ID

11124

Description

CALGB-10501 Summary Response / Progression Form for Leukemia NCT00513747 Early or Delayed Fludarabine and Rituximab in Treating Patients With Previously Untreated Chronic Lymphocytic Leukemia Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=33F80721-319D-3F50-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=33F80721-319D-3F50-E044-0003BA3F9857

Keywords

Versions (3)
  1. 9/19/12 9/19/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 6/18/15 6/18/15 -
Uploaded on

June 18, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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CALGB-10501 Summary Response / Progression Form for Leukemia NCT00513747

English

[Optional Form - may be selected for specific protocols where appropriate.]

1 forms  
  1. StudyEvent: CALGB-10501 Summary Response / Progression Form for Leukemia
    1. [Optional Form - may be selected for specific protocols where appropriate.]
Header
Description

Header

CALGB Form
Description

Form ID CALGB

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3262252
NCI Thesaurus ObjectClass
C19464
UMLS CUI-2
C1516238
NCI Thesaurus Property
C25364
NCI Thesaurus ObjectClass-2
C25442
CALGB Study No
Description

Protocol ID CALGB

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1516238
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25442
CALGB Patient ID
Description

Trial subject ID CALGB

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1516238
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25442
Date of Assessment
Description

Assessment Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2985720
NCI Thesaurus ObjectClass
C25367
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus Property
C38000
Are data amended
Description

Data amended

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Patient demographics
Description

Patient demographics

Patient Initials (Last, First Middle)
Description

Patient Initials

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Patient Hospital No.
Description

Medical Record Number

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1301894
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25261
NCI Thesaurus Property-2
C25198
Institution/Affiliate
Description

Institution Name

Data type

text

Alias
NCI Thesaurus ObjectClass
C25454
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass-2
C21541
NCI Thesaurus Property
C25364
NCI Thesaurus ValueDomain
C25191
NCI Thesaurus ValueDomain-2
C21541
Participating Group
Description

Participating Group

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2347449
NCI Thesaurus ObjectClass
C25608
NCI Thesaurus ObjectClass-2
C17005
NCI Thesaurus Property
C25364
Participating Group Study No.
Description

Study Number Participating Group

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Participating Group Patient ID
Description

Trial subject ID Participating Group

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Leukemia Response Assessment
Description

Leukemia Response Assessment

Has the patient achieved a response? (during this time period)
Description

TumorResponseInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus Property
C25755
UMLS 2011AA Property
C0871261
NCI Thesaurus ValueDomain-2
C25755
UMLS 2011AA ValueDomain-2
C0871261
Complete Response (CR) First Observed Date (MM DD YYYY)
Description

Complete Response First Observed Date

Data type

date

Alias
NCI Thesaurus ObjectClass
C25755
UMLS CUI-1
C0677874
NCI Thesaurus ObjectClass-2
C25250
UMLS CUI-2
C1115465
NCI Thesaurus Property
C25509
NCI Thesaurus Property-2
C25599
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
Nodular partial response (NPR) first observed date (MM DD YYYY)
Description

NodalPartialResponseFirstObservedDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C25755
UMLS 2011AA ObjectClass
C0871261
NCI Thesaurus ObjectClass-2
C25378
UMLS 2011AA ObjectClass-2
C0728938
NCI Thesaurus ObjectClass-3
C25323
UMLS 2011AA ObjectClass-3
C0443268
NCI Thesaurus Property
C25509
UMLS 2011AA Property
C1279901
NCI Thesaurus Property-2
C25599
UMLS 2011AA Property-2
C1441672
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Partial Response (PR) First Observed Date (MM DD YYYY)
Description

Partial Response First Observed Date

Data type

date

Alias
NCI Thesaurus ObjectClass
C25755
UMLS CUI-1
C1521726
NCI Thesaurus ObjectClass-2
C25378
UMLS CUI-2
C1115465
NCI Thesaurus Property
C25509
NCI Thesaurus Property-2
C25599
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
Stable Disease First Observed Date (SD)
Description

StableResponseFirstObservedDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C25755
UMLS 2011AA ObjectClass
C0871261
NCI Thesaurus ObjectClass-2
C18213
UMLS 2011AA ObjectClass-2
C0677946
NCI Thesaurus Property
C25509
UMLS 2011AA Property
C1279901
NCI Thesaurus Property-2
C25599
UMLS 2011AA Property-2
C1441672
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
Has the patient been diagnosed with a new progression (during this reporting period not previously reported)
Description

DiseaseNewProgressionInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25586
UMLS 2011AA Property
C0205314
NCI Thesaurus Property-2
C25331
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
Progressive Disease (PD) Observed Date (Second MM DD YYYY)
Description

