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Labs and Liver Toxicity Clinical Questions

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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
Cherny_t2t_200.png Gordon_Shift_Plot_200.png Gordon_LiverTestSafety_200.png
Click here for Lab Shift Plots Data Click here for Lab Parameter Shift Plots Data Click here for Liver Test Safety Panel Data
Comment on Lab Shift Plots Comment on Lab Parameter Shift Plots Comment on Liver Test Safety Panel

2. Is there a temporal relationship between treatment and lab values?

EG Mean of ALT EG Cumulative Incidence EG Distribution of ALT
Fig1_MeanALT_200.jpg GordonCumulIncidencePlot_200.png Gordon_Distribution_ALT_200.png
Click here for Mean of ALT Data Click here for Cumulative Incidence Data Click here for Distribution of ALT by Time and Treatment Data
Comment on Mean of ALT Comment on Cumulative Incidence Comment on Distribution of ALT
   
EG Liver Test Safety Panel  
Gordon_LiverTestSafety_200.png
Click here for Liver Test Safety Panel Data    
Comment on Liver Test Safety Panel    

3. What are the toxicity grade trends over time?

EG Distribution of ALT
Gordon_Distribution_ALT_250.png
Click here for Distribution of ALT Data
Comment on Distribution of ALT

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  
Gordon_TimeCourseTest_200.png Gordon_LFTTrialDay_200.png
Click here for Time Course of Lab Test Values Data Click here for Liver Function Tests by Trial Day Data
Comment on Time Course of Lab Test Values Comment on Liver Function Tests

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    
Cherny_t2t_200.png    
Click here for Lab Shift Plots Data    
Comment on Lab Shift Plots    

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  
MaxBilirubin_200.png Gordon_LFTTrialDay_200.png
Click here for Max Transaminase Data Click here for Liver Function Tests by Trial Day Data
Comment Scatter Plot on Max Transminase Comment on Liver Function Tests  

Are there Graphics which can Aid in Determining Emerging Safety Signals?

EG Frequency Plot  
Gordon_FreqPlot_200.png
Click here for Frequency Plot Data    
Comment on Frequency Plot    

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Topic revision: r34 - 02 May 2013 - 14:03:54 - MaryBanach
 

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