Table 4 SAEs (≥2 patients across all cohorts) regardless of study drug relationship
From: Dabrafenib plus trametinib in BRAFV600E-mutated rare cancers: the phase 2 ROAR trial
Preferred term | ATC (n = 36) | BTC (n = 43) | GIST (n = 1) | LGG (n = 13) | HGG (n = 45) | ASI (n = 3) | HCL (n = 55) | MM (n = 10) | Total (n = 206) |
|---|---|---|---|---|---|---|---|---|---|
Any event | 20 (55.6%) | 17 (39.5%) | 1 (100.0%) | 3 (23.1%) | 16 (35.6%) | 0 | 32 (58.2%) | 4 (40.0%) | 93 (45.1%) |
Pyrexia | 1 (2.8%) | 9 (20.9%) | 0 | 1 (7.7%) | 1 (2.2%) | 0 | 10 (18.2%) | 1 (10.0%) | 23 (11.2%) |
Pneumonia | 8 (22.2%) | 1 (2.3%) | 0 | 0 | 0 | 0 | 4 (7.3%) | 0 | 13 (6.3%) |
Urinary tract infection | 2 (5.6%) | 1 (2.3%) | 0 | 1 (7.7%) | 1 (2.2%) | 0 | 2 (3.6%) | 1 (10.0%) | 8 (3.9%) |
Vomiting | 0 | 1 (2.3%) | 0 | 1 (7.7%) | 3 (6.7%) | 0 | 2 (3.6%) | 0 | 7 (3.4%) |
Sepsis | 1 (2.8%) | 3 (7.0%) | 0 | 0 | 0 | 0 | 1 (1.8%) | 0 | 5 (2.4%) |
Basal cell carcinoma | 0 | 0 | 0 | 0 | 0 | 0 | 4 (7.3%) | 0 | 4 (1.9%) |
Chills | 0 | 0 | 0 | 0 | 0 | 0 | 4 (7.3%) | 0 | 4 (1.9%) |
Seizure | 0 | 0 | 0 | 0 | 4 (8.9%) | 0 | 0 | 0 | 4 (1.9%) |
Squamous cell carcinoma | 0 | 0 | 0 | 0 | 0 | 0 | 4 (7.3%) | 0 | 4 (1.9%) |
Squamous cell carcinoma of the skin | 0 | 0 | 0 | 0 | 0 | 0 | 4 (7.3%) | 0 | 4 (1.9%) |
Nausea | 0 | 0 | 0 | 0 | 3 (6.7%) | 0 | 0 | 1 (10.0%) | 4 (1.9%) |
Acute kidney injury | 2 (5.6%) | 1 (2.3%) | 0 | 0 | 0 | 0 | 0 | 0 | 3 (1.5%) |
Cholangitis | 0 | 3 (7.0%) | 0 | 0 | 0 | 0 | 0 | 0 | 3 (1.5%) |
Dehydration | 1 (2.8%) | 1 (2.3%) | 0 | 0 | 0 | 0 | 1 (1.8%) | 0 | 3 (1.5%) |
Fatigue | 1 (2.8%) | 0 | 0 | 0 | 0 | 0 | 1 (1.8%) | 1 (10.0%) | 3 (1.5%) |
Decreased neutrophil count | 2 (5.6%) | 0 | 0 | 0 | 0 | 0 | 1 (1.8%) | 0 | 3 (1.5%) |
Pleural effusion | 3 (8.3%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 (1.5%) |
Pulmonary embolism | 1 (2.8%) | 0 | 0 | 0 | 1 (2.2%) | 0 | 1 (1.8%) | 0 | 3 (1.5%) |
Vertigo | 0 | 0 | 0 | 0 | 1 (2.2%) | 0 | 2 (3.6%) | 0 | 3 (1.5%) |
Anemia | 1 (2.8%) | 0 | 0 | 1 (7.7%) | 0 | 0 | 0 | 0 | 2 (1.0%) |
Atrial fibrillation | 0 | 1 (2.3%) | 0 | 0 | 0 | 0 | 1 (1.8%) | 0 | 2 (1.0%) |
Bladder neoplasm | 0 | 0 | 0 | 0 | 0 | 0 | 2 (3.6%) | 0 | 2 (1.0%) |
Cellulitis | 0 | 0 | 0 | 0 | 0 | 0 | 2 (3.6%) | 0 | 2 (1.0%) |
Diarrhea | 0 | 1 (2.3%) | 0 | 0 | 0 | 0 | 0 | 1 (10.0%) | 2 (1.0%) |
Dizziness | 1 (2.8%) | 0 | 0 | 0 | 1 (2.2%) | 0 | 0 | 0 | 2 (1.0%) |
Decreased ejection fraction | 1 (2.8%) | 0 | 0 | 0 | 1 (2.2%) | 0 | 0 | 0 | 2 (1.0%) |
Febrile neutropenia | 0 | 1 (2.3%) | 0 | 0 | 0 | 0 | 1 (1.8%) | 0 | 2 (1.0%) |
Femoral neck fracture | 1 (2.8%) | 1 (2.3%) | 0 | 0 | 0 | 0 | 0 | 0 | 2 (1.0%) |
Hematochezia | 2 (5.6%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 (1.0%) |
Hematuria | 1 (2.8%) | 0 | 0 | 0 | 0 | 0 | 1 (1.8%) | 0 | 2 (1.0%) |
Headache | 0 | 0 | 0 | 0 | 2 (4.4%) | 0 | 0 | 0 | 2 (1.0%) |
Hypotension | 1 (2.8%) | 0 | 0 | 0 | 0 | 0 | 1 (1.8%) | 0 | 2 (1.0%) |
Infection | 0 | 0 | 0 | 0 | 0 | 0 | 2 (3.6%) | 0 | 2 (1.0%) |
Leukopenia | 2 (5.6%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 (1.0%) |
Neutropenia | 1 (2.8%) | 0 | 0 | 0 | 1 (2.2%) | 0 | 0 | 0 | 2 (1.0%) |
Wound infection | 1 (2.8%) | 0 | 0 | 0 | 0 | 0 | 1 (1.8%) | 0 | 2 (1.0%) |
