ID

10285

Description

E2100 On-Study Form (E2100) Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=AC34564B-C2DB-255C-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=AC34564B-C2DB-255C-E034-0003BA12F5E7

Keywords

Versions (2)
  1. 8/27/12 8/27/12 -
  2. 5/23/15 5/23/15 -
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May 23, 2015

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E2100 On-Study Form (E2100)

English

Form No. 1575

1 forms  
  1. StudyEvent: E2100 On-Study Form (E2100)
    1. Form No. 1575
ECOG Clinical trial administrative data
Description

ECOG Clinical trial administrative data

ECOG Protocol No.
Description

ECOGProtocolNo.

Data type

text

ECOG Patient ID
Description

ECOGPatientID

Data type

text

Registration Step
Description

RegistrationStep

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ValueDomain-2
C16154
UMLS 2011AA ValueDomain-2
C1704379
Patient's Name
Description

Patient'sName

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

Are data amended?
Description

AmendedDataInd

Data type

boolean

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

Patient Characteristics

Menopausal Status (Choose one:)
Description

MenopausalStatus

Data type

text

Alias
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
Advanced Disease Description
Description

Advanced Disease Description

ER Status (most recent)
Description

ERStatus

Data type

text

Receptor Status Timing (most recent)
Description

ReceptorStatusTiming

Data type

text

ER Timing, Other, Specify
Description

ERTiming,Other

Data type

text

PgR Status (most recent)
Description

PgRStatus

Data type

text

PgR Timing, Other, Specify
Description

PgRTiming,Other

Data type

text

Her2/Neu expression status by immunohistochemistry (Choose one:)
Description

Her2/Neuexpressionstatusbyimmunohistochemistry

Data type

text

Her2/Neu expression status by FISH (Choose one:)
Description

Her2/NeuexpressionstatusbyFISH

Data type

text

Date of Initial Diagnosis of Primary Tumor (M D Y)
Description

FirstPositiveBiopsyDate

Data type

date

Date Recurrent, Progressive, or Metastatic Disease First Diagnosed (M D Y)
Description

DateRecurrent,Progressive,orMetastaticDiseaseFirstDiagnosed

Data type

date

Site(s) Of Involvement
Description

Site(s) Of Involvement

Local-regional (sites of involvement) (Circle the involved local-regional sites listed in below:)
Description

Local-regional(sitesofinvolvement)

Data type

text

Ipsilateral supraclavicular nodes (sites of involvement)
Description

Ipsilateralsupraclavicularnodes(sitesofinvolvement)

Data type

boolean

Opposite breast (sites of involvement)
Description

Oppositebreast(sitesofinvolvement)

Data type

boolean

Distant nodes (sites of involvement)
Description

Distantnodes(sitesofinvolvement)

Data type

boolean

Distant skin/subcutaneous tissue (sites of involvement)
Description

Distantskin/subcutaneoustissue(sitesofinvolvement)

Data type

boolean

Bone (sites of involvement)
Description

Bone(sitesofinvolvement)

Data type

boolean

Bone marrow (sites of involvement)
Description

Bonemarrow(sitesofinvolvement)

Data type

boolean

Lung (sites of involvement)
Description

Lung(sitesofinvolvement)

Data type

boolean

Liver (sites of involvement)
Description

Liver(sitesofinvolvement)

Data type

boolean

Pleura (sites of involvement)
Description

Pleura(sitesofinvolvement)

Data type

boolean

Brain (sites of involvement)
Description

Brain(sitesofinvolvement)

Data type

boolean

Other CNS (sites of involvement)
Description

OtherCNS(sitesofinvolvement)

Data type

boolean

First Other, specify (sites of involvement)
Description

FirstOther,specify(sitesofinvolvement)

Data type

boolean

Second Other, specify (sites of involvement)
Description

SecondOther,specify(sitesofinvolvement)

Data type

boolean

First Other, specify
Description

FirstOther,specify

Data type

text

Second Other, specify
Description

SecondOther,specify

Data type

text

Prior Systemic Therapy
Description

Prior Systemic Therapy

Prior Adjuvant Hormonal Therapy? (do not include steroids given with chemotherapy)
Description

PriorAdjuvantHormonalTherapyInd

Data type

boolean

Prior Metastatic/Recurrent Hormonal Therapy? (do not include steroids given with chemotherapy)
Description

PriorMetastatic/RecurrentHormonalTherapyInd

Data type

boolean

Prior Adjuvant Chemotherapy? (include pre-op chemotherapy at diagnosis)
Description

PriorAdjuvantChemotherapyInd

Data type

boolean

Prior Chemotherapy for Metastasis or Recurrence?
Description

PriorMetastatic/RecurrentChemotherapyInd

Data type

boolean

Prior Adjuvant High Dose Chemotherapy/Autologous Stem Cell Transplant?
Description

PriorAdjuvantHighDoseChemotherapy/AutologousStemCellTransplant?

