Trial Outcomes & Findings for Safety and Efficacy of Elagolix in Pre-Menopausal Women With Heavy Uterine Bleeding and Uterine Fibroids (NCT NCT01441635)

Last Updated: 2021-07-13

Results Overview

The alkaline hematin method was used for the assessment of MBL. Sanitary products were collected at screening and for any spotting or bleeding episodes that occurred during treatment. Participants with missing MBL volume for the last treatment period and no bleeding indicated in the electronic daily bleeding diary (eDiary) in the last treatment period, and participants with no post-baseline MBL data were assigned an MBL value of zero.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

271 participants

Primary outcome timeframe

Baseline (last menstrual cycle during the screening period) and the last 28 days of treatment (approximately days 61 to 90)

Results posted on

2021-07-13

Participant Flow

Overall, 271 female participants were enrolled into the study across 45 sites in the United States.

Six cohorts of participants were enrolled, with 3 double-blind cohorts comparing elagolix with placebo, 2 open-label cohorts assessing add-back therapies, and 1 open-label cohort assessing the elagolix 600 mg QD dosing regimen.

Participant milestones

Participant milestones
Measure	Cohort 4 Elagolix 400 mg QD Participants received elagolix 400 mg once a day (QD) for 3 months.	Cohort 4 Elagolix 100 mg BID Participants received elagolix 100 mg twice a day (BID) for 3 months.	Cohort 4 Placebo Participants received placebo to elagolix BID for 3 months.	Cohort 1 Elagolix 200 mg BID Participants received elagolix 200 mg twice a day for 3 months.	Cohort 1 Placebo Participants received placebo to elagolix twice a day for 3 months.	Cohort 3 Elagolix 200 mg BID + LD E2/NETA Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.	Cohort 5 Elagolix 600 mg QD Participants received elagolix 600 mg once a day for 3 months.	Cohort 2 Elagolix 300 mg BID Participants received elagolix 300 mg twice a day for 3 months.	Cohort 2 Placebo Participants received placebo to elagolix BID for 3 months.	Cohort 6 Elagolix 300 mg BID + CEP Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.
Overall Study STARTED	32	33	16	35	18	34	30	30	16	27
Overall Study COMPLETED	26	27	13	28	16	29	24	26	14	25
Overall Study NOT COMPLETED	6	6	3	7	2	5	6	4	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 4 Elagolix 400 mg QD Participants received elagolix 400 mg once a day (QD) for 3 months.	Cohort 4 Elagolix 100 mg BID Participants received elagolix 100 mg twice a day (BID) for 3 months.	Cohort 4 Placebo Participants received placebo to elagolix BID for 3 months.	Cohort 1 Elagolix 200 mg BID Participants received elagolix 200 mg twice a day for 3 months.	Cohort 1 Placebo Participants received placebo to elagolix twice a day for 3 months.	Cohort 3 Elagolix 200 mg BID + LD E2/NETA Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.	Cohort 5 Elagolix 600 mg QD Participants received elagolix 600 mg once a day for 3 months.	Cohort 2 Elagolix 300 mg BID Participants received elagolix 300 mg twice a day for 3 months.	Cohort 2 Placebo Participants received placebo to elagolix BID for 3 months.	Cohort 6 Elagolix 300 mg BID + CEP Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.
Overall Study Adverse Event	4	3	1	5	1	2	2	2	1	0
Overall Study Withdrawal by Subject	1	1	0	1	0	0	2	0	1	1
Overall Study Lost to Follow-up	0	1	1	1	1	3	1	1	0	1
Overall Study Noncompliance	0	1	0	0	0	0	1	0	0	0
Overall Study Surgery or Invasive Intervention	0	0	1	0	0	0	0	0	0	0
Overall Study Received Exclusionary Medication	1	0	0	0	0	0	0	0	0	0
Overall Study Other	0	0	0	0	0	0	0	1	0	0

Baseline Characteristics

Safety and Efficacy of Elagolix in Pre-Menopausal Women With Heavy Uterine Bleeding and Uterine Fibroids

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 4 Elagolix 400 mg QD n=32 Participants Participants received elagolix 400 mg once a day (QD) for 3 months.	Cohort 4 Elagolix 100 mg BID n=33 Participants Participants received elagolix 100 mg twice a day (BID) for 3 months.	Cohort 4 Placebo n=16 Participants Participants received placebo to elagolix BID for 3 months.	Cohort 1 Elagolix 200 mg BID n=35 Participants Participants received elagolix 200 mg twice a day for 3 months.	Cohort 1 Placebo n=18 Participants Participants received placebo to elagolix twice a day for 3 months.	Cohort 3 Elagolix 200 mg BID + LD E2/NETA n=34 Participants Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.	Cohort 5 Elagolix 600 mg QD n=30 Participants Participants received elagolix 600 mg once a day for 3 months.	Cohort 2 Elagolix 300 mg BID n=30 Participants Participants received elagolix 300 mg twice a day for 3 months.	Cohort 2 Placebo n=16 Participants Participants received placebo to elagolix BID for 3 months.	Cohort 6 Elagolix 300 mg BID + CEP n=27 Participants Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.	Total n=271 Participants Total of all reporting groups
Age, Continuous	40.8 years STANDARD_DEVIATION 5.50 • n=5 Participants	42.1 years STANDARD_DEVIATION 5.09 • n=7 Participants	41.1 years STANDARD_DEVIATION 5.88 • n=5 Participants	43.1 years STANDARD_DEVIATION 4.29 • n=4 Participants	44.0 years STANDARD_DEVIATION 4.24 • n=21 Participants	40.9 years STANDARD_DEVIATION 6.02 • n=8 Participants	40.8 years STANDARD_DEVIATION 5.78 • n=8 Participants	42.6 years STANDARD_DEVIATION 5.55 • n=24 Participants	41.6 years STANDARD_DEVIATION 7.10 • n=42 Participants	41.6 years STANDARD_DEVIATION 5.26 • n=42 Participants	41.8 years STANDARD_DEVIATION 5.4 • n=42 Participants
Age, Customized < 35 years	7 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	5 Participants n=8 Participants	4 Participants n=8 Participants	3 Participants n=24 Participants	3 Participants n=42 Participants	3 Participants n=42 Participants	32 Participants n=42 Participants
Age, Customized 35 to < 40 years	6 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	5 Participants n=4 Participants	2 Participants n=21 Participants	8 Participants n=8 Participants	6 Participants n=8 Participants	5 Participants n=24 Participants	3 Participants n=42 Participants	6 Participants n=42 Participants	51 Participants n=42 Participants
Age, Customized 40 to < 45 years	8 Participants n=5 Participants	13 Participants n=7 Participants	2 Participants n=5 Participants	13 Participants n=4 Participants	7 Participants n=21 Participants	10 Participants n=8 Participants	11 Participants n=8 Participants	9 Participants n=24 Participants	3 Participants n=42 Participants	10 Participants n=42 Participants	86 Participants n=42 Participants
Age, Customized ≥ 45 years	11 Participants n=5 Participants	12 Participants n=7 Participants	7 Participants n=5 Participants	15 Participants n=4 Participants	9 Participants n=21 Participants	11 Participants n=8 Participants	9 Participants n=8 Participants	13 Participants n=24 Participants	7 Participants n=42 Participants	8 Participants n=42 Participants	102 Participants n=42 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	33 Participants n=7 Participants	16 Participants n=5 Participants	35 Participants n=4 Participants	18 Participants n=21 Participants	34 Participants n=8 Participants	30 Participants n=8 Participants	30 Participants n=24 Participants	16 Participants n=42 Participants	27 Participants n=42 Participants	271 Participants n=42 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	8 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants	6 Participants n=8 Participants	0 Participants n=24 Participants	2 Participants n=42 Participants	12 Participants n=42 Participants	33 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	31 Participants n=5 Participants	25 Participants n=7 Participants	15 Participants n=5 Participants	34 Participants n=4 Participants	17 Participants n=21 Participants	33 Participants n=8 Participants	24 Participants n=8 Participants	30 Participants n=24 Participants	14 Participants n=42 Participants	15 Participants n=42 Participants	238 Participants n=42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race/Ethnicity, Customized White	5 Participants n=5 Participants	10 Participants n=7 Participants	3 Participants n=5 Participants	7 Participants n=4 Participants	3 Participants n=21 Participants	7 Participants n=8 Participants	5 Participants n=8 Participants	6 Participants n=24 Participants	6 Participants n=42 Participants	11 Participants n=42 Participants	63 Participants n=42 Participants
Race/Ethnicity, Customized Black	25 Participants n=5 Participants	23 Participants n=7 Participants	13 Participants n=5 Participants	28 Participants n=4 Participants	14 Participants n=21 Participants	26 Participants n=8 Participants	24 Participants n=8 Participants	23 Participants n=24 Participants	9 Participants n=42 Participants	15 Participants n=42 Participants	200 Participants n=42 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	4 Participants n=42 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	3 Participants n=42 Participants
Race/Ethnicity, Customized Multirace	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants

PRIMARY outcome

Timeframe: Baseline (last menstrual cycle during the screening period) and the last 28 days of treatment (approximately days 61 to 90)

Population: Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants, excluding participants with less than 28 days of treatment. Last observation carried forward (LOCF) imputation was used for participants with no MBL volume reported by alkaline hematin method but with light to heavy bleeding reported in the eDiary.

