ID

2805

Description

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

Keywords

Versions (4)
  1. 9/19/12 9/19/12 -
  2. 5/28/15 5/28/15 -
  3. 6/3/15 6/3/15 -
  4. 9/20/21 9/20/21 -
Uploaded on

September 19, 2012

DOI

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License

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

English

No Instruction available.

1 forms  
  1. StudyEvent: On-Study Form
    1. No Instruction available.
Unnamed1
Description

Unnamed1

Registration Step
Description

RegistrationStep

Data type

text

Patient?s Name
Description

Patient'sName

Data type

text

ECOG Protocol No.
Description

ECOGProtocolNo.

Data type

text

ECOG Protocol No.
Description

ECOGProtocolNo.

Data type

text

ECOG Patient ID
Description

ECOGPatientID

Data type

text

ECOG Patient ID
Description

ECOGPatientID

Data type

text

Participating Group Protocol No.
Description

ParticipatingGroupProtocolNo.

Data type

text

Participating Group Patient ID
Description

ParticipatingGroupPatientID

Data type

text

Institution/Affiliate
Description

MainMemberInstitution/Affiliate

Data type

text

Unnamed2
Description

Unnamed2

Are data amended?
Description

AmendedDataInd

Data type

text

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

PerformanceStatus

Data type

text

Weight loss in previous 6 months (choose one)
Description

WeightLossPriorSixMonths

Data type

text

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

Disease Description

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

FirstPositiveBiopsyDate

Data type

date

Primary Site, other specify
Description

PrimarySite,Other

Data type

text

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

PriorRecentRecurrenceDate

Data type

date

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

PrimarySite

Data type

text

Histologic grade (choose one)
Description

HistologicGrade

Data type

text

Histologic Type (choose one)
Description

HistologicType

Data type

text

Other specify
Description

HistologicType,OtherName

Data type

text

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

Istherehistologicproofofresidualormetastaticmalignantdisease?

Data type

text

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

Unnamed3

Form No.
Description

FormNo.

