ID

11198

Beschrijving

CALGB-40502 Follow-Up Form NCT00785291 Paclitaxel, Paclitaxel Albumin-Stabilized Nanoparticle Formulation, or Ixabepilone With or Without Bevacizumab in Treating Patients With Stage IIIC or Stage IV Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=51FC17F4-984D-0C38-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=51FC17F4-984D-0C38-E044-0003BA3F9857

Trefwoorden

Versies (4)
  1. 27-08-12 27-08-12 -
  2. 08-01-15 08-01-15 - Martin Dugas
  3. 09-01-15 09-01-15 - Martin Dugas
  4. 21-06-15 21-06-15 -
Geüploaded op

21 juni 2015

DOI

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Licentie

Creative Commons BY-NC 3.0 Legacy
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CALGB-40502 Follow-Up Form NCT00785291

Engels

INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy complete the form electronically. After entering all data, click the "Print and/or Submit to CALGB" button located at the bottom of the last page of the form. Retain a copy of the form for your records. Submit supporting documentation by fax (919-416-4990) or mail. If data are amended, circle amended items, check the "Yes" box, and submit by fax or mail

1 Formulieren  
Header
Beschrijving

Header

CALGB Form
Beschrijving

Form ID CALGB

Datatype

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
Beschrijving

Protocol ID CALGB

Datatype

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
Beschrijving

Trial subject ID CALGB

Datatype

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
Reporting Period Start Date
Beschrijving

Reporting Period Start Date

Datatype

date

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25616
UMLS CUI-1
C2361257
NCI Thesaurus Property-2
C25651
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25431
Reporting Period End Date (date of last contact or death)
Beschrijving

Reporting Period End Date

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2361259
NCI Thesaurus Property
C25616
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property-2
C25651
Are data amended
Beschrijving

Data amended

Datatype

boolean

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

Patient demographics

Patient Initials
Beschrijving

Patient Initials

Datatype

text

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

Medical Record Number

Datatype

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
Beschrijving

Institution Name

Datatype

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
Beschrijving

Participating Group

Datatype

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.
Beschrijving

Study Number Participating Group

Datatype

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
Beschrijving

Trial subject ID Participating Group

Datatype

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
Vital Status
Beschrijving

Vital Status

Patient's vital status (Mark one with an X. If the patient is lost, follow instructions on form C-1742 and in the CALGB Policies and Procedures chapter 8 to have Data Operations change a patient's survival status to: "Confirmed lost to follow-up")
Beschrijving

Patient Status

Datatype

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS CUI-1
C3846084
NCI Thesaurus ValueDomain
C18003
NCI Thesaurus ValueDomain-2
C25688
NCI Thesaurus Property
C25717
Primary cause of death (Mark one with an X.)
Beschrijving

Primary Cause of Death

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS CUI-1
C0007465
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C28554
NCI Thesaurus ValueDomain-2
C25251
Describe cause of death
Beschrijving

Cause of Death, specify

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C0007465
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1521902
NCI Thesaurus Property
C28554
Has the patient had a documented clinical assessment for this cancer (during this reporting period?)
Beschrijving

Documented clinical assessment for this cancer

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C1522577
NCI Thesaurus Property
C16033
UMLS CUI-2
C0006826
NCI Thesaurus ObjectClass
C9305
NCI Thesaurus Property-2
C25365
Date of Last Clinical Assessment (MM DD YYYY)
Beschrijving

Follow-Up Date

Datatype

date

Alias
NCI Thesaurus ObjectClass
C9305
UMLS CUI-1
C3694716
NCI Thesaurus Property
C16033
NCI Thesaurus Property-2
C25365
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25367
Notice Of Progression
Beschrijving

Notice Of Progression

Has the patient been diagnosed with first local-regional recurrence (since submission of the last follow-up form?)
Beschrijving

Neoplasm Recurrence, locoregional

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C19987
UMLS CUI-1
C0027643
NCI Thesaurus Property
C25388
NCI Thesaurus Property-2
C25509
NCI Thesaurus Property-3
C15220
NCI Thesaurus ValueDomain
C38148
Date of First Local-Regional Progression (MM DD YYYY)
Beschrijving

