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 |