ID

8021

Description

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

Keywords

Versions (2)
  1. 8/27/12 8/27/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
Uploaded on

January 9, 2015

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License

Creative Commons BY-NC 3.0 Legacy
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Cervical Cancer NCT00064077 Toxicity - GOG Common Toxicity Reporting Form - 2059265v3.0

English

FORM T

1 forms  
  1. StudyEvent: GOG Common Toxicity Reporting Form
    1. FORM T
Header Module
Description

Header Module

Date form originally completed (m d y)
Description

FormCompletionDate,Original

Data type

date

Date form amended (m d y)
Description

FormCompletionDate,Amended

Data type

date

Person amending form, last name
Description

Person Amending Form

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C0680532
NCI Thesaurus ObjectClass
C25190
UMLS CUI-2
C1547383
NCI Thesaurus Property
C25364
Patient Name, Last
Description

PatientName,Last

Data type

text

Patient Name, First
Description

PatientName,First

Data type

text

Patient Study ID
Description

PatientStudyID

Data type

text

Person Completing Form, Last Name
Description

PersonCompletingForm,LastName

Data type

text

Adverse Events - Section 1
Description

Adverse Events - Section 1

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

Cycle Number Chemotherapeutics

Data type

float

Alias
UMLS CUI-1
C2045829
Has the patient received any transfusions during this course of therapy?
Description

TransfusionInd

Data type

text

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

InpatientHospitalizationInd

Data type

boolean

Were cytokines administered this course?
Description

Cytokine Therapy

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0199974
NCI Thesaurus Property
C20464
NCI Thesaurus ObjectClass
C1708
NCI Thesaurus Property-2
C25382
Yes (Cytokines), specify
Description

AgentCytokineAdministeredSpecify

Data type

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-2
C25382
UMLS 2011AA Property-2
C1521801
Has an Adverse Drug Reaction Report been filed?
Description

ADRFiledInd

Data type

boolean

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

Adverse Events - Section 2

Peripheral WBC count, Done
Description

WBC done

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0023508
NCI Thesaurus Property
C12529
NCI Thesaurus Property-2
C20200
NCI Thesaurus ObjectClass
C25294
Peripheral WBC count (1000/mm3 Nadir)
Description

Lab,Hematology,WBC

Data type

float

Peripheral WBC count, Date (m d y)
Description

Lab,Hematology,WBCDate

Data type

date

Peripheral Granulocytes count, Done
Description

LaboratoryProcedureAbsoluteNeutrophilCountGranulocyteOutcomeInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C12530
UMLS 2011AA Property-2
C0018183
NCI Thesaurus Property-3
C63321
UMLS 2011AA Property-3
C0948762
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Peripheral Granulocytes count (ANC, 1000/mm3 Nadir)
Description

Lab,Hematology,GranulocyteCount

Data type

float

Peripheral Granulocytes count, Date
Description

Lab,Hematology,GranDate

Data type

date

Peripheral Platelet count, Done
Description

Platelets

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0005821
NCI Thesaurus Property
C20200
NCI Thesaurus Property-2
C12520
NCI Thesaurus ObjectClass
C25294
Peripheral Platelet count (mm3 Nadir)
Description

Lab,Hematology,Platelets

Data type

float

Peripheral Platelet count, Date
Description

Lab,Hematology,PlateletDate

Data type

date

Hemoglobin, Done
Description

Hemoglobin

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C0019046
NCI Thesaurus Property
C16676
NCI Thesaurus Property-2
C20200
NCI Thesaurus ObjectClass
C25294
Hemoglobin (G/DL Nadir)
Description

