Table 1

Unadjusted analyses of efficacy outcomes

Outcome at day 90Scale descriptionRelative risk (95% CI)
P value
Modified NIHSS 0–46 model*Original NIHSS 0–42 model†
Modified Rankin Scale
0 or 1 vs >1		Scores range from 0 (no symptoms at all) to 6 (death). A score of 0 or 1 indicates no disability. 1.16 (1.01 to 1.34)
0.039
Barthel Index
≥95 vs <95		Assesses the ability to perform activities of daily living on a scale that ranges from 0 (complete dependence) to 100 (independence).1.08 (0.97 to 1.21)
0.157
Modified NIHSS 0–46
0 or 1 vs >1		Original NIHSS score modified with addition of distal motor function with scores ranging from 0 to 46. 1.16 (1.00 to 1.35)
0.044
Original NIHSS 0–42
0 or 1 vs >1		Scores on the NIHSS range from 0 to 42, with higher values reflecting more severe neurological impairment.1.15 (0.99 to 1.32)
0.062
Glasgow Outcome Scale
1 vs >1		A 5-point scale on which 1 indicates independence, 3 severe disability and 5 death.1.12 (0.97 to 1.29)
0.113
Global outcome‡A multidimensional calculation of a favourable outcome, defined by several individual outcome scales and entered into a statistical algorithm. 1.28 (1.00 to 1.64)
0.049 		1.27 (0.995 to 1.63)
0.055

  • Intention-to-treat population (alteplase (n=418) vs placebo (n=403)).

  • Significant differences are in bold.

  • *Modified NIHSS 0–46 model uses the original NIHSS score with 15 items and addition of distal motor function left/right as two items, both with scores 0–2, and total score range 0–46.

  • †Original NIHSS 0–42 model uses original NIHSS score with 15 items and total score range 0–42.

  • ‡The statistical approach is a global OR test based on a linear logistic regression model. The global OR is the probability of a favourable outcome with alteplase as compared with placebo.

  • NIHSS, National Institutes of Health Stroke Scale.