Diclofenac–hyaluronate conjugate (diclofenac etalhyaluronate) intra-articular injection for hip, ankle, shoulder, and elbow osteoarthritis: a randomized controlled trial

Table 4 Overview of treatment-emergent adverse events

	Hip		Ankle		Shoulder		Elbow		Total
	DF-HA N = 46	Placebo N = 44	DF-HA N = 30	Placebo N = 30	DF-HA N = 45	Placebo N = 45	DF-HA N = 25	Placebo N = 25	DF-HA N = 146	Placebo N = 144
All events	24 (52.2)	15 (34.1)	15 (50.0)	10 (33.3)	23 (51.1)	18 (40.0)	10 (40.0)	9 (36.0)	72 (49.3)	52 (36.1)
Severity
Mild	23 (50.0)	13 (29.5)	15 (50.0)	9 (30.0)	20 (44.4)	17 (37.8)	8 (32.0)	8 (32.0)	66 (45.2)	47 (32.6)
Moderate	1 (2.2)	2 (4.5)	0	1 (3.3)	3 (6.7)	1 (2.2)	2 (8.0)	1 (4.0)	6 (4.1)	5 (3.5)
Severe	0	0	0	0	0	0	0	0	0	0
Serious events	1 (2.2)	0	0	0	1 (2.2)	1 (2.2)	1 (4.0)	0	3 (2.1)	1 (0.7)
Events leading to study drug withdrawal	0	0	0	0	0	0	0	0	0	0
Common events (≥ 2%)^a
Nasopharyngitis	8 (17.4)	4 (9.1)	6 (20.0)	2 (6.7)	5 (11.1)	5 (11.1)	2 (8.0)	2 (8.0)	21 (14.4)	13 (9.0)
Injection site joint pain	3 (6.5)	1 (2.3)	2 (6.7)	2 (6.7)	1 (2.2)	0	0	0	6 (4.1)	3 (2.1)
Nausea	4 (8.7)	0	1 (3.3)	0	0	0	0	0	5 (3.4)	0
Palpitations	2 (4.3)	0	0	0	1 (2.2)	0	0	0	3 (2.1)	0
Arthralgia	0	0	1 (3.3)	2 (6.7)	0	2 (4.4)	0	0	1 (0.7)	4 (2.8)
Special-interest events
Events at the injection site^b	3 (6.5)	2 (4.5)	4 (13.3)	3 (10.0)	3 (6.7)	0	0	2 (8.0)	10 (6.8)	7 (4.9)
Gastrointestinal disorders^c	0	0	0	0	1 (2.2)	0	0	0	1 (0.7)	0
Cardiovascular disorders^d	2 (4.3)	0	0	0	1 (2.2)	0	0	0	3 (2.1)	0
Renal dysfunction^e	0	0	0	0	1 (2.2)	0	0	0	1 (0.7)	0
Hypersensitivity^f	1 (2.2)	0	1 (3.3)	1 (3.3)	3 (6.7)	3 (6.7)	0	1 (4.0)	5 (3.4)	5 (3.5)
Anaphylactic reaction^g	3 (6.5)	0	1 (3.3)	0	1 (2.2)	2 (4.4)	0	2 (8.0)	5 (3.4)	4 (2.8)

Data are presented as n (%)
DF-HA diclofenac etalhyaluronate
Classifications of adverse events are according to the Medical Dictionary for Regulatory Activities (MedDRA), version 22.0
^aTreatment-emergent adverse events (TEAEs) that occurred at a frequency of ≥2% in the DF-HA and/or placebo groups in total joints
^bInjection-site events included joint pain, bruising, eczema, hypoesthesia, injury, joint swelling, musculoskeletal pain, joint space narrowing, and cubital tunnel syndrome
^cStandardized MedDRA query (broad scope) term. TEAEs indicate gastrointestinal perforation, ulceration, hemorrhage, or obstruction
^dStandardized MedDRA query (broad scope) term. TEAEs indicate acute cardiac failure, ischemic heart disease, or cardiac arrhythmias
^eStandardized MedDRA query (broad scope) term. TEAEs indicate acute renal failure or chronic kidney disease
^fStandardized MedDRA query (broad scope) term. TEAEs indicate hypersensitivity
^gStandardized MedDRA query (broad scope) term. TEAEs indicate anaphylactic reaction

ISSN: 1471-2474