Table II.

Incidence of subjects with at least one (serious) adverse event, with OHSS or with mild local tolerance reaction.

	Cycle 1 (N = 682)	Cycle 2 (N = 375)	Cycle 3 (N = 198)
Subjects with AEs, % (95% CI)	46.8 (43.0–50.6)	35.2 (30.4–40.3)	31.3 (24.9–38.3)
Procedural pain	14.2 (11.7–17.1)	11.2 (8.2–14.8)	10.1 (6.3–15.2)
Headache	5.6 (4.0–7.6)	5.3 (3.3–8.1)	5.6 (2.8–9.7)
Pelvic pain	4.8 (3.4–6.7)	3.7 (2.1–6.2)	2.5 (0.8–5.8)
Subjects with SAEs, % (95% CI)	3.4 (2.1–5.0)	1.6 (0.6–3.4)	1.5 (0.3–4.4)
OHSS, any grade, % (95% CI)	3.5 (2.3–5.2)	1.9 (0.8–3.8)	0
Mild	1.8	0.8
Moderate	0.9	0.5
Severe	0.9	0.5
Local tolerance
Mild, % (95% CI)	2.5 (1.5–4.0)	4.3 (2.5–6.8)	2.5 (0.8–5.8)

CI, confidence interval.