0 Ratings
ID

4996

Description

ODM derived from http://clinicaltrials.gov/show/NCT00766779

Link

http://clinicaltrials.gov/show/NCT00766779

Keywords

Versions (2)
  1. 12/6/13 12/6/13 - Martin Dugas
  2. 4/16/14 4/16/14 - Julian Varghese
Uploaded on

April 16, 2014

DOI

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License

Creative Commons BY 4.0
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    Eligibility NCT00766779 Acute Myeloid Leukemia

    German English

    Eligibility

    1 forms  
    1. StudyEvent: Eligibility
      1. Eligibility
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI 2011AA
    CL425202
    age 60 Years to 75 Years
    Description

    age 60 Years to 75 Years

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0001779
    SNOMED CT 2011_0131
    397669002
    primary or secondary AML as defined by WHO or refractory anemia with excess of blasts (RAEB)
    Description

    primary or secondary AML as defined by WHO or refractory anemia with excess of blasts (RAEB)

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    CL414904
    UMLS CUI 2011AA
    C0023467
    SNOMED CT 2011_0131
    91861009
    MedDRA 14.1
    10000880
    ICD-10-CM Version 2010
    C92.0
    ICD-9-CM Version 2011
    205.0
    UMLS CUI 2011AA
    C0011900
    SNOMED CT 2011_0131
    439401001
    LOINC Version 232
    MTHU008876
    UMLS CUI 2011AA
    C0280449
    UMLS CUI 2011AA
    C1704788
    UMLS CUI 2011AA
    C0451584
    SNOMED CT 2011_0131
    273931002
    UMLS CUI 2011AA
    C0002894
    SNOMED CT 2011_0131
    398623004
    MedDRA 14.1
    10038270
    ICD-10-CM Version 2010
    D46.20
    First complete remission following one or two cycles of induction chemotherapy
    Description

    First complete remission following one or two cycles of induction chemotherapy

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0205435
    SNOMED CT 2011_0131
    255216001
    UMLS CUI 2011AA
    C0677874
    SNOMED CT 2011_0131
    103338009
    UMLS CUI 2011AA
    C0332282
    SNOMED CT 2011_0131
    255260001
    UMLS CUI 2011AA
    C0439596
    SNOMED CT 2011_0131
    44180009
    UMLS CUI 2011AA
    C0600558
    Chemotherapy was administered according to current participating cooperative group protocols
    Description

    Chemotherapy was administered according to current participating cooperative group protocols

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0392920
    SNOMED CT 2011_0131
    150415003
    UMLS CUI 2011AA
    C1521801
    UMLS CUI 2011AA
    C0680240
    UMLS CUI 2011AA
    C0679823
    HL7 V3 2006_05
    PART
    UMLS CUI 2011AA
    CL415249
    HL7 V3 2006_05
    RGRP
    UMLS CUI 2011AA
    C2348563
    Karnofsky performance status (assessment scale)
    Description

    Karnofsky score >= 70

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0206065
    SNOMED CT 2011_0131
    273546003
    Written informed consent
    Description

    Written informed consent

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0021430
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI 2011AA
    CL425201
    AML FAB M3
    Description

    AML FAB M3

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0023467
    SNOMED CT 2011_0131
    91861009
    MedDRA 14.1
    10000880
    ICD-10-CM Version 2010
    C92.0
    ICD-9-CM Version 2011
    205.0
    UMLS CUI 2011AA
    C0457329
    SNOMED CT 2011_0131
    278165002
    HIV Seropositivity
    Description

    HIV positivity

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0019699
    SNOMED CT 2011_0131
    165816005
    MedDRA 14.1
    10020188
    ICD-10-CM Version 2010
    Z21
    Participation in another clinical trial without prior consent of the coordinating investigator, patients may exceptionally take part in a further study only if
    Description

    Participation in another clinical trial without prior consent of the coordinating investigator, patients may exceptionally take part in a further study only if

