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Safety_Case data set

in the Safety_Case data set

Data Series Title

Description

Location in Argus Safety

SeriousIndicator

Whether the case is serious.

Case Form / Analysis / Case Serious

OccurenceCountryCode

Where the adverse event occurred.

Case Form/ General / General Information / Country of Incidence

SeriousnessDeathIndicator

Whether the case resulted in death.

Case Form / Analysis / Case Serious / Notes

SeriousnessLifeThreatening Indicator

Whether the case is life threatening.

Case Form / Analysis / Case Serious / Notes

SeriousnessHospitalization Indicator

Whether the case requires inpatient hospitalization or prolonging of existing hospitalization.

Case Form / Analysis / Case Serious / Notes

SeriousnessDisablingIndicator

Whether the case results in persistent or significant disability or incapacity.

Case Form / Analysis / Case Serious / Notes

SeriousnessCongenital AnomalyIndicator

Whether the case results in a congenital anomaly or birth defect.

Case Form / Analysis / Case Serious / Notes

SeriousnessOtherIndicator

Whether the case contains a medically important condition.

Case Form / Analysis / Case Serious / Notes

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