ID

10097

Beskrivning

E5103 Hematology/Chemistry Form Doxorubicin, Cyclophosphamide, and Paclitaxel With or Without Bevacizumab in Treating Patients With Lymph Node-Positive or High-Risk, Lymph Node-Negative Breast Cancer NCT00433511 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=3AE26832-8814-18AE-E044-0003BA3F9857

Länk

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=3AE26832-8814-18AE-E044-0003BA3F9857

Nyckelord

Versioner (5)
  1. 2012-08-26 2012-08-26 -
  2. 2015-01-08 2015-01-08 - Martin Dugas
  3. 2015-01-09 2015-01-09 - Martin Dugas
  4. 2015-01-09 2015-01-09 - Martin Dugas
  5. 2015-03-27 2015-03-27 - Martin Dugas
Uppladdad den

27 mars 2015

DOI

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Licens

Creative Commons BY-NC 3.0 Legacy
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Breast Cancer Hematology/Chemistry NCT00433511

Tysk Engelsk

INSTRUCTIONS: Complete this form and submit original to the ECOG Coordinating Center within one week of registration. Keep a copy for your files

1 Formulär  
Header
Beskrivning

Header

Alias
UMLS CUI-1
C1320722
ECOG Protocol Number
Beskrivning

Protocol Number ECOG

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1512162
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25491
ECOG Patient ID
Beskrivning

Patient ID ECOG

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1512162
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25491
DCI Name
Beskrivning

Generic drug form

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C3242750
NCI Thesaurus Property
C19464
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus ObjectClass-2
C25452
Registration Step
Beskrivning

Registration Number

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1514821
NCI Thesaurus ObjectClass
C25646
UMLS CUI-2
C0237753
NCI Thesaurus Property
C16154
NCI Thesaurus ValueDomain-2
C16154
Patient Initials (Last, First)
Beskrivning

Patient Initials

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Participating Group Protocol Number
Beskrivning

Study Number Participating Group

Datatyp

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
Beskrivning

Trial subject ID Participating Group

Datatyp

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
Institution/Affiliate
Beskrivning

Institution Name

Datatyp

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
Please mark an 'X' if data have been amended. (Please circle amended items in red)
Beskrivning

Data amended

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Date data amended (MM/DD/YYYY)
Beskrivning

Data amended date

Datatyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
UMLS CUI-2
C0011008
NCI Thesaurus Property
C25416
NCI Thesaurus ValueDomain-2
C25367
Investigator Signature
Beskrivning

Investigator Signature

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C2346576
NCI Thesaurus Property
C25678
NCI Thesaurus ObjectClass
C17089
Investigator Signature Date
Beskrivning

Investigator Signature Date

Datatyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2346576
NCI Thesaurus Property
C25678
UMLS CUI-2
C0011008
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C17089
Pre-registration Hematology/chemistry
Beskrivning

Pre-registration Hematology/chemistry

On Treatment Report Period
Beskrivning

Cycle number

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C2045829
NCI Thesaurus Property
C25214
NCI Thesaurus Property-2
C25616
NCI Thesaurus ObjectClass
C15368
Date Hematology (Blood) Sample Obtained
Beskrivning

HematologyLabCollectedDate

Datatyp

date

Alias
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus Property
C20200
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain-2
C25452
UMLS CUI-1
C1317250
Were hematology/chemistry results obtained this report period (cycle)?
Beskrivning

HematologyAssessedInd-3

Datatyp

boolean

Alias
NCI Thesaurus ValueDomain
C38148
NCI Thesaurus Property
C25217
NCI Thesaurus ObjectClass
C16673
UMLS CUI-1
C0474523
Peripheral Granulocytes Count (AGC/ANC/mm^3 - Do not report % granulocytes: report absolute count without decimal.)
Beskrivning

Granulocyte count

Datatyp

float

Måttenheter
  • 1000/uL
Alias
NCI Thesaurus Property
C20200
UMLS CUI-1
C0857490
NCI Thesaurus Property-2
C12530
NCI Thesaurus ValueDomain
C25463
NCI Thesaurus ObjectClass
C25294
1000/uL
Peripheral Platelet Count (/mm^3x1000)
Beskrivning

Platelets

Datatyp

float

Måttenheter
  • 1000/uL
Alias
NCI Thesaurus Property
C20200
UMLS CUI-1
C0005821
NCI Thesaurus Property-2
C12520
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25712
1000/uL
Hemoglobin
Beskrivning

Hemoglobin

Datatyp

float

Alias
NCI Thesaurus Property
C16676
UMLS CUI-1
C0019046
NCI Thesaurus Property-2
C20200
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus ValueDomain
C25712
Creatinine
Beskrivning

Creatinine, Serum

Datatyp

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0201976
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C399
NCI Thesaurus ValueDomain
C38046
NCI Thesaurus ValueDomain-2
C25712
Creatinine ULN
Beskrivning

Creatinine, serum ULN

Datatyp

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS CUI-1
C0201976
NCI Thesaurus Property
C20200
UMLS CUI-2
C1519815
NCI Thesaurus Property-2
C399
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus ValueDomain-2
C25706
Sodium
Beskrivning