Local-RegionalProgressionFirstDate

Datatype

date

Alias
NCI Thesaurus ObjectClass
C25331
NCI Thesaurus ObjectClass-2
C25388
UMLS 2011AA ObjectClass
C1947913
NCI Thesaurus Property
C25509
UMLS 2011AA Property
C1279901
NCI Thesaurus Property-2
C25275
UMLS 2011AA Property-2
C2745955
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25509
UMLS 2011AA ValueDomain-2
C1279901
Site of First Local-Regional Progression (s)
Beschrijving

BreastFirstProgressionLocal-RegionalSite

Datatype

text

Alias
NCI Thesaurus ValueDomain
C13717
UMLS 2011AA ValueDomain
C1515974
NCI Thesaurus Property
C25331
NCI Thesaurus ObjectClass
C12971
UMLS 2011AA ObjectClass
C0006141
NCI Thesaurus Property-2
C25509
UMLS 2011AA Property
C1279901
Has the patient been diagnosed with first distant recurrence/progression? (since submission of the last follow-up form?)
Beschrijving

Neoplasm recurrence, Distal

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C19987
UMLS CUI-1
C0027627
NCI Thesaurus Property
C25321
NCI Thesaurus Property-2
C25509
NCI Thesaurus Property-3
C15220
NCI Thesaurus ValueDomain
C25180
Date of First Distant Progression (MM DD YYYY)
Beschrijving

Date of Neoplasm distal recurrence

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0027627
NCI Thesaurus ObjectClass
C25331
NCI Thesaurus ValueDomain-2
C25509
UMLS CUI-2
C0011008
NCI Thesaurus Property
C25275
Site of First Distant Recurrence (s)
Beschrijving

RecurrentDiseaseFirstDistantDiagnosisText

Datatype

text

Alias
NCI Thesaurus ObjectClass
C38155
UMLS 2011AA ObjectClass
C0277556
NCI Thesaurus Property
C25321
UMLS 2011AA Property
C0443203
NCI Thesaurus Property-2
C25509
UMLS 2011AA Property-2
C1279901
NCI Thesaurus Property-3
C15220
UMLS 2011AA Property-3
C0011900
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
How was this progression information obtained? (Mark one with an X.)
Beschrijving

ProgressionAssessmentSource

Datatype

text

Alias
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ObjectClass
C25331
NCI Thesaurus ValueDomain
C25683
UMLS 2011AA ValueDomain
C0449416
How was this progression information obtained? (Mark one with an X.)
Beschrijving

ProgressionAssessmentSource

Datatype

text

Alias
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ObjectClass
C25331
NCI Thesaurus ValueDomain
C25683
UMLS 2011AA ValueDomain
C0449416
Non-protocol Therapy
Beschrijving

Non-protocol Therapy

Did the patient receive additional therapy? (during this reporting period)
Beschrijving

AdditionalTherapyAdministeredInd-3

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C25406
UMLS 2011AA ObjectClass
C1524062
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Subsequent Treatment Type (Specify subsequent therapy type as: Chemotherapye.g., adriamycin, capecitabine, gemcitabine, taxanes, vinorelbine, vinblastine Hormonal e.g., anastrozole, exemestane, fulvestrant, letrozole, toremifene, tamoxifen, raloxifene Biological e.g., bevacizumab, lapatinib, sorafenib, sunitinib, trastuzumab Bisphosphonate e.g., pamidronate, zoledronic acid Radiation Surgery Other)
Beschrijving

AdditionalTreatmentProgressionText

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus Property
C25331
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C25406
UMLS 2011AA ObjectClass
C1524062
Agent
Beschrijving

Agent

Datatype

text

Alias
NCI Thesaurus Property
C25364
UMLS CUI-1
C1521826
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus ValueDomain
C1708
NCI Thesaurus ValueDomain-2
C42614
Agent Total Cumulative Dose (During this reporting period)
Beschrijving

