ID

10640

Description

NCI Cooperative Group Not for Arm G Patients Colorectal Ca - Adjuvant Disease Treatment Summary Form NCT00079274 Comparison of Combination Chemotherapy Regimens With or Without Cetuximab in Treating Patients Who Have Undergone Surgery For Stage III Colon Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=DFAA3B47-A18B-66D4-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=DFAA3B47-A18B-66D4-E034-0003BA12F5E7

Keywords

  1. 8/27/12 8/27/12 -
  2. 1/8/15 1/8/15 - Martin Dugas
  3. 6/3/15 6/3/15 -
Uploaded on

June 3, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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NCI Cooperative Group Not for Arm G Patients Colorectal Ca - Adjuvant Disease Treatment Summary Form NCT00079274

Visit: Off Treatment

  1. StudyEvent: NCI Cooperative Group Not for Arm G Patients Colorectal Ca - Adjuvant Disease Treatment Summary Form
    1. Visit: Off Treatment
Header module
Description

Header module

Coordinating Group Protocol Number
Description

Protocol ID Coordinating Group

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1711341
NCI Thesaurus Property
C25462
NCI Thesaurus Property-2
C25364
Coordinating Group Code
Description

Coordinating Group Code

Data type

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS CUI-1
C1711341
NCI Thesaurus ObjectClass
C17005
UMLS CUI-2
C0805701
NCI Thesaurus ObjectClass-2
C25462
NCI Thesaurus Property
C25364
Protocol Title
Description

Protocol Title

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986303
NCI Thesaurus ObjectClass
C25320
NCI Thesaurus Property
C42774
Patient Study ID
Description

Patient Study ID

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25462
NCI Thesaurus Property-2
C25364
Patient Medical Record Number
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
Patient Initials (L, FM)
Description

Patient Initials

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Participating Group Code (Cooperative Group where credit will be applied)
Description

ParticipatingGroupIdentifierCode

Data type

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus ObjectClass
C25608
UMLS 2011AA ObjectClass
C0679823
NCI Thesaurus ObjectClass-2
C17005
UMLS 2011AA ObjectClass-2
C1257890
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Institution Name (treating location/performance site)
Description

Institution Name

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass
C21541
NCI Thesaurus ValueDomain-2
C21541
NCI Thesaurus Property
C25364
Are data amended? (If data are amended, please circle in red when using paper form)
Description

Data amended

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Colorectal: Treatment Summary Interval - End Of Treatment
Description

Colorectal: Treatment Summary Interval - End Of Treatment

First Date Protocol Therapy was Given (MM DD YYYY)
Description

Treatment Start Date

Data type

date

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass-2
C25509
UMLS CUI-1
C3173309
NCI Thesaurus Property
C25431
NCI Thesaurus Property-2
C25275
NCI Thesaurus ValueDomain
C25164
NCI Thesaurus ValueDomain-2
C25431
Last Date Protocol Therapy was Given (MM DD YYYY)
Description

Treatment End Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1531784
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25275
NCI Thesaurus Property-2
C25496
Reason Treatment Ended (check one)
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
Colorectal: Treatment Schedule - Systemic Therapy
Description

Colorectal: Treatment Schedule - Systemic Therapy

Total Number of Cycles Given
Description

Total number of cycles

Data type

float

Alias
NCI Thesaurus Property
C25304
UMLS CUI-1
C2045831
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ValueDomain
C25463
NCI Thesaurus Property-2
C25379
Were there any dose modifications or additions/omissions to protocol treatment? (decreases/increases)
Description

Dose Modification

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS CUI-1
C1707811
NCI Thesaurus ObjectClass
C25256
NCI Thesaurus Property
C25572
NCI Thesaurus ValueDomain-2
C25572
Agent Name (Pre-filled with response: C225 [cetuximab])
Description

Agent

Data type

text

Alias
NCI Thesaurus Property
C25364
UMLS CUI-1
C1521826
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus ValueDomain
C1708
NCI Thesaurus ValueDomain-2
C42614
Agent Name (Pre-filled with response: C225 [cetuximab])
Description

