ID

2805

Beschrijving

On-Study Form A Phase III, Randomized Study of Gemcitabine (Fixed-Dose Rate Infusion) and Oxaliplatin (NSC 266046) Versus Gemcitabine (Fixed-Dose Rate Infusion) Versus Gemcitabine (30-Minute Infusion) in Pancreatic Carcinoma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A65D6B91-79C6-4288-E034-0003BA0B1A09

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A65D6B91-79C6-4288-E034-0003BA0B1A09

Trefwoorden

Versies (4)
  1. 19-09-12 19-09-12 -
  2. 28-05-15 28-05-15 -
  3. 03-06-15 03-06-15 -
  4. 20-09-21 20-09-21 -
Geüploaded op

19 september 2012

DOI

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Licentie

Creative Commons BY-NC 3.0 Legacy
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Pancreatic Cancer NCT00058149 On-Study - On-Study Form - 2048401v3.0

Engels

No Instruction available.

1 Formulieren  
  1. StudyEvent: On-Study Form
    1. No Instruction available.
Unnamed1
Beschrijving

Unnamed1

Registration Step
Beschrijving

RegistrationStep

Datatype

text

Patient?s Name
Beschrijving

Patient'sName

Datatype

text

ECOG Protocol No.
Beschrijving

ECOGProtocolNo.

Datatype

text

ECOG Protocol No.
Beschrijving

ECOGProtocolNo.

Datatype

text

ECOG Patient ID
Beschrijving

ECOGPatientID

Datatype

text

ECOG Patient ID
Beschrijving

ECOGPatientID

Datatype

text

Participating Group Protocol No.
Beschrijving

ParticipatingGroupProtocolNo.

Datatype

text

Participating Group Patient ID
Beschrijving

ParticipatingGroupPatientID

Datatype

text

Institution/Affiliate
Beschrijving

MainMemberInstitution/Affiliate

Datatype

text

Unnamed2
Beschrijving

Unnamed2

Are data amended?
Beschrijving

AmendedDataInd

Datatype

text

Alias
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C25416
UMLS 2011AA Property
C1691222
Performance status
Beschrijving

PerformanceStatus

Datatype

text

Weight loss in previous 6 months (choose one)
Beschrijving

WeightLossPriorSixMonths

Datatype

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C3445
UMLS 2011AA Property
C0043096
Disease Description
Beschrijving

Disease Description

Date of initial diagnosis of primary tumor (first positive biopsy date)
Beschrijving

FirstPositiveBiopsyDate

Datatype

date

Primary Site, other specify
Beschrijving

PrimarySite,Other

Datatype

text

Date of most recent prior recurrence (if patient has responded to prior treatment)
Beschrijving

PriorRecentRecurrenceDate

Datatype

date

Alias
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus Property
C25279
UMLS 2011AA Property
C0332162
Primary site (choose one)
Beschrijving

PrimarySite

Datatype

text

Histologic grade (choose one)
Beschrijving

HistologicGrade

Datatype

text

Histologic Type (choose one)
Beschrijving

HistologicType

Datatype

text

Other specify
Beschrijving

HistologicType,OtherName

Datatype

text

Is there histologic proof of residual or metastatic malignant disease?
Beschrijving

Istherehistologicproofofresidualormetastaticmalignantdisease?

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Unnamed3
Beschrijving

Unnamed3

Form No.
Beschrijving

FormNo.

Datatype

text

Patient?s Name
Beschrijving

Patient'sName

Datatype

text

ECOG Patient ID
Beschrijving

ECOGPatientID

Datatype

text

Site(s) Of Involvement
Beschrijving

Site(s) Of Involvement

Pancreas
Beschrijving

Primarytumor/Pancreas

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Regional lymph nodes
Beschrijving

RegionalLymphNode(s)Ind

Datatype

text

Distant lymph nodes
Beschrijving

DistantLymphNode(s)Ind

Datatype

text

Adjacent viscera/vessels
Beschrijving

Adjacentviscera/vessels

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Liver
Beschrijving

LiverSiteInd

Datatype

text

Peritoneum
Beschrijving

PeritoneumInd

Datatype

text

Lung
Beschrijving

LungSiteInd

Datatype

text

Bone
Beschrijving

BoneSiteInd

Datatype

text

Other
Beschrijving

OtherSiteInd

Datatype

text

Other specify
Beschrijving

OtherSiteName

Datatype

text

Advanced Disease Status at Registration
Beschrijving

AdvancedDiseaseRegistrationStatus

Datatype

text

CEA (ng/dl)
Beschrijving

CEA

Datatype

text

CEA ULN
Beschrijving

LaboratoryProcedureCarcinoembryonicAntigenOutcomeUpperLimitNormalValue

Datatype

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C25159
UMLS 2011AA Property
C0007082
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25706
UMLS 2011AA ValueDomain
C1519815
Date CEA obtained (M D Y)
Beschrijving

