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

Documents

Study protocol

Initial protocol

2022-10-14 CONFIRMS Simulation Study Protocol rev2

English (267.37 KB - PDF) View document

Study results

Summary

English (37.51 KB - PDF) View document

Summary V1.1

English (43.63 KB - PDF) View document

Study report

Other information

Study, other information

Literature Review Rev. 2

English (1.49 MB - PDF) View document

Summary NPH

English (43.63 KB - PDF) View document

Publications

Study publications

Secondary tabs