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ID

10580

Descrição

E1900 Induction Treatment Form NCT00049517 Combination Chemotherapy With or Without Monoclonal Antibody Therapy Followed by Stem Cell Transplant in Treating Patients With Acute Myeloid Leukemia Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A7294EC6-E15C-2FD0-E034-0003BA0B1A09

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=A7294EC6-E15C-2FD0-E034-0003BA0B1A09

Palavras-chave

  1. 19/09/2012 19/09/2012 -
  2. 28/05/2015 28/05/2015 -
  3. 03/06/2015 03/06/2015 -
Transferido a

3 de junho de 2015

DOI

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Licença

Creative Commons BY-NC 3.0 Legacy

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    E1900 Induction Treatment Form NCT00049517

    No Instruction available.

    1. StudyEvent: E1900 Induction Treatment Form
      1. No Instruction available.
    ECOG clinical trial administrative data
    Descrição

    ECOG clinical trial administrative data

    ECOG Protocol No.
    Descrição

    ECOGProtocolNo.

    Tipo de dados

    text

    ECOG Patient ID
    Descrição

    ECOGPatientID

    Tipo de dados

    text

    Registration Step
    Descrição

    RegistrationStep

    Tipo de dados

    text

    Patient?s Name
    Descrição

    Patient'sName

    Tipo de dados

    text

    Participating Group Protocol No.
    Descrição

    ParticipatingGroupProtocolNo.

    Tipo de dados

    text

    Participating Group Patient ID
    Descrição

    ParticipatingGroupPatientID

    Tipo de dados

    text

    Institution/Affiliate
    Descrição

    MainMemberInstitution/Affiliate

    Tipo de dados

    text

    Are data amended? (If yes, please circle amended items in red)
    Descrição

    AmendedDataInd

    Tipo de dados

    boolean

    Alias
    NCI Thesaurus ObjectClass
    C25474
    UMLS 2011AA ObjectClass
    C1511726
    NCI Thesaurus Property
    C25416
    UMLS 2011AA Property
    C1691222
    Vital Status
    Descrição

    Vital Status

    Patient?s Vital Status
    Descrição

    Patient'sVitalStatus

    Tipo de dados

    text

    Date of Last Contact or Death (M D Y)
    Descrição

    DeathDate/LastContactDate

    Tipo de dados

    date

    Cause of Death (if applicable)
    Descrição

    Causeofdeath

    Tipo de dados

    text

    Describe cause of death
    Descrição

    DeathReason,Specify

    Tipo de dados

    text

    Treatment Cycle Information
    Descrição

    Treatment Cycle Information

    Assigned Treatment Arm (Choose one)
    Descrição

    TreatmentArmNumber

    Tipo de dados

    text

    Cycle
    Descrição

    CourseIdentification

    Tipo de dados

    text

    Weight for this cycle (kg)
    Descrição

    PatientWeight

    Tipo de dados

    float

    Treatment Begin Date
    Descrição

    TreatmentBeginDate

    Tipo de dados

    date

    Cytarabine Initial Dose
    Descrição

    AgentInitialDose

    Tipo de dados

    float

    Number of days GM-CSF was given
    Descrição

    AgentDuration

    Tipo de dados

    float

    GM-CSF Total Cumulative Dose
    Descrição

    AgentTotalCumulativeDose

    Tipo de dados

    float

    Was intrathecal methotrexate or cytarabine administered? (choose one)
    Descrição

    Wasintrathecalmethotrexateorcytarabineadministered?

    Tipo de dados

    boolean

    Alias
    NCI Thesaurus ValueDomain
    C25180
    UMLS 2011AA ValueDomain
    C1522602
    Were there any dose modifications or additions/omissions to protocol treatment? (Choose one:)
    Descrição

    DoseModification(Change)

    Tipo de dados

    text

    Was any non-protocol therapy given during protocol treatment? (not previously reported)
    Descrição

    Non-ProtocolTherapyInd,DuringTreatment

    Tipo de dados

    boolean

    Last date (any modality of) protocol therapy was given
    Descrição

    TreatmentEndDate

    Tipo de dados

    date

    Reason Treatment Ended (Choose one)
    Descrição

    OffTreatmentReason

    Tipo de dados

    text

    Specify complicating disease (reason treatment ended)
    Descrição

    OffTreatmentReason,ComplicatingDisease

    Tipo de dados

    text

    Specify other Reasons (reason treatment ended)
    Descrição

    OffTreatmentReason,Other

    Tipo de dados

    text

    Comments
    Descrição

    Comments

    Comments
    Descrição

    Comments

    Tipo de dados

    text

    Investigator Signature
    Descrição

    InvestigatorSignature

    Tipo de dados

    text

    Alias
    NCI Thesaurus Property
    C25678
    UMLS 2011AA Property
    C1519316
    NCI Thesaurus ObjectClass
    C17089
    UMLS 2011AA ObjectClass
    C0035173
    Date
    Descrição

    InvestigatorSignatureDate

    Tipo de dados

    date

    Ccrr Module For E1900 Induction Treatment Form
    Descrição

    Ccrr Module For E1900 Induction Treatment Form

    Agent Name
    Descrição

    AgentName

    Tipo de dados

    text

    Similar models

    No Instruction available.

