ID

43354

Description

E1305 On-Study Form NCT00588770 Chemotherapy With or Without Bevacizumab in Treating Patients With Recurrent or Metastatic Head and Neck Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=1A0A6D56-A371-47E3-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=1A0A6D56-A371-47E3-E044-0003BA3F9857

Keywords

Head and Neck Neoplasms

Clinical Trial

On-Study Form

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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E1305 On-Study Form NCT00588770

model
Details

INSTRUCTIONS: Complete this form and submit original to the ECOG Coordinating Center within one week of patient¿s entry on study. Keep a copy for your files.

1 forms

StudyEvent: E1305 On-Study Form
1. INSTRUCTIONS: Complete this form and submit original to the ECOG Coordinating Center within one week of patient¿s entry on study. Keep a copy for your files.

Name

Type

Description | Question | Decode (Coded Value)

Data type

Alias

Header

Item Group

Header

Protocol Number ECOG

Item

ECOG Protocol Number

text

C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)

Patient ID ECOG

Item

ECOG Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)

Generic drug form

Item

DCI Name

text

C25191 (NCI Thesaurus ValueDomain)
C3242750 (UMLS CUI-1)
C19464 (NCI Thesaurus Property)
C25474 (NCI Thesaurus ObjectClass)
C25452 (NCI Thesaurus ObjectClass-2)

Registration Number

Item

Registration Step

text

C25337 (NCI Thesaurus ValueDomain)
C1514821 (UMLS CUI-1)
C25646 (NCI Thesaurus ObjectClass)
C0237753 (UMLS CUI-2)
C16154 (NCI Thesaurus Property)
C16154 (NCI Thesaurus ValueDomain-2)

Clinical Trial Period

Item

Reporting Period

text

C25284 (NCI Thesaurus ValueDomain)
C2347804 (UMLS CUI-1)
C25214 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C25651 (NCI Thesaurus ObjectClass-2)

CL.1

Code List

Reporting Period

CL Item

Baseline (Baseline)

C25213 (NCI Thesaurus)
C1442488 (UMLS 2011AA)

Patient Initials

Item

Patient Initials (Last, First)

text

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

Study Number Participating Group

Item

Participating Group Protocol Number

text

C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)

Trial subject ID Participating Group

Item

Participating Group Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)

Institution Name

Item

Institution/Affiliate

text

C25454 (NCI Thesaurus ObjectClass)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)

Data amendment

Item Group

Data amendment

Data amended

Item

Please mark an 'X' if data have been amended (Please circle amended items in red)

text

C25704 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)

Data amended date

Item

Date data amended (M D Y)

date

C25164 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C0011008 (UMLS CUI-2)
C25416 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)

Patient Information

Item Group

Patient Information

ECOG Performance Status

Item

ECOG Performance Status (at study entry)

text

C25664 (NCI Thesaurus ValueDomain)
C1520224 (UMLS CUI-1)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain-2)
C20641 (NCI Thesaurus ObjectClass)

CL.2

Code List

ECOG Performance Status (at study entry)

CL Item

Fully Active, Able To Carry On All Pre-disease Performance Without Restriction. (0)

CL Item

Restricted In Physically Strenuous Activity But Ambulatory And Able To Carry Out Work Of A Light Or Sedentary Nature, E.g., Light Housework, Office Work. (1)

CL Item

Ambulatory And Capable Of All Selfcare But Unable To Carry Out Any Work Activities. Up And About More Than 50% Of Waking Hours. (2)

CL Item

Capable Of Only Limited Selfcare, Confined To Bed Or Chair More Than 50% Of Waking Hours. (3)

CL Item

Completely Disabled. Cannot Carry On Any Selfcare. Totally Confined To Bed Or Chair. (4)

Patient Height

Item

Height

float

C25209 (NCI Thesaurus ValueDomain)
C0489786 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25347 (NCI Thesaurus Property)

Weight Loss past six months

Item

Weight Loss in Previous Six Months

text

C25664 (NCI Thesaurus ValueDomain)
C1262477 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C3828652 (UMLS CUI-2)
C3445 (NCI Thesaurus Property)
C25613 (NCI Thesaurus ValueDomain-2)

