Skip to main content

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