Outcome measures

Outcome measures
Measure	Cohort 1 Placebo n=18 Participants Participants received placebo to elagolix twice a day for 3 months.	Cohort 6 Elagolix 300 mg BID + CEP n=26 Participants Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.	Cohort 4 Elagolix 400 mg QD n=31 Participants Participants received elagolix 400 mg once a day (QD) for 3 months.	Cohort 4 Elagolix 100 mg BID n=31 Participants Participants received elagolix 100 mg twice a day (BID) for 3 months.	Cohort 4 Placebo n=15 Participants Participants received placebo to elagolix BID for 3 months.	Cohort 1 Elagolix 200 mg BID n=32 Participants Participants received elagolix 200 mg twice a day for 3 months.	Cohort 3 Elagolix 200 mg BID + LD E2/NETA n=33 Participants Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.	Cohort 5 Elagolix 600 mg QD n=28 Participants Participants received elagolix 600 mg once a day for 3 months.	Cohort 2 Elagolix 300 mg BID n=30 Participants Participants received elagolix 300 mg twice a day for 3 months.	Cohort 2 Placebo n=15 Participants Participants received placebo to elagolix BID for 3 months.
Mean Change From Baseline to the Last 28 Days of Treatment in Menstrual Blood Loss (MBL) Baseline	251.72 mL Standard Deviation 160.29	257.99 mL Standard Deviation 207.33	213.70 mL Standard Deviation 108.08	269.36 mL Standard Deviation 163.17	321.73 mL Standard Deviation 327.57	335.11 mL Standard Deviation 322.68	247.70 mL Standard Deviation 177.72	215.62 mL Standard Deviation 122.84	206.27 mL Standard Deviation 125.08	349.17 mL Standard Deviation 424.12
Mean Change From Baseline to the Last 28 Days of Treatment in Menstrual Blood Loss (MBL) Change from Baseline	-79.00 mL Standard Deviation 161.33	-216.15 mL Standard Deviation 157.08	-183.97 mL Standard Deviation 132.19	-184.69 mL Standard Deviation 187.05	-10.46 mL Standard Deviation 85.04	-272.97 mL Standard Deviation 271.39	-192.33 mL Standard Deviation 191.51	-189.05 mL Standard Deviation 151.15	-202.57 mL Standard Deviation 127.93	-175.31 mL Standard Deviation 342.14

SECONDARY outcome

Timeframe: Baseline (last menstrual cycle during the screening period) and the last 28 days of treatment (approximately days 61 to 90)

Outcome measures

Outcome measures
Measure	Cohort 1 Placebo n=18 Participants Participants received placebo to elagolix twice a day for 3 months.	Cohort 6 Elagolix 300 mg BID + CEP n=26 Participants Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.	Cohort 4 Elagolix 400 mg QD n=31 Participants Participants received elagolix 400 mg once a day (QD) for 3 months.	Cohort 4 Elagolix 100 mg BID n=31 Participants Participants received elagolix 100 mg twice a day (BID) for 3 months.	Cohort 4 Placebo n=15 Participants Participants received placebo to elagolix BID for 3 months.	Cohort 1 Elagolix 200 mg BID n=32 Participants Participants received elagolix 200 mg twice a day for 3 months.	Cohort 3 Elagolix 200 mg BID + LD E2/NETA n=33 Participants Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.	Cohort 5 Elagolix 600 mg QD n=28 Participants Participants received elagolix 600 mg once a day for 3 months.	Cohort 2 Elagolix 300 mg BID n=30 Participants Participants received elagolix 300 mg twice a day for 3 months.	Cohort 2 Placebo n=15 Participants Participants received placebo to elagolix BID for 3 months.
Percent Change From Baseline to the Last 28 Days of Treatment in Menstrual Blood Loss (MBL)	-11.12 percent change Standard Deviation 103.11	-85.39 percent change Standard Deviation 28.08	-83.83 percent change Standard Deviation 35.23	-71.85 percent change Standard Deviation 49.20	-6.98 percent change Standard Deviation 40.78	-81.03 percent change Standard Deviation 55.77	-79.60 percent change Standard Deviation 43.63	-88.58 percent change Standard Deviation 39.58	-97.31 percent change Standard Deviation 12.57	-42.64 percent change Standard Deviation 39.68

SECONDARY outcome

Timeframe: Baseline (last menstrual cycle during the screening period) and the last 28 days of treatment (approximately days 61 to 90)

Population: Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants, excluding participants with less than 28 days of treatment. LOCF imputation was used for participants with no MBL volume reported by alkaline hematin method but with light to heavy bleeding reported in the eDiary.

Outcome measures

Outcome measures
Measure	Cohort 1 Placebo n=18 Participants Participants received placebo to elagolix twice a day for 3 months.	Cohort 6 Elagolix 300 mg BID + CEP n=26 Participants Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.	Cohort 4 Elagolix 400 mg QD n=31 Participants Participants received elagolix 400 mg once a day (QD) for 3 months.	Cohort 4 Elagolix 100 mg BID n=31 Participants Participants received elagolix 100 mg twice a day (BID) for 3 months.	Cohort 4 Placebo n=15 Participants Participants received placebo to elagolix BID for 3 months.	Cohort 1 Elagolix 200 mg BID n=33 Participants Participants received elagolix 200 mg twice a day for 3 months.	Cohort 3 Elagolix 200 mg BID + LD E2/NETA n=33 Participants Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.	Cohort 5 Elagolix 600 mg QD n=28 Participants Participants received elagolix 600 mg once a day for 3 months.	Cohort 2 Elagolix 300 mg BID n=30 Participants Participants received elagolix 300 mg twice a day for 3 months.	Cohort 2 Placebo n=15 Participants Participants received placebo to elagolix BID for 3 months.
Percentage of Participants With MBL < 80 mL and With a ≥ 50% Reduction From Baseline in MBL During the Last 28 Days of Treatment	17 percentage of participants	85 percentage of participants	84 percentage of participants	74 percentage of participants	13 percentage of participants	85 percentage of participants	85 percentage of participants	93 percentage of participants	97 percentage of participants	33 percentage of participants

SECONDARY outcome

Timeframe: The last 28 days of treatment (approximately days 61 to 90)

Outcome measures

Outcome measures
Measure	Cohort 1 Placebo n=18 Participants Participants received placebo to elagolix twice a day for 3 months.	Cohort 6 Elagolix 300 mg BID + CEP n=26 Participants Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.	Cohort 4 Elagolix 400 mg QD n=31 Participants Participants received elagolix 400 mg once a day (QD) for 3 months.	Cohort 4 Elagolix 100 mg BID n=31 Participants Participants received elagolix 100 mg twice a day (BID) for 3 months.	Cohort 4 Placebo n=15 Participants Participants received placebo to elagolix BID for 3 months.	Cohort 1 Elagolix 200 mg BID n=33 Participants Participants received elagolix 200 mg twice a day for 3 months.	Cohort 3 Elagolix 200 mg BID + LD E2/NETA n=33 Participants Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.	Cohort 5 Elagolix 600 mg QD n=28 Participants Participants received elagolix 600 mg once a day for 3 months.	Cohort 2 Elagolix 300 mg BID n=30 Participants Participants received elagolix 300 mg twice a day for 3 months.	Cohort 2 Placebo n=15 Participants Participants received placebo to elagolix BID for 3 months.
Percentage of Participants With MBL < 80 mL During the Last 28 Days of Treatment	22 percentage of participants	88 percentage of participants	84 percentage of participants	74 percentage of participants	13 percentage of participants	85 percentage of participants	88 percentage of participants	93 percentage of participants	97 percentage of participants	47 percentage of participants

SECONDARY outcome

Timeframe: Baseline (last menstrual cycle during the screening period) and the last 28 days of treatment (approximately days 61 to 90)

Outcome measures

Outcome measures
Measure	Cohort 1 Placebo n=18 Participants Participants received placebo to elagolix twice a day for 3 months.	Cohort 6 Elagolix 300 mg BID + CEP n=26 Participants Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.	Cohort 4 Elagolix 400 mg QD n=31 Participants Participants received elagolix 400 mg once a day (QD) for 3 months.	Cohort 4 Elagolix 100 mg BID n=31 Participants Participants received elagolix 100 mg twice a day (BID) for 3 months.	Cohort 4 Placebo n=15 Participants Participants received placebo to elagolix BID for 3 months.	Cohort 1 Elagolix 200 mg BID n=33 Participants Participants received elagolix 200 mg twice a day for 3 months.	Cohort 3 Elagolix 200 mg BID + LD E2/NETA n=33 Participants Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.	Cohort 5 Elagolix 600 mg QD n=28 Participants Participants received elagolix 600 mg once a day for 3 months.	Cohort 2 Elagolix 300 mg BID n=30 Participants Participants received elagolix 300 mg twice a day for 3 months.	Cohort 2 Placebo n=15 Participants Participants received placebo to elagolix BID for 3 months.
Percentage of Participants With a ≥ 50% Reduction From Baseline in MBL During the Last 28 Days of Treatment	28 percentage of participants	88 percentage of participants	84 percentage of participants	74 percentage of participants	13 percentage of participants	91 percentage of participants	85 percentage of participants	93 percentage of participants	97 percentage of participants	40 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Month 3

Population: Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants with available hemoglobin data.