CarcinoembryonicAntigenSpecimenCollectionDate

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25159
UMLS 2011AA ObjectClass
C0007082
NCI Thesaurus Property
C25453
UMLS 2011AA Property
C1516698
NCI Thesaurus ObjectClass
C19157
UMLS 2011AA ObjectClass
C0370003
CA19-9 (U/ml)
Beschrijving

CA19-9

Datatype

text

Date CA19-9 obtained (M D Y)
Beschrijving

DateCA19-9obtained

Datatype

text

Baseline Hematology/chemistry
Beschrijving

Baseline Hematology/chemistry

WBC count (x1000), LLN
Beschrijving

WBCcount(x1000),LLN

Datatype

text

WBC count (x1000), Value
Beschrijving

Lab,Hematology,WBC

Datatype

double

Granulocyte count (AGC/ANC), Value
Beschrijving

Lab,Hematology,GranulocyteCount

Datatype

double

Platelets count (x1000), LLN
Beschrijving

Plateletscount(x1000),LLN

Datatype

double

Alias
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25555
UMLS 2011AA ValueDomain
C1518030
Platelets count (x1000), Value
Beschrijving

Lab,Hematology,Platelets

Datatype

double

Hemoglobin (g/dl), LLN
Beschrijving

Hemoglobin(g/dl),LLN

Datatype

text

Hemoglobin (g/dl), Value
Beschrijving

Lab,Hematology,Hemoglobin

Datatype

double

Albumin (g/dl), LLN
Beschrijving

Albumin(g/dl),LLN

Datatype

double

Alias
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25555
UMLS 2011AA ValueDomain
C1518030
Albumin (g/dl), Value
Beschrijving

Lab,Chemistry,Albumin

Datatype

double

Creatinine (mg/dl), ULN
Beschrijving

Creatinine(mg/dl),ULN

Datatype

text

Creatinine (mg/dl), Value
Beschrijving

Lab,Renal,Creatinine

Datatype

double

SGOT (AST) (U/L), ULN
Beschrijving

SGOT(AST)ULN

Datatype

double

Alias
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25706
UMLS 2011AA ValueDomain
C1519815
SGOT (AST) (U/L), Value
Beschrijving

Lab,Hepatic,SGOT

Datatype

double

Date Obtained (M D Y)
Beschrijving

Lab,Hematology,SampleCollectionDate

Datatype

date

Date Obtained (M D Y)
Beschrijving

Lab,Hematology,SampleCollectionDate

Datatype

date

Date Obtained (M D Y)
Beschrijving

Lab,Hematology,SampleCollectionDate

Datatype

date

Date Obtained (M D Y)
Beschrijving

Lab,Hematology,SampleCollectionDate

Datatype

date

Date Obtained (M D Y)
Beschrijving

Lab,Hematology,SampleCollectionDate

Datatype

date

Date Obtained (M D Y)
Beschrijving

Lab,Hematology,SampleCollectionDate

Datatype

date

Date Obtained (M D Y)
Beschrijving

Lab,Hematology,SampleCollectionDate

Datatype

date

Bilirubin (mg/dl), ULN
Beschrijving

Bilirubin(mg/dl),ULN

Datatype

double

Alias
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25706
UMLS 2011AA ValueDomain
C1519815
Bilirubin (mg/dl), Value
Beschrijving

Lab,Hepatic,Bilirubin

Datatype

double

Unnamed4
Beschrijving

Unnamed4

Form No.
Beschrijving

FormNo.

Datatype

text

Patient?s Name
Beschrijving

Patient'sName

Datatype

text

ECOG Patient ID
Beschrijving

ECOGPatientID

Datatype

text

Prior Therapy
Beschrijving

Prior Therapy

Prior radiation therapy? (Choose one:)
Beschrijving

PriorRTInd

Datatype

text

Prior RT begin date (M D Y)
Beschrijving

PriorRTBeginDate

Datatype

date

Prior RT end date (M D Y)
Beschrijving

PriorRTEndDate

Datatype

date

RT site:
Beschrijving

RTSite

Datatype

text

Unnamed5
Beschrijving

Unnamed5

Comments
Beschrijving

Comments

Datatype

text

Investigator Signature
Beschrijving

InvestigatorSignature

Datatype

text

Alias
NCI Thesaurus Property
C25678
UMLS 2011AA Property
C1519316
NCI Thesaurus ObjectClass
C17089
UMLS 2011AA ObjectClass
C0035173
Date
Beschrijving

