ID

8164

Beschreibung

NCIC MA.32 Death Report Form A Phase III Randomized Trial of Metformin vs Placebo in Early Stage Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=805B03D5-89D0-F93C-E040-BB89AD433826

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=805B03D5-89D0-F93C-E040-BB89AD433826

Stichworte

Versionen (2)
  1. 27.08.12 27.08.12 -
  2. 09.01.15 09.01.15 - Martin Dugas
Hochgeladen am

9. Januar 2015

DOI

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Breast Cancer NCT01101438 Off Treatment - NCIC MA.32 Death Report Form - 3017307v1.0

Englisch

The aim of the "Death Report" Folder is to collect death information. The "Death Report" Folder should be completed at the time of death. It should be submitted electronically within 8 weeks of the patient's death.

1 Formulare  
Date/cause Of Death/autopsy
Beschreibung

Date/cause Of Death/autopsy

Date of Death (dd mmm yyyy)
Beschreibung

DeathDocumentedDate

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C28554
UMLS 2011AA ObjectClass
C0011065
NCI Thesaurus Property
C25356
UMLS 2011AA Property
C1301725
Other primary malignancy
Beschreibung

OtherPrimaryMalignantNeoplasmPresentStatus

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C17649
UMLS 2011AA ObjectClass
C0205394
NCI Thesaurus ObjectClass-2
C25251
UMLS 2011AA ObjectClass-2
C0205225
NCI Thesaurus ObjectClass-3
C9305
UMLS 2011AA ObjectClass-3
C0006826
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
Primary cause of death
Beschreibung

BreastCancerPatientDeathReason

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C28554
UMLS 2011AA Property
C0011065
NCI Metathesaurus ObjectClass
C0006142
Due to other cause specify
Beschreibung

Primary Cause of Death, specify

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS CUI-1
C0007465
NCI Thesaurus ObjectClass-2
C25251
NCI Metathesaurus ObjectClass
C0007465
NCI Thesaurus Property
C17649
NCI Thesaurus Property-2
C25365
NCI Thesaurus ValueDomain
C25685
Comments
Beschreibung

Research Comments

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
Autopsy
Beschreibung

Autopsy

Was autopsy performed
Beschreibung

AutopsyPerformedInd-3

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C25153
UMLS 2011AA ObjectClass
C0004398
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
Cause of death (autopsy finding)
Beschreibung

AutopsyFindingPatientDeathReason

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
NCI Thesaurus ObjectClass
C25153
UMLS 2011AA ObjectClass
C0004398
NCI Thesaurus Property
C3367
UMLS 2011AA Property
C0037088
Specify
Beschreibung

AutopsyFindingSpecify

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C25153
UMLS 2011AA ObjectClass
C0004398
NCI Thesaurus Property
C3367
UMLS 2011AA Property
C0037088
Adverse Events - Death Report
Beschreibung

Adverse Events - Death Report

Has there been a new diagnosis of diabetes since the last report
Beschreibung

DiabetesMellitusNewInd-3

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25586
UMLS 2011AA Property
C0205314
NCI Thesaurus ObjectClass
C2985
UMLS 2011AA ObjectClass
C0011849
NCI Thesaurus Property-2
C15220
UMLS 2011AA Property-2
C0011900
CTC Adverse Event Term
Beschreibung

AdverseEventCommonTerminologyforAdverseEventsVersion4TermName

Datentyp

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
Grade
Beschreibung

CommonToxicityCriteriaAdverseEventReportingGrade

Datentyp

float

Alias
NCI Thesaurus ObjectClass
C49704
UMLS 2011AA ObjectClass
C1516728
NCI Thesaurus Property
C25651
UMLS 2011AA Property
C0700287
NCI Thesaurus ValueDomain
C18000
UMLS 2011AA ValueDomain
C0919553
NCI Thesaurus Property-2
C25365
UMLS 2011AA Property-2
C0678257
Attribution
Beschreibung

CTC Adverse Event Attribution Category

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS CUI-1
C1706735
NCI Thesaurus ObjectClass
C49704
NCI Thesaurus Property
C25358
Seriousness Attributed to Adverse Event
Beschreibung

