Skip to main content

Advertisement

Table 2 Overall Summary of Adverse Events in Retreatment Group A and Nonretreatment Group B

From: Evidence for safety of retreatment with a single intra-articular injection of Gel-200 for treatment of osteoarthritis of the knee from the double-blind pivotal and open-label retreatment clinical trials

  Nonretreatment Group B Retreatment Group A
(N = 106) (N = 125)
Events Patients (%) Events Patients (%)
AEs 187 73 (68.9) 233 84 (67.2)
AEs occurring in ≥5 % of patients     
 Joint swelling 33 27 (25.5) 49 37 (29.6)
 Joint effusion 29 24 (22.6) 35 30 (24.0)
 Arthralgia 22 17 (16.0) 24 19 (15.2)
 Upper respiratory tract infection 3 3 (2.8) 13 13 (10.4)
Related AEs 48 27 (25.5) 59 31 (24.8)
Related AEs occurring in ≥5 % of patients     
 Joint swelling 15 14 (13.2) 22 15 (12.0)
 Joint effusion 13 12 (11.3) 14 12 (9.6)
 Arthralgia 9 7 (6.6) 13 10 (8.0)
  1. No statistically significant difference was identified between groups