Statistical issues in the analysis of adverse events in time-to-event data-Reference-Cited by-同舟云学术

Statistical issues in the analysis of adverse events in time-to-event data

Published:2016-03-01 Issue:4 Volume:15 Page:297-305
ISSN:1539-1604
Container-title:Pharmaceutical Statistics
language:en
Short-container-title:Pharmaceut. Statist.

Author:

Allignol Arthur¹,Beyersmann Jan¹,Schmoor Claudia²

Affiliation:

1. Institute of Statistics; Ulm University; Ulm Germany

2. Clinical Trials Unit; University Medical Center Freiburg; Freiburg Germany

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology,Statistics and Probability

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1002/pst.1739/fullpdf

Reference28 articles.

1. ICH Expert Working Group ICH Harmonised Tripartite Guideline. Statistical principles for clinical trials E9 1995 http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E9/Step4/E9_Guideline.pdf

2. Statistical analyses of adverse event data from clinical trials special emphasis on serious events;O'Neill;Drug Information Journal,1987

3. Evaluation of safety data from controlled clinical trials: the clinical principles explained;Gait;Drug Information Journal,2000

4. Moore K van der Laan M Application of time-to-event methods in the assessment of safety in clinical trials Design and Analysis of Clinical Trials with Time-to-Event Endpoints Taylor & Francis Chapman & Hall/CRC, Boca Raton 2009 455 482

5. Non-parametric inference of adverse events under informative censoring;Nishikawa;Statistics in Medicine,2006

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