Table 2.

Characteristics, diagnostic measures, treatment and outcomes of major abnormal vaginal bleeding events in the Hokusai‐VTE trial

	Edoxaban	Warfarin
Number of women with major abnormal vaginal bleeding	8	3
Classifying for FIGO criteria AUB, n (%)	8 (100)	3 (100)
Prolonged menstrual bleeding	2	0
Intermenstrual bleeding	2	0
Heavy menstrual bleeding	8	3
Anaemia	5	2
Unscheduled contact	8	3
Diagnostic tests applieda, n (%)	4 (50)	1 (33)
Ultrasonography	2	1
Biopsy	2	1
Hysteroscopy	1	0
Unknown	0	0
Diagnosis, n (%)	2 (25)	3 (100)
Uterine myoma	2	1
Endometriosis	0	1
Cervical cancer	0	1
Haematoma	0	0
Hospital admission, n (%)	7 (88)	3 (100)
Treatment, n (%)
Transfusion of packed cells	3 (38)	2 (67)
Iron supplements	2 (25)	0
Hormone therapy
Estrogen containing	0	0
Progestagen containing	0	0
IUD	0	0
Tranexamic acid	2 (25)	0
Unknown	2 (25)	1 (33)
No treatment	2 (25)	0
Radiologic or surgical interventions, n (%)
Hysterectomy	2 (25)	2 (67)
Endometrial ablation or curettage	1 (12)	0
No interventions	5 (63)	1 (33)
Other	0	0
Unknown	0	0
Change in anticoagulant, n (%)
Unchanged	2 (25)	0
Temporary interruption	3 (38)	3 (100)
Permanent stop	1 (12)	0
Switch to another anticoagulant	1 (12)	0
Adjusted treatment dose	1 (12)	0
Unknown	0	0
Life‐threatening bleeding – n (%)	0	1 (33)
Fatal bleeding – n (%)	0	0
Repetitive bleeding, n (%)	1 (13)	0
Recurrent VTE, n (%)	2 (25)	0
Classification of presentation of major vaginal bleed, n (%)
Category 1	3 (38)	0
Category 2	4 (50)	2 (67)
Category 3	1 (12)	1 (33)
Category 4	0	0
Classification of course of major vaginal bleed, n (%)
Category 1	2 (25)	1 (33)
Category 2	6 (75)	2 (67)
Category 3	0	0
Category 4	0	0

AUB, abnormal uterine bleeding; FIGO, International Federation of Gynaecology and Obstetrics; IUD, intrauterine device; VTE, venous thromboembolism.

^aPatients may have undergone multiple diagnostic tests.