ID

6485

Description

CALGB: 80802 Treatment Form Sorafenib Tosylate With or Without Doxorubicin Hydrochloride in Treating Patients With Locally Advanced or Metastatic Liver Cancer NCT01015833 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=741A6270-CE1B-C531-E040-BB89AD431F2C

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=741A6270-CE1B-C531-E040-BB89AD431F2C

Keywords

Versions (2)
  1. 9/19/12 9/19/12 -
  2. 1/3/15 1/3/15 - Martin Dugas
Uploaded on

January 3, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Treatment Form Liver Cancer CALGB 80802

English

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

1 forms  
Header Module
Description

Header Module

Alias
UMLS CUI-1
C1320722
CALGB Form
Description

Form ID CALGB

Data type

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.
Description

Protocol ID CALGB

Data type

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
Description

Trial subject ID CALGB

Data type

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
Date of First dose for this reporting period
Description

TreatmentFirstDoseBeginDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25509
UMLS 2011AA Property
C1279901
NCI Thesaurus Property-2
C25256
UMLS 2011AA Property-2
C1265611
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25431
UMLS 2011AA ValueDomain-2
C0439659
Cycle end date
Description

Chemotherapy Cycle End Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1302181
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25379
UMLS CUI-2
C0806020
Are data amended
Description

Data amended

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Patient Initials (Last, First Middle)
Description

Patient Initials

Data type

text

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

Medical Record Number

Data type

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
Description

Institution Name

Data type

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
Description

Participating Group

Data type

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.
Description

Study Number Participating Group

Data type

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

Data type

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
Completed by
Description

Person Completing Form

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass
C25657
NCI Thesaurus Property
C25364
Date Form Originally Completed
Description

FormOriginalCompleteDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C19464
UMLS 2011AA ObjectClass
C0376315
NCI Thesaurus Property
C25250
UMLS 2011AA Property
C0205197
NCI Thesaurus Property-2
C25604
UMLS 2011AA Property-2
C0205313
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
Treatment Data
Description

Treatment Data

Cycle Number
Description

Cycle Number

Data type

integer

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2045829
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25379
BSA
Description

Body Surface Area

Data type

float

Measurement units
  • m2
Alias
NCI Thesaurus ObjectClass
C25190
NCI Thesaurus ValueDomain
C25712
NCI Thesaurus Property
C25157
UMLS CUI-1
C0005902
m2
Total doxorubicin dose received this cycle (mg)
Description

Doxorubicin dose received this cycle

Data type

float

Alias
NCI Thesaurus ObjectClass
C456
UMLS CUI-1
C0013089
NCI Thesaurus ObjectClass-2
C1708
UMLS CUI-2
C0178602
NCI Thesaurus Property
C25379
NCI Thesaurus ValueDomain
C25304
NCI Thesaurus ValueDomain-2
C25488
Dose level received on reporting period start date
Description

Agent dose administered

Data type

text

Alias
NCI Thesaurus ObjectClass
C1708
UMLS CUI-1
C0678766
NCI Thesaurus Property
C25616
UMLS CUI-2
C1521801
NCI Thesaurus Property-2
C25375
NCI Thesaurus Property-3
C25431
NCI Thesaurus Property-4
C25256
NCI Thesaurus ValueDomain
C25488
Method of administration
Description

Drug administration method

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C0449311
NCI Metathesaurus ObjectClass
CL111054
NCI Thesaurus Property
C25409
Was the doxorubicin dose reduced this cycle
Description

Doxorubicin dose reduced this cycle

Data type

text

Alias
NCI Thesaurus ObjectClass
C456
UMLS CUI-1
C0013089
NCI Thesaurus ObjectClass-2
C1708
UMLS CUI-2
C1707814
NCI Thesaurus Property
C25640
NCI Thesaurus Property-2
C25472
NCI Thesaurus Property-3
C25256
NCI Thesaurus ValueDomain
C25180
NCI Thesaurus ValueDomain-2
C25488
Total sorafenib dose received this cycle
Description

Sorafenib dose received this cycle

Data type

float

Alias
NCI Thesaurus ValueDomain
C25304
UMLS CUI-1
C1516119
NCI Thesaurus Property
C25379
UMLS CUI-2
C0178602
NCI Thesaurus ValueDomain-2
C25488
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus ObjectClass-2
C61948
Was the sorafenib dose reduced during this cycle
Description

Sorafenib dose reduced

Data type

text

Alias
NCI Thesaurus ObjectClass
C1708
UMLS CUI-1
C1516119
NCI Thesaurus ObjectClass-2
C61948
UMLS CUI-2
C1707814
NCI Thesaurus Property
C25640
NCI Thesaurus Property-2
C25472
NCI Thesaurus Property-3
C25256
NCI Thesaurus ValueDomain
C25180
NCI Thesaurus ValueDomain-2
C25488
Were any doses of sorafenib missed this cycle
Description

SorafenibAgentCycleMissingDoseIndicator

Data type

text

Alias
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus ObjectClass-2
C61948
NCI Thesaurus Property
C54031
NCI Thesaurus Property-2
C25472
NCI Thesaurus Property-3
C25256
NCI Thesaurus ValueDomain
C25180
NCI Thesaurus ValueDomain-2
C25488
UMLS CUI-1
C1516119
UMLS CUI-2
C1709043
Number of missed Sorafenib doses
Description

SorafenibAgentNotAdministeredTotalDoseCount

Data type

integer

Alias
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus ObjectClass-2
C61948
NCI Thesaurus Property
C25594
NCI Thesaurus Property-2
C25382
NCI Thesaurus ValueDomain
C25463
UMLS CUI-1
C1516119
UMLS CUI-2
C0750480
UMLS CUI-3
C1709043
Did patient receive G-CSF or GM-CSF per protocol
Description

G-CSF or GM-CSF

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0796404
NCI Thesaurus ObjectClass
C20586
NCI Thesaurus Property
C25340
Date of first dose of G-CSF/GM-CSF during this reporting period
Description

G-CSF or GM-CSF start date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C0796404
NCI Thesaurus ObjectClass
C20586
UMLS CUI-2
C0808070
NCI Thesaurus Property
C25340
Specify deviation (If no,)
Description

Protocol Deviation Description

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C1705236
NCI Thesaurus ObjectClass
C50996
NCI Thesaurus Property
C25365
Did the patient receive any additional supportive care during this reporting period
Description

Supportive Care non-Protocol

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0344211
NCI Thesaurus Property
C15368
NCI Thesaurus ObjectClass
C25590
UMLS CUI-2
C1518384
NCI Thesaurus ObjectClass-2
C37902
Yes specify
Description

Supportive Care non-Protocol, specify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0344211
NCI Thesaurus Property
C15368
NCI Thesaurus ObjectClass
C25590
UMLS CUI-2
C1518384
NCI Thesaurus ObjectClass-2
C37902
UMLS CUI-3
C1521902
Off Treatment Reason (only applicable if protocol therapy has been discontinued permanently Mark one with an X.)
Description

Off Treatment Reason

Data type

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS CUI-1
C1518544
NCI Thesaurus ObjectClass
C25601
UMLS CUI-2
C0566251
NCI Thesaurus Property
C25365
Other specify
Description

Off Treatment Reason, specify

Data type

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
Alternative therapy, specify
Description

Alternative therapy, specify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C0949216
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C25415
NCI Thesaurus Property
C25382
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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. Mark an X in the appropriate box for fields with a choice

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header Module
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)
TreatmentFirstDoseBeginDate
Item
Date of First dose for this reporting period
date
C15368 (NCI Thesaurus ObjectClass)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C25256 (NCI Thesaurus Property-2)
C1265611 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)
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)
Data amended
Item
Are data amended
boolean
C38148 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
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)
Person Completing Form
Item
Completed by
text
C25191 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
FormOriginalCompleteDate
Item
Date Form Originally Completed
date
C19464 (NCI Thesaurus ObjectClass)
C0376315 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25604 (NCI Thesaurus Property-2)
C0205313 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
Item Group
Treatment Data
Cycle Number
Item
Cycle Number
integer
C25337 (NCI Thesaurus ValueDomain)
C2045829 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25379 (NCI Thesaurus Property)
Body Surface Area
Item
BSA
float
C25190 (NCI Thesaurus ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C25157 (NCI Thesaurus Property)
C0005902 (UMLS CUI-1)
Doxorubicin dose received this cycle
Item
Total doxorubicin dose received this cycle (mg)
float
C456 (NCI Thesaurus ObjectClass)
C0013089 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass-2)
C0178602 (UMLS CUI-2)
C25379 (NCI Thesaurus Property)
C25304 (NCI Thesaurus ValueDomain)
C25488 (NCI Thesaurus ValueDomain-2)
Item
Dose level received on reporting period start date
text
C1708 (NCI Thesaurus ObjectClass)
C0678766 (UMLS CUI-1)
C25616 (NCI Thesaurus Property)
C1521801 (UMLS CUI-2)
C25375 (NCI Thesaurus Property-2)
C25431 (NCI Thesaurus Property-3)
C25256 (NCI Thesaurus Property-4)
C25488 (NCI Thesaurus ValueDomain)
CL.5
Code List
Dose level received on reporting period start date
CL Item
400 Mg Every 12 Hrs (400 mg every 12 hrs)
CL Item
400 Mg Every Day (400 mg every day)
CL Item
400 Mg Every Other Day (400 mg every other day)
CL Item
Not Received (Not received)
Item
Method of administration
text
C25284 (NCI Thesaurus ValueDomain)
C0449311 (UMLS CUI-1)
CL111054 (NCI Metathesaurus ObjectClass)
C25409 (NCI Thesaurus Property)
CL.3
Code List
Method of administration
CL Item
Bolus Injection (Bolus injection)
CL Item
Infusion (Infusion)
C15388 (NCI Thesaurus)
C0574032 (UMLS 2011AA)
Item
Was the doxorubicin dose reduced this cycle
text
C456 (NCI Thesaurus ObjectClass)
C0013089 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass-2)
C1707814 (UMLS CUI-2)
C25640 (NCI Thesaurus Property)
C25472 (NCI Thesaurus Property-2)
C25256 (NCI Thesaurus Property-3)
C25180 (NCI Thesaurus ValueDomain)
C25488 (NCI Thesaurus ValueDomain-2)
CL.4
Code List
Was the doxorubicin dose reduced this cycle
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes, Planned Per Protocol (Yes, planned per protocol)
CL Item
Yes, Unplanned Per Protocol (Yes, unplanned per protocol)
Sorafenib dose received this cycle
Item
Total sorafenib dose received this cycle
float
C25304 (NCI Thesaurus ValueDomain)
C1516119 (UMLS CUI-1)
C25379 (NCI Thesaurus Property)
C0178602 (UMLS CUI-2)
C25488 (NCI Thesaurus ValueDomain-2)
C1708 (NCI Thesaurus ObjectClass)
C61948 (NCI Thesaurus ObjectClass-2)
Item
Was the sorafenib dose reduced during this cycle
text
C1708 (NCI Thesaurus ObjectClass)
C1516119 (UMLS CUI-1)
C61948 (NCI Thesaurus ObjectClass-2)
C1707814 (UMLS CUI-2)
C25640 (NCI Thesaurus Property)
C25472 (NCI Thesaurus Property-2)
C25256 (NCI Thesaurus Property-3)
C25180 (NCI Thesaurus ValueDomain)
C25488 (NCI Thesaurus ValueDomain-2)
CL.6
Code List
Was the sorafenib dose reduced during this cycle
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes, Planned Per Protocol (Yes, planned per protocol)
CL Item
Yes, Unplanned Per Protocol (Yes, unplanned per protocol)
Item
Were any doses of sorafenib missed this cycle
text
C1708 (NCI Thesaurus ObjectClass)
C61948 (NCI Thesaurus ObjectClass-2)
C54031 (NCI Thesaurus Property)
C25472 (NCI Thesaurus Property-2)
C25256 (NCI Thesaurus Property-3)
C25180 (NCI Thesaurus ValueDomain)
C25488 (NCI Thesaurus ValueDomain-2)
C1516119 (UMLS CUI-1)
C1709043 (UMLS CUI-2)
CL.7
Code List
Were any doses of sorafenib missed this cycle
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes, Planned Per Protocol (Yes, planned per protocol)
CL Item
Yes, Unplanned Per Protocol (Yes, unplanned per protocol)
Number of missed doses Sorafenib
Item
Number of missed Sorafenib doses
integer
C1708 (NCI Thesaurus ObjectClass)
C61948 (NCI Thesaurus ObjectClass-2)
C25594 (NCI Thesaurus Property)
C25382 (NCI Thesaurus Property-2)
C25463 (NCI Thesaurus ValueDomain)
C1516119 (UMLS CUI-1)
C0750480 (UMLS CUI-2)
C1709043 (UMLS CUI-3)
G-CSF or GM-CSF
Item
Did patient receive G-CSF or GM-CSF per protocol
boolean
C38148 (NCI Thesaurus ValueDomain)
C0796404 (UMLS CUI-1)
C20586 (NCI Thesaurus ObjectClass)
C25340 (NCI Thesaurus Property)
G-CSF or GM-CSF start date
Item
Date of first dose of G-CSF/GM-CSF during this reporting period
date
C25164 (NCI Thesaurus ValueDomain)
C0796404 (UMLS CUI-1)
C20586 (NCI Thesaurus ObjectClass)
C0808070 (UMLS CUI-2)
C25340 (NCI Thesaurus Property)
Protocol Deviation Description
Item
Specify deviation (If no,)
text
C25704 (NCI Thesaurus ValueDomain)
C1705236 (UMLS CUI-1)
C50996 (NCI Thesaurus ObjectClass)
C25365 (NCI Thesaurus Property)
Item
Did the patient receive any additional supportive care during this reporting period
text
C38148 (NCI Thesaurus ValueDomain)
C0344211 (UMLS CUI-1)
C15368 (NCI Thesaurus Property)
C25590 (NCI Thesaurus ObjectClass)
C1518384 (UMLS CUI-2)
C37902 (NCI Thesaurus ObjectClass-2)
CL.9
Code List
Did the patient receive any additional supportive care during this reporting period
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)
Supportive Care non-Protocol, specify
Item
Yes specify
text
C25704 (NCI Thesaurus ValueDomain)
C0344211 (UMLS CUI-1)
C15368 (NCI Thesaurus Property)
C25590 (NCI Thesaurus ObjectClass)
C1518384 (UMLS CUI-2)
C37902 (NCI Thesaurus ObjectClass-2)
C1521902 (UMLS CUI-3)
Item
Off Treatment Reason (only applicable if protocol therapy has been discontinued permanently Mark one with an X.)
text
C25638 (NCI Thesaurus ValueDomain)
C1518544 (UMLS CUI-1)
C25601 (NCI Thesaurus ObjectClass)
C0566251 (UMLS CUI-2)
C25365 (NCI Thesaurus Property)
CL.10
Code List
Off Treatment Reason (only applicable if protocol therapy has been discontinued permanently Mark one with an X.)
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
Other 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)
Alternative therapy, specify
Item
Alternative therapy, specify
text
C25685 (NCI Thesaurus ValueDomain)
C0949216 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25415 (NCI Thesaurus ObjectClass-2)
C25382 (NCI Thesaurus Property)
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