ID
9483
Beschrijving
CALGB Adverse Event (AE) Form (CTCAE v4) - Phase III, Specify Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=77004C80-3180-DC10-E040-BB89AD430A30
Link
Trefwoorden
Versies (3)
- 19-09-12 19-09-12 -
- 09-01-15 09-01-15 - Martin Dugas
- 09-01-15 09-01-15 - Martin Dugas
Geüploaded op
9 januari 2015
DOI
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Licentie
Creative Commons BY-NC 3.0 Legacy
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Toxicity - CALGB Adverse Event (AE) Form (CTCAE v4) - Phase III, Specify - 2956281v1.0
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
Beschrijving
Unnamed2
Beschrijving
Patient Initials
Datatype
text
Alias
- NCI Thesaurus ValueDomain
- C25191
- UMLS CUI-1
- C2986440
- NCI Thesaurus ObjectClass
- C16960
- NCI Thesaurus Property
- C25536
Beschrijving
Medical Record Number
Datatype
text
Alias
- NCI Thesaurus ValueDomain
- C25337
- UMLS CUI-1
- C1301894
- NCI Thesaurus ObjectClass
- C16960
- NCI Thesaurus Property
- C25261
- NCI Thesaurus Property-2
- C25198
Beschrijving
Institution Name
Datatype
text
Alias
- NCI Thesaurus ObjectClass
- C25454
- UMLS CUI-1
- C1301943
- NCI Thesaurus ObjectClass-2
- C21541
- NCI Thesaurus Property
- C25364
- NCI Thesaurus ValueDomain
- C25191
- NCI Thesaurus ValueDomain-2
- C21541
Beschrijving
Participating Group
Datatype
text
Alias
- NCI Thesaurus ValueDomain
- C25191
- UMLS CUI-1
- C2347449
- NCI Thesaurus ObjectClass
- C25608
- NCI Thesaurus ObjectClass-2
- C17005
- NCI Thesaurus Property
- C25364
Beschrijving
Study Number Participating Group
Datatype
text
Alias
- NCI Thesaurus ValueDomain
- C25337
- UMLS CUI-1
- C3274381
- NCI Thesaurus ObjectClass
- C25320
- UMLS CUI-2
- C2347449
- NCI Thesaurus Property
- C25608
- NCI Thesaurus Property-2
- C25364
Beschrijving
Trial subject ID Participating Group
Datatype
text
Alias
- NCI Thesaurus ValueDomain
- C25337
- UMLS CUI-1
- C2348585
- NCI Thesaurus ObjectClass
- C16960
- UMLS CUI-2
- C2347449
- NCI Thesaurus Property
- C25608
- NCI Thesaurus Property-2
- C25364
Beschrijving
Unnamed3
Beschrijving
AdverseEventReportInd-3
Datatype
boolean
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-2
- C17648
- UMLS 2011AA ObjectClass-2
- C0439064
Beschrijving
Expected Adverse Events
Beschrijving
CTC Adverse Event Attribution Category
Datatype
text
Alias
- NCI Thesaurus ValueDomain
- C25664
- UMLS CUI-1
- C1706735
- NCI Thesaurus ObjectClass
- C49704
- NCI Thesaurus Property
- C25358
Beschrijving
CTC Adverse Event Attribution Category
Datatype
text
Alias
- NCI Thesaurus ValueDomain
- C25664
- UMLS CUI-1
- C1706735
- NCI Thesaurus ObjectClass
- C49704
- NCI Thesaurus Property
- C25358
Beschrijving
CTC Adverse Event Reported Term
Datatype
text
Alias
- NCI Thesaurus ValueDomain
- C25685
- UMLS CUI-1
- C1516728
- NCI Thesaurus ObjectClass
- C49704
- UMLS CUI-2
- C2699044
- NCI Thesaurus Property
- C25161
Beschrijving
Primary Site MedDRA Code
Datatype
float
Alias
- NCI Thesaurus ObjectClass
- C41331
- UMLS CUI-1
- C0449695
- NCI Thesaurus ObjectClass-2
- C71886
- UMLS CUI-2
- C1552878
- NCI Thesaurus Property
- C25162
- NCI Thesaurus Property-2
- C43820
- NCI Thesaurus ValueDomain
- C25162
- NCI Thesaurus ValueDomain-2
- C41331
- NCI Thesaurus ValueDomain-3
- C45255
- NCI Thesaurus ValueDomain-4
- C43820
- NCI Thesaurus ValueDomain-5
- C25714
Beschrijving
Primary Site MedDRA Code
Datatype
float
Alias
- NCI Thesaurus ObjectClass
- C41331
- UMLS CUI-1
- C0449695
- NCI Thesaurus ObjectClass-2
- C71886
- UMLS CUI-2
- C1552878
- NCI Thesaurus Property
- C25162
- NCI Thesaurus Property-2
- C43820
- NCI Thesaurus ValueDomain
- C25162
