Incidence of thromboses and hemorrhages at different time intervals
| . | Between ITP diagnosis and TRA start . | During TRA therapy . | ||||||
|---|---|---|---|---|---|---|---|---|
| No. of events . | No. of patients (%) . | Incidence rate, per 100 patient-years . | Cumulative incidence (%) . | No. of events . | No. of patients (%) . | Incidence rate, per 100 patient-years . | Cumulative incidence (%) . | |
| Overall thromboses | 23 | 22 (5.7) | 1.1 | 1.6 at 1 y 3.1 at 2 y | 43 | 35 (9.1) | 3.6 | 6.2 at 1 y 8.5 at 2 y |
| VTEs | 13 | 12 (3.1) | 0.6 | 1.3 at 1 y 2.7 at 2 y | 23 | 18 (4.9) | 1.8 | 2.9 at 1 y 3.4 at 2 y |
| Deep vein thrombosis of the limbs with or without pulmonary embolism | 8 | 8 (2.1) | 0.4 | 0.9 at 1 y 1.8 at 2 y | 15 | 13 (3.4) | 1.3 | 1.8 at 1 y 2.3 at 2 y |
| Superficial vein thrombosis of the limbs | 4 | 3 (0.8) | 0.1 | 0.4 at 1 y 0.4 at 2 y | 6 | 6 (1.6) | 0.6 | 1.7 at 1 y 1.7 at 2 y |
| Other venous thromboses* | 1 | 1 (0.2) | 0.05 | 0 at 1 y 0.5 at 2 y | 2 | 2 (0.5) | 0.2 | 0 at 1 y 0 at 2 y |
| Arterial thromboses | 10 | 10 (2.6) | 0.5 | 0.3 at 1 y 0.3 at 2 y | 20 | 18 (4.7) | 1.8 | 3.3 at 1 y 5.2 at 2 y |
| Acute myocardial infarction | 6 | 6 (1.6) | 0.3 | 0.3 at 1 y 0.3 at 2 y | 9 | 9 (2.3) | 0.9 | 1.5 at 1 y 3.3 at 2 y |
| Ischemic stroke | 2 | 2 (0.5) | 0.1 | 0 at 1 y 0.5 at 2 y | 5 | 5 (1.3) | 0.6 | 0.7 at 1 y 0.7 at 2 y |
| Transient ischemic attack | 0 | — | — | — | 2 | 2 (0.5) | 0.4 | 0.8 at 1 y 0.8 at 2 y |
| Peripheral arterial thrombosis | 2 | 2 (0.5) | 0.1 | 0 at 1 y 0 at 2 y | 4 | 2 (0.5) | 0.2 | 0.6 at 1 y 0.6 at 2 y |
| Overall hemorrhages | 120 | 82 (21.3) | 4.4 | 11.6 at 1 y 15.1 at 2 y | 104 | 65 (16.9) | 6.8 | 12.6 at 1 y 17.3 at 2 y |
| Minor (grade 1-2) | 97 | 69 (18) | 3.7 | 10.7 at 1 y 13.9 at 2 y | 90 | 56 (14.6) | 5.8 | 11.1 at 1 y 14.1 at 2 y |
| Major (grade 3-4) | 23 | 17 (4.4) | 0.9 | 1.3 at 1 y 1.8 at 2 y | 14 | 10 (2.6) | 1.1 | 1.5 at 1 y 3.3 at 2 y |
| . | Between ITP diagnosis and TRA start . | During TRA therapy . | ||||||
|---|---|---|---|---|---|---|---|---|
| No. of events . | No. of patients (%) . | Incidence rate, per 100 patient-years . | Cumulative incidence (%) . | No. of events . | No. of patients (%) . | Incidence rate, per 100 patient-years . | Cumulative incidence (%) . | |
| Overall thromboses | 23 | 22 (5.7) | 1.1 | 1.6 at 1 y 3.1 at 2 y | 43 | 35 (9.1) | 3.6 | 6.2 at 1 y 8.5 at 2 y |
