ID

2163

Descripción

Form 9 - Relapse/ Progressive Disease Report 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=A06B0201-DAB9-5179-E034-080020C9C0E0

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A06B0201-DAB9-5179-E034-080020C9C0E0

Palabras clave

Versiones (3)
  1. 19/9/12 19/9/12 -
  2. 22/12/14 22/12/14 - Martin Dugas
  3. 9/1/15 9/1/15 - Martin Dugas
Subido en

19 de septiembre de 2012

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0 Legacy
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Lung Cancer NCT00049543 Response - Form 9 - Relapse/ Progressive Disease Report - 2034459v3.0

Inglés

No Instruction available.

1 formularios  
  1. StudyEvent: Form 9 - Relapse/ Progressive Disease Report
    1. No Instruction available.
1. Patient Information
Descripción

1. Patient Information

Pt. Serial #
Descripción

PatientStudyID,CoordinatingGroup

Tipo de datos

text

Hospital #
Descripción

PatientMedicalRecordNumber

Tipo de datos

text

Pt. Initials
Descripción

PatientInitialsName

Tipo de datos

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 #
Descripción

PatientStudyID,ParticipatingGroup

Tipo de datos

text

Site #
Descripción

NCIInstitutionNumber

Tipo de datos

text

Patient's Social Security # (USA only)
Descripción

PatientSocialSecurityNumber

Tipo de datos

double

Institution
Descripción

InstitutionName

Tipo de datos

text

Investigator
Descripción

RegisteredInvestigator

Tipo de datos

text

2. Radiology
Descripción

2. Radiology

Chest x-ray
Descripción

ChestX-RayResult

Tipo de datos

text

ultrasound/CT scan of abdomen/MRI
Descripción

CT/MRI/USupperabdomen

Tipo de datos

text

ultrasound/CT scan of abdomen/MRI (circle one)
Descripción

AssessmentType

Tipo de datos

text

bone scan
Descripción

bonescan

Tipo de datos

text

CT of brain
Descripción

HeadCTResult

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C17204
UMLS 2011AA ObjectClass
C0040405
NCI Thesaurus ObjectClass
C12419
UMLS 2011AA ObjectClass
C0018670
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
other: (specify)
Descripción

other:(specify)

Tipo de datos

text

other: (specify)2
Descripción

AssessmentType,Specify

Tipo de datos

text

Date
Descripción

AssessmentDate

Tipo de datos

date

6. COMMENTS
Descripción

Comments

Tipo de datos

text

3. Disease Status
Descripción

3. Disease Status

Date of documented relapse or progression
Descripción

ProgressionDate

Tipo de datos

date

Ncic Ctg Use Only
Descripción

Ncic Ctg Use Only

Logged
Descripción

LoggedEntryInitials

Tipo de datos

text

Unnamed1
Descripción

LoggedEntryDate

Tipo de datos

date

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

CoordinatorReviewInitials

Tipo de datos

text

Unnamed2
Descripción

CoordinatorReviewDate

Tipo de datos

date

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

PhysicianReviewInitials

Tipo de datos

text

Data Ent'd
Descripción

DataEntryInitials

Tipo de datos

text

Verified
Descripción

DataVerificationInitials

Tipo de datos

text

Unnamed1
Descripción

Unnamed1

Pt. Serial #
Descripción

PatientStudyID,CoordinatingGroup

Tipo de datos

text

Pt. Initials
Descripción

PatientInitialsName

Tipo de datos

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
4. Recurrence Table
Descripción

4. Recurrence Table

Lung (* Local recurrence in the area of tumour bed or Hilum.)
Descripción

LungSiteInd

Tipo de datos

text

Liver
Descripción

LiverSiteInd

Tipo de datos

text

Pleura (to be discussed)
Descripción

PleuraSiteInd

Tipo de datos

text

CNS (excluding brain)
Descripción

CNSSiteInd

Tipo de datos

text

Brain
Descripción

BrainSiteInd

Tipo de datos

text

Bone
Descripción

BoneSiteInd

Tipo de datos

text

Opposite Lung
Descripción

OppositeLungInd

Tipo de datos

text

Regional Lymph nodes (** Mediastinal lymph nodes)
Descripción

RegionalLymphNode(s)Ind

Tipo de datos

text

Distant Lymph Nodes (*** Spread of disease beyond limits specified as same lung or regional lymph)
Descripción

DistantLymphNode(s)Ind

Tipo de datos

text

Distant Skin or Subcutaneous tissue
Descripción

DistantSkin/SubcutaneousTissueInd

Tipo de datos

text

Other
Descripción

OtherSiteInd

Tipo de datos

text

Other (please describe)
Descripción

OtherSiteName

Tipo de datos

text

Suspected Date
Descripción

ProgressionSuspectedBeginDate

Tipo de datos

date

Definite Date
Descripción

ProgressionDefiniteBeginDate

Tipo de datos

date

Supporting Evidence (please describe)
Descripción

ProgressionCriteria

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C25331
NCI Thesaurus Property
C25466
UMLS 2011AA Property
C0243161
Unnamed2
Descripción

Unnamed2

Pt. Serial #
Descripción

PatientStudyID,CoordinatingGroup

Tipo de datos

text

Pt. Initials
Descripción

PatientInitialsName

Tipo de datos

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
5. Treatment Plan
Descripción

5. Treatment Plan

5. TREATMENT PLAN (please describe)
Descripción

TreatmentAssignmentCode

Tipo de datos

text

6. Comments
Descripción

6. Comments

6. COMMENTS
Descripción

Comments

Tipo de datos

text

7. Have You Attached Copies Of
Descripción

7. Have You Attached Copies Of

7. HAVE YOU ATTACHED COPIES OF (please _)
Descripción

HAVEYOUATTACHEDCOPIESOF

Tipo de datos

text

Other: specify
Descripción

VisitReportMonthSpecify

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C29846
UMLS 2011AA Property
C0439231
NCI Thesaurus ObjectClass
C25375
UMLS 2011AA ObjectClass
C0684224
NCI Thesaurus ObjectClass
C25716
UMLS 2011AA ObjectClass
C0545082
8. Investigator Signature
Descripción

8. Investigator Signature

Signature of Responsible Investigator
Descripción

InvestigatorSignature

Tipo de datos

text

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

PersonCompletingForm,LastName

Tipo de datos

text

Date
Descripción

FormCompletionDate,Original

Tipo de datos

date

Ccrr Module For Form 9 - Relapse/ Progressive Disease Report
Descripción

Ccrr Module For Form 9 - Relapse/ Progressive Disease Report

Person Completing Form, First Name
Descripción

PersonCompletingForm,FirstName

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Ascites
Descripción

AscitesInd

Tipo de datos

text

Pleural Effusion
Descripción

PleuralEffusionInd

Tipo de datos

text

Local Lung Site Ind
Descripción

LocalLungSiteIndicator

Tipo de datos

text

Distant Lung Site Ind
Descripción

DistantLungSiteInd

Tipo de datos

text

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Similar models

No Instruction available.

1 formularios
  1. StudyEvent: Form 9 - Relapse/ Progressive Disease Report
    1. No Instruction available.
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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. Radiology
Item
Chest x-ray
text
CL.1
Code List
Chest x-ray
CL Item
Not Done (Not Done)
CL Item
Negative (Normal)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Abnormal Not Malignant (Abnormal Not Malignant)
CL Item
Positive (Abnormal Malignant)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
Item
ultrasound/CT scan of abdomen/MRI
text
CL.2
Code List
ultrasound/CT scan of abdomen/MRI
CL Item
Not Done (Not Done)
CL281691 (NCI Metathesaurus)
CL Item
Normal (Normal)
CL Item
Abnormal Not Malignant (Abnormal Not Malignant)
CL Item
Abnormal Malignant (Abnormal Malignant)
Item
ultrasound/CT scan of abdomen/MRI (circle one)
text
CL.3
Code List
ultrasound/CT scan of abdomen/MRI (circle one)
CL Item
Ultrasound (Ultrasound)
C64384 (NCI Thesaurus)
C1456803 (UMLS 2011AA)
CL Item
Ct Scan (CT scan of abdomen)
CL Item
Mri (MRI)
Item
bone scan
text
CL.4
Code List
bone scan
CL Item
Not Done (Not Done)
CL281691 (NCI Metathesaurus)
CL Item
Normal (Normal)
CL Item
Abnormal Not Malignant (Abnormal Not Malignant)
CL Item
Abnormal Malignant (Abnormal Malignant)
Item
CT of brain
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C17204 (NCI Thesaurus ObjectClass)
C0040405 (UMLS 2011AA ObjectClass)
C12419 (NCI Thesaurus ObjectClass)
C0018670 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
CL.5
Code List
CT of brain
CL Item
Head Ct Was Not Done (Not Done)
CL Item
Head Ct Was Done, And Results Were Negative (Normal)
CL Item
Abnormal Not Malignant (Abnormal Not Malignant)
CL Item
Head Ct Was Done, And Results Were Positive (Abnormal Malignant)
Item
other: (specify)
text
CL.6
Code List
other: (specify)
CL Item
Not Done (Not Done)
CL281691 (NCI Metathesaurus)
CL Item
Normal (Normal)
CL Item
Abnormal Not Malignant (Abnormal Not Malignant)
CL Item
Abnormal Malignant (Abnormal Malignant)
AssessmentType,Specify
Item
other: (specify)2
text
AssessmentDate
Item
Date
date
Comments
Item
6. COMMENTS
text
Item Group
3. Disease Status
ProgressionDate
Item
Date of documented relapse or progression
date
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
4. Recurrence Table
Item
Lung (* Local recurrence in the area of tumour bed or Hilum.)
text
CL.7
Code List
Lung (* Local recurrence in the area of tumour bed or Hilum.)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Liver
text
CL.8
Code List
Liver
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Pleura (to be discussed)
text
CL.9
Code List
Pleura (to be discussed)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
CNS (excluding brain)
text
CL.10
Code List
CNS (excluding brain)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Brain
text
CL.11
Code List
Brain
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Bone
text
CL.12
Code List
Bone
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Opposite Lung
text
CL.13
Code List
Opposite Lung
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Regional Lymph nodes (** Mediastinal lymph nodes)
text
CL.14
Code List
Regional Lymph nodes (** Mediastinal lymph nodes)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Distant Lymph Nodes (*** Spread of disease beyond limits specified as same lung or regional lymph)
text
CL.15
Code List
Distant Lymph Nodes (*** Spread of disease beyond limits specified as same lung or regional lymph)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Distant Skin or Subcutaneous tissue
text
CL.16
Code List
Distant Skin or Subcutaneous tissue
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Other
text
CL.17
Code List
Other
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
OtherSiteName
Item
Other (please describe)
text
ProgressionSuspectedBeginDate
Item
Suspected Date
date
ProgressionDefiniteBeginDate
Item
Definite Date
date
ProgressionCriteria
Item
Supporting Evidence (please describe)
text
C25331 (NCI Thesaurus ObjectClass)
C25466 (NCI Thesaurus Property)
C0243161 (UMLS 2011AA Property)
Item Group
Unnamed2
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
5. Treatment Plan
TreatmentAssignmentCode
Item
5. TREATMENT PLAN (please describe)
text
Item Group
6. Comments
Comments
Item
6. COMMENTS
text
Item Group
7. Have You Attached Copies Of
Item
7. HAVE YOU ATTACHED COPIES OF (please _)
text
CL.18
Code List
7. HAVE YOU ATTACHED COPIES OF (please _)
CL Item
chest x-ray (chest x-ray)
CL Item
CT of abdomen/pelvis (CT of abdomen/pelvis)
CL Item
pathology/cytology report(s) (pathology/cytology report(s))
CL Item
other radiology (other radiology)
CL Item
MRI (MRI)
CL Item
Other: specify (Other: specify)
VisitReportMonthSpecify
Item
Other: specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C29846 (NCI Thesaurus Property)
C0439231 (UMLS 2011AA Property)
C25375 (NCI Thesaurus ObjectClass)
C0684224 (UMLS 2011AA ObjectClass)
C25716 (NCI Thesaurus ObjectClass)
C0545082 (UMLS 2011AA ObjectClass)
Item Group
8. 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 Form 9 - Relapse/ Progressive Disease Report
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)
Item
Ascites
text
CL.20
Code List
Ascites
CL Item
Yes (YES)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (NO)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Item
Pleural Effusion
text
CL.21
Code List
Pleural Effusion
CL Item
No (NO)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (YES)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Local Lung Site Ind
text
CL.22
Code List
Local Lung Site Ind
CL Item
NO (NO)
CL Item
YES (YES)
Item
Distant Lung Site Ind
text
CL.19
Code List
Distant Lung Site Ind
CL Item
No (NO)
CL Item
Yes (YES)
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