Safety and Efficacy of Nerinetide at Year 1 in Participants Enrolled in ESCAPE‐NEXT: A Multicenter, Double‐Blind, Randomized Controlled Trial

Figures

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  Figure 1. Trial profile at Year 1 follow‐up. Primary analysis population (n=442) is presented in the main paper. Analysis of all known Year 1 outcomes (n=513 for the primary end point) as prespecified in the statistical analysis plan is presented in Data S1.

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  Figure 2. Distribution of modified Rankin Scale scores at Day 90 and Year 1. Stacked bars are labeled with percentages within each mRS category for (A) the entire primary analysis population (n=442); (B) the subgroup of participants randomized within 3 hours of stroke onset (n=163); and (C) the subgroup of participants randomized within 3 to 12 hours from stroke onset (n=279). mRS indicates modified Rankin Scale.

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  Figure 3. Overall outcomes and sensitivity analyses for the primary analysis population (n=442). Forest plot of efficacy outcomes in the (A) overall, (B) early window, and (C) late window participants presented as adjusted odds ratios that were adjusted per statistical analysis plan for the prerandomization variables of participant age, baseline National Institutes of Health Stroke Scale score, baseline Alberta Stroke Program Early CT Score, time from CT to randomization, sex, geographic region (North America, Europe, rest of world), occlusion location (internal carotid artery/middle cerebral artery), and enrollment stratum. Sensitivity cases trend in the same direction as the main efficacy analysis for the (D) early window participants despite imputing data to worst outcome or last observation carried forward (LOCF). No significant trend was observed in the (E) late window sensitivity cases. aOR indicates adjusted odds ratio; CT, computed tomography; EQ, EuroQoL; and LOCF, last observation carried forward.

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  Figure 4. Unadjusted and adjusted survival curves. Unadjusted Kaplan–Meier curves for the (A) overall, (C) early window, and (E) late window participants with P values obtained from an unadjusted Cox proportional hazards model. Cox proportional hazards curve for the (B) overall, (D) early window, and (F) late window participants are adjusted per statistical analysis plan for the same prerandomization variables as the primary end point: participant age, baseline National Institutes of Health Stroke Scale score, baseline Alberta Stroke Program Early CT Score, time from CT to randomization, sex, geographic region (North America, Europe, rest of world), occlusion location (internal carotid artery/middle cerebral artery), and enrollment stratum. CT indicates computed tomography.

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  Figure 5. Alluvial plot of evolution in mRS outcomes from Day 90 to Year 1. Stacked bars represent the proportion of participants with the given mRS outcome and the bands between Day 90 and Year 1 outcomes are proportional to the number of participants retaining or changing mRS outcome. aOR indicates adjusted odds ratio; and mRS, modified Rankin Scale.