ID
3092
Description
CALGB Adverse Event (AE) Form (CTCAE v4) - Phase I, II, Solicited Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=77004C80-3307-DC10-E040-BB89AD430A30
Link
Keywords
Versions (3)
- 9/19/12 9/19/12 -
- 1/9/15 1/9/15 - Martin Dugas
- 1/9/15 1/9/15 - Martin Dugas
Uploaded on
September 19, 2012
DOI
To request one please log in.
License
Creative Commons BY-NC 3.0 Legacy
Model comments :
You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
Toxicity - CALGB Adverse Event (AE) Form (CTCAE v4) - Phase I, II, Solicited - 2956553v1.0
INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy use black ink. If data are amended, circle amended items and check the "Yes" box. If submitting by mail, retain a copy for your records. If submitting by fax, use an original form for maximum clarity in transmission and fax to 919-416-4990. AE is defined as adverse event. Use NCI CTCAE v4.x or most current version with MedDRA codes posted at http://www.calgb.org to grade each adverse event. Grade = -1 if category not evaluated. Grade = 0 if category evaluated but event not present. TREATMENT ATTRIBUTION CODES: 1 = unrelated, 2 = unlikely, 3 = possible, 4 = probable, 5 = definite
Description
Unnamed2
Description
PatientInitialsName
Data type
text
Alias
- NCI Thesaurus ValueDomain
- C25191
- UMLS 2011AA ValueDomain
- C1547383
- NCI Thesaurus ObjectClass
- C16960
- UMLS 2011AA ObjectClass
- C0030705
- NCI Thesaurus Property
- C25536
- UMLS 2011AA Property
- C1555582
Description
PatientMedicalRecordNumber
Data type
text
Alias
- NCI Thesaurus ValueDomain
- C25337
- UMLS 2011AA ValueDomain
- C0237753
- NCI Thesaurus ObjectClass
- C16960
- UMLS 2011AA ObjectClass
- C0030705
- NCI Thesaurus Property
- C25261
- UMLS 2011AA Property
- C0205476
- NCI Thesaurus Property
- C25198
- UMLS 2011AA Property
- C0034869
Description
CombinedInstitutionName
Data type
text
Alias
- NCI Thesaurus ObjectClass
- C25454
- UMLS 2011AA ObjectClass
- C0205195
- NCI Thesaurus ObjectClass
- C21541
- UMLS 2011AA ObjectClass
- C0018704
- NCI Thesaurus Property
- C25364
- UMLS 2011AA Property
- C0600091
- NCI Thesaurus ValueDomain
- C25191
- UMLS 2011AA ValueDomain
- C1547383
- NCI Thesaurus ValueDomain
- C21541
- UMLS 2011AA ValueDomain
- C0018704
Description
ParticipatingGroupName
Data type
text
Alias
- NCI Thesaurus ValueDomain
- C25191
- UMLS 2011AA ValueDomain
- C1547383
- NCI Thesaurus ObjectClass
- C25608
- UMLS 2011AA ObjectClass
- C0679823
- NCI Thesaurus ObjectClass
- C17005
- UMLS 2011AA ObjectClass
- C1257890
- NCI Thesaurus Property
- C25364
- UMLS 2011AA Property
- C0600091
Description
ProtocolParticipatingIdentifierNumber
Data type
text
Alias
- NCI Thesaurus ValueDomain
- C25337
- UMLS 2011AA ValueDomain
- C0237753
- NCI Thesaurus ObjectClass
- C25320
- UMLS 2011AA ObjectClass
- C1507394
- NCI Thesaurus Property
- C25608
- UMLS 2011AA Property
- C0679823
- NCI Thesaurus Property
- C25364
- UMLS 2011AA Property
- C0600091
Description
PatientParticipatingIdentifierNumber
Data type
text
Alias
- NCI Thesaurus ValueDomain
- C25337
- UMLS 2011AA ValueDomain
- C0237753
- NCI Thesaurus ObjectClass
- C16960
- UMLS 2011AA ObjectClass
- C0030705
- NCI Thesaurus Property
- C25608
- UMLS 2011AA Property
- C0679823
- NCI Thesaurus Property
- C25364
- UMLS 2011AA Property
- C0600091
Description
Unnamed3
Description
AdverseEventReportInd-3
Data type
text
Alias
- NCI Thesaurus ValueDomain
- C38148
- UMLS 2011AA ValueDomain
- C1512699
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus Property
- C25375
- UMLS 2011AA Property
- C0684224
- NCI Thesaurus ObjectClass