Progressive Disease Observed Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1335499
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C25331
NCI Thesaurus Property
C25599
UMLS CUI-2
C0011008
Progressive Disease (PD) Observed Date (Second MM DD YYYY)
Description

Progressive Disease Observed Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1335499
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C25331
NCI Thesaurus Property
C25599
UMLS CUI-2
C0011008
Liver Assessment
Description

LiverProgressionCriteriaInd-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C25331
NCI Thesaurus ObjectClass-2
C12392
UMLS 2011AA ObjectClass
C0023884
NCI Thesaurus Property
C25466
UMLS 2011AA Property
C0243161
Spleen Assessment
Description

SpleenProgressionCriteriaInd-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C25331
NCI Thesaurus ObjectClass-2
C12432
UMLS 2011AA ObjectClass
C0037993
NCI Thesaurus Property
C25466
UMLS 2011AA Property
C0243161
Lymph Node Assessment
Description

LymphNodeProgressionCriteriaInd-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C25331
NCI Thesaurus ObjectClass-2
C12745
UMLS 2011AA ObjectClass
C0024204
NCI Thesaurus Property
C25466
UMLS 2011AA Property
C0243161
Lymphocytes (> 50% increase in absolute number of circulating lymphocyctes to at least 5000/uL)
Description

LymphocyteProgressionCriteriaInd-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C25331
NCI Thesaurus ObjectClass-2
C12535
UMLS 2011AA ObjectClass
C0024264
NCI Thesaurus Property
C25466
UMLS 2011AA Property
C0243161
Comments
Description

Comments

Completed by (Last name, First name)
Description

Person Completing Form

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass
C25657
NCI Thesaurus Property
C25364
Date Form Completed (MM DD YYYY)
Description

Date Form Completed

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1115437
NCI Thesaurus ObjectClass
C40988
NCI Thesaurus Property
C25250
NCI Thesaurus ValueDomain-2
C25367
Comments
Description

Comments

Data type

text

Alias
UMLS CUI-1
C0947611
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Similar models

[Optional Form - may be selected for specific protocols where appropriate.]