InvestigatorSignatureDate

Datatype

date

Ccrr Module For On-study Form
Beschrijving

Ccrr Module For On-study Form

Site(s) of Involvement, Other specify
Beschrijving

DiseaseInvolvementSite,Other

Datatype

text

Prior surgery
Beschrijving

PriorSurgeryInd

Datatype

text

Specify prior thrombotic event
Beschrijving

Specifypriorthromboticevent

Datatype

text

Does the patient have a prior history of deep vein thrombosis or pulmonary embolus?
Beschrijving

Doesthepatienthaveapriorhistoryofdeepveinthrombosisorpulmonaryembolus?

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Prior thrombosis?
Beschrijving

Priorthrombosis?

Datatype

text

Time frame of thrombosis
Beschrijving

Timeframeofthrombosis

Datatype

text

Prior embolus?
Beschrijving

Priorembolus?

Datatype

text

Time frame of embolus
Beschrijving

Timeframeofembolus

Datatype

text

date of prior surgery
Beschrijving

PriorSurgeryDate

Datatype

date

Date of initial diagnosis of unresectable locally advanced disease
Beschrijving

InitialDiagnosisDate,LocallyAdvanced

Datatype

date

Date of initial diagnosis of metastatic disease
Beschrijving

InitialDiagnosisDate,Metastatic

Datatype

date

Is measurable disease present?
Beschrijving

DiseaseAssessment,MeasurableInd

Datatype

text

Is non-measurable disease present?
Beschrijving

DiseaseAssessment,Non-measurableInd

Datatype

text

Prior adjuvant chemotherapy end date
Beschrijving

PriorAdjuvantChemotherapyEndDate

Datatype

date

Prior adjuvant chemotherapy begin date
Beschrijving

PriorAdjuvantChemotherapyBeginDate

Datatype

date

Prior adjuvant chemotherapy end date
Beschrijving

PriorAdjuvantChemotherapyEndDate

Datatype

date

Primary Site, other specify
Beschrijving

PrimarySite,Other

Datatype

text

Specify agents
Beschrijving

Specifyagents

Datatype

text

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No Instruction available.

