Table 4.
Safety outcomes
| AEs | Patients treated with ravulizumab during the RCP or OLEa | Patients treated with placebo during the RCP | ||
|---|---|---|---|---|
| n = 169, PY = 141.6 | n = 89, PY = 43.0 | |||
| Patients, n (%) | Events, n (rate per 100 PY) | Patients, n (%) | Events, n (rate per 100 PY) | |
| Any AE | 150 (88.8) | 881 (622.0) | 77 (86.5) | 341 (793.1) |
| Related to trial agentb | 58 (34.3) | 146 (103.1) | 30 (33.7) | 61 (141.9) |
| Any AE, by severityc | ||||
| Grade 1 | 127 (75.1) | 577e | 66 (74.2) | 250e |
| Grade 2 | 82 (48.5) | 210e | 30 (33.7) | 70e |
| Grade 3 | 39 (23.1) | 81e | 14 (15.7) | 20e |
| Grade 4 | 9 (5.3) | 9e | 1 (1.1) | 1e |
| Grade 5 | 4 (2.4) | 4e | 0 | 0 |
| Any SAE | 41 (24.3) | 75 (53.0) | 14 (15.7) | 16 (37.2) |
| Related to trial agentb | 5 (3.0) | 6e | 4 (4.5) | 4e |
| Deathd | 4 (2.4) | 4e | 0 | 0 |
| AE reported in > 5% of patients in either group | ||||
| Headache | 28 (16.6) | 43 (30.4) | 23 (25.8) | 27 (62.8) |
| Diarrhea | 23 (13.6) | 26 (18.4) | 11 (12.4) | 15 (34.9) |
| Nausea | 16 (9.5) | 25 (17.7) | 9 (10.1) | 10 (23.3) |
| Fatigue | 16 (9.5) | 19 (13.4) | 6 (6.7) | 6 (14.0) |
| Back pain | 16 (9.5) | 16 (11.3) | 5 (5.6) | 5 (11.6) |
| Arthralgia | 15 (8.9) | 23 (16.2) | 7 (7.9) | 8 (18.6) |
| Nasopharyngitis | 15 (8.9) | 17 (12.0) | 5 (5.6) | 7 (16.3) |
| Urinary tract infection | 15 (8.9) | 17 (12.0) | 4 (4.5) | 5 (11.6) |
| Dizziness | 14 (8.3) | 19 (13.4) | 3 (3.4) | 3 (7.0) |
| COVID-19 | 9 (5.3) | 13 (9.2) | 3 (3.4) | 4 (9.3) |
| Abdominal pain | 9 (5.3) | 11 (7.8) | 0 | 0 |
| Upper respiratory tract infection | 9 (5.3) | 10 (7.1) | 2 (2.2) | 2 (4.7) |
| Pyrexia | 6 (3.6) | 6 (4.2) | 5 (5.6) | 6 (14.0) |
| Infusion-related reaction | 1 (0.6) | 2 (1.4) | 5 (5.6) | 5 (11.6) |
AE, adverse event; COVID-19, coronavirus disease 2019; OLE, open-label extension; PY, patient-years; RCP, randomized controlled period; SAE, serious adverse event
aSafety set: includes data available for all patients who received ≥ 1 dose of ravulizumab in the RCP or the OLE, up to Week 60 at data cut-off (9 November 2021)
bAs determined by the investigator
cGraded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03
dTwo deaths occurred during the RCP and two during the OLE (see text for details)
eRate not calculated