Characteristics of patients and end points according to “as treated” and ITT analysis
| Patient . | Sex . | Age, y . | BMI, kg/m2 . | Arm . | History of events . | Event . | Description . | Days from randomization . |
|---|---|---|---|---|---|---|---|---|
| 1 | F | 44 | 49.6 | R | A+V+O | Bleeding | Metrorrhagia causing acute Hb fall | 21 |
| 2 | M | 39 | 25.2 | R | V | Thrombosis | Acute myocardial infarction | 709 |
| 3 | F | 47 | 35.6 | R | A+O | Bleeding | Rectorrhagia requiring transfusion | 429 |
| 4 | M | 59 | 24.5 | R | A+O | Thrombosis | Ischemic Stroke | 322 |
| 5 | F | 35 | 32.8 | R | A | Thrombosis | Ischemic Stroke | 36 |
| 6 | F | 57 | 26.1 | R | V | Thrombosis | Ischemic Stroke | 299 |
| 7 | F | 55 | 24.7 | R | A | Thrombosis | Acute myocardial infarction | 253 |
| 8 | M | 52 | 19.8 | R | A | Bleeding | Gastrointestinal bleeding causing acute Hb fall | 681 |
| 9 | F | 58 | 24.2 | R | A+V | Thrombosis | Ischemic Stroke | 110 |
| 10 | M | 47 | 29.6 | R | V | Thrombosis | Acute myocardial infarction | 20 |
| 11 | F | 43 | 19.1 | R | V | Bleeding | Hb fall | 28 |
| 12 | F | 51 | 20.5 | W | A+V | Bleeding | Provoked Hb fall | 365 |
| 13 | F | 36 | 21.3 | W | A+V | Bleeding | Metrorrhagia requiring intervention | 280 |
| Additional end points considered in ITT analysis | ||||||||
| 14 | M | 47 | 22.5 | R | V | Thrombosis | Bilateral DVT in the lower limbs | 175 |
| 15 | M | 55 | 27.4 | R | A | Death | Cardiovascular death | 475 |
| Patient . | Sex . | Age, y . | BMI, kg/m2 . | Arm . | History of events . | Event . | Description . | Days from randomization . |
|---|---|---|---|---|---|---|---|---|
| 1 | F | 44 | 49.6 | R | A+V+O | Bleeding | Metrorrhagia causing acute Hb fall | 21 |
| 2 | M | 39 | 25.2 | R | V | Thrombosis | Acute myocardial infarction | 709 |
| 3 | F | 47 | 35.6 | R | A+O | Bleeding | Rectorrhagia requiring transfusion | 429 |
| 4 | M | 59 | 24.5 | R | A+O | Thrombosis | Ischemic Stroke | 322 |
| 5 | F | 35 | 32.8 | R | A | Thrombosis | Ischemic Stroke | 36 |
| 6 | F | 57 | 26.1 | R | V | Thrombosis | Ischemic Stroke | 299 |
| 7 | F | 55 | 24.7 | R | A | Thrombosis | Acute myocardial infarction | 253 |
| 8 | M | 52 | 19.8 | R | A | Bleeding | Gastrointestinal bleeding causing acute Hb fall | 681 |
| 9 | F | 58 | 24.2 | R | A+V | Thrombosis | Ischemic Stroke | 110 |
| 10 | M | 47 | 29.6 | R | V | Thrombosis | Acute myocardial infarction | 20 |
| 11 | F | 43 | 19.1 | R | V | Bleeding | Hb fall | 28 |
| 12 | F | 51 | 20.5 | W | A+V | Bleeding | Provoked Hb fall | 365 |
| 13 | F | 36 | 21.3 | W | A+V | Bleeding | Metrorrhagia requiring intervention | 280 |
| Additional end points considered in ITT analysis | ||||||||
| 14 | M | 47 | 22.5 | R | V | Thrombosis | Bilateral DVT in the lower limbs | 175 |
| 15 | M | 55 | 27.4 | R | A | Death | Cardiovascular death | 475 |
Hb fall denotes a decrease in hemoglobin >2 g/L; all thrombotic events were documented by imaging.
A, arterial event; BMI, body mass index; DVT, deep vein thrombosis; F, female; M, male; O, obstetric event; R, rivaroxaban; V, venous event; W, warfarin.