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Table 3 Drug related adverse effects seen in phase 1 trials of liposomal irinotecan.

From: Cancer nanomedicine: a review of recent success in drug delivery

  60 mg/m2
N = 1
120 mg/m2
N = 6
180 mg/m2
N = 4
All grade G 3/4 All grade G 3/4 All grade G 3/4
N (%) N (%) N (%) N (%) N (%) N (%)
A
 Diarrhoea 1 (100) 0 (0) 6 (100) 2 (33.3) 4 (100) 1 (25)
 Vomiting 1 (100) 0 (0) 5 (83.3) 4 (66.7) 2 (50) 2 (50)
 Nausea 1 (100) 0 (0) 4 (66.7) 2 (33.3) 2 (50) 1 (25)
 Alopecia 0 (0) NA 3 (50) NA 3 (75) NA
 Fatigue 1 (100) 0 (0) 3 (50) 1 (16.7) 1 (25) 0 (0)
 Leukopenia 0 (0) 0 (0) 2 (33.3) 1 (16.7) 2 (50) 2 (50)
 Neutropenia 0 (0) 0 (0) 2 (33.3) 1 (16.7) 2 (50) 2 (50)
 Weight decreased 1 (100) 0 (0) 2 (33.3) 0 (0) 1 (25) 0 (0)
 Dizziness 0 (0) 0 (0) 2 (33.3) 0 (0) 0 (0) 0 (0)
 Anaemia 0 (0) 0 (0) 1 (16.7) 0 (0) 1 (25) 0 (0)
 Anorexia 0 (0) 0 (0) 1 (16.7) 0 (0) 1 (25) 0 (0)
 Electrolyte imbalance 0 (0) 0 (0) 1 (16.7) 0 (0) 1 (25) 0 (0)
AE Total (N = 16) 60 mg/m2
N = 3
80 mg/m2
N = 6
100 mg/m2
N = 5
120 mg/m2
N = 2
All grade Grade 3–4
B
 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 path 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. A shows the adverse effects seen in Chang et al.’s study, while B shows the adverse effects seen in Chiang et al.’s study
  2. AE adverse event