2 | 2 (15.4) | 2 |
E, events; TEAEs, treatment-emergent adverse events.