ID

5689

Beschreibung

Phase II Consortium - Phase II Lung Cancer - SCLC On-Study Form Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=005B53D3-2C60-14E5-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=005B53D3-2C60-14E5-E044-0003BA3F9857

Stichworte

Lungentumoren

On-Study Form

Hochgeladen am

11. August 2014

DOI

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Lizenz

Creative Commons BY-NC 3.0 Legacy

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On-Study - Phase II Lung Cancer - SCLC On-Study Form - 2404433v1.0

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1 Formulare

StudyEvent: Phase II Lung Cancer - SCLC On-Study Form
1. No Instruction available.

Name

Typ

Description | Question | Decode (Coded Value)

Datentyp

Alias

CRF Header

Item Group

Crf Header

ProtocolCoordinatingIdentifierNumber

Item

Coordinating Group Protocol No.

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25462 (NCI Thesaurus Property)
C0700114 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

CoordinatingGroupIdentifierCode

Item

Coordinating Group Code

text

C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C17005 (NCI Thesaurus ObjectClass)
C1257890 (UMLS 2011AA ObjectClass)
C25462 (NCI Thesaurus ObjectClass)
C0700114 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

ProtocolTitleName

Item

Protocol Title

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C42774 (NCI Thesaurus Property)
C1705823 (UMLS 2011AA Property)

PatientCoordinatingIdentifierNumber

Item

Patient Study ID

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25462 (NCI Thesaurus Property)
C0700114 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

RegisteringGroupIdentifierCode

Item

Registering Group Code

text

C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C17005 (NCI Thesaurus ObjectClass)
C1257890 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25645 (NCI Thesaurus ObjectClass)

PatientMedicalRecordNumber

Item

Patient Medical Record Number

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25261 (NCI Thesaurus Property)
C0205476 (UMLS 2011AA Property)
C25198 (NCI Thesaurus Property)
C0034869 (UMLS 2011AA Property)

PatientParticipatingIdentifierNumber

Item

Other Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

CombinedInstitutionName

Item

Institution/Affiliate

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25454 (NCI Thesaurus ObjectClass)
C0205195 (UMLS 2011AA ObjectClass)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C21541 (NCI Thesaurus ValueDomain)
C0018704 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

RegisteringInstitutionIdentifierCode

Item

Registering Institution Code

text

C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25645 (NCI Thesaurus ObjectClass)

RegisteredInvestigatorName

Item

Physician of Record

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
C25644 (NCI Thesaurus ObjectClass)

Form Administration

Item Group

Form Administration

ResponsiblePersonName

Item

Person Completing Form

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

FormCompleteDate

Item

Date Form Completed (MM DD YYYY)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C40988 (NCI Thesaurus ObjectClass)
C1516308 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain)

DataAmendedInd-3

Item

Are data amended (If data are amended, please circle in red when using paper form)

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)

CL.1

Code List

Are data amended (If data are amended, please circle in red when using paper form)

CL Item

Yes (yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (no)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

Lung: Pre-Treatment Characteristics

Item Group

Lung: Pre-treatment Characteristics

PatientWeightMeasurement

Item

Patient Weight (kg)

double

C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25208 (NCI Thesaurus Property)
C0043100 (UMLS 2011AA Property)

PatientWeightLossPercentageScale

Item

Weight Loss in Previous Six Months (Approximate check one)

text

C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3445 (NCI Thesaurus Property)
C0043096 (UMLS 2011AA Property)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)

CL.2

Code List

Weight Loss in Previous Six Months (Approximate check one)

CL Item

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

CL Item

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

CL Item

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

CL Item

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

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

PatientWeightLossPercentageValue

Item

Weight loss in previous 6 months (Approximate kg)

double

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3445 (NCI Thesaurus Property)
C0043096 (UMLS 2011AA Property)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

Smoking history

Item

Smoking History

text

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

CL.3

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

CL Item

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

text

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

CL.4

Code List

Does the patient currently smoke

CL Item

Yes (yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (no)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

