90 2 10 mg 85.1% label for days 0 daily white; uterus < UPA mean age 16 weeks, 40.0 years; at least mean BMI one 25.4; 96.0% myoma ≥ of 3 cm diameter, 3 x potential; nil larger of 90 mean than 10 day (median) cm, PBAC score eligible for at baseline = 319 or (216). 13 5 mg 88.0% PBAC (n= 50 white; score > placebo 96) or mean age 100, 10 mg 41.6 years; (n= mean BMI uterus ≤ 98) 25.3; 92.1% 16 weeks of gestation potential; at least mean one (median) myoma ≥ PBAC score 3 cm at baseline diameter, = 452 nil larger (361). than 10 cm, fibroid related anaemia defined as Hb ≤ 10.2g/dL, eligible for surgery Double 13 5mg Mean age PBAC (n= 40.4 years; score > double 102) mean BMI 100, dummy, or 10 25.5; 96.3% active mg of uterus ≤ (n= 16 weeks 103) potential; gestation daily mean
2 for UPA 90 days 10 mg daily 85.1% white; mean age 40.0 years; mean BMI 25.4; 96.0% of potential; mean (median) PBAC score at baseline = 319 (216). uterus < 16 weeks, at least one myoma ≥ 3 cm diameter, nil larger than 10 cm, eligible for or of 3 x 90 day placebo 13 5 mg (n= 96) or 10 mg (n= 98) 88.0% white; mean age 41.6 years; mean BMI 25.3; 92.1% of potential; mean (median) PBAC score at baseline = 452 (361). PBAC score > 100, uterus ≤ 16 weeks gestation at least one myoma ≥ 3 cm diameter, nil larger than 10 cm, fibroid related anaemia defined as Hb ≤ 10.2g/dL, eligible for surgery Double double dummy, active 13 5mg (n= 102) or 10 mg (n= 103) daily Mean age 40.4 years; mean BMI 25.5; 96.3% of potential; mean PBAC score > 100, uterus ≤ 16 weeks gestation 50 0 label
auspar-ulipristal-acetate-161019-cer.docx