ID

8207

Beschreibung

RTOG 1016 F1: Radiation Therapy Oncology Group Phase III Head and Neck Cancer Follow-Up Form Radiation Therapy With Cisplatin or Cetuximab in Treating Patients With Oropharyngeal Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=944181D6-4EF9-82FB-E040-BB89AD43799B

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=944181D6-4EF9-82FB-E040-BB89AD43799B

Stichworte

Hochgeladen am

9. Januar 2015

DOI

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Lizenz

Creative Commons BY-NC 3.0 Legacy

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NCT01302834 Follow-Up - RTOG 1016 F1: Radiation Therapy Oncology Group Phase III Head and Neck Cancer Follow-Up Form - 3156608v1.0

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1 Formulare

StudyEvent: RTOG 1016 F1: Radiation Therapy Oncology Group Phase III Head and Neck Cancer Follow-Up Form
1. No Instruction available.

Name

Typ

Description | Question | Decode (Coded Value)

Datentyp

Alias

Header Module

Item Group

Header

Protocol ID RTOG

Item

RTOG Study No.

text

C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1514695 (UMLS CUI-2)
C19778 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)

RadiationTherapyOncologyGroupPatientCaseIdentifierNumber

Item

Case #

text

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C19778 (NCI Thesaurus ObjectClass-2)
C1514695 (UMLS 2011AA ObjectClass-2)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C49152 (NCI Thesaurus Property-2)
C1706256 (UMLS 2011AA Property-2)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)

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)

Institution Number

Item

Institution No.

text

C25337 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C0805701 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)

Patient Initials

Item

Patient Initials

text

C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)

Trial subject ID RTOG

Item

RTOG Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1514695 (UMLS CUI-2)
C19778 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)

Header

Item Group

Unnamed2

Data amended

Item

Amended data

boolean

C38148 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)

Unnamed2

Item Group

Unnamed3

Date last contact

Item

Date of Last Contact or Death (MM/DD/YYYY)

date

C16960 (NCI Thesaurus ObjectClass)
C0805839 (UMLS CUI-1)
C25461 (NCI Thesaurus Property)
C25551 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)

Patient Status

Item

Patient's Vital Status

text

C16960 (NCI Thesaurus ObjectClass)
C3846084 (UMLS CUI-1)
C18003 (NCI Thesaurus ValueDomain)
C25688 (NCI Thesaurus ValueDomain-2)
C25717 (NCI Thesaurus Property)

CL.2

Code List

Patient's Vital Status

CL Item

Alive (Alive)

CL Item

Dead (Dead)

Primary Cause of Death

Item

Primary Cause of Death

text

C25638 (NCI Thesaurus ValueDomain)
C0007465 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C28554 (NCI Thesaurus Property)
C25251 (NCI Thesaurus ValueDomain-2)

CL.3

Code List

Primary Cause of Death

CL Item

Due To This Disease (Due to this disease)

CL Item

Due To Second Primary Or Other Malignancy (Due to second primary or other malignancy)

CL Item

Due To Protocol Treatment (Due to protocol treatment)

CL Item

Due To Other Cause (Due to other cause)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

DeathProtocolTreatmentRelatedSpecify

Item

Due to protocol treatment, specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus Property)
C1507394 (UMLS 2011AA Property)
C28554 (NCI Thesaurus ObjectClass)
C0011065 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus Property-2)

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)

Unnamed3

Item Group

Tumor Measurements At Presentation

GavageCurrentAdministrationInd-3

Item

Does the patient currently require tube feeding

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25471 (NCI Thesaurus Property)
C0521116 (UMLS 2011AA Property)
C73430 (NCI Thesaurus ObjectClass)
C0041281 (UMLS 2011AA ObjectClass)
C25409 (NCI Thesaurus Property-2)
C1533734 (UMLS 2011AA Property-2)

CL.4

Code List

Does the patient currently require tube feeding

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

GavagePrimaryAdministrationInd-3

Item

Is patient dependent on tube feeding for >50% of nutritional support (If yes,)

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25251 (NCI Thesaurus Property)
C0205225 (UMLS 2011AA Property)
C73430 (NCI Thesaurus ObjectClass)
C0041281 (UMLS 2011AA ObjectClass)
C25409 (NCI Thesaurus Property-2)
C1533734 (UMLS 2011AA Property-2)

CL.5

Code List

Is patient dependent on tube feeding for >50% of nutritional support (If yes,)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