The percentage of subjects with changes in hemoglobin concentration from Baseline to Month 3 in each of the following categories: * No change from baseline in hemoglobin * Decrease from baseline in hemoglobin ≥ -0.5 g/dL * Decrease from baseline in hemoglobin ≥ -1.0 g/dL * Increase from baseline in hemoglobin ≥ 0.5 g/dL * Increase from baseline in hemoglobin ≥ 1.0 g/dL The above categories are not all mutually exclusive or exhaustive.

Outcome measures

Outcome measures
Measure	Cohort 1 Placebo n=14 Participants Participants received placebo to elagolix twice a day for 3 months.	Cohort 6 Elagolix 300 mg BID + CEP n=21 Participants Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.	Cohort 4 Elagolix 400 mg QD n=23 Participants Participants received elagolix 400 mg once a day (QD) for 3 months.	Cohort 4 Elagolix 100 mg BID n=24 Participants Participants received elagolix 100 mg twice a day (BID) for 3 months.	Cohort 4 Placebo n=11 Participants Participants received placebo to elagolix BID for 3 months.	Cohort 1 Elagolix 200 mg BID n=27 Participants Participants received elagolix 200 mg twice a day for 3 months.	Cohort 3 Elagolix 200 mg BID + LD E2/NETA n=28 Participants Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.	Cohort 5 Elagolix 600 mg QD n=23 Participants Participants received elagolix 600 mg once a day for 3 months.	Cohort 2 Elagolix 300 mg BID n=25 Participants Participants received elagolix 300 mg twice a day for 3 months.	Cohort 2 Placebo n=14 Participants Participants received placebo to elagolix BID for 3 months.
Percentage of Participants With No Change, Decrease From Baseline, or Increase From Baseline in Hemoglobin at Month 3 No Change	0 percentage of participants	5 percentage of participants	0 percentage of participants	0 percentage of participants	9 percentage of participants	0 percentage of participants	0 percentage of participants	4 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With No Change, Decrease From Baseline, or Increase From Baseline in Hemoglobin at Month 3 Decreases from -0.5 to 0 g/dL	21 percentage of participants	5 percentage of participants	9 percentage of participants	17 percentage of participants	0 percentage of participants	4 percentage of participants	14 percentage of participants	4 percentage of participants	0 percentage of participants	21 percentage of participants
Percentage of Participants With No Change, Decrease From Baseline, or Increase From Baseline in Hemoglobin at Month 3 Decreases from -1.0 to -0.5 g/dL	14 percentage of participants	10 percentage of participants	4 percentage of participants	4 percentage of participants	27 percentage of participants	11 percentage of participants	0 percentage of participants	4 percentage of participants	0 percentage of participants	7 percentage of participants
Percentage of Participants With No Change, Decrease From Baseline, or Increase From Baseline in Hemoglobin at Month 3 Increase ≥ 0.5 g/dL	29 percentage of participants	71 percentage of participants	78 percentage of participants	71 percentage of participants	18 percentage of participants	67 percentage of participants	75 percentage of participants	83 percentage of participants	76 percentage of participants	29 percentage of participants
Percentage of Participants With No Change, Decrease From Baseline, or Increase From Baseline in Hemoglobin at Month 3 Increase ≥ 1.0 g/dL	29 percentage of participants	62 percentage of participants	61 percentage of participants	71 percentage of participants	9 percentage of participants	59 percentage of participants	43 percentage of participants	57 percentage of participants	52 percentage of participants	29 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Month 3

Population: Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants with available hemoglobin data at baseline and month 3.

Outcome measures

Outcome measures
Measure	Cohort 1 Placebo n=14 Participants Participants received placebo to elagolix twice a day for 3 months.	Cohort 6 Elagolix 300 mg BID + CEP n=21 Participants Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.	Cohort 4 Elagolix 400 mg QD n=23 Participants Participants received elagolix 400 mg once a day (QD) for 3 months.	Cohort 4 Elagolix 100 mg BID n=24 Participants Participants received elagolix 100 mg twice a day (BID) for 3 months.	Cohort 4 Placebo n=11 Participants Participants received placebo to elagolix BID for 3 months.	Cohort 1 Elagolix 200 mg BID n=27 Participants Participants received elagolix 200 mg twice a day for 3 months.	Cohort 3 Elagolix 200 mg BID + LD E2/NETA n=28 Participants Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.	Cohort 5 Elagolix 600 mg QD n=23 Participants Participants received elagolix 600 mg once a day for 3 months.	Cohort 2 Elagolix 300 mg BID n=25 Participants Participants received elagolix 300 mg twice a day for 3 months.	Cohort 2 Placebo n=14 Participants Participants received placebo to elagolix BID for 3 months.
Change in Hemoglobin Concentration From Baseline to Month 3	0.28 g/dL Standard Deviation 1.33	1.54 g/dL Standard Deviation 1.81	1.18 g/dL Standard Deviation 0.99	1.30 g/dL Standard Deviation 1.19	-0.43 g/dL Standard Deviation 1.28	1.13 g/dL Standard Deviation 1.29	0.92 g/dL Standard Deviation 0.81	1.40 g/dL Standard Deviation 1.18	1.19 g/dL Standard Deviation 0.85	0.31 g/dL Standard Deviation 1.20

SECONDARY outcome

Timeframe: Baseline (average bleeding score over the 30 days prior to first dose) and month 3 (average bleeding score over days 61 to 90)

Population: Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants with available bleeding score data at baseline and month 3.

Participants recorded the previous days' presence and severity of bleeding every morning in an electronic diary (eDiary) according to the Mansfield-Voda-Jorgenson Menstrual Bleeding Scale: * 1 (Spotting): A drop or 2 of blood, not even requiring sanitary protection. * 2 (Very light): Needing to change the least absorbent tampon or pad 1 to 2 times per day. * 3 (Light): Needing to change a low or regular absorbency tampon or pad 2 or 3 times per day. * 4 (Moderate): Needing to change a regular absorbency tampon or pad every 3 to 4 hours. * 5 (Heavy): Needing to change a high absorbency tampon or pad every 3 to 4 hours. * 6 (Very heavy/gushing): Very heavy bleeding, protection hardly works at all; needing to change the highest absorbency tampon or pad every hour or 2.

Outcome measures

Outcome measures
Measure	Cohort 1 Placebo n=17 Participants Participants received placebo to elagolix twice a day for 3 months.	Cohort 6 Elagolix 300 mg BID + CEP n=25 Participants Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.	Cohort 4 Elagolix 400 mg QD n=30 Participants Participants received elagolix 400 mg once a day (QD) for 3 months.	Cohort 4 Elagolix 100 mg BID n=30 Participants Participants received elagolix 100 mg twice a day (BID) for 3 months.	Cohort 4 Placebo n=15 Participants Participants received placebo to elagolix BID for 3 months.	Cohort 1 Elagolix 200 mg BID n=32 Participants Participants received elagolix 200 mg twice a day for 3 months.	Cohort 3 Elagolix 200 mg BID + LD E2/NETA n=32 Participants Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.	Cohort 5 Elagolix 600 mg QD n=26 Participants Participants received elagolix 600 mg once a day for 3 months.	Cohort 2 Elagolix 300 mg BID n=27 Participants Participants received elagolix 300 mg twice a day for 3 months.	Cohort 2 Placebo n=15 Participants Participants received placebo to elagolix BID for 3 months.
Change From Baseline to Month 3 in Uterine Bleeding Score	-0.22 units on a scale Standard Deviation 0.32	-0.25 units on a scale Standard Deviation 0.64	-0.50 units on a scale Standard Deviation 0.56	-0.37 units on a scale Standard Deviation 0.46	-0.19 units on a scale Standard Deviation 0.33	-0.52 units on a scale Standard Deviation 0.65	-0.24 units on a scale Standard Deviation 0.47	-0.44 units on a scale Standard Deviation 0.71	-0.53 units on a scale Standard Deviation 0.33	-0.38 units on a scale Standard Deviation 0.77

SECONDARY outcome

Timeframe: Baseline (average bleeding score over the 30 days prior to first dose) and month 3 (average bleeding score over days 61 to 90)

Population: Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants with available bleeding score data at baseline and month 3.

Outcome measures

Outcome measures
Measure	Cohort 1 Placebo n=17 Participants Participants received placebo to elagolix twice a day for 3 months.	Cohort 6 Elagolix 300 mg BID + CEP n=25 Participants Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.	Cohort 4 Elagolix 400 mg QD n=30 Participants Participants received elagolix 400 mg once a day (QD) for 3 months.	Cohort 4 Elagolix 100 mg BID n=30 Participants Participants received elagolix 100 mg twice a day (BID) for 3 months.	Cohort 4 Placebo n=15 Participants Participants received placebo to elagolix BID for 3 months.	Cohort 1 Elagolix 200 mg BID n=32 Participants Participants received elagolix 200 mg twice a day for 3 months.	Cohort 3 Elagolix 200 mg BID + LD E2/NETA n=32 Participants Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.	Cohort 5 Elagolix 600 mg QD n=26 Participants Participants received elagolix 600 mg once a day for 3 months.	Cohort 2 Elagolix 300 mg BID n=27 Participants Participants received elagolix 300 mg twice a day for 3 months.	Cohort 2 Placebo n=15 Participants Participants received placebo to elagolix BID for 3 months.
Change From Baseline to Month 3 in Percentage of Days With Any Uterine Bleeding	-6.99 percentage of days Standard Deviation 12.82	1.73 percentage of days Standard Deviation 26.09	-15.22 percentage of days Standard Deviation 14.77	-11.00 percentage of days Standard Deviation 15.52	-5.78 percentage of days Standard Deviation 10.58	-15.82 percentage of days Standard Deviation 17.88	3.63 percentage of days Standard Deviation 24.74	-15.38 percentage of days Standard Deviation 23.21	-16.91 percentage of days Standard Deviation 11.13	-13.95 percentage of days Standard Deviation 23.83

SECONDARY outcome

Timeframe: Baseline (average bleeding score over the 30 days prior to first dose) and month 3 (average bleeding score over days 61 to 90)

Population: Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants with available bleeding score data at baseline and month 3.

