Trial Outcomes & Findings for An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids (NCT NCT02925494)

Last Updated: 2021-07-13

Results Overview

Percentage of responders, defined as participants who met the following conditions: * Menstrual blood loss (MBL) volume \< 80 mL during the Final Month (the last 28 days prior to and including the last dose date), and * ≥ 50% reduction in MBL volume from Baseline to the Final Month. Participants who prematurely discontinued study drug due to "lack of efficacy," "requires surgery or invasive intervention for treatment of uterine fibroids," or "adverse events" were considered non-responders regardless of whether she meets the two aforementioned responder criteria or not.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

433 participants

Primary outcome timeframe

From Month 0 (Baseline in Pivotal Study) to Final Month of Treatment Period (up through Month 6 in Extension Study)

Results posted on

2021-07-13

Participant Flow

A total of 433 participants who completed the 6-month Treatment Period in pivotal studies M12-815 (NCT02654054) or M12-817 (NCT02691494) were enrolled in this extension study at 114 sites in 2 countries (US \[including Puerto Rico\] and Canada).

A total of 433 participants were treated in this extension study and were grouped according to the treatment assignments in pivotal studies M12-815 and M12-817 and this extension study.

Participant milestones

Participant milestones
Measure	Placebo->Elagolix Placebo in pivotal study and elagolix 300 mg twice daily (BID) in extension study.	Placebo->Elagolix + E2/NETA Placebo in pivotal study and elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) once daily (QD) in extension study.	Elagolix->Elagolix Elagolix 300 mg BID in pivotal study and elagolix 300 mg BID in extension study.	Elagolix + E2/NETA->Elagolix + E2/NETA Elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in pivotal study and elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in extension study.
Treatment Period STARTED	59	58	98	218
Treatment Period COMPLETED	50	43	79	182
Treatment Period NOT COMPLETED	9	15	19	36
Post-Treatment Follow-Up Period STARTED	54	47	88	184
Post-Treatment Follow-Up Period COMPLETED	40	37	64	134
Post-Treatment Follow-Up Period NOT COMPLETED	14	10	24	50

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo->Elagolix Placebo in pivotal study and elagolix 300 mg twice daily (BID) in extension study.	Placebo->Elagolix + E2/NETA Placebo in pivotal study and elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) once daily (QD) in extension study.	Elagolix->Elagolix Elagolix 300 mg BID in pivotal study and elagolix 300 mg BID in extension study.	Elagolix + E2/NETA->Elagolix + E2/NETA Elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in pivotal study and elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in extension study.
Post-Treatment Follow-Up Period Withdrawal by Subject	8	2	8	23
Post-Treatment Follow-Up Period Lost to Follow-up	3	2	9	10
Post-Treatment Follow-Up Period Other	1	4	3	6
Post-Treatment Follow-Up Period Required Surgery/ Invasive Intervention	1	2	2	6
Post-Treatment Follow-Up Period Pregnancy	1	0	1	2
Post-Treatment Follow-Up Period Non-Compliance	0	0	1	2
Post-Treatment Follow-Up Period Adverse Event	0	0	0	1