Cumulative Dose Agent

Datatype

float

Alias
NCI Thesaurus ObjectClass
C1708
UMLS CUI-1
C2986497
NCI Thesaurus ObjectClass-2
C25470
UMLS CUI-2
C1521826
NCI Thesaurus Property
C25304
NCI Thesaurus Property-2
C25256
NCI Thesaurus ValueDomain
C25304
NCI Thesaurus ValueDomain-2
C25488
Units
Beschrijving

Units

Datatype

text

Alias
NCI Thesaurus ObjectClass
C1708
UMLS CUI-1
C1519795
NCI Thesaurus Property
C25256
NCI Thesaurus ValueDomain
C25709
Agent Start Date (MM DD YYYY)
Beschrijving

Concomitant Medication Start Date

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2826734
NCI Thesaurus ValueDomain-2
C25431
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus Property
C25275
Agent End Date (MM DD YYYY)
Beschrijving

Concomitant Medication End Date

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2826744
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus Property
C25275
Long-term Adverse Events
Beschrijving

Long-term Adverse Events

Has the patient experienced (prior to diagnosis of recurrence or second primary) any severe (Grade >=3), long term toxicity that has not been previously reported (If yes complete the section below)
Beschrijving

AdverseEventPriorCancerProgressionRecurrentNeoplasmPresentInd-3

Datatype

boolean

Alias
NCI Thesaurus ObjectClass
C41331
UMLS 2011AA ObjectClass
C0877248
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus Property-2
C25629
UMLS 2011AA Property-2
C0332152
NCI Thesaurus Property-3
C19987
UMLS 2011AA Property-3
C0242656
NCI Thesaurus Property-4
C4798
UMLS 2011AA Property-4
C0521158
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
MedDRA Code
Beschrijving

MedDRACode

Datatype

float

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Metathesaurus ObjectClass
CL104089
CTC Adverse Event Term
Beschrijving

CTC Adverse Event Term

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C1516728
NCI Thesaurus ObjectClass
C49704
UMLS CUI-2
C2826934
NCI Thesaurus Property
C45559
CTC AE Grade
Beschrijving

CTC Adverse Event Grade

Datatype

float

Alias
NCI Thesaurus ObjectClass
C49704
UMLS CUI-1
C2985911
NCI Thesaurus ValueDomain
C18000
NCI Thesaurus Property
C25365
CTC AE Attribution Code
Beschrijving

CTC Adverse Event Attribution Category

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS CUI-1
C1706735
NCI Thesaurus ObjectClass
C49704
NCI Thesaurus Property
C25358
AE Onset Date (MM DD YYYY)
Beschrijving

Adverse Event Onset Date

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2985916
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C49704
NCI Thesaurus Property
C25279
Notice Of Progression
Beschrijving

Notice Of Progression

Has a new primary cancer or MDS been diagnosed that has not been previously reported? (myelodysplastic syndrome)
Beschrijving

NewCancerDiagnosisInd-3

Datatype

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C25586
UMLS 2011AA ObjectClass
C0205314
NCI Thesaurus ObjectClass-2
C9305
UMLS 2011AA ObjectClass-2
C0006826
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
Date of diagnosis (MM DD YYYY)
Beschrijving

NewCancerDiagnosisDate

Datatype

date

Alias
NCI Thesaurus ObjectClass
C25586
UMLS 2011AA ObjectClass
C0205314
NCI Thesaurus ObjectClass-2
C9305
UMLS 2011AA ObjectClass-2
C0006826
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
Site of new primary (s If new primary site is AML/MDS, submit NCI AML/MDS form.)
Beschrijving

NewCancerSiteText

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C25586
UMLS 2011AA ObjectClass
C0205314
NCI Thesaurus Property
C25341
UMLS 2011AA Property
C0450429
NCI Thesaurus ObjectClass-2
C9305
UMLS 2011AA ObjectClass-2
C0006826
Comments
Beschrijving

Comments

Comments
Beschrijving

Research Comments

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
Completed by (Last name, First name)
Beschrijving