Outcome measures

Outcome measures
Measure	Cohort 1 Placebo n=17 Participants Participants received placebo to elagolix twice a day for 3 months.	Cohort 6 Elagolix 300 mg BID + CEP n=25 Participants Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.	Cohort 4 Elagolix 400 mg QD n=30 Participants Participants received elagolix 400 mg once a day (QD) for 3 months.	Cohort 4 Elagolix 100 mg BID n=30 Participants Participants received elagolix 100 mg twice a day (BID) for 3 months.	Cohort 4 Placebo n=15 Participants Participants received placebo to elagolix BID for 3 months.	Cohort 1 Elagolix 200 mg BID n=32 Participants Participants received elagolix 200 mg twice a day for 3 months.	Cohort 3 Elagolix 200 mg BID + LD E2/NETA n=32 Participants Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.	Cohort 5 Elagolix 600 mg QD n=26 Participants Participants received elagolix 600 mg once a day for 3 months.	Cohort 2 Elagolix 300 mg BID n=27 Participants Participants received elagolix 300 mg twice a day for 3 months.	Cohort 2 Placebo n=15 Participants Participants received placebo to elagolix BID for 3 months.
Change From Baseline to Month 3 in Percentage of Days With Moderate to Very Heavy Bleeding	-3.08 percentage of days Standard Deviation 5.88	-6.80 percentage of days Standard Deviation 10.69	-7.22 percentage of days Standard Deviation 9.27	-5.00 percentage of days Standard Deviation 7.87	-4.00 percentage of days Standard Deviation 5.37	-7.03 percentage of days Standard Deviation 10.89	-7.92 percentage of days Standard Deviation 6.43	-6.15 percentage of days Standard Deviation 8.47	-8.02 percentage of days Standard Deviation 5.41	-3.31 percentage of days Standard Deviation 10.40

SECONDARY outcome

Timeframe: Month 3 (average bleeding score over days 61 to 90)

Population: Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants with available bleeding score data at month 3.

Participants recorded the previous days' presence and severity of bleeding every morning in an eDiary according to the Mansfield-Voda-Jorgenson Menstrual Bleeding Scale: * 1 (Spotting): A drop or 2 of blood, not even requiring sanitary protection. * 2 (Very light): Needing to change the least absorbent tampon or pad 1 to 2 times per day. * 3 (Light): Needing to change a low or regular absorbency tampon or pad 2 or 3 times per day. * 4 (Moderate): Needing to change a regular absorbency tampon or pad every 3 to 4 hours. * 5 (Heavy): Needing to change a high absorbency tampon or pad every 3 to 4 hours. * 6 (Very heavy/gushing): Very heavy bleeding, protection hardly works at all; needing to change the highest absorbency tampon or pad every hour or 2. Any bleeding is defined as a score ≥ 1 and moderate to very heavy bleeding is defined as a score ≥ 3.

Outcome measures

Outcome measures
Measure	Cohort 1 Placebo n=17 Participants Participants received placebo to elagolix twice a day for 3 months.	Cohort 6 Elagolix 300 mg BID + CEP n=26 Participants Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.	Cohort 4 Elagolix 400 mg QD n=30 Participants Participants received elagolix 400 mg once a day (QD) for 3 months.	Cohort 4 Elagolix 100 mg BID n=30 Participants Participants received elagolix 100 mg twice a day (BID) for 3 months.	Cohort 4 Placebo n=15 Participants Participants received placebo to elagolix BID for 3 months.	Cohort 1 Elagolix 200 mg BID n=32 Participants Participants received elagolix 200 mg twice a day for 3 months.	Cohort 3 Elagolix 200 mg BID + LD E2/NETA n=32 Participants Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.	Cohort 5 Elagolix 600 mg QD n=26 Participants Participants received elagolix 600 mg once a day for 3 months.	Cohort 2 Elagolix 300 mg BID n=27 Participants Participants received elagolix 300 mg twice a day for 3 months.	Cohort 2 Placebo n=15 Participants Participants received placebo to elagolix BID for 3 months.
Percentage of Participants With Any Uterine Bleeding or Moderate to Very Heavy Uterine Bleeding at Month 3 Any bleeding	94 percentage of participants	69 percentage of participants	37 percentage of participants	57 percentage of participants	93 percentage of participants	47 percentage of participants	78 percentage of participants	27 percentage of participants	26 percentage of participants	80 percentage of participants
Percentage of Participants With Any Uterine Bleeding or Moderate to Very Heavy Uterine Bleeding at Month 3 Moderate to Very Heavy Bleeding	82 percentage of participants	35 percentage of participants	27 percentage of participants	40 percentage of participants	87 percentage of participants	28 percentage of participants	31 percentage of participants	15 percentage of participants	7 percentage of participants	73 percentage of participants

SECONDARY outcome

Timeframe: The last 56 days of treatment (approximately days 33 to 90)

Population: Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants including participants with less than 56 days of treatment who bled but excluded those who did not bleed.

Suppression of bleeding is defined as no record of bleeding (spotting allowed) in the e-diary and no record of bleeding Indicated in the alkaline hematin data during the last 56 days of treatment. Amenorrhea is defined as no record of bleeding or spotting indicated in the e-diary and no record of bleeding or spotting Indicated in the alkaline hematin data during the last 56 days of treatment.

Outcome measures

Outcome measures
Measure	Cohort 1 Placebo n=18 Participants Participants received placebo to elagolix twice a day for 3 months.	Cohort 6 Elagolix 300 mg BID + CEP n=26 Participants Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.	Cohort 4 Elagolix 400 mg QD n=30 Participants Participants received elagolix 400 mg once a day (QD) for 3 months.	Cohort 4 Elagolix 100 mg BID n=29 Participants Participants received elagolix 100 mg twice a day (BID) for 3 months.	Cohort 4 Placebo n=15 Participants Participants received placebo to elagolix BID for 3 months.	Cohort 1 Elagolix 200 mg BID n=32 Participants Participants received elagolix 200 mg twice a day for 3 months.	Cohort 3 Elagolix 200 mg BID + LD E2/NETA n=32 Participants Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.	Cohort 5 Elagolix 600 mg QD n=26 Participants Participants received elagolix 600 mg once a day for 3 months.	Cohort 2 Elagolix 300 mg BID n=29 Participants Participants received elagolix 300 mg twice a day for 3 months.	Cohort 2 Placebo n=16 Participants Participants received placebo to elagolix BID for 3 months.
Percentage of Participants With Suppression of Bleeding (Spotting Allowed) or Amenorrhea During the Last 56 Days of Treatment Suppression of bleeding	0 percentage of participants	32 percentage of participants	66 percentage of participants	45 percentage of participants	0 percentage of participants	66 percentage of participants	31 percentage of participants	77 percentage of participants	79 percentage of participants	0 percentage of participants
Percentage of Participants With Suppression of Bleeding (Spotting Allowed) or Amenorrhea During the Last 56 Days of Treatment Amenorrhea	0 percentage of participants	19 percentage of participants	60 percentage of participants	31 percentage of participants	0 percentage of participants	44 percentage of participants	19 percentage of participants	73 percentage of participants	66 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Baseline and month 3

Population: Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants with available uterine volume data at baseline and month 3.

Uterine volume was determined using transabdominal ultrasound. The images were analyzed by a central imaging center.

Outcome measures

Outcome measures
Measure	Cohort 1 Placebo n=12 Participants Participants received placebo to elagolix twice a day for 3 months.	Cohort 6 Elagolix 300 mg BID + CEP n=11 Participants Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.	Cohort 4 Elagolix 400 mg QD n=22 Participants Participants received elagolix 400 mg once a day (QD) for 3 months.	Cohort 4 Elagolix 100 mg BID n=20 Participants Participants received elagolix 100 mg twice a day (BID) for 3 months.	Cohort 4 Placebo n=9 Participants Participants received placebo to elagolix BID for 3 months.	Cohort 1 Elagolix 200 mg BID n=22 Participants Participants received elagolix 200 mg twice a day for 3 months.	Cohort 3 Elagolix 200 mg BID + LD E2/NETA n=22 Participants Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.	Cohort 5 Elagolix 600 mg QD n=20 Participants Participants received elagolix 600 mg once a day for 3 months.	Cohort 2 Elagolix 300 mg BID n=20 Participants Participants received elagolix 300 mg twice a day for 3 months.	Cohort 2 Placebo n=12 Participants Participants received placebo to elagolix BID for 3 months.
Percent Change From Baseline to Month 3 in Uterine Volume	-8.62 percent change Standard Deviation 20.58	-10.06 percent change Standard Deviation 30.93	-21.01 percent change Standard Deviation 26.79	-21.37 percent change Standard Deviation 24.84	18.72 percent change Standard Deviation 15.59	-21.68 percent change Standard Deviation 29.80	-17.43 percent change Standard Deviation 19.51	-27.99 percent change Standard Deviation 23.34	-33.25 percent change Standard Deviation 16.55	-1.92 percent change Standard Deviation 17.52

SECONDARY outcome

Timeframe: Baseline and month 3 or the final visit during the treatment period for participants who prematurely discontinued.