- C17648
- UMLS 2011AA ObjectClass
- C0439064
Description
Expected Adverse Events
Description
CTCAdverseEventAttributionScale
Data type
text
Alias
- NCI Thesaurus ValueDomain
- C25664
- UMLS 2011AA ValueDomain
- C0349674
- NCI Thesaurus ObjectClass
- C49704
- UMLS 2011AA ObjectClass
- C1516728
- NCI Thesaurus Property
- C25358
- UMLS 2011AA Property
- C0596130
Description
CTCAdverseEventAttributionScale
Data type
text
Alias
- NCI Thesaurus ValueDomain
- C25664
- UMLS 2011AA ValueDomain
- C0349674
- NCI Thesaurus ObjectClass
- C49704
- UMLS 2011AA ObjectClass
- C1516728
- NCI Thesaurus Property
- C25358
- UMLS 2011AA Property
- C0596130
Description
AdverseEventMedDRALowLevelTermVersionInteger::12.0Code
Data type
double
Alias
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus ObjectClass
- C71886
- UMLS 2011AA ObjectClass
- C2347090
- NCI Thesaurus Property
- C25162
- UMLS 2011AA Property
- C0805701
- NCI Thesaurus Property
- C43820
- UMLS 2011AA Property
- C1140263
- NCI Thesaurus ValueDomain
- C25162
- UMLS 2011AA ValueDomain
- C0805701
- NCI Thesaurus ValueDomain
- C41331
- UMLS 2011AA ValueDomain
- C0877248
- NCI Thesaurus ValueDomain
- C45255
- UMLS 2011AA ValueDomain
- C1708523
- NCI Thesaurus ValueDomain
- C43820
- UMLS 2011AA ValueDomain
- C1140263
- NCI Thesaurus ValueDomain
- C25714
- UMLS 2011AA ValueDomain
- C0333052
Description
AdverseEventMedDRALowLevelTermVersionInteger::12.0Code
Data type
double
Alias
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus ObjectClass
- C71886
- UMLS 2011AA ObjectClass
- C2347090
- NCI Thesaurus Property
- C25162
- UMLS 2011AA Property
- C0805701
- NCI Thesaurus Property
- C43820
- UMLS 2011AA Property
- C1140263
- NCI Thesaurus ValueDomain
- C25162
- UMLS 2011AA ValueDomain
- C0805701
- NCI Thesaurus ValueDomain
- C41331
- UMLS 2011AA ValueDomain
- C0877248
- NCI Thesaurus ValueDomain
- C45255
- UMLS 2011AA ValueDomain
- C1708523
- NCI Thesaurus ValueDomain
- C43820
- UMLS 2011AA ValueDomain
- C1140263
- NCI Thesaurus ValueDomain
- C25714
- UMLS 2011AA ValueDomain
- C0333052
Description
AdverseEventCommonTerminologyforAdverseEventsVersion4TermName
Data type
text
Alias
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus Property
- C49704
- UMLS 2011AA Property
- C1516728
- NCI Thesaurus Property
- C45559
- UMLS 2011AA Property
- C1705313
- NCI Thesaurus ValueDomain
- C45255
- UMLS 2011AA ValueDomain
- C1708523
- NCI Thesaurus ValueDomain
- C49704
- UMLS 2011AA ValueDomain
- C1516728
- NCI Thesaurus ValueDomain
- C42614
- UMLS 2011AA ValueDomain
- C0027365
- NCI Thesaurus ValueDomain
- C45559
- UMLS 2011AA ValueDomain
- C1705313
- NCI Thesaurus ValueDomain
- C25714
- UMLS 2011AA ValueDomain
- C0333052
Description
AdverseEventCommonTerminologyforAdverseEventsVersion4TermName
Data type
text
Alias
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus Property
- C49704
- UMLS 2011AA Property
- C1516728
- NCI Thesaurus Property
- C45559
- UMLS 2011AA Property
- C1705313
- NCI Thesaurus ValueDomain
- C45255
- UMLS 2011AA ValueDomain
- C1708523
- NCI Thesaurus ValueDomain
- C49704
- UMLS 2011AA ValueDomain
- C1516728
- NCI Thesaurus ValueDomain
- C42614
- UMLS 2011AA ValueDomain
- C0027365
- NCI Thesaurus ValueDomain
- C45559
- UMLS 2011AA ValueDomain
- C1705313
- NCI Thesaurus ValueDomain
- C25714
- UMLS 2011AA ValueDomain
- C0333052
Description
AdverseEventSeverityGrade
Data type
text
Alias
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus Property
- C48309
- UMLS 2011AA Property
- C0441800
- NCI Thesaurus Property
- C49705
- UMLS 2011AA Property
- C1710065
