Table 3

TRAEs of any grade occurring in ≥10% of patients

Treatment-related AEs* n (%)Total N=58
Any grade, %Grade 3, %Grade 4, %
Any adverse event58 (100)37 (63.8)8 (13.8)
Treatment-related SAEs10 (17.2)6 (10.3)3 (5.2)
TRAEs leading to discontinuation9 (15.5)4 (6.9)2 (3.4)
TRAEs leading to dose delay20 (34.5)15 (25.9)2 (3.4)
TRAEs leading to dose reduction of irinotecan23 (39.7)16 (27.6)4 (6.9)
TRAEs (≥10%)
Hematologic
 Leukopenia47 (81.0)18 (31.0)2 (3.4)
 Neutropenia45 (77.6)17 (29.3)7 (12.1)
 Anemia28 (48.3)10 (17.2)0
 Decreased lymphocyte count14 (24.1)2 (3.4)0
 Thrombocytopenia9 (15.5)1 (1.7)0
Non-hematologic
 Nausea38 (65.5)4 (6.9)0
 Vomit35 (60.3)4 (6.9)0
 Decreased appetite31 (53.4)5 (8.6)0
 Fatigue29 (50.0)3 (5.2)0
 Diarrhea26 (44.8)01 (1.7)
 Weight loss13 (22.4)1 (1.7)0
 Proteinuria10 (17.2)00
 Hypothyroidism10 (17.2)00
 ALT increased9 (15.5)00
 AST increased9 (15.5)00
 Alopecia9 (15.5)00
 Hypoalbuminaemia8 (13.8)00
 Abdominal pain7 (12.1)1 (1.7)0
 DBIL increased7 (12.1)00
 Rash6 (10.3)00
  • *Attribution of AEs to study treatment was determined by the investigators. Grade 3 and grade 4 are overlapping.

  • AE, adverse event; ALT, alanine aminotransferase; AST, aspartate aminotransferase; DBIL, direct bilirubin; SAE, serious adverse event; TRAEs, treatment-related adverse events.