ID

1961

Description

E1900 Induction Treatment Form 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

Keywords

Versions (3)
  1. 9/19/12 9/19/12 -
  2. 5/28/15 5/28/15 -
  3. 6/3/15 6/3/15 -
Uploaded on

September 19, 2012

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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    Leukemia NCT00049517 Treatment - E1900 Induction Treatment Form - 2054254v3.0

    English

    No Instruction available.

    1 forms  
    1. StudyEvent: E1900 Induction Treatment Form
      1. No Instruction available.
    Unnamed1
    Description

    Unnamed1

    Registration Step
    Description

    RegistrationStep

    Data type

    text

    Patient?s Name
    Description

    Patient'sName

    Data type

    text

    ECOG Protocol No.
    Description

    ECOGProtocolNo.

    Data type

    text

    ECOG Protocol No.
    Description

    ECOGProtocolNo.

    Data type

    text

    ECOG Patient ID
    Description

    ECOGPatientID

    Data type

    text

    ECOG Patient ID
    Description

    ECOGPatientID

    Data type

    text

    Participating Group Protocol No.
    Description

    ParticipatingGroupProtocolNo.

    Data type

    text

    Participating Group Patient ID
    Description

    ParticipatingGroupPatientID

    Data type

    text

    Institution/Affiliate
    Description

    MainMemberInstitution/Affiliate

    Data type

    text

    Unnamed2
    Description

    Unnamed2

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

    AmendedDataInd

    Data type

    text

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

    Vital Status

    Patient?s Vital Status
    Description

    Patient'sVitalStatus

    Data type

    text

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

    DeathDate/LastContactDate

    Data type

    date

    Cause of Death (if applicable)
    Description

    Causeofdeath

    Data type

    text

    Describe cause of death
    Description

    DeathReason,Specify

    Data type

    text

    Treatment Cycle Information
    Description

    Treatment Cycle Information

    Assigned Treatment Arm (Choose one)
    Description

    TreatmentArmNumber

    Data type

    text

    Cycle
    Description

    CourseIdentification

    Data type

    text

    Weight for this cycle (kg)
    Description

    PatientWeight

    Data type

    double

    Treatment Begin Date
    Description

    TreatmentBeginDate

    Data type

    date

    Cytarabine Initial Dose
    Description

    AgentInitialDose

    Data type

    double

    Cytarabine Initial Dose
    Description

    AgentInitialDose

    Data type

    double

    Number of days GM-CSF was given
    Description

    AgentDuration

    Data type

    double

    GM-CSF Total Cumulative Dose
    Description

    AgentTotalCumulativeDose

    Data type

    double

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

    Wasintrathecalmethotrexateorcytarabineadministered?

    Data type

    text

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

    DoseModification(Change)

    Data type

    text

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

    Non-ProtocolTherapyInd,DuringTreatment

    Data type

    text

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

    TreatmentEndDate

    Data type

    date

    Reason Treatment Ended (Choose one)
    Description

    OffTreatmentReason

    Data type

    text

    Specify complicating disease (reason treatment ended)
    Description

    OffTreatmentReason,ComplicatingDisease

    Data type

    text

    Specify other Reasons (reason treatment ended)
    Description

    OffTreatmentReason,Other

    Data type

    text

    Comments
    Description

    Comments

    Comments
    Description

    Comments

    Data type

    text

    Investigator Signature
    Description

    InvestigatorSignature

    Data type

    text

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

    InvestigatorSignatureDate

    Data type

    date

    Ccrr Module For E1900 Induction Treatment Form
    Description

    Ccrr Module For E1900 Induction Treatment Form

    Agent Name
    Description

    AgentName

    Data type

    text

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    No Instruction available.

    1 forms
    1. StudyEvent: E1900 Induction Treatment Form
      1. No Instruction available.
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Unnamed1
    RegistrationStep
    Item
    Registration Step
    text
    Patient'sName
    Item
    Patient?s Name
    text
    ECOGProtocolNo.
    Item
    ECOG Protocol No.
    text
    ECOGProtocolNo.
    Item
    ECOG Protocol No.
    text
    ECOGPatientID
    Item
    ECOG Patient ID
    text
    ECOGPatientID
    Item
    ECOG Patient ID
    text
    ParticipatingGroupProtocolNo.
    Item
    Participating Group Protocol No.
    text
    ParticipatingGroupPatientID
    Item
    Participating Group Patient ID
    text
    MainMemberInstitution/Affiliate
    Item
    Institution/Affiliate
    text
    Item Group
    Unnamed2
    Item
    Are data amended? (If yes, please circle amended items in red)
    text
    C25474 (NCI Thesaurus ObjectClass)
    C1511726 (UMLS 2011AA ObjectClass)
    C25416 (NCI Thesaurus Property)
    C1691222 (UMLS 2011AA Property)
    CL.1
    Code List
    Are data amended? (If yes, please circle amended items in red)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item Group
    Vital Status
    Item
    Patient?s Vital Status
    text
    CL.2
    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
    CL.3
    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
    CL.4
    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
    CL.5
    Code List
    Cycle
    CL Item
    Cycle 1 (Cycle 1)
    CL Item
    Cycle 2 (Cycle 2)
    PatientWeight
    Item
    Weight for this cycle (kg)
    double
    TreatmentBeginDate
    Item
    Treatment Begin Date
    date
    AgentInitialDose
    Item
    Cytarabine Initial Dose
    double
    AgentInitialDose
    Item
    Cytarabine Initial Dose
    double
    AgentDuration
    Item
    Number of days GM-CSF was given
    double
    AgentTotalCumulativeDose
    Item
    GM-CSF Total Cumulative Dose
    double
    Item
    Was intrathecal methotrexate or cytarabine administered? (choose one)
    text
    C25180 (NCI Thesaurus ValueDomain)
    C1522602 (UMLS 2011AA ValueDomain)
    CL.6
    Code List
    Was intrathecal methotrexate or cytarabine administered? (choose one)
    CL Item
    No (no)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    Item
    Were there any dose modifications or additions/omissions to protocol treatment? (Choose one:)
    text
    CL.7
    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)
    Item
    Was any non-protocol therapy given during protocol treatment? (not previously reported)
    text
    CL.8
    Code List
    Was any non-protocol therapy given during protocol treatment? (not previously reported)
    CL Item
    No (No)
    C49487 (NCI Thesaurus)
    C1298908 (UMLS 2011AA)
    CL Item
    Yes (Yes)
    C49488 (NCI Thesaurus)
    C1705108 (UMLS 2011AA)
    TreatmentEndDate
    Item
    Last date (any modality of) protocol therapy was given
    date
    Item
    Reason Treatment Ended (Choose one)
    text
    CL.9
    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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