Population: Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants with available uterine volume data at baseline and month 3.

Uterine volume was determined using transabdominal ultrasound. The images were analyzed by a central imaging center.

Outcome measures

Outcome measures
Measure	Cohort 1 Placebo n=18 Participants Participants received placebo to elagolix twice a day for 3 months.	Cohort 6 Elagolix 300 mg BID + CEP n=24 Participants Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.	Cohort 4 Elagolix 400 mg QD n=30 Participants Participants received elagolix 400 mg once a day (QD) for 3 months.	Cohort 4 Elagolix 100 mg BID n=30 Participants Participants received elagolix 100 mg twice a day (BID) for 3 months.	Cohort 4 Placebo n=15 Participants Participants received placebo to elagolix BID for 3 months.	Cohort 1 Elagolix 200 mg BID n=31 Participants Participants received elagolix 200 mg twice a day for 3 months.	Cohort 3 Elagolix 200 mg BID + LD E2/NETA n=33 Participants Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.	Cohort 5 Elagolix 600 mg QD n=27 Participants Participants received elagolix 600 mg once a day for 3 months.	Cohort 2 Elagolix 300 mg BID n=29 Participants Participants received elagolix 300 mg twice a day for 3 months.	Cohort 2 Placebo n=15 Participants Participants received placebo to elagolix BID for 3 months.
Percentage of Participants With ≥ 25% Reduction in Uterine Volume at Month 3 / Final Visit	11 percentage of participants	25 percentage of participants	53 percentage of participants	43 percentage of participants	7 percentage of participants	48 percentage of participants	42 percentage of participants	56 percentage of participants	69 percentage of participants	7 percentage of participants

SECONDARY outcome

Timeframe: Baseline and month 3

Population: Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants with available fibroid volume data at baseline and month 3.

The volume of the largest fibroid was determined using transabdominal ultrasound. The images were analyzed by a central imaging center.

Outcome measures

Outcome measures
Measure	Cohort 1 Placebo n=12 Participants Participants received placebo to elagolix twice a day for 3 months.	Cohort 6 Elagolix 300 mg BID + CEP n=10 Participants Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.	Cohort 4 Elagolix 400 mg QD n=19 Participants Participants received elagolix 400 mg once a day (QD) for 3 months.	Cohort 4 Elagolix 100 mg BID n=18 Participants Participants received elagolix 100 mg twice a day (BID) for 3 months.	Cohort 4 Placebo n=9 Participants Participants received placebo to elagolix BID for 3 months.	Cohort 1 Elagolix 200 mg BID n=22 Participants Participants received elagolix 200 mg twice a day for 3 months.	Cohort 3 Elagolix 200 mg BID + LD E2/NETA n=22 Participants Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.	Cohort 5 Elagolix 600 mg QD n=18 Participants Participants received elagolix 600 mg once a day for 3 months.	Cohort 2 Elagolix 300 mg BID n=20 Participants Participants received elagolix 300 mg twice a day for 3 months.	Cohort 2 Placebo n=12 Participants Participants received placebo to elagolix BID for 3 months.
Percent Change From Baseline to Month 3 in Volume of the Largest Fibroid	-2.05 percent change Standard Deviation 71.83	-4.94 percent change Standard Deviation 100.68	14.23 percent change Standard Deviation 187.83	-22.19 percent change Standard Deviation 51.14	-7.26 percent change Standard Deviation 36.35	-38.52 percent change Standard Deviation 41.72	-25.77 percent change Standard Deviation 46.64	-16.60 percent change Standard Deviation 39.61	-35.79 percent change Standard Deviation 24.49	6.70 percent change Standard Deviation 45.42

SECONDARY outcome

Timeframe: Baseline and month 3 or the final visit during the treatment period for participants who prematurely discontinued.

Population: Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants with available uterine volume data at baseline and month 3.

The volume of the largest fibroid was determined using transabdominal ultrasound. The images were analyzed by a central imaging center.

Outcome measures

Outcome measures
Measure	Cohort 1 Placebo n=17 Participants Participants received placebo to elagolix twice a day for 3 months.	Cohort 6 Elagolix 300 mg BID + CEP n=21 Participants Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.	Cohort 4 Elagolix 400 mg QD n=28 Participants Participants received elagolix 400 mg once a day (QD) for 3 months.	Cohort 4 Elagolix 100 mg BID n=29 Participants Participants received elagolix 100 mg twice a day (BID) for 3 months.	Cohort 4 Placebo n=15 Participants Participants received placebo to elagolix BID for 3 months.	Cohort 1 Elagolix 200 mg BID n=31 Participants Participants received elagolix 200 mg twice a day for 3 months.	Cohort 3 Elagolix 200 mg BID + LD E2/NETA n=33 Participants Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.	Cohort 5 Elagolix 600 mg QD n=25 Participants Participants received elagolix 600 mg once a day for 3 months.	Cohort 2 Elagolix 300 mg BID n=29 Participants Participants received elagolix 300 mg twice a day for 3 months.	Cohort 2 Placebo n=15 Participants Participants received placebo to elagolix BID for 3 months.
Percentage of Participants With ≥ 25% Reduction in Volume of Largest Fibroid at Month 3 / Final Visit	35 percentage of participants	48 percentage of participants	57 percentage of participants	52 percentage of participants	33 percentage of participants	68 percentage of participants	58 percentage of participants	60 percentage of participants	55 percentage of participants	27 percentage of participants

SECONDARY outcome

Timeframe: Baseline and month 3

Population: Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants with available UFS-QoL data at baseline and month 3.

The UFS-QoL is a disease-specific, self-administered, validated questionnaire developed to evaluate the symptoms associated with uterine fibroids and their impact on health-related quality of life (HRQL) in women with symptomatic uterine fibroids. The questionnaire consists of 37 questions, divided into 2 parts: 1) an 8-item symptom severity scale and 2) a 29-item HRQL subscale comprising 6 domains (concern, activities, energy/mood, control, self-consiousness, and sexual function), with a 4-week recall. All items are scored on a 5-point scale, ranging from "not at all" to "a very great deal" for symptom severity items and "none of the time" to "all of the time" for the HRQL items. Symptom severity and HRQL subscale scores were summed and transformed into a 0 to 100 point scale to provide a total score for each of the 2 components. Lower symptom severity scores indicate better quality of life and higher total HRQL scores indicate better quality of life.

Outcome measures

Outcome measures
Measure	Cohort 1 Placebo n=13 Participants Participants received placebo to elagolix twice a day for 3 months.	Cohort 6 Elagolix 300 mg BID + CEP n=14 Participants Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.	Cohort 4 Elagolix 400 mg QD n=23 Participants Participants received elagolix 400 mg once a day (QD) for 3 months.	Cohort 4 Elagolix 100 mg BID n=21 Participants Participants received elagolix 100 mg twice a day (BID) for 3 months.	Cohort 4 Placebo n=9 Participants Participants received placebo to elagolix BID for 3 months.	Cohort 1 Elagolix 200 mg BID n=26 Participants Participants received elagolix 200 mg twice a day for 3 months.	Cohort 3 Elagolix 200 mg BID + LD E2/NETA n=22 Participants Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.	Cohort 5 Elagolix 600 mg QD n=20 Participants Participants received elagolix 600 mg once a day for 3 months.	Cohort 2 Elagolix 300 mg BID n=25 Participants Participants received elagolix 300 mg twice a day for 3 months.	Cohort 2 Placebo n=13 Participants Participants received placebo to elagolix BID for 3 months.
Change From Baseline to Month 3 in the Uterine Fibroid Symptom Quality of Life Questionnaire (UFS-QoL) Symptom severity	-21.4 units on a scale Standard Deviation 20.63	-39.1 units on a scale Standard Deviation 24.09	-39.0 units on a scale Standard Deviation 24.70	-33.2 units on a scale Standard Deviation 28.17	-19.6 units on a scale Standard Deviation 32.80	-31.6 units on a scale Standard Deviation 28.87	-20.3 units on a scale Standard Deviation 25.35	-36.4 units on a scale Standard Deviation 24.74	-44.1 units on a scale Standard Deviation 22.12	-12.0 units on a scale Standard Deviation 22.49
Change From Baseline to Month 3 in the Uterine Fibroid Symptom Quality of Life Questionnaire (UFS-QoL) HRQL total	18.3 units on a scale Standard Deviation 36.66	33.1 units on a scale Standard Deviation 30.34	35.3 units on a scale Standard Deviation 21.87	29.1 units on a scale Standard Deviation 30.96	16.3 units on a scale Standard Deviation 30.43	36.0 units on a scale Standard Deviation 27.91	28.6 units on a scale Standard Deviation 24.12	29.9 units on a scale Standard Deviation 30.72	33.5 units on a scale Standard Deviation 29.42	11.0 units on a scale Standard Deviation 20.90

SECONDARY outcome

Timeframe: Baseline (average score over the 30 days prior to first dose) and month 3 (average score over days 61 to 90)

Population: Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants with available data at baseline and month 3.

The uterine fibroid daily symptom scale is self-administered questionnaire, with a scale that ranges from 0 to 10 for the symptoms of pelvic pain, fatigue, and cramping and the impact of uterine fibroids on the subject's daily life, with 0 being the absence of the symptom and 10 being the worst severity of the symptoms or completely preventing the subjects from performing daily activities. Participants self-reported values daily in the e-Diary.

