ID

9339

Description

IBCSG Long Term Follow-Up Adverse Event Form (18-LTF-AE) Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=889C3F60-2C61-8540-E040-BB89AD4303DD

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=889C3F60-2C61-8540-E040-BB89AD4303DD

Keywords

Versions (2)
  1. 8/26/12 8/26/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
Uploaded on

January 9, 2015

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.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Breast Cancer Follow-Up - IBCSG Long Term Follow-Up Adverse Event Form (18-LTF-AE) - 3108519v1.0

English

Instructions: This form is to be completed if the patient had a targeted long term follow-up adverse event during this followup period. Use minus one (-1) to indicate that an answer is unknown, unobtainable or not done

1 forms  
Header Module
Description

Header Module

Visit number
Description

Visit number

Data type

float

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1549755
NCI Thesaurus ObjectClass
C16696
NCI Thesaurus Property
C25385
IBCSG Patient ID
Description

PatientInternationalBreastCancerStudyGroupIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property-2
C25530
UMLS 2011AA Property-2
C1512890
IBCSG Study No.
Description

ProtocolInternationalBreastCancerStudyGroupIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property-2
C25530
UMLS 2011AA Property-2
C1512890
Randomization No.
Description

RandomizationNumber

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ValueDomain
C25364
UMLS 2011AA ValueDomain
C0600091
NCI Thesaurus Property
C25196
UMLS 2011AA Property
C0034656
Institution Code Number
Description

Institution Number

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass
C21541
UMLS CUI-2
C0805701
NCI Thesaurus Property
C25364
Institution Name
Description

Institution Name

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass
C21541
NCI Thesaurus ValueDomain-2
C21541
NCI Thesaurus Property
C25364
Protocol Specific Adverse Event Evaluation
Description

Protocol Specific Adverse Event Evaluation

CTC Adverse Event Term
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-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
CTCAE Begin Date (MM DD YYYY)
Description

Adverse Event Start Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2697888
NCI Thesaurus Property
C25375
NCI Thesaurus ValueDomain-2
C25431
NCI Thesaurus ObjectClass
C49704
CTC AE Grade
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-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
Date of Assessment (day month year)
Description

Assessment Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2985720
NCI Thesaurus ObjectClass
C25367
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus Property
C38000
Method of Evaluation
Description

Evaluation method

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C2911685
NCI Thesaurus ObjectClass
C20989
NCI Thesaurus Property
C16847
Other Specify
Description

Evaluation method, specify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C2911685
NCI Thesaurus ObjectClass
C20989
UMLS CUI-2
C1521902
NCI Thesaurus Property
C16847
Bone Events
Description

Bone Events

Did the patient have any bone fractures during this follow-up period (If yes, specify below)
Description

BoneFractureInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C12366
UMLS 2011AA ObjectClass
C0262950
NCI Thesaurus Property
C3046
UMLS 2011AA Property
C0016658
Date of Fracture (month year)
Description

BoneFractureDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C12366
UMLS 2011AA ObjectClass
C0262950
NCI Thesaurus Property
C3046
UMLS 2011AA Property
C0016658
Treatment required
Description

AdverseEventTherapeuticProcedureAdministeredType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus ObjectClass-2
C49236
UMLS 2011AA ObjectClass-2
C0087111
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Site
Description

BoneFractureSite

Data type

text

Alias
NCI Thesaurus ValueDomain
C13717
UMLS 2011AA ValueDomain
C1515974
NCI Thesaurus ObjectClass
C12366
UMLS 2011AA ObjectClass
C0262950
NCI Thesaurus Property
C3046
UMLS 2011AA Property
C0016658
Other, specify
Description

BoneFractureSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C12366
UMLS 2011AA ObjectClass
C0262950
NCI Thesaurus Property
C3046
UMLS 2011AA Property
C0016658
Primary Cause
Description

PatientClinicalSkeletalSystemFractureType

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25398
UMLS 2011AA Property
C0205210
NCI Thesaurus Property-2
C3046
UMLS 2011AA Property-2
C0016658
NCI Thesaurus Property-3
C12788
UMLS 2011AA Property-3
C0037253
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Other, specify
Description

PatientClinicalSkeletalSystemFractureSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25398
UMLS 2011AA Property
C0205210
NCI Thesaurus Property-2
C3046
UMLS 2011AA Property-2
C0016658
NCI Thesaurus Property-3
C12788
UMLS 2011AA Property-3
C0037253
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Other, specify
Description

PatientClinicalSkeletalSystemFractureSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25398
UMLS 2011AA Property
C0205210
NCI Thesaurus Property-2
C3046
UMLS 2011AA Property-2
C0016658
NCI Thesaurus Property-3
C12788
UMLS 2011AA Property-3
C0037253
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Secondary Cause
Description

