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. 2020 Apr 20;2020(4):CD012395. doi: 10.1002/14651858.CD012395.pub2

Comparison 4. Inotersen versus placebo in TTR‐FAP.

Outcome or subgroup title No. of studies No. of participants Statistical method Effect size
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]