Table 3. . Toxicity profiles.
| Adverse event | BREAK 3 % (%G3/4), monotherapy (187 patients) | COMBI-D % (%G3/4), monotherapy (211 patients) | COMBI-D % (%G3/4), combination therapy (209 patients) | COMBI-V % (%G3/4), combination therapy (350 patients) | Vemurafenib % (%G3/4), monotherapy (3222 patients) |
|---|---|---|---|---|---|
| Pyrexia | 33 (5) | 28 (2) | 51 (6) | 53 (4) | 10 (<1) |
| Cutaneous: – Hyperkeratosis – Alopecia – SCC/KA – Phototoxicity – New primary melanomas |
41 29 10 3 1 |
32 26 9 NR 1 |
3 7 2 NR <1 |
4 6 1 4 1 |
19 (<1) 26 (<1) 12 30 (2) 1 |
| Arthralgias | 37 | 27 (0) | 24 (<1) | 24 (1) | 38 (3) |
| Fatigue | 5 | 35 (1) | 35 (2) | 29 | 32 (3) |
| Headache | 3 (1) | 29 (1) | 30 (<1) | 29 | 12 (<1) |
| Hypertension | NR | 14 (5) | 22 (4) | NR | 4 (2) |
| Decreased ejection fraction | NR | 2 (<1) | 4 (<1) | 8 (4) | NR |
| Noncutaneous malignancy | 2 | 3 (1) | 2 (<1) | 1 | 0.3 |
| Abnormal LFTs | NR | 3 (<1) | 11 (3) | NR | 11 (5) |
| Diarrhea | NR | 14 (1) | 24 (1) | 32 (1) | 15 (<1) |
| Nausea | 1 | 26 (1) | 30 (0) | 35 (<1) | 19 (1) |