ID

10512

Descrizione

Nontarget Lesions Supplemental Form NCT00058149 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=A65D5AC6-6244-4284-E034-0003BA0B1A09

collegamento

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A65D5AC6-6244-4284-E034-0003BA0B1A09

Keywords

versioni (3)
  1. 19/09/12 19/09/12 -
  2. 01/06/15 01/06/15 -
  3. 03/06/15 03/06/15 -
Caricato su

3 giugno 2015

DOI

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Licenza

Creative Commons BY-NC 3.0 Legacy
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Nontarget Lesions Supplemental Form NCT00058149

Inglese

No Instruction available.

1 moduli  
  1. StudyEvent: Nontarget Lesions Supplemental Form
    1. No Instruction available.
ECOG clinical trial administrative data
Descrizione

ECOG clinical trial administrative data

ECOG Protocol No.
Descrizione

ECOGProtocolNo.

Tipo di dati

text

ECOG Patient ID
Descrizione

ECOGPatientID

Tipo di dati

text

Registration Step
Descrizione

RegistrationStep

Tipo di dati

text

Cycle Number (Use 00 for baseline; leave blank if off-treatment or N/A)
Descrizione

CycleNumber

Tipo di dati

text

Patient?s Name
Descrizione

Patient'sName

Tipo di dati

text

Participating Group Protocol No.
Descrizione

ParticipatingGroupProtocolNo.

Tipo di dati

text

Participating Group Patient ID
Descrizione

ParticipatingGroupPatientID

Tipo di dati

text

Institution/Affiliate
Descrizione

MainMemberInstitution/Affiliate

Tipo di dati

text

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

AmendedDataInd

Tipo di dati

boolean

Alias
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C25416
UMLS 2011AA Property
C1691222
Nontarget Lesions:
Descrizione

Nontarget Lesions:

Lesion Number
Descrizione

Lesion,ReferenceNumber

Tipo di dati

float

Site of Lesion (Multiple nontarget lesions within an organ may be combined as a single site, but must be reported in same manner as at baseline.)
Descrizione

Lesion,AnatomicSite

Tipo di dati

text

Site Code
Descrizione

LesionMeasurableEvaluationAnatomicSite

Tipo di dati

text

Alias
NCI Thesaurus ValueDomain
C13717
UMLS 2011AA ValueDomain
C1515974
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus Property
C25214
UMLS 2011AA Property
C0220825
NCI Thesaurus Property-2
C37894
UMLS 2011AA Property-2
C1513040
Method of Evaluation
Descrizione

AssessmentType

Tipo di dati

text

Date of Evaluation (M D Y)
Descrizione

AssessmentDate

Tipo di dati

date

Follow-up Status of Lesions (Choose one for each lesion. Leave blank if baseline.)
Descrizione

Follow-UpStatusofLesions

Tipo di dati

text

Cytology Result (For Site Code 04 effusion/ascites ONLY)
Descrizione

CytologyResult

Tipo di dati

text

Alias
NCI Thesaurus ObjectClass
C16491
UMLS 2011AA ObjectClass
C0010819
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
Unequivocal progressive disease in nontarget lesions is based on: (please decribe)
Descrizione

Unequivocalprogressivediseaseinnontargetlesionsisbasedon:(pleasedecribe)

Tipo di dati

text

Comments
Descrizione

Comments

Comments
Descrizione

Comments

Tipo di dati

text

Investigator Signature
Descrizione

InvestigatorSignature

Tipo di dati

text

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

InvestigatorSignatureDate

Tipo di dati

date

Ccrr Module For Nontarget Lesions Supplemental Form
Descrizione

Ccrr Module For Nontarget Lesions Supplemental Form

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Similar models

No Instruction available.

1 moduli
  1. StudyEvent: Nontarget Lesions Supplemental Form
    1. No Instruction available.
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
ECOG clinical trial administrative data
ECOGProtocolNo.
Item
ECOG Protocol No.
text
ECOGPatientID
Item
ECOG Patient ID
text
RegistrationStep
Item
Registration Step
text
CycleNumber
Item
Cycle Number (Use 00 for baseline; leave blank if off-treatment or N/A)
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
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)
Item Group
Nontarget Lesions:
Lesion,ReferenceNumber
Item
Lesion Number
float
Lesion,AnatomicSite
Item
Site of Lesion (Multiple nontarget lesions within an organ may be combined as a single site, but must be reported in same manner as at baseline.)
text
Item
Site Code
text
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C37894 (NCI Thesaurus Property-2)
C1513040 (UMLS 2011AA Property-2)
CL.2
Code List
Site Code
CL Item
Bone (Bone)
C12366 (NCI Thesaurus)
C0262950 (UMLS 2011AA)
CL Item
Brain (Brain)
C12439 (NCI Thesaurus)
C0006104 (UMLS 2011AA)
CL Item
Breast (Breast)
C12971 (NCI Thesaurus)
C0006141 (UMLS 2011AA)
CL Item
Effusion/ascites (Effusion/Ascites)
CL Item
Gi (GI)
CL Item
Gu (GU)
CL Item
Head & Neck (Head & Neck)
CL Item
Liver (Liver)
C12392 (NCI Thesaurus)
C0023884 (UMLS 2011AA)
CL Item
Lung (Lung)
C12468 (NCI Thesaurus)
C0024109 (UMLS 2011AA)
CL Item
Nodes (Nodes)
CL Item
Skin (Skin)
C12470 (NCI Thesaurus)
C1123023 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
Item
Method of Evaluation
text
CL.3
Code List
Method of Evaluation
CL Item
Clinical Examination (Clinical Exam)
CL Item
Chest X-ray (Chest X-Ray)
CL Item
Ct Scan (CT Scan (non-spiral))
CL Item
Spiral Ct Scan (Spiral CT)
CL Item
Mri (MRI)
CL Item
Ultrasound (Ultrasound)
C64384 (NCI Thesaurus)
C1456803 (UMLS 2011AA)
CL Item
Bone Scan (Bone scan)
C17646 (NCI Thesaurus)
C0203668 (UMLS 2011AA)
CL Item
Not Evaluated (Not evaluated)
CL Item
Other (Other (specify in Comments))
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
AssessmentDate
Item
Date of Evaluation (M D Y)
date
Item
Follow-up Status of Lesions (Choose one for each lesion. Leave blank if baseline.)
text
CL.4
Code List
Follow-up Status of Lesions (Choose one for each lesion. Leave blank if baseline.)
CL Item
Cr (CR)
CL Item
Incompl. Resp./sd (Incompl. resp./SD)
CL Item
Pd (PD)
Item
Cytology Result (For Site Code 04 effusion/ascites ONLY)
text
C16491 (NCI Thesaurus ObjectClass)
C0010819 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
CL.5
Code List
Cytology Result (For Site Code 04 effusion/ascites ONLY)
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
CL Item
Not Done (Not done)
CL281691 (NCI Metathesaurus)
Unequivocalprogressivediseaseinnontargetlesionsisbasedon:(pleasedecribe)
Item
Unequivocal progressive disease in nontarget lesions is based on: (please decribe)
text
Item Group
Comments
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 Nontarget Lesions Supplemental Form
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