Smoker amount smoked

Item

Number of Cigarettes per day (If yes,)

text

C17934 (NCI Thesaurus ObjectClass)
C1608325 (UMLS CUI-1)
C25471 (NCI Thesaurus Property)
C0449865 (NCI Metathesaurus Property)
C25473 (NCI Thesaurus ValueDomain)
C25515 (NCI Thesaurus ValueDomain)

CL.5

Code List

Number of Cigarettes per day (If yes,)

CL Item

Fewer Than 10 Cigarettes (Fewer than 10 cigarettes)

CL Item

10 To 20 Cigarettes (10 to 20 cigarettes)

CL Item

More Than 20 Cigarettes (More than 20 cigarettes)

CL Item

Not Applicable (Not applicable)

C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)

SmokingDiscontinuedDuration

Item

Time since last cigarette (If no,)

text

C25484 (NCI Thesaurus Property)
C1444662 (UMLS 2011AA Property)
C17934 (NCI Thesaurus ObjectClass)
C0453996 (UMLS 2011AA ObjectClass)
C25330 (NCI Thesaurus ValueDomain)
C0449238 (UMLS 2011AA ValueDomain)

CL.6

Code List

Time since last cigarette (If no,)

CL Item

Less Than 1 Month (Less than 1 month)

CL Item

1 Month To <6 Months (1 month to <6 months)

CL Item

6 Months To <1 Year (6 months to <1 year)

CL Item

1 Year To <5 Years (1 year to <5 years)

CL Item

5 Years To <10 Years (5 years to <10 years)

CL Item

More Than 10 Years (More than 10 years)

CL Item

Not Applicable (Not applicable)

C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)

Lung: Disease Description - SCLC

Item Group

Lung: Disease Description ¿ Stage I-iii

SmallCellLungCarcinomaInvasionStatus

Item

Extent of disease

text

C4917 (NCI Thesaurus ObjectClass)
C0149925 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
C20625 (NCI Thesaurus Property)
C1269955 (UMLS 2011AA Property)

CL.7

Code List

Extent of disease

CL Item

Limited (Limited)

CL110648 (NCI Metathesaurus)

CL Item

Extensive (Extensive)

C47863 (NCI Thesaurus)
C0205231 (UMLS 2011AA)

CL Item

Recurrent (Recurrent)

C14173 (NCI Thesaurus)
C2945760 (UMLS 2011AA)

CancerProgressionFirstLocal-RegionalDiagnosisInd-3

Item

Has the patient been diagnosed with first local-regional recurrence

text

C19987 (NCI Thesaurus ObjectClass)
C0242656 (UMLS 2011AA ObjectClass)
C25388 (NCI Thesaurus Property)
C1947913 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

CL.8

Code List

Has the patient been diagnosed with first local-regional recurrence

CL Item

Yes (YES)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (NO)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CancerProgressionFirstLocal-RegionalDiagnosisDuration

Item

Time since diagnosis (If yes,)

text

C19987 (NCI Thesaurus ObjectClass)
C0242656 (UMLS 2011AA ObjectClass)
C25388 (NCI Thesaurus Property)
C1947913 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C15220 (NCI Thesaurus ValueDomain)
C0011900 (UMLS 2011AA ValueDomain)
C25330 (NCI Thesaurus ValueDomain)
C0449238 (UMLS 2011AA ValueDomain)

CL.9

Code List

Time since diagnosis (If yes,)

CL Item

Less Than 3 Months (< 3 months)

CL Item

Greater Than Or Equal To 3 Months (>= 3 months)

NeoplasmMixedHistologyInd-3

Item

Mixed histology?

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C16681 (NCI Thesaurus Property)
C0019638 (UMLS 2011AA Property)
C26457 (NCI Thesaurus Property)
C0205430 (UMLS 2011AA Property)

CL.10

Code List

Mixed histology?

