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  1. StudyEvent: On-Study Form
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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

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
Vital status
Description

Vital status

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
Anatomic Description Of Disease
Description

Anatomic Description Of Disease

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

FirstPositiveBiopsyDate

Data type

date

Primary site (choose one)
Description

PrimarySite

Data type

text

Other specify (primary site)
Description

PrimarySite,Other

Data type

text

Histologic Type (choose one)
Description

HistologicType

Data type

text

Other, specify (histologic type)
Description

HistologicType,OtherName

Data type

text

Histologic grade (choose one)
Description

HistologicGrade

Data type

text

Staging
Description

Staging

Clinical T Stage
Description

TStage,Clinical

Data type

text

Clinical N Stage
Description

NStage,Clinical

Data type

text

Clinical M Stage
Description

MStage,Clinical

Data type

text

Site(s) Of Involvement
Description

Site(s) Of Involvement

Primary tumor/Pancreas
Description

Primarytumor/Pancreas

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ValueDomain-2
C25180
UMLS 2011AA ValueDomain-2
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-2
C25180
UMLS 2011AA ValueDomain-2
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

boolean

Specify other disease involvement
Description

OtherSiteName

Data type

text

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

Other, specify
Description

DiseaseInvolvementSite,Other

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
ECOG clinical trial administrative data
ECOGProtocolNo.
Item
ECOG Protocol No.
text
ECOGPatientID
Item
ECOG Patient ID
text
RegistrationStep
Item
Registration Step
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?
boolean
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
Item Group
Vital status
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
Anatomic Description Of Disease
FirstPositiveBiopsyDate
Item
Date of initial diagnosis of primary tumor (first positive biopsy date)
date
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
Pancreas, Not Otherwise Specified (Pancreas, NOS)
CL Item
Other, Specify (Other, specify)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
PrimarySite,Other
Item
Other specify (primary site)
text
Item
Histologic Type (choose one)
text
CL.5
Code List
Histologic Type (choose one)
CL Item
Ductal Adenocarcinoma (Ductal adenocarcinoma)
CL Item
Adenosquamous Carcinoma (Adenosquamous carcinoma)
C3727 (NCI Thesaurus)
C0206623 (UMLS 2011AA)
CL Item
Mucinous Adenocarcinoma (Mucinous adenocarcinoma)
C26712 (NCI Thesaurus)
C0007130 (UMLS 2011AA)
CL Item
Mucinous Noncystic Carcinoma (Mucinous noncystic carcinoma)
CL Item
Neuroendocrine Carcinoma (Neuroendocrine carcinoma)
C3773 (NCI Thesaurus)
C0206695 (UMLS 2011AA)
CL Item
Acinar Cell Carcinoma (Acinar cell carcinoma)
C3768 (NCI Thesaurus)
C0206685 (UMLS 2011AA)
CL Item
Mixed-type (ductal-endocrine Or Acinar-endocrine) (Mixed type (ductal-endocrine or acinar-endocrine)
CL Item
Signet Ring Cell Carcinoma (Signet ring cell carcinoma)
C3774 (NCI Thesaurus)
C0206696 (UMLS 2011AA)
CL Item
Small Cell Carcinoma (Small cell carcinoma)
C3915 (NCI Thesaurus)
C0262584 (UMLS 2011AA)
CL Item
Undifferentiated (anaplastic) Carcinoma (Undifferentiated (anaplastic) carcinoma)
CL Item
Other, Specify (Other, specify)
HistologicType,OtherName
Item
Other, specify (histologic type)
text
Item
Histologic grade (choose one)
text
CL.6
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 Group
Staging
Item
Clinical T Stage
text
CL.7
Code List
Clinical T Stage
CL Item
T0, According To Ajcc Criteria (0)
CL Item
T1, According To Ajcc Criteria (1)
CL Item
T2, According To Ajcc Criteria (2)
CL Item
T3, According To Ajcc Criteria (3)
CL Item
T4, According To Ajcc Criteria (4)
CL Item
Tx, According To Ajcc Criteria (X)
Item
Clinical N Stage
text
CL.8
Code List
Clinical N Stage
CL Item
No Lymph Node Involvement According To Ajcc Guidelines (0)
CL Item
N1, According To Ajcc Criteria (1)
CL Item
Lymph Node Involvement Cannot Be Assessed According To Ajcc Guidelines (use For Esophageal, Gastric, And Pancreatic) (X)
Item
Clinical M Stage
text
CL.9
Code List
Clinical M Stage
CL Item
No Distant Metastases According To Ajcc Guidelines (0)
CL Item
Distant Metastases Present According To Ajcc Guidelines (1)
CL Item
Distant Metastases Presence Or Absence Cannot Be Assessed According To Ajcc Guidelines (X)
Item Group
Site(s) Of Involvement
Item
Primary tumor/Pancreas
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25180 (NCI Thesaurus ValueDomain-2)
C1522602 (UMLS 2011AA ValueDomain-2)
CL.10
Code List
Primary tumor/Pancreas
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
Regional lymph nodes
text
CL.11
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)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Distant lymph nodes
text
CL.12
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)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Adjacent viscera/vessels
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25180 (NCI Thesaurus ValueDomain-2)
C1522602 (UMLS 2011AA ValueDomain-2)
CL.13
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)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Liver
text
CL.14
Code List
Liver
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
Peritoneum
text
CL.15
Code List
Peritoneum
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
Lung
text
CL.16
Code List
Lung
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
Bone
text
CL.17
Code List
Bone
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)
OtherSiteInd
Item
Other
boolean
OtherSiteName
Item
Specify other disease involvement
text
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
Other, specify
text
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