Table 3.
Most common AEs occurring in ≥20% of patients in either arm, regardless of attribution to study drug
| AEs, n (%) | Dacarbazine (n=287) | Vemurafenib (n=336) |
|---|---|---|
| ≥1 AE | 266 (93) | 334 (99) |
| Most common AEs | ||
| Rash (combined terms)a | 16 (6) | 239 (71) |
| Arthralgia | 11 (4) | 189 (56) |
| Alopecia | 7 (2) | 162 (48) |
| Fatigue | 101 (35) | 159 (47) |
| Photosensitivity reaction | 13 (5) | 136 (40) |
| Nausea | 128 (45) | 132 (39) |
| Diarrhoea | 36 (13) | 124 (37) |
| Headache | 29 (10) | 114 (34) |
| Hyperkeratosis | 1 (<1) | 99 (29) |
| Skin papilloma | 1 (<1) | 97 (29) |
| Pruritus | 5 (2) | 86 (26) |
| Dry skin | 2 (<1) | 80 (24) |
| Decreased appetite | 24 (8) | 76 (23) |
| Pain in extremity | 19 (7) | 76 (23) |
| Pyrexia | 28 (10) | 75 (22) |
| Vomiting | 77 (27) | 74 (22) |
| Squamous cell carcinoma of the skin | 2 (<1) | 66 (20) |
| Constipation | 72 (25) | 53 (16) |
a
Preferred terms (in decreasing order of incidence) include: rash, erythema, rash maculo-papular, folliculitis, rash papular, dermatitis, rash erythematous, rash generalized, rash macular, rash pustular, dermatitis allergic, rash follicular, rash pruritic, dermatitis exfoliative, dermatitis bullous, drug eruption, exfoliative rash, generalized erythema, rash vesicular and toxic skin eruption.
AEs, adverse events.