Adverse Event CategoryAdverse Event SubcategorySeverity
| Business Data Model Data Model |
| Description | A defined observation result that describes an 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. For example: Death Back pain Headache Pulmonary embolism Heart attack |
| Attributes | |
| Adverse Event Category |
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| Adverse Event Subcategory |
|
| Severity |
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| Generalization | |
 R_1419 |
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| Dependencies | |
 NONE |
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| Reverse Dependencies | |
| |
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| Attribute Details |
Adverse Event Category
| Description | Classification of the adverse event. For example: Bleeding Hypoglycemia |
| Data Type | Standards - Data Domains.ddm/Data Domains/Enumeration [VARCHAR(20)] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Adverse Event Subcategory
| Description | Specifies a subdivision within a larger category of an adverse event. For example: Neurologic |
| Data Type | Standards - Data Domains.ddm/Data Domains/Enumeration [VARCHAR(20)] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Severity
| Description | Specifies the intensity of an activity, event or condition. For example: Major Moderate Minor |
| Data Type | Standards - Data Domains.ddm/Data Domains/Enumeration [VARCHAR(20)] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
| Generalization Details |
R_1419
| Supertype | Defined Observation Result |
| Subtype | Defined Adverse Event |
| Transform As | TABLE |
| Business Data Model Data Model |