NameDescriptionTypeAdditional 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.