Table 3.

Summary of Treatment-Emergent Adverse Events

		300 mg Elagolix Twice Daily				600 mg Elagolix Daily
	Placebo (n=65)	Without Add-Back (n=65)	+0.5 mg E2/0.1 mg NETA (n=64)	+1.0 mg E2/0.5 mg NETA (n=65)	Placebo (n=78)	Without Add-Back (n=77)	+0.5 mg E2/0.1 mg NETA (n=76)	+1.0 mg E2/0.5 mg NETA (n=77)
Any AE	47 (72)	52 (80)	47 (73)	48 (74)	53 (68)	67 (87)	56 (74)	55 (71)
Any serious AE	6 (9.2)	3 (4.6)	3 (4.7)	1 (1.5)	1 (1.3)	5 (6.5)	3 (3.9)	4 (5.2)
Any discontinuation resulting from AE	7 (11)	4 (6.2)	2 (3.1)	6 (9.2)	1 (1.3)	11 (14)	7 (9.2)	9 (12)
AEs occurring in 5% or greater of women*
Hot flush	2 (3.1)	29 (45)	16 (25)	7 (11)	4 (5.1)	38 (49)	14 (18)	11 (14)
Headache	6 (9.2)	8 (12)	9 (14)	13 (20)	8 (10)	13(17)	11 (15)	14 (18)
Nausea	6 (9.2)	4 (6.2)	4 (6.3)	12 (19)	3 (3.8)	10 (13)	12 (16)	20 (26)
Insomnia	1 (1.5)	7 (11)	5 (7.8)	0	†	†	†	†
Urinary tract infection	2 (3.1)	2 (3.1)	5 (7.8)	4 (6.2)	†	†	†	†
Back pain	6 (9.2)	5 (7.7)	2 (3.1)	3 (4.6)	2 (2.6)	6 (7.8)	6 (7.9)	7 (9.1)
Fatigue	2 (3.1)	3 (4.6)	4 (6.3)	3 (4.6)	†	†	†	†
Menorrhagia	2 (3.1)	3 (4.6)	3 (4.7)	4 (6.2)	†	†	†	†
Pain in extremity	2 (3.1)	4 (6.2)	2 (3.1)	4 (6.2)	†	†	†	†
Anemia	†	†	†	†	7 (9.0)	4 (5.2)	6 (7.9)	5 (6.5)
Diarrhea	†	†	†	†	4 (5.1)	5 (6.5)	3 (3.9)	4 (5.2)
Dizziness	†	†	†	†	3 (3.8)	3 (3.9)	4 (5.3)	5 (6.5)
Vomiting	†	†	†	†	4 (5.1)	4 (5.2)	3 (3.9)	5 (6.5)
Maximum hot flush severity
Mild	1	18	11	5	2	22	12	11
Moderate	1	9	4	2	1	14	2	0
Severe	0	2	1	0	1	2	0	0
Discontinuation as a result of hot flush	0	2 (3.1)	1 (1.6)	0	0	3 (3.9)	0	0

E2, estradiol; NETA, norethindrone acetate; AE, adverse event.

Data are n (%) or n.

There was no statistical comparison between treatment groups.

^*MedDRA preferred terms in descending order for elagolix overall in cohort 1, then cohort 2.

^†Preferred terms with an incidence below 5%.