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Drug Withdrawn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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Mandatory field