Adverse Events including SREs
AEs including SREs
Were any adverse events experienced? Yes  No  
What is the adverse event identifier?
What is the adverse event term?
What is the category of the adverse event? SRE-related  Not SRE-related  
If SRE-related, Indicate type of event
What is the best description of the cause of the fracture?
What is the toxicity grade of the adverse event?
Start Date
 01 Jan 2000
What is the anatomical location of the adverse event?
What is the side of the anatomical location of the adverse event? Right  Left  Bilateral  
Is the adverse event still ongoing? Yes  No  
End Date
 01 Jan 2000
Was the adverse event serious? Yes  No  
Did the adverse event result in death? Yes  No  
Death Date
 01 Jan 2000
Was the adverse event life threatening? Yes  No  
Did the adverse event result in initial or prolonged hospitalization for the subject? Yes  No  
Did the adverse event result in disability or permanent damage? Yes  No  
Was the adverse event associated with a congenital anomaly or birth defect? Yes  No  
Was the adverse event a medically important event not covered by other serious criteria? Yes  No  
Was this adverse event related to study treatment? Yes  No  
What action was taken with study treatment?
What is the outcome of this adverse event?
* Mandatory field