- NCI Thesaurus ValueDomain-2
- C41331
- NCI Thesaurus ValueDomain-3
- C45255
- NCI Thesaurus ValueDomain-4
- C43820
- NCI Thesaurus ValueDomain-5
- C25714
Beschrijving
AdverseEventCommonTerminologyforAdverseEventsVersion4TermName
Datatype
text
Alias
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus Property
- C49704
- UMLS 2011AA Property
- C1516728
- NCI Thesaurus Property-2
- C45559
- UMLS 2011AA Property-2
- C1705313
- NCI Thesaurus ValueDomain
- C45255
- UMLS 2011AA ValueDomain
- C1708523
- NCI Thesaurus ValueDomain-2
- C49704
- UMLS 2011AA ValueDomain-2
- C1516728
- NCI Thesaurus ValueDomain-3
- C42614
- UMLS 2011AA ValueDomain-3
- C0027365
- NCI Thesaurus ValueDomain-4
- C45559
- UMLS 2011AA ValueDomain-4
- C1705313
- NCI Thesaurus ValueDomain-5
- C25714
- UMLS 2011AA ValueDomain-5
- C0333052
Beschrijving
AdverseEventCommonTerminologyforAdverseEventsVersion4TermName
Datatype
text
Alias
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus Property
- C49704
- UMLS 2011AA Property
- C1516728
- NCI Thesaurus Property-2
- C45559
- UMLS 2011AA Property-2
- C1705313
- NCI Thesaurus ValueDomain
- C45255
- UMLS 2011AA ValueDomain
- C1708523
- NCI Thesaurus ValueDomain-2
- C49704
- UMLS 2011AA ValueDomain-2
- C1516728
- NCI Thesaurus ValueDomain-3
- C42614
- UMLS 2011AA ValueDomain-3
- C0027365
- NCI Thesaurus ValueDomain-4
- C45559
- UMLS 2011AA ValueDomain-4
- C1705313
- NCI Thesaurus ValueDomain-5
- C25714
- UMLS 2011AA ValueDomain-5
- C0333052
Beschrijving
AdverseEventSeverityGrade
Datatype
text
Alias
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus Property
- C48309
- UMLS 2011AA Property
- C0441800
- NCI Thesaurus Property-2
- C49705
- UMLS 2011AA Property-2
- C1710065
- NCI Thesaurus Property-3
- C25676
- UMLS 2011AA Property-3
- C0439793
- NCI Thesaurus ValueDomain
- C41331
- UMLS 2011AA ValueDomain
- C0877248
- NCI Thesaurus ValueDomain-2
- C48309
- UMLS 2011AA ValueDomain-2
- C0441800
- NCI Thesaurus ValueDomain-3
- C25676
- UMLS 2011AA ValueDomain-3
- C0439793
Beschrijving
AdverseEventSeverityGrade
Datatype
text
Alias
- NCI Thesaurus ObjectClass
- C41331
- UMLS 2011AA ObjectClass
- C0877248
- NCI Thesaurus Property
- C48309
- UMLS 2011AA Property
- C0441800
- NCI Thesaurus Property-2
- C49705
- UMLS 2011AA Property-2
- C1710065
- NCI Thesaurus Property-3
- C25676
- UMLS 2011AA Property-3
- C0439793
- NCI Thesaurus ValueDomain
- C41331
- UMLS 2011AA ValueDomain
- C0877248
- NCI Thesaurus ValueDomain-2
- C48309
- UMLS 2011AA ValueDomain-2
- C0441800
- NCI Thesaurus ValueDomain-3
- C25676
- UMLS 2011AA ValueDomain-3
- C0439793
Beschrijving
Person Completing Form
Datatype
text
Alias
- NCI Thesaurus ValueDomain
- C25191
- UMLS CUI-1
- C1550483
- NCI Thesaurus ObjectClass
- C25657
- NCI Thesaurus Property
- C25364
Beschrijving
Date Form Completed
Datatype
date
Alias
- NCI Thesaurus ValueDomain
- C25164
- UMLS CUI-1
- C1115437
- NCI Thesaurus ObjectClass
- C40988
- NCI Thesaurus Property
- C25250
- NCI Thesaurus ValueDomain-2
- C25367
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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
C3262252 (UMLS CUI-1)
C19464 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus ObjectClass-2)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus Property-2)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus Property-2)
C2697888 (UMLS CUI-1)
C25375 (NCI Thesaurus Property)
C25431 (NCI Thesaurus ValueDomain-2)
C49704 (NCI Thesaurus ObjectClass)
C2697886 (UMLS CUI-1)
C25375 (NCI Thesaurus Property)
C49704 (NCI Thesaurus ObjectClass)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
