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Examples of ethnicity and geography issues in global clinical trials ...

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% per year<br />

Stroke / SSE<br />

Accord<strong>in</strong>g to center based time <strong>in</strong> therapeutic range (cTTR)<br />

Q1: cTTR < 57.1% Q2: cTTR 57.1-65.5%<br />

Q3: cTTR 65.5 – 72.6% Q4: cTTR > 72.6%<br />

2,4<br />

1,8<br />

* Interaction p-value (D 110mg BID vs W.) = 0.90<br />

† Interaction p-value (D 150mg BID vs W.) = 0.20<br />

*Interaction p evaluated by a multivariable approach<br />

with center based TTR as a cont<strong>in</strong>uous variable.<br />

1,2<br />

0,6<br />

W D* D †<br />

110 150<br />

W D* D †<br />

110 150<br />

W D* D †<br />

110 150<br />

W D* D †<br />

110 150<br />

0<br />

Wallent<strong>in</strong> L., et al. Lancet 2010; <strong>in</strong> press.<br />

Q1 Q2 Q3 Q4<br />

Dabigatran etexilate is <strong>in</strong> cl<strong>in</strong>ical development <strong>and</strong> not licensed for<br />

cl<strong>in</strong>ical use <strong>in</strong> stroke prevention for patients with atrial fibrillation

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