Person Completing Form

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass
C25657
NCI Thesaurus Property
C25364
Date form completed (MM DD YYYY)
Beschrijving

Date Form Completed

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1115437
NCI Thesaurus ObjectClass
C40988
NCI Thesaurus Property
C25250
NCI Thesaurus ValueDomain-2
C25367
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INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy complete the form electronically. After entering all data, click the "Print and/or Submit to CALGB" button located at the bottom of the last page of the form. Retain a copy of the form for your records. Submit supporting documentation by fax (919-416-4990) or mail. If data are amended, circle amended items, check the "Yes" box, and submit by fax or mail

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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)
Reporting Period Start Date
Item
Reporting Period Start Date
date
C15368 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C2361257 (UMLS CUI-1)
C25651 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
Reporting Period End Date
Item
Reporting Period End Date (date of last contact or death)
date
C25164 (NCI Thesaurus ValueDomain)
C2361259 (UMLS CUI-1)
C25616 (NCI Thesaurus Property)
C15368 (NCI Thesaurus ObjectClass)
C25651 (NCI Thesaurus Property-2)
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
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
Vital Status
Item
Patient's vital status (Mark one with an X. If the patient is lost, follow instructions on form C-1742 and in the CALGB Policies and Procedures chapter 8 to have Data Operations change a patient's survival status to: "Confirmed lost to follow-up")
text
C16960 (NCI Thesaurus ObjectClass)
C3846084 (UMLS CUI-1)
C18003 (NCI Thesaurus ValueDomain)
C25688 (NCI Thesaurus ValueDomain-2)
C25717 (NCI Thesaurus Property)
CL.2
Code List
Patient's vital status (Mark one with an X. If the patient is lost, follow instructions on form C-1742 and in the CALGB Policies and Procedures chapter 8 to have Data Operations change a patient's survival status to: "Confirmed lost to follow-up")
CL Item
Alive (Alive)
CL Item
Dead (Dead)
Item
Primary cause of death (Mark one with an X.)
text
C25638 (NCI Thesaurus ValueDomain)
C0007465 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C28554 (NCI Thesaurus Property)
C25251 (NCI Thesaurus ValueDomain-2)
CL.3
Code List
Primary cause of death (Mark one with an X.)
CL Item
Due To This Disease (Due to this disease)
CL Item
Due To Protocol Treatment (Due to protocol treatment)
CL Item
Due To Other Cause (Due to other cause)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Cause of Death, specify
Item
Describe cause of death
text
C25685 (NCI Thesaurus ValueDomain)
C0007465 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1521902 (UMLS CUI-2)
C28554 (NCI Thesaurus Property)
Documented clinical assessment for this cancer
Item
Has the patient had a documented clinical assessment for this cancer (during this reporting period?)
boolean
C38148 (NCI Thesaurus ValueDomain)
C1522577 (UMLS CUI-1)
C16033 (NCI Thesaurus Property)
C0006826 (UMLS CUI-2)
C9305 (NCI Thesaurus ObjectClass)
C25365 (NCI Thesaurus Property-2)
Follow-Up Date
Item
Date of Last Clinical Assessment (MM DD YYYY)
date
C9305 (NCI Thesaurus ObjectClass)
C3694716 (UMLS CUI-1)
C16033 (NCI Thesaurus Property)
C25365 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Item Group
Notice Of Progression
Neoplasm Recurrence, locoregional
Item
Has the patient been diagnosed with first local-regional recurrence (since submission of the last follow-up form?)
boolean
C19987 (NCI Thesaurus ObjectClass)
C0027643 (UMLS CUI-1)
C25388 (NCI Thesaurus Property)
C25509 (NCI Thesaurus Property-2)
C15220 (NCI Thesaurus Property-3)
