Table 2 Patient incidence* of treatment-emergent adverse events (TEAEs).
TEAE, n (%) | Day 1 and day 8 dosing | Day 1 dosing | Total (N = 39) | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
Cohort 1 1.0 mg/m2 (N = 3) | Cohort 2 2.0 mg/m2 (N = 3) | Cohort 3 4.0 mg/m2 (N = 3) | Cohort 4 6.0 mg/m2 (N = 3) | Cohort 5 8.0 mg/m2 (N = 3) | Cohort 6 12.0 mg/m2 (N = 6) | Cohort 7 8.0 mg/m2 (N = 3) | Cohort 8 10.0 mg/m2 (N = 3) | Cohort 9 12.0 mg/m2 (N = 6) | Cohort 10 14.0 mg/m2 (N = 6) | ||
Patients reporting any TEAE | 3 (100.0) | 1 (33.3) | 3 (100.0) | 2 (66.7) | 3 (100.0) | 6 (100.0) | 3 (100.0) | 3 (100.0) | 6 (100.0) | 6 (100.0) | 36 (92.3) |
Patients reporting any grade ≥3 TEAE | 0 | 0 | 1 (33.3) | 1 (33.3) | 1 (33.3) | 6 (100.0) | 2 (66.7) | 2 (66.7) | 2 (33.3) | 4 (66.7) | 19 (48.7) |
TEAEs in > 10% of patients | |||||||||||
Anemia | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 (33.3) | 25 (64.1) |
Thrombocytopenia | 0 | 0 | 0 | 0 | 2 (66.7) | 6 (100.0) | 1 (33.3) | 1 (33.3) | 4 (66.7) | 5 (83.3) | 19 (48.7) |
Lymphocytopenia | 0 | 0 | 0 | 0 | 2 (66.7) | 6 (100.0) | 1 (33.3) | 1 (33.3) | 0 | 2 (33.3) | 7 (17.9) |
Leukopenia | 0 | 0 | 0 | 1 (33.3) | 0 | 2 (33.3) | 0 | 0 | 3 (50.0) | 3 (50.0) | 7 (17.9) |
Neutropenia | 0 | 0 | 1(33.3) | 0 | 0 | 1 (16.7) | 0 | 0 | 2 (33.3) | 2 (33.3) | 6 (15.4) |
Nausea | 1 (33.3) | 0 | 1 (33.3) | 1 (33.3) | 0 | 0 | 1 (33.3) | 2 (66.7) | 2 (33.3) | 2 (33.3) | 10 (25.6) |
Diarrhea | 0 | 0 | 0 | 0 | 0 | 2 (33.3) | 0 | 0 | 2 (33.3) | 1 (16.7) | 5 (12.8) |
Vomiting | 0 | 0 | 1 (33.3) | 0 | 0 | 3 (50.0) | 0 | 0 | 0 | 1 (16.7) | 5 (12.8) |
Fatigue | 1 (33.3) | 0 | 0 | 1 (33.3) | 1 (33.3) | 1 (16.7) | 0 | 2 (66.7) | 2 (33.3) | 0 | 8 (20.5) |
Decreased appetite | 0 | 0 | 0 | 0 | 0 | 3 (50.0) | 0 | 0 | 0 | 1 (16.7) | 4 (10.3) |
Dyspnea | 0 | 0 | 0 | 0 | 0 | 1 (16.7) | 0 | 1 (33.3) | 0 | 2 (33.3) | 4 (10.3) |
