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Examples of understanding safety data using graphical methods

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Abstract Cardiac and hepatic safety are important considerations in drug development. This article focuses on the examination of laboratory and electrocardiogram data using graphical approaches that enable a better understanding of the data. Useful general principles to keep in mind when developing graphics are followed by sections on cardiovascular and hepatic safety. WIREs Comput Stat 2013, 5:78–95. doi: 10.1002/wics.1243 This article is categorized under: Applications of Computational Statistics > Clinical Trials Statistical Learning and Exploratory Methods of the Data Sciences > Exploratory Data Analysis Data: Types and Structure > Data Preparation and Processing Statistical and Graphical Methods of Data Analysis > Statistical Graphics and Visualization

Comparison of QT corrections.

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Relationship of QT to RR at baseline.

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Stylized heart beat and corresponding ECG segments.

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Graphical representation of on‐therapy adverse events.

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Trellis plot of liver test safety panel over time, baseline versus on‐study.

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1 × 4 scatter plot of liver function test shift from baseline to maximum.

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2 × 2 scatter plot of liver function test shift from baseline to maximum.

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Liver function tests by study day: at‐risk subjects.

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Time course of liver function test values.

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Maximum total bilirubin versus maximum alanine aminotransferase (ALT).

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Categorical QTc analysis at Tmax for experimental drug.

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Placebo‐adjusted changes from baseline (95% CI) in QTc.

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QTc change from baseline (95% CI) by time of day for placebo.

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QTc (95% CI) by time of day at baseline.

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Stylized ECG rhythm strip showing TdP.

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Baseline QT versus RR and derivation of QTc.

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Browse by Topic

Statistical and Graphical Methods of Data Analysis > Statistical Graphics and Visualization
Data: Types and Structure > Data Preparation and Processing
Applications of Computational Statistics > Clinical Trials
Statistical Learning and Exploratory Methods of the Data Sciences > Exploratory Data Analysis

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