ID
9490
Description
CALGB Adverse Event (AE) Form (CTCAE v4) - Phase I, II, Specify Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=77004C80-3268-DC10-E040-BB89AD430A30
Lien
Mots-clés
Versions (3)
- 20/09/2012 20/09/2012 -
- 09/01/2015 09/01/2015 - Martin Dugas
- 09/01/2015 09/01/2015 - Martin Dugas
Téléchargé le
9 janvier 2015
DOI
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Creative Commons BY-NC 3.0 Legacy
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Toxicity - CALGB Adverse Event (AE) Form (CTCAE v4) - Phase I, II, Specify - 2956397v1.0
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
Patient Initials
Type de données
text
Alias
- NCI Thesaurus ValueDomain
- C25191
- UMLS CUI-1
- C2986440
- NCI Thesaurus ObjectClass
- C16960
- NCI Thesaurus Property
- C25536
Description
Medical Record Number
Type de données
text
Alias
- NCI Thesaurus ValueDomain
- C25337
- UMLS CUI-1
- C1301894
- NCI Thesaurus ObjectClass
- C16960
- NCI Thesaurus Property
- C25261
- NCI Thesaurus Property-2
- C25198
Description
Institution Name
Type de données
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
Description
Participating Group
Type de données
text
Alias
- NCI Thesaurus ValueDomain
- C25191
- UMLS CUI-1
- C2347449
- NCI Thesaurus ObjectClass
- C25608
- NCI Thesaurus ObjectClass-2
- C17005
- NCI Thesaurus Property
- C25364
Description
Study Number Participating Group
Type de données
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
Description
Trial subject ID Participating Group
Type de données
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
Description
Unnamed3
Description
AdverseEventReportInd-3
Type de données
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
Description
Expected Adverse Events
Description
CTC Adverse Event Attribution Category
Type de données
text
Alias
- NCI Thesaurus ValueDomain
- C25664
- UMLS CUI-1
- C1706735
- NCI Thesaurus ObjectClass
- C49704
- NCI Thesaurus Property
- C25358
Description
CTC Adverse Event Attribution Category
Type de données
text
Alias
- NCI Thesaurus ValueDomain
- C25664
- UMLS CUI-1
- C1706735
- NCI Thesaurus ObjectClass
- C49704
- NCI Thesaurus Property
- C25358
Description
CTC Adverse Event Reported Term
Type de données
text
Alias
- NCI Thesaurus ValueDomain
- C25685
- UMLS CUI-1
- C1516728
- NCI Thesaurus ObjectClass
- C49704
- UMLS CUI-2
- C2699044
- NCI Thesaurus Property
- C25161
Description
Primary Site MedDRA Code
Type de données
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
Description
Primary Site MedDRA Code
Type de données
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
Description
AdverseEventCommonTerminologyforAdverseEventsVersion4TermName
Type de données
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
Description
AdverseEventCommonTerminologyforAdverseEventsVersion4TermName
Type de données
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
Description
AdverseEventSeverityGrade
Type de données
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
Description
AdverseEventSeverityGrade
Type de données
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
Description
Person Completing Form
Type de données
text
Alias
- NCI Thesaurus ValueDomain
- C25191
- UMLS CUI-1
- C1550483
- NCI Thesaurus ObjectClass
- C25657
- NCI Thesaurus Property
- C25364
Description
Date Form Completed
Type de données
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)