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0679823
    HL7 V3 2006_05
    PART
    UMLS CUI 2011AA
    C0205394
    SNOMED CT 2011_0131
    74964007
    UMLS CUI 2011AA
    C0008976
    SNOMED CT 2011_0131
    110465008
    UMLS CUI 2011AA
    C0332197
    SNOMED CT 2011_0131
    2667000
    UMLS CUI 2011AA
    C1511481
    LOINC Version 232
    MTHU035862
    UMLS CUI 2011AA
    CL102947
    UMLS CUI 2011AA
    C1554961
    HL7 V3 2006_05
    E
    The second study exclusively concerns induction therapy
    Description

    The second study exclusively concerns induction therapy

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0205436
    SNOMED CT 2011_0131
    81170007
    UMLS CUI 2011AA
    C0008976
    SNOMED CT 2011_0131
    110465008
    UMLS CUI 2011AA
    C0205171
    SNOMED CT 2011_0131
    50607009
    UMLS CUI 2011AA
    C2699424
    UMLS CUI 2011AA
    C0600558
    Consolidation cycle one and two are given according to the accredited study group policy
    Description

    Consolidation cycle one and two are given according to the accredited study group policy

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0702116
    SNOMED CT 2011_0131
    9656002
    UMLS CUI 2011AA
    C0439596
    SNOMED CT 2011_0131
    44180009
    UMLS CUI 2011AA
    C0680240
    UMLS CUI 2011AA
    C0008976
    SNOMED CT 2011_0131
    110465008
    UMLS CUI 2011AA
    CL415249
    HL7 V3 2006_05
    RGRP
    UMLS CUI 2011AA
    C0242456
    No investigational drugs are used post registration for the HCT vs CT in elderly AML study.
    Description

    No investigational drugs are used post registration for the HCT vs CT in elderly AML study.

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C1518422
    UMLS CUI 2011AA
    C0013230
    UMLS CUI 2011AA
    C0472699
    SNOMED CT 2011_0131
    234336002
    UMLS CUI 2011AA
    C0392920
    SNOMED CT 2011_0131
    150415003
    UMLS CUI 2011AA
    C0001792
    SNOMED CT 2011_0131
    105436006
    MedDRA 14.1
    10014348
    UMLS CUI 2011AA
    C0023467
    SNOMED CT 2011_0131
    91861009
    MedDRA 14.1
    10000880
    ICD-10-CM Version 2010
    C92.0
    ICD-9-CM Version 2011
    205.0
    UMLS CUI 2011AA
    C0008976
    SNOMED CT 2011_0131
    110465008
    Documentation for the HCT vs CT in elderly AML study is not compromised. Second hand data from foreign study is not accepted
    Description

    Documentation for the HCT vs CT in elderly AML study is not compromised. Second hand data from foreign study is not accepted

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0920316
    UMLS CUI 2011AA
    C0472699
    SNOMED CT 2011_0131
    234336002
    UMLS CUI 2011AA
    C0392920
    SNOMED CT 2011_0131
    150415003
    UMLS CUI 2011AA
    C0001792
    SNOMED CT 2011_0131
    105436006
    MedDRA 14.1
    10014348
    UMLS CUI 2011AA
    C0023467
    SNOMED CT 2011_0131
    91861009
    MedDRA 14.1
    10000880
    ICD-10-CM Version 2010
    C92.0
    ICD-9-CM Version 2011
    205.0
    UMLS CUI 2011AA
    C0008976
    SNOMED CT 2011_0131
    110465008
    UMLS CUI 2011AA
    C1518422
    UMLS CUI 2011AA
    C0221099
    SNOMED CT 2011_0131
    260379002
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    Similar models