PatientSkeletalSystemEventType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25499
UMLS 2011AA Property
C0441471
NCI Thesaurus Property-2
C12788
UMLS 2011AA Property-2
C0037253
Protocol Specific Adverse Event Evaluation
Description

Protocol Specific Adverse Event Evaluation

CTC Adverse Event Term
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-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
Other, specify
Description

CTC Adverse Event Term

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C1516728
NCI Thesaurus ObjectClass
C49704
UMLS CUI-2
C2826934
NCI Thesaurus Property
C45559
CTCAE Begin Date (MM DD YYYY)
Description

Adverse Event Start Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2697888
NCI Thesaurus Property
C25375
NCI Thesaurus ValueDomain-2
C25431
NCI Thesaurus ObjectClass
C49704
CTC AE Grade
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-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
Angina requiring percutaneous transluminal coronary angioplasty (PTCA)
Description

HeartPatientAnginaPercutaneousTransluminalCoronaryAngioplastyPersonalMedicalHistoryInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass-2
C12727
UMLS 2011AA ObjectClass-2
C0018787
NCI Thesaurus Property
C51221
UMLS 2011AA Property
C0002962
NCI Thesaurus Property-2
C38078
UMLS 2011AA Property-2
C2936173
NCI Thesaurus Property-3
C18772
UMLS 2011AA Property-3
C0262926
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Angina requiring coronary bypass graft (CABG)
Description

HeartPatientArteryBypassPersonalMedicalHistoryInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass-2
C12727
UMLS 2011AA ObjectClass-2
C0018787
NCI Thesaurus Property
C12372
UMLS 2011AA Property
C0003842
NCI Thesaurus Property-2
C18772
UMLS 2011AA Property-2
C0262926
NCI Thesaurus Property-3
C15723
UMLS 2011AA Property-3
C0741847
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Footer Module
Description

Footer Module

Investigator/Designee Signature
Description

InvestigatorDesignatedSignatureText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus Property
C25678
UMLS 2011AA Property
C1519316
NCI Thesaurus ObjectClass
C17089
UMLS 2011AA ObjectClass
C0035173
NCI Thesaurus Property-2
C25479
UMLS 2011AA Property-2
C1524084
Date (day month year)
Description

Investigator Signature Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2346576
NCI Thesaurus Property
C25678
UMLS CUI-2
C0011008
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C17089
Back to the top of the page

Similar models

Instructions: This form is to be completed if the patient had a targeted long term follow-up adverse event during this followup period. Use minus one (-1) to indicate that an answer is unknown, unobtainable or not done