GingivaAssessmentStatus

Item

Dental gingival health

text

C25367 (NCI Thesaurus Property)
C32677 (NCI Thesaurus ObjectClass)
C0017562 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)

CL.6

Code List

Dental gingival health

CL Item

Normal (Normal)

CL Item

Mild Changes/good Dental Health (Mild changes/good dental health)

CL Item

Moderate/fair Dental Health (Moderate/fair dental health)

CL Item

Severe Changes In Dental Health (Severe changes in dental health)

CL Item

Life-threatening Dental Condition (Life-threatening dental condition)

NativeToothPresentCount

Item

Number of native teeth in place

float

C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C73789 (NCI Thesaurus ObjectClass)
C0302891 (UMLS 2011AA ObjectClass)
C12506 (NCI Thesaurus ObjectClass-2)
C0040426 (UMLS 2011AA ObjectClass-2)

Documented clinical assessment for this cancer

Item

Has the patient had a documented clinical assessment for this cancer? (since submission of the previous follow-up form)

text

C38148 (NCI Thesaurus ValueDomain)
C1522577 (UMLS CUI-1)
C16033 (NCI Thesaurus Property)
C0006826 (UMLS CUI-2)
C9305 (NCI Thesaurus ObjectClass)
C25365 (NCI Thesaurus Property-2)

CL.7

Code List

Has the patient had a documented clinical assessment for this cancer? (since submission of the previous follow-up form)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

Follow-Up Date

Item

Date of Last Clinical Assessment

date

C9305 (NCI Thesaurus ObjectClass)
C3694716 (UMLS CUI-1)
C16033 (NCI Thesaurus Property)
C25365 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)

RECURRENCE OR PROGRESSION

Item Group

Disease Events

RecurrentDiseaseCancerProgressionFirstLocal-RegionalDiagnosisIndicator

Item

Has the patient been diagnosed with first local recurrence or progression (since submission of the previous follow-up form)

text

C38155 (NCI Thesaurus ObjectClass)
C0277556 (UMLS 2011AA ObjectClass)
C25388 (NCI Thesaurus Property)
C1947913 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property-2)
C1279901 (UMLS 2011AA Property-2)
C15220 (NCI Thesaurus Property-3)
C0011900 (UMLS 2011AA Property-3)
C19987 (NCI Thesaurus Property-4)
C0242656 (UMLS 2011AA Property-4)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)

CL.8

Code List

Has the patient been diagnosed with first local recurrence or progression (since submission of the previous follow-up form)

CL Item

Not Applicable, Patient Has Not Been Assessed (Not applicable, patient has not been assessed)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

FirstProgressionLocalAnatomicLocationDate

Item

Date of First Local Progression (MM DD YYYY)

date

C25331 (NCI Thesaurus ObjectClass)
C25509 (NCI Thesaurus ObjectClass-2)
C1279901 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C25421 (NCI Thesaurus Property-2)
C0002808 (UMLS 2011AA Property-2)
C0443133 (NCI Metathesaurus Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)

RecurrentDiseaseCancerProgressionFirstRegionalDiagnosisIndicator

Item

Has the patient been diagnosed with first regional recurrence or progression (since submission of the previous follow-up form)

text

C38155 (NCI Thesaurus ObjectClass)
C0277556 (UMLS 2011AA ObjectClass)
C25643 (NCI Thesaurus Property)
C0205147 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property-2)
C1279901 (UMLS 2011AA Property-2)
C15220 (NCI Thesaurus Property-3)
C0011900 (UMLS 2011AA Property-3)
C19987 (NCI Thesaurus Property-4)
C0242656 (UMLS 2011AA Property-4)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)

CL.9

Code List

Has the patient been diagnosed with first regional recurrence or progression (since submission of the previous follow-up form)

CL Item

Not Applicable, Patient Has Not Been Assessed (Not applicable, patient has not been assessed)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

RecurrentDiseaseCancerProgressionFirstRegionalDiagnosisDate

Item

Date of first regional progression (MM DD YYYY)

date

C38155 (NCI Thesaurus ObjectClass)
C0277556 (UMLS 2011AA ObjectClass)
C25643 (NCI Thesaurus Property)
C0205147 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property-2)
C1279901 (UMLS 2011AA Property-2)
C15220 (NCI Thesaurus Property-3)
C0011900 (UMLS 2011AA Property-3)
C19987 (NCI Thesaurus Property-4)
C0242656 (UMLS 2011AA Property-4)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

