Table 4.
Major congenital anomalies among live-born neonates in fresh and frozen cycles
| MedDRA high-level group term Preferred term |
Fresh cycles | Frozen cycles | Total | |||
|---|---|---|---|---|---|---|
| Follitropin delta | Follitropin alfa | Follitropin delta | Follitropin alfa | Follitropin delta | Follitropin alfa | |
| N | 308 | 310 | 125 | 130 | 433 | 440 |
| Number of neonates with any event (%) | 5 (1.6) | 7 (2.3) | 2 (1.6) | 1 (0.8) | 7 (1.6) | 8 (1.8) |
| Total number of events | 6 | 11 | 3 | 1 | 9 | 12 |
| Cardiac and vascular disorders congenital | ||||||
| Atrial septal defect | 1 (0.3)a | 1 (0.2)a | ||||
| Bicuspid aortic valve | 1 (0.3)a | 1 (0.2)a | ||||
| Coarctation of the aorta | 1 (0.3)a | 1 (0.2)a | ||||
| Double outlet right ventricle | 1 (0.8) | 1 (0.2) | ||||
| Patent ductus arteriosus | 1 (0.3) | 1 (0.8) | 2 (0.5) | |||
| Transposition of the great vessels | 1 (0.3) | 1 (0.2) | ||||
| Ventricular septal defect | 1 (0.3) | 2 (0.6)a | 1 (0.2) | 2 (0.5)a | ||
| Chromosomal abnormalities and abnormal gene carriers | ||||||
| Beckwith-Wiedemann syndrome | 1 (0.3)a | 1 (0.8) | 1 (0.2) | 1 (0.2)a | ||
| Gastrointestinal tract disorders congenital | ||||||
| Cleft palate | 1 (0.3) | 1 (0.3) | 1 (0.2) | 1 (0.2) | ||
| Musculoskeletal and connective tissue disorders congenital | ||||||
| Adactyly | 1 (0.3) | 1 (0.2) | ||||
| Polydactyly | 1 (0.8) | 1 (0.2) | ||||
| Renal and urinary tract disorders congenital | ||||||
| Congenital pyelocaliectasis | 1 (0.3) | 1 (0.2) | ||||
| Pelvic kidney | 1 (0.3) | 1 (0.2) | ||||
| Urethral valves | 1 (0.3) | 1 (0.3) | 1 (0.2) | 1 (0.2) | ||
| Reproductive tract and breast disorders congenital | ||||||
| Cryptorchism | 1 (0.3) | 1 (0.2) | ||||
Values are n (%), unless otherwise stated
aDetected between 24 h and 4 weeks after birth
MedDRA Medical Dictionary for Regulatory Activities, N total number of live-born neonates, n number of live-born neonates with events