Baseline Characteristics

An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo->Elagolix n=59 Participants Placebo in pivotal study and elagolix 300 mg BID in extension study.	Placebo->Elagolix + E2/NETA n=58 Participants Placebo in pivotal study and elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in extension study.	Elagolix->Elagolix n=98 Participants Elagolix 300 mg BID in pivotal study and elagolix 300 mg BID in extension study.	Elagolix + E2/NETA->Elagolix + E2/NETA n=218 Participants Elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in pivotal study and elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in extension study.	Total n=433 Participants Total of all reporting groups
Age, Customized 25 to < 30 years	0 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants	8 Participants n=21 Participants
Age, Customized 30 to < 35 years	4 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants	19 Participants n=4 Participants	32 Participants n=21 Participants
Age, Customized 35 to < 40 years	12 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants	34 Participants n=4 Participants	74 Participants n=21 Participants
Age, Customized 40 to < 45 years	20 Participants n=5 Participants	21 Participants n=7 Participants	36 Participants n=5 Participants	74 Participants n=4 Participants	151 Participants n=21 Participants
Age, Customized 45 to < 50 years	16 Participants n=5 Participants	16 Participants n=7 Participants	30 Participants n=5 Participants	77 Participants n=4 Participants	139 Participants n=21 Participants
Age, Customized >= 50 years	7 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	10 Participants n=4 Participants	29 Participants n=21 Participants
Sex: Female, Male Female	59 Participants n=5 Participants	58 Participants n=7 Participants	98 Participants n=5 Participants	218 Participants n=4 Participants	433 Participants n=21 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
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants	33 Participants n=4 Participants	56 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	52 Participants n=5 Participants	51 Participants n=7 Participants	89 Participants n=5 Participants	185 Participants n=4 Participants	377 Participants n=21 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
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	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
Race (NIH/OMB) Black or African American	43 Participants n=5 Participants	39 Participants n=7 Participants	70 Participants n=5 Participants	146 Participants n=4 Participants	298 Participants n=21 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants	19 Participants n=7 Participants	25 Participants n=5 Participants	65 Participants n=4 Participants	122 Participants n=21 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	5 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants

PRIMARY outcome

Timeframe: From Month 0 (Baseline in Pivotal Study) to Final Month of Treatment Period (up through Month 6 in Extension Study)

Population: All participants who received at least 1 dose of study drug and had an assessment.

Outcome measures

Outcome measures
Measure	Placebo->Elagolix n=56 Participants Placebo in pivotal study and elagolix 300 mg BID in extension study.	Placebo->Elagolix + E2/NETA n=54 Participants Placebo in pivotal study and elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in extension study.	Elagolix->Elagolix n=94 Participants Elagolix 300 mg BID in pivotal study and elagolix 300 mg BID in extension study.	Elagolix + E2/NETA->Elagolix + E2/NETA n=206 Participants Elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in pivotal study and elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in extension study.
Percentage of Participants Meeting the Criteria for Responder	85.7 percentage of participants	66.7 percentage of participants	89.4 percentage of participants	87.9 percentage of participants

SECONDARY outcome

Timeframe: Month 0 (Baseline in Pivotal Study), Extension Study: Day 1 to 28, Day 29 to 56, Day 57 to 84, Day 85 to 112, Day 113 to 140, Day 141 to 168, Final Month of Treatment Period (up through Month 6)

Population: All participants who received at least 1 dose of study drug and had an assessment at given time point.

Baseline MBL volume was defined as the mean of total MBL volume from all the qualified menstrual cycles during the Screening Period of the pivotal study, in which the total MBL volume is from all validated and non-validated sanitary products and the MBL volume of validated sanitary products only (excluding non-validated sanitary products) was greater than 80 mL.

Outcome measures

Outcome measures
Measure	Placebo->Elagolix n=56 Participants Placebo in pivotal study and elagolix 300 mg BID in extension study.	Placebo->Elagolix + E2/NETA n=54 Participants Placebo in pivotal study and elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in extension study.	Elagolix->Elagolix n=94 Participants Elagolix 300 mg BID in pivotal study and elagolix 300 mg BID in extension study.	Elagolix + E2/NETA->Elagolix + E2/NETA n=206 Participants Elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in pivotal study and elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in extension study.
Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period Study Day 1 to 28	-151.7 mL Standard Deviation 184.76	-61.7 mL Standard Deviation 212.01	-253.4 mL Standard Deviation 190.07	-186.5 mL Standard Deviation 164.38
Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period Study Day 29 to 56	-210.9 mL Standard Deviation 234.01	-203.1 mL Standard Deviation 188.15	-249.7 mL Standard Deviation 189.81	-191.9 mL Standard Deviation 166.38
Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period Study Day 57 to 84	-236.9 mL Standard Deviation 162.33	-209.0 mL Standard Deviation 184.90	-255.9 mL Standard Deviation 175.43	-200.6 mL Standard Deviation 159.77
Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period Study Day 85 to 112	-235.1 mL Standard Deviation 184.87	-204.5 mL Standard Deviation 177.65	-252.0 mL Standard Deviation 175.23	-200.5 mL Standard Deviation 156.85
Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period Study Day 113 to 140	-237.3 mL Standard Deviation 234.00	-194.5 mL Standard Deviation 213.69	-253.9 mL Standard Deviation 173.50	-192.9 mL Standard Deviation 165.42
Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period Study Day 141 to 168	-263.8 mL Standard Deviation 199.83	-175.4 mL Standard Deviation 115.43	-279.1 mL Standard Deviation 191.44	-211.4 mL Standard Deviation 165.26
Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period Final Month	-256.6 mL Standard Deviation 194.04	-186.4 mL Standard Deviation 138.16	-250.3 mL Standard Deviation 182.09	-205.6 mL Standard Deviation 151.55

