ID

9391

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

9 de enero de 2015

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

Alemán 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

Patient Initials

Tipo de datos

text

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

float

Institution
Descripción

InstitutionName

Tipo de datos

text

Investigator
Descripción

RegisteredInvestigator

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-2
C25716
UMLS 2011AA ObjectClass-2
C0545082
Radiology
Descripción

Radiology

Alias
UMLS CUI-1
C1299496
Chest X-ray
Descripción

Chest X-ray

Tipo de datos

integer

Alias
UMLS CUI-1
C0039985
ultrasound/CT scan of abdomen/MRI
Descripción

CT/MRI/US upperabdomen

Tipo de datos

integer

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

Assessment type

Tipo de datos

integer

Alias
UMLS CUI-1
C2598109
Bone scan
Descripción

Bone scan

Tipo de datos

integer

Alias
UMLS CUI-1
C0203668
CT of brain
Descripción

CT brain

Tipo de datos

integer

Alias
NCI Thesaurus ValueDomain
C25284
NCI Thesaurus ObjectClass
C17204
NCI Thesaurus ObjectClass-2
C12419
NCI Thesaurus Property
C20200
UMLS CUI-1
C0412585
other: (specify)
Descripción

Other radiologic procedure

Tipo de datos

integer

Assessment Type, Specify
Descripción

Assessment Type, Specify

Tipo de datos

text

Alias
UMLS CUI-1
C2598109
Date
Descripción

Assessment date

Tipo de datos

date

Alias
UMLS CUI-1
C2985720
3. Disease Status
Descripción

3. Disease Status

Date of documented relapse or progression
Descripción

ProgressionDate

Tipo de datos

date

5. TREATMENT PLAN (please describe)
Descripción

TreatmentAssignmentCode

Tipo de datos

text

Ncic Ctg Use Only
Descripción

Ncic Ctg Use Only

Logged
Descripción

LoggedEntryInitials

Tipo de datos

text

Header
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

4. Recurrence Table
Descripción

4. Recurrence Table

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

LungSiteInd

Tipo de datos

boolean

Liver
Descripción

LiverSiteInd

Tipo de datos

boolean

Pleura (to be discussed)
Descripción

PleuraSiteInd

Tipo de datos

boolean

CNS (excluding brain)
Descripción

CNSSiteInd

Tipo de datos

boolean

Brain
Descripción

BrainSiteInd

Tipo de datos

boolean

Bone
Descripción

BoneSiteInd

Tipo de datos

boolean

Opposite Lung
Descripción

OppositeLungInd

Tipo de datos

boolean

Regional Lymph nodes (** Mediastinal lymph nodes)
Descripción

RegionalLymphNode(s)Ind

Tipo de datos

boolean

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

DistantLymphNode(s)Ind

Tipo de datos

boolean

Distant Skin or Subcutaneous tissue
Descripción

DistantSkin/SubcutaneousTissueInd

Tipo de datos

boolean

Distant Lung Site Ind
Descripción

DistantLungSiteInd

Tipo de datos

boolean

Ascites
Descripción

AscitesInd

Tipo de datos

boolean

Pleural Effusion
Descripción

PleuralEffusionInd

Tipo de datos

boolean

Local Lung Site Ind
Descripción

LocalLungSiteIndicator

Tipo de datos

boolean

Other
Descripción

OtherSiteInd

Tipo de datos

boolean

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
5. Treatment Plan
Descripción

5. Treatment Plan

6. Comments
Descripción

6. Comments

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

Attached copies

Tipo de datos

integer

8. Investigator Signature
Descripción

8. Investigator Signature

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
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

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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
Patient Initials
Item
Pt. Initials
text
C25191 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
C2986440 (UMLS CUI-1)
PatientStudyID,ParticipatingGroup
Item
Intergroup Patient Serial #
text
NCIInstitutionNumber
Item
Site #
text
PatientSocialSecurityNumber
Item
Patient's Social Security # (USA only)
float
InstitutionName
Item
Institution
text
RegisteredInvestigator
Item
Investigator
text
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-2)
C0545082 (UMLS 2011AA ObjectClass-2)
Item Group
Radiology
C1299496 (UMLS CUI-1)
Item
Chest X-ray
integer
C0039985 (UMLS CUI-1)
CL.1
Code List
Chest X-ray
CL Item
Not Done (0)
CL Item
Negative (1)
CL Item
Abnormal Not Malignant (2)
CL Item
Positive (3)
Item
ultrasound/CT scan of abdomen/MRI
integer
CL.2
Code List
ultrasound/CT scan of abdomen/MRI
CL Item
Not Done (0)
CL Item
Normal (1)
CL Item
Abnormal Not Malignant (2)
CL Item
Abnormal Malignant (3)
Item
ultrasound/CT scan of abdomen/MRI (circle one)
integer
C2598109 (UMLS CUI-1)
CL.3
Code List
ultrasound/CT scan of abdomen/MRI (circle one)
CL Item
Ultrasound (1)
CL Item
Ct Scan (2)
CL Item
MRI (3)
Item
Bone scan
integer
C0203668 (UMLS CUI-1)
CL.4
Code List
Bone scan
CL Item
Not Done (0)
CL Item
Normal (1)
CL Item
Abnormal Not Malignant (2)
CL Item
Abnormal Malignant (3)
Item
CT of brain
integer
C25284 (NCI Thesaurus ValueDomain)
C17204 (NCI Thesaurus ObjectClass)
C12419 (NCI Thesaurus ObjectClass-2)
C20200 (NCI Thesaurus Property)
C0412585 (UMLS CUI-1)
CL.5
Code List
CT of brain
CL Item
Head CT Was Not Done (0)
CL Item
Head CT Was Done, And Results Were Negative (1)
CL Item
Abnormal Not Malignant (2)
CL Item
Head Ct Was Done, And Results Were Positive (3)
Item
other: (specify)
integer
CL.6
Code List
other: (specify)
CL Item
Not Done (0)
CL Item
Normal (1)
CL Item
Abnormal Not Malignant (2)
CL Item
Abnormal Malignant (3)
Assessment Type
Item
Assessment Type, Specify
text
C2598109 (UMLS CUI-1)
Assessment date
Item
Date
date
C2985720 (UMLS CUI-1)
Item Group
3. Disease Status
ProgressionDate
Item
Date of documented relapse or progression
date
TreatmentAssignmentCode
Item
5. TREATMENT PLAN (please describe)
text
Item Group
Ncic Ctg Use Only
LoggedEntryInitials
Item
Logged
text
LoggedEntryDate
Item
Header
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
4. Recurrence Table
LungSiteInd
Item
Lung (* Local recurrence in the area of tumour bed or Hilum.)
boolean
LiverSiteInd
Item
Liver
boolean
PleuraSiteInd
Item
Pleura (to be discussed)
boolean
CNSSiteInd
Item
CNS (excluding brain)
boolean
BrainSiteInd
Item
Brain
boolean
BoneSiteInd
Item
Bone
boolean
OppositeLungInd
Item
Opposite Lung
boolean
RegionalLymphNode(s)Ind
Item
Regional Lymph nodes (** Mediastinal lymph nodes)
boolean
DistantLymphNode(s)Ind
Item
Distant Lymph Nodes (*** Spread of disease beyond limits specified as same lung or regional lymph)
boolean
DistantSkin/SubcutaneousTissueInd
Item
Distant Skin or Subcutaneous tissue
boolean
DistantLungSiteInd
Item
Distant Lung Site Ind
boolean
AscitesInd
Item
Ascites
boolean
PleuralEffusionInd
Item
Pleural Effusion
boolean
LocalLungSiteIndicator
Item
Local Lung Site Ind
boolean
OtherSiteInd
Item
Other
boolean
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
5. Treatment Plan
Item Group
6. Comments
Item
7. HAVE YOU ATTACHED COPIES OF (please _)
integer
CL.18
Code List
7. HAVE YOU ATTACHED COPIES OF (please _)
CL Item
 (1)
CL Item
 (2)
CL Item
 (3)
CL Item
 (4)
CL Item
 (5)
CL Item
 (6)
Item Group
8. Investigator Signature
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)
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
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