Table 1 Frequency of adverse events by MedDRA preferred term
Cobimetinib + vemurafenib (n = 247) | Placebo + vemurafenib (n = 246) | |
|---|---|---|
Total patients with serous retinopathy, n (%) | 63 (25.5) | 7 (2.8) |
Total events, n | 79 | 7 |
AE preferred term, n/N (%) | ||
Chorioretinopathy | 31/63 (49.2) | 1/7 (14.3) |
Retinal detachment | 21/63 (33.3) | 1/7 (14.3) |
Retinal pigment epithelium detachment | 8/63 (12.7) | 1/7 (14.3) |
Macular edema | 5/63 (7.9) | 1/7 (14.3) |
Macular fibrosis | 2/63 (3.2) | 1/7 (14.3) |
Retinal disorder | 1/63 (1.6) | 2/7 (28.6) |
Retinopathy | 2/63 (3.2) | 0 |
Macular retinal pigment epithelium detachment | 1/63 (1.6) | 0 |
NCI CTCAE grade, n/N (%)a | ||
Grade 1 | 33/63 (52.4) | 6/7 (85.7) |
Grade 2 | 23/63 (36.5) | 1/7 (14.3) |
Grade 3 | 6/63 (9.5) | 0 |
Grade 4 | 1/63 (1.6) | 0 |