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discrete-event simulation in clinical trials - Institut für Statistik ...

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Variation <strong>in</strong> cl<strong>in</strong>ical end po<strong>in</strong>ts<br />

Efficacy submodel<br />

16<br />

Placebo (Conceptual) 50 mg (Conceptual)<br />

100 mg (Conceptual) Placebo (Simulación)<br />

50 mg (Simulación) 100 mg Simulación<br />

Risk AA Y (unities)<br />

Y (unidades)<br />

Riesgo AA<br />

15<br />

14<br />

13<br />

12<br />

11<br />

10<br />

PVMCBV:<br />

1<br />

0,8<br />

0,6<br />

0,4<br />

0,2<br />

0 2 4 6 8 10<br />

Time (months)<br />

Tiempo (meses)<br />

p= 0,0466 [-0,01136; 0,10472],<br />

VMCBP:<br />

0<br />

λ : 0,78 a un 12%<br />

Safety sub-model<br />

Placebo (Conceptual) 50 mg (Conceptual)<br />

100 mg (Conceptual) Placebo (Simulación)<br />

50 mg (Simulación) 100 mg (Simulación)<br />

0<br />

0 2 4 6 8 10<br />

Tiempo (meses)<br />

Time (months)<br />

0<br />

PVMCBV: p= 0,0230 [-0,0208; 0,06699]<br />

32

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