Table 3.
Secondary Efficacy and Safety Outcomes at 3 Months.*
| Outcome | Placebo (N = 843) | Magnesium (N = 857) | Odds Ratio with Magnesium (95% CI) | P Value |
|---|---|---|---|---|
| Efficacy | ||||
| Minimal or no disability: modified Rankin score of 0 or 1 — no. (%) | 311 (36.9) | 313 (36.5) | 0.98 (0.81–1.20) | 0.87 |
| Functional independence: modified Rankin score ≤2 — no. (%) | 445 (52.8) | 449 (52.4) | 0.98 (0.81–1.19) | 0.87 |
| Neurologic deficit assessed by NIHSS score — median (interquartile range) | 3 (0–42) | 3 (0–19) | — | 0.28 |
| Global excellent recovery — no. (%)† | 0.97 (0.82–1.15) | 0.76 | ||
| Modified Rankin score of 0 or 1 | 311 (36.9) | 313 (36.5) | 0.98 (0.81–1.20) | 0.87 |
| Barthel Index ≥95 | 435 (51.6) | 427 (49.8) | 0.93 (0.77–1.13) | 0.47 |
| NIHSS score of 0 or 1 | 353 (41.9) | 349 (40.7) | 0.95 (0.79–1.16) | 0.66 |
| GOS score of 1 | 360 (42.7) | 365 (42.6) | 1.00 (0.82–1.21) | 1.00 |
| Global good recovery — no. (%)‡ | 1.05 (0.89–1.25) | 0.56 | ||
| Modified Rankin score ≤2 | 445 (52.8) | 449 (52.4) | 0.98 (0.81–1.19) | 0.88 |
| Barthel Index ≥60 | 557 (66.1) | 593 (69.2) | 1.15 (0.94–1.41) | 0.18 |
| NIHSS score ≤8 | 537 (63.7) | 569 (66.4) | 1.13 (0.92–1.37) | 0.26 |
| GOS score of 1 or 2 | 486 (57.7) | 503 (58.7) | 1.04 (0.86–1.27) | 0.69 |
| Safety | ||||
| Serious adverse event — no. of patients (%) | 422 (50.1) | 439 (51.2) | 1.05 (0.87–1.27) | 0.67 |
| Symptomatic intracranial hemorrhage — no. of patients (%) | 28 (3.3) | 18 (2.1) | 0.62 (0.34–1.14) | 0.12 |
| Death — no. (%) | 131 (15.5) | 132 (15.4) | 0.99 (0.76–1.29) | 0.95 |
*
Values on the Barthel Index range from 0 to 100, with higher values indicating more functional independence. Scores on the Glasgow Outcome Scale (GOS) range from 1 to 5, with higher scores indicating worse function. CI denotes confidence interval.
†
Global excellent recovery was defined by four outcomes (modified Rankin score of 0 or 1, Barthel Index ≥95, NIHSS score of 0 or 1, and GOS score of 1, with outcomes analyzed simultaneously with the use of the global test statistic).
‡
Global good recovery was defined by four outcomes (modified Rankin score ≤2, Barthel Index ≥60, NIHSS score ≤8, and GOS score of 1 or 2, with outcomes analyzed simultaneously with the use of the global test statistic).