ID

11922

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

Lien

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

Mots-clés

Versions (2)
  1. 18/12/2014 18/12/2014 - Martin Dugas
  2. 22/08/2015 22/08/2015 - Martin Dugas
Téléchargé le

22 août 2015

DOI

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Licence

Creative Commons BY-NC 3.0 Legacy
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Drug Dose Form Cervical Cancer GOG NCT00064077

Anglais

FORM D2R

1 Formulaires  
  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

Type de données

date

Date form amended (m d y)
Description

FormCompletionDate,Amended

Type de données

date

Person amending form, last name
Description

ResponsiblePersonReportingChangeLastName

Type de données

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

Type de données

text

Patient Name, First
Description

PatientName,First

Type de données

text

Patient Study ID
Description

PatientStudyID

Type de données

text

Person Completing Form, Last Name
Description

PersonCompletingForm,LastName

Type de données

text

Treatment Cycle And Modification
Description

Treatment Cycle And Modification

Cycle start date (Day 1 m d y)
Description

CourseBeginDate

Type de données

date

Current cycle number
Description

CourseIdentification

Type de données

text

Cycle delayed
Description

CycleDelayedInd

Type de données

boolean

Number of days treatment course was delayed
Description

CourseDelayDayCount

Type de données

float

Agent Name
Description

Agent Name

Type de données

text

Alias
UMLS CUI [1]
C1521826
Dose level
Description

AgentDoseLevelValue

Type de données

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)
Description

DoseModification(Change)

Type de données

text

Total dose of agents/drugs for this cycle
Description

AgentTotalDose(percourse)

Type de données

float

Units
Description

AgentDoseUnits

Type de données

text

Body weight
Description

Body weight

Type de données

float

Unités de mesure
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body surface area
Description

Body surface area

Type de données

float

Unités de mesure
  • m²
Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25157
UMLS CUI [1]
C0005902
m²
Performance status
Description

PerformanceStatus

Type de données

text

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

AssessmentDate

Type de données

date

Hemoglobin
Description

Hemoglobin

Type de données

float

Unités de mesure
  • g/dL
Alias
UMLS CUI [1]
C0019046
g/dL
Peripheral hematocrit count (1000/L)
Description

Lab,Hematology,HematocritCount

Type de données

float

WBC
Description

WBC

Type de données

float

Unités de mesure
  • /ul
Alias
UMLS CUI [1]
C0023508
/ul
ANC
Description

ANC

Type de données

float

Unités de mesure
  • 1000/ul
Alias
UMLS CUI [1]
C0200633
1000/ul
Peripheral Platelet Count
Description

Peripheral Platelet Count

Type de données

float

Unités de mesure
  • 1000/uL
Alias
UMLS CUI [1]
C0005821
1000/uL
BUN
Description

BUN

Type de données

float

Unités de mesure
  • mg/dL
Alias
UMLS CUI [1]
C0005845
mg/dL
Creatinine
Description

Creatinine

Type de données

float

Unités de mesure
  • mg/dL
Alias
UMLS CUI [1]
C0201976
mg/dL
Creatinine Clearance
Description

Creatinine Clearance

Type de données

float

Unités de mesure
  • mL/min
Alias
UMLS CUI [1]
C0373595
mL/min
AST (SGOT)
Description

AST (SGOT)

Type de données

float

Unités de mesure
  • U/L
Alias
UMLS CUI [1]
C0201899
U/L
Bilirubin, total
Description

Bilirubin, total

Type de données

float

Unités de mesure
  • mg/dL
Alias
UMLS CUI [1]
C0201913
mg/dL
Result of CA125 (IU/ml)
Description

TumorMarker,CA125Result

Type de données

float

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

LaboratoryProcedureFirstOptionalPerformedSpecify

Type de données

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
Description

LaboratoryProcedureFirstOptionalPerformedValue

Type de données

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
Description

LaboratoryProcedureSecondOptionalPerformedSpecify

Type de données

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
Description

LaboratoryProcedureSecondOptionalPerformedValue

Type de données

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
Description

Comments

COMMENTS
Description

Comments

Type de données

text

Footer Module
Description

Footer Module

Participating Group Code
Description

ParticipatingGroupCode

Type de données

text

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

ParticipatingGroupProtocolNumber

Type de données

float

Participating Patient Study ID
Description

PatientParticipatingIdentifierNumber

Type de données

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
Description

Ccrr Module For Gog Cycle Dose Drug Form

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Similar models

FORM D2R

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