Table 3.
| Diarrhea | ALT/AST Elevation | Myelosuppressiona | |
|---|---|---|---|
| (n = 344) | (n = 89) | (n = 216) | |
| Median (range) time to first event, days | |||
| CP 2L | 2 (1–1330) | 35 (3–1400) | 29 (1–1767) |
| CP 3L | 2 (1–210) | 81 (8–492) | 26 (1–1202) |
| Median (range) duration of an event,b days | |||
| CP 2L | 1 (1–1510) | 26 (1–1714) | 15 (1–1373) |
| CP 3L | 2 (1–413) | 15 (4–236) | 15 (1–769) |
| Event management, n (%) | |||
| Received dose reduction | 23 (7) | 17 (19) | 78 (36) |
| Received dose interruption | 58 (17) | 32 (36) | 106 (49) |
| Received concurrent medication | 231 (67) | 12 (13)c | 39 (18)d |
| Permanent treatment discontinuation due to evente | 6/405 (1)f | 9/405 (2)f | 33/405 (8) |
Myelosuppression events include anemia, hemoglobin decreased, neutropenia, neutrophil count decreased, thrombocytopenia, and platelet count decreased (includes unpublished results).
Defined as from start to stop of event with no grade change; any change in grade represents a new event.
Concurrent medications used for management of ALT and/or AST elevations included essential phospholipids, ursodiol, steroids, S-adenosylmethionine, milk thistle extract, and glycyrrhizic acid. Patients may have received ≥1 medication.
Two patients received transfusion(s) and 33 patients received growth factor(s).
Patients could report multiple TEAEs as reasons for discontinuation of treatment.
Includes patients with no rechallenge or unsuccessful rechallenge following dose interruption, as well as those who discontinued treatment because of an event without dose interruption.