CL.3

Code List

Weight Loss in Previous Six Months

CL Item

<5% Of Body Weight (< 5% of body weight)

CL Item

5 To 10% Of Body Weight (5-10% of body weight)

CL Item

10 To <20% Of Body Weight (10 -<20% of body weight)

CL Item

> Or = 20% Of Body Weight (> or = 20% of body weight)

PriorRadiationTherapyHeadandNeckAdministeredInd-2

Item

Prior Radiation Therapy to head and neck

boolean

C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C12418 (NCI Thesaurus Property)
C0460004 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PriorHeadandNeckRadiationTherapyOccurrenceEndDate

Item

Date prior RT to head and neck ended (If yes: - most recent)

date

C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C12418 (NCI Thesaurus ObjectClass-2)
C0460004 (UMLS 2011AA ObjectClass-2)
C25629 (NCI Thesaurus ObjectClass-3)
C0332152 (UMLS 2011AA ObjectClass-3)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

RadiationTherapyPriorOtherAnatomicSiteAdministeredInd-2

Item

Prior Radiation Therapy to other sites

boolean

C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C13717 (NCI Thesaurus Property)
C1515974 (UMLS 2011AA Property)
C17649 (NCI Thesaurus Property-2)
C0205394 (UMLS 2011AA Property-2)
C25629 (NCI Thesaurus Property-3)
C0332152 (UMLS 2011AA Property-3)
C25382 (NCI Thesaurus Property-4)
C1521801 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

PriorOtherSiteRadiationTherapyOccurrenceEndDate

Item

Date prior RT to other sites ended (If yes: - most recent)

date

C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C13717 (NCI Thesaurus Property)
C1515974 (UMLS 2011AA Property)
C17649 (NCI Thesaurus Property-2)
C0205394 (UMLS 2011AA Property-2)
C25629 (NCI Thesaurus Property-3)
C0332152 (UMLS 2011AA Property-3)
C25382 (NCI Thesaurus Property-4)
C1521801 (UMLS 2011AA Property-4)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

ChemotherapyRegimenType

Item

Planned Chemotherapy Regimen

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C15697 (NCI Thesaurus Property)
C0040808 (UMLS 2011AA Property)

CL.6

Code List

Planned Chemotherapy Regimen

CL Item

Cisplatin And Docetaxel (Cisplatin and Docetaxel)

CL Item

Cisplatin And 5-fluorouracil (Cisplatin and 5-Fluorouracil)

CL Item

Carboplatin And Docetaxel (Carboplatin and Docetaxel)

CL Item

Carboplatin And 5-fluorouracil (Carboplatin and 5-Fluorouracil)

Smoking history

Item

Smoking History

text

C25284 (NCI Thesaurus ValueDomain)
C1519384 (UMLS CUI-1)
C17934 (NCI Thesaurus ObjectClass)
C18772 (NCI Thesaurus Property)

CL.7

Code List

Smoking History

CL Item

Never Smoked (Never smoked)

CL Item

Pipe Or Cigar Smoker Only (Pipe or cigar smoker only)

CL Item

Cigarette Smoker 20-40 Pack-years (Cigarette smoker, 20-40 pack-years)

CL Item

Cigarette Smoker <20 Pack-years (Cigarette smoker, <20 pack-years)

CL Item

Cigarette Smoker >40 Pack-years (Cigarette smoker, >40 pack-years)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

Current Smoker

Item

Does the patient currently smoke

boolean

C38148 (NCI Thesaurus ValueDomain)
C3241966 (UMLS CUI-1)
C25471 (NCI Thesaurus Property)
C17934 (NCI Thesaurus ObjectClass)
C0449865 (NCI Metathesaurus Property)

AlcoholCurrentUseInd-2

Item

Does the patient currently consume alcohol

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25471 (NCI Thesaurus Property)
C0521116 (UMLS 2011AA Property)
C2190 (NCI Thesaurus ObjectClass)
C0001962 (UMLS 2011AA ObjectClass)
C25340 (NCI Thesaurus Property-2)
C0457083 (UMLS 2011AA Property-2)

