Skip to main content

Table 1 Frequency of adverse events by MedDRA preferred term

From: Clinical features of serous retinopathy observed with cobimetinib in patients with BRAF-mutated melanoma treated in the randomized coBRIM study

  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
  1. MedDRA Medical Dictionary for Regulatory Activities, AE adverse event, NCI CTCAE National Cancer Institute Common Terminology Criteria for Adverse Events
  2. aHighest severity grade per patient