ID

1287

Beschreibung

GOG Common Toxicity Reporting Form Comparison of Four Combination Chemotherapy Regimens Using Cisplatin in Treating Patients With Stage IVB, Recurrent, or Persistent Cancer of the Cervix Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=ABA3B3D1-8528-2473-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=ABA3B3D1-8528-2473-E034-0003BA12F5E7

Stichworte

Versionen (2)
  1. 27.08.12 27.08.12 -
  2. 09.01.15 09.01.15 - Martin Dugas
Hochgeladen am

27. August 2012

DOI

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Cervical Cancer NCT00064077 Toxicity - GOG Common Toxicity Reporting Form - 2059265v3.0

Englisch

FORM T

1 Formulare  
  1. StudyEvent: GOG Common Toxicity Reporting Form
    1. FORM T
Header Module
Beschreibung

Header Module

Date form originally completed (m d y)
Beschreibung

FormCompletionDate,Original

Datentyp

date

Date form amended (m d y)
Beschreibung

FormCompletionDate,Amended

Datentyp

date

Person amending form, last name
Beschreibung

ResponsiblePersonReportingChangeLastName

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Patient Name, Last
Beschreibung

PatientName,Last

Datentyp

text

Patient Name, First
Beschreibung

PatientName,First

Datentyp

text

Patient Study ID
Beschreibung

PatientStudyID

Datentyp

text

Person Completing Form, Last Name
Beschreibung

PersonCompletingForm,LastName

Datentyp

text

Adverse Events - Section 1
Beschreibung

Adverse Events - Section 1

Current course number (The toxicities listed below occurred following this course of therapy)
Beschreibung

CurrentCourseNumber

Datentyp

double

Has the patient received any transfusions during this course of therapy?
Beschreibung

TransfusionInd

Datentyp

text

Was patient hospitalized as a result of reported adverse events?
Beschreibung

InpatientHospitalizationInd

Datentyp

text

Were cytokines administered this course?
Beschreibung

AgentCytokineAdministeredInd-3

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C20464
UMLS 2011AA Property
C0079189
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Yes (Cytokines), specify
Beschreibung

AgentCytokineAdministeredSpecify

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus Property
C20464
UMLS 2011AA Property
C0079189
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Has an Adverse Drug Reaction Report been filed?
Beschreibung

ADRFiledInd

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C25410
UMLS 2011AA ObjectClass
C1521800
NCI Thesaurus Property
C25175
UMLS 2011AA Property
C1522646
Adverse Events - Section 2
Beschreibung

Adverse Events - Section 2

Peripheral WBC count, Done
Beschreibung

LaboratoryProcedureLeukocyteResultInd-3

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C12529
UMLS 2011AA Property
C0023516
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
Peripheral WBC count (1000/mm3 Nadir)
Beschreibung

Lab,Hematology,WBC

Datentyp

double

Peripheral WBC count, Date (m d y)
Beschreibung

Lab,Hematology,WBCDate

Datentyp

date

Peripheral Granulocytes count, Done
Beschreibung

LaboratoryProcedureAbsoluteNeutrophilCountGranulocyteOutcomeInd-3

Datentyp

text

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C12530
UMLS 2011AA Property
C0018183
NCI Thesaurus Property
C63321
UMLS 2011AA Property
C0948762
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Peripheral Granulocytes count (ANC, 1000/mm3 Nadir)
Beschreibung

Lab,Hematology,GranulocyteCount

Datentyp

double

Peripheral Granulocytes count, Date
Beschreibung

Lab,Hematology,GranDate

Datentyp

date

Peripheral Platelet count, Done
Beschreibung

LaboratoryProcedurePlateletResultInd-3

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C12520
UMLS 2011AA Property
C0005821
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
Peripheral Platelet count (mm3 Nadir)
Beschreibung

Lab,Hematology,Platelets

Datentyp

double

Peripheral Platelet count, Date
Beschreibung

Lab,Hematology,PlateletDate

Datentyp

date

Hemoglobin, Done
Beschreibung

LaboratoryProcedureHemoglobinResultInd-3

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus Property
C16676
UMLS 2011AA Property
C0019046
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
Hemoglobin (G/DL Nadir)
Beschreibung

Lab,Hematology,Hemoglobin

Datentyp

double

Hemoglobin, Date
Beschreibung

Lab,Hematology,HGBDate

Datentyp

date

CTC Adverse Event Grade
Beschreibung

CTCAdverseEventGrade

Datentyp

text

CTC Adverse Event Attribution (* Attribution Codes for Relationship of Event to Treatment: 1 = Unrelated, 2 = Unlikely, 3 = Possibly, 4 = Probably, 5 = Definitely)
Beschreibung

CTCAdverseEventAttributionCode

Datentyp

text

Adverse Events - Section 3
Beschreibung

Adverse Events - Section 3

CTC Adverse Event Term
Beschreibung

CTCAdverseEventTerm

Datentyp

text

CTC Adverse Event Grade
Beschreibung

CTCAdverseEventGrade

Datentyp

text

CTC Adverse Event Attribution (* Attribution Codes for Relationship of Event to Treatment: 1 = Unrelated, 2 = Unlikely, 3 = Possibly, 4 = Probably, 5 = Definitely)
Beschreibung

CTCAdverseEventAttributionCode

Datentyp

text

Comments
Beschreibung

Comments

COMMENTS
Beschreibung

Comments

Datentyp

text

Footer Module
Beschreibung

Footer Module

Participating Group Code
Beschreibung

ParticipatingGroupCode

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
Participating Group Protocol Number
Beschreibung

ParticipatingGroupProtocolNumber

Datentyp

double

Participating Patient Study ID
Beschreibung

PatientParticipatingIdentifierNumber

Datentyp

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25608
UMLS 2011AA Property
C0679823
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Ccrr Module For Gog Common Toxicity Reporting Form
Beschreibung

