Table 3.
Characteristics, diagnostics, treatment and outcomes of CRNM abnormal vaginal bleeding events in the Hokusai‐VTE trial
| Edoxaban | Warfarin | |
|---|---|---|
| Number of women with CRNM abnormal vaginal bleeding | 53 | 37 |
| Classifying for FIGO criteria AUB, n (%) | 53 (100) | 36 (97) |
| Prolonged menstrual bleeding | 8 | 5 |
| Intermenstrual bleeding | 8 | 2 |
| Heavy menstrual bleeding | 45 | 32 |
| Anaemia | 11 | 2 |
| Unscheduled contact | 29 | 14 |
| Diagnostic tests applieda, n (%) | 10 (19) | 3 (8) |
| Ultrasonography | 6 | 3 |
| Biopsy | 0 | 0 |
| Hysteroscopy | 1 | 0 |
| Unknown | 3 | 1 |
| Diagnosis, n (%) | 4 (8) | 2 (5) |
| Uterine myoma | 2 | 1 |
| Endometriosis | 0 | 0 |
| Cervical cancer | 2 | 0 |
| Haematoma | 0 | 1 |
| Hospital admission, n (%) | 7 (13) | 4 (11) |
| Treatment, n (%) | ||
| Transfusion of packed cells | 2 (4) | 1 (3) |
| Iron supplements | 5 (9) | 1 (3) |
| Hormone therapy | ||
| Estrogen‐containing | 1 (2) | 1 (3) |
| Progestagen‐containing | 1 (2) | 0 |
| IUD | 0 | 1 (3) |
| Tranexamic acid | 3 (6) | 0 |
| Unknown | 10 (19) | 8 (22) |
| No treatment | 31 (58) | 24 (66) |
| Radiologic or surgical interventions, n (%) | ||
| Hysterectomy | 0 | 1 (3) |
| Endometrial ablation or curettage | 1 (2) | 0 |
| No interventions | 51 (96) | 34 (94) |
| Other | 0 | 1 (3) |
| Unknown | 1 (2) | 0 |
| Change in anticoagulant, n (%) | ||
| Unchanged | 38 (72) | 25 (69) |
| Temporary interruption | 12 (22) | 8 (22) |
| Permanent stop | 2 (4) | 1 (3) |
| Switch to another anticoagulant | 0 | 0 |
| Adjusted treatment dose | 0 | 0 |
| Unknown | 1 (2) | 2 (6) |
| Repetitive bleeding, n (%) | 28 (53) | 18 (50) |
| Recurrent VTE, n (%) | 0 | 0 |
| Classification of CRNM vaginal bleed, n (%) | ||
| Category 1 | 18 (34) | 18 (50) |
| Category 2 | 10 (19) | 5 (14) |
| Category 3 | 17 (32) | 10 (28) |
| Category 4 | 7 (13) | 3 (8) |
| Unknown | 1 (2) | 0 |
AUB, abnormal uterine bleeding; CRNM, clinically relevant nonmajor; FIGO, International Federation of Gynaecology and Obstetrics; IUD, intrauterine device; VTE, venous thromboembolism.
a
Patients may have undergone multiple diagnostic tests.