Overview of TEAEs with danicopan treatment over the entire trial (safety population)
| TEAE . | Danicopan-danicopan (n = 57) . | Placebo-danicopan∗ (n = 27) . | Total (N = 84) . |
|---|---|---|---|
| Any TEAE | 56 (98.2), 503 | 27 (100), 273 | 83 (98.8), 776 |
| Common TEAEs (≥5% of total population) | |||
| COVID-19 | 15 (26.3), 15 | 11 (40.7), 11 | 26 (31.0), 26 |
| Pyrexia | 19 (33.3), 30 | 3 (11.1), 5 | 22 (26.2), 35 |
| Headache | 15 (26.3), 22 | 3 (11.1), 3 | 18 (21.4), 25 |
| Nausea | 10 (17.5), 12 | 3 (11.1), 6 | 13 (15.5), 18 |
| Diarrhea | 8 (14.0), 13 | 4 (14.8), 9 | 12 (14.3), 22 |
| Asthenia | 6 (10.5), 6 | 5 (18.5), 12 | 11 (13.1), 18 |
| Fatigue | 8 (14.0), 11 | 2 (7.4), 2 | 10 (11.9), 13 |
| Arthralgia | 7 (12.3), 8 | 3 (11.1), 4 | 10 (11.9), 12 |
| Urinary tract infection | 7 (12.3), 8 | 3 (11.1), 4 | 10 (11.9), 12 |
| Nasopharyngitis | 7 (12.3), 9 | 1 (3.7), 1 | 8 (9.5), 10 |
| Anemia | 6 (10.5), 7 | 1 (3.7), 3 | 7 (8.3), 10 |
| Vomiting | 6 (10.5), 7 | 1 (3.7), 3 | 7 (8.3), 10 |
| Hemolysis | 4 (7.0), 4 | 3 (11.1), 6 | 7 (8.3), 10 |
| Constipation | 3 (5.3), 3 | 4 (14.8), 5 | 7 (8.3), 8 |
| Back pain | 4 (7.0), 4 | 3 (11.1), 3 | 7 (8.3), 7 |
| Thrombocytopenia | 3 (5.3), 3 | 3 (11.1), 13 | 6 (7.1), 16 |
| Pain in extremity | 6 (10.5), 9 | 0 | 6 (7.1), 9 |
| Abdominal pain | 3 (5.3), 3 | 3 (11.1), 4 | 6 (7.1), 7 |
| Cough | 5 (8.8), 6 | 1 (3.7), 1 | 6 (7.1), 7 |
| Dizziness | 5 (8.8), 5 | 1 (3.7), 1 | 6 (7.1), 6 |
| Insomnia | 3 (5.3), 3 | 3 (11.1), 3 | 6 (7.1), 6 |
| Myalgia | 4 (7.0), 7 | 1 (3.7), 1 | 5 (6.0), 8 |
| BTH | 5 (8.8), 7 | 0 | 5 (6.0), 7 |
| Dyspnea | 3 (5.3), 4 | 2 (7.4), 2 | 5 (6.0), 6 |
| Neutropenia | 4 (7.0), 5 | 1 (3.7), 1 | 5 (6.0), 6 |
| Dark urine | 3 (5.3), 3 | 2 (7.4), 2 | 5 (6.0), 5 |
| Dyspepsia | 1 (1.8), 1 | 4 (14.8), 4 | 5 (6.0), 5 |
| Oropharyngeal pain | 5 (8.8), 5 | 0 | 5 (6.0), 5 |
| TEAEs by relationship | |||
| Related | 13 (22.8), 43 | 9 (33.3), 28 | 22 (26.2), 71 |
| Not related | 55 (96.5), 460 | 26 (96.3), 245 | 81 (96.4), 705 |
| SAEs by relationship | |||
| Related | 1 (1.8), 2 | 1 (3.7), 1 | 2 (2.4), 3 |
| Not related | 11 (19.3), 20 | 9 (33.3), 20 | 20 (23.8), 40 |
| Grade ≥3 TEAEs | 25 (43.9), 53 | 15 (55.6), 43 | 40 (47.6), 96 |
| AESI | |||
| Meningococcal infections | 0 | 0 | 0 |
| Liver enzyme elevations | 11 (19.3), 21 | 4 (14.8), 4 | 15 (17.9), 25 |
| TEAE leading to withdrawal of study drug | 4 (7.0), 6 | 2 (7.4), 2 | 6 (7.1), 8 |
| TEAE leading to death | 0 | 1 (3.8), 1 | 1 (3.8), 1 |
| TEAE . | Danicopan-danicopan (n = 57) . | Placebo-danicopan∗ (n = 27) . | Total (N = 84) . |