C38148 (NCI Thesaurus ValueDomain)
Local-RegionalProgressionFirstDate
Item
Date of First Local-Regional Progression (MM DD YYYY)
date
C25331 (NCI Thesaurus ObjectClass)
C25388 (NCI Thesaurus ObjectClass-2)
C1947913 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C25275 (NCI Thesaurus Property-2)
C2745955 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25509 (NCI Thesaurus ValueDomain-2)
C1279901 (UMLS 2011AA ValueDomain-2)
Item
Site of First Local-Regional Progression (s)
text
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
C25331 (NCI Thesaurus Property)
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus Property-2)
C1279901 (UMLS 2011AA Property)
CL.6
Code List
Site of First Local-Regional Progression (s)
CL Item
Ipsilateral Breast (Ipsilateral breast)
CL Item
Axillary Nodes (Axillary nodes)
CL Item
Supraclavicular Nodes (Supraclavicular nodes)
CL Item
Infraclavicular Nodes (Infraclavicular nodes)
CL Item
Chest Wall (Chest wall)
CL035093 (NCI Metathesaurus)
C62484 (NCI Thesaurus)
C0205076 (UMLS 2011AA)
CL Item
Internal Mammary Nodes (Internal mammary nodes)
CL Item
Axilla (Axilla)
C12674 (NCI Thesaurus)
C0004454 (UMLS 2011AA)
Neoplasm recurrence, Distal
Item
Has the patient been diagnosed with first distant recurrence/progression? (since submission of the last follow-up form?)
boolean
C19987 (NCI Thesaurus ObjectClass)
C0027627 (UMLS CUI-1)
C25321 (NCI Thesaurus Property)
C25509 (NCI Thesaurus Property-2)
C15220 (NCI Thesaurus Property-3)
C25180 (NCI Thesaurus ValueDomain)
Date of Neoplasm distal recurrence
Item
Date of First Distant Progression (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0027627 (UMLS CUI-1)
C25331 (NCI Thesaurus ObjectClass)
C25509 (NCI Thesaurus ValueDomain-2)
C0011008 (UMLS CUI-2)
C25275 (NCI Thesaurus Property)
RecurrentDiseaseFirstDistantDiagnosisText
Item
Site of First Distant Recurrence (s)
text
C38155 (NCI Thesaurus ObjectClass)
C0277556 (UMLS 2011AA ObjectClass)
C25321 (NCI Thesaurus Property)
C0443203 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property-2)
C1279901 (UMLS 2011AA Property-2)
C15220 (NCI Thesaurus Property-3)
C0011900 (UMLS 2011AA Property-3)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
Item
How was this progression information obtained? (Mark one with an X.)
text
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25331 (NCI Thesaurus ObjectClass)
C25683 (NCI Thesaurus ValueDomain)
C0449416 (UMLS 2011AA ValueDomain)
CL.9
Code List
How was this progression information obtained? (Mark one with an X.)
CL Item
Clinical Assessment (Clinical assessment)
CL Item
Patient Self Report Only (Patient self-report only)
Item
How was this progression information obtained? (Mark one with an X.)
text
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25331 (NCI Thesaurus ObjectClass)
C25683 (NCI Thesaurus ValueDomain)
C0449416 (UMLS 2011AA ValueDomain)
CL.9
Code List
How was this progression information obtained? (Mark one with an X.)
CL Item
Clinical Assessment (Clinical assessment)
CL Item
Patient Self Report Only (Patient self-report only)
Item Group
Non-protocol Therapy
AdditionalTherapyAdministeredInd-3
Item
Did the patient receive additional therapy? (during this reporting period)
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25406 (NCI Thesaurus ObjectClass-2)
C1524062 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
AdditionalTreatmentProgressionText
Item
Subsequent Treatment Type (Specify subsequent therapy type as: Chemotherapye.g., adriamycin, capecitabine, gemcitabine, taxanes, vinorelbine, vinblastine Hormonal e.g., anastrozole, exemestane, fulvestrant, letrozole, toremifene, tamoxifen, raloxifene Biological e.g., bevacizumab, lapatinib, sorafenib, sunitinib, trastuzumab Bisphosphonate e.g., pamidronate, zoledronic acid Radiation Surgery Other)
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25331 (NCI Thesaurus Property)
