Table IX.
Overview of the proportion of patients experiencing TEAEs during the stimulation and post-stimulation phases (safety population).
| r-hFSH/r-hLH (n = 462) | r-hFSH (n = 477) | |
|---|---|---|
| Nervous system disorders | 36 (7.8) | 38 (8.0) |
| Gastrointestinal disorders | 29 (6.3) | 35 (7.3) |
| Pregnancy, puerperium and perinatal conditions | 17 (3.7) | 32 (6.7) |
| Reproductive system and breast disorders | 13 (2.8) | 20 (4.2) |
| Maximum severity of TEAE experienced* | ||
| No TEAE | 370 (80.1) | 349 (73.2) |
| Mild | 64 (13.9) | 88 (18.4) |
| Moderate | 21 (4.8) | 27 (5.7) |
| Severe | 7 (1.5) | 13 (2.7) |
*Maximum severity of TEAEs experienced by each patient (no TEAE, mild, moderate and severe; this includes all TEAEs and not just those in the four System Organ Classes detailed in the table).
Data are presented as n (%). The four System Organ Classes most frequently associated with TEAEs during the stimulation and post-stimulation phases are presented. Reported values are for patients having experienced at least one TEAE during the stimulation and post-stimulation phases r-hFSH, recombinant human FSH; r-hLH, recombinant human LH; TEAE, treatment-emergent adverse event..