Table 7.

Treatment-Emergent Adverse Events in Ovaleap® Cycles 2 and 3 Combined

		Previous Treatment in Main Study
MedDRA Preferred Term	Total Group	Ovaleap®	Gonal-f®
	N = 147	N = 80	N = 67
	n (%)	n (%)	n (%)
Any TEAE	19 (12.9)	9 (11.3)	10 (14.9)
Abdominal pain lower	1 (0.7)	0	1 (1.5)
Anemia	1 (0.7)	0	1 (1.5)
Appendicitis	1 (0.7)	0	1 (1.5)
Application site erythema	1 (0.7)	1 (1.3)	0
Application site hematoma	1 (0.7)	0	1 (1.5)
Application site pruritus	1 (0.7)	1 (1.3)	0
Back pain	1 (0.7)	1 (1.3)	0
Borderline ovarian tumor	1 (0.7)	1 (1.3)	0
Cyst aspiration	1 (0.7)	0	1 (1.5)
Depressed mood	1 (0.7)	0	1 (1.5)
Influenza-like illness	1 (0.7)	1 (1.3)	0
Injection-site erythema	1 (0.7)	0	1 (1.5)
Injection-site pruritus	1 (0.7)	0	1 (1.5)
Menorrhagia	1 (0.7)	1 (1.3)	0
Metrorrhagia	1 (0.7)	1 (1.3)	0
Muscle spasms	1 (0.7)	1 (1.3)	0
Nausea	1 (0.7)	0	1 (1.5)
OHSS	1 (0.7)	0	1 (1.5)
Procedural pain	1 (0.7)	0	1 (1.5)
Pyrexia	1 (0.7)	1 (1.3)	0
Respiratory tract inflammation	1 (0.7)	0	1 (1.5)
Sinusitis	1 (0.7)	0	1 (1.5)
Upper respiratory tract infection	1 (0.7)	1 (1.3)	0
Vaginal discharge	1 (0.7)	1 (1.3)	0
Vaginal infection	2 (1.4)	2 (2.5)	0
Vulvovaginal pruritus	1 (0.7)	1 (1.3)	0

OHSS ovarian hyperstimulation syndrome; TEAE treatment-emergent adverse event