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Table 3 Summary of all related adverse events

From: Efficacy of platelet-rich plasma and plasma for symptomatic treatment of knee osteoarthritis: a double-blinded placebo-controlled randomized clinical trial

Adverse events, n (%)

PRP (n = 20)

Plasma (n = 21)

Placebo (n = 21)

p-value

No

7 (35%)

16 (76%)

14 (67%)

0.025

Yes

13 (65%)

5 (24%)

7 (33%)

 

 SAEs

0 (0%)

0 (0%)

0 (0%)

-

 Deaths

0 (0%)

0 (0%)

0 (0%)

-

 TEAEs, n (%)

   

0.914

  Application site pain

8 (40%)

5 (24%)

5 (24%)

 

  Index knee swelling

1 (5%)

0 (0%)

1 (5%)

 

  Application site pain and index knee swelling

3 (15%)

0 (0%)

1 (5%)

 

  Index knee stiffness

1 (5%)

0 (0%)

0 (0%)

 

  Application site ecchymosis/Bleeding

0 (0%)

0 (0%)

0 (0%)

 

 Pain intensity, n (%)

   

0.202

  0 - Mild (0 to < 3)

6 (30%)

2 (10%)

4 (19%)

 

  1 - Moderate (3 to 8)

7 (35%)

2 (10%)

1 (5%)

 

  2 - Intense (> 8 to 10)

0 (0%)

1 (5%)

2 (10%)

 

 Duration of pain in days, mean (SD)

2.1 ± 1.3

2.2 ± 1.1

3.6 ± 2.9

0.681

  1. Abbreviations: PRP platelet-rich plasma, TEAEs treatment-emergent adverse events, SD standard deviation