1 Formulieren
  1. StudyEvent: On-Study Form
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Unnamed1
RegistrationStep
Item
Registration Step
text
Patient'sName
Item
Patient?s Name
text
ECOGProtocolNo.
Item
ECOG Protocol No.
text
ECOGProtocolNo.
Item
ECOG Protocol No.
text
ECOGPatientID
Item
ECOG Patient ID
text
ECOGPatientID
Item
ECOG Patient ID
text
ParticipatingGroupProtocolNo.
Item
Participating Group Protocol No.
text
ParticipatingGroupPatientID
Item
Participating Group Patient ID
text
MainMemberInstitution/Affiliate
Item
Institution/Affiliate
text
Item Group
Unnamed2
Item
Are data amended?
text
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
CL.1
Code List
Are data amended?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Performance status
text
CL.2
Code List
Performance status
CL Item
0 (Fully active, able to carry on all pre-disease performance without restriction (Karnofsky 90-100))
C0919414 (NCI Metathesaurus)
CL Item
1 (Restricted in physically strenuous activity but ambulatory (K 70-80))
CL Item
2 (Ambulatory and capable of all selfcare but unable to carry out any work activities (K 50-60))
C66833 (NCI Thesaurus)
C0205448 (UMLS 2011AA)
CL Item
3 (Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours (K 30-40))
CL Item
4 (completely disabled (K 10-20))
Item
Weight loss in previous 6 months (choose one)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3445 (NCI Thesaurus Property)
C0043096 (UMLS 2011AA Property)
CL.3
Code List
Weight loss in previous 6 months (choose one)
CL Item
<5% Of Body Weight (less than 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 (greater than or equal to 20% of body weight)
Item Group
Disease Description
FirstPositiveBiopsyDate
Item
Date of initial diagnosis of primary tumor (first positive biopsy date)
date
PrimarySite,Other
Item
Primary Site, other specify
text
PriorRecentRecurrenceDate
Item
Date of most recent prior recurrence (if patient has responded to prior treatment)
date
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25279 (NCI Thesaurus Property)
C0332162 (UMLS 2011AA Property)
Item
Primary site (choose one)
text
CL.4
Code List
Primary site (choose one)
CL Item
Head Of Pancreas (Head of pancreas)
C0227579 (NCI Metathesaurus)
CL Item
Body Of Pancreas (Body of pancreas)
C0227582 (NCI Metathesaurus)
CL Item
Tail Of Pancreas (Tail of pancreas)
C0227590 (NCI Metathesaurus)
CL Item
Uncinate Process (Uncinate process)
CL Item
Diffuse (Diffuse)
C14175 (NCI Thesaurus)
C0205219 (UMLS 2011AA)
CL Item
Other, Specify (Other)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Histologic grade (choose one)
text
CL.5
Code List
Histologic grade (choose one)
CL Item
Tumor Is Well Differentiated According To Who Grading System (Well differentiated)
CL Item
Tumor Is Moderately Differentiated According To Who Grading System (Moderately differentiated)
CL Item
Tumor Is Poorly Differentiated According To Who Grading System (Poorly differentiated)
CL Item
Tumor Is Undifferentiated According To Who Grading System (Undifferentiated)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Histologic Type (choose one)
text
CL.6
Code List
Histologic Type (choose one)
CL Item
Ductal Adenocarcinoma (Ductal adenocarcinoma)
CL Item
Neuroendocrine Carcinoma (Neuroendocrine carcinoma)
C3773 (NCI Thesaurus)
C0206695 (UMLS 2011AA)
CL Item
Mixed-type (ductal-endocrine Or Acinar-endocrine) (Mixed ductal - endocrine carcinoma)
CL Item
Undifferentiated (anaplastic) Carcinoma (Undifferentiated (anaplastic) carcinoma)
CL Item
Other, Specify (Other)
HistologicType,OtherName
Item
Other specify
text
Item
Is there histologic proof of residual or metastatic malignant disease?
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.7
Code List
Is there histologic proof of residual or metastatic malignant disease?
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 Group
Unnamed3
FormNo.
Item
Form No.
text
Patient'sName
Item
Patient?s Name
text
ECOGPatientID
Item
ECOG Patient ID
text
Item Group
Site(s) Of Involvement
Item
Pancreas
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.8
Code List
Pancreas
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Regional lymph nodes
text
CL.9
Code List
Regional lymph nodes
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Distant lymph nodes
text
CL.10
Code List
Distant lymph nodes
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Adjacent viscera/vessels
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.11
Code List
Adjacent viscera/vessels
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Liver
text
CL.12
Code List
Liver
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Peritoneum
text
CL.13
Code List
Peritoneum
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Lung
text
CL.14
Code List
Lung
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Bone
text
CL.15
Code List
Bone
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Other
text
CL.16
Code List
Other
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
OtherSiteName
Item
Other specify
text
Item
Advanced Disease Status at Registration
text
CL.17
Code List
Advanced Disease Status at Registration
CL Item
Initial Diagnosis (Initial diagnosis)
CL Item
Recurrence (Recurrence)
CEA
Item
CEA (ng/dl)
text
LaboratoryProcedureCarcinoembryonicAntigenOutcomeUpperLimitNormalValue
Item
CEA ULN
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25159 (NCI Thesaurus Property)