Outcome measures

Outcome measures
Measure	Cohort 1 Placebo n=11 Participants Participants received placebo to elagolix twice a day for 3 months.	Cohort 6 Elagolix 300 mg BID + CEP n=11 Participants Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.	Cohort 4 Elagolix 400 mg QD n=18 Participants Participants received elagolix 400 mg once a day (QD) for 3 months.	Cohort 4 Elagolix 100 mg BID n=18 Participants Participants received elagolix 100 mg twice a day (BID) for 3 months.	Cohort 4 Placebo n=9 Participants Participants received placebo to elagolix BID for 3 months.	Cohort 1 Elagolix 200 mg BID n=18 Participants Participants received elagolix 200 mg twice a day for 3 months.	Cohort 3 Elagolix 200 mg BID + LD E2/NETA n=22 Participants Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.	Cohort 5 Elagolix 600 mg QD n=16 Participants Participants received elagolix 600 mg once a day for 3 months.	Cohort 2 Elagolix 300 mg BID n=20 Participants Participants received elagolix 300 mg twice a day for 3 months.	Cohort 2 Placebo n=9 Participants Participants received placebo to elagolix BID for 3 months.
Change From Baseline to Month 3 in the Uterine Fibroids Daily Symptom Scale Scores Pelvic pain	-1.4 units on a scale Standard Deviation 1.62	-2.4 units on a scale Standard Deviation 3.00	-1.0 units on a scale Standard Deviation 2.27	-0.2 units on a scale Standard Deviation 2.39	-0.3 units on a scale Standard Deviation 1.45	-0.6 units on a scale Standard Deviation 1.75	-1.1 units on a scale Standard Deviation 1.35	-0.9 units on a scale Standard Deviation 2.15	-1.0 units on a scale Standard Deviation 1.75	-1.2 units on a scale Standard Deviation 1.73
Change From Baseline to Month 3 in the Uterine Fibroids Daily Symptom Scale Scores Fatigue	-0.5 units on a scale Standard Deviation 1.69	-2.1 units on a scale Standard Deviation 3.11	-0.5 units on a scale Standard Deviation 1.26	-0.0 units on a scale Standard Deviation 2.23	-0.6 units on a scale Standard Deviation 1.45	-0.6 units on a scale Standard Deviation 1.29	-1.2 units on a scale Standard Deviation 1.92	-1.0 units on a scale Standard Deviation 2.57	-1.5 units on a scale Standard Deviation 1.16	-0.5 units on a scale Standard Deviation 2.88
Change From Baseline to Month 3 in the Uterine Fibroids Daily Symptom Scale Scores Menstrual cramping	-1.2 units on a scale Standard Deviation 0.80	-1.3 units on a scale Standard Deviation 2.15	-1.2 units on a scale Standard Deviation 1.31	-0.7 units on a scale Standard Deviation 2.51	-0.5 units on a scale Standard Deviation 1.55	-0.9 units on a scale Standard Deviation 1.16	-0.9 units on a scale Standard Deviation 1.25	-1.1 units on a scale Standard Deviation 1.35	-1.2 units on a scale Standard Deviation 1.09	-1.0 units on a scale Standard Deviation 2.33
Change From Baseline to Month 3 in the Uterine Fibroids Daily Symptom Scale Scores Impact of uterine fibroids	-1.0 units on a scale Standard Deviation 1.81	-3.1 units on a scale Standard Deviation 2.78	-1.1 units on a scale Standard Deviation 1.18	-0.4 units on a scale Standard Deviation 1.86	-0.8 units on a scale Standard Deviation 1.40	-1.0 units on a scale Standard Deviation 1.37	-0.9 units on a scale Standard Deviation 1.62	-1.7 units on a scale Standard Deviation 2.41	-1.3 units on a scale Standard Deviation 1.11	-1.0 units on a scale Standard Deviation 2.18

SECONDARY outcome

Timeframe: Baseline and month 3

Population: Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants with available data at baseline and month 3.

The Subject Intention Questionnaire (SSIQ) is a non-validated, exploratory questionnaires intended to evaluate the subject's intent to undergo surgical procedures if current endometriosis-associated symptoms continued. The scoring scale ranged from 0 (not at all likely to consider surgery) to 10 (very likely to consider surgery). SSIQ included the 2 following questions: 1. How likely are you to consider having myomectomy surgery to treat your uterine fibroid if your symptoms continue as they are now? 2. How likely are you to consider hysterectomy surgery if your uterine fibroid symptoms continue as they are now?

Outcome measures

Outcome measures
Measure	Cohort 1 Placebo n=6 Participants Participants received placebo to elagolix twice a day for 3 months.	Cohort 6 Elagolix 300 mg BID + CEP n=14 Participants Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.	Cohort 4 Elagolix 400 mg QD n=23 Participants Participants received elagolix 400 mg once a day (QD) for 3 months.	Cohort 4 Elagolix 100 mg BID n=21 Participants Participants received elagolix 100 mg twice a day (BID) for 3 months.	Cohort 4 Placebo n=9 Participants Participants received placebo to elagolix BID for 3 months.	Cohort 1 Elagolix 200 mg BID n=9 Participants Participants received elagolix 200 mg twice a day for 3 months.	Cohort 3 Elagolix 200 mg BID + LD E2/NETA n=22 Participants Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.	Cohort 5 Elagolix 600 mg QD n=20 Participants Participants received elagolix 600 mg once a day for 3 months.	Cohort 2 Elagolix 300 mg BID n=25 Participants Participants received elagolix 300 mg twice a day for 3 months.	Cohort 2 Placebo n=13 Participants Participants received placebo to elagolix BID for 3 months.
Change From Baseline to Month 3 in the Subject Surgery Intention Questionnaire (SSIQ) Version 2.0 Likelihood of having myomectomy	2.3 units on a scale Standard Deviation 5.35	0.1 units on a scale Standard Deviation 2.63	-1.2 units on a scale Standard Deviation 3.68	-3.1 units on a scale Standard Deviation 4.52	1.0 units on a scale Standard Deviation 2.12	-1.8 units on a scale Standard Deviation 4.70	-1.4 units on a scale Standard Deviation 4.34	-1.7 units on a scale Standard Deviation 4.18	-0.6 units on a scale Standard Deviation 5.10	0.4 units on a scale Standard Deviation 4.16
Change From Baseline to Month 3 in the Subject Surgery Intention Questionnaire (SSIQ) Version 2.0 Likelihood of having hysterectomy	-0.3 units on a scale Standard Deviation 0.52	-1.5 units on a scale Standard Deviation 3.92	0.0 units on a scale Standard Deviation 4.04	-1.9 units on a scale Standard Deviation 4.19	2.0 units on a scale Standard Deviation 3.64	-0.8 units on a scale Standard Deviation 4.91	-0.7 units on a scale Standard Deviation 3.10	-0.8 units on a scale Standard Deviation 4.42	0.2 units on a scale Standard Deviation 3.65	0.0 units on a scale Standard Deviation 1.96

SECONDARY outcome

Timeframe: Baseline and month 3

Population: Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants with available data at baseline and month 3.

The Physician Intention Questionnaire (PSIQ) is a non-validated, exploratory questionnaire intended to evaluate the investigator's intent to recommend surgical procedures if current endometriosis-associated symptoms continued. The scoring scale ranged from 0 (not at all likely to recommend surgery) to 10 (very likely to recommend surgery). The PSIQ included the 2 following questions: 1. How likely are you to recommend myomectomy to treat this patient's uterine fibroid if her symptoms continue as they are now? 2. How likely are you to recommend definitive surgery hysterectomy for this patient if her uterine fibroid symptoms continue as they are now?

Outcome measures

Outcome measures
Measure	Cohort 1 Placebo n=7 Participants Participants received placebo to elagolix twice a day for 3 months.	Cohort 6 Elagolix 300 mg BID + CEP n=14 Participants Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.	Cohort 4 Elagolix 400 mg QD n=23 Participants Participants received elagolix 400 mg once a day (QD) for 3 months.	Cohort 4 Elagolix 100 mg BID n=21 Participants Participants received elagolix 100 mg twice a day (BID) for 3 months.	Cohort 4 Placebo n=9 Participants Participants received placebo to elagolix BID for 3 months.	Cohort 1 Elagolix 200 mg BID n=9 Participants Participants received elagolix 200 mg twice a day for 3 months.	Cohort 3 Elagolix 200 mg BID + LD E2/NETA n=22 Participants Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.	Cohort 5 Elagolix 600 mg QD n=20 Participants Participants received elagolix 600 mg once a day for 3 months.	Cohort 2 Elagolix 300 mg BID n=24 Participants Participants received elagolix 300 mg twice a day for 3 months.	Cohort 2 Placebo n=13 Participants Participants received placebo to elagolix BID for 3 months.
Change From Baseline to Month 3 in the Physician Surgery Intention Questionnaire (PSIQ) Version 2.0 Likelihood to recommend myomectomy	0.7 units on a scale Standard Deviation 1.11	0.0 units on a scale Standard Deviation 3.94	-0.9 units on a scale Standard Deviation 2.86	-1.3 units on a scale Standard Deviation 3.31	-2.7 units on a scale Standard Deviation 3.53	-0.8 units on a scale Standard Deviation 1.76	-0.6 units on a scale Standard Deviation 2.97	-1.3 units on a scale Standard Deviation 3.62	-1.2 units on a scale Standard Deviation 3.59	0.0 units on a scale Standard Deviation 3.25
Change From Baseline to Month 3 in the Physician Surgery Intention Questionnaire (PSIQ) Version 2.0 Likelihood to recommend hysterectomy	0.4 units on a scale Standard Deviation 1.62	-2.8 units on a scale Standard Deviation 2.98	-0.8 units on a scale Standard Deviation 3.34	-1.8 units on a scale Standard Deviation 4.37	-0.2 units on a scale Standard Deviation 3.15	-2.2 units on a scale Standard Deviation 2.82	-1.4 units on a scale Standard Deviation 3.08	-2.3 units on a scale Standard Deviation 3.99	-1.5 units on a scale Standard Deviation 3.96	-0.6 units on a scale Standard Deviation 2.81