LaboratoryProcedureSodiumElectrolytesOutcomeUnspecifiedValue

Datatyp

float

Måttenheter
  • mmol/L
Alias
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C830
NCI Thesaurus Property-3
C464
NCI Thesaurus ValueDomain
C38046
NCI Thesaurus ValueDomain-2
C25712
UMLS CUI-1
C0337443
mmol/L
Test not done (Please mark "X" in Box only if test not done)
Beskrivning

Laboratory Procedure Not Performed

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0022885
NCI Thesaurus Property
C25594
UMLS CUI-2
C0445106
NCI Thesaurus Property-2
C38000
NCI Thesaurus ObjectClass
C25294
Units
Beskrivning

Units

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C20989
NCI Thesaurus Property
C37984
NCI Thesaurus ValueDomain
C25709
UMLS CUI-1
C1519795
CTC AE Attribution Code (Leave attribution box blank if no adverse event.)
Beskrivning

CTC AE Attribution Code (Leave attribution box blank if no adverse event.)

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25664
NCI Thesaurus ObjectClass
C49704
NCI Thesaurus Property
C25358
UMLS CUI-1
C1706735
Action taken for this AE for Chemotherapy
Beskrivning

DoseChemotherapyAdverseEventModificationStatus

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C25488
NCI Thesaurus Property
C15632
NCI Thesaurus Property-2
C41331
NCI Thesaurus Property-3
C25572
NCI Thesaurus ValueDomain
C25688
UMLS CUI-1
C0178602
UMLS CUI-2
C0392920
UMLS CUI-3
C0877248
UMLS CUI-4
C0449438
Tillbaka till toppen

Similar models

INSTRUCTIONS: Complete this form and submit original to the ECOG Coordinating Center within one week of registration. Keep a copy for your files

