Table 1.
Summary of adverse events
| Risedronate | |||
|---|---|---|---|
| 5 mg IR daily | 35 mg DR FB weekly | 35 mg DR BB weekly | |
| (N = 307) | (N = 307) | (N = 308) | |
| n (%) | n (%) | n (%) | |
| Adverse events | 243 (79.2) | 250 (81.4) | 264 (85.7) |
| Serious adverse events | 31 (10.1) | 32 (10.4) | 32 (10.4) |
| Deaths | 1 (0.3) | 1 (0.3) | 0 (0.0) |
| Withdrawn due to an adverse event | 28 (9.1) | 37 (12.1) | 25 (8.1) |
| Most common adverse events associated with withdrawal | |||
| Gastrointestinal disorder | 13 (4.2) | 21 (6.8) | 14 (4.5) |
| Most common adverse events | |||
| Arthralgia | 33 (10.7) | 29 (9.4) | 27 (8.8) |
| Back pain | 27 (8.8) | 29 (9.4) | 29 (9.4) |
| Nasopharyngitis | 24 (7.8) | 32 (10.4) | 38 (12.3) |
| Influenza | 23 (7.5) | 27 (8.8) | 25 (8.1) |
| Urinary tract infection | 20 (6.5) | 21 (6.8) | 22 (7.1) |
| Diarrhea | 19 (6.2) | 30 (9.8) | 21 (6.8) |
| Upper abdominal pain | 8 (2.6) | 11 (3.6) | 26 (8.4) |
| Adverse events of special interest | |||
| Clinical vertebral fracture | 1 (0.3) | 0 (0.0) | 3 (1.0) |
| Clinical nonvertebral fracture | 15 (4.9) | 13 (4.2) | 20 (6.5) |
| Upper gastrointestinal tract adverse events | 56 (18.2) | 59 (19.2) | 69 (22.4) |
| Selected musculoskeletal adverse eventsa | 66 (22.1) | 67 (21.8) | 77 (25.0) |
| Adverse events potentially associated with acute phase reactionb | 4 (1.3) | 7 (2.3) | 4 (1.3) |
aIncludes arthralgia, back pain, bone pain, musculoskeletal pain, musculoskeletal discomfort, myalgia, and neck pain
bIncludes symptoms of influenza-like illness or pyrexia with a start date within the first 3 days after the first dose of study drug and duration of 7 days or less