Table 3:
Exposure-adjusted rates (per 100 patient-year) of thromboembolic events
Ruxolitinib rate (n=110)* |
Best available therapy rate (n=111)† |
Crossover rate (n=98)‡ |
|||||||
---|---|---|---|---|---|---|---|---|---|
All grades | Grade 1 or 2 | Grade 3 or 4 | All grades | Grade 1 or 2 | Grade 3 or 4 | All grades | Grade 1 or 2 | Grade 3 or 4 | |
All thromboembolic events | 5 (1·2) | 2 (0·5) | 3 (0·7) | 6 (8·2) | 4 (5·5) | 2 (2·7) | 9 (2·7) | 4 (1·2) | 5 (1·5) |
Cerebral infarction | 1 (0·2) | 0 | 1 (0·2) | 0 | 0 | 0 | 0 | 0 | 0 |
Ischaemic stroke | 1 (0·2) | 1 (0·2) | 0 | 0 | 0 | 0 | 1 (0·3) | 0 | 1 (0·3) |
Transient ischaemic attack | 0 | 0 | 0 | 0 | 0 | 0 | 2 (0·6) | 0 | 2 (0·6) |
Portal vein thrombosis | 1 (0·2) | 0 | 1 (0·2) | 0 | 0 | 0 | 0 | 0 | 0 |
Pulmonary embolism | 1 (0·2) | 0 | 1 (0·2) | 1 (1·4) | 0 | 1 (1·4) | 0 | 0 | 0 |
Retinal vascular thrombosis | 1 (0·2) | 1 (0·2) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Myocardial infarction | 0 | 0 | 0 | 0 | 0 | 0 | 2 (0·6) | 1 (0·3) | 1 (0·3) |
Acute myocardial infarction | 0 | 0 | 0 | 1 (1·4) | 0 | 1 (1·4) | 0 | 0 | 0 |
Deep vein thrombosis | 0 | 0 | 0 | 2 (2·7) | 1 (1·3) | 1 (1·4) | 1 (0·3) | 1 (0·3) | 0 |
Thrombophlebitis | 0 | 0 | 0 | 1 (1·4) | 1 (1·4) | 0 | 1 (0·3) | 1 (0·3) | 0 |
Thrombosis | 0 | 0 | 0 | 1 (1·4) | 1 (1·4) | 0 | 1 (0·3) | 1 (0·3) | 0 |
Bone infarction | 0 | 0 | 0 | 0 | 0 | 0 | 1 (0·3) | 1 (0·3) | 0 |
Coronary artery occlusion | 0 | 0 | 0 | 0 | 0 | 0 | 1 (0·3) | 1 (0·3) | 0 |
Disseminated intravascular coagulation | 0 | 0 | 0 | 0 | 0 | 0 | 1 (0·3) | 0 | 1 (0·3) |
Splenic infarction | 0 | 0 | 0 | 1 (1·4) | 1 (1·4) | 0 | 0 | 0 | 0 |
Data are n (rate). Adjusted rates were calculated as the number of patients with events per 100 patient-year of exposure. Events occurring at a rate of 0・2 per 100 patient-years of exposure in any group. MedDRA version 19.1 was used to code the events.
Exposure=428 4 patient-years.
Exposure=73 6 patient-years.
Exposure=329 9 patient-years.