SECONDARY outcome

Population: All participants who received at least 1 dose of study drug and had an assessment at given time point.

Outcome measures

Outcome measures
Measure	Placebo->Elagolix n=56 Participants Placebo in pivotal study and elagolix 300 mg BID in extension study.	Placebo->Elagolix + E2/NETA n=54 Participants Placebo in pivotal study and elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in extension study.	Elagolix->Elagolix n=94 Participants Elagolix 300 mg BID in pivotal study and elagolix 300 mg BID in extension study.	Elagolix + E2/NETA->Elagolix + E2/NETA n=206 Participants Elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in pivotal study and elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in extension study.
Percent Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period Final Month	-91.0 percentage change Standard Deviation 28.74	-78.5 percentage change Standard Deviation 36.76	-96.6 percentage change Standard Deviation 18.29	-90.8 percentage change Standard Deviation 33.01
Percent Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period Study Day 57 to 84	-89.9 percentage change Standard Deviation 37.62	-82.9 percentage change Standard Deviation 34.79	-96.9 percentage change Standard Deviation 16.88	-90.6 percentage change Standard Deviation 32.60
Percent Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period Study Day 1 to 28	-46.5 percentage change Standard Deviation 66.57	-28.2 percentage change Standard Deviation 72.69	-94.0 percentage change Standard Deviation 24.90	-87.7 percentage change Standard Deviation 36.24
Percent Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period Study Day 29 to 56	-87.2 percentage change Standard Deviation 46.33	-79.4 percentage change Standard Deviation 41.80	-93.3 percentage change Standard Deviation 28.77	-87.8 percentage change Standard Deviation 43.17
Percent Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period Study Day 85 to 112	-90.3 percentage change Standard Deviation 30.26	-82.7 percentage change Standard Deviation 32.76	-95.2 percentage change Standard Deviation 19.38	-91.2 percentage change Standard Deviation 28.42
Percent Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period Study Day 113 to 140	-90.0 percentage change Standard Deviation 40.38	-75.0 percentage change Standard Deviation 65.97	-97.7 percentage change Standard Deviation 13.01	-87.5 percentage change Standard Deviation 40.67
Percent Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period Study Day 141 to 168	-91.8 percentage change Standard Deviation 30.77	-79.3 percentage change Standard Deviation 32.25	-99.2 percentage change Standard Deviation 4.31	-89.7 percentage change Standard Deviation 36.67

SECONDARY outcome

Timeframe: Final Month of Treatment Period (up through Month 6)

Population: All participants who received at least 1 dose of study drug and had an assessment.

Suppression of bleeding is defined as having 0 days of bleeding (spotting is allowed) during the Final Month with the interval starting from Study Day 11.

Outcome measures

Outcome measures
Measure	Placebo->Elagolix n=53 Participants Placebo in pivotal study and elagolix 300 mg BID in extension study.	Placebo->Elagolix + E2/NETA n=50 Participants Placebo in pivotal study and elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in extension study.	Elagolix->Elagolix n=93 Participants Elagolix 300 mg BID in pivotal study and elagolix 300 mg BID in extension study.	Elagolix + E2/NETA->Elagolix + E2/NETA n=206 Participants Elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in pivotal study and elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in extension study.
Percentage of Participants With Suppression of Bleeding at the Final Month	88.7 percentage of participants	56.0 percentage of participants	89.2 percentage of participants	74.8 percentage of participants

SECONDARY outcome

Timeframe: Month 6

Population: All participants who received at least 1 dose of study drug, had a baseline hemoglobin concentration of \<= 10.5 g/dL and had an assessment.

