analyses and to do this I would like to give a little background on MedDRA. MedDRA
stands for the Medical Dictionary for Regulatory Activities; it was developed by the
International Conference on Harmonization (ICH). The ICH is involved in harmonizing
requirements for drug development across the United States, European Union and Japan,
and in a way to improve efficiency and reduce redundancy. MedDRA is what drug
applicants use to code adverse events occurring during their clinical trials. An
investigator can report the same adverse event in many different ways and it would be
very impractical to try and use these verbatim investigated terms to tabulate the incidence
of various adverse events.
extension studies. These extension studies were un-blinded but patients again
remained on original randomized treatment and these extensions were voluntary -
patients had the option of whether they wanted to continue or not. Patients in either
“Population A” or “B" requiring glycemic rescue were withdrawn from the study.
verbatim terms and match them to what is known as the lowest level term in MedDRA.
Each lowest level term is automatically linked to what is known as a preferred term and
then when analyses of adverse events are done we use these preferred terms, which
represents single medical entities. So, as an example, a patient can present with an
arrhythmia and one investigator might report that as an arrhythmia, another might report
it as a dysrhythmia. The arrhythmia would get coded to the arrhythmia lowest level term,
dysrhythmia would get coded to the dysrhythmia lower level term, but both those level
terms will code to the preferred term of arrhythmia. This is kind of a way of
standardizing the terms that we will be using for analyses.
I would now like to turn to the endpoints we used for the cardiovascular
There are coders who are trained in MedDRA who review the investigated
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