Trial Outcomes & Findings for PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata (NCT NCT01629563)

Last Updated: 2019-09-04

Results Overview

Amenorrhoea was defined as no more than 1 day of spotting within a 35 day interval. Subjects need to be in amenorrhoea at the end of all four treatment courses, i.e for at least 4x35 days.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

451 participants

Primary outcome timeframe

18 months study duration per subject (4 3-month intermittent treatment courses)

Results posted on

2019-09-04

Participant Flow

Participant milestones

Participant milestones
Measure	Ulipristal Acetate (PGL4001) 5mg PGL4001 5 mg: PGL4001 5 mg daily administration	Ulipristal Acetate (PGL4001) 10mg PGL4001 10 mg: PGL4001 10mg daily administration
Overall Study STARTED	228	223
Overall Study Safety Population	230	221
Overall Study Started Treatment Course 2	213	207
Overall Study Started Treatment Course 3	191	190
Overall Study Started Treatment Course 4	178	176
Overall Study COMPLETED	167	170
Overall Study NOT COMPLETED	61	53

Reasons for withdrawal

Reasons for withdrawal
Measure	Ulipristal Acetate (PGL4001) 5mg PGL4001 5 mg: PGL4001 5 mg daily administration	Ulipristal Acetate (PGL4001) 10mg PGL4001 10 mg: PGL4001 10mg daily administration
Overall Study Adverse Event	16	16
Overall Study Death	2	0
Overall Study Lack of Efficacy	2	3
Overall Study Lost to Follow-up	1	0
Overall Study Pregnancy	1	2
Overall Study Protocol Violation	0	1
Overall Study Withdrawal by Subject	27	20
Overall Study surgery	0	3
Overall Study Lack of return of menses	12	7

Baseline Characteristics

PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ulipristal Acetate (PGL4001) 5mg n=228 Participants PGL4001 5 mg: PGL4001 5 mg daily administration	Ulipristal Acetate (PGL4001) 10mg n=223 Participants PGL4001 10 mg: PGL4001 10mg daily administration	Total n=451 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	228 Participants n=5 Participants	223 Participants n=7 Participants	451 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	41.6 years STANDARD_DEVIATION 5.4 • n=5 Participants	41.4 years STANDARD_DEVIATION 5.1 • n=7 Participants	41.5 years STANDARD_DEVIATION 5.2 • n=5 Participants
Sex: Female, Male Female	228 Participants n=5 Participants	223 Participants n=7 Participants	451 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Total volume of the 3 largest myoma	42.6 cm3 n=5 Participants	43.6 cm3 n=7 Participants	43.3 cm3 n=5 Participants
Pain Assessment (Visual Analogue Scale)	39.0 units on a scale n=5 Participants	43.0 units on a scale n=7 Participants	40.5 units on a scale n=5 Participants
Uterine Fibroid Symptom Quality of Life Questionnaire Symptom Severity (UFSQoL)	50.0 units on a scale n=5 Participants	50.0 units on a scale n=7 Participants	50.0 units on a scale n=5 Participants
Uterine Fibroid Symptom Quality of Life Questionnaire Health related Quality of Life (HRQL)	56.9 units on a scale n=5 Participants	55.2 units on a scale n=7 Participants	56.0 units on a scale n=5 Participants

PRIMARY outcome

Timeframe: 18 months study duration per subject (4 3-month intermittent treatment courses)

Population: Full Analysis Set 1 (subjects who received study treatment at least once for treatment course 1) (subjects with missing values were excluded from analysis)

Amenorrhoea was defined as no more than 1 day of spotting within a 35 day interval. Subjects need to be in amenorrhoea at the end of all four treatment courses, i.e for at least 4x35 days.

