0 Avaliações
ID

43394

Descrição

ODM derived from http://clinicaltrials.gov/show/NCT00632749

Link

http://clinicaltrials.gov/show/NCT00632749

Palavras-chave

Versões (3)
  1. 09/12/2013 09/12/2013 - Martin Dugas
  2. 15/04/2014 15/04/2014 - Julian Varghese
  3. 20/09/2021 20/09/2021 -
Transferido a

20 de setembro de 2021

DOI

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Licença

Creative Commons BY 4.0
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    Eligibility DRKS00003742 NCT00632749 Leukemia, Myeloid, Acute

    Alemão Inglês

    Eligibility

    1 Formulários  
    1. StudyEvent: Eligibility
      1. Eligibility
    Einschlusskriterien
    Descrição

    Einschlusskriterien

    Alias
    UMLS CUI 2011AA
    CL425202
    Alter mindestens 18 Jahre
    Descrição

    age at least 18 Years

    Tipo de dados

    boolean

    Alias
    UMLS CUI 2011AA
    C0001779
    SNOMED CT 2011_0131
    397669002
    Male or female adult with previously untreated acute myeloid leukaemia (AML)
    Descrição

    Male or female adult with previously untreated acute myeloid leukaemia (AML)

    Tipo de dados

    boolean

    Alias
    UMLS CUI 2011AA
    C0086582
    SNOMED CT 2011_0131
    248153007
    HL7 V3 2006_05
    M
    UMLS CUI 2011AA
    C0086287
    SNOMED CT 2011_0131
    248152002
    HL7 V3 2006_05
    F
    UMLS CUI 2011AA
    C0001675
    SNOMED CT 2011_0131
    133936004
    UMLS CUI 2011AA
    C0205156
    SNOMED CT 2011_0131
    9130008
    UMLS CUI 2011AA
    C1518422
    UMLS CUI 2011AA
    CL415147
    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
    Confirmed diagnosis of AML according to the WHO definition (except for acute promyelocytic leukaemia, APL)
    Descrição

    Confirmed diagnosis of AML according to the WHO definition (except for acute promyelocytic leukaemia, APL)

    Tipo de dados

    boolean

    Alias
    UMLS CUI 2011AA
    C0750484
    UMLS CUI 2011AA
    C0011900
    SNOMED CT 2011_0131
    439401001
    LOINC Version 232
    MTHU008876
    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
    C0680240
    UMLS CUI 2011AA
    C0043237
    UMLS CUI 2011AA
    C1704788
    UMLS CUI 2011AA
    C1554961
    HL7 V3 2006_05
    E
    UMLS CUI 2011AA
    C0023487
    SNOMED CT 2011_0131
    110004001
    MedDRA 14.1
    10001019
    ICD-10-CM Version 2010
    C92.4
    Patient is considered ineligible for intensive treatment
    Descrição

    Patient is considered ineligible for intensive treatment

    Tipo de dados

    boolean

    Alias
    UMLS CUI 2011AA
    C0022423
    SNOMED CT 2011_0131
    61254005
    UMLS CUI 2011AA
    C0030705
    SNOMED CT 2011_0131
    116154003
    UMLS CUI 2011AA
    C1518422
    UMLS CUI 2011AA
    C1548635
    HL7 V3 2006_05
    ELG
    UMLS CUI 2011AA
    C0522510
    SNOMED CT 2011_0131
    103370009
    UMLS CUI 2011AA
    C0039798
    Patient is eligible for low-dose cytarabine (LD-Ara-C) treatment
    Descrição

    Patient is eligible for low-dose cytarabine (LD-Ara-C) treatment

    Tipo de dados

    boolean

    Alias
    UMLS CUI 2011AA
    C0030705
    SNOMED CT 2011_0131
    116154003
    UMLS CUI 2011AA
    C1548635
    UMLS CUI 2011AA
    C1708745
    UMLS CUI 2011AA
    C0010711
    SNOMED CT 2011_0131
    89265009
    Life expectancy > 3 months
    Descrição

