| |
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 eventa
|
3 (2.5)
|
3 (2.5)
|
|
With most frequently reported adverse eventsb
| | |
|
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.