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Header
C1320722 (UMLS CUI-1)
Protocol Number ECOG
Item
ECOG Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Patient ID ECOG
Item
ECOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1512162 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25491 (NCI Thesaurus Property-2)
Generic drug form
Item
DCI Name
text
C25191 (NCI Thesaurus ValueDomain)
C3242750 (UMLS CUI-1)
C19464 (NCI Thesaurus Property)
C25474 (NCI Thesaurus ObjectClass)
C25452 (NCI Thesaurus ObjectClass-2)
Registration Number
Item
Registration Step
text
C25337 (NCI Thesaurus ValueDomain)
C1514821 (UMLS CUI-1)
C25646 (NCI Thesaurus ObjectClass)
C0237753 (UMLS CUI-2)
C16154 (NCI Thesaurus Property)
C16154 (NCI Thesaurus ValueDomain-2)
Patient Initials
Item
Patient Initials (Last, First)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Study Number Participating Group
Item
Participating Group Protocol Number
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)
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)
Data amended
Item
Please mark an 'X' if data have been amended. (Please circle amended items in red)
text
C25704 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Data amended date
Item
Date data amended (MM/DD/YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C0011008 (UMLS CUI-2)
C25416 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)
Investigator Signature
Item
Investigator Signature
text
C25704 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
Investigator Signature Date
Item
Investigator Signature Date
date
C25164 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C25367 (NCI Thesaurus ValueDomain-2)
C17089 (NCI Thesaurus ObjectClass)
Item Group
Pre-registration Hematology/chemistry
Item
On Treatment Report Period
text
C25284 (NCI Thesaurus ValueDomain)
C2045829 (UMLS CUI-1)
C25214 (NCI Thesaurus Property)
C25616 (NCI Thesaurus Property-2)
C15368 (NCI Thesaurus ObjectClass)
CL.1
Code List
On Treatment Report Period
CL Item
Baseline (Baseline)
C25213 (NCI Thesaurus)
C1442488 (UMLS 2011AA)
C25213 (NCI Thesaurus-3)
C1442488 (UMLS 2011AA-4)
CL Item
Cycle 1 (Cycle 1)
CL Item
Cycle 10 (Cycle 10)
CL Item
Cycle 11 (Cycle 11)
CL Item
Cycle 12 (Cycle 12)
CL Item
Cycle 13 (Cycle 13)
CL Item
Cycle 14 (Cycle 14)
CL Item
Cycle 15 (Cycle 15)
CL Item
Cycle 16 (Cycle 16)
CL Item
Cycle 17 (Cycle 17)
CL Item
Cycle 18 (Cycle 18)
CL Item
Cycle 2 (Cycle 2)
CL Item
Cycle 3 (Cycle 3)
CL Item
Cycle 4 (cycle 4)
CL Item
Cycle 5 (Cycle 5)
CL Item
Cycle 6 (Cycle 6)
CL Item
Cycle 7 (Cycle 7)
CL Item
Cycle 8 (cycle 8)
CL Item
Cycle 9 (Cycle 9)
HematologyLabCollectedDate
Item
Date Hematology (Blood) Sample Obtained
date
C25164 (NCI Thesaurus ValueDomain)
C20200 (NCI Thesaurus Property)
C25294 (NCI Thesaurus ObjectClass)
C25452 (NCI Thesaurus ValueDomain-2)
C1317250 (UMLS CUI-1)
Hematology lab
Item
Were hematology/chemistry results obtained this report period (cycle)?
boolean
C38148 (NCI Thesaurus ValueDomain)
C25217 (NCI Thesaurus Property)
C16673 (NCI Thesaurus ObjectClass)
C0474523 (UMLS CUI-1)
Granulocyte count
Item
Peripheral Granulocytes Count (AGC/ANC/mm^3 - Do not report % granulocytes: report absolute count without decimal.)
float
C20200 (NCI Thesaurus Property)
C0857490 (UMLS CUI-1)
C12530 (NCI Thesaurus Property-2)
C25463 (NCI Thesaurus ValueDomain)
C25294 (NCI Thesaurus ObjectClass)
Platelets
Item
Peripheral Platelet Count (/mm^3x1000)
float
C20200 (NCI Thesaurus Property)
C0005821 (UMLS CUI-1)
C12520 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
Hemoglobin
Item
Hemoglobin
float
C16676 (NCI Thesaurus Property)
C0019046 (UMLS CUI-1)
C20200 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
Creatinine, Serum
Item
Creatinine
float
C25294 (NCI Thesaurus ObjectClass)
C0201976 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C399 (NCI Thesaurus Property-2)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
Creatinine, serum ULN
Item
Creatinine ULN
float
C25294 (NCI Thesaurus ObjectClass)
C0201976 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C1519815 (UMLS CUI-2)
C399 (NCI Thesaurus Property-2)
C25712 (NCI Thesaurus ValueDomain)
C25706 (NCI Thesaurus ValueDomain-2)
Sodium
Item
Sodium
float
C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C830 (NCI Thesaurus Property-2)
C464 (NCI Thesaurus Property-3)
C38046 (NCI Thesaurus ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C0337443 (UMLS CUI-1)
Laboratory Procedure Not Performed
Item
Test not done (Please mark "X" in Box only if test not done)
text
C25704 (NCI Thesaurus ValueDomain)
C0022885 (UMLS CUI-1)
C25594 (NCI Thesaurus Property)
C0445106 (UMLS CUI-2)
C38000 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
Item
Units
text
C20989 (NCI Thesaurus ObjectClass)
C37984 (NCI Thesaurus Property)
C25709 (NCI Thesaurus ValueDomain)
C1519795 (UMLS CUI-1)
CL.4
Code List
Units
CL Item
Grams Per Deciliter (g/dL)
C0439267 (UMLS CUI-1)
CL Item
Grams Per Liter (g/L)
C0439294 (UMLS CUI-1)
CL Item
Milligrams Per Deciliter (mg/dL)
C0439269 (UMLS CUI-1)
CL Item
Milligrams Per Liter (mg/L)
C0439268 (UMLS CUI-1)
CL Item
Millimole Per Liter (mmol/L)
C1532563 (UMLS CUI-1)
CL Item
Milliequivalent Per Liter (mEq/L)
C0439375 (UMLS CUI-1)
Item
CTC AE Attribution Code (Leave attribution box blank if no adverse event.)
text
C25664 (NCI Thesaurus ValueDomain)
C49704 (NCI Thesaurus ObjectClass)
C25358 (NCI Thesaurus Property)
C1706735 (UMLS CUI-1)
CL.5
Code List
CTC AE Attribution Code (Leave attribution box blank if no adverse event.)
CL Item
Definite (Definite)
CL209464 (NCI Metathesaurus)
C1704787 (UMLS CUI-1)
CL Item
Possible (Possible)
C0332149 (NCI Metathesaurus)
C0332149 (UMLS CUI-1)
CL Item
Probable (Probable)
C0332148 (NCI Metathesaurus)
C1709683 (UMLS CUI-1)
CL Item
Unlikely (Unlikely)
C0750558 (UMLS CUI-1)
CL Item
Unrelated (Unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS CUI-1)
Item
Action taken for this AE for Chemotherapy
text
C25488 (NCI Thesaurus ObjectClass)
C15632 (NCI Thesaurus Property)
C41331 (NCI Thesaurus Property-2)
C25572 (NCI Thesaurus Property-3)
C25688 (NCI Thesaurus ValueDomain)
C0178602 (UMLS CUI-1)
C0392920 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
C0449438 (UMLS CUI-4)
CL.6
Code List
Action taken for this AE for Chemotherapy
CL Item
Dose Held (Dose held)
C0178602 (UMLS CUI-1)
C0549178 (UMLS CUI-2)
CL Item
Dose Delayed (Dose delayed)
C0178602 (UMLS CUI-1)
C0205421 (UMLS CUI-2)
CL Item
Dose Reduced (Dose reduced)
C49505 (NCI Thesaurus)
C49505 (NCI Thesaurus-3)
C1707814 (UMLS CUI-1)
CL Item
Dose Held and Reduced (Dose held and reduced)
C49505 (NCI Thesaurus)
C49505 (NCI Thesaurus-3)
C1553387 (UMLS CUI-1)
C1707814 (UMLS CUI-2)
CL Item
Drug Discontinued (Drug discontinued)
C0558681 (UMLS CUI-1)
Tillbaka till toppen 

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