ID

6232

Description

GOG Cycle Dose Drug 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=ABA3A924-559C-246C-E034-0003BA12F5E7

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=ABA3A924-559C-246C-E034-0003BA12F5E7

Keywords

Versions (2)
  1. 12/18/14 12/18/14 - Martin Dugas
  2. 8/22/15 8/22/15 - Martin Dugas
Uploaded on

December 18, 2014

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Cervical Cancer NCT00064077 Treatment - GOG Cycle Dose Drug Form - 2059160v3.0

English

FORM D2R

1 forms  
  1. StudyEvent: GOG Cycle Dose Drug Form
    1. FORM D2R
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

ResponsiblePersonReportingChangeLastName

Data type

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
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

Treatment Cycle And Modification
Description

Treatment Cycle And Modification

Cycle start date (Day 1 m d y)
Description

CourseBeginDate

Data type

date

Current cycle number
Description

CourseIdentification

Data type

text

Cycle delayed
Description

CycleDelayedInd

Data type

text

Number of days treatment course was delayed
Description

CourseDelayDayCount

Data type

double

Agent name (Drug)
Description

AgentName

Data type

text

Dose level
Description

AgentDoseLevelValue

Data type

text

Alias
NCI Thesaurus Property
C25488
UMLS 2011AA Property
C0178602
NCI Thesaurus ObjectClass
C1708
UMLS 2011AA ObjectClass
C0450442
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus Property
C25554
UMLS 2011AA Property
C0441889
Dose modification (change) (* P = Planned, U = Unplanned)
Description

DoseModification(Change)

Data type

text

Total dose of agents/drugs for this cycle
Description

AgentTotalDose(percourse)

Data type

double

Units
Description

AgentDoseUnits

Data type

text

Patient weight (kg)
Description

PatientWeight

Data type

double

Body surface area (m2)
Description

BodySurfaceArea

Data type

double

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25157
UMLS 2011AA Property
C0005902
Performance status
Description

PerformanceStatus

Data type

text

Assessment date (m d y Pretreatment hematology and chemistry values Specify individual dates when assessment dates differ)
Description

AssessmentDate

Data type

date

Hemoglobin
Description

Lab,Hematology,Hemoglobin

Data type

double

Peripheral hematocrit count (1000/L)
Description

Lab,Hematology,HematocritCount

Data type

double

Peripheral WBC count (mm3)
Description

Lab,Hematology,WBC

Data type

double

Peripheral granulocytes count (mm3)
Description

Lab,Hematology,GranulocyteCount

Data type

double

Peripheral platelet count (mm3)
Description

Lab,Hematology,Platelets

Data type

double

BUN (mg/dl)
Description

Lab,Renal,BUN

Data type

double

Creatinine (mg/dl)
Description

Lab,Renal,Creatinine

Data type

double

Creatinine Clearance (ml/min)
Description

Lab,Renal,CreatinineClearance

Data type

double

SGOT (IU/ml)
Description

Lab,Hepatic,SGOT

Data type

double

Bilirubin (mg %)
Description

Lab,Hepatic,Bilirubin

Data type

double

Result of CA125 (IU/ml)
Description

TumorMarker,CA125Result

Data type

double

Alias
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
Other (1st Lab Test), specify
Description

LaboratoryProcedureFirstOptionalPerformedSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus Property
C25509
UMLS 2011AA Property
C1279901
NCI Thesaurus Property
C25603
UMLS 2011AA Property
C1518600
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Other (1st Lab Value), specify
Description

LaboratoryProcedureFirstOptionalPerformedValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus Property
C25509
UMLS 2011AA Property
C1279901
NCI Thesaurus Property
C25603
UMLS 2011AA Property
C1518600
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
Other (2nd Lab Test), specify
Description

LaboratoryProcedureSecondOptionalPerformedSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus Property
C25666
UMLS 2011AA Property
C0205436
NCI Thesaurus Property
C25603
UMLS 2011AA Property
C1518600
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Other (2nd Lab Value), specify
Description

LaboratoryProcedureSecondOptionalPerformedValue

Data type

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus Property
C25666
UMLS 2011AA Property
C0205436
NCI Thesaurus Property
C25603
UMLS 2011AA Property
C1518600
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
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

double

Participating Patient Study ID
Description

PatientParticipatingIdentifierNumber

Data type

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 Cycle Dose Drug Form
Description