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

LungTumorHistologicClassificationLungTumorHistologicCategory

Item

Histologic Type (If yes check all apply)

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12468 (NCI Thesaurus ObjectClass)
C0024109 (UMLS 2011AA ObjectClass)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25161 (NCI Thesaurus Property)
C0008902 (UMLS 2011AA Property)
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C25526 (NCI Thesaurus ValueDomain)
C0205462 (UMLS 2011AA ValueDomain)

CL.11

Code List

Histologic Type (If yes check all apply)

CL Item

Squamous Cell Carcinoma (Squamous cell carcinoma)

C2929 (NCI Thesaurus)
C0007137 (UMLS 2011AA)

CL Item

Adenocarcinoma (Adenocarcinoma)

C2852 (NCI Thesaurus)
C0001418 (UMLS 2011AA)

CL Item

Large Cell Undifferentiated (Large cell undifferentiated)

CL Item

Non-small Cell Lung Cancer (nsclc), Nos (Non-small cell lung cancer NOS)

CL Item

Large Cell With Neuroendocrine Features (Large cell with neuroendocrine features)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

TumorHistologicCategorySpecify

Item

Specify Other Histologic Type

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25161 (NCI Thesaurus Property)
C0008902 (UMLS 2011AA Property)

MeasurableDiseasePresentInd-3

Item

Is measurable disease present? (only applicable in studies where there is disease at baseline)

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C37894 (NCI Thesaurus ObjectClass)
C1513040 (UMLS 2011AA ObjectClass)

CL.12

Code List

Is measurable disease present? (only applicable in studies where there is disease at baseline)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

Non-measurableDiseasePresentInd-3

Item

Is non-measurable disease present? (only applicable in studies where there is disease at baseline)

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25589 (NCI Thesaurus ObjectClass)
C1518373 (UMLS 2011AA ObjectClass)

CL.13

Code List

Is non-measurable disease present? (only applicable in studies where there is disease at baseline)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

LungMalignantNeoplasmMetastaticInvolvementSite

Item

Metastatic Sites (check all that apply)

text

C12468 (NCI Thesaurus ObjectClass)
C0024109 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C14174 (NCI Thesaurus Property)
C0036525 (UMLS 2011AA Property)
C25548 (NCI Thesaurus Property)
C1314939 (UMLS 2011AA Property)
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)

CL.14

Code List

Metastatic Sites (check all that apply)

CL Item

Hilar Nodes (Hilar nodes)

CL Item

Mediastinal Nodes (Mediastinal nodes)

CL Item

Supraclavicular Or Scalene Nodes (Supraclavicular/scalene nodes)

CL Item

Pleura (Pleura)

C12469 (NCI Thesaurus)
C0032225 (UMLS 2011AA)

CL Item

Liver (Liver)

C12392 (NCI Thesaurus)
C0023884 (UMLS 2011AA)

CL Item

Adrenal Gland (Adrenal(s))

C12666 (NCI Thesaurus)
C0001625 (UMLS 2011AA)

CL Item

Bone (Bone)

C12366 (NCI Thesaurus)
C0262950 (UMLS 2011AA)

CL Item

Bone Marrow (Bone marrow)

C12431 (NCI Thesaurus)
C0005953 (UMLS 2011AA)

CL Item

Brain (Brain)

C12439 (NCI Thesaurus)
C0006104 (UMLS 2011AA)

CL Item

Skin (Skin)

C12470 (NCI Thesaurus)
C1123023 (UMLS 2011AA)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

MalignantNeoplasmMetastaticInvolvementSpecify

Item

Other specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C14174 (NCI Thesaurus Property)
C0036525 (UMLS 2011AA Property)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25548 (NCI Thesaurus Property)
C1314939 (UMLS 2011AA Property)

LungPleuralEffusionInd-3

Item

Is Pleural Effusion present?

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12468 (NCI Thesaurus ObjectClass)
C0024109 (UMLS 2011AA ObjectClass)
C3003 (NCI Thesaurus Property)
C0013687 (UMLS 2011AA Property)
C25223 (NCI Thesaurus Property)
C1522720 (UMLS 2011AA Property)

CL.15

Code List

Is Pleural Effusion present?

