| Business Data Model Data Model |
| Description | A performed observation result that is 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 |
| Generalization | |
 Generalization1 |
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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 |
End Relative To Reference
| Description | Specifies when this event ended with respect to the sponsor-defined reference period. For example: Before During During/after After |
| 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 |
Expected Ind
| Description | Specifies whether the specificity (nature), frequency, or severity of an adverse event is consistent with the applicable study documentation (for example, investigator's brochure, protocol document, or consent document) or product labeling (package insert). |
| Data Type | Standards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Highlighted Ind
| Description | Specifies whether the adverse event or reaction term is a major concern or reason for reporting the adverse event. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Hospitalization Required Ind
| Description | Specifies whether the subject or study subject requires hospitalization or prolongation of existing hospitalization as a result of the adverse event. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Injury Grade Code
| Description | A coded value specifying the level of injury suffered by the subject or study subject for whom the event is reported. For example: The grade code could be 3 if the CTCAE coding system is being used. |
| 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 |
Location Descr
| Description | The textual representation of the physical location of the subject or study subject when the adverse event began. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Text Large [VARCHAR(1024)] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Occurrence From Ts
| Description | The date and time span in which the adverse event began. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Timestamp [TIMESTAMP] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Occurrence Pattern
| Description | Specifies the time recurrence by which an adverse event occurs. For example: Intermittent Continuous Single event |
| 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 |
Occurrence To Ts
| Description | The date and time span in which the adverse event ended. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Timestamp [TIMESTAMP] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Post Report Update Date and Time
| Description | The date (and time) on which the adverse event was updated after it had been submitted. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Timestamp [TIMESTAMP] |
| 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 |
Summary Txt
| Description | A description of the adverse event and the treatment of the event. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Text Large [VARCHAR(1024)] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Treatment Emergent Ind
| Description | Specifies whether the adverse event is something that first arose or become more severe during the studied treatment. |
| Data Type | Standards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER] |
| Is Part Of PrimaryKey | false |
| Is Required | false |
| Is Derived | false |
| Is Surrogate Key | false |
Unexpected Reason
| Description | Describes why an adverse event (experience or reaction) is considered unanticipated. For example: Severity Frequency Specificity from what has been previously documented |
| 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 |
Generalization1
| Supertype | Performed Observation Result |
| Subtype | Adverse Event |
| Transform As | TABLE |
| Business Data Model Data Model |