Neoplasm recurrence, Distal

Item

Has the patient been diagnosed with first distant recurrence/progression? (since submission of the previous follow-up form)

text

C19987 (NCI Thesaurus ObjectClass)
C0027627 (UMLS CUI-1)
C25321 (NCI Thesaurus Property)
C25509 (NCI Thesaurus Property-2)
C15220 (NCI Thesaurus Property-3)
C25180 (NCI Thesaurus ValueDomain)

CL.10

Code List

Has the patient been diagnosed with first distant recurrence/progression? (since submission of the previous follow-up form)

CL Item

Not Applicable, Patient Has Not Been Assessed (Not applicable, patient has not been assessed)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

Date of Neoplasm distal recurrence

Item

Date of First Distant Progression (MM DD YYYY)

date

C25164 (NCI Thesaurus ValueDomain)
C0027627 (UMLS CUI-1)
C25331 (NCI Thesaurus ObjectClass)
C25509 (NCI Thesaurus ValueDomain-2)
C0011008 (UMLS CUI-2)
C25275 (NCI Thesaurus Property)

HeadandNeckProgressionDistantSite

Item

Site(s) of distant progression

text

C25331 (NCI Thesaurus ObjectClass)
C12418 (NCI Thesaurus ObjectClass-2)
C0460004 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C25321 (NCI Thesaurus Property-2)
C0443203 (UMLS 2011AA Property-2)
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)

CL.11

Code List

Site(s) of distant progression

CL Item

None (None)

C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)

CL Item

Oral Cavity (Oral cavity)

C12421 (NCI Thesaurus)
C0226896 (UMLS 2011AA)

CL Item

Oropharynx (Oropharynx)

C12762 (NCI Thesaurus)
C0521367 (UMLS 2011AA)

CL Item

Hypopharynx (Hypopharynx)

C12246 (NCI Thesaurus)
C0020629 (UMLS 2011AA)

CL Item

Larynx (Larynx)

C12420 (NCI Thesaurus)
C0023078 (UMLS 2011AA)

CL Item

Nasopharynx (Nasopharynx)

C12423 (NCI Thesaurus)
C0027442 (UMLS 2011AA)

CL Item

Other H + N (Other H + N)

CL Item

Bladder (Bladder)

C12414 (NCI Thesaurus)
C0005682 (UMLS 2011AA)

CL Item

Brain (Brain)

CL Item

Colorectal (Colorectal)

C13363 (NCI Thesaurus)
C0555952 (UMLS 2011AA)

CL Item

Esophageal (Esophageal)

C37950 (NCI Thesaurus)
C1522619 (UMLS 2011AA)

CL Item

Gastric (Gastric)

CL Item

Liver (Liver)

C12392 (NCI Thesaurus)
C0023884 (UMLS 2011AA)

CL Item

Lung (Lung)

C12468 (NCI Thesaurus)
C0024109 (UMLS 2011AA)

CL Item

Pancreatic (Pancreatic)

C25726 (NCI Thesaurus)
C0030274 (UMLS 2011AA)

CL Item

Renal (Renal)

C25225 (NCI Thesaurus)
C0022646 (UMLS 2011AA)

CL Item

Squamous-skin (Squamous-Skin)

CL Item

Other Solid (Other solid)

HeadandNeckProgressionDistantLocationSolidSpecify

Item

Other solid, specify

text

C25331 (NCI Thesaurus ObjectClass)
C12418 (NCI Thesaurus ObjectClass-2)
C0460004 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C25321 (NCI Thesaurus Property-2)
C0443203 (UMLS 2011AA Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C45300 (NCI Thesaurus ValueDomain-2)
C0205208 (UMLS 2011AA ValueDomain-2)

Unnamed4

Item Group

Unnamed4

NewCancerDiagnosisInd-3

Item

Has a new primary cancer or MDS been diagnosed that has not been previously reported?

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)

CL.12

Code List

Has a new primary cancer or MDS been diagnosed that has not been previously reported?

