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ID

11925

Description

Cycle Dose Drug Form (D2R) GOG-0262 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

August 22, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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    Cycle Dose Drug Form (D2R) GOG-0262

    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

    COMMENTS
    Description

    ResearchCommentsText

    Data type

    text

    Treatment Cycle And Modification
    Description

    Treatment Cycle And Modification

    Current Cycle Number
    Description

    TreatmentCurrentCourseNumber

    Data type

    float

    Cycle Delayed?
    Description

    TreatmentDelayedCycleInd-3

    Data type

    boolean

    Number of days treatment cycle was delayed
    Description

    TreatmentDelayDayCount

    Data type

    float

    Cycle delayed reason
    Description

    TreatmentDelayedCycleReason

    Data type

    text

    Cycle start date (Day 1 m d y)
    Description

    TreatmentCourseBeginDate

    Data type

    date

    Agent Name
    Description

    Agent Name

    Data type

    text

    Alias
    UMLS CUI [1]
    C1521826
    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

    float

    Units (eg. mg, kg)
    Description

    AgentDoseUOM

    Data type

    text

    Body weight
    Description

    Body weight

    Data type

    float

    Measurement units
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Body surface area
    Description

    Body surface area

    Data type

    float

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

    ECOG performance status grade

    Data type

    integer

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

    Pretreatment Hematology And Chemistry Values

    Assessment Date (m d y)
    Description

    LesionAssessmentDate

    Data type

    date

    Hemoglobin
    Description

    Hemoglobin

    Data type

    float

    Measurement units
    • g/dL
    Alias
    UMLS CUI [1]
    C0019046
    g/dL
    Peripheral Hematocrit Count (1000/L)
    Description

    LaboratoryProcedureErythrocyteResultCount

    Data type

    float

    WBC
    Description

    WBC

    Data type

    float

    Measurement units
    • /ul
    Alias
    UMLS CUI [1]
    C0023508
    /ul
    ANC
    Description

    ANC

    Data type

    float

    Measurement units
    • 1000/ul
    Alias
    UMLS CUI [1]
    C0200633
    1000/ul
    Peripheral Platelet Count
    Description

    Peripheral Platelet Count

    Data type

    float

    Measurement units
    • 1000/uL
    Alias
    UMLS CUI [1]
    C0005821
    1000/uL
    PT (sec)
    Description

    LaboratoryProcedureProthrombinTimeResultValue

    Data type

    float

    Measurement units
    • seconds
    seconds
    PTT
    Description

    PTT

    Data type

    float

    Measurement units
    • seconds
    Alias
    UMLS CUI [1]
    C0030605
    seconds
    BUN
    Description

    BUN

    Data type

    float

    Measurement units
    • mg/dL
    Alias
    UMLS CUI [1]
    C0005845
    mg/dL
    Creatinine
    Description

    Creatinine

    Data type

    float

    Measurement units
    • mg/dL
    Alias
    UMLS CUI [1]
    C0201976
    mg/dL
    Creatinine Clearance
    Description

    Creatinine Clearance

    Data type

    float

    Measurement units
    • mL/min
    Alias
    UMLS CUI [1]
    C0373595
    mL/min
    AST (SGOT)
    Description

    AST (SGOT)

    Data type

    float

    Measurement units
    • U/L
    Alias
    UMLS CUI [1]
    C0201899
    U/L
    Bilirubin, total
    Description

    Bilirubin, total

    Data type

    float

    Measurement units
    • mg/dL
    Alias
    UMLS CUI [1]
    C0201913
    mg/dL
    Alkaline Phosphatase
    Description

    Alkaline Phosphatase

    Data type

    float

    Measurement units
    • U/L
    Alias
    UMLS CUI [1]
    C0201850
    U/L
    Result of CA125 (IU/ml)
    Description

    LaboratoryProcedureCA-125AntigenTumorMarkerResultValue

    Data type

    float

    INR
    Description

    INR

    Data type

    float

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

    LaboratoryProcedureSecondOptionalPerformedSpecify

    Data type

    text

    Other specify value
    Description

    LaboratoryProcedurePerformedValue

    Data type

    float

    Comments
    Description

    Comments

    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
    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. 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
    float
    AgentDoseUOM
    Item
    Units (eg. mg, kg)
    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])
    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
    Item Group
    Comments

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