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Table 3 Drug-related AEs during VEM1-IPI

From: Phase II study of vemurafenib followed by ipilimumab in patients with previously untreated BRAF-mutated metastatic melanoma

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)

  1. AE adverse event, ALT alanine aminotransferase, AST aspartate aminotransferase, IPI ipilimumab, VEM vemurafenib
  2. aPatients may have experienced more than 1 event
  3. bOnly toxicities that reached Grade 3/4 in severity in ≥ 3 patients are presented
  4. 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)