ID

3076

Description

Hematology/Chemistry 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=A65D4877-9B57-427A-E034-0003BA0B1A09

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A65D4877-9B57-427A-E034-0003BA0B1A09

Keywords

Versions (3)
  1. 9/19/12 9/19/12 -
  2. 1/21/15 1/21/15 - Martin Dugas
  3. 1/21/15 1/21/15 - Martin Dugas
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 Follow-Up - Hematology/Chemistry Form - 2048132v3.0

English

No Instruction available.

1 forms  
  1. StudyEvent: Hematology/Chemistry Form
    1. No Instruction available.
Unnamed1
Description

Unnamed1

Registration Step
Description

RegistrationStep

Data type

text

Cycle Number
Description

CycleNumber

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? (If yes, please circle amended items in red)
Description

AmendedDataInd

Data type

text

Alias
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C25416
UMLS 2011AA Property
C1691222
Unnamed3
Description

Unnamed3

Laboratory Name:
Description

SpecimenLabIdentifierName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C37984
UMLS 2011AA ObjectClass
C0022877
NCI Thesaurus ObjectClass
C19157
UMLS 2011AA ObjectClass
C0370003
Date obtained (M D Y)
Description

Lab,Hematology,SampleCollectionDate

Data type

date

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 (Do not report % granulocytes/neutrophils; report absolute count without decimal.)
Description

Lab,Hematology,GranulocyteCount

Data type

double

Platelet 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
Platelet 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

Total bilirubin (mg/dl), ULN
Description

Totalbilirubin(mg/dl),ULN

Data type

text

Total bilirubin (mg/dl), Value
Description

Lab,Hepatic,Bilirubin

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

Creatinine (mg/dl), ULN
Description

Creatinine(mg/dl),ULN

Data type

text

Creatinine (mg/dl), Value
Description

Lab,Renal,Creatinine

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)
Description

Lab,Chemistry,Albumin

Data type

double

CTC Adverse Event Attribution Code
Description

CTCAdverseEventAttributionCode

Data type

text

Unnamed4
Description

Unnamed4

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 Hematology/chemistry Form
Description

Ccrr Module For Hematology/chemistry Form

Bilirubin ULN
Description

HepaticBilirubinLabUpperLimitNormalValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C305
UMLS 2011AA Property
C0005437
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain
C25706
UMLS 2011AA ValueDomain
C1519815
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Similar models

No Instruction available.

1 forms
  1. StudyEvent: Hematology/Chemistry Form
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Unnamed1
RegistrationStep
Item
Registration Step
text
CycleNumber
Item
Cycle Number
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? (If yes, please circle amended items in red)
text
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
CL.1
Code List
Are data amended? (If yes, please circle amended items in red)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Unnamed3
SpecimenLabIdentifierName
Item
Laboratory Name:
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C37984 (NCI Thesaurus ObjectClass)
C0022877 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
Lab,Hematology,SampleCollectionDate
Item
Date obtained (M D Y)
date
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 (Do not report % granulocytes/neutrophils; report absolute count without decimal.)
double
Plateletscount(x1000),LLN
Item
Platelet count (x1000), LLN
double
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain)
C1518030 (UMLS 2011AA ValueDomain)
Lab,Hematology,Platelets
Item
Platelet count (x1000), Value
double
Hemoglobin(g/dl),LLN
Item
Hemoglobin (g/dl), LLN
text
Lab,Hematology,Hemoglobin
Item
Hemoglobin (g/dl), Value
double
Totalbilirubin(mg/dl),ULN
Item
Total bilirubin (mg/dl), ULN
text
Lab,Hepatic,Bilirubin
Item
Total bilirubin (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
Creatinine(mg/dl),ULN
Item
Creatinine (mg/dl), ULN
text
Lab,Renal,Creatinine
Item
Creatinine (mg/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)
double
Item
CTC Adverse Event Attribution Code
text
CL.2
Code List
CTC Adverse Event Attribution Code
CL Item
Unrelated (unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
CL Item
Unlikely (unlikely)
CL Item
Possibly (possible)
CL Item
Probably (probable)
CL Item
Definitely (definite)
Item Group
Unnamed4
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 Hematology/chemistry Form
HepaticBilirubinLabUpperLimitNormalValue
Item
Bilirubin ULN
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C305 (NCI Thesaurus Property)
C0005437 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)
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