End of Mean (median)% CFS in - 51.3 % (-63.4%) -43.7 % treatment fibroid volume course 2b Percentage (number) of 80.0 (48/60) 79.8 (95/119) subjects with reduction ≥25% in fibroid volumea Percentage (number) of 66.7 (40/60) 64.7 (77/119) subjects with reduction ≥50% in fibroid volumea End of Mean (median)% CFS in - 52.0% (-66.5%) -41.0% treatment fibroid volume course 3b Percentage (number) of 81.8 (45/55) 78.3 (83/106) subjects with reduction ≥25% in fibroid volumea Percentage (number) of 65.5 (36/55) 62.3 (66/106) subjects with reduction ≥50% in fibroid volumea End of Mean (median)% CFS in total -57.3% (-71.2%) -53.5% treatment fibroid volume course 4 Percentage (number) of 84.0 (42/50) 82.3 (79/96) subjects with reduction ≥25% in fibroid volumea Percentage (number) of 66.0 (33/50) 69.8 (67/96) subjects with reduction ≥50% in fibroid volumea Follow up Mean (median)% CFS in total -42.7 (-59.3) -33.7 (-58.8) visit fibroid volume 3 months Percentage (number) of 76.5 (39/51) 72.2 (70/97) after end of subjects with reduction ≥25% treatment) in fibroid volumea Percentage (number) of 60.8 (31/51) 57.7 (56/97) subjects with reduction ≥50% in fibroid volumea a Denominator for percentage is number of subjects with non-missing myoma volume reduction at each visit b Assessment 2 weeks after menstruation following treatment course and placebo / NETA double blind period Other endpoints
End of treatment course 2b Mean (median)% CFS in fibroid volume - 51.3 % (-63.4%) -43.7 % Percentage (number) of subjects with ≥25% reduction in fibroid volumea 80.0 (48/60) 79.8 (95/119) Percentage (number) of subjects with ≥50% reduction in fibroid volumea 66.7 (40/60) 64.7 (77/119) End of treatment course 3b Mean (median)% CFS in fibroid volume - 52.0% (-66.5%) -41.0% Percentage (number) of subjects with ≥25% reduction in fibroid volumea 81.8 (45/55) 78.3 (83/106) Percentage (number) of subjects with ≥50% reduction in fibroid volumea 65.5 (36/55) 62.3 (66/106) End of treatment course 4 Mean (median)% CFS in total fibroid volume -57.3% (-71.2%) -53.5% Percentage (number) of subjects with ≥25% reduction in fibroid volumea 84.0 (42/50) 82.3 (79/96) Percentage (number) of subjects with ≥50% reduction in fibroid volumea 66.0 (33/50) 69.8 (67/96) Follow up visit 3 months after end of treatment) Mean (median)% CFS in total fibroid volume -42.7 (-59.3) -33.7 (-58.8) Percentage (number) of subjects with ≥25% reduction in fibroid volumea 76.5 (39/51) 72.2 (70/97) Percentage (number) of subjects with ≥50% reduction in fibroid volumea 60.8 (31/51) 57.7 (56/97) a Denominator for percentage is number of subjects with non-missing myoma volume reduction at each visit b Assessment 2 weeks after menstruation following treatment course and placebo / NETA double blind period Other endpoints
auspar-ulipristal-acetate-161019-cer.docx