ID

11924

Description

GOG-0241 Cycle Dose Drug Form (D2R) Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=

Lien

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=

Mots-clés

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

22 août 2015

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0 Legacy

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Cycle Dose Drug Form (D2R) GOG-0241

No Instruction available.

  1. StudyEvent: SE.0000
    1. No Instruction available.
Header Module
Description

Header Module

Date form originally completed (m d y)
Description

FormOriginalCompleteDate

Type de données

date

Date form amended (m d y)
Description

FormAmendedCompleteDate

Type de données

date

Person amending form, last name
Description

ResponsiblePersonReportingChangeLastName

Type de données

text

Patient Initials (First, Middle, Last)
Description

PatientInitialsName

Type de données

text

Patient Study ID
Description

PatientGynecologicOncologyGroupIdentifierNumber

Type de données

text

Person Completing Form, Last Name
Description

ResponsiblePersonLastName

Type de données

text

Comments
Description

ResearchCommentsText

Type de données

text

Treatment Cycle And Modification
Description

Treatment Cycle And Modification

Current Cycle Number
Description

TreatmentCurrentCourseNumber

Type de données

float

Cycle Delayed?
Description

TreatmentDelayedCycleInd-3

Type de données

boolean

Number of days treatment cycle was delayed
Description

TreatmentDelayDayCount

Type de données

float

Cycle delayed reason
Description

TreatmentDelayedCycleReason

Type de données

text

Cycle start date (Day 1 m d y)
Description

TreatmentCourseBeginDate

Type de données

date

Agent Name
Description

Agent Name

Type de données

text

Alias
UMLS CUI [1]
C1521826
Agent Dose level (e.g. 175 mg/m^2)
Description

AgentDoseLevelValue

Type de données

text

Dose modification status
Description

DoseModificationStatus

Type de données

text

Dose Modification (Change)
Description

DoseModificationInd

Type de données

text

Dose Modification Reason
Description

DoseModificationReason

Type de données

text

Adverse Event
Description

DoseAdverseEventModificationReason

Type de données

text

Agent Total Dose
Description

AgentCourseTotalDose

Type de données

float

Units (e.g. kgs)
Description

AgentDoseUOM

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
Alias
UMLS CUI [1]
C0005902
ECOG performance status grade
Description

ECOG performance status grade

Type de données

integer

Alias
UMLS CUI [1]
C1632812
Pretreatment Hematology And Chemistry Values
Description

Pretreatment Hematology And Chemistry Values

Assessment Date (m d y)
Description

LesionAssessmentDate

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

LaboratoryProcedureErythrocyteResultCount

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
PT (sec)
Description

LaboratoryProcedureProthrombinTimeResultValue

Type de données

float

Unités de mesure
  • seconds
seconds
PTT
Description

PTT

Type de données

float

Unités de mesure
  • seconds
Alias
UMLS CUI [1]
C0030605
seconds
UPCR
Description

UrinaryCreatinineProteinAssessmentValue

Type de données

float

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
Alkaline Phosphatase
Description

Alkaline Phosphatase

Type de données

float

Unités de mesure
  • U/L
Alias
UMLS CUI [1]
C0201850
U/L
Result of CA125 (IU/ml)
Description

LaboratoryProcedureCA-125AntigenTumorMarkerResultValue

Type de données

float

INR
Description

INR

Type de données

float

Alias
UMLS CUI [1]
C0525032
Other, specify test
Description

LaboratoryProcedureSecondOptionalPerformedSpecify

Type de données

text

Other specify value
Description

LaboratoryProcedurePerformedValue

Type de données

float

Similar models

No Instruction available.