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

HeadandNeckTumorNewPrimarySite

Item

Site(s) of new primary

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12418 (NCI Thesaurus ObjectClass-2)
C0460004 (UMLS 2011AA ObjectClass-2)
C25586 (NCI Thesaurus Property)
C0205314 (UMLS 2011AA Property)
C25251 (NCI Thesaurus Property-2)
C0205225 (UMLS 2011AA Property-2)
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)

CL.13

Code List

Site(s) of new primary

CL Item

None (None)

C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)

CL Item

Oral Cavity (Oral cavity)

C12421 (NCI Thesaurus)
C0226896 (UMLS 2011AA)

CL Item

Oropharynx (Oropharynx)

C12762 (NCI Thesaurus)
C0521367 (UMLS 2011AA)

CL Item

Hypopharynx (Hypopharynx)

C12246 (NCI Thesaurus)
C0020629 (UMLS 2011AA)

CL Item

Larynx (Larynx)

C12420 (NCI Thesaurus)
C0023078 (UMLS 2011AA)

CL Item

Nasopharynx (Nasopharynx)

C12423 (NCI Thesaurus)
C0027442 (UMLS 2011AA)

CL Item

Other H + N (Other H + N)

CL Item

Aml/mds (AML/MDS)

C9441 (NCI Thesaurus)

CL Item

Bcc (BCC)

CL Item

Bladder (Bladder)

C12414 (NCI Thesaurus)
C0005682 (UMLS 2011AA)

CL Item

Brain (Brain)

CL Item

Colorectal (Colorectal)

C13363 (NCI Thesaurus)
C0555952 (UMLS 2011AA)

CL Item

Esophageal (Esophageal)

C37950 (NCI Thesaurus)
C1522619 (UMLS 2011AA)

CL Item

Gastric (Gastric)

CL Item

Liver (Liver)

C12392 (NCI Thesaurus)
C0023884 (UMLS 2011AA)

CL Item

Lung (Lung)

C12468 (NCI Thesaurus)
C0024109 (UMLS 2011AA)

CL Item

Melanoma (Melanoma)

C3224 (NCI Thesaurus)
C0025202 (UMLS 2011AA)

CL Item

Nhl (NHL)

CL Item

Pancreatic (Pancreatic)

C25726 (NCI Thesaurus)
C0030274 (UMLS 2011AA)

CL Item

Renal (Renal)

C25225 (NCI Thesaurus)
C0022646 (UMLS 2011AA)

CL Item

Squamous-skin (Squamous-Skin)

CL Item

Prostate (Prostate)

C12410 (NCI Thesaurus)
C0033572 (UMLS 2011AA)

CL Item

Other Hematologic (Other Hematologic)

CL Item

Other Solid (Other solid)

CL Item

Unknown Primary (Unknown primary)

HeadandNeckTumorNewPrimaryHematologicSpecify

Item

Other Hematologic, specify

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12418 (NCI Thesaurus ObjectClass-2)
C0460004 (UMLS 2011AA ObjectClass-2)
C25586 (NCI Thesaurus Property)
C0205314 (UMLS 2011AA Property)
C25251 (NCI Thesaurus Property-2)
C0205225 (UMLS 2011AA Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C16673 (NCI Thesaurus ValueDomain-2)
C0018943 (UMLS 2011AA ValueDomain-2)

HeadandNeckTumorNewPrimarySolidSpecify

Item

Other solid, specify

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12418 (NCI Thesaurus ObjectClass-2)
C0460004 (UMLS 2011AA ObjectClass-2)
C25586 (NCI Thesaurus Property)
C0205314 (UMLS 2011AA Property)
C25251 (NCI Thesaurus Property-2)
C0205225 (UMLS 2011AA Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C45300 (NCI Thesaurus ValueDomain-2)
C0205208 (UMLS 2011AA ValueDomain-2)

NewCancerDiagnosisDate

Item

Date of diagnosis (MM/DD/YYYY)

date

C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)

NON-PROTOCOL THERAPY

Item Group

Unnamed5

Non-ProtocolTherapyAdministeredType

Item

Non-Protocol Therapy Type (for study cancer, begun since submission of previous follow-up form)

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C1518384 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

CL.14

Code List

Non-Protocol Therapy Type (for study cancer, begun since submission of previous follow-up form)

CL Item

None (None)

C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)

CL Item

Radiation To Primary (Radiation to primary)

CL Item

Radiation To Node(s) (Radiation to node(s))

CL Item

Radiation To Other Sites, Specify (Radiation to other sites)

CL Item

Surgery For Study Cancer (Surgery for study cancer)

CL Item

Surgery For Other Cancer (Surgery for other cancer)

CL Item

Systemic Therapy (Systemic therapy)

CL Item

Biologic/targeted Therapy (Biologic/targeted therapy)