Outcome measures

Outcome measures
Measure	Placebo->Elagolix n=17 Participants Placebo in pivotal study and elagolix 300 mg BID in extension study.	Placebo->Elagolix + E2/NETA n=11 Participants Placebo in pivotal study and elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in extension study.	Elagolix->Elagolix n=28 Participants Elagolix 300 mg BID in pivotal study and elagolix 300 mg BID in extension study.	Elagolix + E2/NETA->Elagolix + E2/NETA n=51 Participants Elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in pivotal study and elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in extension study.
Percentage of Participants With Baseline Hemoglobin Concentration ≤ 10.5 g/dL and an Increase From Baseline > 2 g/dL at Month 6 During the Treatment Period	70.6 percentage of participants	36.4 percentage of participants	71.4 percentage of participants	72.5 percentage of participants

Adverse Events

Placebo->Elagolix

Serious events: 1 serious events

Other events: 38 other events

Deaths: 0 deaths

Placebo->Elagolix + E2/NETA

Serious events: 3 serious events

Other events: 26 other events

Deaths: 1 deaths

Elagolix->Elagolix

Serious events: 2 serious events

Other events: 25 other events

Deaths: 0 deaths

Elagolix + E2/NETA->Elagolix + E2/NETA

Serious events: 6 serious events

Other events: 50 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo->Elagolix n=59 participants at risk Placebo in pivotal study and elagolix 300 mg BID in extension study.	Placebo->Elagolix + E2/NETA n=58 participants at risk Placebo in pivotal study and elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in extension study.	Elagolix->Elagolix n=98 participants at risk Elagolix 300 mg BID in pivotal study and elagolix 300 mg BID in extension study.	Elagolix + E2/NETA->Elagolix + E2/NETA n=218 participants at risk Elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in pivotal study and elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in extension study.
Gastrointestinal disorders ABDOMINAL PAIN	1.7% 1/59 • Number of events 1 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	0.00% 0/58 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	0.00% 0/98 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	0.00% 0/218 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.
Hepatobiliary disorders CHOLECYSTITIS ACUTE	0.00% 0/59 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	0.00% 0/58 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	1.0% 1/98 • Number of events 1 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	0.00% 0/218 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.
Hepatobiliary disorders CHOLELITHIASIS	0.00% 0/59 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	0.00% 0/58 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	1.0% 1/98 • Number of events 1 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	0.00% 0/218 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.
Infections and infestations PILONIDAL CYST	0.00% 0/59 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	0.00% 0/58 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	0.00% 0/98 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	0.46% 1/218 • Number of events 1 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.
Infections and infestations SEPSIS	0.00% 0/59 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	1.7% 1/58 • Number of events 1 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	0.00% 0/98 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	0.00% 0/218 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.
Metabolism and nutrition disorders OBESITY	0.00% 0/59 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	0.00% 0/58 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	1.0% 1/98 • Number of events 1 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	0.00% 0/218 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BREAST CANCER	0.00% 0/59 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	1.7% 1/58 • Number of events 1 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	0.00% 0/98 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	0.00% 0/218 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BREAST CANCER STAGE II	0.00% 0/59 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	0.00% 0/58 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	0.00% 0/98 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	0.46% 1/218 • Number of events 1 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.
Nervous system disorders FACIAL PARALYSIS	0.00% 0/59 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	0.00% 0/58 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	0.00% 0/98 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	0.46% 1/218 • Number of events 1 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.
Pregnancy, puerperium and perinatal conditions ABORTION SPONTANEOUS	0.00% 0/59 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	0.00% 0/58 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	0.00% 0/98 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	0.46% 1/218 • Number of events 1 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.
Reproductive system and breast disorders MENORRHAGIA	0.00% 0/59 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	0.00% 0/58 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	0.00% 0/98 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	0.46% 1/218 • Number of events 1 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.
Reproductive system and breast disorders METRORRHAGIA	0.00% 0/59 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	1.7% 1/58 • Number of events 1 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	0.00% 0/98 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	0.00% 0/218 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.
Reproductive system and breast disorders PELVIC PAIN	0.00% 0/59 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	0.00% 0/58 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	0.00% 0/98 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	0.46% 1/218 • Number of events 1 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.
Surgical and medical procedures HYSTERECTOMY	0.00% 0/59 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	0.00% 0/58 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	0.00% 0/98 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	0.46% 1/218 • Number of events 1 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.

