CTCAdverseEventCategory
Item
CTC Adverse Event Category
text
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C25161 (NCI Thesaurus Property)
C0008902 (UMLS 2011AA Property)
CommonToxicityCriteriaAdverseEventTermType
Item
CTC Adverse Event Term
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C45559 (NCI Thesaurus Property)
C1705313 (UMLS 2011AA Property)
Item
CTC Adverse Event Grade
double
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
Code List
CTC Adverse Event Grade
CL Item
No Adverse Event Or Within Normal Limits (0)
CL Item
Mild Adverse Event (1)
C41338 (NCI Thesaurus)
C1513302 (UMLS 2011AA)
CL Item
Moderate Adverse Event (2)
C41339 (NCI Thesaurus)
C1513374 (UMLS 2011AA)
CL Item
Severe Adverse Event (3)
C41340 (NCI Thesaurus)
C1519275 (UMLS 2011AA)
CL Item
Life-threatening Or Disabling Adverse Event (4)
CL Item
Death Related To Adverse Event (5)
C48275 (NCI Thesaurus)
C1705232 (UMLS 2011AA)
CTCAdverseEventOnsetDate
Item
Adverse Event Onset Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C25279 (NCI Thesaurus Property)
C0332162 (UMLS 2011AA Property)
MedDRACode
Item
MedDRA Code
double
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
CL104089 (NCI Metathesaurus ObjectClass)
AdverseEventDescriptionText
Item
If other CTC event selected, please provide description of event
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C0678257 (NCI Metathesaurus Property)
Item
Was this event expected or anticipated
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C2851 (NCI Thesaurus ObjectClass)
C0001175 (UMLS 2011AA ObjectClass)
C71104 (NCI Thesaurus ObjectClass)
C0008976 (UMLS 2011AA ObjectClass)
C25599 (NCI Thesaurus Property)
C1441672 (UMLS 2011AA Property)
C54156 (NCI Thesaurus Property)
C0681842 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Code List
Was this event expected or anticipated
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
AgentName
Item
Agent Name
text
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C0450442 (UMLS 2011AA ValueDomain)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)
Item
CTC AE Attribution Code
text
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C25358 (NCI Thesaurus Property)
C0596130 (UMLS 2011AA Property)
Code List
CTC AE Attribution Code
CL Item
Definite (Definite)
CL209464 (NCI Metathesaurus)
CL Item
Possible (Possible)
C0332149 (NCI Metathesaurus)
CL Item
Probable (Probable)
C0332148 (NCI Metathesaurus)
CL Item
Unlikely (Unlikely)
CL Item
Unrelated (Unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
Item
Alternative etiology
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C2851 (NCI Thesaurus ObjectClass)
C0001175 (UMLS 2011AA ObjectClass)
C25415 (NCI Thesaurus Property)
C1523987 (UMLS 2011AA Property)
C25358 (NCI Thesaurus Property)
C0596130 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
Code List
Alternative etiology
CL Item
Accident, Trauma, Or External Factors (Accident, trauma, or external factors)
CL Item
Concurrent Illness/condition (not Pre-existing) (Concurrent illness/condition (not pre-existing))
CL Item
None Apparent (None apparent)
CL Item
Other Pre-existing Disease Or Condition (Other pre-existing disease or condition)
CL Item
Study Disease (Study disease)
Item
Action Taken at Time of Adverse Event
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C2851 (NCI Thesaurus ObjectClass)
C0001175 (UMLS 2011AA ObjectClass)
C25404 (NCI Thesaurus Property)
C0441472 (UMLS 2011AA Property)
Code List
Action Taken at Time of Adverse Event
CL Item
Hospitalization For Ae (Hospitalization)
CL Item
Otc/non-rx (OTC/non-Rx)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Prescription (Prescription)
C28180 (NCI Thesaurus)
C1521941 (UMLS 2011AA)
CL Item
Protocol Treatment Was Delayed As A Result Of The Adverse Event (protocol treatment delayed)
CL Item
Protocol Treatment Was Discontinued As A Result Of The Adverse Event (protocol treatment discontinued)
CL Item
Study Dose Was Reduced As A Result Of The Adverse Event (study dose reduced)
AcquiredImmunodeficiencySyndromeAdverseEventActionSpecify
Item
Other, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C2851 (NCI Thesaurus ObjectClass)
C0001175 (UMLS 2011AA ObjectClass)
C25404 (NCI Thesaurus Property)
C0441472 (UMLS 2011AA Property)
Item
If modification was made to study therapy, who initiated modification
text
C15368 (NCI Thesaurus ObjectClass)
C2851 (NCI Thesaurus ObjectClass)
C0001175 (UMLS 2011AA ObjectClass)
C25657 (NCI Thesaurus Property)
C1273518 (UMLS 2011AA Property)
C25572 (NCI Thesaurus Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
Code List
If modification was made to study therapy, who initiated modification
CL Item
Patient Initiated (Patient initiated)
CL Item
Physician Initiated (Physician initiated)
Item
Outcome of Adverse Event
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C2851 (NCI Thesaurus ObjectClass)
C0001175 (UMLS 2011AA ObjectClass)
Code List
Outcome of Adverse Event
CL Item
Adverse Event Is Resolved (Resolved)
CL Item
Adverse Event Is Resolved With Sequelae (Resolved with sequelae)
CL Item
Unresolved At Protocol Completion (Unresolved at protocol completion)
CL Item
Unresolved, Protocol Ongoing (Unresolved, protocol ongoing)
CTCAdverseEventResolutionDate
Item
AE Resolution Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C25655 (NCI Thesaurus Property)
C1514893 (UMLS 2011AA Property)
AcquiredImmunodeficiencySyndromeAdverseEventResolvedwithSequelaeOutcomeSpecify
Item
If resolved with sequelae, specify
text
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C2851 (NCI Thesaurus ObjectClass)
C0001175 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C49495 (NCI Thesaurus Property)
C1709862 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Item
Seriousness Attributed to Adverse Event
text
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25358 (NCI Thesaurus Property)
C0596130 (UMLS 2011AA Property)
Code List
Seriousness Attributed to Adverse Event
CL Item
Congenital Anomaly (Congenital anomaly)
CL Item
Death (Death)
C28554 (NCI Thesaurus)
C0011065 (UMLS 2011AA)
CL Item
Disability (Disability/incapacity)
C21007 (NCI Thesaurus)
C0231170 (UMLS 2011AA)
CL Item
Hospitalized (Hospitalization, initial or prolonged)
CL Item
Life Threatening (Life threatening)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Intervention Required (Required intervention to prevent permanent impairment/damage)
ResearchCommentsText
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0282411 (UMLS 2011AA Property)