Summary of study deaths
| Event (n = 118) . | n (%) . |
|---|---|
| Overall deaths | 22 (19) |
| Death within 30 days of last study dose | 6 (5) |
| Reason for death | |
| Disease progression | 10 (8) |
| AE unrelated to study drug* | 8 (7) |
| AE related to study drug† | 1 (1) |
| Other/unknown‡ | 3 (3) |
| Event (n = 118) . | n (%) . |
|---|---|
| Overall deaths | 22 (19) |
| Death within 30 days of last study dose | 6 (5) |
| Reason for death | |
| Disease progression | 10 (8) |
| AE unrelated to study drug* | 8 (7) |
| AE related to study drug† | 1 (1) |
| Other/unknown‡ | 3 (3) |
Causes of death (days since last dose of bosutinib) included: intracranial hemorrhage (174 days), internal hemorrhage (199 days), internal bleeding secondary to infarcted kidney (348 days), myocardial infarction (1 day), suspected acute myocardial infarction (13 days), respiratory insufficiency (278 days), respiratory failure (112 days), and pulmonary edema secondary to CML (371 days).
Gastrointestinal bleeding that occurred while on study treatment; the patient had a history of gastritis and grade 3 thrombocytopenia, both of which were ongoing at the time of study entry.
Causes of death (days since last dose of bosutinib) included: complications from grade 4 GVHD after cord blood transplant (581 days) and causes that remain unknown (n = 2; 509 and 618 days).