ID

9391

Beskrivning

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

Länk

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

Nyckelord

Versioner (3)
  1. 2012-09-19 2012-09-19 -
  2. 2014-12-22 2014-12-22 - Martin Dugas
  3. 2015-01-09 2015-01-09 - Martin Dugas
Uppladdad den

9 januari 2015

DOI

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Licens

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

Tysk Engelsk

No Instruction available.

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

1. Patient Information

Pt. Serial #
Beskrivning

PatientStudyID,CoordinatingGroup

Datatyp

text

Hospital #
Beskrivning

PatientMedicalRecordNumber

Datatyp

text

Pt. Initials
Beskrivning

Patient Initials

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25191
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
UMLS CUI-1
C2986440
Intergroup Patient Serial #
Beskrivning

PatientStudyID,ParticipatingGroup

Datatyp

text

Site #
Beskrivning

NCIInstitutionNumber

Datatyp

text

Patient's Social Security # (USA only)
Beskrivning

PatientSocialSecurityNumber

Datatyp

float

Institution
Beskrivning

InstitutionName

Datatyp

text

Investigator
Beskrivning

RegisteredInvestigator

Datatyp

text

Other: specify
Beskrivning

VisitReportMonthSpecify

Datatyp

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
Beskrivning

Radiology

Alias
UMLS CUI-1
C1299496
Chest X-ray
Beskrivning

Chest X-ray

Datatyp

integer

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

CT/MRI/US upperabdomen

Datatyp

integer

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

Assessment type

Datatyp

integer

Alias
UMLS CUI-1
C2598109
Bone scan
Beskrivning

Bone scan

Datatyp

integer

Alias
UMLS CUI-1
C0203668
CT of brain
Beskrivning

CT brain

Datatyp

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)
Beskrivning

Other radiologic procedure

Datatyp

integer

Assessment Type, Specify
Beskrivning

Assessment Type, Specify

Datatyp

text

Alias
UMLS CUI-1
C2598109
Date
Beskrivning

Assessment date

Datatyp

date

Alias
UMLS CUI-1
C2985720
3. Disease Status
Beskrivning

3. Disease Status

Date of documented relapse or progression
Beskrivning

ProgressionDate

Datatyp

date

5. TREATMENT PLAN (please describe)
Beskrivning

TreatmentAssignmentCode

Datatyp

text

Ncic Ctg Use Only
Beskrivning

Ncic Ctg Use Only

Logged
Beskrivning

LoggedEntryInitials

Datatyp

text

Header
Beskrivning

LoggedEntryDate

Datatyp

date

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

CoordinatorReviewInitials

Datatyp

text

Unnamed2
Beskrivning

CoordinatorReviewDate

Datatyp

date

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

PhysicianReviewInitials

Datatyp

text

Data Ent'd
Beskrivning

DataEntryInitials

Datatyp

text

Verified
Beskrivning

DataVerificationInitials

Datatyp

text

4. Recurrence Table
Beskrivning

4. Recurrence Table

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

LungSiteInd

Datatyp

boolean

Liver
Beskrivning

LiverSiteInd

Datatyp

boolean

Pleura (to be discussed)
Beskrivning

PleuraSiteInd

Datatyp

boolean

CNS (excluding brain)
Beskrivning

CNSSiteInd

Datatyp

boolean

Brain
Beskrivning

BrainSiteInd

Datatyp

boolean

Bone
Beskrivning

BoneSiteInd

Datatyp

boolean

Opposite Lung
Beskrivning

OppositeLungInd

Datatyp

boolean

Regional Lymph nodes (** Mediastinal lymph nodes)
Beskrivning

RegionalLymphNode(s)Ind

Datatyp

boolean

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

DistantLymphNode(s)Ind

Datatyp

boolean

Distant Skin or Subcutaneous tissue
Beskrivning

DistantSkin/SubcutaneousTissueInd

Datatyp

boolean

Distant Lung Site Ind
Beskrivning

DistantLungSiteInd

Datatyp

boolean

Ascites
Beskrivning

AscitesInd

Datatyp

boolean

Pleural Effusion
Beskrivning

PleuralEffusionInd

Datatyp

boolean

Local Lung Site Ind
Beskrivning

LocalLungSiteIndicator

Datatyp

boolean

Other
Beskrivning

OtherSiteInd

Datatyp

boolean

Other (please describe)
Beskrivning

OtherSiteName

Datatyp

text

Suspected Date
Beskrivning

ProgressionSuspectedBeginDate

Datatyp

date

Definite Date
Beskrivning

ProgressionDefiniteBeginDate

Datatyp

date

Supporting Evidence (please describe)
Beskrivning

ProgressionCriteria

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C25331
NCI Thesaurus Property
C25466
UMLS 2011AA Property
C0243161
5. Treatment Plan
Beskrivning

5. Treatment Plan

6. Comments
Beskrivning

6. Comments

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

Attached copies

Datatyp

integer

8. Investigator Signature
Beskrivning

8. Investigator Signature

Person Completing Form, First Name
Beskrivning

PersonCompletingForm,FirstName

Datatyp

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Signature of Responsible Investigator
Beskrivning

InvestigatorSignature

Datatyp

text

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

PersonCompletingForm,LastName

Datatyp

text

Date
Beskrivning

FormCompletionDate,Original

Datatyp

date

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Similar models

No Instruction available.

1 Formulär
  1. StudyEvent: Form 9 - Relapse/ Progressive Disease Report
    1. No Instruction available.
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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