Table 2

Treatment-related adverse events occurring in ≥5% of patients or of grade 3–4 severity

N=30
Any gradeGrade 3–4
Any treatment-related adverse event19 (63)11 (37)
 Rash5 (17)4 (13)
 Fever4 (13)0
 Maculopapular rash4 (13)0
 Lipase increased3 (10)3 (10)
 Anemia2 (7)1 (3)
 Fatigue2 (7)0
 Hypothyroidism2 (7)0
 Alanine aminotransferase increased2 (7)1 (3)
 Amylase increased2 (7)2 (7)
 Aspartate aminotransferase increased2 (7)1 (3)
 Blood alkaline phosphatase increased2 (7)0
 Gamma-glutamyltransferase increased2 (7)2 (7)
 Infusion-related reaction2 (7)0
 Eczema1 (3)1 (3)
 Lichenoid dermatitis1 (3)1 (3)
 Lip squamous cell carcinoma1 (3)1 (3)
 Seborrheic keratosis1 (3)1 (3)
Skin lesions*2 (7)0
 Keratoacanthoma2 (7)0
  • Data are n (%).

  • *Include MedDRA V.21.0 preferred terms squamous cell carcinoma of the skin, basal cell carcinoma, keratoacanthoma, hyperkeratosis, and actinic keratosis.