AdverseEventSeriousnessAttributionScale

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25358
UMLS 2011AA Property
C0596130
Cardiovascular Mobidity
Beschreibung

Cardiovascular Mobidity

Problem, cardiovascular
Beschreibung

CardiacDiseaseAssessmentType

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ObjectClass
C13306
UMLS 2011AA ObjectClass
C1522601
NCI Thesaurus ObjectClass-2
C2991
UMLS 2011AA ObjectClass-2
C0012634
Specify
Beschreibung

CardiacDiseaseAssessmentSpecify

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ObjectClass
C13306
UMLS 2011AA ObjectClass
C1522601
NCI Thesaurus ObjectClass-2
C2991
UMLS 2011AA ObjectClass-2
C0012634
Date of hospital admission
Beschreibung

HospitalAdmissionDate

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C16696
UMLS 2011AA ObjectClass
C0019994
NCI Thesaurus Property
C25385
UMLS 2011AA Property
C0809949
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Ähnliche Modelle

The aim of the "Death Report" Folder is to collect death information. The "Death Report" Folder should be completed at the time of death. It should be submitted electronically within 8 weeks of the patient's death.

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Date/cause Of Death/autopsy
DeathDocumentedDate
Item
Date of Death (dd mmm yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C28554 (NCI Thesaurus ObjectClass)
C0011065 (UMLS 2011AA ObjectClass)
C25356 (NCI Thesaurus Property)
C1301725 (UMLS 2011AA Property)
Item
Other primary malignancy
text
C17649 (NCI Thesaurus ObjectClass)
C0205394 (UMLS 2011AA ObjectClass)
C25251 (NCI Thesaurus ObjectClass-2)
C0205225 (UMLS 2011AA ObjectClass-2)
C9305 (NCI Thesaurus ObjectClass-3)
C0006826 (UMLS 2011AA ObjectClass-3)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
CL.1
Code List
Other primary malignancy
CL Item
Present (Present)
C25626 (NCI Thesaurus)
C0150312 (UMLS 2011AA)
CL Item
Absent (Absent)
C48190 (NCI Thesaurus)
C0332197 (UMLS 2011AA)
Item
Primary cause of death
text
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C28554 (NCI Thesaurus Property)
C0011065 (UMLS 2011AA Property)
C0006142 (NCI Metathesaurus ObjectClass)
CL.2
Code List
Primary cause of death
CL Item
Breast Cancer Only (Breast Cancer only)
CL Item
Adverse Event Possibly, Probably Or Definitely Related To Protocol Treatment (Adverse event possibly, probably or definitely related to protocol treatment)
CL Item
Complication From A Non-protocol Treatment For This Malignancy (malignant Disease May Or May Not Be Contributory) (Complication from a non-protocol treatment for this malignancy (malignant disease may or may not be contributory))
CL Item
Other Primary Malignancy (Other primary malignancy)
CL Item
Primary Cardiovascular Disease (Primary Cardiovascular Disease)
CL Item
Other Condition Or Circumstance (Other condition or circumstance)
Primary Cause of Death, specify
Item
Due to other cause specify
text
C16960 (NCI Thesaurus ObjectClass)
C0007465 (UMLS CUI-1)
C25251 (NCI Thesaurus ObjectClass-2)
C0007465 (NCI Metathesaurus ObjectClass)
C17649 (NCI Thesaurus Property)
C25365 (NCI Thesaurus Property-2)
C25685 (NCI Thesaurus ValueDomain)
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
Item Group
Autopsy
Item
Was autopsy performed
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25153 (NCI Thesaurus ObjectClass)
C0004398 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
CL.3
Code List
Was autopsy performed
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Cause of death (autopsy finding)
text
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C25153 (NCI Thesaurus ObjectClass)
C0004398 (UMLS 2011AA ObjectClass)
C3367 (NCI Thesaurus Property)
C0037088 (UMLS 2011AA Property)
CL.4
Code List
Cause of death (autopsy finding)
CL Item
Breast Cancer Only (Breast Cancer only)
CL Item
Adverse Event Possibly, Probably Or Definitely Related To Protocol Treatment (Adverse event possibly, probably or definitely related to protocol treatment)
