ID

2554

Description

North Central Cancer Treatment Group N0723 Arm A Evaluation/Treatment Form Pemetrexed or Erlotinib as Second-Line Therapy in Treating Patients With Advanced Non-Small Cell Lung Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=46ACBEC0-51A9-1310-E044-0003BA3F9857

Lien

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=46ACBEC0-51A9-1310-E044-0003BA3F9857

Mots-clés

Versions (3)
  1. 19/09/2012 19/09/2012 -
  2. 08/01/2015 08/01/2015 - Martin Dugas
  3. 08/06/2015 08/06/2015 -
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19 septembre 2012

DOI

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Licence

Creative Commons BY-NC 3.0 Legacy
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Lung Cancer NCT00738881 Treatment - North Central Cancer Treatment Group N0723 Arm A Evaluation/Treatment Form - 2730854v1.0

Anglais

No Instruction available.

1 Formulaires  
  1. StudyEvent: North Central Cancer Treatment Group N0723 Arm A Evaluation/Treatment Form
    1. No Instruction available.
Header
Description

Header

Protocol Number
Description

ProtocolNorthCentralCancerTreatmentGroupIdentifierNumber

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C25320
UMLS 2011AA ObjectClass
C1507394
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C25581
UMLS 2011AA Property
C1518419
Patient ID
Description

PatientNorthCentralCancerTreatmentGroupIdentifierNumber

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus Property
C25581
UMLS 2011AA Property
C1518419
Patient Initials (L F M)
Description

PatientInitialsName

Type de données

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
Institution Number
Description

InstitutionIdentifierNumber

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C21541
UMLS 2011AA ObjectClass
C0018704
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Institution
Description

InstitutionName

Type de données

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 yes, highlight amended areas)
Description

DataAmendedInd-3

Type de données

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
Unnamed 2
Description

Unnamed 2

Current Cycle Number
Description

TreatmentCurrentCourseNumber

Type de données

double

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus Property
C25471
UMLS 2011AA Property
C0521116
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25379
UMLS 2011AA Property
C0750729
Weight (kg used for this cycle, round to the nearest tenth)
Description

PatientWeightMeasurement

Type de données

double

Unités de mesure
  • Kg
Alias
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25208
UMLS 2011AA Property
C0043100
Kg
ECOG Performance Status (check one used for this cycle)
Description

PerformanceStatusAssessmentEasternCooperativeOncologyGroupScale

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS 2011AA ValueDomain
C0349674
NCI Thesaurus Property
C25367
NCI Thesaurus ValueDomain
C25491
UMLS 2011AA ValueDomain
C1512162
NCI Thesaurus ObjectClass
C20641
UMLS 2011AA ObjectClass
C1518965
Was this cycle of treatment held (check one)
Description

TherapyCurrentCourseDiscontinuedIndicator

Type de données

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25471
UMLS 2011AA Property
C0521116
NCI Thesaurus Property
C25379
UMLS 2011AA Property
C0750729
NCI Thesaurus Property
C25484
UMLS 2011AA Property
C1444662
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Primary reason treatment held (If yes, planned or unplanned)
Description

TherapyCurrentCourseDiscontinuedType

Type de données

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25471
UMLS 2011AA Property
C0521116
NCI Thesaurus Property
C25379
UMLS 2011AA Property
C0750729
NCI Thesaurus Property
C25484
UMLS 2011AA Property
C1444662
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Other, specify (not per protocol)
Description

TherapyCurrentCourseDiscontinuedSpecify

Type de données

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25471
UMLS 2011AA Property
C0521116
NCI Thesaurus Property
C25379
UMLS 2011AA Property
C0750729
NCI Thesaurus Property
C25484
UMLS 2011AA Property
C1444662
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ValueDomain
C25484
UMLS 2011AA ValueDomain
C1444662
Agent Dosing
Description

Agent Dosing

Agent (Erlotinib)
Description

AgentName

Type de données

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 Start Date (this cycle mm/dd/yyyy)
Description

AgentBeginDate

Type de données

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain
C25431
UMLS 2011AA ValueDomain
C0439659
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25275
UMLS 2011AA Property
C2745955
Initial Dose (day one this cycle If agent was not given this cycle, enter the dose level received on last day of treatment.)
Description

AgentInitialDose

Type de données

double

Alias
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
NCI Thesaurus Property
C25256
UMLS 2011AA Property
C1265611
NCI Thesaurus ValueDomain
C25488
UMLS 2011AA ValueDomain
C0178602
NCI Thesaurus ValueDomain
C1708
UMLS 2011AA ValueDomain
C0450442
Total Dose of Agents/Drugs for this Cycle (If agent was not given this cycle, enter 0 for dose level.)
Description

AgentCourseTotalDose

Type de données

double

Alias
NCI Thesaurus ValueDomain
C25304
UMLS 2011AA ValueDomain
C0439810
NCI Thesaurus Property
C25379
UMLS 2011AA Property
C0750729
NCI Thesaurus ValueDomain
C25488
UMLS 2011AA ValueDomain
C0178602
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
Were there any dose modifications or additions/omissions to protocol treatment? (Days 1-21 mg)
Description

DoseModificationInd

Type de données

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
Reason(s) Modified
Description

SingleAgentProtocolTherapyModifiedReason

Type de données

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 specify (not per protocol)
Description

SingleAgentProtocolTherapyModifiedSpecify

Type de données

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
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Similar models

