Table 3.
Summary of adverse events
| AE, n (%) | Ibandronate | |
|---|---|---|
| Oral 100 mg/month (n = 205) | IV 1 mg/month (n = 203) | |
| Any AE | 175 (85.4) | 177 (87.2) |
| Drug-related AE | 47 (22.9) | 38 (18.7) |
| Severe intensity AE | 2 (1.0) | 0 |
| Serious AE | 9 (4.4) | 6 (3.0) |
| AEs leading to death | 0 | 0 |
| AEs leading to treatment withdrawal | 4 (2.0) | 4 (2.0) |
| AEs occurring in ≥5 % of patients in either group | ||
| Nasopharyngitis | 48 (23.4) | 62 (30.5) |
| Back pain | 22 (10.7) | 24 (11.8) |
| Contusion | 17 (8.3) | 13 (6.4) |
| Osteoarthritis | 12 (5.9) | 4 (2.0) |
| Muscle pain | 4 (2.0) | 11 (5.4) |
| AEs of special interest | ||
| GI related | 25 (12.2) | 20 (9.9) |
| Esophageal irritation | 2 (1.0) | 5 (2.5) |
| APRa related | 23 (11.2) | 24 (11.8) |
| Back pain | 7 (3.4) | 6 (3.0) |
| APR | 5 (2.4) | 4 (2.0) |
| Malaise | 5 (2.4) | 2 (1.0) |
| Arthralgia | 2 (1.0) | 4 (2.0) |
| Myalgia | 0 | 4 (2.0) |
| Renal function related | 0 | 0 |
| Hypocalcemia | 0 | 0 |
| Osteonecrosis of the jawb | 0 | 0 |
| Atypical fracture of the femurb | 0 | 0 |
AE adverse event, APR acute phase reaction, GI gastrointestinal, IV intravenous
aOccurring within 3 days of dosing and lasting for no longer than 7 days; APR AEs occurring at an incidence of ≥2 % of patients in either treatment group are listed
bAs per the American Society of Bone and Mineral Research case definition