ID

10813

Description

PACCT-1 TAILORx Medication Form NCT00310180 Hormone Therapy With or Without Combination Chemotherapy in Treating Women Who Have Undergone Surgery for Node-Negative Breast Cancer (The TAILORx Trial) Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=8401EEDE-6C53-E54A-E040-BB89AD433901

Lien

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=8401EEDE-6C53-E54A-E040-BB89AD433901

Mots-clés

Versions (3)
  1. 26/08/2012 26/08/2012 -
  2. 08/01/2015 08/01/2015 - Martin Dugas
  3. 08/06/2015 08/06/2015 -
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8 juin 2015

DOI

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Creative Commons BY-NC 3.0 Legacy
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PACCT-1 TAILORx Medication Form NCT00310180

Anglais

INSTRUCTIONS: Complete this form at the end of each cycle, and at required follow-ups if specified by the Long-Term Follow-Up Form (to report late adverse events). Submit original to the ECOG Coordinating Center. Keep a copy for your files. NOTE: The form for the last cycle should include the 30 days following the last dose of protocol drug, or until the initiation of subsequent t reatment, whichever comes first. NOTE: This form should be completed regardless of whether there are adverse events to report for the required submission report period

1 Formulaires  
Header
Description

Header

DCI Name
Description

Generic drug form

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C3242750
NCI Thesaurus Property
C19464
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus ObjectClass-2
C25452
Patient Initials (Last, First)
Description

Patient Initials

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
ECOG Protocol Number
Description

Protocol Number ECOG

Type de données

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 Protocol Number
Description

Protocol Number ECOG

Type de données

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
Description

Patient ID ECOG

Type de données

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
ECOG Patient ID
Description

Patient ID ECOG

Type de données

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
Participating Group Protocol Number
Description

Study Number Participating Group

Type de données

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

Type de données

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
Description

Institution Name

Type de données

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
Data amendment
Description

Data amendment

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

Data amended

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Date data amended (s M D Y)
Description

Data amended date

Type de données

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
On Treatment
Description

On Treatment

Report Period (Choose one)
Description

Cycle number

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C2045829
NCI Thesaurus Property
C25214
NCI Thesaurus Property-2
C25616
NCI Thesaurus ObjectClass
C15368
Assessment Date
Description

Assessment Date

Assessment date
Description

Assessment Date

Type de données

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2985720
NCI Thesaurus ObjectClass
C25367
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus Property
C38000
Section I - Patient Characteristics
Description

Section I - Patient Characteristics

Height (cm complete at BASELINE only)
Description

Patient Height

Type de données

float

Unités de mesure
  • cm
Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0489786
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25347
cm
Weight (kg)
Description

Patient Weight

Type de données

float

Unités de mesure
  • Kg
Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0005910
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25208
Kg
Month of last mentrual period
Description

LastMenstrualCycleOccurrenceMonthYearDate

Type de données

date

Alias
NCI Thesaurus ObjectClass
C25551
UMLS 2011AA ObjectClass
C1517741
NCI Thesaurus ObjectClass-2
C16838
UMLS 2011AA ObjectClass-2
C0025329
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C29846
UMLS 2011AA ValueDomain-2
C0439231
NCI Thesaurus ValueDomain-3
C29848
UMLS 2011AA ValueDomain-3
C0439234
Section Ii - Comorbidities (complete Section At Baseline Only)
Description

Section Ii - Comorbidities (complete Section At Baseline Only)

Hypertension
Description

HypertensionPresentInd-3

Type de données

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C3117
UMLS 2011AA ObjectClass
C0020538
Is patient on anti-hypertensive therapy
Description

HypertensionTreatmentReceivedInd-2

Type de données

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C3117
UMLS 2011AA ObjectClass
C0020538
NCI Thesaurus Property
C25639
UMLS 2011AA Property
C1514756
NCI Thesaurus ObjectClass-2
C15368
Hyperlipidemia
Description

PersonHyperlipidemiaTherapeuticProcedurePersonalMedicalHistoryind-2

Type de données

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C49236
UMLS 2011AA Property
C0087111
NCI Thesaurus Property-2
C34707
UMLS 2011AA Property-2
C0020473
NCI Thesaurus Property-3
C18772
UMLS 2011AA Property-3
C0262926
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Hyperlipidemia
Description

