Table 2:
Outcome | Alteplase (n=429) | Control (n=414) | Odds ratios (95% CI) * | p-value |
---|---|---|---|---|
Primary Efficacy Outcome | ||||
Favourable Outcome (mRS 0–1) at 90 days – no. (%) † | 199 (47%) | 160 (39%) | 1.49 (1.10–2.03) | 0.011 |
Secondary Efficacy Outcomes | ||||
mRS score at 90 days ‡ | 1.38 (1.05–1.80) | 0.019 | ||
Independent Outcome (mRS 0–2) at 90 days – no. (%) † | 273 (65%) | 239 (58) | 1.50 (1.06–2.12) | 0.022 |
Safety Outcomes | ||||
Death at 90 days – no. (%) † | 27 (6%) | 14 (3%) | 2.06 (1.03–4.09) | 0.040 |
Death at 7 days – no. (%) | 10 (2%) | 4 (1%) | 2.54 (0.78–8.32) | 0.19 |
Severe disability or death (MRS 4–6) at 90 days – no. (%) † | 90 (21%) | 102 (25%) | 0.76 (0.52–1.11) | 0.15 |
Dependence or death (MRS 3–6) at 90 days – no. (%) † | 147 (35%) | 170 (42%) | 0.67 (0.47–0.94) | 0.022 |
Symptomatic intracerebral haemorrhage – no. (%) | 11 (3%) | 2 (<1%) | 5.58 (1.22–25.50) | 0.024 |
Parenchymal haemorrhage type 2 (PH-2) – no. (%) ‡ | 11 (3%) | 3 (1%) | 3.51 (0.98–12.60) | 0.068 |
mRS denotes modified Rankin scale
Odds ratios were adjusted for age and symptom severity at baseline.
Numbers are given for patients with available data on the primary efficacy endpoint; mRS at day 90 was missing for 9 patients in the alteplase and 5 in the control group; missing primary outcome values were replaced using multiple imputation.
Radiological assessment of parenchymal haemorrhage type 2 (PH-2) was available for 320 patients in the alteplase and 307 in the control group