Outcome measures

Outcome measures
Measure	Ulipristal Acetate (PGL4001) 5mg n=195 Participants PGL4001 5 mg: PGL4001 5 mg daily administration	Ulipristal Acetate (PGL4001) 10mg n=185 Participants PGL4001 10 mg: PGL4001 10mg daily administration
Percentage of Subjects Who Are in Amenorrhea at the End of All Four Treatment Courses	48.7 percentage of subjects	60.5 percentage of subjects

SECONDARY outcome

Timeframe: After 18 months

Population: Full Analysis Set 1 (all subjects who received study treatment once for treatment course 1) (subjects with missing values were excluded from analysis)

Amenorrhoea was defined as no more than 1 day of spotting within a 35 day interval.

Outcome measures

Outcome measures
Measure	Ulipristal Acetate (PGL4001) 5mg n=227 Participants PGL4001 5 mg: PGL4001 5 mg daily administration	Ulipristal Acetate (PGL4001) 10mg n=220 Participants PGL4001 10 mg: PGL4001 10mg daily administration
Percentage of Subjects Who Were in Amenorrhea at the End of Treatment Course 4	69.6 percentage of participants	74.5 percentage of participants

SECONDARY outcome

Timeframe: After 18 months

Population: Full analysis set 1 (all subject who received study treatment at least once for treatment course 1) (subjects with missing values were excluded from analysis)

Controlled bleeding was defined as no episodes of heavy bleeding and a maximum of 8 days of bleeding during the last 56 days of a treatment course. Subjects need to be in controlled bleeding at the end of all 4 treatment courses i.e. for at least 4x56 days.

Outcome measures

Outcome measures
Measure	Ulipristal Acetate (PGL4001) 5mg n=158 Participants PGL4001 5 mg: PGL4001 5 mg daily administration	Ulipristal Acetate (PGL4001) 10mg n=146 Participants PGL4001 10 mg: PGL4001 10mg daily administration
Percentage of Subjects With Controlled Bleeding at the End of All 4 Treatment Courses	67.1 percentage of participants	71.9 percentage of participants

SECONDARY outcome

Timeframe: After 18 months

Population: Full Analysis Set 1 (all subjects who received study treatment at least once for treatment course 1) (subjects with missing values were excluded from analysis)

For the 3 largest myomas at baseline and the 3 largest myomas at the end of treatment course 4 identified by transvaginal ultrasound, length, height and depth were measured and the volume was estimated by applying the equation for the voulme of an ellipsoid (length x height x depht x π/6). Subjects were exposed to 4 3-month intermittent courses.

Outcome measures

Outcome measures
Measure	Ulipristal Acetate (PGL4001) 5mg n=160 Participants PGL4001 5 mg: PGL4001 5 mg daily administration	Ulipristal Acetate (PGL4001) 10mg n=159 Participants PGL4001 10 mg: PGL4001 10mg daily administration
Percentage of Change From Baseline to End of Treatment Course 4 in the Total Volume of the 3 Largest Fibroids	-67.0 percentage of change from baseline Interval -85.6 to -35.1	-70.4 percentage of change from baseline Interval -88.0 to -41.7

SECONDARY outcome

Timeframe: After 18 months

Population: Full Analysis Set 1 (all subjects who received study treatment at least once for treatment course 1) (subjects with missing values were excluded from analysis)

Quality of Life was assessed using a validated questionnaire measuring uterine fibroid symptom severity (UFSQoL) where lower scores indicate fewer symtoms and where a level of 23 has been reported for healthy subject (scale 0-100). Subjects were exposed to 4 3-month intermittent courses.

Outcome measures

Outcome measures
Measure	Ulipristal Acetate (PGL4001) 5mg n=137 Participants PGL4001 5 mg: PGL4001 5 mg daily administration	Ulipristal Acetate (PGL4001) 10mg n=137 Participants PGL4001 10 mg: PGL4001 10mg daily administration
Percentage of Change From Baseline to End of Treatment Course 4 in Quality of Life (Uterine Fibroid Symptom Severity (UFSQoL)	-31.25 percentage of change from baseline Interval -46.88 to -12.5	-28.13 percentage of change from baseline Interval -43.75 to -18.75

SECONDARY outcome

Timeframe: 18 months

Population: Full Analysis Set 1 (all subjects who received study treatment at least once for treatment course 1) (subjects with missing values were excluded from analysis)

Quality of Life was measured using a validated uterine fibroid symptom questionnaire. Total score for health related quality of Life (HRQL) range from 0 to 100 with higher scores indicating better Quality of Life. Subjects were exposed to 4 3-month intermittent courses.