Other adverse events

Other adverse events
Measure	Placebo->Elagolix n=59 participants at risk Placebo in pivotal study and elagolix 300 mg BID in extension study.	Placebo->Elagolix + E2/NETA n=58 participants at risk Placebo in pivotal study and elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in extension study.	Elagolix->Elagolix n=98 participants at risk Elagolix 300 mg BID in pivotal study and elagolix 300 mg BID in extension study.	Elagolix + E2/NETA->Elagolix + E2/NETA n=218 participants at risk Elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in pivotal study and elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in extension study.
Blood and lymphatic system disorders ANAEMIA	0.00% 0/59 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	5.2% 3/58 • Number of events 3 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	0.00% 0/98 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	0.92% 2/218 • Number of events 2 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.
Gastrointestinal disorders NAUSEA	8.5% 5/59 • Number of events 5 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	5.2% 3/58 • Number of events 3 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	2.0% 2/98 • Number of events 2 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	4.1% 9/218 • Number of events 10 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.
Infections and infestations NASOPHARYNGITIS	1.7% 1/59 • Number of events 2 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	1.7% 1/58 • Number of events 1 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	5.1% 5/98 • Number of events 5 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	4.1% 9/218 • Number of events 11 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.
Infections and infestations TOOTH INFECTION	3.4% 2/59 • Number of events 2 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	5.2% 3/58 • Number of events 3 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	0.00% 0/98 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	0.00% 0/218 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.
Infections and infestations URINARY TRACT INFECTION	0.00% 0/59 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	5.2% 3/58 • Number of events 3 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	4.1% 4/98 • Number of events 4 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	2.3% 5/218 • Number of events 5 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.
Investigations BONE DENSITY DECREASED	3.4% 2/59 • Number of events 2 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	3.4% 2/58 • Number of events 2 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	6.1% 6/98 • Number of events 6 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	0.92% 2/218 • Number of events 2 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.
Musculoskeletal and connective tissue disorders ARTHRALGIA	5.1% 3/59 • Number of events 3 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	3.4% 2/58 • Number of events 2 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	1.0% 1/98 • Number of events 1 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	1.4% 3/218 • Number of events 3 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.
Nervous system disorders HEADACHE	6.8% 4/59 • Number of events 4 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	5.2% 3/58 • Number of events 3 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	4.1% 4/98 • Number of events 4 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	5.5% 12/218 • Number of events 12 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.
Psychiatric disorders ANXIETY	1.7% 1/59 • Number of events 1 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	5.2% 3/58 • Number of events 3 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	1.0% 1/98 • Number of events 1 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	1.4% 3/218 • Number of events 3 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.
Psychiatric disorders MOOD SWINGS	5.1% 3/59 • Number of events 3 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	3.4% 2/58 • Number of events 2 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	1.0% 1/98 • Number of events 1 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	0.92% 2/218 • Number of events 2 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.
Reproductive system and breast disorders METRORRHAGIA	0.00% 0/59 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	6.9% 4/58 • Number of events 4 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	0.00% 0/98 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	0.46% 1/218 • Number of events 1 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.
Skin and subcutaneous tissue disorders ALOPECIA	5.1% 3/59 • Number of events 3 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	1.7% 1/58 • Number of events 1 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	1.0% 1/98 • Number of events 1 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	0.00% 0/218 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.
Skin and subcutaneous tissue disorders NIGHT SWEATS	25.4% 15/59 • Number of events 16 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	6.9% 4/58 • Number of events 4 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	2.0% 2/98 • Number of events 2 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	3.2% 7/218 • Number of events 8 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.
Vascular disorders HOT FLUSH	50.8% 30/59 • Number of events 33 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	6.9% 4/58 • Number of events 4 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	3.1% 3/98 • Number of events 3 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.	6.9% 15/218 • Number of events 15 • From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively Treatment-emergent adverse events are presented.

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