Data type

text

Patient?s Name
Description

Patient'sName

Data type

text

ECOG Patient ID
Description

ECOGPatientID

Data type

text

Site(s) Of Involvement
Description

Site(s) Of Involvement

Pancreas
Description

Primarytumor/Pancreas

Data type

text

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

RegionalLymphNode(s)Ind

Data type

text

Distant lymph nodes
Description

DistantLymphNode(s)Ind

Data type

text

Adjacent viscera/vessels
Description

Adjacentviscera/vessels

Data type

text

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

LiverSiteInd

Data type

text

Peritoneum
Description

PeritoneumInd

Data type

text

Lung
Description

LungSiteInd

Data type

text

Bone
Description

BoneSiteInd

Data type

text

Other
Description

OtherSiteInd

Data type

text

Other specify
Description

OtherSiteName

Data type

text

Advanced Disease Status at Registration
Description

AdvancedDiseaseRegistrationStatus

Data type

text

CEA (ng/dl)
Description

CEA

Data type

text

CEA ULN
Description

LaboratoryProcedureCarcinoembryonicAntigenOutcomeUpperLimitNormalValue

Data type

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)
Description

CarcinoembryonicAntigenSpecimenCollectionDate

Data type

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)
Description

CA19-9

Data type

text

Date CA19-9 obtained (M D Y)
Description

DateCA19-9obtained

Data type

text

Baseline Hematology/chemistry
Description

Baseline Hematology/chemistry

WBC count (x1000), LLN
Description

WBCcount(x1000),LLN

Data type

text

WBC count (x1000), Value
Description

Lab,Hematology,WBC

Data type

double

Granulocyte count (AGC/ANC), Value
Description

Lab,Hematology,GranulocyteCount

Data type

double

Platelets count (x1000), LLN
Description

Plateletscount(x1000),LLN

Data type

double

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

Lab,Hematology,Platelets

Data type

double

Hemoglobin (g/dl), LLN
Description

Hemoglobin(g/dl),LLN

Data type

text

Hemoglobin (g/dl), Value
Description

Lab,Hematology,Hemoglobin

Data type

double

Albumin (g/dl), LLN
Description

Albumin(g/dl),LLN

Data type

double

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

Lab,Chemistry,Albumin

Data type

double

Creatinine (mg/dl), ULN
Description

Creatinine(mg/dl),ULN

Data type

text

Creatinine (mg/dl), Value
Description

Lab,Renal,Creatinine

Data type

double

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

SGOT(AST)ULN

Data type

double

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

Lab,Hepatic,SGOT

Data type

double

Date Obtained (M D Y)
Description

Lab,Hematology,SampleCollectionDate

Data type

date

Date Obtained (M D Y)
Description

Lab,Hematology,SampleCollectionDate

Data type

date

Date Obtained (M D Y)
Description

Lab,Hematology,SampleCollectionDate

Data type

date

Date Obtained (M D Y)
Description

Lab,Hematology,SampleCollectionDate

Data type

date

Date Obtained (M D Y)
Description

Lab,Hematology,SampleCollectionDate

Data type

date

Date Obtained (M D Y)
Description

Lab,Hematology,SampleCollectionDate

Data type

date

Date Obtained (M D Y)
Description

Lab,Hematology,SampleCollectionDate

Data type

date

Bilirubin (mg/dl), ULN
Description

Bilirubin(mg/dl),ULN

Data type

double

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

Lab,Hepatic,Bilirubin

Data type

double

Unnamed4
Description

Unnamed4

Form No.
Description

FormNo.

Data type

text

Patient?s Name
Description

Patient'sName

Data type

text

ECOG Patient ID
Description

ECOGPatientID

Data type

text

Prior Therapy
Description

Prior Therapy

Prior radiation therapy? (Choose one:)
Description

PriorRTInd

Data type

text

Prior RT begin date (M D Y)
Description

PriorRTBeginDate

Data type

date

Prior RT end date (M D Y)
Description

PriorRTEndDate

Data type

date

RT site:
Description

RTSite

Data type

text

Unnamed5
Description

Unnamed5

Comments
Description

Comments

Data type

text

Investigator Signature
Description

InvestigatorSignature

Data type

text

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

InvestigatorSignatureDate

Data type

date

Ccrr Module For On-study Form
Description

Ccrr Module For On-study Form

Site(s) of Involvement, Other specify
Description

DiseaseInvolvementSite,Other

Data type

text

Prior surgery
Description

PriorSurgeryInd

Data type

text

Specify prior thrombotic event
Description

Specifypriorthromboticevent

Data type

text

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

Doesthepatienthaveapriorhistoryofdeepveinthrombosisorpulmonaryembolus?

Data type

text

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

Priorthrombosis?

Data type

text

Time frame of thrombosis
Description

Timeframeofthrombosis

Data type

text

Prior embolus?
Description

Priorembolus?

Data type

text

Time frame of embolus
Description

Timeframeofembolus

Data type

text

date of prior surgery
Description

PriorSurgeryDate

Data type

date

Date of initial diagnosis of unresectable locally advanced disease
Description

InitialDiagnosisDate,LocallyAdvanced

Data type

date

Date of initial diagnosis of metastatic disease
Description

InitialDiagnosisDate,Metastatic

Data type

date

Is measurable disease present?
Description

DiseaseAssessment,MeasurableInd

Data type

text

Is non-measurable disease present?
Description

DiseaseAssessment,Non-measurableInd

Data type

text

Prior adjuvant chemotherapy end date
Description

PriorAdjuvantChemotherapyEndDate

Data type

date

Prior adjuvant chemotherapy begin date
Description

PriorAdjuvantChemotherapyBeginDate

Data type

date

Prior adjuvant chemotherapy end date
Description

PriorAdjuvantChemotherapyEndDate

Data type

date

Primary Site, other specify
Description

PrimarySite,Other

Data type

text

Specify agents
Description

Specifyagents

Data type

text

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1 forms
  1. StudyEvent: On-Study Form
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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