Table 6.
Management of Cardiovascular Treatment-Emergent AEsa
| Parameter | Bosutinib (n = 26) | Imatinib (n = 21) |
|---|---|---|
| Median (range) time to first event, d | 166 (1–1023) | 85 (10–1097) |
| Median (range) duration of an event,b d | 14 (1–750) | 29 (1–474) |
| Cumulative median (range) duration of an episode,c d | 15.5 (1–750) | 29 (1–656) |
| Outcome among patients with cardiovascular TEAEs, n (%) | ||
| Death | 1 (4)d | 0 |
| Persisted | 10 (39) | 6 (29) |
| Resolved | 15 (58) | 15 (71) |
| Cardiovascular TEAE management, n (%) | ||
| Dose reduction | 4 (15) | 0 |
| Dose interruption | 8 (31) | 4 (19) |
| No rechallenge | 1 (13) | 0 |
| Rechallenged | 7 (88) | 4 (100) |
| Successful rechallengee | 5 (71) | 4 (100) |
| Discontinued treatment because of cardiovascular TEAE | 4/248 (2) | 0 |
TEAE, treatment-emergent adverse event.
Cardiovascular TEAEs included Medical Dictionary for Regulatory Activities System Organ Class terms of cardiac disorders or High-Level Group Term (HLGT), which included cardiac and vascular investigations (excluding enzyme tests).
Event defined based on start to stop of cardiovascular TEAE with no grade change; any change in grade represents a new event.
Episode defined based on start to stop of cardiovascular TEAE with resolution across grades.
This patient was a 93-year-old woman who died from congestive heart failure 957 days after treatment initiation. The event was considered unrelated to bosutinib treatment or to a clinical trial procedure by the investigator. The patient had a history of pulmonary edema and hypothyroidism, which in combination with the patient's advanced age, may have contributed to the congestive heart failure event.
Successful rechallenge includes patients who did not experience cardiovascular AEs (bosutinib, n = 1; imatinib, n = 2) or experienced subsequent cardiovascular AEs that did not lead to treatment discontinuation (bosutinib, n = 4; imatinib, n = 2).