ID

10789

Beschreibung

North Central Cancer Treatment Group N0723 Arm A Evaluation/Treatment Form NCT00738881 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

Link

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

Stichworte

Versionen (3)
  1. 19.09.12 19.09.12 -
  2. 08.01.15 08.01.15 - Martin Dugas
  3. 08.06.15 08.06.15 -
Hochgeladen am

8. Juni 2015

DOI

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North Central Cancer Treatment Group N0723 Arm A Evaluation/Treatment Form NCT00738881

Englisch

No Instruction available.

1 Formulare  
  1. StudyEvent: North Central Cancer Treatment Group N0723 Arm A Evaluation/Treatment Form
    1. No Instruction available.
Header module
Beschreibung

Header module

Protocol Number
Beschreibung

Protocol ID NCCTG

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1518419
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25581
Patient ID
Beschreibung

PatientNorthCentralCancerTreatmentGroupIdentifierNumber

Datentyp

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-2
C25581
UMLS 2011AA Property-2
C1518419
Patient Initials (L F M)
Beschreibung

Patient Initials

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Institution Number
Beschreibung

Institution Number

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass
C21541
UMLS CUI-2
C0805701
NCI Thesaurus Property
C25364
Institution
Beschreibung

Institution Name

Datentyp

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 yes, highlight amended areas)
Beschreibung

Data amended

Datentyp

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
Treatment assessment
Beschreibung

Treatment assessment

Current Cycle Number
Beschreibung

Cycle Number Chemotherapeutics

Datentyp

integer

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2045829
NCI Thesaurus Property
C25471
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property-2
C25379
Weight (kg used for this cycle, round to the nearest tenth)
Beschreibung

Patient Weight

Datentyp

float

Maßeinheiten
  • Kg
Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0005910
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25208
Kg
ECOG Performance Status (check one used for this cycle)
Beschreibung

ECOG Performance Status

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS CUI-1
C1520224
NCI Thesaurus Property
C25367
NCI Thesaurus ValueDomain-2
C25491
NCI Thesaurus ObjectClass
C20641
Was this cycle of treatment held (check one)
Beschreibung

TherapyCurrentCourseDiscontinuedIndicator

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25471
UMLS 2011AA Property
C0521116
NCI Thesaurus Property-2
C25379
UMLS 2011AA Property-2
C0750729
NCI Thesaurus Property-3
C25484
UMLS 2011AA Property-3
C1444662
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Primary reason treatment held (If yes, planned or unplanned)
Beschreibung

TherapyCurrentCourseDiscontinuedType

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25471
UMLS 2011AA Property
C0521116
NCI Thesaurus Property-2
C25379
UMLS 2011AA Property-2
C0750729
NCI Thesaurus Property-3
C25484
UMLS 2011AA Property-3
C1444662
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Other, specify (not per protocol)
Beschreibung

TherapyCurrentCourseDiscontinuedSpecify

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C15368
NCI Thesaurus Property
C25471
UMLS 2011AA Property
C0521116
NCI Thesaurus Property-2
C25379
UMLS 2011AA Property-2
C0750729
NCI Thesaurus Property-3
C25484
UMLS 2011AA Property-3
C1444662
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ValueDomain-2
C25484
UMLS 2011AA ValueDomain-2
C1444662
Agent Dosing
Beschreibung

Agent Dosing

Agent (Erlotinib)
Beschreibung

Agent

Datentyp

text

Alias
NCI Thesaurus Property
C25364
UMLS CUI-1
C1521826
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus ValueDomain
C1708
NCI Thesaurus ValueDomain-2
C42614
Agent Start Date (this cycle mm/dd/yyyy)
Beschreibung

Concomitant Medication Start Date

Datentyp

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2826734
NCI Thesaurus ValueDomain-2
C25431
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus Property
C25275
Initial Dose (day one this cycle If agent was not given this cycle, enter the dose level received on last day of treatment.)
Beschreibung

AgentInitialDose

Datentyp

float

Alias
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
NCI Thesaurus Property-2
C25256
UMLS 2011AA Property-2
C1265611
NCI Thesaurus ValueDomain
C25488
UMLS 2011AA ValueDomain
C0178602
NCI Thesaurus ValueDomain-2
C1708
UMLS 2011AA ValueDomain-2
C0450442
Total Dose of Agents/Drugs for this Cycle (If agent was not given this cycle, enter 0 for dose level.)
Beschreibung

Agent Total Dose

Datentyp

float

Alias
NCI Thesaurus ValueDomain
C25304
UMLS CUI-1
C2986497
NCI Thesaurus Property
C25379
NCI Thesaurus ValueDomain-2
C25488
NCI Thesaurus ObjectClass
C1708
Were there any dose modifications or additions/omissions to protocol treatment? (Days 1-21 mg)
Beschreibung

Dose Modification

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS CUI-1
C1707811
NCI Thesaurus ObjectClass
C25256
NCI Thesaurus Property
C25572
NCI Thesaurus ValueDomain-2
C25572
Reason(s) Modified
Beschreibung

SingleAgentProtocolTherapyModifiedReason

Datentyp

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 specify (not per protocol)
Beschreibung

SingleAgentProtocolTherapyModifiedSpecify

Datentyp

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
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Ähnliche Modelle

No Instruction available.

1 Formulare
  1. StudyEvent: North Central Cancer Treatment Group N0723 Arm A Evaluation/Treatment Form
    1. No Instruction available.
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Header module
Protocol ID NCCTG
Item
Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1518419 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25581 (NCI Thesaurus Property-2)
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-2)
C1518419 (UMLS 2011AA Property-2)
Patient Initials
Item
Patient Initials (L F M)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Institution Number
Item
Institution Number
text
C25337 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C0805701 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
Institution Name
Item
Institution
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 yes, highlight amended areas)
boolean
C38148 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
Item Group
Treatment assessment
Cycle Number Chemotherapeutics
Item
Current Cycle Number
integer
C25337 (NCI Thesaurus ValueDomain)
C2045829 (UMLS CUI-1)
C25471 (NCI Thesaurus Property)
C15368 (NCI Thesaurus ObjectClass)
C25379 (NCI Thesaurus Property-2)
Patient Weight
Item
Weight (kg used for this cycle, round to the nearest tenth)
float
C25209 (NCI Thesaurus ValueDomain)
C0005910 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)
Item
ECOG Performance Status (check one used for this cycle)
text
C25664 (NCI Thesaurus ValueDomain)
C1520224 (UMLS CUI-1)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain-2)
C20641 (NCI Thesaurus 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-2)
C0750729 (UMLS 2011AA Property-2)
C25484 (NCI Thesaurus Property-3)
C1444662 (UMLS 2011AA Property-3)
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-2)
C0750729 (UMLS 2011AA Property-2)
C25484 (NCI Thesaurus Property-3)
C1444662 (UMLS 2011AA Property-3)
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-2)
C0750729 (UMLS 2011AA Property-2)
C25484 (NCI Thesaurus Property-3)
C1444662 (UMLS 2011AA Property-3)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25484 (NCI Thesaurus ValueDomain-2)
C1444662 (UMLS 2011AA ValueDomain-2)
Item Group
Agent Dosing
Agent
Item
Agent (Erlotinib)
text
C25364 (NCI Thesaurus Property)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)
Concomitant Medication Start Date
Item
Agent Start Date (this cycle mm/dd/yyyy)
date
C25164 (NCI Thesaurus ValueDomain)
C2826734 (UMLS CUI-1)
C25431 (NCI Thesaurus ValueDomain-2)
C1708 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus 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.)
float
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
C25256 (NCI Thesaurus Property-2)
C1265611 (UMLS 2011AA Property-2)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS 2011AA ValueDomain)
C1708 (NCI Thesaurus ValueDomain-2)
C0450442 (UMLS 2011AA ValueDomain-2)
Agent Total Dose
Item
Total Dose of Agents/Drugs for this Cycle (If agent was not given this cycle, enter 0 for dose level.)
float
C25304 (NCI Thesaurus ValueDomain)
C2986497 (UMLS CUI-1)
C25379 (NCI Thesaurus Property)
C25488 (NCI Thesaurus ValueDomain-2)
C1708 (NCI Thesaurus ObjectClass)
Item
Were there any dose modifications or additions/omissions to protocol treatment? (Days 1-21 mg)
text
C25180 (NCI Thesaurus ValueDomain)
C1707811 (UMLS CUI-1)
C25256 (NCI Thesaurus ObjectClass)
C25572 (NCI Thesaurus Property)
C25572 (NCI Thesaurus ValueDomain-2)
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-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)
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-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)
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