ID

2161

Description

Off Treatment Form Gefitinib in Treating Patients With Non-Small Cell Lung Cancer That Has Been Surgically Removed Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A069F1F1-C7BA-50DA-E034-080020C9C0E0

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A069F1F1-C7BA-50DA-E034-080020C9C0E0

Keywords

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

September 19, 2012

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Lung Cancer NCT00049543 Off Treatment - Off Treatment Form - 2034390v3.0

English

No Instruction available.

1 forms  
  1. StudyEvent: Off Treatment Form
    1. No Instruction available.
1. Patient Information
Description

1. Patient Information

Pt. Serial #
Description

PatientStudyID,CoordinatingGroup

Data type

text

Hospital #
Description

PatientMedicalRecordNumber

Data type

text

Pt. Initials
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
Intergroup Patient Serial #
Description

PatientStudyID,ParticipatingGroup

Data type

text

Site #
Description

NCIInstitutionNumber

Data type

text

Patient's Social Security # (USA only)
Description

PatientSocialSecurityNumber

Data type

double

Institution
Description

InstitutionName

Data type

text

Investigator
Description

RegisteredInvestigator

Data type

text

2. Off Protocol Therapy
Description

2. Off Protocol Therapy

Date final dose of Iressa/placebo given
Description

AgentEndDate

Data type

date

Please indicate the reason study treatment stopped:
Description

OffTreatmentReason

Data type

text

other
Description

OffTreatmentReason,Other

Data type

text

Toxicity(s)
Description

CTCAdverseEventTerm

Data type

text

NCIC CTG Code
Description

CTCAdverseEventCategory

Data type

text

Grade* (* Grade according to NCIC CTG Expanded Common Toxicity Criteria)
Description

CTCAdverseEventGrade

Data type

text

Relation to Protocol Therapy (** 1=unrelated 2=unlikely 3=possible 4=probably 5=definite)
Description

CTCAdverseEventAttributionCode

Data type

text

Ncic Ctg Use Only2
Description

Ncic Ctg Use Only2

Date protocol therapy stopped:
Description

TreatmentEndDate

Data type

date

Off protocol therapy code
Description

Offprotocoltherapycode

Data type

text

Protocol Violation (PV)
Description

ProtocolViolation(PV)

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Coord
Description

Coord

Data type

text

Phy
Description

PhysicianReviewInitials

Data type

text

Ncic Ctg Use Only
Description

Ncic Ctg Use Only

Logged
Description

LoggedEntryInitials

Data type

text

Unnamed1
Description

LoggedEntryDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Study Coord
Description

CoordinatorReviewInitials

Data type

text

Unnamed2
Description

CoordinatorReviewDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Phy
Description

PhysicianReviewInitials

Data type

text

Data Ent'd
Description

DataEntryInitials

Data type

text

Verified
Description

DataVerificationInitials

Data type

text

Unnamed1
Description

Unnamed1

Pt. Serial #
Description

PatientStudyID,CoordinatingGroup

Data type

text

Pt. Initials
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
3. Unblinding
Description

3. Unblinding

Was study treatment unblinded?
Description

Wasstudytreatmentunblinded?

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Date unblinded (If yes,)
Description

TreatmentUnblindedDate

Data type

text

4. Comments
Description

4. Comments

4. COMMENTS
Description

Comments

Data type

text

5. Investigator Signature
Description

5. Investigator Signature

Signature of Responsible Investigator
Description

InvestigatorSignature

Data type

text

Alias
NCI Thesaurus Property
C25678
UMLS 2011AA Property
C1519316
NCI Thesaurus ObjectClass
C17089
UMLS 2011AA ObjectClass
C0035173
Name of Clinical Research Associate
Description

PersonCompletingForm,LastName

Data type

text

Date
Description

FormCompletionDate,Original

Data type

date

Ccrr Module For Off Treatment Form
Description

Ccrr Module For Off Treatment Form

Person Completing Form, First Name
Description

PersonCompletingForm,FirstName

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
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Similar models

No Instruction available.

1 forms
  1. StudyEvent: Off Treatment Form
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
1. Patient Information
PatientStudyID,CoordinatingGroup
Item
Pt. Serial #
text
PatientMedicalRecordNumber
Item
Hospital #
text
PatientInitialsName
Item
Pt. Initials
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)
PatientStudyID,ParticipatingGroup
Item
Intergroup Patient Serial #
text
NCIInstitutionNumber
Item
Site #
text
PatientSocialSecurityNumber
Item
Patient's Social Security # (USA only)
double
InstitutionName
Item
Institution
text
RegisteredInvestigator
Item
Investigator
text
Item Group
2. Off Protocol Therapy
AgentEndDate
Item
Date final dose of Iressa/placebo given
date
Item
Please indicate the reason study treatment stopped:
text
CL.1
Code List
Please indicate the reason study treatment stopped:
CL Item
Patient Withdrawl Or Refusal Prior To Beginning Protocol Therapy (Patient withdrawal or refusal prior to beginning protocol therapy)
CL Item
Disease Progression, Relapse During Active Treatment ((PD) progressive disease)
CL Item
Patient Off-treatment For Other Complicating Disease ((II) intercurrent illness)
CL Item
Treatment Completed Per Protocol Criteria ((TC) treatment completed)
CL Item
Toxicity/side Effects/complications ((PT) toxicity to protocol therapy)
CL Item
Patient Withdrawl Or Refusal After Beginning Protocol Therapy ((RT) patient refusal)
CL Item
Death On Study ((D) death)
CL Item
Other, Specify ((OT/PV) other: specify)
CL Item
(UU) unknown ((UU) unknown)
OffTreatmentReason,Other
Item
other
text
CTCAdverseEventTerm
Item
Toxicity(s)
text
CTCAdverseEventCategory
Item
NCIC CTG Code
text
CTCAdverseEventGrade
Item
Grade* (* Grade according to NCIC CTG Expanded Common Toxicity Criteria)
text
Item
Relation to Protocol Therapy (** 1=unrelated 2=unlikely 3=possible 4=probably 5=definite)
text
CL.2
Code List
Relation to Protocol Therapy (** 1=unrelated 2=unlikely 3=possible 4=probably 5=definite)
CL Item
Unrelated (1=unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
CL Item
Unlikely (2=unlikely)
CL Item
Possibly (3=possible)
CL Item
Probably (4=probable)
CL Item
Definitely (5=definite)
Item Group
Ncic Ctg Use Only2
TreatmentEndDate
Item
Date protocol therapy stopped:
date
Offprotocoltherapycode
Item
Off protocol therapy code
text
Item
Protocol Violation (PV)
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.3
Code List
Protocol Violation (PV)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Coord
Item
Coord
text
PhysicianReviewInitials
Item
Phy
text
Item Group
Ncic Ctg Use Only
LoggedEntryInitials
Item
Logged
text
LoggedEntryDate
Item
Unnamed1
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
CoordinatorReviewInitials
Item
Study Coord
text
CoordinatorReviewDate
Item
Unnamed2
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
PhysicianReviewInitials
Item
Phy
text
DataEntryInitials
Item
Data Ent'd
text
DataVerificationInitials
Item
Verified
text
Item Group
Unnamed1
PatientStudyID,CoordinatingGroup
Item
Pt. Serial #
text
PatientInitialsName
Item
Pt. Initials
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)
Item Group
3. Unblinding
Item
Was study treatment unblinded?
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.4
Code List
Was study treatment unblinded?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
TreatmentUnblindedDate
Item
Date unblinded (If yes,)
text
Item Group
4. Comments
Comments
Item
4. COMMENTS
text
Item Group
5. Investigator Signature
InvestigatorSignature
Item
Signature of Responsible Investigator
text
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
PersonCompletingForm,LastName
Item
Name of Clinical Research Associate
text
FormCompletionDate,Original
Item
Date
date
Item Group
Ccrr Module For Off Treatment Form
PersonCompletingForm,FirstName
Item
Person Completing Form, First Name
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
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