: Public Class
Created: 10/22/2010 3:57:29 PM
Modified: 8/26/2017 2:39:21 AM
Project:
Advanced:
DEFINITION: <br/>A reusable, template description of any unfavorable and unintended sign, symptom, disease, or other medical occurrence with a temporal association with the use of a medical product, procedure or other therapy, or in conjunction with a research study, regardless of causal relationship. <br/><br/>EXAMPLE(S):<br/>death, back pain, headache, pulmonary embolism, heart attack<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Attribute
Public CD
  severityCode
Details:
Map:CTRv1.0=DefinedAdverseEvent.severityCode
Map:SDTM IGv3.1.2=AE.AESEV
Notes: DEFINITION:<br/>A coded value specifying the intensity of the event.<br/><br/>EXAMPLE(S):<br/>Moderate could be used to describe acne.<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Public CD
  categoryCode
Details:
Map:CTRv1.0=DefinedAdverseEvent.categoryCode
Map:SDTM IGv3.1.2=AE.AECAT
Notes: DEFINITION:<br/>A coded value specifying a classification of the adverse event.<br/><br/>EXAMPLE(S):<br/>bleeding, hypoglycemia<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>Theoretically speaking, the category should be derivable from the subcategory, however if there may only be a category and not a subcategory, then both attributes must be present in the model. <br/>
Public CD
  subcategoryCode
Details:
Map:CTRv1.0=DefinedAdverseEvent.subcategoryCode
Map:SDTM IGv3.1.2=AE.AESCAT
Notes: DEFINITION:<br/>A coded value specifying a subdivision within a larger category of an adverse event.<br/><br/>EXAMPLE(S):<br/>neurologic<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>Theoretically speaking, the category should be derivable from the subcategory, however if there may only be a category and not a subcategory, then both attributes must be present in the model. <br/>
Tag Value
Map:CTRv1.0 DefinedAdverseEvent
Details:
 
Map:SDTM IGv3.1.2 AE.AEOCCUR
Details:
 
Object Type Connection Direction Notes
DefinedObservationResult Class Generalization To DESCRIPTION: Each DefinedAdverseEvent always specializes one DefinedObservationResult. Each DefinedObservationResult might be specialized by one DefinedAdverseEvent. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):