Agent

Data type

text

Alias
NCI Thesaurus Property
C25364
UMLS CUI-1
C1521826
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus ValueDomain
C1708
NCI Thesaurus ValueDomain-2
C42614
Agent Name (Pre-filled with response: C225 [cetuximab])
Description

Agent

Data type

text

Alias
NCI Thesaurus Property
C25364
UMLS CUI-1
C1521826
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus ValueDomain
C1708
NCI Thesaurus ValueDomain-2
C42614
Was agent modified (decreased/increased) or omitted?
Description

AgentModifiedInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25572
Was agent modified (decreased/increased) or omitted?
Description

AgentModifiedInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25572
Was agent modified (decreased/increased) or omitted?
Description

AgentModifiedInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25572
Reason(s) Modified (If yes, [C225] decreased/increased/omitted [Reasons modified are based on Dose Modification Table in protocol section 8.0])
Description

SingleAgentProtocolTherapyModifiedReason

Data type

text

Alias
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus ObjectClass-2
C48440
UMLS 2011AA ObjectClass-2
C0205171
NCI Thesaurus Property
C15368
NCI Thesaurus Property-2
C42651
UMLS 2011AA Property
C0442711
NCI Thesaurus Property-3
C25573
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
Reason(s) Modified (If yes, [C225] decreased/increased/omitted [Reasons modified are based on Dose Modification Table in protocol section 8.0])
Description

SingleAgentProtocolTherapyModifiedReason

Data type

text

Alias
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus ObjectClass-2
C48440
UMLS 2011AA ObjectClass-2
C0205171
NCI Thesaurus Property
C15368
NCI Thesaurus Property-2
C42651
UMLS 2011AA Property
C0442711
NCI Thesaurus Property-3
C25573
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
Reason(s) Modified (If yes, [C225] decreased/increased/omitted [Reasons modified are based on Dose Modification Table in protocol section 8.0])
Description

SingleAgentProtocolTherapyModifiedReason

Data type

text

Alias
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus ObjectClass-2
C48440
UMLS 2011AA ObjectClass-2
C0205171
NCI Thesaurus Property
C15368
NCI Thesaurus Property-2
C42651
UMLS 2011AA Property
C0442711
NCI Thesaurus Property-3
C25573
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
Other non-hematologic resaon agent modified ([C225] - decreased/increased/omitted)
Description

SingleClinicalTrialProtocolAgentUnrelatedHematologicModificationText

Data type

text

Alias
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus ObjectClass-2
C1708
UMLS 2011AA ObjectClass-2
C0450442
NCI Thesaurus ObjectClass-3
C48440
UMLS 2011AA ObjectClass-3
C0205171
NCI Thesaurus Property
C62780
UMLS 2011AA Property
C0205488
NCI Thesaurus Property-2
C25328
UMLS 2011AA Property-2
C0445356
NCI Thesaurus Property-3
C25446
UMLS 2011AA Property-3
C0392747
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
Other non-hematologic resaon agent modified ([C225] - decreased/increased/omitted)
Description

SingleClinicalTrialProtocolAgentUnrelatedHematologicModificationText

Data type

text

Alias
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus ObjectClass-2
C1708
UMLS 2011AA ObjectClass-2
C0450442
NCI Thesaurus ObjectClass-3
C48440
UMLS 2011AA ObjectClass-3
C0205171
NCI Thesaurus Property
C62780
UMLS 2011AA Property
C0205488
NCI Thesaurus Property-2
C25328
UMLS 2011AA Property-2
C0445356
NCI Thesaurus Property-3
C25446
UMLS 2011AA Property-3
C0392747
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
Other Reason Agent Modified ([C225] decreased/increased/omitted)
Description

SingleAgentProtocolTherapyModifiedSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus ObjectClass-2
C48440
UMLS 2011AA ObjectClass-2
C0205171
NCI Thesaurus Property
C15368
NCI Thesaurus Property-2
C42651
UMLS 2011AA Property
C0442711
NCI Thesaurus Property-3
C25573
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Other Reason Agent Modified ([C225] decreased/increased/omitted)
Description

SingleAgentProtocolTherapyModifiedSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus ObjectClass-2
C48440
UMLS 2011AA ObjectClass-2
C0205171
NCI Thesaurus Property
C15368
NCI Thesaurus Property-2
C42651
UMLS 2011AA Property
C0442711
NCI Thesaurus Property-3
C25573
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Other Reason Agent Modified ([C225] decreased/increased/omitted)
Description

SingleAgentProtocolTherapyModifiedSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus ObjectClass-2
C48440
UMLS 2011AA ObjectClass-2
C0205171
NCI Thesaurus Property
C15368
NCI Thesaurus Property-2
C42651
UMLS 2011AA Property
C0442711
NCI Thesaurus Property-3
C25573
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Disease Evaluation
Description

Disease Evaluation

Response Status at This Assessment
Description

TumorResponseType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus Property
C25755
UMLS 2011AA Property
C0871261
Assessment Date (mm dd yyyy)
Description

LesionAssessmentDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ValueDomain-2
C25367
Comments
Description

Comments

Comments
Description

Research Comments

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393

Similar models

Visit: Off Treatment

  1. StudyEvent: NCI Cooperative Group Not for Arm G Patients Colorectal Ca - Adjuvant Disease Treatment Summary Form
    1. Visit: Off Treatment
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header module
Protocol ID Coordinating Group
Item
Coordinating Group Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1711341 (UMLS CUI-2)
C25462 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Coordinating Group Code
Item
Coordinating Group Code
text
C25162 (NCI Thesaurus ValueDomain)
C1711341 (UMLS CUI-1)
C17005 (NCI Thesaurus ObjectClass)
C0805701 (UMLS CUI-2)
C25462 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
Protocol Title
Item
Protocol Title
text
C25191 (NCI Thesaurus ValueDomain)
C2986303 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C42774 (NCI Thesaurus Property)
Patient Study ID
Item
Patient Study ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25462 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Medical Record Number
Item
Patient Medical Record Number
text
C25337 (NCI Thesaurus ValueDomain)
C1301894 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25261 (NCI Thesaurus Property)
C25198 (NCI Thesaurus Property-2)
Patient Initials
Item
Patient Initials (L, FM)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
ParticipatingGroupIdentifierCode
Item
Participating Group Code (Cooperative Group where credit will be applied)
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25608 (NCI Thesaurus ObjectClass)
C0679823 (UMLS 2011AA ObjectClass)
C17005 (NCI Thesaurus ObjectClass-2)
C1257890 (UMLS 2011AA ObjectClass-2)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
Institution Name
Item
Institution Name (treating location/performance site)
text
C25191 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C21541 (NCI Thesaurus ValueDomain-2)
C25364 (NCI Thesaurus Property)
Data amended
Item
Are data amended? (If data are amended, please circle in red when using paper form)
boolean
C38148 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Item Group
Colorectal: Treatment Summary Interval - End Of Treatment
Treatment Start Date
Item
First Date Protocol Therapy was Given (MM DD YYYY)
date
C15368 (NCI Thesaurus ObjectClass)
C25509 (NCI Thesaurus ObjectClass-2)
C3173309 (UMLS CUI-1)
C25431 (NCI Thesaurus Property)
C25275 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
Treatment End Date
Item
Last Date Protocol Therapy was Given (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C1531784 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)
C25496 (NCI Thesaurus Property-2)
Item
Reason Treatment Ended (check one)
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 (check one)
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
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
Disease Progression Before Active Treatment (Disease Progression before active treatment)
CL Item
Cytogenetic Resistance (Cytogenetic Resistance)
CL Item
Death On Study (Death on study)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
Item Group
Colorectal: Treatment Schedule - Systemic Therapy
Total number of cycles
Item
Total Number of Cycles Given
float
C25304 (NCI Thesaurus Property)
C2045831 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C25379 (NCI Thesaurus Property-2)
Item
Were there any dose modifications or additions/omissions to protocol treatment? (decreases/increases)
text
C25180 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25256 (NCI Thesaurus ObjectClass)
C25572 (NCI Thesaurus Property)
C25572 (NCI Thesaurus ValueDomain-2)
Code List
Were there any dose modifications or additions/omissions to protocol treatment? (decreases/increases)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes, Planned (i.e., The Treatment Was Changed According To Protocol Guidelines) (Yes, planned (i.e., the treatment was changed according to protocol guidelines))
CL Item
Yes, Unplanned (i.e., The Treatment Change Was Not Part Of Protocol Guidelines) (Yes, unplanned (i.e., the treatment change was not part of protocol guidelines))
Agent
Item
Agent Name (Pre-filled with response: C225 [cetuximab])
text
C25364 (NCI Thesaurus Property)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)
Agent
Item
Agent Name (Pre-filled with response: C225 [cetuximab])
text
C25364 (NCI Thesaurus Property)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)
Agent
Item
Agent Name (Pre-filled with response: C225 [cetuximab])
text
C25364 (NCI Thesaurus Property)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)
AgentModifiedInd-3
Item
Was agent modified (decreased/increased) or omitted?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25572 (NCI Thesaurus Property)
AgentModifiedInd-3
Item
Was agent modified (decreased/increased) or omitted?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25572 (NCI Thesaurus Property)
AgentModifiedInd-3
Item
Was agent modified (decreased/increased) or omitted?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25572 (NCI Thesaurus Property)
Item
Reason(s) Modified (If yes, [C225] decreased/increased/omitted [Reasons modified are based on Dose Modification Table in protocol section 8.0])
text
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C48440 (NCI Thesaurus ObjectClass-2)
C0205171 (UMLS 2011AA ObjectClass-2)
C15368 (NCI Thesaurus Property)
C42651 (NCI Thesaurus Property-2)
C0442711 (UMLS 2011AA Property)
C25573 (NCI Thesaurus Property-3)
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
Code List
Reason(s) Modified (If yes, [C225] decreased/increased/omitted [Reasons modified are based on Dose Modification Table in protocol section 8.0])
CL Item
Allergic Reaction (Allergic reaction)
C0085600 (NCI Metathesaurus)
CL Item
Rash/desquamation (Rash/desquamation)
CL Item
Nail Changes (Nail changes)
CL Item
Gi (specific To Patients >= 70 Years) (GI (specific to patients >= 70 years))
CL Item
Other, Non-hematologic, Specify (Other non-hematologic)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
Item
Reason(s) Modified (If yes, [C225] decreased/increased/omitted [Reasons modified are based on Dose Modification Table in protocol section 8.0])
text
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C48440 (NCI Thesaurus ObjectClass-2)
C0205171 (UMLS 2011AA ObjectClass-2)
C15368 (NCI Thesaurus Property)
C42651 (NCI Thesaurus Property-2)
C0442711 (UMLS 2011AA Property)
C25573 (NCI Thesaurus Property-3)
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
Code List
Reason(s) Modified (If yes, [C225] decreased/increased/omitted [Reasons modified are based on Dose Modification Table in protocol section 8.0])
CL Item
Allergic Reaction (Allergic reaction)
C0085600 (NCI Metathesaurus)
CL Item
Rash/desquamation (Rash/desquamation)
CL Item
Nail Changes (Nail changes)
CL Item
Gi (specific To Patients >= 70 Years) (GI (specific to patients >= 70 years))
CL Item
Other, Non-hematologic, Specify (Other non-hematologic)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
