Table 3.
All abnormal uterine bleeding during the at-risk period in women with and without concomitant hormonal therapy
| Characteristic | No hormone 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 | 148/693.0 | 21.4 (18.1-25.1) | 37/164.8 | 22.5 (15.8-31.0) | 28/96.8 | 28.9 (19.2-41.8) | 9/67.9 | 13.3 (6.1-25.1) |
| Age | ||||||||
| <40 years | 52/266.2 | 19.5 (14.6-25.6) | 19/97.2 | 19.5 (11.8-30.5) | 14/52.3 | 26.8 (14.6-44.9) | 5/44.8 | 11.2 (3.6-26.0) |
| ≥40 years | 96/426.8 | 22.5 (18.2-26.6) | 18/67.6 | 26.6 (15.8-42.1) | 14/44.5 | 31.5 (17.2-52.8) | 4/23.1 | 17.3 (4.7-44.3) |
| Time period after randomization | ||||||||
| Days 1-30 | 89/108.2 | 82.3 (66.1-101.2) | 23/25.1 | 91.5 (58.0-137.2) | 19/18.6 | 102.0 (61.4-159.2) | 4/6.5 | 61.5 (16.8-157.3) |
| Days 31-90 | 31/196.3 | 15.8 (10.7-22.4) | 10/50.2 | 19.9 (9.6-36.7) | 7/30.6 | 22.9 (9.2-47.2) | 3/19.6 | 15.3 (3.2-44.7) |
| Days 91-180 | 24/251.0 | 9.6 (6.1-14.2) | 3/64.5 | 4.7 (1.0-13.6) | 1/34.4 | 2.9 (0.1-16.2) | 2/30.1 | 6.6 (0.8-24.0) |
| Days 181-end | 4/137.5 | 2.9 (0.8-7.5) | 1/24.9 | 4.0 (0.1-22.3) | 1/13.2 | 7.6 (0.2-42.0) | 0/11.7 | 0.0 (0.0-31.5) |
| History of DVT/PE before index event | ||||||||
| Yes | 25/135.2 | 18.5 (12.0-27.3) | 1/16.2 | 6.2 (0.2-34.4) | 1/4.9 | 20.4 (0.5-113.4) | 0/11.3 | 0.0 (0.0-32.7) |
| No | 123/557.7 | 22.1 (18.3-26.3) | 36/148.6 | 24.2 (17.0-33.5) | 27/91.9 | 29.4 (19.4-42.7) | 9/56.7 | 15.9 (7.3-30.1) |
| Presentation of index event | ||||||||
| DVT | 54/299.2 | 18.0 (13.6-21.8) | 14/64.3 | 21.8 (11.9-36.5) | 13/45.6 | 28.5 (15.2-48.7) | 1/18.7 | 5.3 (0.1-29.8) |
| PE ± DVT | 94/393.7 | 23.9 (19.3-29.2) | 23/100.5 | 22.9 (14.5-34.3) | 15/51.2 | 29.3 (16.45.8-48.3) | 8/49.3 | 16.2 (7.0-32.0) |
| Prior use of hormonal therapy | ||||||||
| Yes | 41/186.7 | 22.0 (15.8-29.8) | 34/145.2 | 23.4 (16.2-32.7) | 27/91.9 | 29.4 (19.4-42.7) | 7/53.3 | 13.1 (5.3-27.1) |
| No | 107/506.3 | 21.1 (17.3-25.5) | 3/19.6 | 15.3 (3.2-44.7) | 1/4.9 | 20.3 (0.5-112.9) | 2/14.7 | 13.6 (1.7-49.2) |
| Randomized treatment | ||||||||
| Rivaroxaban | 98/319.1 | 30.7 (24.9-37.4) | 24/80.6 | 29.8 (19.1-44.3) | 19/46.9 | 40.5 (24.4-63.3) | 5/33.8 | 14.8 (4.8-34.5) |
| Enoxaparin/VKA | 50/373.8 | 13.4 (9.9-17.6) | 13/84.1 | 15.5 (8.2-26.4) | 9/50.0 | 18.0 (8.2-34.2) | 4/34.2 | 11.7 (3.2-30.0) |
| Anemia* | ||||||||
| Yes | 45/172.5 | 26.1 (19.0-34.9) | 8/32.7 | 24.5 (10.6-48.2) | 6/20.4 | 29.4 (10.8-63.9) | 2/12.2 | 16.3 (2.0-59.0) |
| No | 103/518.2 | 19.9 (16.2-24.1) | 29/131.6 | 22.0 (14.8-31.7) | 22/75.9 | 29.0 (18.2-43.9) | 7/55.7 | 12.6 (5.1-25.9) |
| Gynecologic disorders (%)† | ||||||||
| Yes | 10/30.6 | 32.7 (15.7-60.1) | 2/5.4 | 37.0 (4.5-133.4) | 2/4.5 | 44.6 (5.4-160.8) | 0/0.9 | 0.0 (0.0-397.6) |
| No | 138/662.4 | 20.8 (17.5-24.6) | 35/159.4 | 22.0 (15.3-30.5) | 26/92.3 | 28.1 (18.4-41.3) | 9/67.0 | 13.4 (6.1-25.5) |
*
As reported at baseline.
†
Defined as presence at baseline of uterine fibroids/adenomyosis, abnormal uterine bleeding, and/or gynecologic cancer.