| VTEs | 13 | 12 (3.1) | 0.6 | 1.3 at 1 y 2.7 at 2 y | 23 | 18 (4.9) | 1.8 | 2.9 at 1 y 3.4 at 2 y |
| Deep vein thrombosis of the limbs with or without pulmonary embolism | 8 | 8 (2.1) | 0.4 | 0.9 at 1 y 1.8 at 2 y | 15 | 13 (3.4) | 1.3 | 1.8 at 1 y 2.3 at 2 y |
| Superficial vein thrombosis of the limbs | 4 | 3 (0.8) | 0.1 | 0.4 at 1 y 0.4 at 2 y | 6 | 6 (1.6) | 0.6 | 1.7 at 1 y 1.7 at 2 y |
| Other venous thromboses* | 1 | 1 (0.2) | 0.05 | 0 at 1 y 0.5 at 2 y | 2 | 2 (0.5) | 0.2 | 0 at 1 y 0 at 2 y |
| Arterial thromboses | 10 | 10 (2.6) | 0.5 | 0.3 at 1 y 0.3 at 2 y | 20 | 18 (4.7) | 1.8 | 3.3 at 1 y 5.2 at 2 y |
| Acute myocardial infarction | 6 | 6 (1.6) | 0.3 | 0.3 at 1 y 0.3 at 2 y | 9 | 9 (2.3) | 0.9 | 1.5 at 1 y 3.3 at 2 y |
| Ischemic stroke | 2 | 2 (0.5) | 0.1 | 0 at 1 y 0.5 at 2 y | 5 | 5 (1.3) | 0.6 | 0.7 at 1 y 0.7 at 2 y |
| Transient ischemic attack | 0 | — | — | — | 2 | 2 (0.5) | 0.4 | 0.8 at 1 y 0.8 at 2 y |
| Peripheral arterial thrombosis | 2 | 2 (0.5) | 0.1 | 0 at 1 y 0 at 2 y | 4 | 2 (0.5) | 0.2 | 0.6 at 1 y 0.6 at 2 y |
| Overall hemorrhages | 120 | 82 (21.3) | 4.4 | 11.6 at 1 y 15.1 at 2 y | 104 | 65 (16.9) | 6.8 | 12.6 at 1 y 17.3 at 2 y |
| Minor (grade 1-2) | 97 | 69 (18) | 3.7 | 10.7 at 1 y 13.9 at 2 y | 90 | 56 (14.6) | 5.8 | 11.1 at 1 y 14.1 at 2 y |
| Major (grade 3-4) | 23 | 17 (4.4) | 0.9 | 1.3 at 1 y 1.8 at 2 y | 14 | 10 (2.6) | 1.1 | 1.5 at 1 y 3.3 at 2 y |
Hemorrhages during TRA therapy were grade 1-2 (minor): mucocutaneous (n = 68, 65.4%), gastrointestinal (n = 11, 10.6%), ocular (n = 5, 4.8%), urinary tract (n = 4, 3.8%), respiratory tract (n = 2, 1.9%); grade 3-4 (major): mucocutaneous (n = 5, 4.8%), gastrointestinal (n = 3, 2.9%), ocular (n = 3, 2.9%), intracranial (n = 2, 1.9%), and urinary tract (n = 1, 1%). One patient experienced a venous thrombosis and an arterial thrombosis during TRA therapy. Four patients had both grade 2 and 3 hemorrhages between ITP diagnosis and TRA start. One patient experienced both grade 2 and 3 hemorrhages during TRA therapy. The 3 patients with a fatal thrombosis had additional CVRFs (hypertension and smoking; hypertension; and previous transient ischemic attack). — indicates values are incalculable due to absence of events.
Other venous thromboses included 1 retinal venous thrombosis between ITP diagnosis and TRA start and 1 hemorrhoidal vein thrombosis and 1 retinal venous thrombosis during TRA therapy.