- NCI Thesaurus Property
- C25676
- UMLS 2011AA Property
- C0439793
- NCI Thesaurus ValueDomain
- C41331
- UMLS 2011AA ValueDomain
- C0877248
- NCI Thesaurus ValueDomain
- C48309
- UMLS 2011AA ValueDomain
- C0441800
- NCI Thesaurus ValueDomain
- C25676
- UMLS 2011AA ValueDomain
- C0439793
Description
AdverseEventSeverityGrade
Data type
text
Alias
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus Property
- C48309
- UMLS 2011AA Property
- C0441800
- NCI Thesaurus Property
- C49705
- UMLS 2011AA Property
- C1710065
- NCI Thesaurus Property
- C25676
- UMLS 2011AA Property
- C0439793
- NCI Thesaurus ValueDomain
- C41331
- UMLS 2011AA ValueDomain
- C0877248
- NCI Thesaurus ValueDomain
- C48309
- UMLS 2011AA ValueDomain
- C0441800
- NCI Thesaurus ValueDomain
- C25676
- UMLS 2011AA ValueDomain
- C0439793
Description
ResponsiblePersonName
Data type
text
Alias
- NCI Thesaurus ValueDomain
- C25191
- UMLS 2011AA ValueDomain
- C1547383
- NCI Thesaurus ObjectClass
- C25657
- UMLS 2011AA ObjectClass
- C1273518
- NCI Thesaurus Property
- C25364
- UMLS 2011AA Property
- C0600091
Description
FormCompleteDate
Data type
date
Alias
- NCI Thesaurus ValueDomain
- C25164
- UMLS 2011AA ValueDomain
- C0011008
- NCI Thesaurus ObjectClass
- C40988
- UMLS 2011AA ObjectClass
- C1516308
- NCI Thesaurus Property
- C25250
- UMLS 2011AA Property
- C0205197
- NCI Thesaurus ValueDomain
- C25367
Similar models
INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy use black ink. If data are amended, circle amended items and check the "Yes" box. If submitting by mail, retain a copy for your records. If submitting by fax, use an original form for maximum clarity in transmission and fax to 919-416-4990. AE is defined as adverse event. Use NCI CTCAE v4.x or most current version with MedDRA codes posted at http://www.calgb.org to grade each adverse event. Grade = -1 if category not evaluated. Grade = 0 if category evaluated but event not present. TREATMENT ATTRIBUTION CODES: 1 = unrelated, 2 = unlikely, 3 = possible, 4 = probable, 5 = definite
C0237753 (UMLS 2011AA ValueDomain)
C19464 (NCI Thesaurus ObjectClass)
C0376315 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25442 (NCI Thesaurus ObjectClass)
C1516238 (UMLS 2011AA ObjectClass)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25442 (NCI Thesaurus Property)
C1516238 (UMLS 2011AA Property)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25442 (NCI Thesaurus Property)
C1516238 (UMLS 2011AA Property)
C0011008 (UMLS 2011AA ValueDomain)
C25375 (NCI Thesaurus Property)
C0684224 (UMLS 2011AA Property)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C0011008 (UMLS 2011AA ValueDomain)
C25375 (NCI Thesaurus Property)
C0684224 (UMLS 2011AA Property)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C1512699 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25261 (NCI Thesaurus Property)
C0205476 (UMLS 2011AA Property)
C25198 (NCI Thesaurus Property)
C0034869 (UMLS 2011AA Property)
C0205195 (UMLS 2011AA ObjectClass)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ValueDomain)
C0018704 (UMLS 2011AA ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25608 (NCI Thesaurus ObjectClass)
C0679823 (UMLS 2011AA ObjectClass)
C17005 (NCI Thesaurus ObjectClass)
C1257890 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C1512699 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25375 (NCI Thesaurus Property)
C0684224 (UMLS 2011AA Property)
C17648 (NCI Thesaurus ObjectClass)
C0439064 (UMLS 2011AA ObjectClass)
C1298908 (UMLS 2011AA)
C1705108 (UMLS 2011AA)
C0349674 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C25358 (NCI Thesaurus Property)