Adverse Events

Cohort 1 Placebo

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Cohort 1 Elagolix 200 mg BID

Serious events: 0 serious events

Other events: 26 other events

Deaths: 0 deaths

Cohort 2 Placebo

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Cohort 2 Elagolix 300 mg BID

Serious events: 1 serious events

Other events: 20 other events

Deaths: 0 deaths

Cohort 3 Elagolix 200 mg BID + LD E2/NETA

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Cohort 4 Placebo

Serious events: 2 serious events

Other events: 9 other events

Deaths: 0 deaths

Cohort 4 Elagolix 100 mg BID

Serious events: 2 serious events

Other events: 20 other events

Deaths: 0 deaths

Cohort 4 Golix 400 mg QD

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

Cohort 5 Elagolix 600 mg QD

Serious events: 2 serious events

Other events: 22 other events

Deaths: 0 deaths

Cohort 6 Elagolix 300 mg BID + CEP

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1 Placebo n=18 participants at risk Participants received placebo to elagolix twice a day for 3 months.	Cohort 1 Elagolix 200 mg BID n=35 participants at risk Participants received elagolix 200 mg twice a day for 3 months.	Cohort 2 Placebo n=16 participants at risk Participants received placebo to elagolix BID for 3 months.	Cohort 2 Elagolix 300 mg BID n=30 participants at risk Participants received elagolix 300 mg twice a day for 3 months	Cohort 3 Elagolix 200 mg BID + LD E2/NETA n=34 participants at risk Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.	Cohort 4 Placebo n=16 participants at risk Participants received placebo to elagolix BID for 3 months.	Cohort 4 Elagolix 100 mg BID n=33 participants at risk Participants received elagolix 100 mg twice a day (BID) for 3 months.	Cohort 4 Golix 400 mg QD n=32 participants at risk Participants received elagolix 400 mg once a day (QD) for 3 months.	Cohort 5 Elagolix 600 mg QD n=30 participants at risk Participants received elagolix 600 mg once a day for 3 months.	Cohort 6 Elagolix 300 mg BID + CEP n=27 participants at risk Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.
Blood and lymphatic system disorders ANAEMIA	5.6% 1/18 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/35 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	12.5% 2/16 • Number of events 2 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/33 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/32 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) UTERINE LEIOMYOMA	0.00% 0/18 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/35 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	3.3% 1/30 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	3.0% 1/33 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/32 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
General disorders NECROSIS	0.00% 0/18 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/35 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	3.0% 1/33 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/32 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Hepatobiliary disorders CHOLECYSTITIS	0.00% 0/18 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/35 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	3.0% 1/33 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/32 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Metabolism and nutrition disorders HYPOVOLAEMIA	0.00% 0/18 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/35 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	6.2% 1/16 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/33 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/32 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Reproductive system and breast disorders UTERINE HAEMORRHAGE	0.00% 0/18 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/35 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	3.0% 1/33 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/32 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Gastrointestinal disorders PANCREATITIS	0.00% 0/18 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/35 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/33 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/32 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	3.3% 1/30 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Surgical and medical procedures ABORTION INDUCED	0.00% 0/18 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/35 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/33 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/32 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	3.3% 1/30 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.