C1301894 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25261 (NCI Thesaurus Property)
C25198 (NCI Thesaurus Property-2)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)
C2347449 (UMLS CUI-1)
C25608 (NCI Thesaurus ObjectClass)
C17005 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
C1512699 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25375 (NCI Thesaurus Property)
C0684224 (UMLS 2011AA Property)
C17648 (NCI Thesaurus ObjectClass-2)
C0439064 (UMLS 2011AA ObjectClass-2)
C1706735 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C25358 (NCI Thesaurus Property)
C0445356 (UMLS 2011AA)
C1706735 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C25358 (NCI Thesaurus Property)
C0445356 (UMLS 2011AA)
C1516728 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C2699044 (UMLS CUI-2)
C25161 (NCI Thesaurus Property)
C0449695 (UMLS CUI-1)
C71886 (NCI Thesaurus ObjectClass-2)
C1552878 (UMLS CUI-2)
C25162 (NCI Thesaurus Property)
C43820 (NCI Thesaurus Property-2)
C25162 (NCI Thesaurus ValueDomain)
C41331 (NCI Thesaurus ValueDomain-2)
C45255 (NCI Thesaurus ValueDomain-3)
C43820 (NCI Thesaurus ValueDomain-4)
C25714 (NCI Thesaurus ValueDomain-5)
C0449695 (UMLS CUI-1)
C71886 (NCI Thesaurus ObjectClass-2)
C1552878 (UMLS CUI-2)
C25162 (NCI Thesaurus Property)
C43820 (NCI Thesaurus Property-2)
C25162 (NCI Thesaurus ValueDomain)
C41331 (NCI Thesaurus ValueDomain-2)
C45255 (NCI Thesaurus ValueDomain-3)
C43820 (NCI Thesaurus ValueDomain-4)
C25714 (NCI Thesaurus ValueDomain-5)
C0877248 (UMLS 2011AA ObjectClass)
C49704 (NCI Thesaurus Property)
C1516728 (UMLS 2011AA Property)
C45559 (NCI Thesaurus Property-2)
C1705313 (UMLS 2011AA Property-2)
C45255 (NCI Thesaurus ValueDomain)
C1708523 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ValueDomain-2)
C1516728 (UMLS 2011AA ValueDomain-2)
C42614 (NCI Thesaurus ValueDomain-3)
C0027365 (UMLS 2011AA ValueDomain-3)
C45559 (NCI Thesaurus ValueDomain-4)
C1705313 (UMLS 2011AA ValueDomain-4)
C25714 (NCI Thesaurus ValueDomain-5)
C0333052 (UMLS 2011AA ValueDomain-5)
C0877248 (UMLS 2011AA ObjectClass)
C49704 (NCI Thesaurus Property)
C1516728 (UMLS 2011AA Property)
C45559 (NCI Thesaurus Property-2)
C1705313 (UMLS 2011AA Property-2)
C45255 (NCI Thesaurus ValueDomain)
C1708523 (UMLS 2011AA ValueDomain)
C49704 (NCI Thesaurus ValueDomain-2)
C1516728 (UMLS 2011AA ValueDomain-2)
C42614 (NCI Thesaurus ValueDomain-3)
C0027365 (UMLS 2011AA ValueDomain-3)
C45559 (NCI Thesaurus ValueDomain-4)
C1705313 (UMLS 2011AA ValueDomain-4)
C25714 (NCI Thesaurus ValueDomain-5)
C0333052 (UMLS 2011AA ValueDomain-5)
C0877248 (UMLS 2011AA ObjectClass)
C48309 (NCI Thesaurus Property)
C0441800 (UMLS 2011AA Property)
C49705 (NCI Thesaurus Property-2)
C1710065 (UMLS 2011AA Property-2)
C25676 (NCI Thesaurus Property-3)
C0439793 (UMLS 2011AA Property-3)
C41331 (NCI Thesaurus ValueDomain)
C0877248 (UMLS 2011AA ValueDomain)
C48309 (NCI Thesaurus ValueDomain-2)
C0441800 (UMLS 2011AA ValueDomain-2)
C25676 (NCI Thesaurus ValueDomain-3)
C0439793 (UMLS 2011AA ValueDomain-3)
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-2)
C1710065 (UMLS 2011AA Property-2)
C25676 (NCI Thesaurus Property-3)
C0439793 (UMLS 2011AA Property-3)
C41331 (NCI Thesaurus ValueDomain)
C0877248 (UMLS 2011AA ValueDomain)
C48309 (NCI Thesaurus ValueDomain-2)
C0441800 (UMLS 2011AA ValueDomain-2)
C25676 (NCI Thesaurus ValueDomain-3)
C0439793 (UMLS 2011AA ValueDomain-3)
C2919019 (UMLS 2011AA)
C1517874 (UMLS 2011AA)
C1705232 (UMLS 2011AA)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
C1115437 (UMLS CUI-1)
C40988 (NCI Thesaurus ObjectClass)
C25250 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)