ID

10103

Description

NSABP PROTOCOL R-04: FOLLOW-UP FORM Radiation Therapy and Either Capecitabine or Fluorouracil With or Without Oxaliplatin Before Surgery in Treating Patients With Resectable Rectal Cancer NCT00058474 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B7822451-67BC-24E6-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B7822451-67BC-24E6-E034-0003BA12F5E7

Keywords

Versions (3)
  1. 8/27/12 8/27/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 3/28/15 3/28/15 - Martin Dugas
Uploaded on

March 28, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Colorectal Cancer Follow-Up NCT00058474

English

No Instruction available.

1 forms  
  1. StudyEvent: NSABP PROTOCOL R-04: FOLLOW-UP FORM
    1. No Instruction available.
Header
Description

Header

Alias
UMLS CUI-1
C1320722
First Three Letters of Patients Last Name
Description

FirstThreeLettersofPatient'sLastName

Data type

text

Patient Study ID
Description

Patient ID NSABP

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1513905
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C15818
Institution Name / Affiliate Name
Description

Affiliate Name

Data type

text

Alias
NCI Thesaurus ObjectClass
C21541
UMLS CUI-1
C1510825
NCI Thesaurus ObjectClass-2
C25413
NCI Thesaurus Property
C25364
NCI Thesaurus ValueDomain
C25191
NCI Thesaurus ValueDomain-2
C21541
Person Completing Form, Last Name
Description

Person Completing Form Last Name

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass-2
C25657
UMLS CUI-2
C1301584
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25551
NCI Thesaurus ValueDomain
C25191
Person Completing Form, First Name
Description

Person Completing Form First Name

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass-2
C25657
UMLS CUI-2
C1443235
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25509
NCI Thesaurus ValueDomain
C25191
Person Completing Form, Phone
Description

Person Completing Form Phone

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass
C25190
UMLS CUI-2
C1515258
NCI Thesaurus ObjectClass-2
C25657
NCI Thesaurus Property
C25395
Are Data Amended?
Description

Data amended

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Comments
Description

Research Comments

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
Follow-Up
Description

Follow-Up

Alias
UMLS CUI-1
C1522577
Patient's Vital Status
Description

Patient Status

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS CUI-1
C3846084
NCI Thesaurus ValueDomain
C18003
NCI Thesaurus ValueDomain-2
C25688
NCI Thesaurus Property
C25365
Date of Last Contact or Death
Description

Date last contact

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0805839
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus Property
C25461
Source of Survival Information
Description

PersonSurvivalInformationSource

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus ValueDomain
C25683
UMLS 2011AA ValueDomain
C0449416
NCI Thesaurus Property
C48191
UMLS 2011AA Property
C1533716
NCI Thesaurus Property-2
C17177
UMLS 2011AA Property-2
C0038952
Other, specify
Description

PatientDeathSourceSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C28554
UMLS 2011AA Property
C0011065
Primary cause of death
Description

PatientDeathPrimaryReason

Data type

text

Alias
NCI Thesaurus ValueDomain
C25638
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C28554
NCI Thesaurus ValueDomain-2
C28554
UMLS CUI-1
C0007465
describe cause of death
Description

describe cause of death

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C28554
UMLS CUI-1
C0007465
Was there evidence of recurrence at the time of death?
Description

Wasthereevidenceofrecurrenceatthetimeofdeath?

Data type

text

Alias
NCI Thesaurus Property
C28554
NCI Thesaurus ObjectClass
C38155
NCI Thesaurus Property-2
C15220
UMLS CUI-1
C0011065
UMLS CUI-2
C0277556
Has the patient had a documented clinical assessment for this cancer?
Description

CancerFollow-upStatusInd

Data type

boolean

Date of last clinical assessment
Description

CancerFollow-upStatusDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Has the patient been diagnosed with first local-regional recurrence?
Description

ProgressionInd,FirstLocal-Regional

Data type

boolean

Alias
UMLS CUI-1
C0027643
Site(s) of disease
Description

Site(s)ofdisease

Data type

text

Alias
UMLS CUI-1
C1290853
Other, specify
Description

DiseaseInvolvementSite,Other

Data type

text

Recurrence Date
Description

Recurrence Date

Data type

date

Alias
UMLS CUI-1
C0807712
Has the patient been diagnosed with first distanct recurrence/progression?
Description

