Table 5.
Management of Myelosuppression Treatment-Emergent AEsa (in Patients With ≥1 AE of Myelosuppression)
| Parameter | Bosutinib (n = 118) | Imatinib (n = 136) |
|---|---|---|
| Median (range) time to first event, d | 29 (8–924) | 32 (1–1009) |
| Median (range) duration of an event,b d | ||
| Any grade | 26 (1–1212) | 27 (1–532) |
| From Grade 3/4 to Grade 0/1 | 22 (2–914) | 16 (2–311) |
| Cumulative median (range) duration of an episode,c d | ||
| Any grade | 56.5 (1–1246) | 85.5 (2–817) |
| Grade 3/4 | 22 (1–913) | 25 (5–199) |
| Myelosuppression management, n (%) | ||
| Received dose reduction | 17 (14) | 24 (18) |
| Received dose interruption | 42 (36) | 64 (47) |
| Discontinued treatment because of myelosuppression | 9/248 (4) | 10/251 (4) |
AE, adverse event.
a
Myelosuppression AEs included Medical Dictionary for Regulatory Activities preferred terms of anemia, hemoglobin decreased, thrombocytopenia, platelets decreased, neutropenia, and neutrophil count decreased.
b
Event defined based on start to stop of myelosuppression with no grade change; any change in grade represents a new event.
b
Episode defined based on start to stop of myelosuppression with resolution across grades.