ID

9391

Beschreibung

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

Stichworte

Versionen (3)
  1. 19.09.12 19.09.12 -
  2. 22.12.14 22.12.14 - Martin Dugas
  3. 09.01.15 09.01.15 - Martin Dugas
Hochgeladen am

9. Januar 2015

DOI

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

Deutsch Englisch

No Instruction available.

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

1. Patient Information

Pt. Serial #
Beschreibung

PatientStudyID,CoordinatingGroup

Datentyp

text

Hospital #
Beschreibung

PatientMedicalRecordNumber

Datentyp

text

Pt. Initials
Beschreibung

Patient Initials

Datentyp

text

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

PatientStudyID,ParticipatingGroup

Datentyp

text

Site #
Beschreibung

NCIInstitutionNumber

Datentyp

text

Patient's Social Security # (USA only)
Beschreibung

PatientSocialSecurityNumber

Datentyp

float

Institution
Beschreibung

InstitutionName

Datentyp

text

Investigator
Beschreibung

RegisteredInvestigator

Datentyp

text

Other: specify
Beschreibung

VisitReportMonthSpecify

Datentyp

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
Beschreibung

Radiology

Alias
UMLS CUI-1
C1299496
Chest X-ray
Beschreibung

Chest X-ray

Datentyp

integer

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

CT/MRI/US upperabdomen

Datentyp

integer

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

Assessment type

Datentyp

integer

Alias
UMLS CUI-1
C2598109
Bone scan
Beschreibung

Bone scan

Datentyp

integer

Alias
UMLS CUI-1
C0203668
CT of brain
Beschreibung

CT brain

Datentyp

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)
Beschreibung

Other radiologic procedure

Datentyp

integer

Assessment Type, Specify
Beschreibung

Assessment Type, Specify

Datentyp

text

Alias
UMLS CUI-1
C2598109
Date
Beschreibung

Assessment date

Datentyp

date

Alias
UMLS CUI-1
C2985720
3. Disease Status
Beschreibung

3. Disease Status

Date of documented relapse or progression
Beschreibung

ProgressionDate

Datentyp

date

5. TREATMENT PLAN (please describe)
Beschreibung

TreatmentAssignmentCode

Datentyp

text

Ncic Ctg Use Only
Beschreibung

Ncic Ctg Use Only

Logged
Beschreibung

LoggedEntryInitials

Datentyp

text

Header
Beschreibung

LoggedEntryDate

Datentyp

date

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

CoordinatorReviewInitials

Datentyp

text

Unnamed2
Beschreibung

CoordinatorReviewDate

Datentyp

date

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

PhysicianReviewInitials

Datentyp

text

Data Ent'd
Beschreibung

DataEntryInitials

Datentyp

text

Verified
Beschreibung

DataVerificationInitials

Datentyp

text

4. Recurrence Table
Beschreibung

4. Recurrence Table

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

LungSiteInd

Datentyp

boolean

Liver
Beschreibung

LiverSiteInd

Datentyp

boolean

Pleura (to be discussed)
Beschreibung

PleuraSiteInd

Datentyp

boolean

CNS (excluding brain)
Beschreibung

CNSSiteInd

Datentyp

boolean

Brain
Beschreibung

BrainSiteInd

Datentyp

boolean

Bone
Beschreibung

BoneSiteInd

Datentyp

boolean

Opposite Lung
Beschreibung

OppositeLungInd

Datentyp

boolean

Regional Lymph nodes (** Mediastinal lymph nodes)
Beschreibung

RegionalLymphNode(s)Ind

Datentyp

boolean

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

DistantLymphNode(s)Ind

Datentyp

boolean

Distant Skin or Subcutaneous tissue
Beschreibung

DistantSkin/SubcutaneousTissueInd

Datentyp

boolean

Distant Lung Site Ind
Beschreibung

DistantLungSiteInd

Datentyp

boolean

Ascites
Beschreibung

AscitesInd

Datentyp

boolean

Pleural Effusion
Beschreibung

PleuralEffusionInd

Datentyp

boolean

Local Lung Site Ind
Beschreibung

LocalLungSiteIndicator

Datentyp

boolean

Other
Beschreibung

OtherSiteInd

Datentyp

boolean

Other (please describe)
Beschreibung

OtherSiteName

Datentyp

text

Suspected Date
Beschreibung

ProgressionSuspectedBeginDate

Datentyp

date

Definite Date
Beschreibung

ProgressionDefiniteBeginDate

Datentyp

date

Supporting Evidence (please describe)
Beschreibung

ProgressionCriteria

Datentyp

text

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

5. Treatment Plan

6. Comments
Beschreibung

6. Comments

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

Attached copies

Datentyp

integer

8. Investigator Signature
Beschreibung

8. Investigator Signature

Person Completing Form, First Name
Beschreibung

PersonCompletingForm,FirstName

Datentyp

text

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

InvestigatorSignature

Datentyp

text

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

PersonCompletingForm,LastName

Datentyp

text

Date
Beschreibung

FormCompletionDate,Original

Datentyp

date

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Ähnliche Modelle

No Instruction available.

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