Table 2. Efficacy Outcome Variables.
| Assessment Variable at 90 d | Alteplase (n = 55) | Placebo (n = 53) | Effect Variablea | Adjusted Effect Variable Value (95% CI) | P Value |
|---|---|---|---|---|---|
| Modified Rankin Scale score | |||||
| 0 or 1, No. (%)b | 31 (59) | 24 (46) | Odds ratio | 1.67 (0.77-3.64) | .20 |
| Median (IQR)c | 1 (0-2) | 2 (1-2) | Common odds ratio | 1.94 (0.95-3.93) | .07 |
| Secondary end points | |||||
| Treatment response, No. (%) | 19 (36) | 7 (14) | Odds ratio | 3.70 (1.38-9.87) | .009 |
| Global outcome score | NA | NA | Odds ratio | 1.43 (0.76-2.67) | .27 |
| Beck Depression Inventory, median (IQR) | 5 (1-10) | 5 (2-9) | Odds ratio | 0.08 (−0.34 to 0.49) | .71 |
| EQ-5D sum, median (IQR) | 1 (0-2) | 1 (0-3) | Mean difference (log) | −0.36 (−1.10 to 0.37) | .33 |
| EQ-5D visual analog scale, median (IQR) | 80 (65-90) | 70 (55-88) | Mean difference | 7.04 (−1.07 to 15.14) | .09 |
| Infarct volume at 22 to 36 h, median (IQR), mL | 0.9 (0.4-1.5) | 0.9 (0.4-1.4) | Mean difference (log) | 0.04 (−0.35 to 0.44) | .84 |
Abbreviations: EQ-5D, EuroQol Group–5 dimensions; IQR, interquartile range.
a
All odds ratios were adjusted for the stratification factors (age and symptom severity).
b
Modified Rankin Scale scores of 0 or 1 represented favorable outcomes; scores were missing in 3 patients (2 in the alteplase group and 1 in the placebo group).
c
Categorical shift in the distribution of modified Rankin Scale scores between the 2 treatment groups.