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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 Genera Principles, Labs Liver, ECGVitals, Adverse Events  
Code Added radio 2 Yes, No  
Question Classification checkbox 2 I-Demographics, II-Incidence of AE:1_Types of AE (treatment vs comparators or different dosage), II-Incidence of AE:2_Incidence rate or ratio, III-AE Occurrence Over Time:1_Time to onset (treatment vs comparator), III-AE Occurrence Over Time:2_Trends of AE occurrence over time, IV-Dosage and Exposure:1_AE occurrence across different dosages, IV-Dosage and Exposure:2_AE occurrence and treatment effects (i.e. efficacy). V-Potential Risk Factors or Temporal Relationship of AE:1_Baseline factors, V-Potential Risk Factors or Temporal Relationship of AE:2_Concomitant medications, V-Potential Risk Factors or Temporal Relationship of AE:3_AE event of interest in relationship with other prior or concurred AEs, V!-Withdraw and Interruption in Relation to the Occurrence of AEs, VII-Patient Profile  
AE Clinical Questions Answered checkbox 1 I-Which adverse events are elevated in patient subgroups (race or gender or age?,
II-1-Which AEs are elevated in treament vs control? Is the occurrence of AEs elevated in particular patient subgroups?,
II-2-What is the treatment of treatment effects over time - e.g. risk difference or risk ratios or odds ratio?,
II-3-Are there any event groups of special interest (e.g. cardiovascular events or hepatic event)?,
II-4-What is the safety profile of the drug?,
III-1 Are there any special patterns of an AE onset? Are there any cyclical and/or seasonal patterns in AE occurrence over drug use?,
III-2-Is there a difference in the time to event across treatment groups?,
IV-1-What is the relationship between AE occurrence and drug exposure?,
V-1-Is there a relationship with other AEs?,
V-2-Is there a temporal relationship between drug exposure and AE occurrence?.
V-3-Are there any risk factors in relation to AE occurrence?,
V-4-How do drug-drug interactions relate to AE occurrence?,
V-5-Is there a relationship between AE occurrence and concomitant medication use?,
VI-1-Are there any AEs associated with drop-outs?,
VII-1-What is the patient profile - that is - study drug or dose or concomitant medications or laboratory values or adverse events?,
VII-2-Are laboratory elevations related to adverse events? Are laboratory elevations and adverse events related to treatments?
Mark all questions answered.
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).
Software-Version text 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: r16 - 21 Jun 2012 - 11:06:56 - MaryBanach
 

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