  1. StudyEvent: SE.0000
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Header Module
FormOriginalCompleteDate
Item
Date form originally completed (m d y)
date
FormAmendedCompleteDate
Item
Date form amended (m d y)
date
ResponsiblePersonReportingChangeLastName
Item
Person amending form, last name
text
PatientInitialsName
Item
Patient Initials (First, Middle, Last)
text
PatientGynecologicOncologyGroupIdentifierNumber
Item
Patient Study ID
text
ResponsiblePersonLastName
Item
Person Completing Form, Last Name
text
ResearchCommentsText
Item
Comments
text
Item Group
Treatment Cycle And Modification
TreatmentCurrentCourseNumber
Item
Current Cycle Number
float
TreatmentDelayedCycleInd-3
Item
Cycle Delayed?
boolean
TreatmentDelayDayCount
Item
Number of days treatment cycle was delayed
float
Item
Cycle delayed reason
text
Code List
Cycle delayed reason
CL Item
Non Protocol Illness (Non protocol illness)
CL Item
Patient Refusal (Patient refusal)
CL Item
Personal Reasons (Personal reasons)
CL Item
Protocol Related Ae (Protocol related AE)
CL Item
Scheduling (Scheduling)
TreatmentCourseBeginDate
Item
Cycle start date (Day 1 m d y)
date
Agent
Item
Agent Name
text
C1521826 (UMLS CUI [1])
AgentDoseLevelValue
Item
Agent Dose level (e.g. 175 mg/m^2)
text
DoseModificationStatus
Item
Dose modification status
text
Item
Dose Modification (Change)
text
Code List
Dose Modification (Change)
CL Item
Yes, Planned (i.e., The Treatment Was Changed According To Protocol Guidelines) (Yes, planned)
CL Item
Yes, Unplanned (i.e., The Treatment Change Was Not Part Of Protocol Guidelines) (Yes, unplanned)
CL Item
No (No)
DoseModificationReason
Item
Dose Modification Reason
text
DoseAdverseEventModificationReason
Item
Adverse Event
text
AgentCourseTotalDose
Item
Agent Total Dose
float
AgentDoseUOM
Item
Units (e.g. kgs)
text
Weight
Item
Body weight
float
C0005910 (UMLS CUI [1])
BSA
Item
Body surface area
float
C0005902 (UMLS CUI [1])
Item
ECOG performance status grade
integer
C1632812 (UMLS CUI [1])
Code List
ECOG performance status grade
CL Item
Fully Active, Able To Carry On All Pre-disease Performance Without Restriction. (0) (0)
CL Item
Restricted In Physically Strenuous Activity But Ambulatory And Able To Carry Out Work Of A Light Or Sedentary Nature, E.g., Light Housework, Office Work. (1) (1)
CL Item
Ambulatory And Capable Of All Selfcare But Unable To Carry Out Any Work Activities. Up And About More Than 50% Of Waking Hours. (2) (2)
CL Item
Capable Of Only Limited Selfcare, Confined To Bed Or Chair More Than 50% Of Waking Hours. (3) (3)
CL Item
Completely Disabled. Cannot Carry On Any Selfcare. Totally Confined To Bed Or Chair. (4) (4)
CL Item
Dead (5) (5)
Item Group
Pretreatment Hematology And Chemistry Values
LesionAssessmentDate
Item
Assessment Date (m d y)
date
Hemoglobin
Item
Hemoglobin
float
C0019046 (UMLS CUI [1])
LaboratoryProcedureErythrocyteResultCount
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])
LaboratoryProcedureProthrombinTimeResultValue
Item
PT (sec)
float
PTT
Item
PTT
float
C0030605 (UMLS CUI [1])
UrinaryCreatinineProteinAssessmentValue
Item
UPCR
float
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])
Alkaline Phosphatase
Item
Alkaline Phosphatase
float
C0201850 (UMLS CUI [1])
LaboratoryProcedureCA-125AntigenTumorMarkerResultValue
Item
Result of CA125 (IU/ml)
float
INR
Item
INR
float
C0525032 (UMLS CUI [1])
LaboratoryProcedureSecondOptionalPerformedSpecify
Item
Other, specify test
text
LaboratoryProcedurePerformedValue
Item
Other specify value
float

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