PI Name
Item
PI Name
text
C0027365 (UMLS CUI [1,1])
C1521895 (UMLS CUI [1,2])
Protocol or IRB Number
Item
Protocol or IRB Number
integer
C2348563 (UMLS CUI [1])
Protocol Short Title
Item
Protocol Short Title
text
C2348563 (UMLS CUI [1,1])
C1705824 (UMLS CUI [1,2])
Subject Initials
Item
Subject Initials
text
C2986440 (UMLS CUI [1])
Subject ID
Item
Subject ID
integer
C2348585 (UMLS CUI [1])
Event Start Date
Item
Event Start Date
date
C2697888 (UMLS CUI [1])
Event End Date
Item
Event End Date
date
C2697886 (UMLS CUI [1])
Date Reported
Item
Date Reported
date
C0011008 (UMLS CUI [1,1])
C0700287 (UMLS CUI [1,2])
Reported to Research Staff Bv
Item
Reported to Research Staff Bv
text
C0700287 (UMLS CUI [1,1])
C2986262 (UMLS CUI [1,2])
Death Date (if applicable)
Item
Death Date (if applicable)
date
C1148348 (UMLS CUI [1])
Item
Death Occurred
text
C1306577 (UMLS CUI [1,1])
C2745955 (UMLS CUI [1,2])
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
C1519255 (UMLS CUI [1,1])
C0678341 (UMLS CUI [1,2])
SAE Description/Narrative
Item
SAE Description/Narrative
text
C1519255 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Treating Physician Comments (if applicable)
Item
Treating Physician Comments (if applicable)
text
C0947611 (UMLS CUI [1,1])
C1710470 (UMLS CUI [1,2])
PI Comments
Item
PI Comments
text
C0947611 (UMLS CUI [1,1])
C1521895 (UMLS CUI [1,2])
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
C0009797 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
SAE Classification
Item
SAE Classification: Fatal (resulted in death)
boolean
C1706737 (UMLS CUI [1,1])
C1302234 (UMLS CUI [1,2])
SAE Classification
Item
SAE Classification: A life-threatening occurrence
boolean
C1706737 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
SAE Classification
Item
SAE Classification: Requires inpatient hospitalization or prolongation of existing hospitalization
boolean
C1706737 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
SAE Classification
Item
SAE Classification: Results in persistent or significant disability/incapacity
boolean
C1706737 (UMLS CUI [1,1])
C0231170 (UMLS CUI [1,2])
SAE Classification
Item
SAE Classification: Results in congenital anomaly/birth defect
boolean
C1706737 (UMLS CUI [1,1])
C0000768 (UMLS CUI [1,2])
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
C1706737 (UMLS CUI [1,1])
C4035998 (UMLS CUI [1,2])
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
C1706737 (UMLS CUI [1,1])
C3845751 (UMLS CUI [1,2])
C0683675 (UMLS CUI [2])
C0870486 (UMLS CUI [3])