Data type

boolean

Prior High Dose Chemotherapy/Autologous Stem Cell Transplant for Metastasis or Recurrence?
Description

PriorHighDoseChemotherapy/AutologousStemCellTransplantforMetastasisorRecurrence?

Data type

boolean

Prior Adjuvant Immunotherapy?
Description

PriorAdjuvantImmunotherapyInd

Data type

boolean

Prior Immunotherapy for Metastasis or Recurrence?
Description

PriorMetastatic/RecurrentImmunotherapyInd

Data type

boolean

Prior Adjuvant Other Therapy?
Description

PriorAdjuvantOtherTherapyInd

Data type

boolean

Prior Metastatic/Recurrent Other Therapy?
Description

PriorMetastatic/RecurrentOtherTherapyInd

Data type

boolean

Prior Systemic Regimens
Description

Prior Systemic Regimens

Prior Treatment Regimen Name(s)
Description

PriorTreatmentRegimenName(s)

Data type

text

Prior Treatment Regimen Start Date (M/D/Y)
Description

PriorTreatmentRegimenBeginDate

Data type

date

Prior Treatment Regimen End Date (M/D/Y)
Description

PriorTreatmentRegimenEndDate

Data type

date

Prior Treatment Regimen Type
Description

PriorTreatmentRegimenType

Data type

text

Comments
Description

Comments

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

Date

Data type

text

Ccrr Module For E2100 On-study Form (e2100)
Description

Ccrr Module For E2100 On-study Form (e2100)

