Primary and secondary efficacy outcomes
| Outcome | GD-11 160 mg (n=80) | GD-11 80 mg (n=79) | Placebo (n=80) |
| Primary outcome | |||
| mRS≤1 | |||
| n (%) | 62 (77.5) | 57 (72.2) | 54 (67.5) |
| OR (95% CI) | 1.66 (0.82 to 3.35) | 1.25 (0.63 to 2.46) | Ref |
| P value | 0.22 | 0.92 | |
| Secondary outcomes | |||
| mRS as ordinal shift | |||
| Common OR | 1.17 (0.66–2.07) | 0.71 (0.40–1.26) | Ref |
| P value | 0.19 | 0.10 | |
| mRS≤2 | |||
| n (%) | 68 (85.0) | 63 (79.7) | 67 (83.8) |
| OR (95% CI) | 1.1 (0.47 to 2.58) | 0.76 (0.34 to 1.71) | Ref |
| P value | 0.54 | 0.37 | |
| NIHSS score changes between baseline and day 10 | |||
| Median (IQR) | −3 (−5 to −2) | −3 (−5 to −2) | −3 (−4 to −2) |
| Mean (SD) | −2.98 (0.35) | −3.06 (0.29) | −2.79 (0.26) |
| P value | 0.27 | 0.40 | |
| NIHSS score ≤1 or reduction ≥4 from baseline to day 10 | |||
| n (%) | 34 (42.5) | 38 (48.1) | 33 (41.3) |
| OR (95% CI) | 1.05 (0.56 to 1.97) | 1.32 (0.71 to 2.47) | Ref |
| P value | 0.75 | 0.36 | |
| NIHSS score ≤1 or reduction ≥4 from baseline to day 30 | |||
| n (%) | 57 (71.3) | 59 (74.7) | 59 (73.8) |
| OR (95% CI) | 0.88 (0.44 to 1.77) | 1.05 (0.52 to 2.14) | Ref |
| P value | 0.62 | 0.72 | |
mRS, modified Rankin Scale; NIHSS, National Institutes of Health Stroke Scale.