TABLE 3.
Safety and tolerability
| Category | Treatment arm (n [%]) |
P value | |||
|---|---|---|---|---|---|
| All | 450 mg (10 mg/kg; n = 20) | 900 mg (20 mg/kg; n = 20) | 1,350 mg (30 mg/kg; n = 20) | ||
| All AEa | |||||
| Grade I–II AE | 51 (85) | 17 (85) | 16 (80) | 18 (90) | 0.676 |
| Grade III–IV AE | 15 (25) | 3 (15) | 8 (40) | 4 (20) | 0.503 |
| Specific adverse effects | |||||
| Purpura | |||||
| Grade I–II | 1 (1.7) | 0 | 0 | 1 (5) | 0.608 |
| Thrombocytopenia | |||||
| Grade I–II | 8 (13.3) | 2 (10) | 4 (20) | 2 (10) | 0.686 |
| Leukopenia | |||||
| Grade I–II | 3 (5) | 0 | 1 (5) | 2 (10) | 0.593 |
| Anemia | |||||
| Grade I–II | 20 (33.3) | 11 (55) | 6 (30) | 3 (15) | 0.107 |
| Grade III | 1 (1.7) | 0 | 1 (5) | 0 | |
| Hepatotoxicity | |||||
| Grade I–II | 26 (43) | 9 (45) | 7 (35) | 10 (50) | 0.824 |
| Grade III–IV | 12 (20) | 3 (15) | 5 (25) | 4 (20) | |
| Nausea | |||||
| Grade I–II | 27 (45) | 9 (45) | 8 (40) | 10 (50) | 0.444 |
| Vomitus | |||||
| Grade I–II | 21 (35) | 8 (40) | 6 (30) | 7 (35) | 0.359 |
| Abdominal discomfort | |||||
| Grade I–II | 15 (25) | 4(20) | 6 (30) | 5 (25) | 0.189 |
| Diarrhea | |||||
| Grade I–II | 8 (13.3) | 1 (5) | 3(15) | 4 (20) | 0.602 |
| Pruritus | |||||
| Grade I–II | 27 (43.3) | 9 (45) | 6 (30) | 12 (60) | 0.442 |
| Grade III | 1 (1.7) | 0 | 1 (5) | 0 | |
| Rash | |||||
| Grade I–II | 21 (35) | 5 (25) | 5 (25) | 11 (55) | 0.410 |
| Grade III | 1(1.7) | 0 | 1 (5) | 0 | |
a
AE, adverse events; classification was based on the U.S. National Institutes of Health CTCAE version 4.03.