On-demand Trial Results: Efficacy in Women and Girls
Among women and girls in the study, 97.7% of analyzed bleeds were treated successfully with COAGADEX
- 62.5% (10/16) of subjects enrolled in Study TEN01 were women and girls aged 14 to 58 years
80% (8/10) of the women and girls had a history of heavy menstrual bleeding
40% (4/10) of the women and girls had a history of anemia
The majority of analyzed bleeds were covert while an additional 46% were due to heavy menstrual bleeding
- A total of 267 COAGADEX infusions were administered in the women and girls cohort (178 for on-demand treatment and 89 for preventative treatment). A total of 149 bleeds were treated with COAGADEX, of which 132 bleeds were selected by the data review committee for inclusion in the primary efficacy analysis*
- 46% (61/132) of analyzed bleeds in women were due to heavy menstrual bleeding
- 94.3% (67/71) of the remaining bleeds were covert
- 97.7% of bleeds analyzed had a treatment response that was rated as excellent or good
Type of Bleed Assessed
Non-Menstrual Bleeds Covert % vs. Overt %
In clinical studies, the most common adverse events (frequency ≥5% of subjects) with COAGADEX were infusion site erythema, infusion site pain, fatigue and back pain.
*The 132 bleeds included in the analysis were classified as due to heavy menstrual bleeding (n=61), covert (n=67), and overt (n=4).
Reference: Kulkarni R, James AH, Norton M, Shapiro M. J Thromb Haemost. 2018;16:849-857.