Event Start Date
Item
Event Start Date
date
Event End Date
Item
Event End Date
date
Date Reported
Item
Date Reported
date
Reported to Research Staff Bv
Item
Reported to Research Staff Bv
text
Death Date (if applicable)
Item
Death Date (if applicable)
date
CL Item
Within 24 hours of investigational therapy (1)
CL Item
Within 7 days of investigational therapy (2)
CL Item
Within 30 days of investigational therapy (3)
CL Item
After 30 days of investigational therapy (4)
SAE
Item
Did the SAE occur at your site or at a site for which the PI is responsible?
boolean
SAE Description/Narrative
Item
SAE Description/Narrative
text
Treating Physician Comments (if applicable)
Item
Treating Physician Comments (if applicable)
text
PI Comments
Item
PI Comments
text
CL Item
Intervention for AE Continuing (2)
CL Item
Not Recovered/Not Resolved (3)
CL Item
Recovered/Resolved with Sequelae (4)
CL Item
Recovered/Resolved without Sequelae (5)
CL Item
Recovering/Resolving (6)
Consent Form Change Required?
Item
Consent Form Change Required?
boolean
SAE Classification
Item
SAE Classification: Fatal (resulted in death)
boolean
SAE Classification
Item
SAE Classification: A life-threatening occurrence
boolean
SAE Classification
Item
SAE Classification: Requires inpatient hospitalization or prolongation of existing hospitalization
boolean
SAE Classification
Item
SAE Classification: Results in persistent or significant disability/incapacity
boolean
SAE Classification
Item
SAE Classification: Results in congenital anomaly/birth defect
boolean
SAE Classification
Item
SAE Classification: A significant medical incident that, based upon appropriate medical judgment, may jeopardize the subject and require medical or surgical intervention to prevent one of the outcomes listed above.
boolean
SAE Classification
Item
SAE Classification: Loss of confidentiality that results in criminal or civil liability for participation or damage to financial standing, employability, insurability or reputation of the participant.
boolean