Uterine MB and CRNMB definitions
| Uterine MB bleeding was defined as uterine bleeding with one or more of the following: |
| A decrease in hemoglobin ≥2 g/dL |
| Transfusion of ≥2 U of packed red blood cells |
| Fatal bleeding |
| Bleeding requiring surgical intervention |
| Uterine CRNMB was defined as uterine bleeding with one or more of the following: |
| Acute clinically overt uterine bleeding that does not meet criteria for MB and consists of: |
| Any bleeding compromising hemodynamics |
| Any bleeding considered to have clinical consequences for the patient, such as medical intervention, need for an unscheduled visit or phone call with a physician, temporary cessation of study drug, or associated with pain or impairment in activities of daily living |
| AUB was defined as uterine bleeding with the following: |
| Uterine bleeding that is excessive and/or occurs outside of the normal menstrual cycle, including heavy menstrual bleeding, intermenstrual bleeding, prolonged menstrual bleeding, or postmenopausal bleeding |
| Heavy menstrual bleeding or “menorrhagia” was defined as follows: |
| A menstrual period with excessively heavy flow (>80 mL of blood loss per cycle, soaking a pad/tampon at least every 2 h, or bleeding lasting >7 d) |
| Uterine MB bleeding was defined as uterine bleeding with one or more of the following: |
| A decrease in hemoglobin ≥2 g/dL |
| Transfusion of ≥2 U of packed red blood cells |
| Fatal bleeding |
| Bleeding requiring surgical intervention |
| Uterine CRNMB was defined as uterine bleeding with one or more of the following: |
| Acute clinically overt uterine bleeding that does not meet criteria for MB and consists of: |
| Any bleeding compromising hemodynamics |
| Any bleeding considered to have clinical consequences for the patient, such as medical intervention, need for an unscheduled visit or phone call with a physician, temporary cessation of study drug, or associated with pain or impairment in activities of daily living |
| AUB was defined as uterine bleeding with the following: |
| Uterine bleeding that is excessive and/or occurs outside of the normal menstrual cycle, including heavy menstrual bleeding, intermenstrual bleeding, prolonged menstrual bleeding, or postmenopausal bleeding |
| Heavy menstrual bleeding or “menorrhagia” was defined as follows: |
| A menstrual period with excessively heavy flow (>80 mL of blood loss per cycle, soaking a pad/tampon at least every 2 h, or bleeding lasting >7 d) |