Table 4.
Uterine bleeding leading to transfusion during the at-risk period in women with and without concomitant hormonal therapy
| Characteristic | No use | All hormonal therapies | Estrogen-containing therapy | Progestin-only therapy | ||||
|---|---|---|---|---|---|---|---|---|
| Events/patient-years | %/year (95% CI) | Events/patient years | %/year (95% CI) | Events/patient-years | %/year (95% CI) | Events/patient-years | %/year (95% CI) | |
| All patients | 19/749.1 | 2.5 (1.5-4.0) | 3/182.0 | 1.6 (0.3-4.8) | 2/104.7 | 1.9 (0.2-6.9) | 1/77.2 | 1.3 (0.0-7.2) |
| Age | ||||||||
| <40 years | 7/285.1 | 2.5 (1.0-5.1) | 0/105.7 | 0.0 (0.0-3.5) | 0/55.3 | 0.0 (0.0-6.7) | 0/50.4 | 0.0 (0.0-7.3) |
| ≥40 years | 12/464.0 | 2.6 (1.3-4.5) | 3/76.2 | 3.9 (0.8-11.5) | 2/49.4 | 4.0 (0.5-14.6) | 1/26.8 | 3.7 (0.1-20.8) |
| Time period after randomization | ||||||||
| Days 1-30 | 10/112.0 | 8.9 (4.3,16.4) | 3/26.4 | 11.4 (2.4,33.2) | 2/19.5 | 10.3 (1.2-37.1) | 1/6.9 | 14.5 (0.4-80.9) |
| Days 31-90 | 2/210.8 | 0.9 (0.1-3.4) | 0/54.8 | 0.0 (0.0-6.7) | 0/33.1 | 0.0 (0.0-11.1) | 0/21.6 | 0.0 (0.0-17.1) |
| Days 91-180 | 6/275.4 | 2.2 (0.8-4.7) | 0/71.3 | 0.0 (0.0-5.2) | 0/37.3 | 0.0 (0.0-9.9) | 0/34.0 | 0.0 (0.0-10.9) |
| Days 181-end | 1/150.9 | 0.7 (0.0-3.7) | 0/29.6 | 0.0 (0.0-12.5) | 0/14.8 | 0.0 (0.0-24.9) | 0/14.7 | 0.0 (0.0-25.1) |
| History of DVT/PE before index event | ||||||||
| Yes | 2/145.9 | 1.4 (0.2-5.0) | 0/18.0 | 0.0 (0.0-20.5) | 0/5.7 | 0.0 (0.0-64.5) | 0/12.3 | 0.0 (0.0-30.1) |
| No | 17/603.1 | 2.8 (1.6-4.5) | 3/164.0 | 1.8 (0.4-5.4) | 2/99.0 | 2.0 (0.2-7.3) | 1/65.0 | 1.5 (0.0-8.6) |
| Index event | ||||||||
| DVT | 10/320.0 | 3.1 (1.5-5.8) | 2/68.8 | 2.9 (0.4-10.5) | 2/47.8 | 4.2 (0.5-15.1) | 0/21.1 | 0.0 (0.0-17.5) |
| PE ± DVT | 9/429.1 | 2.1 (0.9-4.0) | 1/113.1 | 0.9 (0.0-4.9) | 0/57.0 | 0.0 (0.0-6.5) | 1/56.2 | 1.8 (0.1-9.9) |
| Prior use of hormonal therapy | ||||||||
| Yes | 4/200.1 | 2.0 (0.5-5.1) | 3/158.4 | 1.9 (0.4-5.5) | 2/99.1 | 2.0 (0.2-7.3) | 1/59.3 | 1.7 (0.0-9.4) |
| No | 15/549.0 | 2.7 (1.5-4.5) | 0/23.6 | 0.0 (0.0-15.6) | 0/5.7 | 0.0 (0.0-65.1) | 0/17.9 | 0.0 (0.0-20.6) |
| Randomized treatment | ||||||||
| Rivaroxaban | 17/356.0 | 4.8 (2.8-7.7) | 2/93.5 | 2.1 (0.3-7.7) | 1/52.6 | 1.9 (0.1-10.6) | 1/40.9 | 2.4 (0.1-13.6) |
| Enoxaparin/VKA | 2/393.1 | 0.5 (0.1-1.8) | 1/88.5 | 1.1 (0.0-6.3) | 1/52.2 | 1.9 (0.1-10.7) | 0/36.3 | 0.0 (0.0-10.2) |
| Anemia* | ||||||||
| Yes | 18/186.2 | 9.7 (5.7-15.3) | 2/35.8 | 5.6 (0.7-20.2) | 2/22.0 | 9.1 (1.1-32.8) | 0/13.7 | 0.0 (0.0-26.9) |
| No | 1/560.5 | 0.2 (0.0-1.0) | 1/145.7 | 0.7 (0.0-3.8) | 0/82.2 | 0.0 (0.0-4.5) | 1/63.5 | 1.6 (0.0-8.8) |
| Gynecologic disorders*,† | ||||||||
| Yes | 7/35.7 | 19.6 (7.9-40.4) | 3/4.3 | 69.0 (14.2-201.3) | 2/3.7 | 53.8 (6.5-193.9) | 1/0.6 | 158.8 (4.0-876.1) |
| No | 12/713.4 | 1.7 (0.9-2.9) | 0/177.6 | 0.0 (0.0-2.1) | 0/101.0 | 0.0 (0.0-3.7) | 0/76.6 | 0.0 (0.0-4.8) |
*
As reported at baseline.
†
Defined as presence at baseline of uterine fibroids/adenomyosis, abnormal uterine bleeding events, and/or gynecologic cancer.