Table 1.

Unadjusted analyses of efficacy outcomes

Outcome at day 90	Scale description	Relative 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.