Statistical controversies in clinical research: Value of adverse events relatedness to study treatment: analyses of data from randomized double-blind placebo-controlled clinical trials

Author:

Le-Rademacher J.,Hillman S.L.,Meyers J.,Loprinzi C.L.,Limburg P.J.,Mandrekar S.J.

Publisher

Elsevier BV

Subject

Oncology,Hematology

Reference27 articles.

1. http://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/aeguidelines.pdf (14 February 2017, date last accessed).

2. Electronic Federal Code of Regulations (eCFR).http://www.ecfr.gov/cgi-bin/text-idx?SID=ad4ebd797341eff5960a93bc3b75a85c&mc=true&node=pt21.5.312&rgn=div5#se21.5.312_160 (14 February 2017, date last accessed).

3. Mortality associated with irinotecan plus bolus fluorouracil/leucovorin: summary findings of an independent panel;Rothenberg;JCO,2001

4. A qualitative study evaluating causality attribution for serious adverse events during early phase oncology clinical trials;Mukherjee;Invest New Drugs,2011

5. The reliability of medical record review for estimating adverse event rates;Thomas;Ann Intern Med,2002

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