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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

From: 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

Primary System Organ Class /Preferred Term n (%) Placebo (N = 220) Single 6 ml Hylan G-F 20 injection (N = 218)
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
  1. 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