AUB rates in adult studies of rivaroxaban and apixaban for the treatment of VTE
| Reference (duration) . | Study design/population . | Study drug/comparator (maintenance dose) . | Number of women . | Uterine CRNMB,* n (%) . |
|---|---|---|---|---|
| AMPLIFY-EXT4 (12 mo) | Randomized, double-blind comparison of 2 doses of apixaban vs placebo for extended (beyond 6-12 mo) therapy in patients with VTE | Apixaban 5 mg twice daily | 334 | 3 (0.9%) |
| Apixaban 2.5 mg twice daily | 353 | 4 (1.1%) | ||
| Placebo | 361 | 2 (0.6%) | ||
| EINSTEIN CHOICE5 (12 mo) | Randomized, double-blind comparison of 2 doses of rivaroxaban vs aspirin for extended (beyond 6-12 mo) therapy in patients with VTE | Rivaroxaban 20 mg daily | 505 | 6 (1.2%) |
| Rivaroxaban 10 mg daily | 507 | 4 (0.8%) | ||
| Aspirin 100 mg daily | 488 | 1 (0.2%) | ||
| SELECT-D6 (6 mo) | Randomized, open-label pilot in patients with cancer and VTE | Rivaroxaban 20 mg daily | 87 | 1 (1.1%) |
| Dalteparin 150 IU/kg/d | 105 | 0 (0.0%) | ||
| Caravaggio7 (6 mo) | Randomized, open-label, noninferiority trial in patients with cancer and VTE | Apixaban 5 mg twice daily | 284 | 4 (1.4%) |
| Dalteparin 150 IU/kg/d | 303 | 3 (1.0%) | ||
| Schastlivtsev et al8 (3-6 mo) | Single-center prospective observational study on patients with upper extremity DVT | Rivaroxaban 20 mg daily | 17 | 1 (5.9%) |
| Rusin et al9 (3-6 mo) | Single-center prospective case series on patients with CSVT treated with DOACs | Dabigatran 150 mg twice daily | 18 | 0 (0.0%) |
| Rivaroxaban 20 mg daily | 10 | 2 (20.0%)† | ||
| Apixaban 5 mg twice daily | 8 | 0 (0.0%) | ||
| Christen et al10 (variable) | Prospective cohort study of patients with sickle cell disease undergoing VTE treatment with DOACs | Rivaroxaban 20 mg daily | 8 | 4 (50%)† |
| Reference (duration) . | Study design/population . | Study drug/comparator (maintenance dose) . | Number of women . | Uterine CRNMB,* n (%) . |
|---|---|---|---|---|
| AMPLIFY-EXT4 (12 mo) | Randomized, double-blind comparison of 2 doses of apixaban vs placebo for extended (beyond 6-12 mo) therapy in patients with VTE | Apixaban 5 mg twice daily | 334 | 3 (0.9%) |
| Apixaban 2.5 mg twice daily | 353 | 4 (1.1%) | ||
| Placebo | 361 | 2 (0.6%) | ||
| EINSTEIN CHOICE5 (12 mo) | Randomized, double-blind comparison of 2 doses of rivaroxaban vs aspirin for extended (beyond 6-12 mo) therapy in patients with VTE | Rivaroxaban 20 mg daily | 505 | 6 (1.2%) |
| Rivaroxaban 10 mg daily | 507 | 4 (0.8%) | ||
| Aspirin 100 mg daily | 488 | 1 (0.2%) | ||
| SELECT-D6 (6 mo) | Randomized, open-label pilot in patients with cancer and VTE | Rivaroxaban 20 mg daily | 87 | 1 (1.1%) |
| Dalteparin 150 IU/kg/d | 105 | 0 (0.0%) | ||
| Caravaggio7 (6 mo) | Randomized, open-label, noninferiority trial in patients with cancer and VTE | Apixaban 5 mg twice daily | 284 | 4 (1.4%) |
| Dalteparin 150 IU/kg/d | 303 | 3 (1.0%) | ||
| Schastlivtsev et al8 (3-6 mo) | Single-center prospective observational study on patients with upper extremity DVT | Rivaroxaban 20 mg daily | 17 | 1 (5.9%) |
| Rusin et al9 (3-6 mo) | Single-center prospective case series on patients with CSVT treated with DOACs | Dabigatran 150 mg twice daily | 18 | 0 (0.0%) |
| Rivaroxaban 20 mg daily | 10 | 2 (20.0%)† | ||
| Apixaban 5 mg twice daily | 8 | 0 (0.0%) | ||
| Christen et al10 (variable) | Prospective cohort study of patients with sickle cell disease undergoing VTE treatment with DOACs | Rivaroxaban 20 mg daily | 8 | 4 (50%)† |