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

Cited by 50 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Competing Risks and Multistate Modelsin Oncology Clinical Trials;Japanese Journal of Biometrics;2024-07-30

2. Survival analysis for AdVerse events with VarYing follow-up times (SAVVY): summary of findings and assessment of existing guidelines;Trials;2024-05-31

3. [Special issue PRO] Considering endpoints for comparative tolerability of cancer treatments using patient report given the estimand framework;Journal of Biopharmaceutical Statistics;2024-02-15

4. Adverse events in single-arm clinical trials with non-fatal time-to-event efficacy endpoint: from clinical questions to methods for statistical analysis;BMC Medical Research Methodology;2024-01-03

5. Favorable impact of therapy management by an interactive eHealth system on severe adverse events in patients with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer treated by palbociclib and endocrine therapy;Cancer Treatment Reviews;2023-12