ID

11922

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

22 augustus 2015

DOI

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Licentie

Creative Commons BY-NC 3.0 Legacy

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Drug Dose Form Cervical Cancer GOG NCT00064077

  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

boolean

Number of days treatment course was delayed
Beschrijving

CourseDelayDayCount

Datatype

float

Agent Name
Beschrijving

Agent Name

Datatype

text

Alias
UMLS CUI [1]
C1521826
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-2
C25554
UMLS 2011AA Property-2
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

float

Units
Beschrijving

AgentDoseUnits

Datatype

text

Body weight
Beschrijving

Body weight

Datatype

float

Maateenheden
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body surface area
Beschrijving

Body surface area

Datatype

float

Maateenheden
Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25157
UMLS CUI [1]
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

Hemoglobin

Datatype

float

Maateenheden
  • g/dL
Alias
UMLS CUI [1]
C0019046
g/dL
Peripheral hematocrit count (1000/L)
Beschrijving

Lab,Hematology,HematocritCount

Datatype

float

WBC
Beschrijving

WBC

Datatype

float

Maateenheden
  • /ul
Alias
UMLS CUI [1]
C0023508
/ul
ANC
Beschrijving

ANC

Datatype

float

Maateenheden
  • 1000/ul
Alias
UMLS CUI [1]
C0200633
1000/ul
Peripheral Platelet Count
Beschrijving

Peripheral Platelet Count

Datatype

float

Maateenheden
  • 1000/uL
Alias
UMLS CUI [1]
C0005821
1000/uL
BUN
Beschrijving

BUN

Datatype

float

Maateenheden
  • mg/dL
Alias
UMLS CUI [1]
C0005845
mg/dL
Creatinine
Beschrijving

Creatinine

Datatype

float

Maateenheden
  • mg/dL
Alias
UMLS CUI [1]
C0201976
mg/dL
Creatinine Clearance
Beschrijving

Creatinine Clearance

Datatype

float

Maateenheden
  • mL/min
Alias
UMLS CUI [1]
C0373595
mL/min
AST (SGOT)
Beschrijving

AST (SGOT)

Datatype

float

Maateenheden
  • U/L
Alias
UMLS CUI [1]
C0201899
U/L
Bilirubin, total
Beschrijving

Bilirubin, total

Datatype

float

Maateenheden
  • mg/dL
Alias
UMLS CUI [1]
C0201913
mg/dL
Result of CA125 (IU/ml)
Beschrijving

TumorMarker,CA125Result

Datatype

float

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-2
C25509
UMLS 2011AA Property-2
C1279901
NCI Thesaurus Property-3
C25603
UMLS 2011AA Property-3
C1518600
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Other (1st Lab Value), specify
Beschrijving

LaboratoryProcedureFirstOptionalPerformedValue

Datatype

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus Property-2
C25509
UMLS 2011AA Property-2
C1279901
NCI Thesaurus Property-3
C25603
UMLS 2011AA Property-3
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-2
C25666
UMLS 2011AA Property-2
C0205436
NCI Thesaurus Property-3
C25603
UMLS 2011AA Property-3
C1518600
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Other (2nd Lab Value), specify
Beschrijving

LaboratoryProcedureSecondOptionalPerformedValue

Datatype

float

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus Property-2
C25666
UMLS 2011AA Property-2
C0205436
NCI Thesaurus Property-3
C25603
UMLS 2011AA Property-3
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

float

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-2
C25364
UMLS 2011AA Property-2
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
CycleDelayedInd
Item
Cycle delayed
boolean
CourseDelayDayCount
Item
Number of days treatment course was delayed
float
Agent
Item
Agent Name
text
C1521826 (UMLS CUI [1])
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-2)
C0441889 (UMLS 2011AA Property-2)
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
float
AgentDoseUnits
Item
Units
text
Weight
Item
Body weight
float
C0005910 (UMLS CUI [1])
BSA
Item
Body surface area
float
C16960 (NCI Thesaurus ObjectClass)
C25157 (NCI Thesaurus Property)
C0005902 (UMLS CUI [1])
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
Hemoglobin
Item
Hemoglobin
float
C0019046 (UMLS CUI [1])
Lab,Hematology,HematocritCount
Item
Peripheral hematocrit count (1000/L)
float
Leukocytes (WBC)
Item
WBC
float
C0023508 (UMLS CUI [1])
Neutrophil count
Item
ANC
float
C0200633 (UMLS CUI [1])
Platelets
Item
Peripheral Platelet Count
float
C0005821 (UMLS CUI [1])
BUN
Item
BUN
float
C0005845 (UMLS CUI [1])
Creatinine, Serum
Item
Creatinine
float
C0201976 (UMLS CUI [1])
Creatinine Clearance
Item
Creatinine Clearance
float
C0373595 (UMLS CUI [1])
AST
Item
AST (SGOT)
float
C0201899 (UMLS CUI [1])
Bilirubin, total
Item
Bilirubin, total
float
C0201913 (UMLS CUI [1])
TumorMarker,CA125Result
Item
Result of CA125 (IU/ml)
float
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-2)
C1279901 (UMLS 2011AA Property-2)
C25603 (NCI Thesaurus Property-3)
C1518600 (UMLS 2011AA Property-3)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
LaboratoryProcedureFirstOptionalPerformedValue
Item
Other (1st Lab Value), specify
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25509 (NCI Thesaurus Property-2)
C1279901 (UMLS 2011AA Property-2)
C25603 (NCI Thesaurus Property-3)
C1518600 (UMLS 2011AA Property-3)
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-2)
C0205436 (UMLS 2011AA Property-2)
C25603 (NCI Thesaurus Property-3)
C1518600 (UMLS 2011AA Property-3)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
LaboratoryProcedureSecondOptionalPerformedValue
Item
Other (2nd Lab Value), specify
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25666 (NCI Thesaurus Property-2)
C0205436 (UMLS 2011AA Property-2)
C25603 (NCI Thesaurus Property-3)
C1518600 (UMLS 2011AA Property-3)
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
float
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-2)
C0600091 (UMLS 2011AA Property-2)
Item Group
Ccrr Module For Gog Cycle Dose Drug Form

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