CL Item

Yes (YES)

CL Item

No (NO)

LungPleuralEffusionMalignantInd

Item

Is it Malignant? (If yes)

text

C12468 (NCI Thesaurus ObjectClass)
C0024109 (UMLS 2011AA ObjectClass)
C3003 (NCI Thesaurus Property)
C0013687 (UMLS 2011AA Property)
C25223 (NCI Thesaurus Property)
C1522720 (UMLS 2011AA Property)
C14143 (NCI Thesaurus ValueDomain)
C0205282 (UMLS 2011AA ValueDomain)
C0021212 (NCI Metathesaurus ValueDomain)

CL.16

Code List

Is it Malignant? (If yes)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Unknown (Unknown (not tapped))

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

LesionSite

Item

Lesion Site (Primary)

text

C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)

AdverseEventMedDRALowLevelTermVersionInteger::12.0Code

Item

MedDRA Code (for Primary Disease Site)

double

C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C71886 (NCI Thesaurus ObjectClass)
C2347090 (UMLS 2011AA ObjectClass)
C25162 (NCI Thesaurus Property)
C0805701 (UMLS 2011AA Property)
C43820 (NCI Thesaurus Property)
C1140263 (UMLS 2011AA Property)
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C41331 (NCI Thesaurus ValueDomain)
C0877248 (UMLS 2011AA ValueDomain)
C45255 (NCI Thesaurus ValueDomain)
C1708523 (UMLS 2011AA ValueDomain)
C43820 (NCI Thesaurus ValueDomain)
C1140263 (UMLS 2011AA ValueDomain)
C25714 (NCI Thesaurus ValueDomain)
C0333052 (UMLS 2011AA ValueDomain)

PatientParaneoplasticSyndromePresentInd-3

Item

Paraneoplastic syndrome

text

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C0030705 (NCI Metathesaurus ObjectClass)
C3311 (NCI Thesaurus Property)
C0030472 (UMLS 2011AA Property)

CL.17

Code List

Paraneoplastic syndrome

CL Item

Yes (yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (no)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

PatientParaneoplasticSyndromePresentSpecify

Item

Specify (If yes)

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C0030705 (NCI Metathesaurus ObjectClass)
C3311 (NCI Thesaurus Property)
C0030472 (UMLS 2011AA Property)

Lung: Prior Treatment (CDUS Module) - SCLC

Item Group

Lung: Prior Treatment (cdus Module) ¿ Nsclc Stage I-iii

PriorTherapyAdministeredType

Item

Prior therapy type (per CDUS reporting guidelines check all that apply)

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)

CL.18

Code List

Prior therapy type (per CDUS reporting guidelines check all that apply)

CL Item

Agents Administered To Control The Replication And/or Spread Of Viruses (Anti-retroviral therapy)

CL Item

Treatment With An Agent That Prevents Or Impairs The Translation Of The Genetic Message For Production Of A Specific Protein (Antisense)

CL Item

High Dose Chemotherapy Combined With Transplantation Of Bone Marrow Cells (Bone marrow transplant)

CL Item

Non-systemic Chemotherapy Treatment Or Chemotherapy Not Described By Chemotherapy Single Agent Systemic Or Multi-agent Systemic (Chemotherapy (NOS))

CL Item

Systemic Chemotherapy With A Regimen Containing Multiple Agents (Chemotherapy multiple agents systemic)

CL Item

Prior Therapy With Agents That Are Not Known To Cause Damage To Cycling Cells (Chemotherapy non-cytotoxic)

CL Item

Systemic Chemotherapy With A Single Agent Regimen (Chemotherapy single agent systemic)

CL Item

Treatment Of Human Disease By Gene Transfer (Gene transfer)

CL Item

Cancer Therapy Which Incorporates Hormonal Manipulation (Hormonal therapy)

CL Item

Drug And/or Immunotherapy (Drug and/or Immunotherapy)

CL Item

No Previous Exposure To Drug (nos) (No prior therapy)

CL Item

Anticancer Treatment With A Live, Replication-competent Virus (Oncolytic virotherapy)

CL Item

Prior Therapy (nos) (Prior therapy NOS)

CL Item

Targeted Ionizing Radiation Therapy Utilizing Radioactive Implants Or Seeds (Radiation therapy)

CL Item

Surgical Procedure, Or Operation, With Therapeutic Intent (Surgery)

CL Item

Therapy Nos (Therapy (NOS))

