Name | Description | Type | Additional information |
---|---|---|---|
GSTermId | The internally assigned numeric Gold Standard adverse reaction term code. | integer |
Required |
GSTermName | Gold Standard adverse reaction term name. | string |
Required |
BoxedWarning | Informational alert that, if ‘true’, indicates that a boxed warning exists. | boolean |
Required |
Drugs | A collection of Gold Standard, Generic Product Clinical (GPC) drug concepts associated to this adverse reaction. Each GPC will have a collection of associated Gold Standard product information. | Collection of MonographGPCInfo |
None. |
Gender | The Gender information for the adverse reaction. | GenderEnum |
Required |
Onset | The onset for the adverse reaction. | ADROnsetEnum |
Required |
Severity | The severity for the adverse reaction. | ADRSeverityEnum |
Required |
IncidenceFrom | Low-end range (in decimal format) of the incidence occurrence for that adverse affect (per package insert). | decimal number |
None. |
IncidenceTo | Upper-end range (in decimal format) of the incidence occurrence for that adverse affect (per package insert). | decimal number |
None. |
IncidenceInclusive | Indicates whether the range includes the IncidenceFrom and IncidenceTo values | boolean |
None. |
Reported | Indicates whether an incident range exists. | boolean |
None. |
MonographAdverseReactionDetail
Represents detailed monograph adverse reaction information.