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	Choose Pathological Fracture Non-Pathological Fracture Spinal Cord Compression Other SRE-Related Event
What is the best description of the cause of the fracture?	Choose Bone Metastasis Osteoporosis Trauma Other Unknown
What is the toxicity grade of the adverse event?	Choose Grade 1 Grade 2 Grade 3 Grade 4 Grade 5
Start Date	01 Jan 2000
What is the anatomical location of the adverse event?	Choose Pelvic Bone Lumbar Spine Lower Extremity Upper Extremity
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?	Choose Dose Increased Dose not Changed Dose Reduced Drug Interrupted Drug Withdrawn Not Applicable Unknown
What is the outcome of this adverse event?	Choose Recovering/Resolving Not Recovered/Not Resolved Recovered/Resolved Recovered/Resolved with Sequelae Fatal Unknown

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