Table 4.
Summary of selected adverse events in treated patients (safety population)
| Dacarbazine (n=287)
|
Vemurafenib (n=337)
|
|||||
|---|---|---|---|---|---|---|
| Grade 1–2 | Grade 3 | Grade 4 | Grade 1–2 | Grade 3 | Grade 4 | |
| Arthralgia | 8 (3%) | 3 (1%) | ·· | 169 (50%) | 20 (6%) | ·· |
|
| ||||||
| Rash | 6 (2%) | ·· | ·· | 108 (32%) | 30 (9%) | ·· |
|
| ||||||
| Fatigue | 94 (33%) | 6 (2%) | ·· | 146 (43%) | 10 (3%) | ·· |
|
| ||||||
| Photosensitivity | 13 (5%) | ·· | ·· | 124 (37%) | 13 (4%) | ·· |
|
| ||||||
| Increase in LFTs | 16 (6%) | 6 (2%) | ·· | 83 (25%) | 35 (10%) | 3 (1%) |
|
| ||||||
| Cutaneous squamous-cell carcinoma | ·· | 2 (<1%) | ·· | ·· | 65 (19%) | ·· |
|
| ||||||
| Keratoacanthoma | ·· | 2 (<1%) | ·· | 3 (<1%) | 34 (10%) | ·· |
|
| ||||||
| Skin papilloma | 1 (<1%) | ·· | ·· | 94 (28%) | 2 (<1%) | ·· |
|
| ||||||
| Nausea | 123 (43%) | 5 (2%) | ·· | 121 (36%) | 7 (2%) | ·· |
|
| ||||||
| Neutropenia | 8 (3%) | 17 (6%) | 9 (3%) | 1 (<1%) | ·· | 1 (<1%) |
|
| ||||||
| New primary melanoma | ·· | ·· | ·· | 2 (<1%) | 6 (2%) | ·· |
Data are number of patients (%). LFT=liver function test.