Labs and Liver Toxicity Clinical Questions

Baseline and Trending over Time

1. What are the changes and percent changes from baseline over time? ie, are abnormal lab values a result of an abnormal baseline or have values changed on study?

EG: Lab Shift Plots	EG Lab Parameter Shift Plots	EG Liver Test Safety Panel
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Click here for Lab Shift Plots Data	Click here for Lab Parameter Shift Plots Data	Click here for Liver Test Safety Panel Data
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2. Is there a temporal relationship between treatment and lab values?

EG Mean of ALT	EG Cumulative Incidence	EG Distribution of ALT
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Click here for Mean of ALT Data	Click here for Cumulative Incidence Data	Click here for Distribution of ALT by Time and Treatment Data
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EG Liver Test Safety Panel
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3. What are the toxicity grade trends over time?

EG Distribution of ALT

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4. What is the patient's profile over time? ie display values for multiple lab parameters for subject(s) of interest

EG Time Course of Lab Test Values	EG Liver Function Tests by Trial Day
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Association Between Lab Variables

1. What is the association between lab assessments? Are there multiple lab values that are elevated or abnormal, either concurrently or not? ie, how can we easily identify patients with simultaneous elevations in multiple lab tests over time?

EG: Lab Shift Plots
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Liver Function Tests

1. How do we perform a comprehensive assessment of hepato-toxicity so that possible cases of drug induced liver injury are efficiently identified?

EG Scatter Plot Max Transaminase	EG Liver Function Tests by Trial Day
Click here for Max Transaminase Data	Click here for Liver Function Tests by Trial Day Data
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Are there Graphics which can Aid in Determining Emerging Safety Signals?

EG Frequency Plot
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