|---|---|---|---|
| Any TEAE | 56 (98.2), 503 | 27 (100), 273 | 83 (98.8), 776 |
| Common TEAEs (≥5% of total population) | |||
| COVID-19 | 15 (26.3), 15 | 11 (40.7), 11 | 26 (31.0), 26 |
| Pyrexia | 19 (33.3), 30 | 3 (11.1), 5 | 22 (26.2), 35 |
| Headache | 15 (26.3), 22 | 3 (11.1), 3 | 18 (21.4), 25 |
| Nausea | 10 (17.5), 12 | 3 (11.1), 6 | 13 (15.5), 18 |
| Diarrhea | 8 (14.0), 13 | 4 (14.8), 9 | 12 (14.3), 22 |
| Asthenia | 6 (10.5), 6 | 5 (18.5), 12 | 11 (13.1), 18 |
| Fatigue | 8 (14.0), 11 | 2 (7.4), 2 | 10 (11.9), 13 |
| Arthralgia | 7 (12.3), 8 | 3 (11.1), 4 | 10 (11.9), 12 |
| Urinary tract infection | 7 (12.3), 8 | 3 (11.1), 4 | 10 (11.9), 12 |
| Nasopharyngitis | 7 (12.3), 9 | 1 (3.7), 1 | 8 (9.5), 10 |
| Anemia | 6 (10.5), 7 | 1 (3.7), 3 | 7 (8.3), 10 |
| Vomiting | 6 (10.5), 7 | 1 (3.7), 3 | 7 (8.3), 10 |
| Hemolysis | 4 (7.0), 4 | 3 (11.1), 6 | 7 (8.3), 10 |
| Constipation | 3 (5.3), 3 | 4 (14.8), 5 | 7 (8.3), 8 |
| Back pain | 4 (7.0), 4 | 3 (11.1), 3 | 7 (8.3), 7 |
| Thrombocytopenia | 3 (5.3), 3 | 3 (11.1), 13 | 6 (7.1), 16 |
| Pain in extremity | 6 (10.5), 9 | 0 | 6 (7.1), 9 |
| Abdominal pain | 3 (5.3), 3 | 3 (11.1), 4 | 6 (7.1), 7 |
| Cough | 5 (8.8), 6 | 1 (3.7), 1 | 6 (7.1), 7 |
| Dizziness | 5 (8.8), 5 | 1 (3.7), 1 | 6 (7.1), 6 |
| Insomnia | 3 (5.3), 3 | 3 (11.1), 3 | 6 (7.1), 6 |
| Myalgia | 4 (7.0), 7 | 1 (3.7), 1 | 5 (6.0), 8 |
| BTH | 5 (8.8), 7 | 0 | 5 (6.0), 7 |
| Dyspnea | 3 (5.3), 4 | 2 (7.4), 2 | 5 (6.0), 6 |
| Neutropenia | 4 (7.0), 5 | 1 (3.7), 1 | 5 (6.0), 6 |
| Dark urine | 3 (5.3), 3 | 2 (7.4), 2 | 5 (6.0), 5 |
| Dyspepsia | 1 (1.8), 1 | 4 (14.8), 4 | 5 (6.0), 5 |
| Oropharyngeal pain | 5 (8.8), 5 | 0 | 5 (6.0), 5 |
| TEAEs by relationship | |||
| Related | 13 (22.8), 43 | 9 (33.3), 28 | 22 (26.2), 71 |
| Not related | 55 (96.5), 460 | 26 (96.3), 245 | 81 (96.4), 705 |
| SAEs by relationship | |||
| Related | 1 (1.8), 2 | 1 (3.7), 1 | 2 (2.4), 3 |
| Not related | 11 (19.3), 20 | 9 (33.3), 20 | 20 (23.8), 40 |
| Grade ≥3 TEAEs | 25 (43.9), 53 | 15 (55.6), 43 | 40 (47.6), 96 |
| AESI | |||
| Meningococcal infections | 0 | 0 | 0 |
| Liver enzyme elevations | 11 (19.3), 21 | 4 (14.8), 4 | 15 (17.9), 25 |
| TEAE leading to withdrawal of study drug | 4 (7.0), 6 | 2 (7.4), 2 | 6 (7.1), 8 |
| TEAE leading to death | 0 | 1 (3.8), 1 | 1 (3.8), 1 |
Data are presented as the number of patients who had an AE (with the percentage of patients in parentheses) followed by the total number of events.
AESI, AE of special interest; SAE, serious AE.
In the placebo-danicopan arm, only TEAEs that occurred after switching to danicopan were included.