C15368 (NCI Thesaurus ObjectClass)
C25406 (NCI Thesaurus ObjectClass-2)
C1524062 (UMLS 2011AA ObjectClass)
Agent
Item
Agent
text
C25364 (NCI Thesaurus Property)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)
Cumulative Dose Agent
Item
Agent Total Cumulative Dose (During this reporting period)
float
C1708 (NCI Thesaurus ObjectClass)
C2986497 (UMLS CUI-1)
C25470 (NCI Thesaurus ObjectClass-2)
C1521826 (UMLS CUI-2)
C25304 (NCI Thesaurus Property)
C25256 (NCI Thesaurus Property-2)
C25304 (NCI Thesaurus ValueDomain)
C25488 (NCI Thesaurus ValueDomain-2)
Units
Item
Units
text
C1708 (NCI Thesaurus ObjectClass)
C1519795 (UMLS CUI-1)
C25256 (NCI Thesaurus Property)
C25709 (NCI Thesaurus ValueDomain)
Concomitant Medication Start Date
Item
Agent Start Date (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C2826734 (UMLS CUI-1)
C25431 (NCI Thesaurus ValueDomain-2)
C1708 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)
Concomitant Medication End Date
Item
Agent End Date (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C2826744 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)
Item Group
Long-term Adverse Events
AdverseEventPriorCancerProgressionRecurrentNeoplasmPresentInd-3
Item
Has the patient experienced (prior to diagnosis of recurrence or second primary) any severe (Grade >=3), long term toxicity that has not been previously reported (If yes complete the section below)
boolean
C41331 (NCI Thesaurus ObjectClass)
C0877248 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C19987 (NCI Thesaurus Property-3)
C0242656 (UMLS 2011AA Property-3)
C4798 (NCI Thesaurus Property-4)
C0521158 (UMLS 2011AA Property-4)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
MedDRACode
Item
MedDRA Code
float
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
CL104089 (NCI Metathesaurus ObjectClass)
Item
CTC Adverse Event Term
text
C25284 (NCI Thesaurus ValueDomain)
C1516728 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C2826934 (UMLS CUI-2)
C45559 (NCI Thesaurus Property)
CL.12
Code List
CTC Adverse Event Term
CL Item
Peripheral Motor Neuropathy (Neuropathy: motor)
C3500 (NCI Thesaurus)
C0018995 (UMLS 2011AA)
CL Item
Peripheral Sensory Neuropathy (Neuropathy: sensory)
C3501 (NCI Thesaurus)
C0151313 (UMLS 2011AA)
CTC Adverse Event Grade
Item
CTC AE Grade
float
C49704 (NCI Thesaurus ObjectClass)
C2985911 (UMLS CUI-1)
C18000 (NCI Thesaurus ValueDomain)
C25365 (NCI Thesaurus Property)
Item
CTC AE Attribution Code
text
C25664 (NCI Thesaurus ValueDomain)
C1706735 (UMLS CUI-1)
C49704 (NCI Thesaurus ObjectClass)
C25358 (NCI Thesaurus Property)
CL.14
Code List
CTC AE Attribution Code
CL Item
Definite (Definite)
CL209464 (NCI Metathesaurus)
CL Item
Possible (Possible)
C0332149 (NCI Metathesaurus)
CL Item
Probable (Probable)
C0332148 (NCI Metathesaurus)
CL Item
Unlikely (Unlikely)
CL Item
Unrelated (Unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
Adverse Event Onset Date
Item
AE Onset Date (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C2985916 (UMLS CUI-1)
C25367 (NCI Thesaurus ValueDomain-2)
C49704 (NCI Thesaurus ObjectClass)
C25279 (NCI Thesaurus Property)
Item Group
Notice Of Progression
NewCancerDiagnosisInd-3
Item
Has a new primary cancer or MDS been diagnosed that has not been previously reported? (myelodysplastic syndrome)
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
NewCancerDiagnosisDate
Item
Date of diagnosis (MM DD YYYY)
date
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
NewCancerSiteText
Item
Site of new primary (s If new primary site is AML/MDS, submit NCI AML/MDS form.)
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
Item Group
Comments
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
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)
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