Highly purified human-derived follicle-stimulating hormone (Bravelle®) has equivalent efficacy to follitropin-beta (Follistim ®) in infertile women undergoing in vitro fertilization

Table 3 Summary of adverse events

	No.(%) of patients
Patients	Bravelle^® (n = 120)	Follistim^® (n = 118)
With any adverse event	73 (60.8)	75 (63.6)
With serious or severe adverse event^a	3 (2.5)	3 (2.5)
With most frequently reported adverse events^b
Vaginal spotting/hemorrhage	11 (9.2)	16 (13.6)
Headache	18 (15.0)	17 (14.4)
Abdominal cramps	17 (14.2)	20 (16.9)
Nausea	12 (10.0)	15 (12.7)
Abdominal pain	6 (5.0)	10 (8.5)
Pelvic pain/cramps	8 (6.7)	6 (5.1)
OHSS	6 (5)	6 (5.1)

^aIn the Bravelle^® group, one patient had an ectopic pregnancy that was resolved through surgery. One patient had a case of OHSS that was deemed severe in nature and required hospitalization. It was resolved without sequelae. One other patient had OHSS that was deemed moderate in nature, at the time of resolution, she had a continuing twin pregnancy. In the Follistim^® group, there were three patients that had OHSS, all deemed mild in nature, one of which had a continuing pregnancy at the time of resolution. ^bThis tabulation involves adverse events, regardless of relationship to treatment, that occurred in either treatment group.

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