    Eligibility

    1 forms
    1. StudyEvent: Eligibility
      1. Eligibility
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Inclusion Criteria
    CL425202 (UMLS CUI 2011AA)
    age 60 Years to 75 Years
    Item
    age 60 Years to 75 Years
    boolean
    C0001779 (UMLS CUI 2011AA)
    397669002 (SNOMED CT 2011_0131)
    primary or secondary AML as defined by WHO or refractory anemia with excess of blasts (RAEB)
    Item
    primary or secondary AML as defined by WHO or refractory anemia with excess of blasts (RAEB)
    boolean
    CL414904 (UMLS CUI 2011AA)
    C0023467 (UMLS CUI 2011AA)
    91861009 (SNOMED CT 2011_0131)
    10000880 (MedDRA 14.1)
    C92.0 (ICD-10-CM Version 2010)
    205.0 (ICD-9-CM Version 2011)
    C0011900 (UMLS CUI 2011AA)
    439401001 (SNOMED CT 2011_0131)
    MTHU008876 (LOINC Version 232)
    C0280449 (UMLS CUI 2011AA)
    C1704788 (UMLS CUI 2011AA)
    C0451584 (UMLS CUI 2011AA)
    273931002 (SNOMED CT 2011_0131)
    C0002894 (UMLS CUI 2011AA)
    398623004 (SNOMED CT 2011_0131)
    10038270 (MedDRA 14.1)
    D46.20 (ICD-10-CM Version 2010)
    First complete remission following one or two cycles of induction chemotherapy
    Item
    First complete remission following one or two cycles of induction chemotherapy
    boolean
    C0205435 (UMLS CUI 2011AA)
    255216001 (SNOMED CT 2011_0131)
    C0677874 (UMLS CUI 2011AA)
    103338009 (SNOMED CT 2011_0131)
    C0332282 (UMLS CUI 2011AA)
    255260001 (SNOMED CT 2011_0131)
    C0439596 (UMLS CUI 2011AA)
    44180009 (SNOMED CT 2011_0131)
    C0600558 (UMLS CUI 2011AA)
    Chemotherapy was administered according to current participating cooperative group protocols
    Item
    Chemotherapy was administered according to current participating cooperative group protocols
    boolean
    C0392920 (UMLS CUI 2011AA)
    150415003 (SNOMED CT 2011_0131)
    C1521801 (UMLS CUI 2011AA)
    C0680240 (UMLS CUI 2011AA)
    C0679823 (UMLS CUI 2011AA)
    PART (HL7 V3 2006_05)
    CL415249 (UMLS CUI 2011AA)
    RGRP (HL7 V3 2006_05)
    C2348563 (UMLS CUI 2011AA)
    Karnofsky score >= 70
    Item
    Karnofsky performance status (assessment scale)
    boolean
    C0206065 (UMLS CUI 2011AA)
    273546003 (SNOMED CT 2011_0131)
    Written informed consent
    Item
    Written informed consent
    boolean
    C0021430 (UMLS CUI 2011AA)
    Item Group
    Exclusion Criteria
    CL425201 (UMLS CUI 2011AA)
    AML FAB M3
    Item
    AML FAB M3
    boolean
    C0023467 (UMLS CUI 2011AA)
    91861009 (SNOMED CT 2011_0131)
    10000880 (MedDRA 14.1)
    C92.0 (ICD-10-CM Version 2010)
    205.0 (ICD-9-CM Version 2011)
    C0457329 (UMLS CUI 2011AA)
    278165002 (SNOMED CT 2011_0131)
    HIV positivity
    Item
    HIV Seropositivity
    boolean
    C0019699 (UMLS CUI 2011AA)
    165816005 (SNOMED CT 2011_0131)
    10020188 (MedDRA 14.1)
    Z21 (ICD-10-CM Version 2010)
    Participation in another clinical trial without prior consent of the coordinating investigator, patients may exceptionally take part in a further study only if
    Item
