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Table 5 Summary of treatment-emergent/treatment-related adverse events (safety set)

From: Comparison of two hyaluronic acid formulations for safety and efficacy (CHASE) study in knee osteoarthritis: a multicenter, randomized, double-blind, 26-week non-inferiority trial comparing Durolane to Artz

Adverse event category Artz Durolane
(5 × 2.5 ml) (1 × 3 ml, 4 × sham)
( n= 174) ( n= 175)
Patients with at least one treatment-emergent adverse event 74 (42.5%) 83 (47.4%)
Treatment-related adverse event 17 (9.8%) 23 (13.1%)
Treatment adjustment 1 (0.6%) 0
Treatment permanent stop 1 (0.6%) 0
Importanta 2 (1.1%) 0
Severe 8 (4.6%) 6 (3.4%)
Seriousb 6 (3.4%) 3 (1.7%)
All treatment-related adverse eventsc 17 (9.8%) 23 (13.1%)
Musculoskeletal and connective tissue disorders 16 (9.2%) 18 (10.3%)
Arthralgia 13 (7.5%) 15 (8.6%)
Joint swelling 3 (1.7%) 3 (1.7%)
Arthropathy 0 1 (0.6%)
Epicondylitis 1 (0.6%) 0
Joint effusion 0 1 (0.6%)
Limb discomfort 1 (0.6%) 0
Muscular weakness 0 1 (0.6%)
Musculoskeletal discomfort 0 1 (0.6%)
Myalgia 1 (0.6%) 0
Pain in extremity 0 1 (0.6%)
Skin and subcutaneous tissue disorders 0 1 (0.6%)
Erythema 0 1 (0.6%)
  1. Data presented as number (%). Patients who experienced more than one adverse event are counted once in each row. Durolane from Q-med AB (Sweden) and Artz from Seikagaku Corporation (Japan). aAn important adverse event is any nonsevere adverse event leading to dose adjustment, interruption, or permanent stop. bNone of the serious adverse events were reported to be treatment related. cTreatment-related adverse events were judged to have a definite, possible, or uncertain relationship to treatment.