HyperlipidemiaDiseasesandDisordersMedicationBaselineUseInd-2

Type de données

boolean

Alias
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus ObjectClass-2
C459
UMLS 2011AA ObjectClass-2
C0013227
NCI Thesaurus ObjectClass-3
C34707
UMLS 2011AA ObjectClass-3
C0020473
NCI Thesaurus Property
C25213
UMLS 2011AA Property
C1442488
NCI Thesaurus Property-2
C25340
UMLS 2011AA Property-2
C0457083
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Diabetes
Description

DiabetesMellitusDiseasePresentInd-2

Type de données

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus ObjectClass-2
C2985
UMLS 2011AA ObjectClass-2
C0011849
Diabetes (if yes, is patient taking medication for this condition)
Description

DiabetesMellitusDiseasesandDisordersMedicationBaselineUseInd-2

Type de données

boolean

Alias
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus ObjectClass-2
C2985
UMLS 2011AA ObjectClass-2
C0011849
NCI Thesaurus ObjectClass-3
C459
UMLS 2011AA ObjectClass-3
C0013227
NCI Thesaurus Property
C25213
UMLS 2011AA Property
C1442488
NCI Thesaurus Property-2
C25340
UMLS 2011AA Property-2
C0457083
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Osteoarthritis
Description

OsteoarthritisPresentInd-2

Type de données

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C3293
UMLS 2011AA ObjectClass
C0029408
Osteoarthritis
Description

OsteoarthritisMedicationUseInd-2

Type de données

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C3293
UMLS 2011AA ObjectClass
C0029408
NCI Thesaurus ObjectClass-2
C459
UMLS 2011AA ObjectClass-2
C0013227
NCI Thesaurus Property
C25340
UMLS 2011AA Property
C0457083
Arthritic conditions other than osteoarthritis (conditions other than osteoarthritis e.g., rheumatoid arthritis)
Description

PatientArthritisPersonalMedicalHistoryInd-3

Type de données

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C2883
UMLS 2011AA Property
C0003864
NCI Thesaurus Property-2
C18772
UMLS 2011AA Property-2
C0262926
Arthritic conditions other than osteoarthritis
Description

ArthritisMedicationUseInd-2

Type de données

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C459
UMLS 2011AA ObjectClass
C0013227
NCI Thesaurus ObjectClass-2
C2883
UMLS 2011AA ObjectClass-2
C0003864
NCI Thesaurus Property
C25340
UMLS 2011AA Property
C0457083
Fibromylagia
Description

FibromyalgiaPresentInd-2

Type de données

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C87497
Fibromyalgia
Description

FibromyalgiaMedicationUseInd-2

Type de données

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C459
UMLS 2011AA ObjectClass
C0013227
NCI Thesaurus ObjectClass-2
C87497
NCI Thesaurus Property
C25340
UMLS 2011AA Property
C0457083
Depression
Description

DiseaseDepressionPresentInd-3

Type de données

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus Property-2
C2982
UMLS 2011AA Property-2
C0011570
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
Depression
Description

DepressionMedicationUseInd-2

Type de données

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C2982
UMLS 2011AA ObjectClass
C0011570
NCI Thesaurus ObjectClass-2
C459
UMLS 2011AA ObjectClass-2
C0013227
NCI Thesaurus Property
C25340
UMLS 2011AA Property
C0457083
Cardiovascular Disease
Description

CardiovascularDiseasePresentInd-2

Type de données

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C25292
UMLS 2011AA ObjectClass
C0007226
NCI Thesaurus ObjectClass-2
C2991
UMLS 2011AA ObjectClass-2
C0012634
Cardiovascular Disease (If yes, is patient taking medication for this condition)
Description

CardiovascularSystemDiseasesandDisordersMedicationBaselineUseInd-2

Type de données

boolean

Alias
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus ObjectClass-2
C459
UMLS 2011AA ObjectClass-2
C0013227
NCI Thesaurus ObjectClass-3
C12686
UMLS 2011AA ObjectClass-3
C0007226
NCI Thesaurus Property
C25213
UMLS 2011AA Property
C1442488
NCI Thesaurus Property-2
C25340
UMLS 2011AA Property-2
C0457083
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Cerebrovascular disease (e.g., prior TIA)
Description

PatientCerebrovascularAccidentHistoryInd-3

Type de données

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C3390
UMLS 2011AA Property
C0038454
NCI Thesaurus Property-2
C18772
UMLS 2011AA Property-2
C0262926
Cerebrovascular disease
Description