CL Item

Substance Or Group Of Substances Administered To Induce The Immune System To Recognize And Destroy Tumors Or Microorganisms (Vaccine)

PriorTreatmentRegimenCount

Item

Number of prior therapy regimens (For example, planned treatment of chemotherapy + RT = 1 regimen)

double

C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C15697 (NCI Thesaurus Property)
C0040808 (UMLS 2011AA Property)

AdverseEventMedDRALowLevelTermVersionInteger::12.0Code

Item

MedDRA Code (for Primary Disease Site)

double

Lung: Prior Systemic Therapy - SCLC

Item Group

Lung: Prior Systemic Therapy ¿ Nsclc Advanced

PriorSystemicTherapyAdministeredInd-2

Item

Prior systemic therapy

text

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15698 (NCI Thesaurus ObjectClass)
C1515119 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

CL.19

Code List

Prior systemic therapy

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

PriorTreatmentRegimenCount

Item

Number of prior therapy regimens (For example, planned treatment of chemotherapy + RT = 1 regimen)

double

AgentName

Item

Agent Name

text

C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C0450442 (UMLS 2011AA ValueDomain)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)

AgentBeginDate

Item

Agent Start Date (MM DD YYYY)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)

AgentEndDate

Item

Agent End Date (MM DD YYYY)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)

CumulativeAgentTotalDose

Item

Agent Total Cumulative Dose

double

C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25470 (NCI Thesaurus ObjectClass)
C1511559 (UMLS 2011AA ObjectClass)
C25304 (NCI Thesaurus Property)
C0439810 (UMLS 2011AA Property)
C25256 (NCI Thesaurus Property)
C1265611 (UMLS 2011AA Property)
C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)

AgentQuantityUnitText

Item

Units

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C44278 (NCI Thesaurus ValueDomain)
C0439148 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25256 (NCI Thesaurus Property)
C1265611 (UMLS 2011AA Property)

ResponseOverallDuration

Item

Overall Response Duration (weeks)

double

C25755 (NCI Thesaurus ObjectClass)
C0871261 (UMLS 2011AA ObjectClass)
C25605 (NCI Thesaurus Property)
C1561607 (UMLS 2011AA Property)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25605 (NCI Thesaurus ValueDomain)
C1561607 (UMLS 2011AA ValueDomain)
C25330 (NCI Thesaurus ValueDomain)
C0449238 (UMLS 2011AA ValueDomain)

Lung: Prior Surgery - SCLC

Item Group

Lung: Prior Surgery ¿ Nsclc Advanced

PriorSurgeryPerformedInd-3

Item

Prior Surgery

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)

CL.20

Code List

Prior Surgery

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

Surgical Procedure Description

Item Group

Procedure Description

LungSurgicalProcedureAdministeredType

Item

Surgical Approach

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C12468 (NCI Thesaurus ObjectClass)
C0024109 (UMLS 2011AA ObjectClass)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

CL.21

Code List

Surgical Approach

CL Item

Thoracotomy (thoracotomy)

CL Item

Thoracoscopy / Video-assisted (vats) (Thoracoscopy / Video-assisted (VATS))

CL Item

Thoracoscopy / Video-assisted (vats), With Conversion To Thoracotomy (Thoracoscopy / Video-assisted (VATS), with conversion to Thoracotomy)

LungPrimarySurgicalProcedurePerformedType

Item

Primary Surgery Type

text

C25251 (NCI Thesaurus ObjectClass)
C0205225 (UMLS 2011AA ObjectClass)
C12468 (NCI Thesaurus ObjectClass)
C0024109 (UMLS 2011AA ObjectClass)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.22

Code List

Primary Surgery Type

CL Item

Exploration, No Resection (Exploration, No Resection)

CL Item

Segmentectomy (Segmentectomy)

CL Item

Wedge Resection (Wedge Resection)

CL Item

Lobectomy (Lobectomy)

C15272 (NCI Thesaurus)
C0023928 (UMLS 2011AA)

CL Item

Bilobectomy (Bilobectomy)

CL Item

Pneumonectomy (Pneumonectomy)

