Table 3.
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 |
Abbreviations: PRP platelet-rich plasma, TEAEs treatment-emergent adverse events, SD standard deviation