Table 6.
Safety results (safety analysis set)
| csDMARDs plus denosumab (N = 23) |
csDMARD therapy alone (N = 23) |
|
|---|---|---|
| Any AEs | 12 (52.2) | 13 (56.5) |
| AEs that occurred in at least two patients in any treatment group | ||
| Herpes zoster | 2 (8.7) | 0 (0.0) |
| Nasopharyngitis | 1 (4.3) | 4 (17.4) |
| Hypocalcemia | 4 (17.4) | 1 (4.3) |
| Hepatic function abnormal | 1 (4.3) | 2 (8.7) |
| Liver disorders | 0 (0.0) | 2 (8.7) |
| Serious AEs | 1 (4.3)a | 2 (8.7)b |
| Any ADRs | 6 (26.1) | 0 (0.0) |
| Hypocalcemia | 4 (17.4) | 0 (0.0) |
| Rash erythematous | 1 (4.3) | 0 (0.0) |
| Arthralgia | 1 (4.3) | 0 (0.0) |
| Muscle spasms | 1 (4.3) | 0 (0.0) |
| Pain in extremity | 1 (4.3) | 0 (0.0) |
| Malaise | 1 (4.3) | 0 (0.0) |
| Platelet count decreased | 1 (4.3) | 0 (0.0) |
| Serious ADRs | 0 (0.0) | 0 (0.0) |
According to the Medical Dictionary for Regulatory Activities/Japanese version 23.1
ADR adverse drug reaction, AE adverse event, csDMARD conventional synthetic disease-modifying anti-rheumatic drug
aOne event of osteoarthritis
bOne event each of lung cancer and subdural hematoma