Table 2. Adverse Events in 618 Patients*.
| Adverse Event | Vemurafenib (N = 336)† |
Dacarbazine (N = 282) |
|---|---|---|
| no. of patients (%) | ||
| Arthralgia | ||
| Grade 2 | 60 (18) | 1 (<1) |
| Grade 3 | 11 (3) | 2 (<1) |
| Rash | ||
| Grade 2 | 33 (10) | 0 |
| Grade 3 | 28 (8) | 0 |
| Fatigue | ||
| Grade 2 | 38 (11) | 33 (12) |
| Grade 3 | 6 (2) | 5 (2) |
| Cutaneous squamous-cell carcinoma‡ | ||
| Grade 3 | 40 (12) | 1 (<1) |
| Keratoacanthoma§ | ||
| Grade 2 | 7 (2) | 0 |
| Grade 3 | 20 (6) | 0 |
| Nausea | ||
| Grade 2 | 25 (7) | 32 (11) |
| Grade 3 | 4 (1) | 5 (2) |
| Alopecia | ||
| Grade 2 | 26 (8)¶ | 0 |
| Pruritus | ||
| Grade 2 | 19 (6) | 0 |
| Grade 3 | 5 (1) | 0 |
| Hyperkeratosis | ||
| Grade 2 | 17 (5) | 0 |
| Grade 3 | 4 (1) | 0 |
| Diarrhea | ||
| Grade 2 | 16 (5) | 4 (1) |
| Grade 3 | 2 (<1) | 1 (<1) |
| Headache | ||
| Grade 2 | 15 (4) | 5 (2) |
| Grade 3 | 2 (<1) | 0 |
| Vomiting | ||
| Grade 2 | 9 (3) | 14 (5) |
| Grade 3 | 4 (1) | 3 (1) |
| Neutropenia | ||
| Grade 2 | 1 (<1) | 4 (1) |
| Grade 3 | 0 | 15 (5) |
| Grade 4 | 1 (<1) | 8 (3) |
| Grade 5 | 0 | 1 (<1) |
Listed are all adverse events of grade 2 or higher that were reported in more than 5% of patients in either study group.
One patient in the dacarbazine group who was treated with vemurafenib in error was included in the vemurafenib group for the assessment of adverse events.
The criteria for the diagnosis of cutaneous squamous-cell carcinoma were defined in the protocol and were reported as grade 3, according to the National Cancer Institute Common Terminology Criteria for Adverse Events. These events were evaluated by the investigators as grade 1 in one patient and as grade 2 in one patient.
Three patients with keratoacanthomas that were assessed by the investigator as grade 1 are included among the grade 2 keratoacanthomas.
In one patient, alopecia that was scored as grade 3 by the investigator was re-scored as grade 2 since the Common Terminology Criteria for Adverse Events do not include grade 3 alopecia.