SAEs
| Type of SAE . | RCT arm A (dapsone), n = 30 patients (with 50 events/46 patients) . | Observational study cohort, n = 14 patients (with 16 events/46 patients) . |
|---|---|---|
| Hemolytic anemia∗ | 21 (45.6)/4 (8.7)/55 d | 6 (13) |
| Methemoglobinemia∗ | 10 (21.7)/5 (10.9)/21 d | 4 (8.7) |
| Drug-related skin reactions∗ | 8 (17.4)/3 (6.5)/24 d | 3 (6.5) |
| Hepatitis, n (%) | 0 | 1 (2.2) |
| Death, n (%) | 1 (2.2) | 0 |
| Other SAEs, n (%)/n requiring treatment cessation (%) | 10 (21.7)/6 (13.0)† | 2 (4.3) |
| Type of SAE . | RCT arm A (dapsone), n = 30 patients (with 50 events/46 patients) . | Observational study cohort, n = 14 patients (with 16 events/46 patients) . |
|---|---|---|
| Hemolytic anemia∗ | 21 (45.6)/4 (8.7)/55 d | 6 (13) |
| Methemoglobinemia∗ | 10 (21.7)/5 (10.9)/21 d | 4 (8.7) |
| Drug-related skin reactions∗ | 8 (17.4)/3 (6.5)/24 d | 3 (6.5) |
| Hepatitis, n (%) | 0 | 1 (2.2) |
| Death, n (%) | 1 (2.2) | 0 |
| Other SAEs, n (%)/n requiring treatment cessation (%) | 10 (21.7)/6 (13.0)† | 2 (4.3) |