ID

6232

Beschrijving

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

Trefwoorden

  1. 18-12-14 18-12-14 - Martin Dugas
  2. 22-08-15 22-08-15 - Martin Dugas
Geüploaded op

18 december 2014

DOI

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Licentie

Creative Commons BY-NC 3.0 Legacy

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Cervical Cancer NCT00064077 Treatment - GOG Cycle Dose Drug Form - 2059160v3.0

  1. StudyEvent: GOG Cycle Dose Drug Form
    1. FORM D2R
Header Module
Beschrijving

Header Module

Date form originally completed (m d y)
Beschrijving

FormCompletionDate,Original

Datatype

date

Date form amended (m d y)
Beschrijving

FormCompletionDate,Amended

Datatype

date

Person amending form, last name
Beschrijving

ResponsiblePersonReportingChangeLastName

Datatype

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
Beschrijving

PatientName,Last

Datatype

text

Patient Name, First
Beschrijving

PatientName,First

Datatype

text

Patient Study ID
Beschrijving

PatientStudyID

Datatype

text

Person Completing Form, Last Name
Beschrijving

PersonCompletingForm,LastName

Datatype

text

Treatment Cycle And Modification
Beschrijving

Treatment Cycle And Modification

Cycle start date (Day 1 m d y)
Beschrijving

CourseBeginDate

Datatype

date

Current cycle number
Beschrijving

CourseIdentification

Datatype

text

Cycle delayed
Beschrijving

CycleDelayedInd

Datatype

text

Number of days treatment course was delayed
Beschrijving

CourseDelayDayCount

Datatype

double

Agent name (Drug)
Beschrijving

AgentName

Datatype

text

Dose level
Beschrijving

AgentDoseLevelValue

Datatype

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)
Beschrijving

DoseModification(Change)

Datatype

text

Total dose of agents/drugs for this cycle
Beschrijving

AgentTotalDose(percourse)

Datatype

double

Units
Beschrijving

AgentDoseUnits

Datatype

text

Patient weight (kg)
Beschrijving

PatientWeight

Datatype

double

Body surface area (m2)
Beschrijving

BodySurfaceArea

Datatype

double

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

PerformanceStatus

Datatype

text

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

AssessmentDate

Datatype

date

Hemoglobin
Beschrijving

Lab,Hematology,Hemoglobin

Datatype

double

Peripheral hematocrit count (1000/L)
Beschrijving

Lab,Hematology,HematocritCount

Datatype

double

Peripheral WBC count (mm3)
Beschrijving

Lab,Hematology,WBC

Datatype

double

Peripheral granulocytes count (mm3)
Beschrijving

Lab,Hematology,GranulocyteCount

Datatype

double

Peripheral platelet count (mm3)
Beschrijving

Lab,Hematology,Platelets

Datatype

double

BUN (mg/dl)
Beschrijving

Lab,Renal,BUN

Datatype

double

Creatinine (mg/dl)
Beschrijving

Lab,Renal,Creatinine

Datatype

double

Creatinine Clearance (ml/min)
Beschrijving

Lab,Renal,CreatinineClearance

Datatype

double

SGOT (IU/ml)
Beschrijving

Lab,Hepatic,SGOT

Datatype

double

Bilirubin (mg %)
Beschrijving

Lab,Hepatic,Bilirubin

Datatype

double

Result of CA125 (IU/ml)
Beschrijving

TumorMarker,CA125Result

Datatype

double

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

LaboratoryProcedureFirstOptionalPerformedSpecify

Datatype

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
Beschrijving

LaboratoryProcedureFirstOptionalPerformedValue

Datatype

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
Beschrijving

LaboratoryProcedureSecondOptionalPerformedSpecify

Datatype

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
Beschrijving

LaboratoryProcedureSecondOptionalPerformedValue

Datatype

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
Beschrijving

Comments

COMMENTS
Beschrijving

Comments

Datatype

text

Footer Module
Beschrijving

Footer Module

Participating Group Code
Beschrijving

ParticipatingGroupCode

Datatype

text

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

ParticipatingGroupProtocolNumber

Datatype

double

Participating Patient Study ID
Beschrijving

PatientParticipatingIdentifierNumber

Datatype

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
Beschrijving

Ccrr Module For Gog Cycle Dose Drug Form

Similar models

  1. StudyEvent: GOG Cycle Dose Drug Form
    1. FORM D2R
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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
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
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
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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