ProgressionInd,FirstDistant

Data type

boolean

Date of first distant recurrence
Description

RecurrentDiseaseFirstDistantDiagnosisDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C38155
NCI Thesaurus Property
C25321
NCI Thesaurus Property-2
C25509
NCI Thesaurus Property-3
C15220
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0804769
UMLS CUI-2
C0011008
Site(s) of First Distant Recurrence
Description

RecurrentDiseaseFirstDistantDiagnosisText

Data type

text

Alias
NCI Thesaurus ObjectClass
C38155
NCI Thesaurus Property
C25321
NCI Thesaurus Property-2
C25509
NCI Thesaurus Property-3
C15220
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0807713
Has a new primary or MDS been diagnosed that has not been previously reported?
Description

NewCancerDiagnosisInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
NCI Thesaurus ObjectClass
C25586
NCI Thesaurus ObjectClass-2
C9305
NCI Thesaurus Property
C15220
UMLS CUI-1
C0751623
Date of diagnosis
Description

NewCancerDiagnosisDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ObjectClass
C9305
NCI Thesaurus Property
C15220
UMLS CUI-1
C0205314
UMLS CUI-2
C0006826
UMLS CUI-3
C0011900
UMLS CUI-4
C0011008
Site(s) of new primary
Description

NewCancerSiteText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C25586
UMLS 2011AA ObjectClass
C0205314
NCI Thesaurus Property
C25341
UMLS 2011AA Property
C0450429
NCI Thesaurus ObjectClass-2
C9305
UMLS 2011AA ObjectClass-2
C0006826
Late Adverse Events
Description

Late Adverse Events

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C0205087
Adverse Event
Description

CommonTerminologyCriteriaforAdverseEventsVersion4.0LowLevelTermName

Data type

text

Alias
NCI Thesaurus ObjectClass
C41331
NCI Thesaurus Property
C49704
NCI Thesaurus Property-2
C45559
NCI Thesaurus ValueDomain
C45255
NCI Thesaurus ValueDomain-2
C49704
NCI Thesaurus ValueDomain-3
C42614
NCI Thesaurus ValueDomain-4
C45559
NCI Thesaurus ValueDomain-5
C25714
UMLS CUI-1
C1516728
UMLS CUI-2
C2826934
Grade
Description

Grade

Data type

text

Alias
NCI Thesaurus ObjectClass
C41331
NCI Thesaurus Property
C48309
NCI Thesaurus Property-2
C49705
NCI Thesaurus Property-3
C25676
NCI Thesaurus ValueDomain
C41331
NCI Thesaurus ValueDomain-2
C48309
NCI Thesaurus ValueDomain-3
C25676
UMLS CUI-1
C2985921
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Similar models

