DefinedAdverseEvent

: Public Class

Created:	10/22/2010 3:57:29 PM
Modified:	2/23/2012 4:12:29 PM

Project:
Author:	BRIDG SCC
Version:	1.0
Phase:	1.0
Status:
Complexity:	Easy
Difficulty:
Priority:
Multiplicity:
Advanced:
UUID:	{DA17866B-18A7-42ae-A94A-F2585766E8E2}
Appears In:	UML-Based Comprehensive BRIDG Model Diagram, View AE: Adverse Event, View PR: Protocol Representation

DEFINITION: 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. EXAMPLE(S): death, back pain, headache, pulmonary embolism, heart attack OTHER NAME(S): NOTE(S):

Attributes
Tagged Values
Other Links

Attribute

Public CD
severityCode

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	False
IsID:	False

Map:CTRv1.0=DefinedAdverseEvent.severityCode
Map:SDTM IGv3.1.2=AE.AESEV

Notes:

DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying the intensity of the event.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Moderate could be used to describe acne.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;

Public CD
categoryCode

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	False
IsID:	False

Map:CTRv1.0=DefinedAdverseEvent.categoryCode
Map:SDTM IGv3.1.2=AE.AECAT

Notes:

DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying a classification of the adverse event.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;bleeding, hypoglycemia#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;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. #lt;br /#gt;#lt;/p#gt;

Public CD
subcategoryCode

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	False
IsID:	False

Map:CTRv1.0=DefinedAdverseEvent.subcategoryCode
Map:SDTM IGv3.1.2=AE.AESCAT

Notes:

DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying a subdivision within a larger category of an adverse event.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;neurologic#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;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. #lt;br /#gt;#lt;/p#gt;

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):