Table 3.

Adverse events (safety set).

	Test Group (n = 141) n (%) Events	Comparator Group (n = 141) n (%) Events
TEAEs *	43 (30.5) 62	47 (33.3) 75
TEAE severity
Mild	28 (19.9) 35	27 (19.1) 37
Moderate	18 (12.8) 25	26 (18.4) 35
Severe	2 (1.4) 2	3 (2.1) 3
Serious TEAEs	1 (0.7) 1	2 (1.4) 2
TEAEs with local reactions	1 (0.7) 1	4 (2.8) 5
TEAEs by preferred term †
Arthralgia	5 (3.5) 6	7 (5.0) 7
Headache	5 (3.5) 7	4 (2.8) 4
ADEs	5 (3.5) 6	8 (5.7) 12
ADEs by preferred term
Arthralgia	2 (1.4) 2	3 (2.1) 3
Injection site pain	2 (1.4) 2	2 (1.4) 2
Joint swelling	1 (0.7) 1	3 (2.1) 3
Injection site joint effusion	0	1 (0.7) 2
Dermatitis contact	0	1 (0.7) 2
Mobility decreased	1 (0.7) 1	0
Osteoarthritis	0	1 (0.7) 1

ADE, adverse device effect (includes both device-related and injection procedure-related ADEs); TEAE, treatment-emergent adverse event. Any missing severity, relationship, or outcome was not imputed, but was classified as missing. Patients with more than one TEAE in a particular category (system organ class/preferred term) were counted only once in that category. * TEAEs were any events not present before the study device injection or any events already present that worsened in either intensity or frequency after the study device injection. ^† Occurring in ≥3% of patients.