Statistical methods for time-to-event endpoints with non-proportional hazards in clinical trials pivotal for benefit risk decision making

First published 29/03/2022

Last updated 02/07/2024

EU PAS number:

EUPAS46420

Study

Finalised

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Documents

Study protocol

Initial protocol

2022-10-14 CONFIRMS Simulation Study Protocol rev2

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Study results

Study results

Summary

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Summary V1.1

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Study report

Other information

Study, other information

Literature Review Rev. 2

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Summary NPH

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Publications

Study publications

Bardo M, Huber C, Benda N, Brugger J, Fellinger T, Galaune V, Heinz J, Heinzl H…

F Klinglmüller, T Fellinger, F König, T Friede, AC Hooker, H Heinzl, M Mittlböc…