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
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)
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)
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)
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)
Item Group
Patient Information
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)
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)
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)
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)
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)
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)
Item
Smoking History
text
C25284 (NCI Thesaurus ValueDomain)
C1519384 (UMLS CUI-1)
C17934 (NCI Thesaurus ObjectClass)
C18772 (NCI Thesaurus Property)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Item Group
Head & Neck: Disease Description
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)
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))
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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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