    1. StudyEvent: E1900 Induction Treatment Form
      1. No Instruction available.
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    ECOG clinical trial administrative data
    ECOGProtocolNo.
    Item
    ECOG Protocol No.
    text
    ECOGPatientID
    Item
    ECOG Patient ID
    text
    RegistrationStep
    Item
    Registration Step
    text
    Patient'sName
    Item
    Patient?s Name
    text
    ParticipatingGroupProtocolNo.
    Item
    Participating Group Protocol No.
    text
    ParticipatingGroupPatientID
    Item
    Participating Group Patient ID
    text
    MainMemberInstitution/Affiliate
    Item
    Institution/Affiliate
    text
    AmendedDataInd
    Item
    Are data amended? (If yes, please circle amended items in red)
    boolean
    C25474 (NCI Thesaurus ObjectClass)
    C1511726 (UMLS 2011AA ObjectClass)
    C25416 (NCI Thesaurus Property)
    C1691222 (UMLS 2011AA Property)
    Item Group
    Vital Status
    Item
    Patient?s Vital Status
    text
    Code List
    Patient?s Vital Status
    CL Item
    Alive (Alive)
    CL Item
    Dead (Dead)
    DeathDate/LastContactDate
    Item
    Date of Last Contact or Death (M D Y)
    date
    Item
    Cause of Death (if applicable)
    text
    Code List
    Cause of Death (if applicable)
    CL Item
    Due To Protocol Treatment (Due to protocol treatment)
    CL Item
    Due To This Disease (Due to this disease)
    CL Item
    Due To Other Cause (Due to other cause)
    CL Item
    Unknown (Unknown)
    C17998 (NCI Thesaurus)
    C0439673 (UMLS 2011AA)
    DeathReason,Specify
    Item
    Describe cause of death
    text
    Item Group
    Treatment Cycle Information
    Item
    Assigned Treatment Arm (Choose one)
    text
    Code List
    Assigned Treatment Arm (Choose one)
    CL Item
    Arm A - Daunorubicin 45 mg/m2 (Arm A - Daunorubicin 45 mg/m2)
    CL Item
    Arm B - Daunorubicin 90 mg/m2 (Arm B - Daunorubicin 90 mg/m2)
    Item
    Cycle
    text
    Code List
    Cycle
    CL Item
    Cycle 1 (Cycle 1)
    CL Item
    Cycle 2 (Cycle 2)
    PatientWeight
    Item
    Weight for this cycle (kg)
    float
    TreatmentBeginDate
    Item
    Treatment Begin Date
    date
    AgentInitialDose
    Item
    Cytarabine Initial Dose
    float
    AgentDuration
    Item
    Number of days GM-CSF was given
    float
    AgentTotalCumulativeDose
    Item
    GM-CSF Total Cumulative Dose
    float
    Wasintrathecalmethotrexateorcytarabineadministered?
    Item
    Was intrathecal methotrexate or cytarabine administered? (choose one)
    boolean
    C25180 (NCI Thesaurus ValueDomain)
    C1522602 (UMLS 2011AA ValueDomain)
    Item
    Were there any dose modifications or additions/omissions to protocol treatment? (Choose one:)
    text
    Code List
    Were there any dose modifications or additions/omissions to protocol treatment? (Choose one:)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    (i.e., The Treatment Was Changed According To Protocol Guidelines) (Yes, planned)
    CL Item
    (i.e., The Treatment Change Was Not Part Of Protocol Guidelines) (Yes, unplanned)
    Non-ProtocolTherapyInd,DuringTreatment
    Item
    Was any non-protocol therapy given during protocol treatment? (not previously reported)
    boolean
    TreatmentEndDate
    Item
    Last date (any modality of) protocol therapy was given
    date
    Item
    Reason Treatment Ended (Choose one)
    text
    Code List
    Reason Treatment Ended (Choose one)
    CL Item
    Treatment Completed Per Protocol Criteria (Treatment completed per protocol criteria)
    CL Item
    Disease Progression, Relapse During Active Treatment (Disease progression, relapse during active treatment)
    CL Item
    Toxicity/side Effects/complications (Toxicity/side effects/complications)
    CL Item
    Death After Beginning Protocol Therapy (Death after beginning protocol therapy)
    CL Item
    Patient Withdrawal Or Refusal After Beginning Protocol Therapy (Patient withdrawal or refusal after beginning protocol therapy)
    CL Item
    Alternative Therapy (Alternative therapy)
    CL Item
    Patient Off-treatment For Other Complicating Disease (Other complicating disease)
    CL Item
    Other (Other)
    C17649 (NCI Thesaurus)
    C0205394 (UMLS 2011AA)
    OffTreatmentReason,ComplicatingDisease
    Item
    Specify complicating disease (reason treatment ended)
    text
    OffTreatmentReason,Other
    Item
    Specify other Reasons (reason treatment ended)
    text
    Item Group
    Comments
    Comments
    Item
    Comments
    text
    InvestigatorSignature
    Item
    Investigator Signature
    text
    C25678 (NCI Thesaurus Property)
    C1519316 (UMLS 2011AA Property)
    C17089 (NCI Thesaurus ObjectClass)
    C0035173 (UMLS 2011AA ObjectClass)
    InvestigatorSignatureDate
    Item
    Date
    date
    Item Group
    Ccrr Module For E1900 Induction Treatment Form
    AgentName
    Item
    Agent Name
    text

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