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header Module
Visit number
Item
Visit number
float
C25337 (NCI Thesaurus ValueDomain)
C1549755 (UMLS CUI-1)
C16696 (NCI Thesaurus ObjectClass)
C25385 (NCI Thesaurus Property)
PatientInternationalBreastCancerStudyGroupIdentifierNumber
Item
IBCSG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25530 (NCI Thesaurus Property-2)
C1512890 (UMLS 2011AA Property-2)
ProtocolInternationalBreastCancerStudyGroupIdentifierNumber
Item
IBCSG Study No.
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25530 (NCI Thesaurus Property-2)
C1512890 (UMLS 2011AA Property-2)
RandomizationNumber
Item
Randomization No.
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus ValueDomain)
C0600091 (UMLS 2011AA ValueDomain)
C25196 (NCI Thesaurus Property)
C0034656 (UMLS 2011AA Property)
Institution Number
Item
Institution Code Number
text
C25337 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C0805701 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
Institution Name
Item
Institution Name
text
C25191 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C21541 (NCI Thesaurus ValueDomain-2)
C25364 (NCI Thesaurus Property)
Item Group
Protocol Specific Adverse Event Evaluation
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)
CL.9
Code List
CTC Adverse Event Term
CL Item
Myocardial Infarction (Myocardial infarction)
C27996 (NCI Thesaurus)
C0027051 (UMLS 2011AA)
CL Item
Cerebrovascular Accident (Stroke)
CL Item
Transient Ischemic Attack (Transient ischemic attacks)
C50781 (NCI Thesaurus)
C0007787 (UMLS 2011AA)
CL Item
Angina (Chest pain - cardiac)
CL Item
Thromboembolism (Thromboembolic event)
CL Item
Heart Disorder Other Specify (Cardiac disorders - Other, specify)
Adverse Event Start Date
Item
CTCAE Begin Date (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C2697888 (UMLS CUI-1)
C25375 (NCI Thesaurus Property)
C25431 (NCI Thesaurus ValueDomain-2)
C49704 (NCI Thesaurus ObjectClass)
Item
CTC AE Grade
text
C41331 (NCI Thesaurus ObjectClass)
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)
CL.10
Code List
CTC AE Grade
CL Item
Mild Adverse Event (1)
C84263 (NCI Thesaurus)
C1513302 (UMLS 2011AA)
CL Item
Moderate Adverse Event (2)
C84264 (NCI Thesaurus)
C1513374 (UMLS 2011AA)
CL Item
Severe Adverse Event (3)
C84265 (NCI Thesaurus)
C2919019 (UMLS 2011AA)
CL Item
Life Threatening Adverse Event (4)
C84266 (NCI Thesaurus)
C1517874 (UMLS 2011AA)
CL Item
Death Related To Adverse Event (5)
C48275 (NCI Thesaurus)
C1705232 (UMLS 2011AA)
Assessment Date
Item
Date of Assessment (day month year)
date
C25164 (NCI Thesaurus ValueDomain)
C2985720 (UMLS CUI-1)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C38000 (NCI Thesaurus Property)
Item
Method of Evaluation
text
C25284 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C16847 (NCI Thesaurus Property)
CL.3
Code List
Method of Evaluation
CL Item
Scan, Dual-energy X-ray Absorpitometry (DEXA scan)
CL Item
X-ray (X-ray)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
Evaluation method, specify
Item
Other Specify
text
C25685 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C1521902 (UMLS CUI-2)
C16847 (NCI Thesaurus Property)
Item Group
Bone Events
BoneFractureInd-3
Item
Did the patient have any bone fractures during this follow-up period (If yes, specify below)
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12366 (NCI Thesaurus ObjectClass)
C0262950 (UMLS 2011AA ObjectClass)
C3046 (NCI Thesaurus Property)
C0016658 (UMLS 2011AA Property)
BoneFractureDate
Item
Date of Fracture (month year)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C12366 (NCI Thesaurus ObjectClass)
C0262950 (UMLS 2011AA ObjectClass)
C3046 (NCI Thesaurus Property)
C0016658 (UMLS 2011AA Property)
Item
Treatment required
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C49236 (NCI Thesaurus ObjectClass-2)
C0087111 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
CL.5
Code List
Treatment required
CL Item
Present, Not Requiring Surgery (Present, not requiring surgery)
CL Item
Requiring Surgery (Requiring surgery)
Item
Site
text
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
C12366 (NCI Thesaurus ObjectClass)
C0262950 (UMLS 2011AA ObjectClass)
C3046 (NCI Thesaurus Property)
C0016658 (UMLS 2011AA Property)
CL.6
Code List
Site
CL Item
Pelvis (Pelvis)
CL Item
Wrist (Wrist)
C33894 (NCI Thesaurus)
C1322271 (UMLS 2011AA)
CL Item
Ankle (Ankle)
c32078 (NCI Thesaurus)
CL Item
Femur (Femur)
C12717 (NCI Thesaurus)
C0015811 (UMLS 2011AA)
CL Item
Tibia (Tibia)
C12800 (NCI Thesaurus)
C0040184 (UMLS 2011AA)
CL Item
Cervical Spine (Cervical spine)
C69313 (NCI Thesaurus)
C0728985 (UMLS 2011AA)
CL Item
Thoracic Spine (Thoracic spine)
C69315 (NCI Thesaurus)
C0581269 (UMLS 2011AA)
CL Item
Lumbar Spine (Lumbar spine)
C69314 (NCI Thesaurus)
C0024091 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Rib (Rib)
C12782 (NCI Thesaurus)
C0035561 (UMLS 2011AA)
CL Item
Humerus (Humerus)
C12731 (NCI Thesaurus)
C0020164 (UMLS 2011AA)
CL Item
Radius (Radius)
CL Item
Ulna (Ulna)
