Table 4. Treatment-emergent adverse events occurring in ≥2 volunteers in any group (safety population).
Denosumab 60 mg (N = 23) |
Denosumab 120 mg (N = 23) |
Placebo (N = 17) |
|
---|---|---|---|
Any adverse event, n (%) | 18 (78) | 19 (83) | 11 (65) |
Decrease in blood calcium levels | 13 (57) | 13 (57) | 1 (6) |
Increase in blood calcium levels | 1 (4) | 2 (9) | 1 (6) |
Alanine aminotransferase increased | 1 (4) | 2 (9) | 0 |
Upper respiratory tract infection | 8 (35) | 6 (26) | 3 (18) |
Diarrhea | 2 (9) | 3 (13) | 1 (6) |
Abdominal pain | 2 (9) | 0 | 1 (6) |
Pain in extremity | 0 | 2 (9) | 2 (12) |
Contusion | 0 | 2 (9) | 0 |