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Similar models

Form No. 1575

1 forms
  1. StudyEvent: E2100 On-Study Form (E2100)
    1. Form No. 1575
Name
Type
Description | Question | Decode (Coded Value)
Data type
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
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16154 (NCI Thesaurus ValueDomain-2)
C1704379 (UMLS 2011AA ValueDomain-2)
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?
boolean
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
Item Group
Patient Characteristics
Item
Menopausal Status (Choose one:)
text
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
CL.2
Code List
Menopausal Status (Choose one:)
CL Item
Pre (Pre)
CL Item
Post (Post)
C38008 (NCI Thesaurus)
C0687676 (UMLS 2011AA)
CL Item
Above Categories Not Applicable And Age <50 (Above categories not applicable AND Age <50)
CL Item
Above Categories Not Applicable And Age >= 50 (Above categories not applicable AND Age >= 50)
Item Group
Advanced Disease Description
Item
ER Status (most recent)
text
CL.3
Code List
ER Status (most recent)
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Receptor Status Timing (most recent)
text
CL.6
Code List
Receptor Status Timing (most recent)
CL Item
Initial Diagnosis (Initial Diagnosis)
CL Item
At Recurrence (At Recurrence)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
ERTiming,Other
Item
ER Timing, Other, Specify
text
Item
PgR Status (most recent)
text
CL.5
Code List
PgR Status (most recent)
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
PgRTiming,Other
Item
PgR Timing, Other, Specify
text
Item
Her2/Neu expression status by immunohistochemistry (Choose one:)
text
CL.7
Code List
Her2/Neu expression status by immunohistochemistry (Choose one:)
CL Item
0 (0)
C0919414 (NCI Metathesaurus)
CL Item
1+ (1+)
CL Item
2+ (2+)
CL Item
3+ (3+)
CL Item
Not Done (Not done)
CL281691 (NCI Metathesaurus)
Item
Her2/Neu expression status by FISH (Choose one:)
text
CL.8
Code List
Her2/Neu expression status by FISH (Choose one:)
CL Item
Non-amplified (Non-amplified)
CL Item
Amplified (Amplified)
CL Item
8 (8)
CL Item
Not Done (Not done)
CL281691 (NCI Metathesaurus)
FirstPositiveBiopsyDate
Item
Date of Initial Diagnosis of Primary Tumor (M D Y)
date
DateRecurrent,Progressive,orMetastaticDiseaseFirstDiagnosed
Item
Date Recurrent, Progressive, or Metastatic Disease First Diagnosed (M D Y)
date
Item Group
Site(s) Of Involvement
Item
Local-regional (sites of involvement) (Circle the involved local-regional sites listed in below:)
text
CL.23
Code List
Local-regional (sites of involvement) (Circle the involved local-regional sites listed in below:)
CL Item
ipsilateraly breast (ipsilateraly breast)
CL Item
chest wall (chest wall)
CL Item
axillary, internal mammary and infraclavicular nodes (axillary, internal mammary and infraclavicular nodes)
CL Item
local regional skin and subcutaneous tissue (local regional skin and subcutaneous tissue)
Ipsilateralsupraclavicularnodes(sitesofinvolvement)
Item
Ipsilateral supraclavicular nodes (sites of involvement)
boolean
Oppositebreast(sitesofinvolvement)
Item
Opposite breast (sites of involvement)
boolean
Distantnodes(sitesofinvolvement)
Item
Distant nodes (sites of involvement)
boolean
Distantskin/subcutaneoustissue(sitesofinvolvement)
Item
Distant skin/subcutaneous tissue (sites of involvement)
boolean
Bone(sitesofinvolvement)
Item
Bone (sites of involvement)
boolean
Bonemarrow(sitesofinvolvement)
Item
Bone marrow (sites of involvement)
boolean
Lung(sitesofinvolvement)
Item
Lung (sites of involvement)
boolean
Liver(sitesofinvolvement)
Item
Liver (sites of involvement)
boolean
Pleura(sitesofinvolvement)
Item
Pleura (sites of involvement)
boolean
Brain(sitesofinvolvement)
Item
Brain (sites of involvement)
boolean
OtherCNS(sitesofinvolvement)
Item
Other CNS (sites of involvement)
boolean
FirstOther,specify(sitesofinvolvement)
Item
First Other, specify (sites of involvement)
boolean
SecondOther,specify(sitesofinvolvement)
Item
Second Other, specify (sites of involvement)
boolean
FirstOther,specify
Item
First Other, specify
text
SecondOther,specify
Item
Second Other, specify
text
Item Group
Prior Systemic Therapy
PriorAdjuvantHormonalTherapyInd
Item
Prior Adjuvant Hormonal Therapy? (do not include steroids given with chemotherapy)
boolean
PriorMetastatic/RecurrentHormonalTherapyInd
Item
Prior Metastatic/Recurrent Hormonal Therapy? (do not include steroids given with chemotherapy)
boolean
PriorAdjuvantChemotherapyInd
Item
Prior Adjuvant Chemotherapy? (include pre-op chemotherapy at diagnosis)
boolean
PriorMetastatic/RecurrentChemotherapyInd
Item
Prior Chemotherapy for Metastasis or Recurrence?
boolean
PriorAdjuvantHighDoseChemotherapy/AutologousStemCellTransplant?
Item
Prior Adjuvant High Dose Chemotherapy/Autologous Stem Cell Transplant?
boolean
PriorHighDoseChemotherapy/AutologousStemCellTransplantforMetastasisorRecurrence?
Item
Prior High Dose Chemotherapy/Autologous Stem Cell Transplant for Metastasis or Recurrence?
boolean
PriorAdjuvantImmunotherapyInd
Item
Prior Adjuvant Immunotherapy?
boolean
PriorMetastatic/RecurrentImmunotherapyInd
Item
Prior Immunotherapy for Metastasis or Recurrence?
boolean
PriorAdjuvantOtherTherapyInd
Item
Prior Adjuvant Other Therapy?
boolean
PriorMetastatic/RecurrentOtherTherapyInd
Item
Prior Metastatic/Recurrent Other Therapy?
boolean
Item Group
Prior Systemic Regimens
PriorTreatmentRegimenName(s)
Item
Prior Treatment Regimen Name(s)
text
PriorTreatmentRegimenBeginDate
Item
Prior Treatment Regimen Start Date (M/D/Y)
date
PriorTreatmentRegimenEndDate
Item
Prior Treatment Regimen End Date (M/D/Y)
date
Item
Prior Treatment Regimen Type
text
CL.34
Code List
Prior Treatment Regimen Type
CL Item
Adjuvant (adjuvant)
C25722 (NCI Thesaurus)
C1522673 (UMLS 2011AA)
CL Item
Neoadjuvant (neoadjuvant)
CL Item
Advanced (advanced)
C25411 (NCI Thesaurus)
C0205179 (UMLS 2011AA)
CL Item
Other (other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
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)
Date
Item
Date
text
Item Group
Ccrr Module For E2100 On-study Form (e2100)
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