Inhibition of bone erosion, determined by high-resolution peripheral quantitative computed tomography (HR-pQCT), in rheumatoid arthritis patients receiving a conventional synthetic disease-modifying anti-rheumatic drug (csDMARD) plus denosumab vs csDMARD therapy alone: an open-label, randomized, parallel-group study

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

ISSN: 1478-6362