Table 4.
Adverse events in the safety population. Treatment-emergent adverse events (TEAEs) were defined as adverse events with a recorded start date beyond or equal to the date of randomisation
| Ibandronate/PSP (n = 548) | Alendronate (n = 529) | |
|---|---|---|
| No. patients with at least 1 TEAE | 371 | 380 |
| TEAEs, n (%)* patients | ||
| Gastrointestinal disorders | 122 (32.9) | 109 (28.7) |
| General disorders and administration site conditions | 44 (11.9) | 42 (11.1) |
| Infections and infestations | 103 (27.8) | 111 (29.2) |
| Musculoskeletal and connective tissue disorders | 123 (33.2) | 131 (34.5) |
| Nervous system disorders | 54 (14.6) | 39 (10.3) |
| Respiratory, thoracic and mediastinal disorders | 37 (10.0) | 49 (12.9) |
| Skin and subcutaneous tissue disorders | 35 (9.4) | 42 (11.1) |
PSP, patient support programme.
*
Percentages are based on the number of patients in the safety population with at least one treatment-emergent adverse event. Data are presented for TEAEs occurring in ≥10% of patients who experienced at least one TEAE in either treatment group.