CerebrovascularDisorderMedicationUseInd-2

Type de données

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C459
UMLS 2011AA ObjectClass
C0013227
NCI Thesaurus ObjectClass-2
C2938
UMLS 2011AA ObjectClass-2
C0007820
NCI Thesaurus Property
C25340
UMLS 2011AA Property
C0457083
Pulmonary Disease (e.g., asthma or other chronic pulmonary conditions)
Description

ChronicDiseasePulmonaryInd-3

Type de données

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus ObjectClass-2
C14141
UMLS 2011AA ObjectClass-2
C0205191
NCI Metathesaurus Property
CL317978
Pulmonary disease
Description

LungDisorderMedicationUseInd-2

Type de données

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C459
UMLS 2011AA ObjectClass
C0013227
NCI Thesaurus ObjectClass-2
C3198
UMLS 2011AA ObjectClass-2
C0024115
NCI Thesaurus Property
C25340
UMLS 2011AA Property
C0457083
Liver disease (e.g., hepatitis C or other conditions)
Description

LiverDiseasePresentInd-2

Type de données

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ObjectClass
C12392
UMLS 2011AA ObjectClass
C0023884
NCI Thesaurus ObjectClass-2
C2991
UMLS 2011AA ObjectClass-2
C0012634
Liver disease
Description

HepaticDisorderMedicationUseInd-2

Type de données

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C459
UMLS 2011AA ObjectClass
C0013227
NCI Thesaurus ObjectClass-2
C3196
UMLS 2011AA ObjectClass-2
C0023895
NCI Thesaurus Property
C25340
UMLS 2011AA Property
C0457083
Neuropathy (e.g., diabetic neuropathy)
Description

AutonomicNeuropathyInvolvedInd-3

Type de données

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C25547
NCI Thesaurus ObjectClass
C27033
UMLS 2011AA ObjectClass
C0259749
Neuropathy
Description

NeuropathyMedicationUseInd-2

Type de données

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C459
UMLS 2011AA ObjectClass
C0013227
NCI Thesaurus ObjectClass-2
C4731
UMLS 2011AA ObjectClass-2
C0031117
NCI Thesaurus Property
C25340
UMLS 2011AA Property
C0457083
Osteopenia/osteoporosis
Description

OsteopeniaDiagnosisInd-3

Type de données

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
NCI Metathesaurus ObjectClass
C0029453
Osteopenia/osteoporosis
Description

OsteopeniaMedicationUseInd-2

Type de données

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C459
UMLS 2011AA ObjectClass
C0013227
NCI Thesaurus ObjectClass-2
C50910
UMLS 2011AA ObjectClass-2
C0029453
NCI Thesaurus Property
C25340
UMLS 2011AA Property
C0457083
Section Iii - Hormonal Medications
Description

Section Iii - Hormonal Medications

Current hormone therapy
Description

HormoneTherapyAgentAdministeredType

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus ObjectClass-2
C1708
UMLS 2011AA ObjectClass-2
C0450442
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Other specify
Description

HormoneTherapyAgentAdministeredSpecify

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C15445
UMLS 2011AA ObjectClass
C0279025
NCI Thesaurus ObjectClass-2
C1708
UMLS 2011AA ObjectClass-2
C0450442
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Section Iv - Concurrent Medications
Description

Section Iv - Concurrent Medications

Number of prescription medications being taken within the last 7 days
Description

ConcomitantPrescriptionMedicationUseCount

Type de données

text

Alias
NCI Thesaurus ObjectClass
C459
UMLS 2011AA ObjectClass
C0013227
NCI Thesaurus ObjectClass-2
C28180
UMLS 2011AA ObjectClass-2
C1521941
NCI Thesaurus ObjectClass-3
C25730
UMLS 2011AA ObjectClass-3
C0521115
NCI Thesaurus Property
C25340
UMLS 2011AA Property
C0457083
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
Did the patient take any of the following within the last 7 days of visit
Description

ConcomitantMedicationReceivedType

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C459
UMLS 2011AA ObjectClass
C0013227
NCI Thesaurus Property
C25639
UMLS 2011AA Property
C1514756
NCI Thesaurus ObjectClass-2
C25730
UMLS 2011AA ObjectClass-2
C0521115
Comments
Description

Comments

Investigator Signature
Description

Investigator Signature

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C2346576
NCI Thesaurus Property
C25678
NCI Thesaurus ObjectClass
C17089
Investigator Signature Date (M D Y)
Description

Investigator Signature Date

Type de données

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
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Similar models

INSTRUCTIONS: Complete this form at the end of each cycle, and at required follow-ups if specified by the Long-Term Follow-Up Form (to report late adverse events). Submit original to the ECOG Coordinating Center. Keep a copy for your files. NOTE: The form for the last cycle should include the 30 days following the last dose of protocol drug, or until the initiation of subsequent t reatment, whichever comes first. NOTE: This form should be completed regardless of whether there are adverse events to report for the required submission report period

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Header
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)
Patient Initials
Item
Patient Initials (Last, First)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
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)
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)
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)
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)
Item Group
Data amendment
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 (s M D Y)
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)
Item Group
On Treatment
Item
Report Period (Choose one)
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
Report Period (Choose one)
CL Item
Baseline (baseline)
C25213 (NCI Thesaurus)
C1442488 (UMLS 2011AA)
C25213 (NCI Thesaurus-3)
C1442488 (UMLS 2011AA-4)
CL Item
3 Months (3 months)
CL Item
6 Months (6 months)
CL Item
12 Months (12 months)
Item Group
Assessment Date
Assessment Date
Item
Assessment date
date
C25164 (NCI Thesaurus ValueDomain)
C2985720 (UMLS CUI-1)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C38000 (NCI Thesaurus Property)
Item Group
Section I - Patient Characteristics
Patient Height
Item
Height (cm complete at BASELINE only)
float
C25209 (NCI Thesaurus ValueDomain)
C0489786 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25347 (NCI Thesaurus Property)
Patient Weight
Item
Weight (kg)
float
C25209 (NCI Thesaurus ValueDomain)
C0005910 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)
LastMenstrualCycleOccurrenceMonthYearDate
Item
Month of last mentrual period
date
C25551 (NCI Thesaurus ObjectClass)
C1517741 (UMLS 2011AA ObjectClass)
C16838 (NCI Thesaurus ObjectClass-2)
C0025329 (UMLS 2011AA ObjectClass-2)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C29846 (NCI Thesaurus ValueDomain-2)
C0439231 (UMLS 2011AA ValueDomain-2)
C29848 (NCI Thesaurus ValueDomain-3)
C0439234 (UMLS 2011AA ValueDomain-3)
Item Group
Section Ii - Comorbidities (complete Section At Baseline Only)
HypertensionPresentInd-3
Item
Hypertension
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C3117 (NCI Thesaurus ObjectClass)
C0020538 (UMLS 2011AA ObjectClass)
HypertensionTreatmentReceivedInd-2
Item
Is patient on anti-hypertensive therapy
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C3117 (NCI Thesaurus ObjectClass)
C0020538 (UMLS 2011AA ObjectClass)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C15368 (NCI Thesaurus ObjectClass-2)
PersonHyperlipidemiaTherapeuticProcedurePersonalMedicalHistoryind-2
Item
Hyperlipidemia
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C49236 (NCI Thesaurus Property)
C0087111 (UMLS 2011AA Property)
C34707 (NCI Thesaurus Property-2)
C0020473 (UMLS 2011AA Property-2)
C18772 (NCI Thesaurus Property-3)
C0262926 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
HyperlipidemiaDiseasesandDisordersMedicationBaselineUseInd-2
Item
Hyperlipidemia
boolean
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C459 (NCI Thesaurus ObjectClass-2)
C0013227 (UMLS 2011AA ObjectClass-2)
C34707 (NCI Thesaurus ObjectClass-3)
C0020473 (UMLS 2011AA ObjectClass-3)
C25213 (NCI Thesaurus Property)
C1442488 (UMLS 2011AA Property)
C25340 (NCI Thesaurus Property-2)
C0457083 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
DiabetesMellitusDiseasePresentInd-2
Item
Diabetes
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C2985 (NCI Thesaurus ObjectClass-2)
C0011849 (UMLS 2011AA ObjectClass-2)
DiabetesMellitusDiseasesandDisordersMedicationBaselineUseInd-2
Item
Diabetes (if yes, is patient taking medication for this condition)
boolean
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C2985 (NCI Thesaurus ObjectClass-2)
C0011849 (UMLS 2011AA ObjectClass-2)
C459 (NCI Thesaurus ObjectClass-3)