Ccrr Module For Gog Common Toxicity Reporting Form

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Ähnliche Modelle

FORM T

1 Formulare
  1. StudyEvent: GOG Common Toxicity Reporting Form
    1. FORM T
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Header Module
FormCompletionDate,Original
Item
Date form originally completed (m d y)
date
FormCompletionDate,Amended
Item
Date form amended (m d y)
date
ResponsiblePersonReportingChangeLastName
Item
Person amending form, last name
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
PatientName,Last
Item
Patient Name, Last
text
PatientName,First
Item
Patient Name, First
text
PatientStudyID
Item
Patient Study ID
text
PersonCompletingForm,LastName
Item
Person Completing Form, Last Name
text
Item Group
Adverse Events - Section 1
CurrentCourseNumber
Item
Current course number (The toxicities listed below occurred following this course of therapy)
double
Item
Has the patient received any transfusions during this course of therapy?
text
CL.1
Code List
Has the patient received any transfusions during this course of therapy?
CL Item
No Transfusion (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Transfusion With Red Blood Cells (Yes, pRBC)
CL Item
Transfusion With Platelets (Yes, platelets)
Item
Was patient hospitalized as a result of reported adverse events?
text
CL.2
Code List
Was patient hospitalized as a result of reported adverse events?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Were cytokines administered this course?
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C20464 (NCI Thesaurus Property)
C0079189 (UMLS 2011AA Property)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
CL.3
Code List
Were cytokines administered this course?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes, specify)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
AgentCytokineAdministeredSpecify
Item
Yes (Cytokines), specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C20464 (NCI Thesaurus Property)
C0079189 (UMLS 2011AA Property)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Item
Has an Adverse Drug Reaction Report been filed?
text
C25410 (NCI Thesaurus ObjectClass)
C1521800 (UMLS 2011AA ObjectClass)
C25175 (NCI Thesaurus Property)
C1522646 (UMLS 2011AA Property)
CL.4
Code List
Has an Adverse Drug Reaction Report been filed?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Adverse Events - Section 2
Item
Peripheral WBC count, Done
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12529 (NCI Thesaurus Property)
C0023516 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
CL.5
Code List
Peripheral WBC count, Done
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Lab,Hematology,WBC
Item
Peripheral WBC count (1000/mm3 Nadir)
double
Lab,Hematology,WBCDate
Item
Peripheral WBC count, Date (m d y)
date
Item
Peripheral Granulocytes count, Done
text
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12530 (NCI Thesaurus Property)
C0018183 (UMLS 2011AA Property)
C63321 (NCI Thesaurus Property)
C0948762 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
CL.6
Code List
Peripheral Granulocytes count, Done
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Lab,Hematology,GranulocyteCount
Item
Peripheral Granulocytes count (ANC, 1000/mm3 Nadir)
double
Lab,Hematology,GranDate
Item
Peripheral Granulocytes count, Date
date
Item
Peripheral Platelet count, Done
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12520 (NCI Thesaurus Property)
C0005821 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
CL.7
Code List
Peripheral Platelet count, Done
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Lab,Hematology,Platelets
Item
Peripheral Platelet count (mm3 Nadir)
double
Lab,Hematology,PlateletDate
Item
Peripheral Platelet count, Date
date
Item
Hemoglobin, Done
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C16676 (NCI Thesaurus Property)
C0019046 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
CL.8
Code List
Hemoglobin, Done
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
Lab,Hematology,Hemoglobin
Item
Hemoglobin (G/DL Nadir)
double
Lab,Hematology,HGBDate
Item
Hemoglobin, Date
date
CTCAdverseEventGrade
Item
CTC Adverse Event Grade
text
Item
CTC Adverse Event Attribution (* Attribution Codes for Relationship of Event to Treatment: 1 = Unrelated, 2 = Unlikely, 3 = Possibly, 4 = Probably, 5 = Definitely)
text
CL.10
Code List
CTC Adverse Event Attribution (* Attribution Codes for Relationship of Event to Treatment: 1 = Unrelated, 2 = Unlikely, 3 = Possibly, 4 = Probably, 5 = Definitely)
CL Item
Unrelated (Unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
CL Item
Unlikely (Unlikely)
CL Item
Possibly (Possibly)
CL Item
Probably (Probably)
CL Item
Definitely (Definitely)
Item Group
Adverse Events - Section 3
CTCAdverseEventTerm
Item
CTC Adverse Event Term
text
CTCAdverseEventGrade
Item
CTC Adverse Event Grade
text
Item
CTC Adverse Event Attribution (* Attribution Codes for Relationship of Event to Treatment: 1 = Unrelated, 2 = Unlikely, 3 = Possibly, 4 = Probably, 5 = Definitely)
text
CL.10
Code List
CTC Adverse Event Attribution (* Attribution Codes for Relationship of Event to Treatment: 1 = Unrelated, 2 = Unlikely, 3 = Possibly, 4 = Probably, 5 = Definitely)
CL Item
Unrelated (Unrelated)
C25328 (NCI Thesaurus)
C0445356 (UMLS 2011AA)
CL Item
Unlikely (Unlikely)
CL Item
Possibly (Possibly)
CL Item
Probably (Probably)
CL Item
Definitely (Definitely)
Item Group
Comments
Comments
Item
COMMENTS
text
Item Group
Footer Module
ParticipatingGroupCode
Item
Participating Group Code
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
ParticipatingGroupProtocolNumber
Item
Participating Group Protocol Number
double
PatientParticipatingIdentifierNumber
Item
Participating Patient Study ID
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
Item Group
Ccrr Module For Gog Common Toxicity Reporting Form
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