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Table 3 Treatment-emergent AEs with maximum CTC grade by dose level (incidence ≥ 20%)

From: A phase I dose-escalation study of PEP02 (irinotecan liposome injection) in combination with 5-fluorouracil and leucovorin in advanced solid tumors

  Total (N = 16) 60 mg/m2
N = 3
80 mg/m2
N = 6
100 mg/m2
N = 5
120 mg/m2
N = 2
AE All grade Grade 3–4
Anemia 7 (43.8%) 0 0 2 (40%) 0
Leukopenia 6 (37.5%) 0 0 2 (40%) 1 (50%)
Neutropenia 6 (37.5%) 1 (33.3%) 1 (16.7%) 2 (40%) 1 (50%)
Abdominal pain 7 (43.8%) 0 0 1 (20%) 1 (50%)
Diarrhea 12 (75.0%) 0 1 (16.7%) 2 (40%) 2 (100%)
Nausea 13 (81.3%) 0 1 (16.7%) 0 0
Vomiting 12 (75.0%) 0 1 (16.7%) 0 0
Fatigue 8 (50.0%) 0 0 1 (20%) 0
Infection 6 (37.5%) 0 0 2 (40%) 1 (50%)
Anorexia 4 (25.0%) 0 0 1 (20%) 0
Hypoalbuminemia 4 (25.0%) 0 1 (16.7%) 0 0
Hypokalemia 8 (50.0%) 1 (33.3%) 2 (33.3%) 2 (40%) 1 (50%)
Hyponatremia 4 (25.0%) 0 0 1 (20%) 1 (50%)
Cough 5 (31.3%) 1 (33.3%) 0 0 0
  1. Abbreviation: AE adverse event