Systemic organ | Bazedoxifene group (n = 57) | Control group (n = 57) |
---|---|---|
Adverse events (AE): no. of patients (%) | 27 (47.4) | 15 (26.3) |
Musculoskeletal | 8 (14.0)§ | 4 (7.0)§ |
Gastrointestinal disorder | 8 (14.0)¶ | 2 (3.5)§ |
Infection* | 5 (8.8)¶ | 1 (1.8) |
Respiratory | 2 (3.5) | 4 (7.0) |
Injury† | 2 (3.5) | 3 (5.3) |
Hepatobiliary disorder | 3 (5.3)¶ | 1 (1.8) |
Skin and subcutaneous tissue disorder | 2 (3.5) | 2 (3.5) |
General disorder | 3 (5.3) | 0 (0.0) |
Hot flushing | 2 (3.5) | 0 (0.0) |
Nervous system disorder | 2 (3.5) | 0 (0.0) |
Renal and urinary | 1 (1.8) | 1 (1.8) |
Other‡ | 1 (1.8) | 3 (5.3) |
Total number of AE | 46 | 23 |
Serious adverse events (SAE): no. of patients (%) | 7 (12.3) | 10 (17.5) |
Musculoskeletal | 3 (5.3) | 3 (5.3) |
Infection£ | 3 (5.3) | 1 (1.8) |
Injury€ | 1 (1.8) | 3 (5.3) |
Renal and urinary | 0 | 1 (1.8) |
Eye | 0 | 1 (1.8) |
Malignancy | 0 | 1 (1.8) |
Total number of SAE | 7 | 10 |