Table 4.

Unadjusted analyses and analyses adjusted for baseline NIHSS score and prior stroke status using reanalysis protocol

Outcome (day 90 unless stated otherwise)	Unadjusted RR (95% CI) P value	Multivariable RR (95% CI) P value	Stratified common RR (95% CI) P value	Unadjusted RD (95% CI) P value	Multivariable RD (95% CI) P value
Modified Rankin Scale* 0 vs >0 (symptom free)	1.26 (0.99 to 1.60) 0.061	1.11 (0.88 to 1.39) 0.395	1.19 (0.94 to 1.50) 0.140	0.06 (−0.002 to 0.12) 0.059	0.03 (−0.03 to 0.09) 0.320
Modified Rankin Scale* 0, 1 vs >1 (disability free)	1.16 (1.01 to 1.34) 0.039	1.05 (0.95 to 1.16) 0.324	1.09 (0.96 to 1.24) 0.163	0.07 (0.004 to 0.14) 0.038	DNC
Modified Rankin Scale* 0, 1, 2 vs >2 (dependence free)	1.08 (0.98 to 1.20) 0.139	1.01 (0.95 to 1.06) 0.848	1.04 (0.95 to 1.14) 0.397	0.05 (−0.02 to 0.12) 0.138	0.02 (−0.05 to 0.08) 0.625
Modified Rankin Scale* 0, 1, 2, 3 vs >3	1.04 (0.96 to 1.13) 0.344	1.00 (0.95 to 1.05) 0.973	1.01 (0.94 to 1.08 0.775	0.03 (−0.03 to 0.09) 0.344	−0.00 (−0.07 to 0.07) 0.971
Modified Rankin Scale* 0, 1, 2, 3, 4 vs >4	0.98 (0.93 to 1.04) 0.555	0.98 (0.93 to 1.04) 0.513	0.97 (0.92 to 1.02) 0.222	−0.01 (−0.06 to 0.03) 0.555	−0.03 (−0.09 to 0.04) 0.446
Modified Rankin Scale* 0, 1, 2, 3, 4, 5 vs 6	1.01 (0.98 to 1.05) 0.495	1.00 (0.95 to 1.05) 0.984	1.00 (0.97 to 1.04) 0.834	0.01 (−0.02 to 0.05) 0.495	−0.00 (−0.06 to 0.06) 0.987
Barthel Index ≥95 vs <95	1.08 (0.97 to 1.21) 0.157	1.00 (0.95 to 1.06) 0.949	1.04 (0.94 to 1.14) 0.463	0.05 (−0.02 to 0.12) 0.155	0.03 (−0.03 to 0.09) 0.362
NIHSS 0 or 1 vs >1	1.15 (0.99 to 1.32) 0.062	1.05 (0.95 to 1.16) 0.375	1.09 (0.95 to 1.23) 0.214	0.07 (−0.003 to 0.13) 0.061	DNC
Glasgow Outcome Scale 1 vs >1	1.12 (0.97 to 1.29) 0.113	1.03 (0.93 to 1.15) 0.568	1.07 (0.94 to 1.21) 0.310	0.06 (−0.01 to 0.12) 0.111	DNC
Global outcome	1.27 (1.00 to 1.63) 0.055	1.14 (0.87 to 1.50) 0.335	NA	NA	NA
Mortality by day 7 Yes vs No	0.89 (0.41 to 1.93) 0.767	1.06 (0.50 to 2.28)† 0.877	1.05 (0.49 to 2.22) 0.902	−0.004 (−0.03 to 0.02) 0.768	0.005 (−0.06 to 0.07) 0.889
Mortality Yes vs No	0.87 (0.53 to 1.42) 0.582	1.05 (0.65 to 1.69)† 0.846	0.99 (0.61 to 1.60) 0.953	−0.01 (−0.05 to 0.03) 0.582	0.003 (−0.06 to 0.06) 0.913
Symptomatic ICH (ECASS II) Yes vs No	2.36 (1.10 to 5.06) 0.028	2.33 (1.08 to 5.01) 0.030	2.17 (1.01 to 4.64) 0.041	0.03 (0.004 to 0.06) 0.021	0.025 (−0.01 to 0.06) 0.118
Symptomatic ICH (NINDS) Yes vs No	2.27 (1.23 to 4.18) 0.008	2.37 (1.31 to 4.29)† 0.004	2.32 (1.23 to 4.39) 0.007	0.04 (0.01 to 0.08) 0.006	0.04 (0.00 to 0.08) 0.049

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

Multivariable analysis adjusted for baseline NIHSS score (continuous) and prior stroke status. Baseline NIHSS scores with missing component values had value of 0 imputed for the missing component(s) and then baseline NIHSS score was computed with range 0–42. NIHSS scores at 90 days had missing component(s) imputed as maximum possible value and then NIHSS score at 90 days was computed with range 0–42. Stratified analyses based on Cochran-Mantel-Haenszel method (baseline NIHSS stratified into three categories: 0–9, 10–19, 20–42). RR and RD analyses based on main effects log-binomial model, or log-Poisson regression if log-binomial model did not converge. Statistically significant differences are in bold. Meaning of functional outcome measures as described in table 1 with NIHSS score interpreted as originally defined with range 0–42.

*Scores on the modified Rankin Scale range from 0 (no symptoms) to 6 (death). A score of 1 indicates some symptoms but no disability.

†Poisson regression model with robust variance (did not converge for log binomial model); all others are log binomial.

DNC, did not converge for log-binomial or log-Poisson regression model; ECASS II, European Cooperative Acute Stroke Study 2; ICH, intracranial haemorrhage; NA, not applicable; NIHSS, National Institutes of Health Stroke Scale; NINDS, National Institute of Neurological Disorders and Stroke; RD, risk difference; RR, relative risk.