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   THE CLINICAL EVALUATION OF QT/QTC   INTERVAL PROLONGATION AND PROARRHYTHMIC POTENTIAL FOR NON-ANTIARRHYTHMIC DRUGSE14,[object Object]
CONTENTS,[object Object],INTRODUCTION,[object Object],CLINICAL TRIALS,[object Object],ANALYSIS OF ECG DATA FROM CLINICAL TRIALS,[object Object],ADVERSE EVENTS,[object Object],REGULATORY IMPLICATIONS, LABELLING, AND RISK MANAGEMENT STRATEGIES,[object Object]
ANALYSIS OF ECG DATA FROM CLINICAL TRIALS,[object Object],INTRODUCTION,[object Object],Evaluation of the effects of a drug on the standard ECG intervals and waveforms ,[object Object],ECG changes recorded as adverse events should be pooled from all studies for analysis,[object Object]
ANALYSIS OF ECG DATA FROM CLINICAL TRIALS,[object Object],QT Interval Correction Formulae,[object Object],Bazett’s and Fridericia’s corrections are the most widely used,[object Object],Population-Derived Correction Formulae,[object Object],Fridericia’s correction:  QTc = QT/RR0.33,[object Object],Bazett’s correction:  QTc =QT/RR0.5,[object Object],Corrections based on linear regression techniques,[object Object]
ANALYSIS OF ECG DATA FROM CLINICAL TRIALS,[object Object],Analysis of QT/QTc Interval Data,[object Object],Increases from baseline in the QT/qtc interval constitute signals of interest,[object Object],The QT/QTc interval data should be presented both as analyses of central tendency (e.g., means, medians) and categorical analyses,[object Object]
ANALYSIS OF ECG DATA FROM CLINICAL TRIALS,[object Object],Analysis of Relationship Between Drug Exposure and QT/QTc Interval Changes,[object Object],Provide additional information to assist the planning and interpretation of studies assessing cardiac repolarization,[object Object],Morphological Analyses of ECG Waveforms,[object Object],The predictive value of changes in ECG morphology should be described and the data presented in terms of the number and percentage of subjects in each treatment group having changes from baseline,[object Object], Represent the appearance or worsening of the morphological abnormality,[object Object]

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