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1 forms
  1. StudyEvent: NSABP PROTOCOL R-04: FOLLOW-UP FORM
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
C1320722 (UMLS CUI-1)
FirstThreeLettersofPatient'sLastName
Item
First Three Letters of Patients Last Name
text
Patient ID NSABP
Item
Patient Study ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1513905 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C15818 (NCI Thesaurus Property-2)
Affiliate Name
Item
Institution Name / Affiliate Name
text
C21541 (NCI Thesaurus ObjectClass)
C1510825 (UMLS CUI-1)
C25413 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)
Person Completing Form Last Name
Item
Person Completing Form, Last Name
text
C25190 (NCI Thesaurus ObjectClass)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass-2)
C1301584 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25551 (NCI Thesaurus Property-2)
C25191 (NCI Thesaurus ValueDomain)
Person Completing Form First Name
Item
Person Completing Form, First Name
text
C25190 (NCI Thesaurus ObjectClass)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass-2)
C1443235 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25509 (NCI Thesaurus Property-2)
C25191 (NCI Thesaurus ValueDomain)
Person Completing Form Phone
Item
Person Completing Form, Phone
text
C25337 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25190 (NCI Thesaurus ObjectClass)
C1515258 (UMLS CUI-2)
C25657 (NCI Thesaurus ObjectClass-2)
C25395 (NCI Thesaurus Property)
Data amended
Item
Are Data Amended?
boolean
C38148 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
Item Group
Follow-Up
C1522577 (UMLS CUI-1)
Item
Patient's Vital Status
text
C16960 (NCI Thesaurus ObjectClass)
C3846084 (UMLS CUI-1)
C18003 (NCI Thesaurus ValueDomain)
C25688 (NCI Thesaurus ValueDomain-2)
C25365 (NCI Thesaurus Property)
CL.2
Code List
Patient's Vital Status
CL Item
Alive (Alive)
CL Item
Dead (Dead)
Date last contact
Item
Date of Last Contact or Death
date
C25164 (NCI Thesaurus ValueDomain)
C0805839 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C25461 (NCI Thesaurus Property)
Item
Source of Survival Information
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25683 (NCI Thesaurus ValueDomain)
C0449416 (UMLS 2011AA ValueDomain)
C48191 (NCI Thesaurus Property)
C1533716 (UMLS 2011AA Property)
C17177 (NCI Thesaurus Property-2)
C0038952 (UMLS 2011AA Property-2)
CL.3
Code List
Source of Survival Information
CL Item
Documentation Of Hospital Or Clinic Visit (Documentation of hospital or clinic visit)
CL Item
Phone Contact To Patient (Phone contact to patient)
CL Item
Other (other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
PatientDeathSourceSpecify
Item
Other, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C28554 (NCI Thesaurus Property)
C0011065 (UMLS 2011AA Property)
Item
Primary cause of death
text
C25638 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C28554 (NCI Thesaurus Property)
C28554 (NCI Thesaurus ValueDomain-2)
C0007465 (UMLS CUI-1)
CL.4
Code List
Primary cause of death
CL Item
Due To This Disease (due to this disease)
CL Item
Due To Protocol Treatment (due to protocol treatment)
CL Item
Due To Other Cause, Specify (due to other cause)
CL Item
Unknown (unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Cause of Death, specify
Item
describe cause of death
text
C25685 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C28554 (NCI Thesaurus Property)
C0007465 (UMLS CUI-1)
Item
Was there evidence of recurrence at the time of death?
text
C28554 (NCI Thesaurus Property)
C38155 (NCI Thesaurus ObjectClass)
C15220 (NCI Thesaurus Property-2)
C0011065 (UMLS CUI-1)
C0277556 (UMLS CUI-2)
CL.5
Code List
Was there evidence of recurrence at the time of death?
CL Item
Yes, Clinical (yes, clinical)
CL Item
Yes, Autopsy (yes, autopsy)
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Clinical assessment
Item
Has the patient had a documented clinical assessment for this cancer?
boolean
CancerFollow-upStatusDate
Item
Date of last clinical assessment
date
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
First local-regional recurrence
Item
Has the patient been diagnosed with first local-regional recurrence?
boolean
C0027643 (UMLS CUI-1)
Item
Site(s) of disease
text
C1290853 (UMLS CUI-1)
