ID

11660

Beschrijving

CALGB 90601: Treatment Form Gemcitabine Hydrochloride and Cisplatin With or Without Bevacizumab in Treating Patients With Advanced Urinary Tract Cancer NCT00942331 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=65402ABE-C4AA-902C-E040-BB89AD435D5A

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=65402ABE-C4AA-902C-E040-BB89AD435D5A

Trefwoorden

  1. 26-08-12 26-08-12 -
  2. 08-01-15 08-01-15 - Martin Dugas
  3. 25-07-15 25-07-15 - Martin Dugas
Geüploaded op

25 juli 2015

DOI

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Licentie

Creative Commons BY-NC 3.0 Legacy

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Treatment Form Bladder Cancer CALGB 90601 NCT00942331

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. Mark an X in the appropriate box for fields with a choice.

Header
Beschrijving

Header

Alias
UMLS CUI-1
C1320722
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
Cycle Start Date (MM DD YYYY)
Beschrijving

Chemotherapy Cycle Start Date

Datatype

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 (MM DD YYYY)
Beschrijving

Chemotherapy Cycle End Date

Datatype

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1302181
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25379
UMLS CUI-2
C0806020
Patient Initials (Last, First Middle)
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
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 has withdrawn consent for clinical follow-up
Beschrijving

PatientWithdrawnConsentClinicalInd-2

Datatype

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
Beschrijving

PatientWithdrawnConsentSurvivalInd-2

Datatype

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
Beschrijving

PatientWithdrawConsentDate

Datatype

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 (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
Clinical Data
Beschrijving

Clinical Data

Alias
UMLS CUI-1
C1516606
Current Cycle Number
Beschrijving

Cycle Number Chemotherapeutics

Datatype

integer

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2045829
NCI Thesaurus Property
C25471
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property-2
C25379
Height
Beschrijving

Height

Datatype

float

Maateenheden
  • cm
Alias
NCI Thesaurus ValueDomain
C25209
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25347
UMLS CUI-1
C0005890
cm
Body weight
Beschrijving

Body weight

Datatype

float

Maateenheden
  • kg
Alias
NCI Thesaurus ValueDomain
C25209
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25208
UMLS CUI-1
C0005910
kg
Body surface area
Beschrijving

Body surface area

Datatype

float

Maateenheden
Alias
NCI Thesaurus ObjectClass
C25190
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus Property
C25157
UMLS CUI-1
C0005902
Gemcitabine
Beschrijving

Gemcitabine

Alias
UMLS CUI-1
C0045093
Agent Name
Beschrijving

Agent

Datatype

text

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

AgentFirstCourseTotalDose

Datatype

float

Alias
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25509
UMLS 2011AA Property
C1279901
NCI Thesaurus Property-2
C25379
UMLS 2011AA Property-2
C0750729
NCI Thesaurus ValueDomain
C25304
UMLS 2011AA ValueDomain
C0439810
NCI Thesaurus ValueDomain-2
C25488
UMLS 2011AA ValueDomain-2
C0178602
Dose modification
Beschrijving

Dose Modification Status

Datatype

text

Alias
NCI Thesaurus ObjectClass
C25488
UMLS CUI-1
C1707811
NCI Thesaurus ValueDomain
C25688
NCI Thesaurus Property
C25572
Dose Modification Reason
Beschrijving

Dose Modification Reason

Datatype

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 reason = 99, specify
Beschrijving

Dose Modification Reason, other

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C1707811
NCI Thesaurus ObjectClass
C25488
UMLS CUI-2
C3840932
NCI Thesaurus Property
C25572
Cisplatin
Beschrijving

Cisplatin

Alias
UMLS CUI-1
C0008838
Agent Name
Beschrijving

Agent

Datatype

text

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

AgentFirstCourseTotalDose

Datatype

float

Alias
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25509
UMLS 2011AA Property
C1279901
NCI Thesaurus Property-2
C25379
UMLS 2011AA Property-2
C0750729
NCI Thesaurus ValueDomain
C25304
UMLS 2011AA ValueDomain
C0439810
NCI Thesaurus ValueDomain-2
C25488
UMLS 2011AA ValueDomain-2
C0178602
Dose modification
Beschrijving

Dose Modification Status

Datatype

text

Alias
NCI Thesaurus ObjectClass
C25488
UMLS CUI-1
C1707811
NCI Thesaurus ValueDomain
C25688
NCI Thesaurus Property
C25572
Dose Modification Reason
Beschrijving

Dose Modification Reason

Datatype

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 reason = 99, specify
Beschrijving

Dose Modification Reason, other

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C1707811
NCI Thesaurus ObjectClass
C25488
UMLS CUI-2
C3840932
NCI Thesaurus Property
C25572
Bevacizumab/placebo
Beschrijving

Bevacizumab/placebo

Agent Name
Beschrijving

Agent

Datatype

text

Alias
NCI Thesaurus Property
C25364
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus ValueDomain
C1708
NCI Thesaurus ValueDomain-2
C42614
UMLS CUI-1
C1521826
Administered
Beschrijving

AgentPlaceboAdministeredInd-2

Datatype

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
Beschrijving

Dose Modification Status

Datatype

text

Alias
NCI Thesaurus ObjectClass
C25488
UMLS CUI-1
C1707811
NCI Thesaurus ValueDomain
C25688
NCI Thesaurus Property
C25572
Dose Modification Reason
Beschrijving

Dose Modification Reason

Datatype

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 reason = 99, specify
Beschrijving

Dose Modification Reason, other

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C1707811
NCI Thesaurus ObjectClass
C25488
UMLS CUI-2
C3840932
NCI Thesaurus Property
C25572
Was treatment permanently discontinued during this cycle (Gemcitabine/Cisplatin)
Beschrijving

Drug treatment discontinued during chemotherapy cycle

Datatype

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 (Gemcitabine/Cisplatin)
Beschrijving

Off Treatment Reason

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS CUI-1
C1518544
NCI Thesaurus ObjectClass
C25601
UMLS CUI-2
C0566251
NCI Thesaurus Property
C25365
Specify
Beschrijving

Off Treatment Reason, specify

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C1518544
NCI Thesaurus ObjectClass
C25601
UMLS CUI-2
C0566251
NCI Thesaurus Property
C25365
UMLS CUI-3
C1521902
Total number of cycles completed (Gemcitabine/Cisplatin)
Beschrijving

ChemotherapyTotalCycleCompleteCount

Datatype

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 (Gemcitabine/Cisplatin)
Beschrijving

LastDoseDate

Datatype

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
Gemcitabine/Cisplatin
Beschrijving

Gemcitabine/Cisplatin

Was treatment permanently discontinued during this cycle (Gemcitabine/Cisplatin)
Beschrijving

Drug treatment discontinued during chemotherapy cycle

Datatype

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 (Gemcitabine/Cisplatin)
Beschrijving

Off Treatment Reason

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS CUI-1
C1518544
NCI Thesaurus ObjectClass
C25601
UMLS CUI-2
C0566251
NCI Thesaurus Property
C25365
Specify
Beschrijving

Off Treatment Reason, specify

Datatype

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C1518544
NCI Thesaurus ObjectClass
C25601
UMLS CUI-2
C0566251
NCI Thesaurus Property
C25365
UMLS CUI-3
C1521902
Total number of cycles completed (Gemcitabine/Cisplatin)
Beschrijving

ChemotherapyTotalCycleCompleteCount

Datatype

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 (Gemcitabine/Cisplatin)
Beschrijving

LastDoseDate

Datatype

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

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. Mark an X in the appropriate box for fields with a choice.

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Header
C1320722 (UMLS CUI-1)
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)
Chemotherapy Cycle Start Date
Item
Cycle Start Date (MM DD YYYY)
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 (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C1302181 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25379 (NCI Thesaurus Property)
C0806020 (UMLS CUI-2)
Patient Initials
Item
Patient Initials (Last, First Middle)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Medical Record Number
Item
Patient Hospital No.
text
C25337 (NCI Thesaurus ValueDomain)
C1301894 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25261 (NCI Thesaurus Property)
C25198 (NCI Thesaurus Property-2)
Institution Name
Item
Institution/Affiliate
text
C25454 (NCI Thesaurus ObjectClass)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)
Participating Group
Item
Participating Group
text
C25191 (NCI Thesaurus ValueDomain)
C2347449 (UMLS CUI-1)
C25608 (NCI Thesaurus ObjectClass)
C17005 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
Study Number Participating Group
Item
Participating Group Study No.
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Trial subject ID Participating Group
Item
Participating Group Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
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 (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)
Item Group
Clinical Data
C1516606 (UMLS CUI-1)
Cycle Number Chemotherapeutics
Item
Current Cycle Number
integer
C25337 (NCI Thesaurus ValueDomain)
C2045829 (UMLS CUI-1)
C25471 (NCI Thesaurus Property)
C15368 (NCI Thesaurus ObjectClass)
C25379 (NCI Thesaurus Property-2)
Height
Item
Height
float
C25209 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25347 (NCI Thesaurus Property)
C0005890 (UMLS CUI-1)
Weight
Item
Body weight
float
C25209 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)
C0005910 (UMLS CUI-1)
BSA
Item
Body surface area
float
C25190 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C25157 (NCI Thesaurus Property)
C0005902 (UMLS CUI-1)
Item Group
Gemcitabine
C0045093 (UMLS CUI-1)
Agent
Item
Agent Name
text
C25364 (NCI Thesaurus Property)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)
C1521826 (UMLS CUI-1)
AgentFirstCourseTotalDose
Item
Agent Total Dose (this cycle)
float
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C25379 (NCI Thesaurus Property-2)
C0750729 (UMLS 2011AA Property-2)
C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C25488 (NCI Thesaurus ValueDomain-2)
C0178602 (UMLS 2011AA ValueDomain-2)
Item
Dose modification
text
C25488 (NCI Thesaurus ObjectClass)
C1707811 (UMLS CUI-1)
C25688 (NCI Thesaurus ValueDomain)
C25572 (NCI Thesaurus Property)
Code List
Dose modification
CL Item
Dose Delayed (Dose delayed)
CL Item
Dose Delayed And Reduced (Dose delayed and reduced)
CL Item
Dose Held (Dose held)
CL Item
Dose Reduced (Dose reduced)
C49505 (NCI Thesaurus)
C1707814 (UMLS 2011AA)
C49505 (NCI Thesaurus-3)
C1707814 (UMLS 2011AA-4)
CL Item
Drug Discontinued (Drug discontinued)
CL Item
No Dose Modification (No dose modification)
Item
Dose Modification Reason
text
C25638 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25488 (NCI Thesaurus ObjectClass)
C0392360 (UMLS CUI-2)
C25572 (NCI Thesaurus Property)
Code List
Dose Modification Reason
CL Item
Cardiotoxicity (Cardiotoxicity)
C27994 (NCI Thesaurus)
C0876994 (UMLS 2011AA)
CL Item
Change In Bsa (Change in BSA)
CL Item
Cns Toxicity (CNS toxicity)
CL Item
Dosing Error (Dosing error)
CL Item
Gi Toxicity (GI toxicity)
CL Item
Hematologic Toxicity (Hematologic toxicity)
CL Item
Hepatic Dysfunction (Hepatic dysfunction)
CL Item
Hypersensitivity (Hypersensitivity)
C3114 (NCI Thesaurus)
C0020517 (UMLS 2011AA)
CL Item
Infection/fever (Infection/fever)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Patient Refusal/noncompliance (Patient refusal/noncompliance)
CL Item
Pns Toxicity (PNS toxicity)
CL Item
Pulmonary Toxicity (Pulmonary toxicity)
CL Item
Renal Toxicity (Renal toxicity)
CL Item
Scheduling (Scheduling)
Dose Modification Reason, other
Item
If dose modification reason = 99, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25488 (NCI Thesaurus ObjectClass)
C3840932 (UMLS CUI-2)
C25572 (NCI Thesaurus Property)
Item Group
Cisplatin
C0008838 (UMLS CUI-1)
Agent
Item
Agent Name
text
C25364 (NCI Thesaurus Property)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)
C1521826 (UMLS CUI-1)
AgentFirstCourseTotalDose
Item
Agent Total Dose (this cycle)
float
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C25379 (NCI Thesaurus Property-2)
C0750729 (UMLS 2011AA Property-2)
C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C25488 (NCI Thesaurus ValueDomain-2)
C0178602 (UMLS 2011AA ValueDomain-2)
Item
Dose modification
text
C25488 (NCI Thesaurus ObjectClass)
C1707811 (UMLS CUI-1)
C25688 (NCI Thesaurus ValueDomain)
C25572 (NCI Thesaurus Property)
Code List
Dose modification
CL Item
Dose Delayed (Dose delayed)
CL Item
Dose Delayed And Reduced (Dose delayed and reduced)
CL Item
Dose Held (Dose held)
CL Item
Dose Reduced (Dose reduced)
C49505 (NCI Thesaurus)
C1707814 (UMLS 2011AA)
C49505 (NCI Thesaurus-3)
C1707814 (UMLS 2011AA-4)
CL Item
Drug Discontinued (Drug discontinued)
CL Item
No Dose Modification (No dose modification)
Item
Dose Modification Reason
text
C25638 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25488 (NCI Thesaurus ObjectClass)
C0392360 (UMLS CUI-2)
C25572 (NCI Thesaurus Property)
Code List
Dose Modification Reason
CL Item
Cardiotoxicity (Cardiotoxicity)
C27994 (NCI Thesaurus)
C0876994 (UMLS 2011AA)
CL Item
Change In Bsa (Change in BSA)
CL Item
Cns Toxicity (CNS toxicity)
CL Item
Dosing Error (Dosing error)
CL Item
Gi Toxicity (GI toxicity)
CL Item
Hematologic Toxicity (Hematologic toxicity)
CL Item
Hepatic Dysfunction (Hepatic dysfunction)
CL Item
Hypersensitivity (Hypersensitivity)
C3114 (NCI Thesaurus)
C0020517 (UMLS 2011AA)
CL Item
Infection/fever (Infection/fever)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Patient Refusal/noncompliance (Patient refusal/noncompliance)
CL Item
Pns Toxicity (PNS toxicity)
CL Item
Pulmonary Toxicity (Pulmonary toxicity)
CL Item
Renal Toxicity (Renal toxicity)
CL Item
Scheduling (Scheduling)
Dose Modification Reason, other
Item
If dose modification reason = 99, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25488 (NCI Thesaurus ObjectClass)
C3840932 (UMLS CUI-2)
C25572 (NCI Thesaurus Property)
Item Group
Bevacizumab/placebo
Agent
Item
Agent Name
text
C25364 (NCI Thesaurus Property)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)
C1521826 (UMLS CUI-1)
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
text
C25488 (NCI Thesaurus ObjectClass)
C1707811 (UMLS CUI-1)
C25688 (NCI Thesaurus ValueDomain)
C25572 (NCI Thesaurus Property)
Code List
Dose modification
CL Item
Dose Delayed (Dose delayed)
CL Item
Dose Delayed And Reduced (Dose delayed and reduced)
CL Item
Dose Held (Dose held)
CL Item
Dose Reduced (Dose reduced)
C49505 (NCI Thesaurus)
C1707814 (UMLS 2011AA)
C49505 (NCI Thesaurus-3)
C1707814 (UMLS 2011AA-4)
CL Item
Drug Discontinued (Drug discontinued)
CL Item
No Dose Modification (No dose modification)
Item
Dose Modification Reason
text
C25638 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25488 (NCI Thesaurus ObjectClass)
C0392360 (UMLS CUI-2)
C25572 (NCI Thesaurus Property)
Code List
Dose Modification Reason
CL Item
Cardiotoxicity (Cardiotoxicity)
C27994 (NCI Thesaurus)
C0876994 (UMLS 2011AA)
CL Item
Change In Bsa (Change in BSA)
CL Item
Cns Toxicity (CNS toxicity)
CL Item
Dosing Error (Dosing error)
CL Item
Gi Toxicity (GI toxicity)
CL Item
Hematologic Toxicity (Hematologic toxicity)
CL Item
Hepatic Dysfunction (Hepatic dysfunction)
CL Item
Hypersensitivity (Hypersensitivity)
C3114 (NCI Thesaurus)
C0020517 (UMLS 2011AA)
CL Item
Infection/fever (Infection/fever)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Patient Refusal/noncompliance (Patient refusal/noncompliance)
CL Item
Pns Toxicity (PNS toxicity)
CL Item
Pulmonary Toxicity (Pulmonary toxicity)
CL Item
Renal Toxicity (Renal toxicity)
CL Item
Scheduling (Scheduling)
Dose Modification Reason, other
Item
If dose modification reason = 99, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25488 (NCI Thesaurus ObjectClass)
C3840932 (UMLS CUI-2)
C25572 (NCI Thesaurus Property)
Drug treatment discontinued during chemotherapy cycle
Item
Was treatment permanently discontinued during this cycle (Gemcitabine/Cisplatin)
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 (Gemcitabine/Cisplatin)
text
C25638 (NCI Thesaurus ValueDomain)
C1518544 (UMLS CUI-1)
C25601 (NCI Thesaurus ObjectClass)
C0566251 (UMLS CUI-2)
C25365 (NCI Thesaurus Property)
Code List
Reason Treatment Ended (Gemcitabine/Cisplatin)
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 After Beginning Protocol Therapy (Patient withdrawal/refusal after beginning protocol therapy)
CL Item
Patient Withdrawal Or Refusal Before Beginning Protocol Therapy (Patient withdrawal/refusal prior to 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 Treatment Reason, specify
Item
Specify
text
C25685 (NCI Thesaurus ValueDomain)
C1518544 (UMLS CUI-1)
C25601 (NCI Thesaurus ObjectClass)
C0566251 (UMLS CUI-2)
C25365 (NCI Thesaurus Property)
C1521902 (UMLS CUI-3)
ChemotherapyTotalCycleCompleteCount
Item
Total number of cycles completed (Gemcitabine/Cisplatin)
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 (Gemcitabine/Cisplatin)
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)
Item Group
Gemcitabine/Cisplatin
Drug treatment discontinued during chemotherapy cycle
Item
Was treatment permanently discontinued during this cycle (Gemcitabine/Cisplatin)
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 (Gemcitabine/Cisplatin)
text
C25638 (NCI Thesaurus ValueDomain)
C1518544 (UMLS CUI-1)
C25601 (NCI Thesaurus ObjectClass)
C0566251 (UMLS CUI-2)
C25365 (NCI Thesaurus Property)
Code List
Reason Treatment Ended (Gemcitabine/Cisplatin)
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 After Beginning Protocol Therapy (Patient withdrawal/refusal after beginning protocol therapy)
CL Item
Patient Withdrawal Or Refusal Before Beginning Protocol Therapy (Patient withdrawal/refusal prior to 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 Treatment Reason, specify
Item
Specify
text
C25685 (NCI Thesaurus ValueDomain)
C1518544 (UMLS CUI-1)
C25601 (NCI Thesaurus ObjectClass)
C0566251 (UMLS CUI-2)
C25365 (NCI Thesaurus Property)
C1521902 (UMLS CUI-3)
ChemotherapyTotalCycleCompleteCount
Item
Total number of cycles completed (Gemcitabine/Cisplatin)
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 (Gemcitabine/Cisplatin)
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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