Lab,Hematology,Hemoglobin

Data type

float

Hemoglobin, Date
Description

Lab,Hematology,HGBDate

Data type

date

CTC Adverse Event Grade
Description

CTCAdverseEventGrade

Data type

text

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

CTCAdverseEventAttributionCode

Data type

text

Adverse Events - Section 3
Description

Adverse Events - Section 3

CTC Adverse Event Term
Description

CTCAdverseEventTerm

Data type

text

CTC Adverse Event Grade
Description

CTCAdverseEventGrade

Data type

text

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

CTCAdverseEventAttributionCode

Data type

text

Comments
Description

Comments

COMMENTS
Description

Comments

Data type

text

Footer Module
Description

Footer Module

Participating Group Code
Description

ParticipatingGroupCode

Data type

text

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

ParticipatingGroupProtocolNumber

Data type

float

Participating Patient Study ID
Description

Trial subject ID Participating Group

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Ccrr Module For Gog Common Toxicity Reporting Form
Description

Ccrr Module For Gog Common Toxicity Reporting Form

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Similar models

FORM T

1 forms
  1. StudyEvent: GOG Common Toxicity Reporting Form
    1. FORM T
Name
Type
Description | Question | Decode (Coded Value)
Data type
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
Person Amending Form
Item
Person amending form, last name
text
C25191 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25190 (NCI Thesaurus ObjectClass)
C1547383 (UMLS CUI-2)
C25364 (NCI Thesaurus 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
Cycle Number Chemotherapeutics
Item
Current course number (The toxicities listed below occurred following this course of therapy)
float
C2045829 (UMLS CUI-1)
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)
InpatientHospitalizationInd
Item
Was patient hospitalized as a result of reported adverse events?
boolean
Item
Were cytokines administered this course?
text
C38148 (NCI Thesaurus ValueDomain)
C0199974 (UMLS CUI-1)
C20464 (NCI Thesaurus Property)
C1708 (NCI Thesaurus ObjectClass)
C25382 (NCI Thesaurus Property-2)
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-2)
C1521801 (UMLS 2011AA Property-2)
ADRFiledInd
Item
Has an Adverse Drug Reaction Report been filed?
boolean
C25410 (NCI Thesaurus ObjectClass)
C1521800 (UMLS 2011AA ObjectClass)
C25175 (NCI Thesaurus Property)
C1522646 (UMLS 2011AA Property)
Item Group
Adverse Events - Section 2
WBC done
Item
Peripheral WBC count, Done
boolean
C38148 (NCI Thesaurus ValueDomain)
C0023508 (UMLS CUI-1)
C12529 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
Lab,Hematology,WBC
Item
Peripheral WBC count (1000/mm3 Nadir)
float
Lab,Hematology,WBCDate
Item
Peripheral WBC count, Date (m d y)
date
LaboratoryProcedureAbsoluteNeutrophilCountGranulocyteOutcomeInd-3
Item
Peripheral Granulocytes count, Done
boolean
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12530 (NCI Thesaurus Property-2)
C0018183 (UMLS 2011AA Property-2)
C63321 (NCI Thesaurus Property-3)
C0948762 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
Lab,Hematology,GranulocyteCount
Item
Peripheral Granulocytes count (ANC, 1000/mm3 Nadir)
float
Lab,Hematology,GranDate
Item
Peripheral Granulocytes count, Date
date
Platelets
Item
Peripheral Platelet count, Done
boolean
C38148 (NCI Thesaurus ValueDomain)
C0005821 (UMLS CUI-1)
C20200 (NCI Thesaurus Property)
C12520 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
Lab,Hematology,Platelets
Item
Peripheral Platelet count (mm3 Nadir)
float
Lab,Hematology,PlateletDate
Item
Peripheral Platelet count, Date
date
Hemoglobin
Item
Hemoglobin, Done
boolean
C38148 (NCI Thesaurus ValueDomain)
C0019046 (UMLS CUI-1)
C16676 (NCI Thesaurus Property)
C20200 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus ObjectClass)
Lab,Hematology,Hemoglobin
Item
Hemoglobin (G/DL Nadir)
float
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
float
Trial subject ID Participating Group
Item
Participating Patient Study ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Item Group
Ccrr Module For Gog Common Toxicity Reporting Form
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