10. Clinical benefit table: Euflexxa (BioHy, Arthrease) versus Hylan G‐F 20. Safety.
Outcome | Event rate in BioHy | Event rate in Hylan | RR (95% CI) | AR difference (95%CI | NNH (95%CI) | No. pts taking BioHy | No. pts taking Hylan |
Total withdrawals overall | 2.5% 4/160 | 1.9% 3/161 | 134% (31 to 590%) | 1% (‐3% to 4%) | 3 | 2 | |
Withdrawals due to adverse events | 0% 0/160 | 0.6% 1/161 | 34% (1 to 817%) | ‐1% (‐2% to 1%) | 0 | 1 | |
Withdrawals due to lack of efficacy | 0% 0/160 | 0% 0/161 | 0% | 0% (‐1% to 1%) | 0 | 0 | 0 |
Number of patients with serious adverse events | 1.9% 3/160 | 1.2% 2/161 | 151% (26 to 891%) | 1% (‐2% to 3%) | 2 | 1 | |
Joint effusion | 0.6% 1/160 | 8% 13/161 | 8% (1 to 58%) | ‐7% (‐12% to ‐3%) | 14 (13‐30) | 8 | 8 |
Number of pts reporting adverse events | 34% 54/160 | 40% 65/161 | 84% (63 to 111%) | ‐7% (‐17% to 4%) | 16 (ns) | 40 | 40 |