Outcome measures

Outcome measures
Measure	Ulipristal Acetate (PGL4001) 5mg n=136 Participants PGL4001 5 mg: PGL4001 5 mg daily administration	Ulipristal Acetate (PGL4001) 10mg n=138 Participants PGL4001 10 mg: PGL4001 10mg daily administration
Percentage of Change From Baseline to End of Treatment Course 4 in Quality of Life -Uterine Fibroid Health Related Quality of Life (HRQL)	20.69 percentage of change from baseline Interval 6.47 to 35.34	15.52 percentage of change from baseline Interval 5.17 to 37.07

SECONDARY outcome

Timeframe: After 18 months

Population: FAS1 (all subjects who received study treatment at least once for treatment course 1) (subjects with missing values were excluded from analysis)

Pain was assessed using a Visual Analogue Scale (VAS) ranging from 0 to 100 with higher score indicating more severe pain. Subjects were exposed to 4 3-month intermittent courses.

Outcome measures

Outcome measures
Measure	Ulipristal Acetate (PGL4001) 5mg n=136 Participants PGL4001 5 mg: PGL4001 5 mg daily administration	Ulipristal Acetate (PGL4001) 10mg n=138 Participants PGL4001 10 mg: PGL4001 10mg daily administration
Percentage of Change From Baseline to End of Treatment Course 4 in Pain Using a Visual Analogue Scale (VAS)	-20.0 percentage of change from baseline Interval -46.1 to -0.5	-23.0 percentage of change from baseline Interval -52.0 to -1.0

Adverse Events

Ulipristal Acetate (PGL4001) 5mg

Serious events: 16 serious events

Other events: 129 other events

Deaths: 0 deaths

Ulipristal Acetate (PGL4001) 10mg

Serious events: 12 serious events

Other events: 131 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Dr Pablo Arriagada

PregLem

Phone: 0041228840355

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee PI shall submit to sponsor results communication for review 60 days prior to publication submission. If in the sponsor judgement, publication at a given time would hinder the sponsor's IP development, PI shall consider modifying the publication schedule. PI agrees to delete information identified by sponsor as confidential or defer publication to permit filing of patent application by the sponsor. Publication based on 1 site results shall not be made before the first muti-centre publication.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	Ulipristal Acetate (PGL4001) 5mg n=230 participants at risk PGL4001 5 mg: PGL4001 5 mg daily administration	Ulipristal Acetate (PGL4001) 10mg n=221 participants at risk PGL4001 10 mg: PGL4001 10mg daily administration
Reproductive system and breast disorders Menorrhagia	1.7% 4/230 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.	0.45% 1/221 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine Leiomyoma	0.43% 1/230 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.	1.4% 3/221 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.
Blood and lymphatic system disorders Anaemia	0.43% 1/230 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.	0.00% 0/221 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.
Blood and lymphatic system disorders Iron deficiency Anaemia	0.43% 1/230 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.	0.00% 0/221 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.
Cardiac disorders arteriospam coronary	0.00% 0/230 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.	0.45% 1/221 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.
Ear and labyrinth disorders tinnitus	0.00% 0/230 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.	0.45% 1/221 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.
Endocrine disorders toxic nodular goitre	0.43% 1/230 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.	0.00% 0/221 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.
Gastrointestinal disorders abdominal pain	0.43% 1/230 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.	0.00% 0/221 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.
Gastrointestinal disorders small intestinal obstruction	0.00% 0/230 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.	0.45% 1/221 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.
General disorders accidental death	0.43% 1/230 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.	0.00% 0/221 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.
General disorders homicide	0.43% 1/230 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.	0.00% 0/221 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.
Hepatobiliary disorders cholelithiasis	0.00% 0/230 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.	0.45% 1/221 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.
Musculoskeletal and connective tissue disorders back pain	0.43% 1/230 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.	0.00% 0/221 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.
Musculoskeletal and connective tissue disorders periarthritis	0.43% 1/230 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.	0.00% 0/221 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) breast cancer	0.00% 0/230 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.	0.45% 1/221 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.
Reproductive system and breast disorders breast hyperplasia	0.00% 0/230 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.	0.45% 1/221 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) endometrial cancer	0.43% 1/230 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.	0.00% 0/221 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) castleman's disease	0.43% 1/230 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.	0.00% 0/221 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.
Nervous system disorders carpal tunnel syndrome	0.00% 0/230 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.	0.45% 1/221 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.
Psychiatric disorders bipolar disorder	0.43% 1/230 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.	0.00% 0/221 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.
Renal and urinary disorders urethral stenesis	0.00% 0/230 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.	0.45% 1/221 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.
Vascular disorders deep vein thrombosis	0.43% 1/230 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.	0.00% 0/221 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.
Reproductive system and breast disorders Endometriosis	0.00% 0/230 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.	0.45% 1/221 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.

