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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