    Participation in another clinical trial without prior consent of the coordinating investigator, patients may exceptionally take part in a further study only if
    boolean
    C0679823 (UMLS CUI 2011AA)
    PART (HL7 V3 2006_05)
    C0205394 (UMLS CUI 2011AA)
    74964007 (SNOMED CT 2011_0131)
    C0008976 (UMLS CUI 2011AA)
    110465008 (SNOMED CT 2011_0131)
    C0332197 (UMLS CUI 2011AA)
    2667000 (SNOMED CT 2011_0131)
    C1511481 (UMLS CUI 2011AA)
    MTHU035862 (LOINC Version 232)
    CL102947 (UMLS CUI 2011AA)
    C1554961 (UMLS CUI 2011AA)
    E (HL7 V3 2006_05)
    The second study exclusively concerns induction therapy
    Item
    The second study exclusively concerns induction therapy
    boolean
    C0205436 (UMLS CUI 2011AA)
    81170007 (SNOMED CT 2011_0131)
    C0008976 (UMLS CUI 2011AA)
    110465008 (SNOMED CT 2011_0131)
    C0205171 (UMLS CUI 2011AA)
    50607009 (SNOMED CT 2011_0131)
    C2699424 (UMLS CUI 2011AA)
    C0600558 (UMLS CUI 2011AA)
    Consolidation cycle one and two are given according to the accredited study group policy
    Item
    Consolidation cycle one and two are given according to the accredited study group policy
    boolean
    C0702116 (UMLS CUI 2011AA)
    9656002 (SNOMED CT 2011_0131)
    C0439596 (UMLS CUI 2011AA)
    44180009 (SNOMED CT 2011_0131)
    C0680240 (UMLS CUI 2011AA)
    C0008976 (UMLS CUI 2011AA)
    110465008 (SNOMED CT 2011_0131)
    CL415249 (UMLS CUI 2011AA)
    RGRP (HL7 V3 2006_05)
    C0242456 (UMLS CUI 2011AA)
    No investigational drugs are used post registration for the HCT vs CT in elderly AML study.
    Item
    No investigational drugs are used post registration for the HCT vs CT in elderly AML study.
    boolean
    C1518422 (UMLS CUI 2011AA)
    C0013230 (UMLS CUI 2011AA)
    C0472699 (UMLS CUI 2011AA)
    234336002 (SNOMED CT 2011_0131)
    C0392920 (UMLS CUI 2011AA)
    150415003 (SNOMED CT 2011_0131)
    C0001792 (UMLS CUI 2011AA)
    105436006 (SNOMED CT 2011_0131)
    10014348 (MedDRA 14.1)
    C0023467 (UMLS CUI 2011AA)
    91861009 (SNOMED CT 2011_0131)
    10000880 (MedDRA 14.1)
    C92.0 (ICD-10-CM Version 2010)
    205.0 (ICD-9-CM Version 2011)
    C0008976 (UMLS CUI 2011AA)
    110465008 (SNOMED CT 2011_0131)
    Documentation for the HCT vs CT in elderly AML study is not compromised. Second hand data from foreign study is not accepted
    Item
    Documentation for the HCT vs CT in elderly AML study is not compromised. Second hand data from foreign study is not accepted
    boolean
    C0920316 (UMLS CUI 2011AA)
    C0472699 (UMLS CUI 2011AA)
    234336002 (SNOMED CT 2011_0131)
    C0392920 (UMLS CUI 2011AA)
    150415003 (SNOMED CT 2011_0131)
    C0001792 (UMLS CUI 2011AA)
    105436006 (SNOMED CT 2011_0131)
    10014348 (MedDRA 14.1)
    C0023467 (UMLS CUI 2011AA)
    91861009 (SNOMED CT 2011_0131)
    10000880 (MedDRA 14.1)
    C92.0 (ICD-10-CM Version 2010)
    205.0 (ICD-9-CM Version 2011)
    C0008976 (UMLS CUI 2011AA)
    110465008 (SNOMED CT 2011_0131)
    C1518422 (UMLS CUI 2011AA)
    C0221099 (UMLS CUI 2011AA)
    260379002 (SNOMED CT 2011_0131)
    Back to the top of the page 

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