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Adverse Events
Adverse Events are unfavorable changes in health, including abnormal
laboratory findings, that occur in trial participants during the
clinical trial or within a specified period following the trial.
Serious Adverse Events
Other Adverse Events
Serious Adverse Events
Serious Adverse Events include adverse events that result in death,
require either inpatient hospitalization or the prolongation of
hospitalization, are life-threatening, result in a persistent or significant
disability/incapacity or result in a congenital anomaly/birth defect. Other
important medical events, based upon appropriate medical judgment,
may also be considered Serious Adverse Events if a trial
participant's health is at risk and intervention is required to
prevent an outcome mentioned.
Other Adverse Events
Other Adverse Events are adverse events that are not Serious Adverse Events but
that exceed the indicated frequency threshold.