AlcoholCurrentUseRangeType

Item

Average Alcohol Consumption (NOTE: 1 drink = 1 oz. whiskey = 12 oz. beer)

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25471 (NCI Thesaurus Property)
C0521116 (UMLS 2011AA Property)
C2190 (NCI Thesaurus ObjectClass)
C0001962 (UMLS 2011AA ObjectClass)
C25340 (NCI Thesaurus Property-2)
C0457083 (UMLS 2011AA Property-2)

CL.10

Code List

Average Alcohol Consumption (NOTE: 1 drink = 1 oz. whiskey = 12 oz. beer)

CL Item

Less Than 1 Drink Per Month (Less than 1 drink per month)

CL Item

1 To 5 Drinks Per Month (1 to 5 drinks per month)

CL Item

1 To 10 Drinks Per Week (1 to 10 drinks per week)

CL Item

11 To 30 Drinks Per Week (11 to 30 drinks per week)

CL Item

More Than 30 Drinks Per Week (More than 30 drinks per week)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

UrinalysisProteinLevelAmount

Item

Urine Dipstick Result

text

C17241 (NCI Thesaurus ObjectClass)
C0042014 (UMLS 2011AA ObjectClass)
C17021 (NCI Thesaurus Property)
C0033684 (UMLS 2011AA Property)
C25417 (NCI Thesaurus ValueDomain)
C25554 (NCI Thesaurus Property-2)
C0441889 (UMLS 2011AA Property-2)

CL.11

Code List

Urine Dipstick Result

CL Item

Negative (Negative)

C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)

CL Item

Trace (Trace)

C80218 (NCI Thesaurus)
C1552622 (UMLS 2011AA)

CL Item

1+ (1+)

CL Item

2+ (2+)

CL Item

3+ (3+)

CL Item

4+ (4+)

DataUnknownText

Item

Mark an 'X' if not done (UPC Ratio)

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C17998 (NCI Thesaurus Property)
C0439673 (UMLS 2011AA Property)

UrineSpecimenCollectionDate

Item

Date of urine dipstick

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C13283 (NCI Thesaurus ObjectClass)
C0042036 (UMLS 2011AA ObjectClass)
C25453 (NCI Thesaurus Property)
C1516698 (UMLS 2011AA Property)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)

UrinaryCreatinineProteinAssessmentValue

Item

Urine Protein/Creatinine Ratio

float

C25711 (NCI Thesaurus ObjectClass)
C1524119 (UMLS 2011AA ObjectClass)
C17021 (NCI Thesaurus ObjectClass-2)
C0033684 (UMLS 2011AA ObjectClass-2)
C0010294 (NCI Metathesaurus ObjectClass)
C25367 (NCI Thesaurus Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

UrinaryCreatinineProteinAssessmentDate

Item

Date of Urine Protein/Creatinine Ratio

date

C25711 (NCI Thesaurus ObjectClass)
C1524119 (UMLS 2011AA ObjectClass)
C17021 (NCI Thesaurus ObjectClass-2)
C0033684 (UMLS 2011AA ObjectClass-2)
C0010294 (NCI Metathesaurus ObjectClass)
C25367 (NCI Thesaurus Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

Cardiac History

Item Group

Patient History

PersonThromboembolismPersonalMedicalHistoryInd-3

Item

Does the patient have a history of thromboembolic events (arterial)

boolean

C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
C0040038 (NCI Metathesaurus Property)

PersonThromboembolismPersonalMedicalHistorySpecify

Item

Specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
C0040038 (NCI Metathesaurus Property)

AdverseEventMostRecentRecoveryDate

Item

Recovery or Latest Date (last known date of disease activity)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25746 (NCI Thesaurus Property)
C2004454 (UMLS 2011AA Property)
C25577 (NCI Thesaurus Property-2)
C1513491 (UMLS 2011AA Property-2)

CardiovascularDiseasePresentInd-2

Item

Has the patient suffered cardiovascular disease?

