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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