Table 3.
VE-BASKET TRIAL (vemurafenib) | NCT01227889 (dabrafenib) | ROAR TRIAL (dabrafenib + trametinib) | COMBI-AD TRIAL (dabrafenib + trametinib) | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
ADVERSE EVENT | ALL GRADES | GRADE 3-4 | ADVERSE EVENT | ALL GRADES | GRADE 3-4 | ADVERSE EVENT | ALL GRADES | GRADE 3-4 | ADVERSE EVENT | ALL GRADES | GRADE 3-4 |
arthralgia | 67% | / | pyrexia | 8% | 3% | fatigue | 41% | 41% | pyrexia | 63% | 5% |
palmar-plantar erythrodysesthesia | 38% | / | arthralgia | 19% | 1% | headache | 38% | 38% | fatigue | 47% | 4% |
photosensitivity reaction | 38% | / | fatigue | 18% | 1% | nausea | 32% | 32% | nausea | 40% | 1% |
fatigue | 29% | 4% | squamous carcinoma keratoacanthoma |
12% | 4% | pyrexia | 31% | 31% | headache | 39% | 1% |
pruritus | 29% | palmar-plantar hyperkeratosis | 16% | 2% | neutropenia | 10% | 10% | chills | 37% | 1% | |
rash maculopapular | 29% | 13% | hyperkeratosis | 12% | <1% | anaemia | 22% | 22% | diarrhea | 33% | 1% |
folliculitis | 25% | / | keratoacanthoma | 12% | 4% | AST/ALT elevation | 17% | 17% | vomiting | 28% | 1% |
hyperkeratosis | 25% | / | headache | 5% | / | chills | 14% | 14% | arthralgia | 28% | 1% |
keratosis pilaris | 25% | / | nausea | 1% | 1% | / | 12% | 12% | rash | 24% | / |
headache | 25% | / | vomiting | 1% | / | ejection fraction decrease | 10% | 10% | cough | 17% | / |
diarrhoea | 21% | / | neutropenia | 1% | 1% | dermatitis acneiform | 10% | 10% | hypertension | 11% | 6% |
nausea | 21% | / | diarrhoea | / | / | hypertension | 3% | 3% | elevated ATS/ALT | 15% | 4% |
decreased appetite | 21% | / | cardiac | / | / | diarrhoea | 14% | 14% | dermatitis acneiform | 12% | / |