C0007082 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
CarcinoembryonicAntigenSpecimenCollectionDate
Item
Date CEA obtained (M D Y)
text
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25159 (NCI Thesaurus ObjectClass)
C0007082 (UMLS 2011AA ObjectClass)
C25453 (NCI Thesaurus Property)
C1516698 (UMLS 2011AA Property)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
CA19-9
Item
CA19-9 (U/ml)
text
DateCA19-9obtained
Item
Date CA19-9 obtained (M D Y)
text
Item Group
Baseline Hematology/chemistry
WBCcount(x1000),LLN
Item
WBC count (x1000), LLN
text
Lab,Hematology,WBC
Item
WBC count (x1000), Value
double
Lab,Hematology,GranulocyteCount
Item
Granulocyte count (AGC/ANC), Value
double
Plateletscount(x1000),LLN
Item
Platelets count (x1000), LLN
double
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain)
C1518030 (UMLS 2011AA ValueDomain)
Lab,Hematology,Platelets
Item
Platelets count (x1000), Value
double
Hemoglobin(g/dl),LLN
Item
Hemoglobin (g/dl), LLN
text
Lab,Hematology,Hemoglobin
Item
Hemoglobin (g/dl), Value
double
Albumin(g/dl),LLN
Item
Albumin (g/dl), LLN
double
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain)
C1518030 (UMLS 2011AA ValueDomain)
Lab,Chemistry,Albumin
Item
Albumin (g/dl), Value
double
Creatinine(mg/dl),ULN
Item
Creatinine (mg/dl), ULN
text
Lab,Renal,Creatinine
Item
Creatinine (mg/dl), Value
double
SGOT(AST)ULN
Item
SGOT (AST) (U/L), ULN
double
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
Lab,Hepatic,SGOT
Item
SGOT (AST) (U/L), Value
double
Lab,Hematology,SampleCollectionDate
Item
Date Obtained (M D Y)
date
Lab,Hematology,SampleCollectionDate
Item
Date Obtained (M D Y)
date
Lab,Hematology,SampleCollectionDate
Item
Date Obtained (M D Y)
date
Lab,Hematology,SampleCollectionDate
Item
Date Obtained (M D Y)
date
Lab,Hematology,SampleCollectionDate
Item
Date Obtained (M D Y)
date
Lab,Hematology,SampleCollectionDate
Item
Date Obtained (M D Y)
date
Lab,Hematology,SampleCollectionDate
Item
Date Obtained (M D Y)
date
Bilirubin(mg/dl),ULN
Item
Bilirubin (mg/dl), ULN
double
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
Lab,Hepatic,Bilirubin
Item
Bilirubin (mg/dl), Value
double
Item Group
Unnamed4
FormNo.
Item
Form No.
text
Patient'sName
Item
Patient?s Name
text
ECOGPatientID
Item
ECOG Patient ID
text
Item Group
Prior Therapy
Item
Prior radiation therapy? (Choose one:)
text
CL.18
Code List
Prior radiation therapy? (Choose one:)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
PriorRTBeginDate
Item
Prior RT begin date (M D Y)
date
PriorRTEndDate
Item
Prior RT end date (M D Y)
date
RTSite
Item
RT site:
text
Item Group
Unnamed5
Comments
Item
Comments
text
InvestigatorSignature
Item
Investigator Signature
text
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
InvestigatorSignatureDate
Item
Date
date
Item Group
Ccrr Module For On-study Form
DiseaseInvolvementSite,Other
Item
Site(s) of Involvement, Other specify
text
Item
Prior surgery
text
CL.19
Code List
Prior surgery
CL Item
no (no)
CL Item
yes (yes)
Item
Specify prior thrombotic event
text
CL.20
Code List
Specify prior thrombotic event
CL Item
Thrombosis (thrombosis)
C26891 (NCI Thesaurus)
C0040053 (UMLS 2011AA)
CL Item
Both Thrombosis And Embolus (both thrombosis and embolus)
CL Item
Embolus (embolus)
C0013932 (NCI Metathesaurus)
Item
Does the patient have a prior history of deep vein thrombosis or pulmonary embolus?
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.21
Code List
Does the patient have a prior history of deep vein thrombosis or pulmonary embolus?
CL Item
yes (yes)
CL Item
no (no)
Item
Prior thrombosis?
text
CL.22
Code List
Prior thrombosis?
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Time frame of thrombosis
text
CL.23
Code List
Time frame of thrombosis
CL Item
> 1 Year Prior To Diagnosis Of Primary Cancer (> 1 year prior to diagnosis of primary cancer)
CL Item
Within 1 Year Of Diagnosis Of Primary Cancer (within 1 year of diagnosis of primary cancer)
Item
Prior embolus?
text
CL.24
Code List
Prior embolus?
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Time frame of embolus
text
CL.25
Code List
Time frame of embolus
CL Item
> 1 Year Prior To Diagnosis Of Primary Cancer (> 1 year prior to diagnosis of primary cancer)
CL Item
Within 1 Year Of Diagnosis Of Primary Cancer (within 1 year of diagnosis of primary cancer)
PriorSurgeryDate
Item
date of prior surgery
date
InitialDiagnosisDate,LocallyAdvanced
Item
Date of initial diagnosis of unresectable locally advanced disease
date
Item
Date of initial diagnosis of metastatic disease
date
CL.26
Code List
Date of initial diagnosis of metastatic disease
CL Item
Metastatic (Metastatic)
CL Item
Locally advanced unresectable (Locally advanced unresectable)
Item
Is measurable disease present?
text
CL.27
Code List
Is measurable disease present?
CL Item
no (no)
CL Item
yes (yes)
Item
Is non-measurable disease present?
text
CL.28
Code List
Is non-measurable disease present?
CL Item
no (no)
CL Item
yes (yes)
PriorAdjuvantChemotherapyEndDate
Item
Prior adjuvant chemotherapy end date
date
PriorAdjuvantChemotherapyBeginDate
Item
Prior adjuvant chemotherapy begin date
date
PriorAdjuvantChemotherapyEndDate
Item
Prior adjuvant chemotherapy end date
date
PrimarySite,Other
Item
Primary Site, other specify
text
Specifyagents
Item
Specify agents
text
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