C15305 (NCI Thesaurus)
C0032284 (UMLS 2011AA)

SurgeryDate

Item

Surgery Date (MM DD YYYY)

date

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

Lung: Prior Radiation Therapy - SCLC

Item Group

Lung: Prior Radiation Therapy ¿ Nsclc Advanced

PriorRTAdministeredInd-3

Item

Prior Radiation Therapy

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

CL.23

Code List

Prior Radiation Therapy

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

RTLungAdministeredTotalDose

Item

Total Dose to Lung (cGy)

double

C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C12468 (NCI Thesaurus Property)
C0024109 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)

RTEndDate

Item

Radiation Therapy End Date (MM DD YYYY)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25496 (NCI Thesaurus Property)
C2746065 (UMLS 2011AA Property)

PatientProphylacticCranialIrradiationReceivedInd-3

Item

Did the patient receive prophylactic cranial irradiation?

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C15913 (NCI Thesaurus Property)
C1514496 (UMLS 2011AA Property)

CL.24

Code List

Did the patient receive prophylactic cranial irradiation?

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

HyperfractionationRadiationTherapyAdministeredInd-2

Item

Was radiation therapy hyperfractionated?

text

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C15745 (NCI Thesaurus ObjectClass)
C1512552 (UMLS 2011AA ObjectClass)

CL.26

Code List

Was radiation therapy hyperfractionated?

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

DailyRadiationTherapyAnatomicSiteAdministeredDose

Item

RT Daily Dose per Field (If yes)

double

C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25473 (NCI Thesaurus ObjectClass)
C0332173 (UMLS 2011AA ObjectClass)
C13717 (NCI Thesaurus Property)
C1515974 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)

DailyRadiationTherapyAnatomicSiteAdministeredDose

Item

RT Daily Dose per Field (If yes)

double

RTAdministeredTotalDose

Item

RT Total Dose

double

C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

RTAdministeredTotalDose

Item

RT Total Dose

double

RTAdministeredTotalDose

Item

RT Total Dose

double

AgentDoseUOM

Item

Units

text

C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25256 (NCI Thesaurus Property)
C1265611 (UMLS 2011AA Property)
C25709 (NCI Thesaurus ValueDomain)
C1519795 (UMLS 2011AA ValueDomain)

CL.29

Code List

Units

CL Item

Grays (Gy)

CL Item

Microcurie (mcCi)

AgentDoseUOM

Item

Units

text

CL.29

Code List

Units

CL Item

Grays (Gy)

CL Item

Microcurie (mcCi)

AgentDoseUOM

Item

Units

text

CL.29

Code List

Units

CL Item

Grays (Gy)

CL Item

Microcurie (mcCi)

AgentDoseUOM

Item

Units

text

CL.29

Code List

Units

CL Item

Grays (Gy)

CL Item

Microcurie (mcCi)

RTSiteName

Item

Radiation Therapy Site

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)

RTFractionsDose

Item

RT Dose per Fraction

double

C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
C25514 (NCI Thesaurus Property)
C1264633 (UMLS 2011AA Property)

RadiationTherapyTotalFractionsCount

Item

Total Number of Fractions

double

C25304 (NCI Thesaurus Property)
C0439810 (UMLS 2011AA Property)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25514 (NCI Thesaurus Property)
C1264633 (UMLS 2011AA Property)

RTInterruptionInd

Item

Were there any unscheduled interruptions in radiation therapy?

text

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25542 (NCI Thesaurus Property)
C1512900 (UMLS 2011AA Property)

CL.30

Code List

Were there any unscheduled interruptions in radiation therapy?

CL Item

Yes, Due To Toxicity (Yes, due to toxicity)

CL Item

Yes, Due To Other Reason (Yes, due to other reasons)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

RadiationTherapyInterruptionText

Item

RT Interruptions Reason (Specify)

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25542 (NCI Thesaurus Property)
C1512900 (UMLS 2011AA Property)

Comments

Item Group

Comments

ResearchCommentsText

Item

Comments

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0282411 (UMLS 2011AA Property)

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On-Study - Phase II Lung Cancer - SCLC On-Study Form - 2404433v1.0

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