ID

1339

Description

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

Versions (3)
  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

August 27, 2012

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Colorectal Cancer NCT00079274 Treatment - NCI Cooperative Group Not for Arm G Patients Colorectal Ca - Adjuvant Disease Treatment Summary Form - 2288742v3.0

English

Visit: Off Treatment

1 forms  
  1. StudyEvent: NCI Cooperative Group Not for Arm G Patients Colorectal Ca - Adjuvant Disease Treatment Summary Form
    1. Visit: Off Treatment
Unnamed1
Description

Unnamed1

Coordinating Group Protocol Number
Description

ProtocolCoordinatingIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus Property
C25462
UMLS 2011AA Property
C0700114
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Coordinating Group Code
Description

CoordinatingGroupIdentifierCode

Data type

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus ObjectClass
C17005
UMLS 2011AA ObjectClass
C1257890
NCI Thesaurus ObjectClass
C25462
UMLS 2011AA ObjectClass
C0700114
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Protocol Title
Description

ProtocolTitleName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus Property
C42774
UMLS 2011AA Property
C1705823
Patient Study ID
Description

PatientCoordinatingIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25462
UMLS 2011AA Property
C0700114
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Patient Medical Record Number
Description

PatientMedicalRecordNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25261
UMLS 2011AA Property
C0205476
NCI Thesaurus Property
C25198
UMLS 2011AA Property
C0034869
Patient Initials (L, FM)
Description

PatientInitialsName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
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
C17005
UMLS 2011AA ObjectClass
C1257890
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Institution Name (treating location/performance site)
Description

InstitutionName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C21541
UMLS 2011AA ObjectClass
C0018704
NCI Thesaurus ValueDomain
C21541
UMLS 2011AA ValueDomain
C0018704
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Are data amended? (If data are amended, please circle in red when using paper form)
Description

DataAmendedInd-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C25474
UMLS 2011AA ObjectClass
C1511726
NCI Thesaurus Property
C25416
UMLS 2011AA Property
C1691222
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

FirstTreatmentBeginDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ObjectClass
C25509
UMLS 2011AA ObjectClass
C1279901
NCI Thesaurus Property
C25431
UMLS 2011AA Property
C0439659
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25431
UMLS 2011AA ValueDomain
C0439659
Last Date Protocol Therapy was Given (MM DD YYYY)
Description

TreatmentEndDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
NCI Thesaurus Property
C25496
UMLS 2011AA Property
C2746065
Reason Treatment Ended (check one)
Description

Off-treatmentReason

Data type

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
NCI Thesaurus ObjectClass
C25601
UMLS 2011AA ObjectClass
C1518544
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Colorectal: Treatment Schedule - Systemic Therapy
Description

Colorectal: Treatment Schedule - Systemic Therapy

Total Number of Cycles Given
Description

TreatmentTotalCourseCount

Data type

double

Alias
NCI Thesaurus Property
C25304
UMLS 2011AA Property
C0439810
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
NCI Thesaurus Property
C25379
UMLS 2011AA Property
C0750729
Were there any dose modifications or additions/omissions to protocol treatment? (decreases/increases)
Description

DoseModificationInd

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C25256
UMLS 2011AA ObjectClass
C1265611
NCI Thesaurus Property
C25572
NCI Thesaurus ValueDomain
C25572
Agent Name (Pre-filled with response: C225 [cetuximab])
Description

AgentName

Data type

text

Alias
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus ValueDomain
C1708
UMLS 2011AA ValueDomain
C0450442
NCI Thesaurus ValueDomain
C42614
UMLS 2011AA ValueDomain
C0027365
Agent Name (Pre-filled with response: C225 [cetuximab])
Description

AgentName

Data type

text

Alias
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus ValueDomain
C1708
UMLS 2011AA ValueDomain
C0450442
NCI Thesaurus ValueDomain
C42614
UMLS 2011AA ValueDomain
C0027365
Agent Name (Pre-filled with response: C225 [cetuximab])
Description

AgentName

Data type

text

Alias
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus ValueDomain
C1708
UMLS 2011AA ValueDomain
C0450442
NCI Thesaurus ValueDomain
C42614
UMLS 2011AA ValueDomain
C0027365
Was agent modified (decreased/increased) or omitted?
Description

AgentModifiedInd-3

Data type

text

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

text

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

text

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
C48440
UMLS 2011AA ObjectClass
C0205171
NCI Thesaurus Property
C15368
NCI Thesaurus Property
C42651
UMLS 2011AA Property
C0442711
NCI Thesaurus Property
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
C48440
UMLS 2011AA ObjectClass
C0205171
NCI Thesaurus Property
C15368
NCI Thesaurus Property
C42651
UMLS 2011AA Property
C0442711
NCI Thesaurus Property
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
C48440
UMLS 2011AA ObjectClass
C0205171
NCI Thesaurus Property
C15368
NCI Thesaurus Property
C42651
UMLS 2011AA Property
C0442711
NCI Thesaurus Property
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
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus ObjectClass
C48440
UMLS 2011AA ObjectClass
C0205171
NCI Thesaurus Property
C62780
UMLS 2011AA Property
C0205488
NCI Thesaurus Property
C25328
UMLS 2011AA Property
C0445356
NCI Thesaurus Property
C25446
UMLS 2011AA Property
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
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus ObjectClass
C48440
UMLS 2011AA ObjectClass
C0205171
NCI Thesaurus Property
C62780
UMLS 2011AA Property
C0205488
NCI Thesaurus Property
C25328
UMLS 2011AA Property
C0445356
NCI Thesaurus Property
C25446
UMLS 2011AA Property
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
C48440
UMLS 2011AA ObjectClass
C0205171
NCI Thesaurus Property
C15368
NCI Thesaurus Property
C42651
UMLS 2011AA Property
C0442711
NCI Thesaurus Property
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
C48440
UMLS 2011AA ObjectClass
C0205171
NCI Thesaurus Property
C15368
NCI Thesaurus Property
C42651
UMLS 2011AA Property
C0442711
NCI Thesaurus Property
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
C48440
UMLS 2011AA ObjectClass
C0205171
NCI Thesaurus Property
C15368
NCI Thesaurus Property
C42651
UMLS 2011AA Property
C0442711
NCI Thesaurus Property
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
C25367
Comments
Description

Comments

Comments
Description

ResearchCommentsText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
UMLS 2011AA Property
C0282411
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Similar models

Visit: Off Treatment

1 forms
  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
Unnamed1
ProtocolCoordinatingIdentifierNumber
Item
Coordinating Group Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25462 (NCI Thesaurus Property)
C0700114 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
CoordinatingGroupIdentifierCode
Item
Coordinating Group Code
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C17005 (NCI Thesaurus ObjectClass)
C1257890 (UMLS 2011AA ObjectClass)
C25462 (NCI Thesaurus ObjectClass)
C0700114 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
ProtocolTitleName
Item
Protocol Title
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C42774 (NCI Thesaurus Property)
C1705823 (UMLS 2011AA Property)
PatientCoordinatingIdentifierNumber
Item
Patient Study ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25462 (NCI Thesaurus Property)
C0700114 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
PatientMedicalRecordNumber
Item
Patient Medical Record Number
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25261 (NCI Thesaurus Property)
C0205476 (UMLS 2011AA Property)
C25198 (NCI Thesaurus Property)
C0034869 (UMLS 2011AA Property)
PatientInitialsName
Item
Patient Initials (L, FM)
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA 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)
C1257890 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
InstitutionName
Item
Institution Name (treating location/performance site)
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C21541 (NCI Thesaurus ValueDomain)
C0018704 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
Item
Are data amended? (If data are amended, please circle in red when using paper form)
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
CL.1
Code List
Are data amended? (If data are amended, please circle in red when using paper form)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item Group
Colorectal: Treatment Summary Interval - End Of Treatment
FirstTreatmentBeginDate
Item
First Date Protocol Therapy was Given (MM DD YYYY)
date
C15368 (NCI Thesaurus ObjectClass)
C25509 (NCI Thesaurus ObjectClass)
C1279901 (UMLS 2011AA ObjectClass)
C25431 (NCI Thesaurus Property)
C0439659 (UMLS 2011AA Property)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)
TreatmentEndDate
Item
Last Date Protocol Therapy was Given (MM DD YYYY)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15368 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25496 (NCI Thesaurus Property)
C2746065 (UMLS 2011AA Property)
Item
Reason Treatment Ended (check one)
text
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C25601 (NCI Thesaurus ObjectClass)
C1518544 (UMLS 2011AA ObjectClass)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.2
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
TreatmentTotalCourseCount
Item
Total Number of Cycles Given
double
C25304 (NCI Thesaurus Property)
C0439810 (UMLS 2011AA Property)
C15368 (NCI Thesaurus ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
Item
Were there any dose modifications or additions/omissions to protocol treatment? (decreases/increases)
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C25256 (NCI Thesaurus ObjectClass)
C1265611 (UMLS 2011AA ObjectClass)
C25572 (NCI Thesaurus Property)
C25572 (NCI Thesaurus ValueDomain)
CL.3
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))
AgentName
Item
Agent Name (Pre-filled with response: C225 [cetuximab])
text
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C0450442 (UMLS 2011AA ValueDomain)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)
AgentName
Item
Agent Name (Pre-filled with response: C225 [cetuximab])
text
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C0450442 (UMLS 2011AA ValueDomain)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)
AgentName
Item
Agent Name (Pre-filled with response: C225 [cetuximab])
text
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C0450442 (UMLS 2011AA ValueDomain)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)
Item
Was agent modified (decreased/increased) or omitted?
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25572 (NCI Thesaurus Property)
CL.8
Code List
Was agent modified (decreased/increased) or omitted?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Was agent modified (decreased/increased) or omitted?
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25572 (NCI Thesaurus Property)
CL.8
Code List
Was agent modified (decreased/increased) or omitted?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Was agent modified (decreased/increased) or omitted?
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25572 (NCI Thesaurus Property)
CL.8
Code List
Was agent modified (decreased/increased) or omitted?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (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)
C0205171 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus Property)
C42651 (NCI Thesaurus Property)
C0442711 (UMLS 2011AA Property)
C25573 (NCI Thesaurus Property)
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
CL.9
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)
C0205171 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus Property)
C42651 (NCI Thesaurus Property)
C0442711 (UMLS 2011AA Property)
C25573 (NCI Thesaurus Property)
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
CL.9
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)
C0205171 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus Property)
C42651 (NCI Thesaurus Property)
C0442711 (UMLS 2011AA Property)
C25573 (NCI Thesaurus Property)
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
CL.9
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)
C0450442 (UMLS 2011AA ObjectClass)
C48440 (NCI Thesaurus ObjectClass)
C0205171 (UMLS 2011AA ObjectClass)
C62780 (NCI Thesaurus Property)
C0205488 (UMLS 2011AA Property)
C25328 (NCI Thesaurus Property)
C0445356 (UMLS 2011AA Property)
C25446 (NCI Thesaurus Property)
C0392747 (UMLS 2011AA Property)
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)
C0450442 (UMLS 2011AA ObjectClass)
C48440 (NCI Thesaurus ObjectClass)
C0205171 (UMLS 2011AA ObjectClass)
C62780 (NCI Thesaurus Property)
C0205488 (UMLS 2011AA Property)
C25328 (NCI Thesaurus Property)
C0445356 (UMLS 2011AA Property)
C25446 (NCI Thesaurus Property)
C0392747 (UMLS 2011AA Property)
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)
C0205171 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus Property)
C42651 (NCI Thesaurus Property)
C0442711 (UMLS 2011AA Property)
C25573 (NCI Thesaurus Property)
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)
C0205171 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus Property)
C42651 (NCI Thesaurus Property)
C0442711 (UMLS 2011AA Property)
C25573 (NCI Thesaurus Property)
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)
C0205171 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus Property)
C42651 (NCI Thesaurus Property)
C0442711 (UMLS 2011AA Property)
C25573 (NCI Thesaurus Property)
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)
CL.10
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)
Item Group
Comments
ResearchCommentsText
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0282411 (UMLS 2011AA Property)
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