Incidence of AEs by preferred term and treatment sequence (full analysis set)
| . | nE, nS (%) . | ||
|---|---|---|---|
| . | Iptacopan 25 mg/100 mg, n = 7 . | Iptacopan 50 mg/200 mg, n = 6 . | Total, n = 13 . |
| Total AEs | 31, 4 (57.1) | 7, 5 (83.3) | 38, 9 (69.2) |
| AEs of mild intensity | 29, 4 (57.1) | 6, 4 (66.7) | 35, 8 (61.5) |
| AEs of moderate intensity | 2, 1 (14.3) | 1, 1 (16.7) | 3, 2 (15.4) |
| AEs of severe/serious intensity | 0 | 0 | 0 |
| Study drug-related AEs | 6, 1 (14.3) | 3, 3 (50.0) | 9, 4 (30.8) |
| AEs leading to discontinuation of study treatment | 0 | 1, 1 (16.7) | 1, 1 (7.7) |
| Study drug-related AEs leading to discontinuation of study treatment | 0 | 1, 1 (16.7) | 1, 1 (7.7) |
| Most common AEs by preferred terms (total incidence, n ≥2), n (%) | |||
| Headache | 1 (14.3) | 3 (50.0) | 4 (30.8) |
| Abdominal discomfort | 2 (28.6) | 0 | 2 (15.4) |
| Blood alkaline phosphatase increased | 1 (14.3) | 1 (16.7) | 2 (15.4) |
| Cough | 2 (28.6) | 0 | 2 (15.4) |
| Oropharyngeal pain | 2 (28.6) | 0 | 2 (15.4) |
| Pyrexia | 2 (28.6) | 0 | 2 (15.4) |
| Upper respiratory tract infection | 2 (28.6) | 0 | 2 (15.4) |
| . | nE, nS (%) . | ||
|---|---|---|---|
| . | Iptacopan 25 mg/100 mg, n = 7 . | Iptacopan 50 mg/200 mg, n = 6 . | Total, n = 13 . |
| Total AEs | 31, 4 (57.1) | 7, 5 (83.3) | 38, 9 (69.2) |
| AEs of mild intensity | 29, 4 (57.1) | 6, 4 (66.7) | 35, 8 (61.5) |
| AEs of moderate intensity | 2, 1 (14.3) | 1, 1 (16.7) | 3, 2 (15.4) |
| AEs of severe/serious intensity | 0 | 0 | 0 |
| Study drug-related AEs | 6, 1 (14.3) | 3, 3 (50.0) | 9, 4 (30.8) |
| AEs leading to discontinuation of study treatment | 0 | 1, 1 (16.7) | 1, 1 (7.7) |
| Study drug-related AEs leading to discontinuation of study treatment | 0 | 1, 1 (16.7) | 1, 1 (7.7) |
| Most common AEs by preferred terms (total incidence, n ≥2), n (%) | |||
| Headache | 1 (14.3) | 3 (50.0) | 4 (30.8) |
| Abdominal discomfort | 2 (28.6) | 0 | 2 (15.4) |
| Blood alkaline phosphatase increased | 1 (14.3) | 1 (16.7) | 2 (15.4) |
| Cough | 2 (28.6) | 0 | 2 (15.4) |
| Oropharyngeal pain | 2 (28.6) | 0 | 2 (15.4) |
| Pyrexia | 2 (28.6) | 0 | 2 (15.4) |
| Upper respiratory tract infection | 2 (28.6) | 0 | 2 (15.4) |
Only data from the on-treatment period are included.
nE, number of events; nS, number of patients.