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C25292 (NCI Thesaurus ObjectClass)
C0007226 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus ObjectClass-2)
C0012634 (UMLS 2011AA ObjectClass-2)

PatientPriorMyocardialInfarctionInd-3

Item

Myocardial infarction

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C27996 (NCI Thesaurus Property)
C0027051 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)

CL.14

Code List

Myocardial infarction

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)

StableAnginaDiseasesandDisordersPresentInd-3

Item

Stable Angina

text

C30103 (NCI Thesaurus ObjectClass)
C0205360 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus ObjectClass-2)
C0012634 (UMLS 2011AA ObjectClass-2)
C51221 (NCI Thesaurus ObjectClass-3)
C0002962 (UMLS 2011AA ObjectClass-3)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

CL.15

Code List

Stable Angina

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

UnstableAnginaDiseasePresentInd-3

Item

Unstable angina

text

C25594 (NCI Thesaurus ObjectClass)
C1518422 (UMLS 2011AA ObjectClass)
C30103 (NCI Thesaurus ObjectClass-2)
C0205360 (UMLS 2011AA ObjectClass-2)
C2991 (NCI Thesaurus ObjectClass-3)
C0012634 (UMLS 2011AA ObjectClass-3)
C51221 (NCI Thesaurus ObjectClass-4)
C0002962 (UMLS 2011AA ObjectClass-4)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

CL.16

Code List

Unstable angina

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)

OtherCardiovascularDiseasePresentInd-3

Item

Other

text

C17649 (NCI Thesaurus ObjectClass)
C0205394 (UMLS 2011AA ObjectClass)
C25292 (NCI Thesaurus ObjectClass-2)
C0007226 (UMLS 2011AA ObjectClass-2)
C2991 (NCI Thesaurus ObjectClass-3)
C0012634 (UMLS 2011AA ObjectClass-3)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

CL.17

Code List

Other

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)

OtherCardiovascularDiseasePresentSpecify

Item

Specify (If other:)

text

C17649 (NCI Thesaurus ObjectClass)
C0205394 (UMLS 2011AA ObjectClass)
C25292 (NCI Thesaurus ObjectClass-2)
C0007226 (UMLS 2011AA ObjectClass-2)
C2991 (NCI Thesaurus ObjectClass-3)
C0012634 (UMLS 2011AA ObjectClass-3)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)

HypertensionHistoryInd-3

Item

Hypertension history

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C3117 (NCI Thesaurus ObjectClass)
C0020538 (UMLS 2011AA ObjectClass)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)

Prior Treatment for Disease

Item Group

Prior Treatment For Disease

PriorNeoadjuvantTherapyAdjuvantTherapyChemotherapyAdministeredInd-2

Item

Prior Induction or Adjuvant Chemotherapy

boolean

C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C15675 (NCI Thesaurus ObjectClass-3)
C0677850 (UMLS 2011AA ObjectClass-3)
C15665 (NCI Thesaurus ObjectClass-4)
C0600558 (UMLS 2011AA ObjectClass-4)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

ChemotherapyAdministeredEndDate

Item

Date Chemotherapy Ended (most recent)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

PriorCurativeSystemicTherapyAdministeredType

Item

Prior systemic therapy (as part of curative therapy) (Provide an answer for all)

text

C15698 (NCI Thesaurus ObjectClass)
C1515119 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
CL282358 (NCI Metathesaurus ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.20

Code List

Prior systemic therapy (as part of curative therapy) (Provide an answer for all)

CL Item

Cisplatin (Cisplatin)

C376 (NCI Thesaurus)
C0008838 (UMLS 2011AA)

CL Item

Carboplatin (Carboplatin)

C1282 (NCI Thesaurus)
C0079083 (UMLS 2011AA)

CL Item

Fluorouracil (Fluorouracil)

C505 (NCI Thesaurus)
C0016360 (UMLS 2011AA)

CL Item

Docetaxel (Docetaxel)

C1526 (NCI Thesaurus)
C0246415 (UMLS 2011AA)

CL Item

Paclitaxel (Paclitaxel)

C1411 (NCI Thesaurus)
C0144576 (UMLS 2011AA)

CL Item

Cetuximab (Cetuximab)

C1723 (NCI Thesaurus)
C0879636 (UMLS 2011AA)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

