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 |