C12809 (NCI Thesaurus)
C0041600 (UMLS 2011AA)
CL Item
Clavicle (Clavicle)
C12695 (NCI Thesaurus)
C0008913 (UMLS 2011AA)
BoneFractureSpecify
Item
Other, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C12366 (NCI Thesaurus ObjectClass)
C0262950 (UMLS 2011AA ObjectClass)
C3046 (NCI Thesaurus Property)
C0016658 (UMLS 2011AA Property)
Item
Primary Cause
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25398 (NCI Thesaurus Property)
C0205210 (UMLS 2011AA Property)
C3046 (NCI Thesaurus Property-2)
C0016658 (UMLS 2011AA Property-2)
C12788 (NCI Thesaurus Property-3)
C0037253 (UMLS 2011AA Property-3)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.7
Code List
Primary Cause
CL Item
Metastases (Metastases)
CL Item
Osteoporosis (Osteoporosis)
C3298 (NCI Thesaurus)
C0029456 (UMLS 2011AA)
CL Item
Trauma (Trauma)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
PatientClinicalSkeletalSystemFractureSpecify
Item
Other, specify
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25398 (NCI Thesaurus Property)
C0205210 (UMLS 2011AA Property)
C3046 (NCI Thesaurus Property-2)
C0016658 (UMLS 2011AA Property-2)
C12788 (NCI Thesaurus Property-3)
C0037253 (UMLS 2011AA Property-3)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
PatientClinicalSkeletalSystemFractureSpecify
Item
Other, specify
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25398 (NCI Thesaurus Property)
C0205210 (UMLS 2011AA Property)
C3046 (NCI Thesaurus Property-2)
C0016658 (UMLS 2011AA Property-2)
C12788 (NCI Thesaurus Property-3)
C0037253 (UMLS 2011AA Property-3)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Item
Secondary Cause
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25499 (NCI Thesaurus Property)
C0441471 (UMLS 2011AA Property)
C12788 (NCI Thesaurus Property-2)
C0037253 (UMLS 2011AA Property-2)
CL.8
Code List
Secondary Cause
CL Item
Metastases (Metastases)
CL Item
Osteoporosis (Osteoporosis)
C3298 (NCI Thesaurus)
C0029456 (UMLS 2011AA)
CL Item
Trauma (Trauma)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
Item Group
Protocol Specific Adverse Event Evaluation
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)
CL.9
Code List
CTC Adverse Event Term
CL Item
Myocardial Infarction (Myocardial infarction)
C27996 (NCI Thesaurus)
C0027051 (UMLS 2011AA)
CL Item
Cerebrovascular Accident (Stroke)
CL Item
Transient Ischemic Attack (Transient ischemic attacks)
C50781 (NCI Thesaurus)
C0007787 (UMLS 2011AA)
CL Item
Angina (Chest pain - cardiac)
CL Item
Thromboembolism (Thromboembolic event)
CL Item
Heart Disorder Other Specify (Cardiac disorders - Other, specify)
CTC Adverse Event Term
Item
Other, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1516728 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C2826934 (UMLS CUI-2)
C45559 (NCI Thesaurus Property)
Adverse Event Start Date
Item
CTCAE Begin Date (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C2697888 (UMLS CUI-1)
C25375 (NCI Thesaurus Property)
C25431 (NCI Thesaurus ValueDomain-2)
C49704 (NCI Thesaurus ObjectClass)
Item
CTC AE Grade
text
C41331 (NCI Thesaurus ObjectClass)
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)
CL.10
Code List
CTC AE Grade
CL Item
Mild Adverse Event (1)
C84263 (NCI Thesaurus)
C1513302 (UMLS 2011AA)
CL Item
Moderate Adverse Event (2)
C84264 (NCI Thesaurus)
C1513374 (UMLS 2011AA)
CL Item
Severe Adverse Event (3)
C84265 (NCI Thesaurus)
C2919019 (UMLS 2011AA)
CL Item
Life Threatening Adverse Event (4)
C84266 (NCI Thesaurus)
C1517874 (UMLS 2011AA)
CL Item
Death Related To Adverse Event (5)
C48275 (NCI Thesaurus)
C1705232 (UMLS 2011AA)
HeartPatientAnginaPercutaneousTransluminalCoronaryAngioplastyPersonalMedicalHistoryInd-3
Item
Angina requiring percutaneous transluminal coronary angioplasty (PTCA)
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C12727 (NCI Thesaurus ObjectClass-2)
C0018787 (UMLS 2011AA ObjectClass-2)
C51221 (NCI Thesaurus Property)
C0002962 (UMLS 2011AA Property)
C38078 (NCI Thesaurus Property-2)
C2936173 (UMLS 2011AA Property-2)
C18772 (NCI Thesaurus Property-3)
C0262926 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
HeartPatientArteryBypassPersonalMedicalHistoryInd-3
Item
Angina requiring coronary bypass graft (CABG)
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C12727 (NCI Thesaurus ObjectClass-2)
C0018787 (UMLS 2011AA ObjectClass-2)
C12372 (NCI Thesaurus Property)
C0003842 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property-2)
C0262926 (UMLS 2011AA Property-2)
C15723 (NCI Thesaurus Property-3)
C0741847 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
Item Group
Footer Module
InvestigatorDesignatedSignatureText
Item
Investigator/Designee Signature
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
C25479 (NCI Thesaurus Property-2)
C1524084 (UMLS 2011AA Property-2)
Investigator Signature Date
Item
Date (day month year)
date
C25164 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C25367 (NCI Thesaurus ValueDomain-2)
C17089 (NCI Thesaurus ObjectClass)
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial