ID

6516

Descripción

CALGB: 90401 TREATMENT FORM Docetaxel and Prednisone With or Without Bevacizumab in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy NCT00110214 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=EF49A3AB-7EC3-51E0-E034-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=EF49A3AB-7EC3-51E0-E034-0003BA3F9857

Palabras clave

Versiones (3)
  1. 19/9/12 19/9/12 -
  2. 8/1/15 8/1/15 - Martin Dugas
  3. 9/1/15 9/1/15 - Martin Dugas
Subido en

8 de enero de 2015

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0 Legacy
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TREATMENT FORM Prostate Cancer (NCT00110214)

Inglés

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 use black ink

1 formularios  
Header
Descripción

Header

CALGB Form
Descripción

Form ID CALGB

Tipo de datos

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.
Descripción

Protocol ID CALGB

Tipo de datos

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
Descripción

Trial subject ID CALGB

Tipo de datos

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
Patient Initials
Descripción

Patient Initials

Tipo de datos

text

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

Medical Record Number

Tipo de datos

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
Descripción

Institution Name

Tipo de datos

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
Descripción

Participating Group

Tipo de datos

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.
Descripción

Study Number Participating Group

Tipo de datos

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
Descripción

Trial subject ID Participating Group

Tipo de datos

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
Are data amended
Descripción

Data amended

Tipo de datos

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Patient has withdrawn consent for clinical follow-up.
Descripción

PatientWithdrawnConsentClinicalInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
NCI Thesaurus Property-2
C38061
UMLS 2011AA Property-2
C2349954
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ValueDomain-2
C25398
UMLS 2011AA ValueDomain-2
C0205210
Patient has withdrawn consent for survival follow-up.
Descripción

PatientWithdrawnConsentSurvivalInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
NCI Thesaurus Property-2
C38061
UMLS 2011AA Property-2
C2349954
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ValueDomain-2
C17177
UMLS 2011AA ValueDomain-2
C0038952
Withdrawn consent date
Descripción

PatientWithdrawConsentDate

Tipo de datos

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25460
UMLS 2011AA Property
C1511481
NCI Thesaurus Property-2
C38061
UMLS 2011AA Property-2
C2349954
Completed by
Descripción

Person Completing Form

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass
C25657
NCI Thesaurus Property
C25364
Date form completed
Descripción

Date Form Completed

Tipo de datos

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1115437
NCI Thesaurus ObjectClass
C40988
NCI Thesaurus Property
C25250
NCI Thesaurus ValueDomain-2
C25367
Clinical Data
Descripción

Clinical Data

Alias
UMLS CUI-1
C1516606
Currrent cycle number
Descripción

Cycle Number Chemotherapeutics

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2045829
NCI Thesaurus Property
C25471
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property-2
C25379
Cycle start date
Descripción

Chemotherapy Cycle Start Date

Tipo de datos

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1302181
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ValueDomain-2
C25431
UMLS CUI-2
C3173309
NCI Thesaurus Property
C25379
Cycle end date
Descripción

Chemotherapy Cycle End Date

Tipo de datos

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1302181
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25379
UMLS CUI-2
C0806020
Height
Descripción

Patient Height

Tipo de datos

float

Unidades de medida
  • cm
Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0489786
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25347
cm
Weight
Descripción

Patient Weight

Tipo de datos

float

Unidades de medida
  • Kg
Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0005910
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25208
Kg
BSA
Descripción

Body Surface Area

Tipo de datos

float

Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0005902
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25157
Agent name
Descripción

Agent

Tipo de datos

text

Alias
NCI Thesaurus Property
C25364
UMLS CUI-1
C1521826
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus ValueDomain
C1708
NCI Thesaurus ValueDomain-2
C42614
Dose
Descripción

AgentAdministeredDose

Tipo de datos

float

Alias
NCI Thesaurus ValueDomain
C25488
UMLS 2011AA ValueDomain
C0178602
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus ValueDomain-2
C1708
UMLS 2011AA ValueDomain-2
C0450442
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
No. of days administered
Descripción

AgentAdministeredDayDuration

Tipo de datos

float

Alias
NCI Thesaurus ValueDomain
C25301
UMLS 2011AA ValueDomain
C0439228
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain-2
C25330
UMLS 2011AA ValueDomain-2
C0449238
Administered?
Descripción

AgentPlaceboAdministeredInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C753
UMLS 2011AA Property
C0032042
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
Dose modification (^1)
Descripción

Dose Modification Status

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C25488
UMLS CUI-1
C1707811
NCI Thesaurus ValueDomain
C25688
NCI Thesaurus Property
C25572
Dose modification reason (^2)
Descripción

Dose Modification Reason

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS CUI-1
C1707811
NCI Thesaurus ObjectClass
C25488
UMLS CUI-2
C0392360
NCI Thesaurus Property
C25572
If dose modification = 99, specify
Descripción

Dose Modification Reason, other

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C1707811
NCI Thesaurus ObjectClass
C25488
UMLS CUI-2
C3840932
NCI Thesaurus Property
C25572
Concomitant medications received this cycle (Mark all that apply with an X.)
Descripción

ConcomitantMedicationReceivedType

Tipo de datos

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
Growth factor (Use per NCCN / ASCO guidelines described in 90401 memorandum dated 8/15/07. Mark all that apply with an X.)
Descripción

GrowthFactorAgentCurrentReportPeriodAdministeredType

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C20424
UMLS 2011AA ObjectClass
C0018284
NCI Thesaurus ObjectClass-2
C1708
UMLS 2011AA ObjectClass-2
C0450442
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property-2
C25471
UMLS 2011AA Property-2
C0521116
NCI Thesaurus Property-3
C25375
UMLS 2011AA Property-3
C0684224
NCI Thesaurus Property-4
C25382
UMLS 2011AA Property-4
C1521801
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Other, specify
Descripción

GrowthFactorAgentCurrentReportPeriodAdministeredSpecify

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C20424
UMLS 2011AA ObjectClass
C0018284
NCI Thesaurus ObjectClass-2
C1708
UMLS 2011AA ObjectClass-2
C0450442
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus Property-2
C25471
UMLS 2011AA Property-2
C0521116
NCI Thesaurus Property-3
C25375
UMLS 2011AA Property-3
C0684224
NCI Thesaurus Property-4
C25382
UMLS 2011AA Property-4
C1521801
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Aspirin (Mark one with an X.)
Descripción

AcetylsalicylicAcidAdministeredDailyAmount

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25473
UMLS 2011AA ValueDomain
C0332173
NCI Thesaurus ObjectClass
C287
UMLS 2011AA ObjectClass
C0004057
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain-2
C25417
Agent code (*)
Descripción

ReducedPlateletAgentAdministeredCode

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C25640
UMLS 2011AA ObjectClass
C0392756
NCI Thesaurus ObjectClass-2
C1708
UMLS 2011AA ObjectClass-2
C0450442
NCI Thesaurus ObjectClass-3
C12520
UMLS 2011AA ObjectClass-3
C0005821
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
Other, specify generic name
Descripción

ReducedPlateletAgentSpecify

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C25640
UMLS 2011AA ObjectClass
C0392756
NCI Thesaurus ObjectClass-2
C1708
UMLS 2011AA ObjectClass-2
C0450442
NCI Thesaurus ObjectClass-3
C12520
UMLS 2011AA ObjectClass-3
C0005821
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Frequency (no. of daily doses)
Descripción

DailyDoseAdministeredCount

Tipo de datos

float

Alias
NCI Thesaurus ObjectClass
C25473
UMLS 2011AA ObjectClass
C0332173
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
NCI Thesaurus ObjectClass-2
C25488
UMLS 2011AA ObjectClass-2
C0178602
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Agent start date
Descripción

Concomitant Medication Start Date

Tipo de datos

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
Descripción

Concomitant Medication End Date

Tipo de datos

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2826744
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus Property
C25275
Agent code (**)
Descripción

AnticoagulantAgentAdministeredName

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C263
UMLS 2011AA ObjectClass
C0003280
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Other, specify generic name
Descripción

AnticoagulantAgentAdministeredSpecify

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C263
UMLS 2011AA ObjectClass
C0003280
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Agent code (***)
Descripción

ReducedLipidAgentAdministeredCode

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C25640
UMLS 2011AA ObjectClass
C0392756
NCI Thesaurus ObjectClass-2
C1708
UMLS 2011AA ObjectClass-2
C0450442
NCI Thesaurus ObjectClass-3
C616
UMLS 2011AA ObjectClass-3
C0023779
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Metathesaurus ValueDomain
C0027365
Other, specify generic name
Descripción

ReducedLipidAgentSpecify

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C25640
UMLS 2011AA ObjectClass
C0392756
NCI Thesaurus ObjectClass-2
C1708
UMLS 2011AA ObjectClass-2
C0450442
NCI Thesaurus ObjectClass-3
C616
UMLS 2011AA ObjectClass-3
C0023779
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Was treatment permanently discontinued during this cycle (bevacizumab/placebo)
Descripción

Drug treatment discontinued during chemotherapy cycle

Tipo de datos

boolean

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25471
UMLS CUI-1
C0558681
NCI Thesaurus Property-2
C25472
UMLS CUI-2
C0347984
NCI Thesaurus Property-3
C25484
UMLS CUI-3
C1302181
NCI Thesaurus ValueDomain
C38147
Reason treatment ended (*)
Descripción

Off Treatment Reason

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS CUI-1
C1518544
NCI Thesaurus ObjectClass
C25601
UMLS CUI-2
C0566251
NCI Thesaurus Property
C25365
If Other reason, specify:
Descripción

Off-TreatmentOtherReasonSpecify

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus ObjectClass
C25601
UMLS 2011AA ObjectClass
C1518544
NCI Thesaurus Property-2
C25365
UMLS 2011AA Property-2
C0678257
Total number of cycles completed (bevacizumab/placebo)
Descripción

ChemotherapyTotalCycleCompleteCount

Tipo de datos

float

Alias
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus Property
C25250
UMLS 2011AA Property
C0205197
NCI Thesaurus Property-2
C25304
UMLS 2011AA Property-2
C0439810
NCI Thesaurus Property-3
C25472
UMLS 2011AA Property-3
C1511572
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
last dose date (bevacizumab/placebo)
Descripción

LastDoseDate

Tipo de datos

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25488
UMLS 2011AA ObjectClass
C0178602
NCI Thesaurus ObjectClass-2
C25551
UMLS 2011AA ObjectClass-2
C1517741
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
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Similar models

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 use black ink

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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)
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)
Data amended
Item
Are data amended
boolean
C38148 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
PatientWithdrawnConsentClinicalInd-2
Item
Patient has withdrawn consent for clinical follow-up.
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C38061 (NCI Thesaurus Property-2)
C2349954 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25398 (NCI Thesaurus ValueDomain-2)
C0205210 (UMLS 2011AA ValueDomain-2)
PatientWithdrawnConsentSurvivalInd-2
Item
Patient has withdrawn consent for survival follow-up.
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C38061 (NCI Thesaurus Property-2)
C2349954 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C17177 (NCI Thesaurus ValueDomain-2)
C0038952 (UMLS 2011AA ValueDomain-2)
PatientWithdrawConsentDate
Item
Withdrawn consent date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25460 (NCI Thesaurus Property)
C1511481 (UMLS 2011AA Property)
C38061 (NCI Thesaurus Property-2)
C2349954 (UMLS 2011AA Property-2)
Person Completing Form
Item
Completed by
text
C25191 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
Date Form Completed
Item
Date form completed
date
C25164 (NCI Thesaurus ValueDomain)
C1115437 (UMLS CUI-1)
C40988 (NCI Thesaurus ObjectClass)
C25250 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)
Item Group
Clinical Data
C1516606 (UMLS CUI-1)
Cycle Number Chemotherapeutics
Item
Currrent cycle number
text
C25337 (NCI Thesaurus ValueDomain)
C2045829 (UMLS CUI-1)
C25471 (NCI Thesaurus Property)
C15368 (NCI Thesaurus ObjectClass)
C25379 (NCI Thesaurus Property-2)
Chemotherapy Cycle Start Date
Item
Cycle start date
date
C25164 (NCI Thesaurus ValueDomain)
C1302181 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25431 (NCI Thesaurus ValueDomain-2)
C3173309 (UMLS CUI-2)
C25379 (NCI Thesaurus Property)
Chemotherapy Cycle End Date
Item
Cycle end date
date
C25164 (NCI Thesaurus ValueDomain)
C1302181 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25379 (NCI Thesaurus Property)
C0806020 (UMLS CUI-2)
Patient Height
Item
Height
float
C25209 (NCI Thesaurus ValueDomain)
C0489786 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25347 (NCI Thesaurus Property)
Patient Weight
Item
Weight
float
C25209 (NCI Thesaurus ValueDomain)
C0005910 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)
Body Surface Area
Item
BSA
float
C25209 (NCI Thesaurus ValueDomain)
C0005902 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25157 (NCI Thesaurus Property)
Agent
Item
Agent name
text
C25364 (NCI Thesaurus Property)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)
AgentAdministeredDose
Item
Dose
float
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ValueDomain-2)
C0450442 (UMLS 2011AA ValueDomain-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
AgentAdministeredDayDuration
Item
No. of days administered
float
C25301 (NCI Thesaurus ValueDomain)
C0439228 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25330 (NCI Thesaurus ValueDomain-2)
C0449238 (UMLS 2011AA ValueDomain-2)
AgentPlaceboAdministeredInd-2
Item
Administered?
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C753 (NCI Thesaurus Property)
C0032042 (UMLS 2011AA Property)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
Item
Dose modification (^1)
text
C25488 (NCI Thesaurus ObjectClass)
C1707811 (UMLS CUI-1)
C25688 (NCI Thesaurus ValueDomain)
C25572 (NCI Thesaurus Property)
CL.3
Code List
Dose modification (^1)
CL Item
No Dose Modification (No dose modification)
CL Item
Dose Held (Dose held)
CL Item
Dose Delayed (Dose delayed)
CL Item
Dose Reduced (Dose reduced)
C49505 (NCI Thesaurus)
C1707814 (UMLS 2011AA)
C49505 (NCI Thesaurus-3)
C1707814 (UMLS 2011AA-4)
CL Item
Dose Delayed And Reduced (Dose delayed and reduced)
CL Item
Drug Discontinued (Drug discontinued)
Item
Dose modification reason (^2)
text
C25638 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25488 (NCI Thesaurus ObjectClass)
C0392360 (UMLS CUI-2)
C25572 (NCI Thesaurus Property)
CL.4
Code List
Dose modification reason (^2)
CL Item
Hypersensitivity (Hypersensitivity)
C3114 (NCI Thesaurus)
C0020517 (UMLS 2011AA)
CL Item
Patient Refusal/noncompliance (Patient refusal/noncompliance)
CL Item
Scheduling (Scheduling)
CL Item
Dosing Error (Dosing error)
CL Item
Change In Bsa (Change in BSA)
CL Item
Hematologic Toxicity (Hematologic toxicity)
CL Item
Hepatic Dysfunction (Hepatic dysfunction)
CL Item
Pns Toxicity (PNS toxicity)
CL Item
Cns Toxicity (CNS toxicity)
CL Item
Gi Toxicity (GI toxicity)
CL Item
Cardiotoxicity (Cardiotoxicity)
C27994 (NCI Thesaurus)
C0876994 (UMLS 2011AA)
CL Item
Pulmonary Toxicity (Pulmonary toxicity)
CL Item
Renal Toxicity (Renal toxicity)
CL Item
Infection/fever (Infection/fever)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
Dose Modification Reason, other
Item
If dose modification = 99, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25488 (NCI Thesaurus ObjectClass)
C3840932 (UMLS CUI-2)
C25572 (NCI Thesaurus Property)
Item
Concomitant medications received this cycle (Mark all that apply with an X.)
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.5
Code List
Concomitant medications received this cycle (Mark all that apply with an X.)
CL Item
Growth Factor (Growth factor)
C20424 (NCI Thesaurus)
C0018284 (UMLS 2011AA)
CL Item
Anti-platelet Agents (Anti-platelet agents)
CL Item
Aspirin (Aspirin)
CL Item
Anti-coagulant Agents (Anti-coagulant agents)
CL Item
Lipid-lowering Drugs (Lipid-lowering drugs)
Item
Growth factor (Use per NCCN / ASCO guidelines described in 90401 memorandum dated 8/15/07. Mark all that apply with an X.)
text
C20424 (NCI Thesaurus ObjectClass)
C0018284 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass-2)
C0450442 (UMLS 2011AA ObjectClass-2)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25471 (NCI Thesaurus Property-2)
C0521116 (UMLS 2011AA Property-2)
C25375 (NCI Thesaurus Property-3)
C0684224 (UMLS 2011AA Property-3)
C25382 (NCI Thesaurus Property-4)
C1521801 (UMLS 2011AA Property-4)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.6
Code List
Growth factor (Use per NCCN / ASCO guidelines described in 90401 memorandum dated 8/15/07. Mark all that apply with an X.)
CL Item
Epoetin Alfa (Epoetin)
C2695 (NCI Thesaurus)
C0357126 (UMLS 2011AA)
CL Item
Granulocyte-macrophage Colony-stimulating Factor (G-CSF)
CL Item
Oprelvekin (Neumega)
C1303 (NCI Thesaurus)
C0537668 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
GrowthFactorAgentCurrentReportPeriodAdministeredSpecify
Item
Other, specify
text
C20424 (NCI Thesaurus ObjectClass)
C0018284 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass-2)
C0450442 (UMLS 2011AA ObjectClass-2)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25471 (NCI Thesaurus Property-2)
C0521116 (UMLS 2011AA Property-2)
C25375 (NCI Thesaurus Property-3)
C0684224 (UMLS 2011AA Property-3)
C25382 (NCI Thesaurus Property-4)
C1521801 (UMLS 2011AA Property-4)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Item
Aspirin (Mark one with an X.)
text
C25473 (NCI Thesaurus ValueDomain)
C0332173 (UMLS 2011AA ValueDomain)
C287 (NCI Thesaurus ObjectClass)
C0004057 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25417 (NCI Thesaurus ValueDomain-2)
CL.7
Code List
Aspirin (Mark one with an X.)
CL Item
81 Mg/daily (81 mg/daily)
CL Item
325 Mg/daily (325 mg/daily)
Item
Agent code (*)
text
C25640 (NCI Thesaurus ObjectClass)
C0392756 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass-2)
C0450442 (UMLS 2011AA ObjectClass-2)
C12520 (NCI Thesaurus ObjectClass-3)
C0005821 (UMLS 2011AA ObjectClass-3)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
CL.8
Code List
Agent code (*)
CL Item
Clopidogrel (clopidogrel)
CL Item
Ticlopidine (ticlopidine)
CL Item
Dipyridamole (dipyridamole)
C445 (NCI Thesaurus)
C0012582 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
ReducedPlateletAgentSpecify
Item
Other, specify generic name
text
C25640 (NCI Thesaurus ObjectClass)
C0392756 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass-2)
C0450442 (UMLS 2011AA ObjectClass-2)
C12520 (NCI Thesaurus ObjectClass-3)
C0005821 (UMLS 2011AA ObjectClass-3)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
DailyDoseAdministeredCount
Item
Frequency (no. of daily doses)
float
C25473 (NCI Thesaurus ObjectClass)
C0332173 (UMLS 2011AA ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25488 (NCI Thesaurus ObjectClass-2)
C0178602 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Concomitant Medication Start Date
Item
Agent start date
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
date
C25164 (NCI Thesaurus ValueDomain)
C2826744 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)
Item
Agent code (**)
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C263 (NCI Thesaurus ObjectClass)
C0003280 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
CL.9
Code List
Agent code (**)
CL Item
Low Molecular Weight Heparin (Low molecular weight heparin)
CL Item
Warfarin (Warfarin)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
AnticoagulantAgentAdministeredSpecify
Item
Other, specify generic name
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C263 (NCI Thesaurus ObjectClass)
C0003280 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Item
Agent code (***)
text
C25640 (NCI Thesaurus ObjectClass)
C0392756 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass-2)
C0450442 (UMLS 2011AA ObjectClass-2)
C616 (NCI Thesaurus ObjectClass-3)
C0023779 (UMLS 2011AA ObjectClass-3)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C0027365 (NCI Metathesaurus ValueDomain)
CL.10
Code List
Agent code (***)
CL Item
Atorvastatin (atorvastatin)
C28837 (NCI Thesaurus)
C0082029 (UMLS 2011AA)
CL Item
Fluvastatin (fluvastatin)
CL Item
Lovastatin (lovastatin)
C620 (NCI Thesaurus)
C0024027 (UMLS 2011AA)
CL Item
Pravastatin (pravastatin)
CL Item
Rosuvastatin (rosuvastatin)
CL Item
Simvastatin (simvastatin)
CL Item
Fenofibrate (fenofibrate)
C29047 (NCI Thesaurus)
C0033228 (UMLS 2011AA)
CL Item
Gemfibrozil (gemfibrozil)
C29071 (NCI Thesaurus)
C0017245 (UMLS 2011AA)
CL Item
Cholestyramine (cholestyramine)
C28929 (NCI Thesaurus)
C0008402 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
ReducedLipidAgentSpecify
Item
Other, specify generic name
text
C25640 (NCI Thesaurus ObjectClass)
C0392756 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass-2)
C0450442 (UMLS 2011AA ObjectClass-2)
C616 (NCI Thesaurus ObjectClass-3)
C0023779 (UMLS 2011AA ObjectClass-3)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Drug treatment discontinued during chemotherapy cycle
Item
Was treatment permanently discontinued during this cycle (bevacizumab/placebo)
boolean
C15368 (NCI Thesaurus ObjectClass)
C25471 (NCI Thesaurus Property)
C0558681 (UMLS CUI-1)
C25472 (NCI Thesaurus Property-2)
C0347984 (UMLS CUI-2)
C25484 (NCI Thesaurus Property-3)
C1302181 (UMLS CUI-3)
C38147 (NCI Thesaurus ValueDomain)
Item
Reason treatment ended (*)
text
C25638 (NCI Thesaurus ValueDomain)
C1518544 (UMLS CUI-1)
C25601 (NCI Thesaurus ObjectClass)
C0566251 (UMLS CUI-2)
C25365 (NCI Thesaurus Property)
CL.14
Code List
Reason treatment ended (*)
CL Item
Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)
CL Item
Disease Progression, Relapse During Active Treatment (Disease progression, relapse during active treatment)
CL Item
Adverse Event/side Effects/complications (Adverse event/side effects/complications)
CL Item
Death On Study (Death on study)
CL Item
Patient Withdrawal Or Refusal (Patient withdrawal or refusal prior to beginning protocol therapy)
CL Item
Patient Withdrawal Or Refusal After Beginning Protocol Therapy (Patient withdrawal/refusal after beginning protocol therapy)
CL Item
Alternative Therapy (Alternative therapy)
CL Item
Patient Off-treatment For Other Complicating Disease (Patient off-treatment for other complicating disease)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
Off-TreatmentOtherReasonSpecify
Item
If Other reason, specify:
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property-2)
C0678257 (UMLS 2011AA Property-2)
ChemotherapyTotalCycleCompleteCount
Item
Total number of cycles completed (bevacizumab/placebo)
float
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25304 (NCI Thesaurus Property-2)
C0439810 (UMLS 2011AA Property-2)
C25472 (NCI Thesaurus Property-3)
C1511572 (UMLS 2011AA Property-3)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
LastDoseDate
Item
last dose date (bevacizumab/placebo)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25488 (NCI Thesaurus ObjectClass)
C0178602 (UMLS 2011AA ObjectClass)
C25551 (NCI Thesaurus ObjectClass-2)
C1517741 (UMLS 2011AA ObjectClass-2)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
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