Table 2 Drug-related grade 3/4 skin, gastrointestinal, and hepatobiliary AEs during VEM1-IPI by investigator-reported preferred term
AE Organ Category, n (%)a | VEM1-IPI (n = 46) |
|---|---|
Skin | 15 (32.6) |
Rash | 9 (19.6) |
Erythema | 2 (4.3) |
Exfoliative rash | 2 (4.3) |
Pruritus | 2 (4.3) |
Rash generalized | 2 (4.3) |
Rash maculo-papular | 1 (2.2) |
Gastrointestinal disorders | 10 (21.7) |
Diarrhea | 5 (10.9) |
Colitis | 2 (4.3) |
Nausea | 2 (4.3) |
Abdominal pain | 1 (2.2) |
Autoimmune colitis | 1 (2.2) |
Vomiting | 1 (2.2) |
Hepatobiliary disorders | 2 (4.3) |
Hepatitis | 1 (2.2) |
Hyperbilirubinemia | 1 (2.2) |