Table 6.
Adverse Event | Risedronate (n = 106) |
Placebo (n = 106) |
P | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Grade 1/2 |
Grade 3 |
Grade 4 |
Grade 1/2 |
Grade 3 |
Grade 4 |
||||||||
No. | % | No. | % | No. | % | No. | % | No. | % | No. | % | ||
Arthralgia | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 3 | 3 | 0 | 0 | .045 |
Chest pain | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 2 | 2 | 2 | 0 | 0 | .045 |
Constipation | 52 | 49 | 1 | 1 | 0 | 0 | 61 | 58 | 0 | 0 | 0 | 0 | .19 |
Headache | 40 | 37 | 2 | 2 | 1 | 1 | 48 | 45 | 3 | 3 | 0 | 0 | .21 |
Irregular menses | 0 | 0 | 10 | 9 | 0 | 0 | 0 | 0 | 8 | 8 | 0 | 0 | .32 |
Neutropenia | 1 | 1 | 2 | 2 | 4 | 4 | 0 | 0 | 1 | 1 | 3 | 3 | .37 |
Leukopenia | 0 | 0 | 5 | 5 | 2 | 2 | 0 | 0 | 0 | 0 | 4 | 4 | .39 |
Dyspnea | 0 | 0 | 2 | 2 | 0 | 0 | 1 | 1 | 2 | 2 | 1 | 1 | .41 |
Lymphopenia | 0 | 0 | 3 | 3 | 0 | 0 | 0 | 0 | 5 | 5 | 0 | 0 | .47 |
Nausea | 2 | 2 | 3 | 3 | 0 | 0 | 2 | 2 | 1 | 1 | 0 | 0 | .47 |
Infection | 2 | 2 | 1 | 1 | 0 | 0 | 1 | 1 | 3 | 3 | 0 | 0 | .57 |
Flatulence | 46 | 43 | 0 | 0 | 0 | 0 | 31 | 29 | 13 | 12 | 0 | 0 | .61 |
Abdominal pain | 31 | 29 | 2 | 2 | 0 | 0 | 27 | 26 | 3 | 3 | 0 | 0 | .62 |
Anemia | 2 | 2 | 1 | 1 | 1 | 1 | 2 | 2 | 1 | 1 | 0 | 0 | .70 |
Dyspepsia | 5 | 5 | 2 | 2 | 0 | 0 | 6 | 6 | 2 | 2 | 0 | 0 | .80 |
Diarrhea | 29 | 28 | 1 | 1 | 0 | 0 | 28 | 27 | 1 | 1 | 0 | 0 | .89 |
Fatigue | 2 | 2 | 2 | 2 | 0 | 0 | 4 | 4 | 0 | 0 | 0 | 0 | .98 |