CL Item
Complication From A Non-protocol Treatment For This Malignancy (malignant Disease May Or May Not Be Contributory) (Complication from a non-protocol treatment for this malignancy (malignant disease may or may not be contributory))
CL Item
Other Primary Malignancy (Other primary malignancy)
CL Item
Primary Cardiovascular Disease (Primary Cardiovascular Disease)
CL Item
Other Condition Or Circumstance (Other condition or circumstance)
AutopsyFindingSpecify
Item
Specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25153 (NCI Thesaurus ObjectClass)
C0004398 (UMLS 2011AA ObjectClass)
C3367 (NCI Thesaurus Property)
C0037088 (UMLS 2011AA Property)
Item Group
Adverse Events - Death Report
Item
Has there been a new diagnosis of diabetes since the last report
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25586 (NCI Thesaurus Property)
C0205314 (UMLS 2011AA Property)
C2985 (NCI Thesaurus ObjectClass)
C0011849 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property-2)
C0011900 (UMLS 2011AA Property-2)
CL.5
Code List
Has there been a new diagnosis of diabetes since the last report
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
AdverseEventCommonTerminologyforAdverseEventsVersion4TermName
Item
CTC Adverse Event Term
text
C41331 (NCI Thesaurus ObjectClass)
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)
CommonToxicityCriteriaAdverseEventReportingGrade
Item
Grade
float
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C25651 (NCI Thesaurus Property)
C0700287 (UMLS 2011AA Property)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)
C25365 (NCI Thesaurus Property-2)
C0678257 (UMLS 2011AA Property-2)
Item
Attribution
text
C25664 (NCI Thesaurus ValueDomain)
C1706735 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C25358 (NCI Thesaurus Property)
CL.7
Code List
Attribution
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
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)
CL.8
Code List
Seriousness Attributed to Adverse Event
CL Item
Not Serious (Not serious)
CL Item
Death (Death)
C28554 (NCI Thesaurus)
C0011065 (UMLS 2011AA)
CL Item
Life Threatening (Life threatening)
CL Item
Hospitalized (Hospitalization, initial or prolonged)
CL Item
Disability (Disability/incapacity)
C21007 (NCI Thesaurus)
C0231170 (UMLS 2011AA)
CL Item
Congenital Anomaly (Congenital anomaly)
CL Item
Intervention Required (Required intervention to prevent permanent impairment/damage)
Item Group
Cardiovascular Mobidity
Item
Problem, cardiovascular
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C13306 (NCI Thesaurus ObjectClass)
C1522601 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus ObjectClass-2)
C0012634 (UMLS 2011AA ObjectClass-2)
CL.9
Code List
Problem, cardiovascular
CL Item
Myocardial Infarction (Myocardial Infarction)
C27996 (NCI Thesaurus)
C0027051 (UMLS 2011AA)
CL Item
Transient Ischemic Attack Cerebrovascular Accident (Stroke / transient inschemic attack TIA)
C50781 (NCI Thesaurus)
C0007787 (UMLS 2011AA)
C3390 (NCI Thesaurus-3)
C0038454 (UMLS 2011AA-4)
CL Item
New Or Worsening Angina (New or worsening angina)
CL Item
Angina Requiring Transluminal Coronary Angioplasty (Angina requiring transluminal coronary angioplasty)
CL Item
Angina Requiring Coronary Artery Bypass Graft (Angina requiring coronary artery bypass graft)
CL Item
Thromboembolism (Thromboembolic Event)
C28195 (NCI Thesaurus)
C0040038 (UMLS 2011AA)
CL Item
Other (Other)
CardiacDiseaseAssessmentSpecify
Item
Specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C13306 (NCI Thesaurus ObjectClass)
C1522601 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus ObjectClass-2)
C0012634 (UMLS 2011AA ObjectClass-2)
HospitalAdmissionDate
Item
Date of hospital admission
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16696 (NCI Thesaurus ObjectClass)
C0019994 (UMLS 2011AA ObjectClass)
C25385 (NCI Thesaurus Property)
C0809949 (UMLS 2011AA Property)
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