gms | German Medical Science

54. Jahrestagung der Deutschen Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie e.V. (GMDS)

Deutsche Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie

07. bis 10.09.2009, Essen

How to consider events occurring after the pre-specified observational period?

Meeting Abstract

Suche in Medline nach

  • Stefan Hantel - Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach
  • Erich Bluhmki - Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach

Deutsche Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie. 54. Jahrestagung der Deutschen Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie (gmds). Essen, 07.-10.09.2009. Düsseldorf: German Medical Science GMS Publishing House; 2009. Doc09gmds126

DOI: 10.3205/09gmds126, URN: urn:nbn:de:0183-09gmds1268

Veröffentlicht: 2. September 2009

© 2009 Hantel et al.
Dieser Artikel ist ein Open Access-Artikel und steht unter den Creative Commons Lizenzbedingungen (http://creativecommons.org/licenses/by-nc-nd/3.0/deed.de). Er darf vervielfältigt, verbreitet und öffentlich zugänglich gemacht werden, vorausgesetzt dass Autor und Quelle genannt werden.


Gliederung

Text

In event driven trials investigating for example new drugs for the treatment of deep vein thrombosis (DVT) or pulmonary embolism (PE), the primary outcome variable is a composite endpoint of recurrent events (e.g., recurrent DVT, PE or VTE related mortality) observed during the pre-specified treatment period. If patients terminate the treatment prematurely, observed events until the planned end of treatment should be included in the primary analysis. However, it is not obvious from the guidelines or publications, whether and how events should be considered, which are observed after the planned end of the treatment period / observational period.

We compare an approach of using only events occurring until the pre-specified cut-off with a procedure using all observed events according to an intent-to-treat principle based on data form controlled clinical trials.


References

1.
Fiessinger JN, et al. Ximelagatran vs Low-Molecular-Weight Heparin and Warfarin fort he Treatment of Deep Vein Thrombosis. JAMA. 2005;293:681-9.
2.
Eriksson BI, et al. Dabigatran etexilate versus enoxaparin for prevention of venous thromboembolism after total hip replacement: a randomized, double blind, non-inferiority trial. Lancet. 2007;370:949-56.
3.
Büller HR, et al. Fondaparinux or Enoxaparin fort he Initial Treatment of Symptomatic Deep Vein Thrombosis. Ann Intern Med. 2004;140:867-73.
4.
Büller HR, et al. Subcutaneous Fondaparinux versus Intravenous Unfractionated Heparin in the Initial Treatment of Pulmonary Embolism. N Engl J Med. 2003;349:1695-702.