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analyses and to do this I would like to give a little background on MedDRA. MedDRA

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stands for the Medical Dictionary for Regulatory Activities; it was developed by the

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International Conference on Harmonization (ICH). The ICH is involved in harmonizing

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requirements for drug development across the United States, European Union and Japan,

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and in a way to improve efficiency and reduce redundancy. MedDRA is what drug

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applicants use to code adverse events occurring during their clinical trials. An

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investigator can report the same adverse event in many different ways and it would be

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very impractical to try and use these verbatim investigated terms to tabulate the incidence

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of various adverse events.

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extension studies. These extension studies were un-blinded but patients again

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remained on original randomized treatment and these extensions were voluntary -

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patients had the option of whether they wanted to continue or not. Patients in either

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“Population A” or “B" requiring glycemic rescue were withdrawn from the study.

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verbatim terms and match them to what is known as the lowest level term in MedDRA.

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Each lowest level term is automatically linked to what is known as a preferred term and

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then when analyses of adverse events are done we use these preferred terms, which

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represents single medical entities. So, as an example, a patient can present with an

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arrhythmia and one investigator might report that as an arrhythmia, another might report

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it as a dysrhythmia. The arrhythmia would get coded to the arrhythmia lowest level term,

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dysrhythmia would get coded to the dysrhythmia lower level term, but both those level

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terms will code to the preferred term of arrhythmia. This is kind of a way of

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standardizing the terms that we will be using for analyses.

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I would now like to turn to the endpoints we used for the cardiovascular

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There are coders who are trained in MedDRA who review the investigated

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