Item
Reason(s) Modified (If yes, [C225] decreased/increased/omitted [Reasons modified are based on Dose Modification Table in protocol section 8.0])
text
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C48440 (NCI Thesaurus ObjectClass-2)
C0205171 (UMLS 2011AA ObjectClass-2)
C15368 (NCI Thesaurus Property)
C42651 (NCI Thesaurus Property-2)
C0442711 (UMLS 2011AA Property)
C25573 (NCI Thesaurus Property-3)
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
Code List
Reason(s) Modified (If yes, [C225] decreased/increased/omitted [Reasons modified are based on Dose Modification Table in protocol section 8.0])
CL Item
Allergic Reaction (Allergic reaction)
C0085600 (NCI Metathesaurus)
CL Item
Rash/desquamation (Rash/desquamation)
CL Item
Nail Changes (Nail changes)
CL Item
Gi (specific To Patients >= 70 Years) (GI (specific to patients >= 70 years))
CL Item
Other, Non-hematologic, Specify (Other non-hematologic)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
SingleClinicalTrialProtocolAgentUnrelatedHematologicModificationText
Item
Other non-hematologic resaon agent modified ([C225] - decreased/increased/omitted)
text
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass-2)
C0450442 (UMLS 2011AA ObjectClass-2)
C48440 (NCI Thesaurus ObjectClass-3)
C0205171 (UMLS 2011AA ObjectClass-3)
C62780 (NCI Thesaurus Property)
C0205488 (UMLS 2011AA Property)
C25328 (NCI Thesaurus Property-2)
C0445356 (UMLS 2011AA Property-2)
C25446 (NCI Thesaurus Property-3)
C0392747 (UMLS 2011AA Property-3)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
SingleClinicalTrialProtocolAgentUnrelatedHematologicModificationText
Item
Other non-hematologic resaon agent modified ([C225] - decreased/increased/omitted)
text
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ObjectClass-2)
C0450442 (UMLS 2011AA ObjectClass-2)
C48440 (NCI Thesaurus ObjectClass-3)
C0205171 (UMLS 2011AA ObjectClass-3)
C62780 (NCI Thesaurus Property)
C0205488 (UMLS 2011AA Property)
C25328 (NCI Thesaurus Property-2)
C0445356 (UMLS 2011AA Property-2)
C25446 (NCI Thesaurus Property-3)
C0392747 (UMLS 2011AA Property-3)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
SingleAgentProtocolTherapyModifiedSpecify
Item
Other Reason Agent Modified ([C225] decreased/increased/omitted)
text
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C48440 (NCI Thesaurus ObjectClass-2)
C0205171 (UMLS 2011AA ObjectClass-2)
C15368 (NCI Thesaurus Property)
C42651 (NCI Thesaurus Property-2)
C0442711 (UMLS 2011AA Property)
C25573 (NCI Thesaurus Property-3)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
SingleAgentProtocolTherapyModifiedSpecify
Item
Other Reason Agent Modified ([C225] decreased/increased/omitted)
text
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C48440 (NCI Thesaurus ObjectClass-2)
C0205171 (UMLS 2011AA ObjectClass-2)
C15368 (NCI Thesaurus Property)
C42651 (NCI Thesaurus Property-2)
C0442711 (UMLS 2011AA Property)
C25573 (NCI Thesaurus Property-3)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
SingleAgentProtocolTherapyModifiedSpecify
Item
Other Reason Agent Modified ([C225] decreased/increased/omitted)
text
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C48440 (NCI Thesaurus ObjectClass-2)
C0205171 (UMLS 2011AA ObjectClass-2)
C15368 (NCI Thesaurus Property)
C42651 (NCI Thesaurus Property-2)
C0442711 (UMLS 2011AA Property)
C25573 (NCI Thesaurus Property-3)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Item Group
Disease Evaluation
Item
Response Status at This Assessment
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25755 (NCI Thesaurus Property)
C0871261 (UMLS 2011AA Property)
Code List
Response Status at This Assessment
CL Item
Ned (NED)
CL Item
Recurrence (Recurrence)
C3352 (NCI Thesaurus)
C0034897 (UMLS 2011AA)
CL Item
Not Evaluated (Not evaluated)
LesionAssessmentDate
Item
Assessment Date (mm dd yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain-2)
Item Group
Comments
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)

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