ID

9749

Beschrijving

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

Trefwoorden

Versies (3)
  1. 19-09-12 19-09-12 -
  2. 21-01-15 21-01-15 - Martin Dugas
  3. 21-01-15 21-01-15 - Martin Dugas
Geüploaded op

21 januari 2015

DOI

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Licentie

Creative Commons BY-NC 3.0 Legacy
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Pancreatic Cancer NCT00058149 Follow-Up - Hematology/Chemistry Form - 2048132v3.0

Engels

No Instruction available.

1 Formulieren  
  1. StudyEvent: Hematology/Chemistry Form
    1. No Instruction available.
Header
Beschrijving

Header

ECOG Protocol No.
Beschrijving

ECOGProtocolNo.

Datatype

text

ECOG Patient ID
Beschrijving

ECOGPatientID

Datatype

text

Registration Step
Beschrijving

RegistrationStep

Datatype

text

Cycle Number
Beschrijving

CycleNumber

Datatype

text

Patient?s Name
Beschrijving

Patient'sName

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

Alias
UMLS CUI-1
C12341234123412341234123412
Comments
Beschrijving

Comments

Datatype

text

Are data amended? (If yes, please circle amended items in red)
Beschrijving

AmendedDataInd

Datatype

boolean

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

Laboratory Name:
Beschrijving

SpecimenLabIdentifierName

Datatype

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-2
C19157
UMLS 2011AA ObjectClass-2
C0370003
Date obtained (M D Y)
Beschrijving

Lab,Hematology,SampleCollectionDate

Datatype

date

WBC count (x1000), LLN
Beschrijving

WBCcount(x1000),LLN

Datatype

text

WBC count (x1000), Value
Beschrijving

Lab,Hematology,WBC

Datatype

float

Granulocyte count (AGC/ANC), Value (Do not report % granulocytes/neutrophils; report absolute count without decimal.)
Beschrijving

Lab,Hematology,GranulocyteCount

Datatype

float

Platelet count (x1000), LLN
Beschrijving

Plateletscount(x1000),LLN

Datatype

float

Alias
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25555
UMLS 2011AA ValueDomain-2
C1518030
Platelet count (x1000), Value
Beschrijving

Lab,Hematology,Platelets

Datatype

float

Hemoglobin (g/dl), LLN
Beschrijving

Hemoglobin(g/dl),LLN

Datatype

text

Hemoglobin (g/dl), Value
Beschrijving

Lab,Hematology,Hemoglobin

Datatype

float

Total bilirubin (mg/dl), ULN
Beschrijving

Totalbilirubin(mg/dl),ULN

Datatype

text

Total bilirubin (mg/dl), Value
Beschrijving

Lab,Hepatic,Bilirubin

Datatype

float

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

SGOT(AST)ULN

Datatype

float

Alias
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25706
UMLS 2011AA ValueDomain-2
C1519815
SGOT (AST) (U/L), Value
Beschrijving

Lab,Hepatic,SGOT

Datatype

float

Creatinine (mg/dl), ULN
Beschrijving

Creatinine(mg/dl),ULN

Datatype

text

Creatinine (mg/dl), Value
Beschrijving

Lab,Renal,Creatinine

Datatype

float

Albumin (g/dl), LLN
Beschrijving

Albumin(g/dl),LLN

Datatype

float

Alias
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25555
UMLS 2011AA ValueDomain-2
C1518030
Albumin (g/dl)
Beschrijving

Lab,Chemistry,Albumin

Datatype

float

CTC Adverse Event Attribution Code
Beschrijving

CTCAdverseEventAttributionCode

Datatype

text

Bilirubin ULN
Beschrijving

HepaticBilirubinLabUpperLimitNormalValue

Datatype

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C305
UMLS 2011AA Property-2
C0005437
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus ValueDomain-2
C25706
UMLS 2011AA ValueDomain-2
C1519815
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No Instruction available.

1 Formulieren
  1. StudyEvent: Hematology/Chemistry Form
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Header
ECOGProtocolNo.
Item
ECOG Protocol No.
text
ECOGPatientID
Item
ECOG Patient ID
text
RegistrationStep
Item
Registration Step
text
CycleNumber
Item
Cycle Number
text
Patient'sName
Item
Patient?s Name
text
ParticipatingGroupProtocolNo.
Item
Participating Group Protocol No.
text
ParticipatingGroupPatientID
Item
Participating Group Patient ID
text
MainMemberInstitution/Affiliate
Item
Institution/Affiliate
text
C12341234123412341234123412 (UMLS CUI-1)
Comments
Item
Comments
text
AmendedDataInd
Item
Are data amended? (If yes, please circle amended items in red)
boolean
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
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
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-2)
C0370003 (UMLS 2011AA ObjectClass-2)
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
float
Lab,Hematology,GranulocyteCount
Item
Granulocyte count (AGC/ANC), Value (Do not report % granulocytes/neutrophils; report absolute count without decimal.)
float
Plateletscount(x1000),LLN
Item
Platelet count (x1000), LLN
float
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
C1518030 (UMLS 2011AA ValueDomain-2)
Lab,Hematology,Platelets
Item
Platelet count (x1000), Value
float
Hemoglobin(g/dl),LLN
Item
Hemoglobin (g/dl), LLN
text
Lab,Hematology,Hemoglobin
Item
Hemoglobin (g/dl), Value
float
Totalbilirubin(mg/dl),ULN
Item
Total bilirubin (mg/dl), ULN
text
Lab,Hepatic,Bilirubin
Item
Total bilirubin (mg/dl), Value
float
SGOT(AST)ULN
Item
SGOT (AST) (U/L), ULN
float
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)
Lab,Hepatic,SGOT
Item
SGOT (AST) (U/L), Value
float
Creatinine(mg/dl),ULN
Item
Creatinine (mg/dl), ULN
text
Lab,Renal,Creatinine
Item
Creatinine (mg/dl), Value
float
Albumin(g/dl),LLN
Item
Albumin (g/dl), LLN
float
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25555 (NCI Thesaurus ValueDomain-2)
C1518030 (UMLS 2011AA ValueDomain-2)
Lab,Chemistry,Albumin
Item
Albumin (g/dl)
float
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)
HepaticBilirubinLabUpperLimitNormalValue
Item
Bilirubin ULN
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C305 (NCI Thesaurus Property-2)
C0005437 (UMLS 2011AA Property-2)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
C1519815 (UMLS 2011AA ValueDomain-2)
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