1 Severity of peripheral neuropathy (expressed as the change from baseline in the mNIS+7Ionis), at 66 weeks |
1 |
172 |
Mean Difference (IV, Fixed, 95% CI) |
‐19.73 [‐26.50, ‐12.96] |
2 Change in mBMI from baseline to 65 weeks |
1 |
172 |
Mean Difference (IV, Fixed, 95% CI) |
11.89 [‐17.29, 41.07] |
3 Quality of life (change in Norfolk QOL‐DN total score), at 66 weeks |
1 |
172 |
Mean Difference (IV, Fixed, 95% CI) |
‐10.85 [‐17.25, ‐4.45] |
4 Quality of life (change in SF‐36 physical component), at 66 weeks |
1 |
172 |
Mean Difference (IV, Fixed, 95% CI) |
‐3.6 [‐6.13, ‐1.07] |
5 Number of participants who died during the trial |
1 |
172 |
Risk Ratio (M‐H, Fixed, 95% CI) |
5.94 [0.33, 105.60] |
6 Number of participants experiencing at least one adverse event |
1 |
172 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.99 [0.96, 1.03] |
7 Number of participants experiencing at least one adverse event related to the study medication |
1 |
172 |
Risk Ratio (M‐H, Fixed, 95% CI) |
2.03 [1.45, 2.84] |
8 Number of participants experiencing mild adverse events |
1 |
172 |
Risk Ratio (M‐H, Fixed, 95% CI) |
0.99 [0.95, 1.02] |
9 Number of dropouts due to adverse events |
1 |
172 |
Risk Ratio (M‐H, Fixed, 95% CI) |
8.57 [1.16, 63.07] |
10 Number of participants experiencing at least one severe adverse event |
1 |
172 |
Risk Ratio (M‐H, Fixed, 95% CI) |
1.48 [0.85, 2.57] |
11 Number of participants experiencing at least one severe adverse event related to the study medication |
1 |
172 |
Risk Ratio (M‐H, Fixed, 95% CI) |
4.29 [0.55, 33.46] |