PriorCurativeSystemicTherapySpecify

Item

Other, specify

text

C15698 (NCI Thesaurus ObjectClass)
C1515119 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
CL282358 (NCI Metathesaurus ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)

Prior Surgery

Item

Prior Surgery

boolean

C38148 (NCI Thesaurus ValueDomain)
C0744961 (UMLS CUI-1)
C38000 (NCI Thesaurus Property)
C15329 (NCI Thesaurus ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)

RecentSurgeryDate

Item

Date of Most Recent Surgery

date

C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C25280 (NCI Thesaurus ObjectClass-2)
C0332185 (UMLS 2011AA ObjectClass-2)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)

Disease Status at Initial Diagnosis

Item Group

Head & Neck: Disease Description

HeadandNeckTumorHistologicGrade

Item

Histologic Grade

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12418 (NCI Thesaurus ObjectClass-2)
C0460004 (UMLS 2011AA ObjectClass-2)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property-2)
C0678257 (UMLS 2011AA Property-2)
C25526 (NCI Thesaurus ValueDomain)
C0205462 (UMLS 2011AA ValueDomain)
C18000 (NCI Thesaurus ValueDomain-2)
C0919553 (UMLS 2011AA ValueDomain-2)

CL.22

Code List

Histologic Grade

CL Item

Well Differentiated (grade I) (Well differentiated (Grade I))

CL Item

Moderately Differentiated (grade Ii) (Moderately differentiated (Grade II))

CL Item

Poorly Differentiated (grade Iii) (Poorly differentiated (Grade III))

CL Item

Undifferentiated (grade Iv) (Undifferentiated (Grade IV))

CL Item

Cannot Be Assessed (grade X) (Grade cannot be assessed (Grade X))

HeadandNeckTumorPrimaryLocation

Item

Primary Site (Select region category bolded only if specific site is unknown or there are > 1 specific sites)

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12418 (NCI Thesaurus ObjectClass-2)
C0460004 (UMLS 2011AA ObjectClass-2)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C25251 (NCI Thesaurus Property-2)
C0205225 (UMLS 2011AA Property-2)
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)

CL.23

Code List

Primary Site (Select region category bolded only if specific site is unknown or there are > 1 specific sites)

CL Item

Lip And Oral Cavity (Lip and oral cavity)

CL Item

Oral Tongue (Oral Tongue)

CL Item

Floor Of Mouth (Floor of mouth)

C0026638 (NCI Metathesaurus)

CL Item

Buccal Mucosa (Buccal mucosa)

C12505 (NCI Thesaurus)
C1578559 (UMLS 2011AA)

CL Item

Hard Palate (Hard palate)

C12230 (NCI Thesaurus)
C0226901 (UMLS 2011AA)

CL Item

Retromolar Trigone (Retromolar trigone)

CL Item

Lower Gingiva (Lower gingiva)

CL Item

Upper Gingiva (Upper gingiva)

CL Item

Oral Cavity Nos (Oral cavity NOS)

CL Item

Posterior Superior Wall (Posterior superior wall)

CL Item

Lateral Wall (Lateral wall)

CL Item

Nasopharynx Nos (Nasopharynx NOS)

CL Item

Faucial Arch (Faucial arch)

CL Item

Tonsillar Fossa Tonsil (Tonsillar fossa, tonsil)

CL Item

Posterior Pharyngeal Wall (Posterior pharyngeal wall)

CL Item

Base Of Tongue (Base of tongue)

C0226958 (NCI Metathesaurus)

CL Item

Soft Palate (Soft palate)

C12231 (NCI Thesaurus)
C0030219 (UMLS 2011AA)

CL Item

Oropharynx Nos (Oropharynx NOS)

CL Item

Pyriform Fossa (Pyriform fossa)

CL Item

Postcricoid Area (Postcricoid area)

CL Item

Posterior Wall (Posterior wall)

CL Item

Hypopharynx Nos (Hypopharynx NOS)

CL Item

Supraglottic Larynx (Supraglottic larynx)

CL Item

Glottic Larynx (Glottic larynx)

CL Item

Subglottic Larynx (Subglottic larynx)