Other adverse events
Measure	Ulipristal Acetate (PGL4001) 5mg n=230 participants at risk PGL4001 5 mg: PGL4001 5 mg daily administration	Ulipristal Acetate (PGL4001) 10mg n=221 participants at risk PGL4001 10 mg: PGL4001 10mg daily administration
Nervous system disorders headache	13.5% 31/230 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.	13.6% 30/221 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.
Reproductive system and breast disorders hot flush	7.8% 18/230 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.	10.4% 23/221 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.
Infections and infestations influenza	5.2% 12/230 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.	4.5% 10/221 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.
Infections and infestations nasopharyngitis	3.0% 7/230 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.	5.4% 12/221 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.
Reproductive system and breast disorders breast pain/breast tenderness/breast disconfort	4.3% 10/230 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.	3.6% 8/221 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.
Reproductive system and breast disorders pelvic pain	4.3% 10/230 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.	2.3% 5/221 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.
General disorders fatigue	3.0% 7/230 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.	3.6% 8/221 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.
Gastrointestinal disorders nausea	3.5% 8/230 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.	2.7% 6/221 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.
Reproductive system and breast disorders vaginal discharge	2.2% 5/230 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.	3.2% 7/221 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.
Musculoskeletal and connective tissue disorders back pain	2.2% 5/230 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.	2.7% 6/221 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.
Gastrointestinal disorders abdominal pain	2.2% 5/230 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.	2.3% 5/221 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.
Skin and subcutaneous tissue disorders acne	2.2% 5/230 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.	1.8% 4/221 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.
Psychiatric disorders anxiety	2.2% 5/230 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.	1.8% 4/221 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.
Blood and lymphatic system disorders aneamia	2.2% 5/230 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.	1.4% 3/221 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.
Infections and infestations tonsillitis	1.7% 4/230 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.	2.3% 5/221 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.
Vascular disorders hypertension	2.2% 5/230 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.	1.8% 4/221 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.
Ear and labyrinth disorders vertigo	2.6% 6/230 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.	0.90% 2/221 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.
Investigations weight increased	2.2% 5/230 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.	1.4% 3/221 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.
Infections and infestations cystitis	1.3% 3/230 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.	2.3% 5/221 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.
Respiratory, thoracic and mediastinal disorders cough	0.87% 2/230 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.	2.7% 6/221 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.
Investigations blood creatine phosphokinase increased	2.2% 5/230 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.	0.90% 2/221 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.
Respiratory, thoracic and mediastinal disorders oropharyngeal pain	0.00% 0/230 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.	2.3% 5/221 • Serious Adverse events were reported where the start date was on or after the first dose of study medication, up to the end of study follow-up (21 months on average).Other Adverse Events are summarised as on-treatment TEAEs. 2 subjects randomised to Ulipristal acetate 10 mg received 5 mg by mistake. They are included in the safety set according to treatment received. On-treatment TEAEs are events where the start date was on or after the first dose of study medication, up to and including 7 days after the last dose of study medication within each treatment course.