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The transparency commission wishes that the laboratory Lilly France sets up a follow-up study describing the conditions of use of Xigris® in France.
The purpose of this study is to describe the characteristics of the treated patients, the conditions of drug use, in particular the conditions of treatment initiation and the clinical development of the patients during normal clinical practice, in particular rate and cause of mortality within one month.
The objectives of the study as defined by the specific requirements of Transparency Commission are as follows:
- To describe the characteristics of the patients treated with Xigris®
- socio-demographic characteristics,
- clinical profile
- To determine the conditions of use of Xigris®
- To describe previous treatments,
- To observe delay before Xigris® initiation,
- To describe dose, duration of treatment,
- To study the concomitant treatments and the associated treatments
- To describe the clinical evolution of the patients
- To observe mortality after 1 month
- To describe reasons of death
Observational Model: Cohort
For additional information regarding investigative sites for this study, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559)
Eli Lilly and Company
Published on BioPortfolio: 2014-08-27T03:25:49-0400
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