CL Item

Larynx Nos (Larynx NOS)

CL Item

Parotid (Parotid)

CL Item

Submandibular (Submandibular)

CL Item

Salivary Glands Nos (Salivary glands NOS)

CL Item

Antrum (Antrum)

CL Item

Ethmoid (Ethmoid)

CL Item

Sphenoid (Sphenoid)

CL Item

Frontal (Frontal)

CL Item

Paranasal Sinuses Nos (Paranasal sinuses NOS)

CL Item

Nasal Cavity (Nasal cavity)

C12424 (NCI Thesaurus)
C0027423 (UMLS 2011AA)

CL Item

Nose Nos (Nose NOS)

CL Item

No Primary Identified (no primary identified)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

Primary Disease Site

Item

Other specify

text

C25685 (NCI Thesaurus ValueDomain)
C0449695 (UMLS CUI-1)
C25341 (NCI Thesaurus Property)
C25251 (NCI Thesaurus ObjectClass)
C2991 (NCI Thesaurus ObjectClass-2)

Disease Status at Time of Study Entry

Item Group

Disease Description

MetastaticRecurrentDiseaseInitialDiagnosisDate

Item

Date of initial diagnosis of metastatic/recurrent disease

date

C14174 (NCI Thesaurus ObjectClass)
C0036525 (UMLS 2011AA ObjectClass)
C14173 (NCI Thesaurus ObjectClass-2)
C2945760 (UMLS 2011AA ObjectClass-2)
C2991 (NCI Thesaurus ObjectClass-3)
C0012634 (UMLS 2011AA ObjectClass-3)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property-2)
C0011900 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

DiseaseRegistrationType

Item

Disease Status

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)

CL.24

Code List

Disease Status

CL Item

Recurrent (Recurrent)

C14173 (NCI Thesaurus)
C2945760 (UMLS 2011AA)

CL Item

Metastatic (Metastatic)

C14174 (NCI Thesaurus)
C0036525 (UMLS 2011AA)

CL Item

Both (Both)

C49636 (NCI Thesaurus)
C1706086 (UMLS 2011AA)

NeckDiseaseStatusType

Item

Primary disease status

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C13063 (NCI Thesaurus ObjectClass)
C0027530 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus ObjectClass-2)
C0012634 (UMLS 2011AA ObjectClass-2)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)

CL.25

Code List

Primary disease status

CL Item

Eradicated No Recurrence (Eradicated, no recurrence)

CL Item

Eradicated But Recurred Locally (Eradicated, but recurred locally)

CL Item

Residual Disease After Prior Therapy (Residual disease after prior therapy)

CL Item

Untreated (Untreated)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

RegionalLymphNodeDescriptionType

Item

Regional Lymph Node Status (Local/)

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25643 (NCI Thesaurus ObjectClass-2)
C0205147 (UMLS 2011AA ObjectClass-2)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)

CL.26

Code List

Regional Lymph Node Status (Local/)

CL Item

Never Involved (never involved)

CL Item

Never Involved, But Removed Prophylactically (never involved, but removed prophylactically)

CL Item

Involved Nodes Eradicated (involved nodes eradicated)

CL Item

Involved Nodes Eradicated, But New Involvement (involved nodes eradicated, but new involvement)

CL Item

Involved Nodes Not Treated (involved nodes not treated)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

MalignantNeoplasmLungMetastaticInvolvementStatus

Item

Lung

text

C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C14174 (NCI Thesaurus Property)
C0036525 (UMLS 2011AA Property)
C12468 (NCI Thesaurus Property-2)
C0024109 (UMLS 2011AA Property-2)
C25548 (NCI Thesaurus Property-3)
C1314939 (UMLS 2011AA Property-3)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)

CL.27

Code List

Lung

CL Item

Not Involved Or No Clinical Evidence Of Involvement (Not involved or no clinical evidence of involvement)

CL Item

Involved (involved)

