Table 4. TEAEs by MedDRA system organ class and preferred terms.
| System organ class (preferred term) | Patient with TEAE (N=637) | Mild TEAE | Moderate TEAE | Total TEAE |
|---|---|---|---|---|
| Nervous system disorder | 5 (0.8) | 4 | 1 | 5 (33.3) |
| Headache | 3 (0.5) | 2 | 1 | 3 (20.0) |
| Dizziness | 1 (0.2) | 1 | 0 | 1 (6.7) |
| Somnolence | 1 (0.2) | 1 | 0 | 1 (6.7) |
| Vascular disorder | 3 (0.5) | 2 | 1 | 3 (20.0) |
| Hot flush | 2 (0.3) | 2 | 0 | 2 (13.3) |
| Flushing | 1 (0.2) | 0 | 1 | 1 (6.7) |
| Musculoskeletal and connective tissue disorder | 1 (0.2) | 1 | 0 | 1 (6.7) |
| Limb discomfort | 1 (0.2) | 1 | 0 | 1 (6.7) |
| General disorders and administration site condition | 1 (0.2) | 0 | 1 | 1 (6.7) |
| Pyrexia | 1 (0.2) | 0 | 1 | 1 (6.7) |
| Eye disorder | 1 (0.2) | 1 | 0 | 1 (6.7) |
| Ocular hyperemia | 1 (0.2) | 1 | 0 | 1 (6.7) |
| Renal and urinary disorder | 1 (0.2) | 1 | 0 | 1 (6.7) |
| Micturition urgency | 1 (0.2) | 1 | 0 | 1 (6.7) |
| Skin and subcutaneous tissue disorder | 1 (0.2) | 0 | 1 | 1 (6.7) |
| Swelling face | 1 (0.2) | 0 | 1 | 1 (6.7) |
| Respiratory, thoracic, and mediastinal disorder | 1 (0.2) | 0 | 1 | 1 (6.7) |
| Dyspnea | 1 (0.2) | 0 | 1 | 1 (6.7) |
| Investigation | 1 (0.2) | 1 | 0 | 1 (6.7) |
| Semen volume decreased | 1 (0.2) | 1 | 0 | 1 (6.7) |
| Total | 13 (2.0) | 10 | 5 | 15 (100) |
Values are presented as number (%). Patients may appear in >1 category. TEAE: treatment-emergent adverse events, MedDRA: Medical Dictionary for Regulatory Activities version 19.0.