Form AE - Adverse Events
AE - Adverse Events
Were any adverse events experienced?	No  Yes
* What is the adverse event term?
* What is the adverse event start date?	01 Jan 2000
Is the adverse event ongoing (as of [the study-specific time point or period])?	No  Yes
What was the adverse event end date?	01 Jan 2000
What is the severity of the adverse event?	Mild  Moderate  Severe
Was the adverse event serious?	No  Yes
Did the adverse event result in death?	No  Yes
Was the adverse event life threatening?	No  Yes
Did the adverse event result in initial or prolonged hospitalization for the subject?	No  Yes
Did the adverse event result in disability or permanent damage?	No  Yes
Was the adverse event associated with a congenital anomaly or birth defect?	No  Yes
Was the adverse event a medically important event not covered by other serious criteria?	No  Yes
* Was this adverse event related to study treatment?	No  Yes
What action was taken with study treatment?	Choose Dose Increased Dose Not Changed Dose Rate Reduced Dose Reduced Drug Interrupted Drug Withdrawn Not Applicable Unknown
What other action was taken?
What is the outcome of this adverse event?	Choose Fatal Not Recovered or Not Resolved Recovered or Resolved Recovered or Resolved with Sequelae Recovering or Resolving Unknown

* Mandatory field