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1 Formulaires
  1. StudyEvent: North Central Cancer Treatment Group N0723 Arm A Evaluation/Treatment Form
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Header
ProtocolNorthCentralCancerTreatmentGroupIdentifierNumber
Item
Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25581 (NCI Thesaurus Property)
C1518419 (UMLS 2011AA Property)
PatientNorthCentralCancerTreatmentGroupIdentifierNumber
Item
Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25581 (NCI Thesaurus Property)
C1518419 (UMLS 2011AA Property)
PatientInitialsName
Item
Patient Initials (L F M)
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)
InstitutionIdentifierNumber
Item
Institution Number
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
InstitutionName
Item
Institution
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 yes, highlight amended areas)
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 yes, highlight amended areas)
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Unnamed 2
TreatmentCurrentCourseNumber
Item
Current Cycle Number
double
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25471 (NCI Thesaurus Property)
C0521116 (UMLS 2011AA Property)
C15368 (NCI Thesaurus ObjectClass)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
PatientWeightMeasurement
Item
Weight (kg used for this cycle, round to the nearest tenth)
double
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25208 (NCI Thesaurus Property)
C0043100 (UMLS 2011AA Property)
Item
ECOG Performance Status (check one used for this cycle)
text
C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain)
C1512162 (UMLS 2011AA ValueDomain)
C20641 (NCI Thesaurus ObjectClass)
C1518965 (UMLS 2011AA ObjectClass)
CL.2
Code List
ECOG Performance Status (check one used for this cycle)
CL Item
Fully Active, Able To Carry On All Pre-disease Performance Without Restriction. (0)
CL Item
Restricted In Physically Strenuous Activity But Ambulatory And Able To Carry Out Work Of A Light Or Sedentary Nature, E.g., Light Housework, Office Work. (1)
CL Item
Ambulatory And Capable Of All Selfcare But Unable To Carry Out Any Work Activities. Up And About More Than 50% Of Waking Hours. (2)
CL Item
Capable Of Only Limited Selfcare, Confined To Bed Or Chair More Than 50% Of Waking Hours. (3)
CL Item
Completely Disabled. Cannot Carry On Any Selfcare. Totally Confined To Bed Or Chair. (4)
Item
Was this cycle of treatment held (check one)
text
C15368 (NCI Thesaurus ObjectClass)
C25471 (NCI Thesaurus Property)
C0521116 (UMLS 2011AA Property)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
C25484 (NCI Thesaurus Property)
C1444662 (UMLS 2011AA Property)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.3
Code List
Was this cycle of treatment held (check one)
CL Item
Yes, Planned (i.e., The Treatment Was Changed According To Protocol Guidelines) (Yes, planned)
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes, Unplanned (i.e., The Treatment Change Was Not Part Of Protocol Guidelines) (Yes, unplanned)
Item
Primary reason treatment held (If yes, planned or unplanned)
text
C15368 (NCI Thesaurus ObjectClass)
C25471 (NCI Thesaurus Property)
C0521116 (UMLS 2011AA Property)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
C25484 (NCI Thesaurus Property)
C1444662 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.4
Code List
Primary reason treatment held (If yes, planned or unplanned)
CL Item
Diarrhea (Diarrhea)
C2987 (NCI Thesaurus)
C0011991 (UMLS 2011AA)
CL Item
Hematologic (Hematologic)
C0205488 (NCI Metathesaurus)
CL Item
Metabolic/laboratory (Metabolic/laboratory)
CL Item
Mucositis/stomatitis (Mucositis/stomatitis)
CL Item
Ocular/visual (Ocular/visual)
CL Item
Pain (Pain)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Other Nonhematologic Adverse Events (Other nonhematologic adverse events)
TherapyCurrentCourseDiscontinuedSpecify
Item
Other, specify (not per protocol)
text
C15368 (NCI Thesaurus ObjectClass)
C25471 (NCI Thesaurus Property)
C0521116 (UMLS 2011AA Property)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
C25484 (NCI Thesaurus Property)
C1444662 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25484 (NCI Thesaurus ValueDomain)
C1444662 (UMLS 2011AA ValueDomain)
Item Group
Agent Dosing
AgentName
Item
Agent (Erlotinib)
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)
AgentBeginDate
Item
Agent Start Date (this cycle mm/dd/yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
AgentInitialDose
Item
Initial Dose (day one this cycle If agent was not given this cycle, enter the dose level received on last day of treatment.)
double
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
C25256 (NCI Thesaurus Property)
C1265611 (UMLS 2011AA Property)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ValueDomain)
C0450442 (UMLS 2011AA ValueDomain)
AgentCourseTotalDose
Item
Total Dose of Agents/Drugs for this Cycle (If agent was not given this cycle, enter 0 for dose level.)
double
C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C25379 (NCI Thesaurus Property)
C0750729 (UMLS 2011AA Property)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
Item
Were there any dose modifications or additions/omissions to protocol treatment? (Days 1-21 mg)
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.5
Code List
Were there any dose modifications or additions/omissions to protocol treatment? (Days 1-21 mg)
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)
CL Item
Yes, Unplanned (i.e., The Treatment Change Was Not Part Of Protocol Guidelines) (Yes, unplanned)
Item
Reason(s) Modified
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.6
Code List
Reason(s) Modified
CL Item
Hematologic (Hematologic)
C0205488 (NCI Metathesaurus)
CL Item
Diarrhea (Diarrhea)
C2987 (NCI Thesaurus)
C0011991 (UMLS 2011AA)
CL Item
Mucositis/stomatitis (Mucositis/stomatitis)
CL Item
Metabolic/laboratory (Metabolic/laboratory)
CL Item
Pain (Pain)
C3303 (NCI Thesaurus)
C0030193 (UMLS 2011AA)
CL Item
Other Nonhematologic Adverse Events (Other nonhematologic adverse events)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Increased Per Protocol (Increased per protocol)
SingleAgentProtocolTherapyModifiedSpecify
Item
Other specify (not per protocol)
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)
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