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.