C25547 (NCI Thesaurus)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

MalignantNeoplasmBrainMetastaticInvolvementStatus

Item

Brain

text

C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C14174 (NCI Thesaurus Property)
C0036525 (UMLS 2011AA Property)
C12439 (NCI Thesaurus Property-2)
C0006104 (UMLS 2011AA Property-2)
C25548 (NCI Thesaurus Property-3)
C1314939 (UMLS 2011AA Property-3)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)

CL.28

Code List

Brain

CL Item

Not Involved Or No Clinical Evidence Of Involvement (Not involved or no clinical evidence of involvement)

CL Item

Involved (involved)

C25547 (NCI Thesaurus)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

MalignantNeoplasmLiverMetastaticInvolvementStatus

Item

Liver

text

C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C14174 (NCI Thesaurus Property)
C0036525 (UMLS 2011AA Property)
C12392 (NCI Thesaurus Property-2)
C0023884 (UMLS 2011AA Property-2)
C25548 (NCI Thesaurus Property-3)
C1314939 (UMLS 2011AA Property-3)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)

CL.29

Code List

Liver

CL Item

Not Involved Or No Clinical Evidence Of Involvement (Not involved or no clinical evidence of involvement)

CL Item

Involved (involved)

C25547 (NCI Thesaurus)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

MalignantNeoplasmMetastaticSkinInvolvementStatus

Item

Skin

text

C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C14174 (NCI Thesaurus Property)
C0036525 (UMLS 2011AA Property)
C12470 (NCI Thesaurus Property-2)
C1123023 (UMLS 2011AA Property-2)
C25548 (NCI Thesaurus Property-3)
C1314939 (UMLS 2011AA Property-3)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)

CL.30

Code List

Skin

CL Item

Not Involved Or No Clinical Evidence Of Involvement (Not involved or no clinical evidence of involvement)

CL Item

Involved (involved)

C25547 (NCI Thesaurus)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

MalignantNeoplasmDistantLymphNodeMetastaticInvolvementStatus

Item

Distant lymph nodes

text

C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C14174 (NCI Thesaurus Property)
C0036525 (UMLS 2011AA Property)
C12745 (NCI Thesaurus Property-2)
C0024204 (UMLS 2011AA Property-2)
C25321 (NCI Thesaurus Property-3)
C0443203 (UMLS 2011AA Property-3)
C25548 (NCI Thesaurus Property-4)
C1314939 (UMLS 2011AA Property-4)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)

CL.31

Code List

Distant lymph nodes

CL Item

Not Involved Or No Clinical Evidence Of Involvement (Not involved or no clinical evidence of involvement)

CL Item

Involved (involved)

C25547 (NCI Thesaurus)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

MalignantNeoplasmDistantLymphNodeMetastaticInvolvementSpecify

Item

Distant nodes specify

text

C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C14174 (NCI Thesaurus Property)
C0036525 (UMLS 2011AA Property)
C12745 (NCI Thesaurus Property-2)
C0024204 (UMLS 2011AA Property-2)
C25321 (NCI Thesaurus Property-3)
C0443203 (UMLS 2011AA Property-3)
C25548 (NCI Thesaurus Property-4)
C1314939 (UMLS 2011AA Property-4)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)

MalignantNeoplasmMetastaticMediastinalLymphNodeInvolvementStatus

Item

Mediatstinal lymph nodes

text

C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C14174 (NCI Thesaurus Property)
C0036525 (UMLS 2011AA Property)
C33073 (NCI Thesaurus Property-2)
C0588055 (UMLS 2011AA Property-2)
C25548 (NCI Thesaurus Property-3)
C1314939 (UMLS 2011AA Property-3)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)

CL.32

Code List

Mediatstinal lymph nodes

CL Item

Not Involved Or No Clinical Evidence Of Involvement (Not involved or no clinical evidence of involvement)

CL Item

Involved (involved)

C25547 (NCI Thesaurus)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

MalignantNeoplasmBoneMetastaticInvolvementStatus

Item

Bone

text

C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C14174 (NCI Thesaurus Property)
C0036525 (UMLS 2011AA Property)
C12366 (NCI Thesaurus Property-2)
C0262950 (UMLS 2011AA Property-2)
C25548 (NCI Thesaurus Property-3)
C1314939 (UMLS 2011AA Property-3)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)

