TABLE 3.
Treatment-emergent adverse events occurring in >10% of total patients on delamanid plus an optimized background regimen
| Adverse event, n (%) | Value for group: |
||||
|---|---|---|---|---|---|
| 12–17 yrs (n = 7) | 6–11 yrs (n = 6) | 3–5 yrs (n = 12) | 0–2 yrs (n = 12) | Total (n = 37) | |
| Phase I | |||||
| Vomiting | 2 (28.6) | 2 (33.3) | 3 (25.0) | 2 (16.7) | 9 (24.3) |
| Pyrexia | 2 (28.6) | 0 (0.0) | 4 (33.3) | 1 (8.3) | 7 (18.9) |
| Nausea | 4 (57.1) | 0 (0.0) | 1 (8.3) | 0 (0.0) | 5 (13.5) |
| Toothache | 1 (14.3) | 2 (33.3) | 2 (16.7) | 0 (0.0) | 5 (13.5) |
| Hyperuricemia | 2 (28.6) | 1 (16.7) | 0 (0.0) | 2 (16.7) | 5 (13.5) |
| Lower respiratory tract infection | 0 (0.0) | 0 (0.0) | 3 (25.0) | 1 (8.3) | 4 (10.8) |
| Upper respiratory tract infection | 0 (0.0) | 1 (16.7) | 0 (0.0) | 3 (25.0) | 4 (10.8) |
| Arthralgia | 2 (28.6) | 1 (16.7) | 1 (8.3) | 0 (0.0) | 4 (10.8) |
| Headache | 2 (28.6) | 1 (16.7) | 1 (8.3) | 0 (0.0) | 4 (10.8) |
| Phase II extension | |||||
| Upper respiratory tract infection | 4 (57.1) | 3 (50.0) | 5 (41.7) | 2 (16.7) | 14 (37.8) |
| Headache | 5 (71.4) | 3 (50.0) | 2 (16.7) | 0 (0.0) | 10 (27.0) |
| Hyperuricemia | 2 (28.6) | 1 (16.7) | 4 (33.3) | 3 (25.0) | 10 (27.0) |
| Arthralgia | 3 (42.9) | 2 (33.3) | 3 (25.0) | 0 (0.0) | 8 (21.6) |
| Gastroenteritis | 1 (14.3) | 1 (16.7) | 1 (8.3) | 4 (33.3) | 7 (18.9) |
| Pneumonia | 1 (14.3) | 1 (16.7) | 3 (25.0) | 2 (16.7) | 7 (18.9) |
| Vomiting | 2 (28.6) | 1 (16.7) | 2 (16.7) | 1 (8.3) | 6 (16.2) |
| Lower respiratory tract infection | 0 (0.0) | 1 (16.7) | 3 (25.0) | 2 (16.7) | 6 (16.2) |
| Hypothyroidism | 0 (0.0) | 1 (16.7) | 2 (16.7) | 2 (16.7) | 5 (13.5) |
| Pyrexia | 2 (28.6) | 0 (0.0) | 2 (16.7) | 1 (8.3) | 5 (13.5) |
| Respiratory tract infection | 0 (0.0) | 0 (0.0) | 1 (8.3) | 4 (33.3) | 5 (13.5) |
| Otitis media | 0 (0.0) | 0 (0.0) | 1 (8.3) | 3 (25.0) | 4 (10.8) |
| Skin laceration | 0 (0.0) | 1 (16.7) | 2 (16.7) | 1 (8.3) | 4 (10.8) |
| Wt decreased | 0 (0.0) | 0 (0.0) | 1 (8.3) | 3 (25.0) | 4 (10.8) |