Other adverse events

Other adverse events
Measure	Cohort 1 Placebo n=18 participants at risk Participants received placebo to elagolix twice a day for 3 months.	Cohort 1 Elagolix 200 mg BID n=35 participants at risk Participants received elagolix 200 mg twice a day for 3 months.	Cohort 2 Placebo n=16 participants at risk Participants received placebo to elagolix BID for 3 months.	Cohort 2 Elagolix 300 mg BID n=30 participants at risk Participants received elagolix 300 mg twice a day for 3 months	Cohort 3 Elagolix 200 mg BID + LD E2/NETA n=34 participants at risk Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.	Cohort 4 Placebo n=16 participants at risk Participants received placebo to elagolix BID for 3 months.	Cohort 4 Elagolix 100 mg BID n=33 participants at risk Participants received elagolix 100 mg twice a day (BID) for 3 months.	Cohort 4 Golix 400 mg QD n=32 participants at risk Participants received elagolix 400 mg once a day (QD) for 3 months.	Cohort 5 Elagolix 600 mg QD n=30 participants at risk Participants received elagolix 600 mg once a day for 3 months.	Cohort 6 Elagolix 300 mg BID + CEP n=27 participants at risk Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.
Nervous system disorders LETHARGY	0.00% 0/18 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/35 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	6.2% 1/16 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/33 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/32 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Gastrointestinal disorders ABDOMINAL PAIN	5.6% 1/18 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	5.7% 2/35 • Number of events 2 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	10.0% 3/30 • Number of events 5 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/33 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/32 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	6.7% 2/30 • Number of events 2 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	14.8% 4/27 • Number of events 5 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Gastrointestinal disorders NAUSEA	0.00% 0/18 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	8.6% 3/35 • Number of events 4 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	12.5% 2/16 • Number of events 2 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	6.7% 2/30 • Number of events 2 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	6.2% 1/16 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/33 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	15.6% 5/32 • Number of events 5 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	30.0% 9/30 • Number of events 9 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	14.8% 4/27 • Number of events 4 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
General disorders FATIGUE	5.6% 1/18 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	5.7% 2/35 • Number of events 2 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	11.8% 4/34 • Number of events 4 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	3.0% 1/33 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	12.5% 4/32 • Number of events 4 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	6.7% 2/30 • Number of events 2 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
General disorders OEDEMA PERIPHERAL	5.6% 1/18 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/35 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	6.2% 1/16 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/33 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	6.2% 2/32 • Number of events 2 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Infections and infestations BRONCHITIS	5.6% 1/18 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/35 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	5.9% 2/34 • Number of events 2 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/33 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/32 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Infections and infestations VAGINITIS BACTERIAL	5.6% 1/18 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	2.9% 1/35 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	6.2% 1/16 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/33 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/32 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Investigations BLOOD PRESSURE INCREASED	5.6% 1/18 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/35 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/33 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/32 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	7.4% 2/27 • Number of events 2 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Investigations WEIGHT INCREASED	5.6% 1/18 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/35 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/33 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/32 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Metabolism and nutrition disorders DECREASED APPETITE	0.00% 0/18 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	5.7% 2/35 • Number of events 2 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	6.2% 1/16 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/33 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/32 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Metabolism and nutrition disorders DIABETES MELLITUS	5.6% 1/18 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	2.9% 1/35 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/33 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/32 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Musculoskeletal and connective tissue disorders BACK PAIN	5.6% 1/18 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	8.6% 3/35 • Number of events 4 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	6.7% 2/30 • Number of events 3 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	6.2% 1/16 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	3.0% 1/33 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	9.4% 3/32 • Number of events 3 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	16.7% 5/30 • Number of events 5 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Musculoskeletal and connective tissue disorders MUSCLE SPASMS	5.6% 1/18 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/35 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	6.2% 1/16 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	8.8% 3/34 • Number of events 3 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/33 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/32 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	6.7% 2/30 • Number of events 2 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Nervous system disorders DIZZINESS	0.00% 0/18 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	5.7% 2/35 • Number of events 2 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	12.5% 2/16 • Number of events 2 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	10.0% 3/30 • Number of events 3 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	8.8% 3/34 • Number of events 3 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	3.0% 1/33 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	9.4% 3/32 • Number of events 3 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	20.0% 6/30 • Number of events 6 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Nervous system disorders HEADACHE	0.00% 0/18 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	8.6% 3/35 • Number of events 3 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	18.8% 3/16 • Number of events 3 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	20.0% 6/30 • Number of events 6 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	14.7% 5/34 • Number of events 5 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	9.1% 3/33 • Number of events 3 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	12.5% 4/32 • Number of events 4 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	30.0% 9/30 • Number of events 11 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	7.4% 2/27 • Number of events 2 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Nervous system disorders MIGRAINE	5.6% 1/18 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/35 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/33 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/32 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Psychiatric disorders DEPRESSION	11.1% 2/18 • Number of events 2 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	2.9% 1/35 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/33 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/32 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Psychiatric disorders MOOD SWINGS	5.6% 1/18 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	5.7% 2/35 • Number of events 3 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/33 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/32 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Reproductive system and breast disorders DYSMENORRHOEA	5.6% 1/18 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/35 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	6.2% 1/16 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	6.2% 1/16 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/33 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	3.1% 1/32 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	7.4% 2/27 • Number of events 2 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Reproductive system and breast disorders MENORRHAGIA	5.6% 1/18 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	5.7% 2/35 • Number of events 3 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/33 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/32 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Reproductive system and breast disorders PELVIC PAIN	0.00% 0/18 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	5.7% 2/35 • Number of events 2 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/33 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/32 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Reproductive system and breast disorders VULVOVAGINAL DRYNESS	0.00% 0/18 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	5.7% 2/35 • Number of events 2 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/33 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/32 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Skin and subcutaneous tissue disorders ACNE	5.6% 1/18 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/35 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	3.0% 1/33 • Number of events 2 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	6.2% 2/32 • Number of events 2 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Skin and subcutaneous tissue disorders NIGHT SWEATS	0.00% 0/18 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	8.6% 3/35 • Number of events 3 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	6.2% 1/16 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	3.3% 1/30 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	3.0% 1/33 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	6.2% 2/32 • Number of events 3 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Skin and subcutaneous tissue disorders RASH GENERALISED	5.6% 1/18 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/35 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/33 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/32 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Skin and subcutaneous tissue disorders RASH MACULAR	5.6% 1/18 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/35 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/33 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/32 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Vascular disorders HOT FLUSH	5.6% 1/18 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	54.3% 19/35 • Number of events 20 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	18.8% 3/16 • Number of events 3 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	50.0% 15/30 • Number of events 15 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	26.5% 9/34 • Number of events 9 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	12.5% 2/16 • Number of events 2 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	45.5% 15/33 • Number of events 16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	62.5% 20/32 • Number of events 21 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	50.0% 15/30 • Number of events 15 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	18.5% 5/27 • Number of events 5 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Blood and lymphatic system disorders ANAEMIA	0.00% 0/18 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/35 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	6.2% 1/16 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	3.3% 1/30 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	6.2% 1/16 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	6.1% 2/33 • Number of events 2 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/32 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Blood and lymphatic system disorders LEUKOCYTOSIS	0.00% 0/18 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/35 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	6.2% 1/16 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/33 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/32 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Gastrointestinal disorders ABDOMINAL DISCOMFORT	0.00% 0/18 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/35 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	6.2% 1/16 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	3.3% 1/30 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/33 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/32 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Gastrointestinal disorders ABDOMINAL DISTENSION	0.00% 0/18 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/35 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	6.7% 2/30 • Number of events 2 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	6.2% 1/16 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	3.0% 1/33 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/32 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Gastrointestinal disorders ABDOMINAL PAIN LOWER	0.00% 0/18 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/35 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	6.7% 2/30 • Number of events 2 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/33 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/32 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Gastrointestinal disorders CONSTIPATION	0.00% 0/18 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/35 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	6.2% 1/16 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	12.5% 2/16 • Number of events 2 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/33 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/32 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Gastrointestinal disorders DIARRHOEA	0.00% 0/18 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/35 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	6.2% 1/16 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	3.3% 1/30 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/33 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/32 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	10.0% 3/30 • Number of events 3 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	11.1% 3/27 • Number of events 3 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Gastrointestinal disorders GASTROOESOPHAGEAL REFLUX DISEASE	0.00% 0/18 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/35 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	6.2% 1/16 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	12.5% 2/16 • Number of events 2 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/33 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/32 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Gastrointestinal disorders VOMITING	0.00% 0/18 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/35 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	6.2% 1/16 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	3.3% 1/30 • Number of events 2 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/33 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/32 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	6.7% 2/30 • Number of events 2 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
General disorders CHILLS	0.00% 0/18 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/35 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	6.2% 1/16 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/33 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/32 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
General disorders INFLUENZA LIKE ILLNESS	0.00% 0/18 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/35 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	6.2% 1/16 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/33 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/32 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
General disorders IRRITABILITY	0.00% 0/18 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/35 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	12.5% 2/16 • Number of events 2 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/33 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/32 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
General disorders MALAISE	0.00% 0/18 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/35 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	6.2% 1/16 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/33 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/32 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
General disorders VESSEL PUNCTURE SITE PAIN	0.00% 0/18 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/35 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	6.2% 1/16 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/33 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/32 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Infections and infestations FUNGAL INFECTION	0.00% 0/18 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/35 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	12.5% 2/16 • Number of events 2 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/33 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/32 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Infections and infestations VULVOVAGINITIS	0.00% 0/18 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/35 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	6.2% 1/16 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/33 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/32 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Investigations BLOOD GLUCOSE INCREASED	0.00% 0/18 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/35 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	6.2% 1/16 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/33 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/32 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Nervous system disorders BALANCE DISORDER	0.00% 0/18 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/35 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	6.2% 1/16 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/33 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/32 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Renal and urinary disorders NEPHROLITHIASIS	0.00% 0/18 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/35 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	6.2% 1/16 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/33 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/32 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Renal and urinary disorders POLLAKIURIA	0.00% 0/18 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/35 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	6.2% 1/16 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/33 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/32 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Renal and urinary disorders URINARY INCONTINENCE	0.00% 0/18 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/35 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	6.2% 1/16 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/33 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/32 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Respiratory, thoracic and mediastinal disorders ASTHMA	0.00% 0/18 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/35 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	6.2% 1/16 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/33 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/32 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	0.00% 0/18 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/35 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	6.2% 1/16 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/33 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/32 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Skin and subcutaneous tissue disorders DRY SKIN	0.00% 0/18 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/35 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	6.2% 1/16 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/33 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/32 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Skin and subcutaneous tissue disorders HYPERHIDROSIS	0.00% 0/18 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/35 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	6.2% 1/16 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/33 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/32 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Vascular disorders SPIDER VEIN	0.00% 0/18 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/35 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	6.2% 1/16 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/33 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/32 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	0.00% 0/18 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/35 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	5.9% 2/34 • Number of events 3 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/33 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/32 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Psychiatric disorders LIBIDO DECREASED	0.00% 0/18 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/35 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	5.9% 2/34 • Number of events 2 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/33 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/32 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Reproductive system and breast disorders AMENORRHOEA	0.00% 0/18 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/35 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	5.9% 2/34 • Number of events 2 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/33 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/32 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Reproductive system and breast disorders BREAST CYST	0.00% 0/18 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/35 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	5.9% 2/34 • Number of events 2 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/33 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/32 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Reproductive system and breast disorders METRORRHAGIA	0.00% 0/18 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/35 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	5.9% 2/34 • Number of events 2 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/33 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/32 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Gastrointestinal disorders DRY MOUTH	0.00% 0/18 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/35 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/33 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	6.2% 2/32 • Number of events 2 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Gastrointestinal disorders PEPTIC ULCER	0.00% 0/18 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/35 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	6.2% 1/16 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/33 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/32 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Infections and infestations FURUNCLE	0.00% 0/18 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/35 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	6.2% 1/16 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/33 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/32 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Infections and infestations INFECTED BITES	0.00% 0/18 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/35 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	6.2% 1/16 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/33 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/32 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Infections and infestations NASOPHARYNGITIS	0.00% 0/18 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/35 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/33 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	6.2% 2/32 • Number of events 2 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	0.00% 0/18 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/35 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/33 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	6.2% 2/32 • Number of events 2 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	6.7% 2/30 • Number of events 2 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Infections and infestations URINARY TRACT INFECTION	0.00% 0/18 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/35 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	3.0% 1/33 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	9.4% 3/32 • Number of events 3 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Investigations ALANINE AMINOTRANSFERASE INCREASED	0.00% 0/18 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/35 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	6.2% 1/16 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/33 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	3.1% 1/32 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	0.00% 0/18 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/35 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	6.2% 1/16 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/33 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/32 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Musculoskeletal and connective tissue disorders ARTHRALGIA	0.00% 0/18 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/35 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	9.1% 3/33 • Number of events 3 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	3.1% 1/32 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	6.7% 2/30 • Number of events 3 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Musculoskeletal and connective tissue disorders OSTEOPENIA	0.00% 0/18 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/35 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/33 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	6.2% 2/32 • Number of events 2 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Psychiatric disorders ANXIETY	0.00% 0/18 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/35 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	6.1% 2/33 • Number of events 2 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/32 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Psychiatric disorders INSOMNIA	0.00% 0/18 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/35 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	6.2% 1/16 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	6.1% 2/33 • Number of events 2 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	3.1% 1/32 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Reproductive system and breast disorders DYSPAREUNIA	0.00% 0/18 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/35 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	6.2% 1/16 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/33 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/32 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Reproductive system and breast disorders OVARIAN CYST	0.00% 0/18 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/35 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	6.1% 2/33 • Number of events 2 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	3.1% 1/32 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Skin and subcutaneous tissue disorders CHLOASMA	0.00% 0/18 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/35 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	6.2% 1/16 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/33 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/32 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Skin and subcutaneous tissue disorders URTICARIA	0.00% 0/18 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/35 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	6.2% 1/16 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/33 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/32 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Vascular disorders HYPERTENSION	0.00% 0/18 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/35 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	6.2% 1/16 • Number of events 1 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/33 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/32 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	10.0% 3/30 • Number of events 3 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Injury, poisoning and procedural complications LACERATION	0.00% 0/18 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/35 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/33 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/32 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	6.7% 2/30 • Number of events 2 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/27 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
Immune system disorders HYPERSENSITIVITY	0.00% 0/18 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/35 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/34 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/16 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/33 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/32 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	0.00% 0/30 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.	7.4% 2/27 • Number of events 2 • From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.

Additional Information

Global Medical Services

AbbVie (prior sponsor, Abbott)

Phone: 800-633-9110

Results disclosure agreements

Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Publication restrictions are in place

Restriction type: OTHER