E
Reaction/Event
Reaction and event information
총 19개의 필드
E.I.1.1AReaction / Event as Reported by the Primary Source in Native LanguageReaction / Event as Reported by the Primary Source in Native Language
AN
E.I.1.1BReaction / Event as Reported by the Primary Source LanguageReaction / Event as Reported by the Primary Source Language
A
E.I.1.2Reaction / Event as Reported by the Primary Source for TranslationReaction / Event as Reported by the Primary Source for Translation
AN
E.I.2.1AMedDRA Version for Reaction / EventMedDRA Version for Reaction / Event
AN필수
E.I.2.1BReaction / Event (MedDRA code)Reaction / Event (MedDRA code)
N필수
E.I.3.1Term Highlighted by the ReporterTerm Highlighted by the Reporter
N
E.I.3.2AResults in DeathResults in Death
Boolean필수
E.I.3.2BLife ThreateningLife Threatening
Boolean필수
E.I.3.2CCaused / Prolonged HospitalisationCaused / Prolonged Hospitalisation
Boolean필수
E.I.3.2DDisabling / IncapacitatingDisabling / Incapacitating
Boolean필수
E.I.3.2ECongenital Anomaly / Birth DefectCongenital Anomaly / Birth Defect
Boolean필수
E.I.3.2FOther Medically Important ConditionOther Medically Important Condition
Boolean필수
E.I.4Date of Start of Reaction / EventDate of Start of Reaction / Event
Date/Time
E.I.5Date of End of Reaction / EventDate of End of Reaction / Event
Date/Time
E.I.6ADuration of Reaction / Event (number)Duration of Reaction / Event (number)
N
E.I.6BDuration of Reaction / Event (unit)Duration of Reaction / Event (unit)
AN
E.I.7Outcome of Reaction / Event at the Time of Last ObservationOutcome of Reaction / Event at the Time of Last Observation
N필수
E.I.8Medical Confirmation by Healthcare ProfessionalMedical Confirmation by Healthcare Professional
Boolean
E.I.9Identification of the Country Where the Reaction / Event OccurredIdentification of the Country Where the Reaction / Event Occurred
A