Table 5.
Frequent Adverse Drug Reactions (more than 2% of subjects).
| r-hFSH biosimilar n=49 |
Original α r-hFSH n=44 |
|
|---|---|---|
| Subjects % (n) | 46.9% (23) | 29.5% (13) |
| Reactions % (n) | 42% (0.9) | 29 (0.7) |
| Headache | 14.3% (7) 13 reactions |
4.5% (2) 2 reactions |
| Myalgia | 4.1% (2) 2 reactions |
2.3% (1) 1 reaction |
| Ovarian pain | 14.3% (7) 9 reactions |
20.5% (9) 14 reactions |
| Abdominal pain | 16.3% (8) 8 reactions |
11.4% (5) 6 reactions |
| Hematuria | 0 | 2.3% (1) 1 reaction |
| Insomnia | 2.0% (1) 1 reaction |
0 |
| Dizziness | 4.1% (2) 2 reactions |
2.3% (1) 1 reaction |
| Migraine | 0 | 2.3% (1) 1 reaction |
| Nausea | 4.1% (2) 2 reactions |
0 |
| Vulvar pruritus | 2.0% (1) 1 reaction |
0 |
| Rash | 2.0% (1) 1 reaction |
0 |
| Breast pain | 0 | 4.5% (2) 3 reactions |
n=number.