C0596130 (UMLS 2011AA Property)
C0445356 (UMLS 2011AA)
C0349674 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C25358 (NCI Thesaurus Property)
C0596130 (UMLS 2011AA Property)
C0445356 (UMLS 2011AA)
C0877248 (UMLS 2011AA ObjectClass)
C71886 (NCI Thesaurus ObjectClass)
C2347090 (UMLS 2011AA ObjectClass)
C25162 (NCI Thesaurus Property)
C0805701 (UMLS 2011AA Property)
C43820 (NCI Thesaurus Property)
C1140263 (UMLS 2011AA Property)
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ValueDomain)
C0877248 (UMLS 2011AA ValueDomain)
C45255 (NCI Thesaurus ValueDomain)
C1708523 (UMLS 2011AA ValueDomain)
C43820 (NCI Thesaurus ValueDomain)
C1140263 (UMLS 2011AA ValueDomain)
C25714 (NCI Thesaurus ValueDomain)
C0333052 (UMLS 2011AA ValueDomain)
C0877248 (UMLS 2011AA ObjectClass)
C71886 (NCI Thesaurus ObjectClass)
C2347090 (UMLS 2011AA ObjectClass)
C25162 (NCI Thesaurus Property)
C0805701 (UMLS 2011AA Property)
C43820 (NCI Thesaurus Property)
C1140263 (UMLS 2011AA Property)
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ValueDomain)
C0877248 (UMLS 2011AA ValueDomain)
C45255 (NCI Thesaurus ValueDomain)
C1708523 (UMLS 2011AA ValueDomain)
C43820 (NCI Thesaurus ValueDomain)
C1140263 (UMLS 2011AA ValueDomain)
C25714 (NCI Thesaurus ValueDomain)
C0333052 (UMLS 2011AA ValueDomain)
C0877248 (UMLS 2011AA ObjectClass)
C49704 (NCI Thesaurus Property)
C1516728 (UMLS 2011AA Property)
C45559 (NCI Thesaurus Property)
C1705313 (UMLS 2011AA Property)
C45255 (NCI Thesaurus ValueDomain)
C1708523 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ValueDomain)
C1516728 (UMLS 2011AA ValueDomain)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)
C45559 (NCI Thesaurus ValueDomain)
C1705313 (UMLS 2011AA ValueDomain)
C25714 (NCI Thesaurus ValueDomain)
C0333052 (UMLS 2011AA ValueDomain)
C0877248 (UMLS 2011AA ObjectClass)
C49704 (NCI Thesaurus Property)
C1516728 (UMLS 2011AA Property)
C45559 (NCI Thesaurus Property)
C1705313 (UMLS 2011AA Property)
C45255 (NCI Thesaurus ValueDomain)
C1708523 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ValueDomain)
C1516728 (UMLS 2011AA ValueDomain)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)
C45559 (NCI Thesaurus ValueDomain)
C1705313 (UMLS 2011AA ValueDomain)
C25714 (NCI Thesaurus ValueDomain)
C0333052 (UMLS 2011AA ValueDomain)
C0877248 (UMLS 2011AA ObjectClass)
C48309 (NCI Thesaurus Property)
C0441800 (UMLS 2011AA Property)
C49705 (NCI Thesaurus Property)
C1710065 (UMLS 2011AA Property)
C25676 (NCI Thesaurus Property)
C0439793 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ValueDomain)
C0877248 (UMLS 2011AA ValueDomain)
C48309 (NCI Thesaurus ValueDomain)
C0441800 (UMLS 2011AA ValueDomain)
C25676 (NCI Thesaurus ValueDomain)
C0439793 (UMLS 2011AA ValueDomain)
C2919019 (UMLS 2011AA)
C1517874 (UMLS 2011AA)
C1705232 (UMLS 2011AA)
C0877248 (UMLS 2011AA ObjectClass)
C48309 (NCI Thesaurus Property)
C0441800 (UMLS 2011AA Property)
C49705 (NCI Thesaurus Property)
C1710065 (UMLS 2011AA Property)
C25676 (NCI Thesaurus Property)
C0439793 (UMLS 2011AA Property)
C41331 (NCI Thesaurus ValueDomain)
C0877248 (UMLS 2011AA ValueDomain)
C48309 (NCI Thesaurus ValueDomain)
C0441800 (UMLS 2011AA ValueDomain)
C25676 (NCI Thesaurus ValueDomain)
C0439793 (UMLS 2011AA ValueDomain)
C2919019 (UMLS 2011AA)
C1517874 (UMLS 2011AA)
C1705232 (UMLS 2011AA)
C1547383 (UMLS 2011AA ValueDomain)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C0011008 (UMLS 2011AA ValueDomain)
C40988 (NCI Thesaurus ObjectClass)
C1516308 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain)
No comments