Table 1 Incidence of treatment-related TEAE that occurred in more than 1 patient.
Preferred Term, n (%) N | Cohort 1 20 mg/m2 | Cohort 2 30 mg/m2 | Cohort 3 45 mg/m2 | Cohort 4 60 mg/m2 | Overall |
|---|---|---|---|---|---|
(n = 8) | (n = 3) | (n = 4) | (n = 10) | (n = 25) | |
Patients with at least 1 event | 6 (75.0) | 3 (100.0) | 4 (100.0) | 10 (100.0) | 23 (92.0) |
Infusion-related reactions | 4 (50.0) | 3 (100.0) | 3 (75.0) | 6 (60.0) | 16 (64.0) |
Fatigue | 1 (12.5) | 2 (66.7) | 1 (25.0) | 4 (40.0) | 8 (32.0) |
Diarrhea | – | 1 (33.3) | 1 (25.0) | 2 (20.0) | 4 (16.0) |
Dysgeusia | 1 (12.5) | 0 | 1 (25.0) | 1 (10.0) | 3 (12.0) |
Anemia | – | – | – | 2 (20.0) | 2 (8.0) |
Hyperglycemia | – | 1 (33.3) | – | 1 (10.0) | 2 (8.0) |
Flushing | 1 (12.5) | 0 | 0 | 1 (10.0) | 2 (8.0) |
Erythema | 0 | 0 | 1 (25.0) | 1 (10.0) | 2 (8.0) |
