Details
Verbatim (i.e., investigator-reported term) description of the adverse event.
text
Date when the adverse event started.
partialDate
Indicates AE is ongoing when no End Date is provided.
text
Date when the adverse event resolved.
partialDate
Description of the severity of the adverse event.
text
Indicates whether or not the adverse event is determined to be “serious” based on what is defined in the protocol.
text
Indicates if a “serious” adverse event was associated with a congenital anomaly or birth defect.
text
Indicates if a “serious” adverse event was associated with a persistent or significant disability or incapacity.
text
Indicates if a “serious” adverse event resulted in death.
text
Indicates if a “serious” adverse event resulted in an initial or prolonged hospitalization for the subject.
text
Indicates if a “serious” adverse event was life threatening.
text
Indicates if a “serious” adverse event is associated with other serious or important medical events.
text
Indication of whether the study treatment had a causal effect on the adverse event, as reported by the clinician/investigator.
text
Changes made to the study treatment in response to the adverse event.
text
Describes Other Action(s) taken in response to the adverse event that are unrelated to study treatment dose changes.
text
Description of the subject’s status associated with an event.
text
Indication of whether the adverse event caused the subject to discontinue from the study.
text