CL Item

Other Specify (Other)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

Non-protocolTherapyAdministeredBeginDate

Item

Non-protocol Therapy Start Date

date

C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C1518384 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)

Non-ProtocolTherapyDetailsText

Item

Details

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C1518384 (UMLS 2011AA ObjectClass)
C25480 (NCI Thesaurus Property)
C1522508 (UMLS 2011AA Property)

Protocol Specific Adverse Event Evaluation

Item Group

Protocol Specific Adverse Event Evaluation

CommonTerminologyCriteriaforAdverseEventsVersion4.0LowLevelTermName

Item

CTCAE 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)

AdverseEventSeverityGrade

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.20

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)

CTCAdverseEventReportBeginDate

Item

CTCAE Begin Date (MM DD YYYY)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25375 (NCI Thesaurus Property)
C0684224 (UMLS 2011AA Property)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)
C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)

CTC Adverse Event Attribution Category

Item

CTC AE Attribution Code

text

C25664 (NCI Thesaurus ValueDomain)
C1706735 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C25358 (NCI Thesaurus Property)

CL.21

Code List

CTC AE Attribution Code

CL Item

Unrelated (Unrelated)

C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)

CL Item

Unlikely (Unlikely)

CL Item

Possible (Possible)

C0332149 (NCI Metathesaurus)

CL Item

Probable (Probable)

C0332148 (NCI Metathesaurus)

CL Item

Definite (Definite)

CL209464 (NCI Metathesaurus)

SAE report

Item

SAE report submitted

text

C38148 (NCI Thesaurus ValueDomain)
C1519255 (UMLS CUI-1)
C41331 (NCI Thesaurus ObjectClass)
C0684224 (UMLS CUI-2)
C25375 (NCI Thesaurus Property)
C54035 (NCI Thesaurus ObjectClass-2)

CL.22

Code List

SAE report submitted

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

New or continuing adverse events

Item Group

Protocol Specific Adverse Event Evaluation

Adverse Event

Item

New or continuing adverse events (not reported Q11)

text

C38148 (NCI Thesaurus ValueDomain)
C0877248 (UMLS CUI-1)
C25586 (NCI Thesaurus ObjectClass)
C41331 (NCI Thesaurus ObjectClass-2)
C25275 (NCI Thesaurus Property)

CL.19

Code List

New or continuing adverse events (not reported Q11)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

CommonTerminologyCriteriaforAdverseEventsVersion4.0LowLevelTermName

Item

CTCAE Term

text

MedDRACode

Item

MedDRA Code

float

C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
CL104089 (NCI Metathesaurus ObjectClass)

AdverseEventSeverityGrade

Item

CTC AE Grade

text

CL.20

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)

CTCAdverseEventReportBeginDate

Item

CTCAE Begin Date (MM DD YYYY)

date

CTC Adverse Event Attribution Category

Item

CTC AE Attribution Code

text

C25664 (NCI Thesaurus ValueDomain)
C1706735 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C25358 (NCI Thesaurus Property)

CL.21

Code List

CTC AE Attribution Code

CL Item

Unrelated (Unrelated)

C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)

CL Item

Unlikely (Unlikely)

CL Item

Possible (Possible)

C0332149 (NCI Metathesaurus)

CL Item

Probable (Probable)

C0332148 (NCI Metathesaurus)

CL Item

Definite (Definite)

CL209464 (NCI Metathesaurus)

SAE report

Item

SAE report submitted

text

C38148 (NCI Thesaurus ValueDomain)
C1519255 (UMLS CUI-1)
C41331 (NCI Thesaurus ObjectClass)
C0684224 (UMLS CUI-2)
C25375 (NCI Thesaurus Property)
C54035 (NCI Thesaurus ObjectClass-2)

CL.22

Code List

SAE report submitted

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

Footer Module

Item Group

Comments

Research Comments

Item

COMMENTS

text

C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)

Person Completing Form

Item

Person Completing Form

text

C25191 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)

Form Completion Date

Item

Form completion date, original (MM DD YYYY)

date

C19464 (NCI Thesaurus ObjectClass)
C1549507 (UMLS CUI-1)
C25250 (NCI Thesaurus Property)
C25604 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)

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NCT01302834 Follow-Up - RTOG 1016 F1: Radiation Therapy Oncology Group Phase III Head and Neck Cancer Follow-Up Form - 3156608v1.0

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