Treatment-emergent AEs in patients with PNH
| . | Part 2: eculizumab naive (n = 10) . | Part 3: switched to crovalimab (n = 19) . | Part 2 + part 3 (N = 29) . | |||
|---|---|---|---|---|---|---|
| Duration of exposure period, median (range), wk | 83.5 (40-97) | 37.1 (13-69) | NA | |||
| Total patients with ≥1 AE, n (%) | 10 (100.0) | 17 (89.5) | 27 (93.1) | |||
| Total patients with ≥1 related AE, n (%) | 1 (10.0) | 7 (36.8) | 8 (27.6) | |||
| Total AEs, n | 40 | 105 | 145 | |||
| Total related AEs, n | 2 | 17 | 19 | |||
| Most common AEs,* no. of participants (%) | All causality | Related | All causality | Related | All causality | Related |
| Nasopharyngitis | 3 (30.0) | 0 | 6 (31.6) | 0 | 9 (31.0) | 0 |
| Upper respiratory tract infection | 4 (40.0) | 0 | 3 (15.8) | 0 | 7 (24.1) | 0 |
| Headache | 2 (20.0) | 1 (10.0) | 3 (15.8) | 2 (10.5) | 5 (17.2) | 3 (10.3) |
| Diarrhea | 0 | 0 | 4 (21.1) | 0 | 4 (13.8) | 0 |
| Arthralgia | 0 | 0 | 3 (15.8) | 1 (5.3) | 3 (10.3) | 1 (3.4) |
| Asthenia | 0 | 0 | 3 (15.8) | 1 (5.3) | 3 (10.3) | 1 (3.4) |
| Back pain | 2 (20.0) | 0 | 1 (5.3) | 0 | 3 (10.3) | 0 |
| Pyrexia | 1 (10.0) | 0 | 2 (10.5) | 0 | 3 (10.3) | 0 |
| Urticaria | 1 (10.0) | 1 (10.0) | 2 (10.5) | 1 (5.3) | 3 (10.3) | 2 (6.9) |
| Abdominal pain | 2 (20.0) | 0 | 0 | 0 | 2 (6.9) | 0 |
| Bronchitis | 0 | 0 | 2 (10.5) | 0 | 2 (6.9) | 0 |
| Dizziness | 0 | 0 | 2 (10.5) | 1 (5.3) | 2 (6.9) | 1 (3.4) |
| Exertional dyspnea | 0 | 0 | 2 (10.5) | 0 | 2 (6.9) | 0 |
| Dysuria | 0 | 0 | 2 (10.5) | 0 | 2 (6.9) | 0 |
| Hemolysis | 0 | 0 | 2 (10.5) | 1 (5.3) | 2 (6.9) | 1 (3.4) |
| Influenza | 0 | 0 | 2 (10.5) | 0 | 2 (6.9) | 0 |
| Vertigo | 2 (20.0) | 0 | 0 | 0 | 2 (6.9) | 0 |
| Patients with ≥1 SAE, n (%) | 3 (30.0) | 0 | 2 (10.5) | 0 | 5 (17.2) | 0 |
| AE leading to discontinuation of treatment, n | 0 | 0 | 0 | 0 | 0 | 0 |
| . | Part 2: eculizumab naive (n = 10) . | Part 3: switched to crovalimab (n = 19) . | Part 2 + part 3 (N = 29) . | |||
|---|---|---|---|---|---|---|
| Duration of exposure period, median (range), wk | 83.5 (40-97) | 37.1 (13-69) | NA | |||
| Total patients with ≥1 AE, n (%) | 10 (100.0) | 17 (89.5) | 27 (93.1) | |||
| Total patients with ≥1 related AE, n (%) | 1 (10.0) | 7 (36.8) | 8 (27.6) | |||
| Total AEs, n | 40 | 105 | 145 | |||
| Total related AEs, n | 2 | 17 | 19 | |||
| Most common AEs,* no. of participants (%) | All causality | Related | All causality | Related | All causality | Related |
| Nasopharyngitis | 3 (30.0) | 0 | 6 (31.6) | 0 | 9 (31.0) | 0 |
| Upper respiratory tract infection | 4 (40.0) | 0 | 3 (15.8) | 0 | 7 (24.1) | 0 |
| Headache | 2 (20.0) | 1 (10.0) | 3 (15.8) | 2 (10.5) | 5 (17.2) | 3 (10.3) |
| Diarrhea | 0 | 0 | 4 (21.1) | 0 | 4 (13.8) | 0 |
| Arthralgia | 0 | 0 | 3 (15.8) | 1 (5.3) | 3 (10.3) | 1 (3.4) |
| Asthenia | 0 | 0 | 3 (15.8) | 1 (5.3) | 3 (10.3) | 1 (3.4) |
| Back pain | 2 (20.0) | 0 | 1 (5.3) | 0 | 3 (10.3) | 0 |
| Pyrexia | 1 (10.0) | 0 | 2 (10.5) | 0 | 3 (10.3) | 0 |
| Urticaria | 1 (10.0) | 1 (10.0) | 2 (10.5) | 1 (5.3) | 3 (10.3) | 2 (6.9) |
| Abdominal pain | 2 (20.0) | 0 | 0 | 0 | 2 (6.9) | 0 |
| Bronchitis | 0 | 0 | 2 (10.5) | 0 | 2 (6.9) | 0 |
| Dizziness | 0 | 0 | 2 (10.5) | 1 (5.3) | 2 (6.9) | 1 (3.4) |
| Exertional dyspnea | 0 | 0 | 2 (10.5) | 0 | 2 (6.9) | 0 |
| Dysuria | 0 | 0 | 2 (10.5) | 0 | 2 (6.9) | 0 |
| Hemolysis | 0 | 0 | 2 (10.5) | 1 (5.3) | 2 (6.9) | 1 (3.4) |
| Influenza | 0 | 0 | 2 (10.5) | 0 | 2 (6.9) | 0 |
| Vertigo | 2 (20.0) | 0 | 0 | 0 | 2 (6.9) | 0 |
| Patients with ≥1 SAE, n (%) | 3 (30.0) | 0 | 2 (10.5) | 0 | 5 (17.2) | 0 |
| AE leading to discontinuation of treatment, n | 0 | 0 | 0 | 0 | 0 | 0 |
AEs are presented as Medical Dictionary for Regulatory Activities (v21.1) Preferred Terms. AE counts are per individual, and multiple occurrences of the same event in an individual are counted only once.
Most common AEs include AEs with a frequency ≥2 in part 2 or 3.