ID

6281

Description

GOG-0262: Cycle Dose Drug Form (D2R) Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=

Link

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

Keywords

  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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GOG-0262: Cycle Dose Drug Form (D2R) - 2917656v1.0

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

Data type

date

Date form amended (m d y)
Description

FormAmendedCompleteDate

Data type

date

Person amending form, last name
Description

ResponsiblePersonReportingChangeLastName

Data type

text

Patient Initials (First, Middle, Last)
Description

PatientInitialsName

Data type

text

Patient Study ID
Description

PatientGynecologicOncologyGroupIdentifierNumber

Data type

text

Person Completing Form, Last Name
Description

ResponsiblePersonLastName

Data type

text

Treatment Cycle And Modification
Description

Treatment Cycle And Modification

Current Cycle Number
Description

TreatmentCurrentCourseNumber

Data type

double

Cycle Delayed?
Description

TreatmentDelayedCycleInd-3

Data type

text

Number of days treatment cycle was delayed
Description

TreatmentDelayDayCount

Data type

double

Cycle delayed reason
Description

TreatmentDelayedCycleReason

Data type

text

Cycle start date (Day 1 m d y)
Description

TreatmentCourseBeginDate

Data type

date

Agent name (Drug)
Description

AgentName

Data type

text

Agent Dose level (e.g. mg/m^2)
Description

AgentDoseLevelValue

Data type

text

Were there any dose modifications or additions/omissions to protocol treatment (1=Yes, planned; 2 =Yes, unplanned; 3=No)
Description

DoseModificationInd

Data type

text

Total dose of agents/drugs for this cycle
Description

AgentCourseTotalDose

Data type

double

Units (eg. mg, kg)
Description

AgentDoseUOM

Data type

text

Patient weight (kg)
Description

PatientWeightMeasurement

Data type

double

Measurement units
  • Kg
Kg
Body Surface Area (m^2)
Description

PersonBodySurfaceAreaValue

Data type

double

Measurement units
  • m2
m2
Performance status (Zubrod)
Description

PerformanceStatusAssessmentEasternCooperativeOncologyGroupScale

Data type

text

Pretreatment Hematology And Chemistry Values
Description

Pretreatment Hematology And Chemistry Values

Assessment Date (m d y)
Description

LesionAssessmentDate

Data type

date

Hemoglobin
Description

LaboratoryProcedureHemoglobinResultSpecifiedValue

Data type

double

Measurement units
  • g/dL
g/dL
Peripheral Hematocrit Count (1000/L)
Description

LaboratoryProcedureErythrocyteResultCount

Data type

double

Peripheral WBC Count (mm3)
Description

LaboratoryProcedureLeukocyteResultSpecifiedValue

Data type

double

Measurement units
  • 1000/uL
1000/uL
Peripheral Granulocytes Count (mm3)
Description

LaboratoryProcedureGranulocyteResultCount

Data type

double

Measurement units
  • 1000/uL
1000/uL
Peripheral Platelet Count (mm3)
Description

LaboratoryProcedurePlateletResultSpecifiedValue

Data type

double

Measurement units
  • 1000/uL
1000/uL
PT (sec)
Description

LaboratoryProcedureProthrombinTimeResultValue

Data type

double

Measurement units
  • seconds
seconds
PTT (sec) (sec)
Description

LaboratoryProcedurePartialThromboplastinTimeResultValue

Data type

double

BUN (mg/dl)
Description

LaboratoryProcedureBloodUreaNitrogenResultUnspecifiedValue

Data type

double

Creatinine (mg/dl)
Description

LaboratoryProcedureCreatinineResultSpecifiedValue

Data type

double

Measurement units
  • mg/dL
mg/dL
Creatinine Clearance (ml/min)
Description

LaboratoryProcedureCreatinineClearanceOutcomeValue

Data type

double

SGOT
Description

LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedValue

Data type

double

Bilirubin
Description

LaboratoryProcedureTotalBilirubinResultValue

Data type

double

Measurement units
  • mg/dL
mg/dL
Alkaline Phosphatase
Description

LaboratoryProcedureAlkalinePhosphataseResultValue

Data type

double

Result of CA125 (IU/ml)
Description

LaboratoryProcedureCA-125AntigenTumorMarkerResultValue

Data type

double

International Normalization Ratio (INR)
Description

LaboratoryProcedureInternationalNormalizationRatioResultValue

Data type

double

Other, specify test
Description

LaboratoryProcedureSecondOptionalPerformedSpecify

Data type

text

Other specify value
Description

LaboratoryProcedurePerformedValue

Data type

double

Comments
Description

Comments

COMMENTS
Description

ResearchCommentsText

Data type

text

Similar models

No Instruction available.