CL.33

Code List

Bone

CL Item

Not Involved Or No Clinical Evidence Of Involvement (Not involved or no clinical evidence of involvement)

CL Item

Involved (involved)

C25547 (NCI Thesaurus)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

MalignantNeoplasmBoneMetastaticInvolvementSpecify

Item

Bone specify

text

C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C14174 (NCI Thesaurus Property)
C0036525 (UMLS 2011AA Property)
C12366 (NCI Thesaurus Property-2)
C0262950 (UMLS 2011AA Property-2)
C25548 (NCI Thesaurus Property-3)
C1314939 (UMLS 2011AA Property-3)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)

MalignantNeoplasmSoftTissueMetastaticInvolvementStatus

Item

Soft tissue

text

C14174 (NCI Thesaurus Property)
C0036525 (UMLS 2011AA Property)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25548 (NCI Thesaurus Property-2)
C1314939 (UMLS 2011AA Property-2)
C12471 (NCI Thesaurus Property-3)
C0225317 (UMLS 2011AA Property-3)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)

CL.34

Code List

Soft tissue

CL Item

Not Involved Or No Clinical Evidence Of Involvement (Not involved or no clinical evidence of involvement)

CL Item

Involved (involved)

C25547 (NCI Thesaurus)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

MalignantNeoplasmSoftTissueMetastaticInvolvementSpecify

Item

Soft tissue specify

text

C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C14174 (NCI Thesaurus Property)
C0036525 (UMLS 2011AA Property)
C25548 (NCI Thesaurus Property-2)
C1314939 (UMLS 2011AA Property-2)
C12471 (NCI Thesaurus Property-3)
C0225317 (UMLS 2011AA Property-3)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)

MalignantNeoplasmVisceralMetastaticInvolvementStatus

Item

Other visceral

text

C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C14174 (NCI Thesaurus Property)
C0036525 (UMLS 2011AA Property)
C25548 (NCI Thesaurus Property-2)
C1314939 (UMLS 2011AA Property-2)
C25315 (NCI Thesaurus Property-3)
C0442045 (UMLS 2011AA Property-3)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)

CL.35

Code List

Other visceral

CL Item

Not Involved Or No Clinical Evidence Of Involvement (Not involved or no clinical evidence of involvement)

CL Item

Involved (involved)

C25547 (NCI Thesaurus)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

MalignantNeoplasmVisceralMetastaticInvolvementSpecify

Item

Other visceral specify

text

C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C14174 (NCI Thesaurus Property)
C0036525 (UMLS 2011AA Property)
C25548 (NCI Thesaurus Property-2)
C1314939 (UMLS 2011AA Property-2)
C25315 (NCI Thesaurus Property-3)
C0442045 (UMLS 2011AA Property-3)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)

MalignantNeoplasmMetastaticInvolvementStatus

Item

Other

text

C14174 (NCI Thesaurus Property)
C0036525 (UMLS 2011AA Property)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25548 (NCI Thesaurus Property-2)
C1314939 (UMLS 2011AA Property-2)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)

CL.36

Code List

Other

CL Item

Not Involved Or No Clinical Evidence Of Involvement (Not involved or no clinical evidence of involvement)

CL Item

Involved (involved)

C25547 (NCI Thesaurus)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

TumorExtensionSpecify

Item

Other specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25270 (NCI Thesaurus Property)
C0231448 (UMLS 2011AA Property)

Baseline Abnormalities

Item Group

Baseline Abnormalities

CommonTerminologyCriteriaforAdverseEventsVersion4.0LowLevelTermName

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)

AdverseEventSeverityGrade

Item

CTC Adverse Event 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.37

Code List

CTC Adverse Event 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)

Footer Module

Item Group

Comments

Investigator Signature

Item

Investigator Signature

text

C25704 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)

Investigator Signature Date

Item

Investigator Signature Date

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)

Comments

Item

Comments

text

C0947611 (UMLS CUI-1)

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E1305 On-Study Form NCT00588770

INSTRUCTIONS: Complete this form and submit original to the ECOG Coordinating Center within one week of patient¿s entry on study. Keep a copy for your files.

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