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Vilaprisan in women with uterine fibroids: the randomized phase 2b ASTEROID 1 study
Linda D. Bradley, M.D., Sukhbir S. Singh, M.D., James Simon, M.D., Kristina Gemzell-Danielsson, Ph.D., Kathrin Petersdorf, M.D., Esther Groettrup-Wolfers, M.D., Xiaowei Ren, M.S., Michal Zvolanek, M.D., Christian Seitz, M.D. Fertility and Sterility Volume 111, Issue 2, Pages (February 2019) DOI: /j.fertnstert Copyright © 2018 The Authors Terms and Conditions
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Figure 1 Patient disposition. VPR = vilaprisan. a“Other” reason. bProtocol violation (n = 1) and “other” reason (n = 1). cProtocol violation (n = 2) and “other” reason (n = 1). dFourteen women prematurely discontinued study treatment: three because of adverse events, two because of lack of efficacy, four lost to follow-up, one protocol violation, one “other” reason, and three withdrew. Fertility and Sterility , DOI: ( /j.fertnstert ) Copyright © 2018 The Authors Terms and Conditions
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Figure 2 (A) Kaplan-Meier plot for the time to onset of amenorrhea. (B) Cumulative amenorrhea rate (<2 mL) at the end of treatment (12 weeks). VPR = vilaprisan. Fertility and Sterility , DOI: ( /j.fertnstert ) Copyright © 2018 The Authors Terms and Conditions
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Supplemental Figure 1 Study design. Treatment day 1 was the first day of study drug intake. EoT = end of treatment; FUP = follow-up; RND = randomization; SCR = screening; T = treatment; VPR = vilaprisan. Fertility and Sterility , DOI: ( /j.fertnstert ) Copyright © 2018 The Authors Terms and Conditions
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Supplemental Figure 2 (A) Kaplan-Meier plot for the time to onset of controlled bleeding (full analysis set). (B) Rate of controlled bleeding at the end of treatment. VPR = vilaprisan. Fertility and Sterility , DOI: ( /j.fertnstert ) Copyright © 2018 The Authors Terms and Conditions
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Supplemental Figure 3 Volume of menstrual blood loss at baseline, during, and after treatment. EoT = end of treatment; VPR = vilaprisan. Fertility and Sterility , DOI: ( /j.fertnstert ) Copyright © 2018 The Authors Terms and Conditions
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Supplemental Figure 4 Percentage change in volume of largest fibroid according to magnetic resonance imaging. EoT = end of treatment; VPR = vilaprisan. Fertility and Sterility , DOI: ( /j.fertnstert ) Copyright © 2018 The Authors Terms and Conditions
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Supplemental Figure 5 Change in fibroid symptoms at the end-of-treatment visit (Patient Global Impression of Change). VPR = vilaprisan. Fertility and Sterility , DOI: ( /j.fertnstert ) Copyright © 2018 The Authors Terms and Conditions
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