  1. StudyEvent: SE.0000
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
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
Item Group
Treatment Cycle And Modification
TreatmentCurrentCourseNumber
Item
Current Cycle Number
double
Item
Cycle Delayed?
text
Code List
Cycle Delayed?
CL Item
No (No)
CL Item
Yes (Yes)
TreatmentDelayDayCount
Item
Number of days treatment cycle was delayed
double
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
AgentName
Item
Agent name (Drug)
text
AgentDoseLevelValue
Item
Agent Dose level (e.g. mg/m^2)
text
Item
Were there any dose modifications or additions/omissions to protocol treatment (1=Yes, planned; 2 =Yes, unplanned; 3=No)
text
Code List
Were there any dose modifications or additions/omissions to protocol treatment (1=Yes, planned; 2 =Yes, unplanned; 3=No)
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)
AgentCourseTotalDose
Item
Total dose of agents/drugs for this cycle
double
AgentDoseUOM
Item
Units (eg. mg, kg)
text
PatientWeightMeasurement
Item
Patient weight (kg)
double
PersonBodySurfaceAreaValue
Item
Body Surface Area (m^2)
double
Code List
Performance status (Zubrod)
CL Item
Fully Active, Able To Carry On All Pre-disease Performance Without Restriction. (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)
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)
CL Item
Capable Of Only Limited Selfcare, Confined To Bed Or Chair More Than 50% Of Waking Hours. (3)
CL Item
Completely Disabled. Cannot Carry On Any Selfcare. Totally Confined To Bed Or Chair. (4)
Item Group
Pretreatment Hematology And Chemistry Values
LesionAssessmentDate
Item
Assessment Date (m d y)
date
LaboratoryProcedureHemoglobinResultSpecifiedValue
Item
Hemoglobin
double
LaboratoryProcedureErythrocyteResultCount
Item
Peripheral Hematocrit Count (1000/L)
double
LaboratoryProcedureLeukocyteResultSpecifiedValue
Item
Peripheral WBC Count (mm3)
double
LaboratoryProcedureGranulocyteResultCount
Item
Peripheral Granulocytes Count (mm3)
double
LaboratoryProcedurePlateletResultSpecifiedValue
Item
Peripheral Platelet Count (mm3)
double
LaboratoryProcedureProthrombinTimeResultValue
Item
PT (sec)
double
LaboratoryProcedurePartialThromboplastinTimeResultValue
Item
PTT (sec) (sec)
double
LaboratoryProcedureBloodUreaNitrogenResultUnspecifiedValue
Item
BUN (mg/dl)
double
LaboratoryProcedureCreatinineResultSpecifiedValue
Item
Creatinine (mg/dl)
double
LaboratoryProcedureCreatinineClearanceOutcomeValue
Item
Creatinine Clearance (ml/min)
double
LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedValue
Item
SGOT
double
LaboratoryProcedureTotalBilirubinResultValue
Item
Bilirubin
double
LaboratoryProcedureAlkalinePhosphataseResultValue
Item
Alkaline Phosphatase
double
LaboratoryProcedureCA-125AntigenTumorMarkerResultValue
Item
Result of CA125 (IU/ml)
double
LaboratoryProcedureInternationalNormalizationRatioResultValue
Item
International Normalization Ratio (INR)
double
LaboratoryProcedureSecondOptionalPerformedSpecify
Item
Other, specify test
text
LaboratoryProcedurePerformedValue
Item
Other specify value
double
Item Group
Comments
ResearchCommentsText
Item
COMMENTS
text

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