AEs, regardless of relationship to study treatment (≥30% of patients with BRAF V600–mutant LCH in either study)
| Category . | CDRB436A2102 (dabrafenib monotherapy) (n = 13) . | CTMT212X2101 (dabrafenib + trametinib) (n = 12) . | ||
|---|---|---|---|---|
| Any grade . | Grade ≥3 . | Any grade . | Grade ≥3 . | |
| Any AE, n (%) | 13 (100) | 11 (84.6) | 12 (100) | 9 (75.0) |
| Pyrexia | 9 (69.2) | 3 (23.1) | 10 (83.3) | 4 (33.3) |
| Vomiting | 9 (69.2) | 0 | 9 (75.0) | 0 |
| Cough | 8 (61.5) | 0 | 7 (58.3) | 0 |
| Dry skin | 6 (42.6) | 0 | 6 (50.0) | 0 |
| Upper respiratory tract infection | 6 (46.2) | 0 | 6 (50.0) | 1 (8.3) |
| Headache | 5 (38.5) | 0 | 2 (16.7) | 0 |
| Hypophosphatemia | 5 (38.5) | 0 | 3 (25.0) | 0 |
| Blood creatinine increased | 5 (38.5) | 0 | 3 (25.0) | 0 |
| Constipation | 5 (38.5) | 0 | 2 (16.7) | 0 |
| WBC count decreased | 5 (38.5) | 0 | 1 (8.3) | 0 |
| Nausea | 4 (30.8) | 1 (7.7) | 3 (25.0) | 0 |
| Conjunctivitis | 4 (30.8) | 1 (7.7) | 2 (16.7) | 0 |
| Rash | 4 (30.8) | 0 | 2 (16.7) | 0 |
| Diarrhea | 4 (30.8) | 0 | 6 (50.0) | 0 |
| Melanocytic naevus | 4 (30.8) | 0 | 0 | 0 |
| Anemia | 4 (30.8) | 0 | 2 (16.7) | 1 (8.3) |
| Rhinitis | 4 (30.8) | 0 | 0 | 0 |
| Rhinorrhea | 4 (30.8) | 0 | 1 (8.3) | 0 |
| Nasal congestion | 4 (30.8) | 0 | 4 (33.3) | 0 |
| Arthropod bite | 4 (30.8) | 0 | 0 | 0 |
| Maculopapular rash | 2 (15.4) | 0 | 6 (50.0) | 0 |
| Abdominal pain | 2 (15.4) | 0 | 5 (41.7) | 0 |
| Neutrophil count decreased | 2 (15.4) | 1 (7.7) | 5 (41.7) | 3 (25.0) |
| AST increased | 3 (23.1) | 0 | 4 (33.3) | 1 (8.3) |
| Fatigue | 3 (23.1) | 0 | 4 (33.3) | 0 |
| Pain in extremities | 3 (23.1) | 0 | 4 (33.3) | 0 |
| Category . | CDRB436A2102 (dabrafenib monotherapy) (n = 13) . | CTMT212X2101 (dabrafenib + trametinib) (n = 12) . | ||
|---|---|---|---|---|
| Any grade . | Grade ≥3 . | Any grade . | Grade ≥3 . | |
| Any AE, n (%) | 13 (100) | 11 (84.6) | 12 (100) | 9 (75.0) |
| Pyrexia | 9 (69.2) | 3 (23.1) | 10 (83.3) | 4 (33.3) |
| Vomiting | 9 (69.2) | 0 | 9 (75.0) | 0 |
| Cough | 8 (61.5) | 0 | 7 (58.3) | 0 |
| Dry skin | 6 (42.6) | 0 | 6 (50.0) | 0 |
| Upper respiratory tract infection | 6 (46.2) | 0 | 6 (50.0) | 1 (8.3) |
| Headache | 5 (38.5) | 0 | 2 (16.7) | 0 |
| Hypophosphatemia | 5 (38.5) | 0 | 3 (25.0) | 0 |
| Blood creatinine increased | 5 (38.5) | 0 | 3 (25.0) | 0 |
| Constipation | 5 (38.5) | 0 | 2 (16.7) | 0 |
| WBC count decreased | 5 (38.5) | 0 | 1 (8.3) | 0 |
| Nausea | 4 (30.8) | 1 (7.7) | 3 (25.0) | 0 |
| Conjunctivitis | 4 (30.8) | 1 (7.7) | 2 (16.7) | 0 |
| Rash | 4 (30.8) | 0 | 2 (16.7) | 0 |
| Diarrhea | 4 (30.8) | 0 | 6 (50.0) | 0 |
| Melanocytic naevus | 4 (30.8) | 0 | 0 | 0 |
| Anemia | 4 (30.8) | 0 | 2 (16.7) | 1 (8.3) |
| Rhinitis | 4 (30.8) | 0 | 0 | 0 |
| Rhinorrhea | 4 (30.8) | 0 | 1 (8.3) | 0 |
| Nasal congestion | 4 (30.8) | 0 | 4 (33.3) | 0 |
| Arthropod bite | 4 (30.8) | 0 | 0 | 0 |
| Maculopapular rash | 2 (15.4) | 0 | 6 (50.0) | 0 |
| Abdominal pain | 2 (15.4) | 0 | 5 (41.7) | 0 |
| Neutrophil count decreased | 2 (15.4) | 1 (7.7) | 5 (41.7) | 3 (25.0) |
| AST increased | 3 (23.1) | 0 | 4 (33.3) | 1 (8.3) |
| Fatigue | 3 (23.1) | 0 | 4 (33.3) | 0 |
| Pain in extremities | 3 (23.1) | 0 | 4 (33.3) | 0 |
AST, aspartate aminotransferase; WBC, white blood cell.