Event, n (%)a | VEM1-IPI (n = 46) | ||
---|---|---|---|
Any Grade | Grade 3 | Grade 4 | |
Any drug-related AE | 43 (93.5) | 27 (58.7) | 3 (6.5) |
AEs occurring in ≥ 3 patientsb | |||
Rash | 28 (60.9) | 9 (19.6) | 0 (0) |
Diarrhea | 17 (37.0) | 5 (10.9) | 0 (0) |
AST increased | 9 (19.6) | 3 (6.5) | 1 (2.2) |
ALT increased | 8 (17.4) | 4 (8.7) | 0 (0) |
Squamous cell carcinomac | 3 (6.5) | 3 (6.5) | 0 (0) |
Any drug-related serious AEs | 18 (39.1) | 15 (32.6) | 2 (4.3) |
AEs leading to discontinuation of treatment | 16 (34.8) | 9 (19.6) | 1 (2.2) |
AE adverse event, ALT alanine aminotransferase, AST aspartate aminotransferase, IPI ipilimumab, VEM vemurafenib
aPatients may have experienced more than 1 event
bOnly toxicities that reached Grade 3/4 in severity in ≥ 3 patients are presented
cSquamous cell carcinoma was classified as a serious adverse event (SAE) and was the only SAE that was observed in 3 or more patients (n = 3, grade 3 events)