Table 3.
Common grade 3 or higher adverse events
| Etirinotecan pegol | TPC | |||
|---|---|---|---|---|
| BMH (n = 34) | ITT (n = 425) | BMH (n = 27) | ITT (n = 406) | |
| Number of patients with at least one AE grade 3 or higher | 17 (50.0%) | 204 (48.0%) | 19 (70.4%) | 256 (63.1%) |
| Hematologic | ||||
| Neutropenia-related events | 5 (14.7%) | 41 (9.6%) | 9 (33.3%) | 125 (30.8%)b |
| Anemia | 1 (2.9%)a | 20 (4.7%)a | 1 (3.7%) | 19 (4.7%) |
| Non-hematologic | ||||
| Diarrhea | 2 (5.9%)a | 41 (9.6%)a | 1 (3.7%)a | 5 (1.2%)a |
| Nausea | 2 (5.9%)a | 15 (3.5%)a | 0 | 8 (2.0%)a |
| Pleural effusion | 2 (5.9%) | 15 (3.5%) | 0 | 16 (3.9%) |
| Dehydration | 1 (2.9%)a | 17 (3.5%)a | 1 (3.7%)b | 8 (2.0%)b |
| Hypokalemia | 1 (2.9%) | 10 (2.4%) | 1 (3.7%) | 7 (2.0%) |
| Hyponatremia | 0 | 3 (<1%)a | 2 (7.4%) | 8 (2.0%) |
| Neuropathy-related events | 0 | 2 (<1%) | 0 | 15 (3.7%)a |
AE adverse event, BMH history of treated, stable breast cancer brain metastases, ITT intention-to-treat, TPC treatment of physician’s choice
aNo grade 4 reported
bGrade 5 event(s) reported