1 forms
  1. StudyEvent: CALGB-10501 Summary Response / Progression Form for Leukemia
    1. [Optional Form - may be selected for specific protocols where appropriate.]
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
Form ID CALGB
Item
CALGB Form
text
C25337 (NCI Thesaurus ValueDomain)
C3262252 (UMLS CUI-1)
C19464 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus ObjectClass-2)
Protocol ID CALGB
Item
CALGB Study No
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus Property-2)
Trial subject ID CALGB
Item
CALGB Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus Property-2)
Assessment Date
Item
Date of Assessment
date
C25164 (NCI Thesaurus ValueDomain)
C2985720 (UMLS CUI-1)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C38000 (NCI Thesaurus Property)
Data amended
Item
Are data amended
boolean
C38148 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Item Group
Patient demographics
Patient Initials
Item
Patient Initials (Last, First Middle)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Medical Record Number
Item
Patient Hospital No.
text
C25337 (NCI Thesaurus ValueDomain)
C1301894 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25261 (NCI Thesaurus Property)
C25198 (NCI Thesaurus Property-2)
Institution Name
Item
Institution/Affiliate
text
C25454 (NCI Thesaurus ObjectClass)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)
Participating Group
Item
Participating Group
text
C25191 (NCI Thesaurus ValueDomain)
C2347449 (UMLS CUI-1)
C25608 (NCI Thesaurus ObjectClass)
C17005 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
Study Number Participating Group
Item
Participating Group Study No.
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Trial subject ID Participating Group
Item
Participating Group Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Item Group
Leukemia Response Assessment
TumorResponseInd-3
Item
Has the patient achieved a response? (during this time period)
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25755 (NCI Thesaurus Property)
C0871261 (UMLS 2011AA Property)
C25755 (NCI Thesaurus ValueDomain-2)
C0871261 (UMLS 2011AA ValueDomain-2)
Complete Response First Observed Date
Item
Complete Response (CR) First Observed Date (MM DD YYYY)
date
C25755 (NCI Thesaurus ObjectClass)
C0677874 (UMLS CUI-1)
C25250 (NCI Thesaurus ObjectClass-2)
C1115465 (UMLS CUI-2)
C25509 (NCI Thesaurus Property)
C25599 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
NodalPartialResponseFirstObservedDate
Item
Nodular partial response (NPR) first observed date (MM DD YYYY)
date
C25755 (NCI Thesaurus ObjectClass)
C0871261 (UMLS 2011AA ObjectClass)
C25378 (NCI Thesaurus ObjectClass-2)
C0728938 (UMLS 2011AA ObjectClass-2)
C25323 (NCI Thesaurus ObjectClass-3)
C0443268 (UMLS 2011AA ObjectClass-3)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C25599 (NCI Thesaurus Property-2)
C1441672 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Partial Response First Observed Date
Item
Partial Response (PR) First Observed Date (MM DD YYYY)
date
C25755 (NCI Thesaurus ObjectClass)
C1521726 (UMLS CUI-1)
C25378 (NCI Thesaurus ObjectClass-2)
C1115465 (UMLS CUI-2)
C25509 (NCI Thesaurus Property)
C25599 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
StableResponseFirstObservedDate
Item
Stable Disease First Observed Date (SD)
date
C25755 (NCI Thesaurus ObjectClass)
C0871261 (UMLS 2011AA ObjectClass)
C18213 (NCI Thesaurus ObjectClass-2)
C0677946 (UMLS 2011AA ObjectClass-2)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C25599 (NCI Thesaurus Property-2)
C1441672 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
DiseaseNewProgressionInd-2
Item
Has the patient been diagnosed with a new progression (during this reporting period not previously reported)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25586 (NCI Thesaurus Property)
C0205314 (UMLS 2011AA Property)
C25331 (NCI Thesaurus Property-2)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
Progressive Disease Observed Date
Item
Progressive Disease (PD) Observed Date (Second MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C1335499 (UMLS CUI-1)
C25367 (NCI Thesaurus ValueDomain-2)
C25331 (NCI Thesaurus ObjectClass)
C25599 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
Progressive Disease Observed Date
Item
Progressive Disease (PD) Observed Date (Second MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C1335499 (UMLS CUI-1)
C25367 (NCI Thesaurus ValueDomain-2)
C25331 (NCI Thesaurus ObjectClass)
C25599 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
Item
Liver Assessment
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25331 (NCI Thesaurus ObjectClass)
C12392 (NCI Thesaurus ObjectClass-2)
C0023884 (UMLS 2011AA ObjectClass)
C25466 (NCI Thesaurus Property)
C0243161 (UMLS 2011AA Property)
CL.4
Code List
Liver Assessment
CL Item
No (NO)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C49487 (NCI Thesaurus-3)
C1298908 (UMLS 2011AA-4)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Yes (YES)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus-3)
C1705108 (UMLS 2011AA-4)
Item
Spleen Assessment
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25331 (NCI Thesaurus ObjectClass)
C12432 (NCI Thesaurus ObjectClass-2)
C0037993 (UMLS 2011AA ObjectClass)
C25466 (NCI Thesaurus Property)
C0243161 (UMLS 2011AA Property)
CL.5
Code List
Spleen Assessment
CL Item
No (NO)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C49487 (NCI Thesaurus-3)
C1298908 (UMLS 2011AA-4)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Yes (YES)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus-3)
C1705108 (UMLS 2011AA-4)
Item
Lymph Node Assessment
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25331 (NCI Thesaurus ObjectClass)
C12745 (NCI Thesaurus ObjectClass-2)
C0024204 (UMLS 2011AA ObjectClass)
C25466 (NCI Thesaurus Property)
C0243161 (UMLS 2011AA Property)
CL.6
Code List
Lymph Node Assessment
CL Item
No (NO)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C49487 (NCI Thesaurus-3)
C1298908 (UMLS 2011AA-4)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Yes (YES)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus-3)
C1705108 (UMLS 2011AA-4)
Item
Lymphocytes (> 50% increase in absolute number of circulating lymphocyctes to at least 5000/uL)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25331 (NCI Thesaurus ObjectClass)
C12535 (NCI Thesaurus ObjectClass-2)
C0024264 (UMLS 2011AA ObjectClass)
C25466 (NCI Thesaurus Property)
C0243161 (UMLS 2011AA Property)
CL.7
Code List
Lymphocytes (> 50% increase in absolute number of circulating lymphocyctes to at least 5000/uL)
CL Item
No (NO)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C49487 (NCI Thesaurus-3)
C1298908 (UMLS 2011AA-4)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Yes (YES)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus-3)
C1705108 (UMLS 2011AA-4)
Item Group
Comments
Person Completing Form
Item
Completed by (Last name, First name)
text
C25191 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
Date Form Completed
Item
Date Form Completed (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C1115437 (UMLS CUI-1)
C40988 (NCI Thesaurus ObjectClass)
C25250 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)
Comments
Item
Comments
text
C0947611 (UMLS CUI-1)
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