Study Coordinating Center, Identification number
Item
Center number
integer
C2825181 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
Patient number
Item
Patient Number
integer
C1830427 (UMLS CUI [1])
Person Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Serious Adverse Event, Reporter
Item
Person Reporting SAE
text
C1519255 (UMLS CUI [1,1])
C0335038 (UMLS CUI [1,2])
Serious Adverse Event
Item
Serious Adverse Experience
text
C1519255 (UMLS CUI [1])
Serious Adverse Event, Start Date, Start time
Item
Onset Date and Time
datetime
C1519255 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Serious Adverse Event, End Date, End time
Item
End Date and Time (if ongoing please leave blank)
datetime
C1519255 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
Item
Outcome
text
C1519255 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Item
Experience Course
text
C1519255 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Code List
Experience Course
Item
Common Toxicity Grade
text
C1519255 (UMLS CUI [1,1])
C2826262 (UMLS CUI [1,2])
Code List
Common Toxicity Grade
Item
Action Taken with Respect to Investigational Drug
text
C1519255 (UMLS CUI [1,1])
C2826626 (UMLS CUI [1,2])
Code List
Action Taken with Respect to Investigational Drug
CL Item
Dose increased (3)
CL Item
Drug interrupted/restarted (4)
CL Item
Dose delayed & reduced (7)
Item
Relationship to Investigational Drug
text
C1519255 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Code List
Relationship to Investigational Drug
CL Item
Suspected (reasonable possibility) (3)
Serious Adverse Event, Therapeutic procedure
Item
Corrective therapy
boolean
C1519255 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Serious Adverse Event, Withdraw
Item
Was patient withdrawn due to this specific SAE?
boolean
C1519255 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
Item
Specify reason(s) for considering this a serious AE.
text
C1519255 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Code List
Specify reason(s) for considering this a serious AE.
CL Item
life threatening (2)
CL Item
disabling/incapacitating (3)
CL Item
results in hospitalization (excluding elective surgery or routine clinical procedures) (4)
CL Item
hospitalization prolonged (5)
CL Item
congenital abnormality (6)
CL Item
Investigator considers serious or a significant hazard, contraindication, side effect or precaution (9)
Serious Adverse Event, Abate
Item
Did the SAE abate?
boolean
C1519255 (UMLS CUI [1,1])
C3853704 (UMLS CUI [1,2])
Serious Adverse Event, Experimental drug, Drug dosage altered
Item
If study medication was interrupted, stopped or dose reduced: Was study medication reintroduced (or dose increased)?
boolean
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0420247 (UMLS CUI [1,3])
Serious Adverse Event, Experimental drug, Drug dosage altered, Recurrence
Item
If yes, did SAE recur?
boolean
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0420247 (UMLS CUI [1,3])
C0034897 (UMLS CUI [1,4])
Item
Assessment: SAE is probably associated with
text
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
Code List
Assessment: SAE is probably associated with
CL Item
Protocol design or procedures (but not to study drug); Please specify (1)
CL Item
Another condition (e.g. condition under study, intercurrent illness); Please specify (2)
CL Item
Another drug; Please specify (3)
Serious Adverse Event, Causations
Item
Please specify
text
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
Serious Adverse Event, Laboratory Procedures
Item
Test
text
C1519255 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
Serious Adverse Event, Laboratory Procedures, Date in time
Item
Date
date
C1519255 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Serious Adverse Event, Laboratory Procedures, Numerical value
Item
Value
float
C1519255 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
C1522609 (UMLS CUI [1,3])
Serious Adverse Event, Laboratory Procedures, Unit of Measure
Item
Units
text
C1519255 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])
Serious Adverse Event, Laboratory Procedures, Normal Range
Item
Normal Range
text
C1519255 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
C0086715 (UMLS CUI [1,3])
Serious Adverse Event, Comment
Item
Please provide a brief narrative description of the AE, attaching extra pages e.g. hospital discharge summary if necessary
text
C1519255 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Serious Adverse Event, Randomization, Revealed
Item
If applicable, was randomization code broken at investigational site?
boolean
C1519255 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
C0443289 (UMLS CUI [1,3])
Serious Adverse Event, Randomization, Numbers
Item
Randomization / Study Medication Number
boolean
C1519255 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Serious Adverse Event, Investigator Signature
Item
Investigator's Signature (confirming that the above data are accurate and complete)
text
C1519255 (UMLS CUI [1,1])
C2346576 (UMLS CUI [1,2])
Serious Adverse Event, Investigator Signature, Date in time
Item
Date
date
C1519255 (UMLS CUI [1,1])
C2346576 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Serious Adverse Event, Investigator Name
Item
Name
text
C1519255 (UMLS CUI [1,1])
C2826892 (UMLS CUI [1,2])