Emergent adverse events according to the summary of product characteristics19 and those leading to drug withdrawal
| Patients with an event (%) | Patients with an event leading to treatment withdrawal (%) | |||||
|---|---|---|---|---|---|---|
| Strontium ranelate 1 g/day (n=548) | Strontium ranelate 2 g/day (n=564) | Placebo (n=556) | Strontium ranelate 1 g/day (n=548) | Strontium ranelate 2 g/day (n=564) | Placebo (n=556) | |
| Gastrointestinal disorders | ||||||
| Diarrhoea | 32 (6%) | 44 (8%) | 24 (4%) | 6 (1%) | 9 (2%) | 8 (1%) |
| Nausea | 19 (4%) | 21 (4%) | 21 (4%) | 5 (0.9%) | 7 (1%) | 3 (0.5%) |
| Vomiting | 11 (2%) | 9 (2%) | 7 (1%) | 1 (0.2%) | 2 (0.4%) | 3 (0.5%) |
| Venous thromboembolism events | ||||||
| Deep venous thrombosis | 4 (0.7%) | 1 (0.2%) | 1 (0.2%) | 2 (0.4%) | 1 (0.2%) | – |
| Pulmonary embolism | 2 (0.4%) | 2 (0.4%) | 1 (0.2%) | 1 (0.2%) | 1 (0.2%) | 1 (0.2%) |
| Skin and subcutaneous disorders | ||||||
| Dermatitis | 1 (0.2%) | 5 (0.9%) | 1 (0.2%) | – | 1 (0.2%) | – |
| Allergic dermatitis | 8 (2%) | 6 (1%) | 3 (0.5%) | 2 (0.4%) | 4 (0.7%) | 2 (0.4%) |
| Eczema | 5 (0.9%) | 11 (2%) | 6 (1%) | – | 1 (0.2%) | 1 (0.2%) |
| Rash | 4 (0.7%) | 4 (0.7%) | 10 (2%) | 1 (0.2%) | 1 (0.2%) | 2 (0.4%) |
Data are number of events or number of patients (%) in patients included in the study who had taken at least one dose of study drug.