C0013227 (UMLS 2011AA ObjectClass-3)
C25213 (NCI Thesaurus Property)
C1442488 (UMLS 2011AA Property)
C25340 (NCI Thesaurus Property-2)
C0457083 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
OsteoarthritisPresentInd-2
Item
Osteoarthritis
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C3293 (NCI Thesaurus ObjectClass)
C0029408 (UMLS 2011AA ObjectClass)
OsteoarthritisMedicationUseInd-2
Item
Osteoarthritis
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C3293 (NCI Thesaurus ObjectClass)
C0029408 (UMLS 2011AA ObjectClass)
C459 (NCI Thesaurus ObjectClass-2)
C0013227 (UMLS 2011AA ObjectClass-2)
C25340 (NCI Thesaurus Property)
C0457083 (UMLS 2011AA Property)
PatientArthritisPersonalMedicalHistoryInd-3
Item
Arthritic conditions other than osteoarthritis (conditions other than osteoarthritis e.g., rheumatoid arthritis)
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C2883 (NCI Thesaurus Property)
C0003864 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property-2)
C0262926 (UMLS 2011AA Property-2)
ArthritisMedicationUseInd-2
Item
Arthritic conditions other than osteoarthritis
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C2883 (NCI Thesaurus ObjectClass-2)
C0003864 (UMLS 2011AA ObjectClass-2)
C25340 (NCI Thesaurus Property)
C0457083 (UMLS 2011AA Property)
FibromyalgiaPresentInd-2
Item
Fibromylagia
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C87497 (NCI Thesaurus ObjectClass)
FibromyalgiaMedicationUseInd-2
Item
Fibromyalgia
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C87497 (NCI Thesaurus ObjectClass-2)
C25340 (NCI Thesaurus Property)
C0457083 (UMLS 2011AA Property)
DiseaseDepressionPresentInd-3
Item
Depression
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C2982 (NCI Thesaurus Property-2)
C0011570 (UMLS 2011AA Property-2)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
DepressionMedicationUseInd-2
Item
Depression
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C2982 (NCI Thesaurus ObjectClass)
C0011570 (UMLS 2011AA ObjectClass)
C459 (NCI Thesaurus ObjectClass-2)
C0013227 (UMLS 2011AA ObjectClass-2)
C25340 (NCI Thesaurus Property)
C0457083 (UMLS 2011AA Property)
CardiovascularDiseasePresentInd-2
Item
Cardiovascular Disease
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C25292 (NCI Thesaurus ObjectClass)
C0007226 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus ObjectClass-2)
C0012634 (UMLS 2011AA ObjectClass-2)
CardiovascularSystemDiseasesandDisordersMedicationBaselineUseInd-2
Item
Cardiovascular Disease (If yes, is patient taking medication for this condition)
boolean
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C459 (NCI Thesaurus ObjectClass-2)
C0013227 (UMLS 2011AA ObjectClass-2)
C12686 (NCI Thesaurus ObjectClass-3)
C0007226 (UMLS 2011AA ObjectClass-3)
C25213 (NCI Thesaurus Property)
C1442488 (UMLS 2011AA Property)
C25340 (NCI Thesaurus Property-2)
C0457083 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientCerebrovascularAccidentHistoryInd-3
Item
Cerebrovascular disease (e.g., prior TIA)
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3390 (NCI Thesaurus Property)
C0038454 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property-2)
C0262926 (UMLS 2011AA Property-2)
CerebrovascularDisorderMedicationUseInd-2
Item
Cerebrovascular disease
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C2938 (NCI Thesaurus ObjectClass-2)
C0007820 (UMLS 2011AA ObjectClass-2)
C25340 (NCI Thesaurus Property)
C0457083 (UMLS 2011AA Property)
ChronicDiseasePulmonaryInd-3
Item
Pulmonary Disease (e.g., asthma or other chronic pulmonary conditions)
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C14141 (NCI Thesaurus ObjectClass-2)
C0205191 (UMLS 2011AA ObjectClass-2)
CL317978 (NCI Metathesaurus Property)
LungDisorderMedicationUseInd-2
Item
Pulmonary disease
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C3198 (NCI Thesaurus ObjectClass-2)
C0024115 (UMLS 2011AA ObjectClass-2)
C25340 (NCI Thesaurus Property)
C0457083 (UMLS 2011AA Property)
LiverDiseasePresentInd-2
Item
Liver disease (e.g., hepatitis C or other conditions)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C12392 (NCI Thesaurus ObjectClass)
C0023884 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus ObjectClass-2)
C0012634 (UMLS 2011AA ObjectClass-2)
HepaticDisorderMedicationUseInd-2
Item
Liver disease
