|
Event term
|
Goserelin
|
XM17
|
Gonal-f®
|
|---|
|
(n = 39)
|
(n = 36)
|
(n = 36)
|
|---|
|
x (y, z %)
|
x (y, z %)
|
x (y, z %)
|
|---|
|
Overall
|
26 (17, 43.6 %)
|
43 (25, 69.4 %)
|
42 (20, 55.6 %)
|
|
Headache
|
11 (10, 25.6 %)
|
15 (14, 38.9 %)
|
14 (11, 30.6 %)
|
|
Hot flushes
|
–
|
5 (5, 13.9 %)
|
5 (5, 13.9 %)
|
|
Abdominal pain, lower
|
–
|
1 (1, 2.8 %)
|
3 (3, 8.3 %)
|
|
Nausea
|
–
|
2 (2, 5.6 %)
|
2 (2, 5.6 %)
|
|
Dizziness
|
2 (2, 5.1 %)
|
2 (2, 5.6 %)
|
2 (2, 5.6 %)
|
|
Metrorrhagia
|
–
|
2 (2, 5.6 %)
|
1 (1, 2.8 %)
|
|
Dysgeusia
|
–
|
1 (1, 2.8 %)
|
2 (2, 5.6 %)
|
|
Rash
|
–
|
1 (1, 2.8 %)
|
2 (2, 5.6 %)
|
|
Injection site pain
|
–
|
–
|
2 (2, 5.6 %)a
|
|
Abdominal pain
|
2 (2, 5.1 %)
|
1 (1, 2.8 %)
|
1 (1, 2.8 %)
|
|
Breast pain
|
2 (2, 5.1 %)
|
–
|
–
|
|
Oropharyngeal pain
|
2 (2, 5.1 %)
|
1 (1, 2.8 %)
|
–
|
-
aThese AEs occurred immediately upon injection/drug administration and lasted only one minute each and thus were included in the AE assessment but not the first local tolerability assessment (1 h post-dose). Abbreviation: x (y, z %) = number of events (number of participants, percent by treatment)
