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Table 4 Overall Summary of Adverse Events in Retreatment Group A and PBS Gel Group C

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

  PBS Gel–Group C Retreatment Group A
(N = 74) (N = 125)
Events Patients (%) Events Patients (%)
AEs 38 26 (35.1) 76 50 (40.0)
TEAEs occurring in ≥5 % of patients     
 Joint effusion 7 7 (9.5) 13 13 (10.4)
 Arthralgia 6 6 (8.1) 12 12 (9.6)
 Joint swelling 7 7 (9.5) 10 10 (8.0)
Related AEs 12 8 (10.8) 31 18 (14.4)
Related AEs occurring in ≥5 % of patients     
 Arthralgia 5 5 (6.8) 9 9 (7.2)
 Joint swelling 3 3 (4.1) 7 7 (5.6)
  1. No statistically significant difference was identified between groups