Table 2. Efficacy Outcomes.
| Outcomes | GDLM group (n = 1725) | Placebo group (n = 1723) | Risk difference (95% CI), % | Odds ratio (95% CI) | Relative risk (95% CI) | P value |
|---|---|---|---|---|---|---|
| Primary outcome | ||||||
| mRS score of 0 or 1 at day 90, No. (%)a | 877 (50.8) | 759 (44.1) | 6.79 (3.46 to 10.10) | 1.31 (1.15 to 1.50) | 1.15 (1.08 to 1.24) | <.001 |
| Secondary outcomes | ||||||
| mRS score of ≤2 at day 90, No. (%)a | 1446 (83.8) | 1197 (69.5) | 14.35 (11.56 to 17.12) | 2.28 (1.93 to 2.68) | 1.21 (1.16 to 1.25) | <.001 |
| NIHSS scoreb change of ≤−4 from baseline to day 7, No. (%)c | 461 (27.7) | 414 (25.0) | 2.70 (−0.29 to 5.69) | 1.15 (0.98 to 1.34) | 1.11 (0.99 to 1.24) | .08 |
| NIHSS scoreb change of ≤−4 from baseline to day 14, No. (%)d | 1000 (61.3) | 810 (50.2) | 11.13 (7.72 to 14.51) | 1.57 (1.37 to 1.81) | 1.22 (1.15 to 1.30) | <.001 |
| NIHSS scoreb change of ≥4 from baseline to day 7, No. (%)c | 13 (0.8) | 11 (0.7) | 0.12 (−0.50 to 0.74) | 1.18 (0.53 to 2.64) | 1.18 (0.53 to 2.62) | .69 |
| NIHSS scoreb change of ≥3 from baseline to day 7, No. (%)c | 17 (1.0) | 18 (1.1) | −0.07 (−0.80 to 0.66) | 0.94 (0.48 to 1.83) | 0.94 (0.49 to 1.82) | .85 |
| NIHSS scoreb change of ≥2 from baseline to day 7, No. (%)c | 32 (1.9) | 35 (2.1) | −0.19 (−1.18 to 0.79) | 0.91 (0.56 to 1.47) | 0.91 (0.57 to 1.46) | .70 |
| NIHSS scoreb change of ≥1 from baseline to day 7, No. (%)c | 50 (3.0) | 77 (4.6) | −1.64 (−2.98 to −0.34) | 0.64 (0.44 to 0.91) | 0.65 (0.46 to 0.92) | .01 |
| Safety outcomes | ||||||
| Adverse events, No. (%) | 303 (17.6) | 298 (17.3) | 0.27 (−2.26 to 2.80) | 1.02 (0.85 to 1.21) | 1.02 (0.88 to 1.17) | .83 |
| Severe adverse events, No. (%) | 26 (1.5) | 22 (1.3) | 0.23 (−0.57 to 1.05) | 1.18 (0.67 to 2.10) | 1.18 (0.67 to 2.07) | .56 |
Abbreviations: GDLM, ginkgo diterpene lactone meglumine; mRS, modified Rankin Scale; NIHSS, National Institutes of Health Stroke Scale.
The mRS is a global stroke disability scale with scores ranging from 0 (no symptoms or completely recovered) to 6 (death).
The NIHSS is a tool used by clinicians to quantify impairment caused by stroke (range, 0-42, with higher scores indicating greater severity). A decrease in score indicates a functional improvement, while an increase in score indicates symptom regression.
The number of patients with missing data was similar in the 2 treatment groups. Missing data for NIHSS score on day 7 occurred in 61 patients in the GDLM group and 67 patients in the placebo group.
The number of patients with missing data was similar in the 2 treatment groups. Missing data for NIHSS score on day 14 occurred in 95 patients in the GDLM group and 110 patients in the placebo group.