Ccrr Module For Gog Cycle Dose Drug Form

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Similar models

FORM D2R

1 forms
  1. StudyEvent: GOG Cycle Dose Drug Form
    1. FORM D2R
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
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
Treatment Cycle And Modification
CourseBeginDate
Item
Cycle start date (Day 1 m d y)
date
CourseIdentification
Item
Current cycle number
text
Item
Cycle delayed
text
CL.1
Code List
Cycle delayed
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CourseDelayDayCount
Item
Number of days treatment course was delayed
double
AgentName
Item
Agent name (Drug)
text
AgentDoseLevelValue
Item
Dose level
text
C25488 (NCI Thesaurus Property)
C0178602 (UMLS 2011AA Property)
C1708 (NCI Thesaurus ObjectClass)
C0450442 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25554 (NCI Thesaurus Property)
C0441889 (UMLS 2011AA Property)
Item
Dose modification (change) (* P = Planned, U = Unplanned)
text
CL.2
Code List
Dose modification (change) (* P = Planned, U = Unplanned)
CL Item
(i.e., The Treatment Was Changed According To Protocol Guidelines) (Planned)
CL Item
(i.e., The Treatment Change Was Not Part Of Protocol Guidelines) (Unplanned)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
AgentTotalDose(percourse)
Item
Total dose of agents/drugs for this cycle
double
AgentDoseUnits
Item
Units
text
PatientWeight
Item
Patient weight (kg)
double
BodySurfaceArea
Item
Body surface area (m2)
double
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25157 (NCI Thesaurus Property)
C0005902 (UMLS 2011AA Property)
Item
Performance status
text
CL.3
Code List
Performance status
CL Item
Fully active, able to carry on all pre-disease performance without restriction (Karnofsky 90 - 100) (Fully active, able to carry on all pre-disease performance without restriction (Karnofsky 90 - 100))
CL Item
Restricted in physically strenuous activity but ambulatory (K 70 - 80) (Restricted in physically strenuous activity but ambulatory (K 70 - 80))
CL Item
Completely disabled (K 10 - 20) (Completely disabled (K 10 - 20))
CL Item
Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours (K 30 - 40) (Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours (K 30 - 40))
CL Item
Ambulatory and capable of all selfcare but unable to carry out any work activities (K 50 - 60) (Ambulatory and capable of all selfcare but unable to carry out any work activities (K 50 - 60))
AssessmentDate
Item
Assessment date (m d y Pretreatment hematology and chemistry values Specify individual dates when assessment dates differ)
date
Lab,Hematology,Hemoglobin
Item
Hemoglobin
double
Lab,Hematology,HematocritCount
Item
Peripheral hematocrit count (1000/L)
double
Lab,Hematology,WBC
Item
Peripheral WBC count (mm3)
double
Lab,Hematology,GranulocyteCount
Item
Peripheral granulocytes count (mm3)
double
Lab,Hematology,Platelets
Item
Peripheral platelet count (mm3)
double
Lab,Renal,BUN
Item
BUN (mg/dl)
double
Lab,Renal,Creatinine
Item
Creatinine (mg/dl)
double
Lab,Renal,CreatinineClearance
Item
Creatinine Clearance (ml/min)
double
Lab,Hepatic,SGOT
Item
SGOT (IU/ml)
double
Lab,Hepatic,Bilirubin
Item
Bilirubin (mg %)
double
TumorMarker,CA125Result
Item
Result of CA125 (IU/ml)
double
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
LaboratoryProcedureFirstOptionalPerformedSpecify
Item
Other (1st Lab Test), specify
text
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C25603 (NCI Thesaurus Property)
C1518600 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
LaboratoryProcedureFirstOptionalPerformedValue
Item
Other (1st Lab Value), specify
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property)
C1279901 (UMLS 2011AA Property)
C25603 (NCI Thesaurus Property)
C1518600 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
LaboratoryProcedureSecondOptionalPerformedSpecify
Item
Other (2nd Lab Test), specify
text
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25666 (NCI Thesaurus Property)
C0205436 (UMLS 2011AA Property)
C25603 (NCI Thesaurus Property)
C1518600 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
LaboratoryProcedureSecondOptionalPerformedValue
Item
Other (2nd Lab Value), specify
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25666 (NCI Thesaurus Property)
C0205436 (UMLS 2011AA Property)
C25603 (NCI Thesaurus Property)
C1518600 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
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 Cycle Dose Drug Form
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