CL.8
Code List
Site(s) of disease
CL Item
Anastomosis (anastomosis)
C15609 (NCI Thesaurus)
C0677554 (UMLS CUI-1)
CL Item
Perineum (perineum)
C33301 (NCI Thesaurus)
C0031066 (UMLS CUI-1)
CL Item
Pelvis (pelvis)
C12767 (NCI Thesaurus)
C0030797 (UMLS CUI-1)
CL Item
Rectum (rectum)
C12390 (NCI Thesaurus)
C0034896 (UMLS CUI-1)
CL Item
Intra-pelvic Lymph Nodes (intra-pelvic lymph nodes)
C1277114 (UMLS CUI-1)
CL Item
Retroperitoneal Nodes (retroperitoneal nodes)
C1264215 (UMLS CUI-1)
CL Item
Other, Specify (Other, specify)
C3844311 (UMLS CUI-1)
DiseaseInvolvementSite,Other
Item
Other, specify
text
RecurrenceDate
Item
Recurrence Date
date
C0807712 (UMLS CUI-1)
ProgressionInd,FirstDistant
Item
Has the patient been diagnosed with first distanct recurrence/progression?
boolean
Date of first distant recurrence
Item
Date of first distant recurrence
date
C38155 (NCI Thesaurus ObjectClass)
C25321 (NCI Thesaurus Property)
C25509 (NCI Thesaurus Property-2)
C15220 (NCI Thesaurus Property-3)
C25164 (NCI Thesaurus ValueDomain)
C0804769 (UMLS CUI-1)
C0011008 (UMLS CUI-2)
Site First Distant Recurrence
Item
Site(s) of First Distant Recurrence
text
C38155 (NCI Thesaurus ObjectClass)
C25321 (NCI Thesaurus Property)
C25509 (NCI Thesaurus Property-2)
C15220 (NCI Thesaurus Property-3)
C25704 (NCI Thesaurus ValueDomain)
C0807713 (UMLS CUI-1)
New primary cancer
Item
Has a new primary or MDS been diagnosed that has not been previously reported?
boolean
C38148 (NCI Thesaurus ValueDomain)
C25586 (NCI Thesaurus ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C15220 (NCI Thesaurus Property)
C0751623 (UMLS CUI-1)
New Primary Cancer Date
Item
Date of diagnosis
date
C25164 (NCI Thesaurus ValueDomain)
C9305 (NCI Thesaurus ObjectClass)
C15220 (NCI Thesaurus Property)
C0205314 (UMLS CUI-1)
C0006826 (UMLS CUI-2)
C0011900 (UMLS CUI-3)
C0011008 (UMLS CUI-4)
NewCancerSiteText
Item
Site(s) of new primary
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
Item Group
Late Adverse Events
C0877248 (UMLS CUI-1)
C0205087 (UMLS CUI-2)
Item
Adverse Event
text
C41331 (NCI Thesaurus ObjectClass)
C49704 (NCI Thesaurus Property)
C45559 (NCI Thesaurus Property-2)
C45255 (NCI Thesaurus ValueDomain)
C49704 (NCI Thesaurus ValueDomain-2)
C42614 (NCI Thesaurus ValueDomain-3)
C45559 (NCI Thesaurus ValueDomain-4)
C25714 (NCI Thesaurus ValueDomain-5)
C1516728 (UMLS CUI-1)
C2826934 (UMLS CUI-2)
CL.11
Code List
Adverse Event
CL Item
Acute Coronary Syndrome (Acute coronary syndrome)
E10066 (CTCAE)
CL Item
Anorexia (Anorexia)
E12252 (CTCAE)
CL Item
Arthralgia (Arthralgia)
E12374 (CTCAE)
CL Item
Back Pain (Back pain)
E12388 (CTCAE)
CL Item
Cholesterol High (Cholesterol high)
E12127 (CTCAE)
CL Item
Constipation (Constipation)
E10562 (CTCAE)
CL Item
Depression (Depression)
E12909 (CTCAE)
CL Item
Diarrhea (Diarrhea)
E10572 (CTCAE)
CL Item
Dizziness (Dizziness)
E12631 (CTCAE)
CL Item
Dyspnea (Dyspnea)
E13368 (CTCAE)
CL Item
Edema Limbs (Edema limbs)
E11086 (CTCAE)
CL Item
Fatigue (Fatigue)
E11098 (CTCAE)
CL Item
Headache (Headache)
E12678 (CTCAE)
CL Item
Hot Flashes (Hot flashes)
E13781 (CTCAE)
CL Item
Hypertriglyceridemia (Hypertriglyceridemia)
E12299 (CTCAE)
CL Item
Insomnia (Insomnia)
E12925 (CTCAE)
CL Item
Ischemia Cerebrovascular (Ischemia cerebrovascular)
E12702 (CTCAE)
CL Item
Myalgia (Myalgia)
E12485 (CTCAE)
CL Item
Myocardial Infarction (Myocardial infarction)
E10152 (CTCAE)
CL Item
Nausea (Nausea)
E10878 (CTCAE)
CL Item
Peripheral Ischemia (Peripheral ischemia)
E13810 (CTCAE)
CL Item
Somnolence (Somnolence)
E12814 (CTCAE)
CL Item
Stroke (Stroke)
E12826 (CTCAE)
CL Item
Thromboembolic Event (Thromboembolic event)
E13825 (CTCAE)
CL Item
Transient Ischemic Attacks (Transient ischemic attacks)
E12834 (CTCAE)
CL Item
Vaginal Hemorrhage (Vaginal hemorrhage)
E13264 (CTCAE)
CL Item
Visceral Arterial Ischemia (Visceral arterial ischemia)
E13843 (CTCAE)
Item
Grade
text
C41331 (NCI Thesaurus ObjectClass)
C48309 (NCI Thesaurus Property)
C49705 (NCI Thesaurus Property-2)
C25676 (NCI Thesaurus Property-3)
C41331 (NCI Thesaurus ValueDomain)
C48309 (NCI Thesaurus ValueDomain-2)
C25676 (NCI Thesaurus ValueDomain-3)
C2985921 (UMLS CUI-1)
CL.12
Code List
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)
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