Table 5.
Serious adverse events and treatment-emergent SAEs reported during the study by primary system organ class and preferred term in the safety analysis set (n=954)
| SAEs, n (%) | Study drug-related SAEs, n (%) | |
|---|---|---|
| Ear and labyrinth disorders | ||
| Deafness unilateral | 1 (0.1) | 1 (0.1) |
| Hepatobiliary disorders | ||
| Cholecystitis | 1 (0.1) | 1 (0.1) |
| Hepatitis cholestatic | 1 (0.1) | 1 (0.1) |
| Injury, poisoning and procedural complications | ||
| Ankle fracture | 1 (0.1) | 0 |
| Neoplasms benign, malignant and unspecified (incl. cysts/polyps) | ||
| Brain neoplasm benign | 1 (0.1) | 0 |
| Fibroadenoma of breast | 1 (0.1) | 0 |
| Papillary thyroid cancer | 1 (0.1) | 0 |
| Tubular breast carcinoma | 1 (0.1) | 0 |
| Nervous system disorders | ||
| Hypesthesia | 1 (0.1) | 1 (0.1) |
| Pregnancy, puerperium and perinatal conditions | ||
| Imminent abortion | 1 (0.1) | 0 |
| Renal and urinary disorders | ||
| Calculus ureteric | 1 (0.1) | 0 |
| Reproductive system and breast disorders | ||
| Cervical dysplasia | 1 (0.1) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||
| Vocal cord polyp | 1 (0.1) | 0 |
Abbreviation: SAEs, serious adverse events.