Table 3.
AEs (reported ⩾10% in all grades and in all patients) regardless of relationship with drug and AESIs.
| Preferred term | Crizanlizumab 5.0 mg/kg (N = 45) | Crizanlizumab 7.5 mg/kg (N = 12) | All patients (N = 57) | |||
|---|---|---|---|---|---|---|
| All grades, n (%) | Grade ⩾3, n (%) | All grades, n (%) | Grade ⩾3, n (%) | All grades, n (%) | Grade ⩾3, n (%) | |
| Patients with ⩾1 AE | 45 (100) | 27 (60.0) | 12 (100) | 7 (58.3) | 57 (100) | 34 (59.6) |
| Pyrexia | 14 (31.1) | 0 | 3 (25.0) | 1 (8.3) | 17 (29.8) | 1 (1.8) |
| Headache | 12 (26.7) | 0 | 2 (16.7) | 0 | 14 (24.6) | 0 |
| Hypokalemia | 12 (26.7) | 7 (15.6) | 2 (16.7) | 0 | 14 (24.6) | 7 (12.3) |
| Upper respiratory tract infection | 11 (24.4) | 2 (4.4) | 2 (16.7) | 0 | 13 (22.8) | 2 (3.5) |
| Arthralgia | 9 (20.0) | 0 | 2 (16.7) | 0 | 11 (19.3) | 0 |
| COVID-19 | 8 (17.8) | 3 (6.7) | 3 (25.0) | 0 | 11 (19.3) | 3 (3.5) |
| Chest pain | 8 (17.8) | 0 | 1 (8.3) | 0 | 9 (15.8) | 0 |
| Nausea | 6 (13.3) | 0 | 2 (16.7) | 0 | 8 (14.0) | 0 |
| Back pain | 6 (13.3) | 0 | 1 (8.3) | 0 | 7 (12.3) | 0 |
| Road traffic accident | 5 (11.1) | 0 | 2 (16.7) | 0 | 7 (12.3) | 0 |
| Vomiting | 4 (8.9) | 0 | 3 (25.0) | 0 | 7 (12.3) | 0 |
| Diarrhea | 4 (8.9) | 0 | 2 (16.7) | 0 | 6 (10.5) | 0 |
| Peripheral edema | 6 (13.3) | 0 | 0 | 0 | 6 (10.5) | 0 |
| Pain in extremity | 6 (13.3) | 0 | 0 | 0 | 6 (10.5) | 0 |
| Pneumonia | 5 (11.1) | 4 (8.9) | 1 (8.3) | 0 | 6 (10.5) | 4 (7.0) |
| Pruritus | 5 (11.1) | 0 | 1 (8.3) | 0 | 6 (10.5) | 0 |
| Patients with ⩾1 AESI | ||||||
| Infections | 31 (68.9) | 13 (28.9) | 8 (66.7) | 1 (8.3) | 39 (68.4) | 14 (24.6) |
| IRRs (standard search) a | 18 (40.0) | 1 (2.2) | 5 (41.7) | 0 | 23 (40.4) | 1 (1.8) |
| Pain events | 11 (24.4) | 2 (4.4) | 1 (8.3) | 0 | 12 (21.1) | 2 (3.5) |
AE, adverse event; AESI, AEs of special interest; COVID-19, Coronavirus disease 2019; IRR, infusion-related reaction.
a
Nonspecific, potential signs and symptoms indicative of IRRs were identified through standard search.