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. Author manuscript; available in PMC: 2021 Nov 14.
Published in final edited form as: Lancet. 2020 Nov 8;396(10262):1574–1584. doi: 10.1016/S0140-6736(20)32163-2

Table 2:

Efficacy and Safety Outcomes

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