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Name Type Size Values Tooltip message
Title text 25    
Figure No. text 25    
Image text 25    
Graph Displayed radio 3 class, individual  
Graph Subgroup radio 4 General Principles, Labs Liver, ECGVitals, Adverse Events  
Code Added radio 2 Yes, No  
Question Classification checkbox 4 Baseline and Trending over Time, Association between Lab Variables, Liver Function Tests, General Labs Liver  
Clinical Questions Answered checkbox 1 Are abnormal lab values a result of a borderline baseline lab value?, What are the changes and percent changes from baseline for subjects whose baseline values were within normal limits?, Is it possible to display the time course of changes in lab value?, What are the toxicity grade trends over time? (What specifically would you be looking for in a trend?), What is the patientís profile over time?, Are there multiple lab values that are abnormal (either concurrently or not)?, How can we easily identify patients with simultaneous elevations in LFTs or lab tests over time?, Once we have identified subjects of interest - what are the specific lab values over time and is it possible to see multiple parameters at once?, Were there concurrent elevations in multiple lab parameters (by study and by subject)?, How do we perform a comprehensive assessment of hepato-toxicity?, How can we efficiently identify possible cases of drug induced liver injury?, What are the maximum LFT values (or any max lab values) over time during the course of the study?, Does there seem to be a relationship between the timing of lab abnormalities and start of treatment?, How many subjects were above the ULN for any given lab parameter during the study?, What is the lab profile of the entire study?, Are there graphics which can aid in determining emerging safety signals?, Does there seem to be a treatment effect for any of the lab values?, How does the treatment affect the subjects biochemistry?, What is the hazard for developing a low lab count over time while on treatment?, Are there specific events that occur simultaneously with abnormal lab values?, Are there effective means of transitioning from whole population level to individual level?, How can we display values for multiple lab parameters for subjects of interest?  
Description textarea 20    
Special Considerations textarea 80x10   List any special considerations in using this graphic.
Data Types checkbox 1 Categorical, Continuous, Categorical and Continuous, Time to Event  
Contributor/Email textarea 15   Name and email contact of the contributor
Classification-Graph Type checkbox 4 Bar charts, Histogram, Boxplot, Density Plot, Dotplot, Forest Plot, Line Plot, Modeling Plots, Mosaic Plot, Other, Perspective Plot, Pie Chart, Scatterplot, Survival Plot, Volcano Plots  
Graphic checkbox 2 Reference Graphic, Created Graphic  
Source - Reference Graphic textarea 20    
Source - Created Graphic textarea 20    
Created by text 25    
Datasets checkbox 4 CDISC Datasets, Vanderbilt Datasets, Other Mark dataset(s) used.
Data textarea 80x10   Description of the data used to create the graphic
Attached Data textarea 40 x 5   Attach data
Software Program radio 4 R, SAS, Stata, other  
Software textarea 25   What software was used to create the graphic (include any relevant version numbers).
R-Code - Attachment text 80    
R-Code textarea 80x10    
SAS-Code - Attachment text 80    
SAS-Code textarea 80x10    
Stata-Code - Attachment text 80    
Stata-Code textarea 80x10    
Other Code - Attachment text 80    
Other Code textarea 80x10    
Special Cases textarea 80x10   List any special cases of this graphic.
Keywords text 80   listing of any keywords that can be used to identify the graphic (these may be hyperlinked). Some examples are: liver, labs, ECG, vitals, adverse events, MedDRA.
Disclaimer label 80x10 The views expressed within CTSpedia are those of the author and must not be taken to represent policy or guidance on the behalf of any organization or institution with which the author is affiliated.  
Permission label 80x10 Permission is hereby granted, free of charge, to any person obtaining a copy of this software and associated documentation files (the "Software"), to deal in the Software without restriction, including without limitation the rights to use, copy, modify, merge, publish, distribute, sublicense, and/or sell copies of the Software, and to permit persons to whom the Software is furnished to do so, subject to the following conditions:

The above copyright notice and this permission notice shall be included in all copies or substantial portions of the Software.

THE SOFTWARE IS PROVIDED "AS IS", WITHOUT WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO THE WARRANTIES OF ERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT. IN NO EVENT SHALL THE AUTHORS OR COPYRIGHT OLDERS BE LIABLE FOR ANY CLAIM, DAMAGES OR OTHER LIABILITY, WHETHER IN AN ACTION OF CONTRACT, TORT OR OTHERWISE, ARISING FROM, OUT OF OR IN CONNECTION WITH THE SOFTWARE OR THE USE OR OTHER DEALINGS IN THE SOFTWARE.
 
Reference Image text 25    

Topic revision: r26 - 06 Sep 2012 - 12:35:06 - MaryBanach
 

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