Efficacy and safety of a single intra-articular injection of 6 ml Hylan G-F 20 compared to placebo in Chinese patients with symptomatic knee osteoarthritis

Table 6 General disorders and administration site conditions. Number (%) of patients with TEAE(s) regardless of relationship and related to treatment by Primary SOC, and PT

Primary System Organ Class /Preferred Term n (%)	Placebo (N = 220)		Single 6 ml Hylan G-F 20 injection (N = 218)
Primary System Organ Class /Preferred Term n (%)	All	Related to Placebo injections	All	Related to Hylan G-F 20 injections
Arthralgia	24 (10.9)	7 (3.2)	26 (11.9))	7 (3.2)
Asthenia	0	0	3 (1.4)	0
Injection site joint pain	1 (0.5)	1 (0.5)	2 (0.9)	1 (0.5)
Injection site pain	1 (0.5)	0	2 (0.9)	1 (0.5)
Joint swelling	4 (1.8)	2 (0.9)	16 (7.3)	8 (3.7)
Pyrexia	0	0	2 (0.9)	0
Axillary pain	0	0	1 (0.5)	0
Chest discomfort	1 (0.5)	0	1 (0.5)	0
Injection site edema	0	0	1 (0.5)	1 (0.5)
Injection site swelling	0	0	1 (0.5)	1 (0.5)
Non-cardiac chest pain	0	0	1 (0.5)	0
Edema peripheral	0	0	1 (0.5)	1 (0.5)
Chills	1 (0.5)	0	0	0
Injection site joint swelling	1 (0.5)	1 (0.5)	0	0
Malaise	1 (0.5)	0	0	0
Puncture site hemorrhage	1 (0.5)	0	0	0
Thirst	1 (0.5)	0	0	0

TEAE Treatment emergent adverse event, SOC System organ class, PT Preferred term MedDRA 21.1 n (%) = number and percentage of patients with at least one TEAE. Table sorted by SOC internationally agreed order and by decreasing frequency of PT according to all TEAE summary in Hylan G-F 20 treatment group

ISSN: 1471-2474