Thrombotic, hemorrhagic and transformation events after trial entry and in the year before diagnosis
| . | MPL mutant . | MPL− . | OR versus V617F+ (95% CI) . | OR versus V617F− (95% CI) . | P* (vs V617F+) . | P* (vs V617F−) . | |
|---|---|---|---|---|---|---|---|
| V617F+ . | V617F− . | ||||||
| Number | 32 | 411 | 333 | ||||
| Arterial thrombosis | |||||||
| In year before diagnosis† | 4 | 38 | 20 | 1.4 (0.5-4.2) | 2.2 (0.7-7.0) | .5 | .2 |
| Myocardial infarction | 0 | 6 | 5 | ||||
| Stroke | 1 | 10 | 4 | ||||
| Transient ischemic attack | 3 | 23 | 13 | ||||
| After trial entry† | 2 | 25 | 19 | 1.0 (0.2-4.3) | 1.1 (0.2-5.2) | .9 | .9 |
| Myocardial infarction | 1 | 7 | 6 | ||||
| Unstable angina | 0 | 5 | 1 | ||||
| Stroke | 1 | 7 | 7 | ||||
| Transient ischemic attack | 1 | 5 | 6 | ||||
| Other‡ | 0 | 2 | 1 | ||||
| Venous thromboembolism | |||||||
| In year before diagnosis† | 1 | 10 | 2 | 1.3 (0.2-10.4) | 5.3 (0.5-60.6) | .6 | .2 |
| Deep vein thrombosis | 0 | 3 | 1 | ||||
| Pulmonary embolism | 0 | 3 | 1 | ||||
| Splanchnic vein thrombosis | 0 | 2 | 0 | ||||
| Retinal vein thrombosis | 1 | 2 | 1 | ||||
| Cerebral sinus thrombosis | 0 | 1 | 0 | ||||
| After trial entry† | 2 | 11 | 3 | 2.6 (0.4-19.3) | 34.3 (1.6-725) | .3 | .02 (.09)§ |
| Deep vein thrombosis | 2 | 5 | 3 | ||||
| Pulmonary embolism | 0 | 5 | 0 | ||||
| Splanchnic vein thrombosis | 0 | 2 | 0 | ||||
| Major hemorrhage | |||||||
| After trial entry† | 2 | 18 | 12 | 1.3 (0.3-6.8) | 1.9 (0.3-12.1) | .7 | .5 |
| Gastrointestinal | 2 | 6 | 6 | ||||
| Intracranial | 0 | 3 | 4 | ||||
| Epistaxis | 0 | 5 | 0 | ||||
| Other¶ | 0 | 4 | 2 | ||||
| Death | 5 | 34 | 18 | 1.8 (0.6-5.5) | 4.5 (1.1-18.4) | .3 | .04 (.07‖) |
| Hematologic transformation | |||||||
| Myelofibrosis# | 2 | 7 | 11 | 6.2 (0.6-66.6) | 2.5 (0.3-17.7) | .1 | .4 |
| Acute leukemia/MDS | 0 | 5 | 2 | 0.3 (0.02-7.2) | 0.3 (0.01-47.0) | .5 | .7 |
| Polycythemia vera | 0 | 6 | 0 | 0.3 (0.02-6.5) | NA | .5 | NA |
| . | MPL mutant . | MPL− . | OR versus V617F+ (95% CI) . | OR versus V617F− (95% CI) . | P* (vs V617F+) . | P* (vs V617F−) . | |
|---|---|---|---|---|---|---|---|
| V617F+ . | V617F− . | ||||||
| Number | 32 | 411 | 333 | ||||
| Arterial thrombosis | |||||||
| In year before diagnosis† | 4 | 38 | 20 | 1.4 (0.5-4.2) | 2.2 (0.7-7.0) | .5 | .2 |
| Myocardial infarction | 0 | 6 | 5 | ||||
| Stroke | 1 | 10 | 4 | ||||
| Transient ischemic attack | 3 | 23 | 13 | ||||
| After trial entry† | 2 | 25 | 19 | 1.0 (0.2-4.3) | 1.1 (0.2-5.2) | .9 | .9 |
| Myocardial infarction | 1 | 7 | 6 | ||||
| Unstable angina | 0 | 5 | 1 | ||||
| Stroke | 1 | 7 | 7 | ||||
| Transient ischemic attack | 1 | 5 | 6 | ||||
| Other‡ | 0 | 2 | 1 | ||||
| Venous thromboembolism | |||||||
| In year before diagnosis† | 1 | 10 | 2 | 1.3 (0.2-10.4) | 5.3 (0.5-60.6) | .6 | .2 |
| Deep vein thrombosis | 0 | 3 | 1 | ||||
| Pulmonary embolism | 0 | 3 | 1 | ||||
| Splanchnic vein thrombosis | 0 | 2 | 0 | ||||
| Retinal vein thrombosis | 1 | 2 | 1 | ||||
| Cerebral sinus thrombosis | 0 | 1 | 0 | ||||
| After trial entry† | 2 | 11 | 3 | 2.6 (0.4-19.3) | 34.3 (1.6-725) | .3 | .02 (.09)§ |
| Deep vein thrombosis | 2 | 5 | 3 | ||||
| Pulmonary embolism | 0 | 5 | 0 | ||||
| Splanchnic vein thrombosis | 0 | 2 | 0 | ||||
| Major hemorrhage | |||||||
| After trial entry† | 2 | 18 | 12 | 1.3 (0.3-6.8) | 1.9 (0.3-12.1) | .7 | .5 |
| Gastrointestinal | 2 | 6 | 6 | ||||
| Intracranial | 0 | 3 | 4 | ||||
| Epistaxis | 0 | 5 | 0 | ||||
| Other¶ | 0 | 4 | 2 | ||||
| Death | 5 | 34 | 18 | 1.8 (0.6-5.5) | 4.5 (1.1-18.4) | .3 | .04 (.07‖) |
| Hematologic transformation | |||||||
| Myelofibrosis# | 2 | 7 | 11 | 6.2 (0.6-66.6) | 2.5 (0.3-17.7) | .1 | .4 |
| Acute leukemia/MDS | 0 | 5 | 2 | 0.3 (0.02-7.2) | 0.3 (0.01-47.0) | .5 | .7 |
| Polycythemia vera | 0 | 6 | 0 | 0.3 (0.02-6.5) | NA | .5 | NA |
Data are numbers, with 95% CI where indicated.
Assessed by Pearson chi-square test with Yates continuity correction for events preceding diagnosis and log-rank test for events after trial entry.
Indicates total patients rather than total events; some patients had more than one event.
Lower limb arterial embolus (2); upper limb arterial thrombosis.
Multivariate analysis including patient age and previous history of venous thrombosis.
Pericardial (2), urinary (2), postoperative and obstetric.
Multivariate analysis including patient age and previous history of arterial thrombosis.
MPL-mutant group comprises 1 patient with MPL S505N and 1 patient with MPL W515K.