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C3196 (NCI Thesaurus ObjectClass-2)
C0023895 (UMLS 2011AA ObjectClass-2)
C25340 (NCI Thesaurus Property)
C0457083 (UMLS 2011AA Property)
Item
Neuropathy (e.g., diabetic neuropathy)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25547 (NCI Thesaurus Property)
C27033 (NCI Thesaurus ObjectClass)
C0259749 (UMLS 2011AA ObjectClass)
CL.24
Code List
Neuropathy (e.g., diabetic neuropathy)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
NeuropathyMedicationUseInd-2
Item
Neuropathy
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C4731 (NCI Thesaurus ObjectClass-2)
C0031117 (UMLS 2011AA ObjectClass-2)
C25340 (NCI Thesaurus Property)
C0457083 (UMLS 2011AA Property)
OsteopeniaDiagnosisInd-3
Item
Osteopenia/osteoporosis
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C0029453 (NCI Metathesaurus ObjectClass)
OsteopeniaMedicationUseInd-2
Item
Osteopenia/osteoporosis
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C50910 (NCI Thesaurus ObjectClass-2)
C0029453 (UMLS 2011AA ObjectClass-2)
C25340 (NCI Thesaurus Property)
C0457083 (UMLS 2011AA Property)
Item Group
Section Iii - Hormonal Medications
Item
Current hormone therapy
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass-2)
C0450442 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
CL.28
Code List
Current hormone therapy
CL Item
Tamoxifen (Tamoxifen)
C855 (NCI Thesaurus)
C0039286 (UMLS 2011AA)
CL Item
Anastrazole (Anastrazole)
CL Item
Letrozole (Letrozole)
C1527 (NCI Thesaurus)
C0246421 (UMLS 2011AA)
CL Item
Exemestrane (Exemestrane)
CL Item
None (None)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
HormoneTherapyAgentAdministeredSpecify
Item
Other specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass-2)
C0450442 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Item Group
Section Iv - Concurrent Medications
Item
Number of prescription medications being taken within the last 7 days
text
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C28180 (NCI Thesaurus ObjectClass-2)
C1521941 (UMLS 2011AA ObjectClass-2)
C25730 (NCI Thesaurus ObjectClass-3)
C0521115 (UMLS 2011AA ObjectClass-3)
C25340 (NCI Thesaurus Property)
C0457083 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
CL.29
Code List
Number of prescription medications being taken within the last 7 days
CL Item
None (None)
CL Item
1-3 (1-3)
CL Item
4-7 (4-7)
CL Item
>7 (>7)
Item
Did the patient take any of the following within the last 7 days of visit
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C459 (NCI Thesaurus ObjectClass)
C0013227 (UMLS 2011AA ObjectClass)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
C25730 (NCI Thesaurus ObjectClass-2)
C0521115 (UMLS 2011AA ObjectClass-2)
CL.30
Code List
Did the patient take any of the following within the last 7 days of visit
CL Item
Diabetes - Metformin Containing Agents (Diabetes - Metformin containing agents)
CL Item
Diabetes - Insulin (Diabetes - Insulin)
CL Item
Opioids (Opioids)
CL Item
Anxiolytics Or Sedatives (Anxiolytics or sedatives)
CL Item
Prophylactic Antiplatelet Therapy (Prophylactic antiplatelet therapy)
CL Item
Non-steriodal Anti-inflammatory Agents (Non-steriodal anti-inflammatory agents)
CL Item
Cox-2 Inhibitor (COX-2 inhibitor)
CL Item
Tricyclic Antidepressants (Tricyclic antidepressants)
CL Item
Antidepressants - Strong Cyp2d6 Inhibitors (Antidepressants - Strong CYP2D6 inhibitors)
CL Item
Antidepressants - Moderate Cyp2d6 Inhibitors (Antidepressants - Moderate CYP2D6 inhibitors)
CL Item
Antidepressants - Weak Cyp2d2 Inhibitors Or Non-inhibitors (Antidepressants - weak CYP2D2 inhibitors or non-inhibitors)
CL Item
Intravaginal Estrogen Preparations (Intravaginal estrogen preparations)
CL Item
Prescription Medications For Relief Of Hot Flashes (Prescription medications for relief of hot flashes)
CL Item
Prescription Medications For Relief Of Hot Flashes (Non-prescription supplements for relief of hot flashes)
CL Item
Non-prescription Supplements For Memory (Non-prescription supplements for memory)
CL Item
Bisphosophonates For Treatment/prevention Of Bone Loss (Bisphosophonates for treatment/prevention of bone loss)
Item Group
Comments
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 (M D Y)
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)
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