| Outcome |
Event rate Durolane |
Event rate Saline |
RR (95% CI) |
AR diff (95% CI) |
NNH (95% CI) |
No. pts taking Durol |
No. pts taking Salin |
| Total withdrawals overall |
39 |
35 |
1.12 (0.75,1.68) |
0.02 (‐0.06,0.11) |
|
173 |
174 |
| Withdrawals due to inefficacy |
10 |
6 |
1.68 (0.62,4.51) |
0.02 (‐0.02,0.07) |
|
173 |
174 |
| Withdrawals due to adverse events |
13 |
6 |
2.18 (0.85,5.60) |
0.04 (‐0.01,0.09) |
|
173 |
174 |
| Number of patients affected by device‐related adverse events |
3 |
2 |
1.51 (0.26,8.92) |
0.01 (‐0.02,0.03) |
|
173 |
174 |
| Number of patients with injection only adverse events |
1 |
2 |
0.50 (0.05,5.49) |
‐0.01 (‐0.03,0.01) |
|
173 |
174 |
| Number of patients with non‐serious treatment‐related adverse events |
22 |
15 |
1.48 (0.79,2.75) |
0.04 (‐0.02,0.11) |
|
173 |
174 |
| Number of patients with non‐serious adverse events |
112 |
114 |
0.99 (0.85,1.15) |
‐0.01 (‐0.11,0.09) |
|
173 |
174 |
| Number of patients with treated unrelated adverse events |
101 |
109 |
0.93 (0.79,1.10) |
‐0.04 (‐0.15,0.06) |
|
173 |
174 |
| Number of patientts with serious treatment‐unrelated adverse events |
7 |
3 |
2.35(0.62,8.93) |
0.02 (‐0.01,0.06) |
|
173 |
174 |
