On-therapy plus 1 day thromboembolic events (safety population)
| . | Eltrombopag (N = 302) . | |
|---|---|---|
| All AEs . | SAEs . | |
| Patients with thromboembolic AEs, n (%)* | 19 (6) | 16 (5) |
| Thromboembolic events, n (%) | 24 (8) | 18 (6) |
| Venous events | 10 (3) | 9 (3) |
| Arterial events† | 14 (5) | 9 (3) |
| Individual events, n (%) | ||
| Deep vein thrombosis‡ | 8 (3) | 6 (2) |
| Cerebral infarction | 4 (1) | 3 (1) |
| Acute myocardial infarction | 2 (<1) | 2 (<1) |
| Myocardial infarction§ | 3 (1) | 3 (1) |
| Transient ischemic attack† | 3 (1) | 0 |
| Cerebral ischemia | 1 (<1) | 1 (<1) |
| Pulmonary embolism | 1 (<1) | 1 (<1) |
| Pulmonary infarction | 1 (<1) | 1 (<1) |
| Thrombophlebitis superficial | 1 (<1) | 1 (<1) |
| . | Eltrombopag (N = 302) . | |
|---|---|---|
| All AEs . | SAEs . | |
| Patients with thromboembolic AEs, n (%)* | 19 (6) | 16 (5) |
| Thromboembolic events, n (%) | 24 (8) | 18 (6) |
| Venous events | 10 (3) | 9 (3) |
| Arterial events† | 14 (5) | 9 (3) |
| Individual events, n (%) | ||
| Deep vein thrombosis‡ | 8 (3) | 6 (2) |
| Cerebral infarction | 4 (1) | 3 (1) |
| Acute myocardial infarction | 2 (<1) | 2 (<1) |
| Myocardial infarction§ | 3 (1) | 3 (1) |
| Transient ischemic attack† | 3 (1) | 0 |
| Cerebral ischemia | 1 (<1) | 1 (<1) |
| Pulmonary embolism | 1 (<1) | 1 (<1) |
| Pulmonary infarction | 1 (<1) | 1 (<1) |
| Thrombophlebitis superficial | 1 (<1) | 1 (<1) |
Patients could have more than 1 event. Two patients had 2 events, and 2 other patients had 3 events, while on study. Two additional patients had 1 on-study event (a pulmonary embolism and a pulmonary infarction, respectively) and 1 off-study event (a deep vein thrombosis and a pulmonary infarction, respectively).
One patient had both a speech disorder and unsteadiness on the same day, and was later considered to have a transient ischemic attack.
One patient had 2 deep vein thromboses. Another patient was classified as having thrombosis and then later considered to have had a deep vein thrombosis.
One patient had 2 myocardial infarctions.