    Life expectancy > 3 months

    Tipo de dados

    boolean

    Alias
    UMLS CUI 2011AA
    C0023671
    LOINC Version 232
    LP75025-4
    UMLS CUI 2011AA
    C2825406
    UMLS CUI 2011AA
    C0439234
    SNOMED CT 2011_0131
    258707000
    HL7 V3 2006_05
    Y
    Eastern co-operative oncology group (ECOG, R01-0787) performance score <=2 at screening
    Descrição

    Eastern co-operative oncology group (ECOG, R01-0787) performance score <=2 at screening

    Tipo de dados

    boolean

    Alias
    UMLS CUI 2011AA
    C1828127
    SNOMED CT 2011_0131
    424122007
    UMLS CUI 2011AA
    C1520224
    SNOMED CT 2011_0131
    423740007
    MedDRA 14.1
    10067961
    UMLS CUI 2011AA
    C1409616
    Signed written informed consent consistent with international conference on harmonisation good clinical practice (ICH-GCP) and local legislation
    Descrição

    Signed written informed consent consistent with international conference on harmonisation good clinical practice (ICH-GCP) and local legislation

    Tipo de dados

    boolean

    Alias
    UMLS CUI 2011AA
    C1561610
    UMLS CUI 2011AA
    C0600657
    Ausschlusskriterien
    Descrição

    Ausschlusskriterien

    Alias
    UMLS CUI 2011AA
    CL425201
    Patient with APL (AML subtype M3 according to the French-American-British (FAB) classification).
    Descrição

    Patient with APL (AML subtype M3 according to the French-American-British (FAB) classification).

    Tipo de dados

    boolean

    Alias
    UMLS CUI 2011AA
    C0023487
    SNOMED CT 2011_0131
    110004001
    MedDRA 14.1
    10001019
    ICD-10-CM Version 2010
    C92.4
    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
    C0449560
    SNOMED CT 2011_0131
    260837004
    UMLS CUI 2011AA
    C0680240
    UMLS CUI 2011AA
    CL421536
    Relapsed or treatment refractory AML.
    Descrição

    Relapsed or treatment refractory AML.

    Tipo de dados

    boolean

    Alias
    UMLS CUI 2011AA
    C0278780
    UMLS CUI 2011AA
    C0039798
    UMLS CUI 2011AA
    C0205269
    SNOMED CT 2011_0131
    20646008
    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
    Hypersensitivity to one of the trial drugs or the excipients.
    Descrição

    Hypersensitivity to one of the trial drugs or the excipients.

    Tipo de dados

    boolean

    Alias
    UMLS CUI 2011AA
    C0020517
    SNOMED CT 2011_0131
    418634005
    ICD-10-CM Version 2010
    T78.40
    UMLS CUI 2011AA
    C0008976
    SNOMED CT 2011_0131
    110465008
    UMLS CUI 2011AA
    C0013227
    UMLS CUI 2011AA
    C0015237
    SNOMED CT 2011_0131
    360215002
    Other malignancy requiring treatment.
    Descrição

    Other malignancy requiring treatment.

    Tipo de dados

    boolean

    Alias
    UMLS CUI 2011AA
    C0205394
    SNOMED CT 2011_0131
    74964007
    UMLS CUI 2011AA
    C0006826
    SNOMED CT 2011_0131
    363346000
    MedDRA 14.1
    10028997
    LOINC Version 232
    MTHU010328
    ICD-10-CM Version 2010
    C00-C96
    UMLS CUI 2011AA
    C1514873
    UMLS CUI 2011AA
    C0039798
    Known central nervous system involvement.
    Descrição

    Known central nervous system involvement.

    Tipo de dados

    boolean

    Alias
    UMLS CUI 2011AA
    C0205309
    SNOMED CT 2011_0131
    36692007
    UMLS CUI 2011AA
    C0449389
    SNOMED CT 2011_0131
    260766009
    Aspartate amino transferase (AST) or alanine amino transferase (ALT) > 2.5 times the upper limit of normal (ULN).
    Descrição

    Aspartate amino transferase (AST) or alanine amino transferase (ALT) > 2.5 times the upper limit of normal (ULN).

    Tipo de dados

    boolean

    Alias
    UMLS CUI 2011AA
    C0004002
    SNOMED CT 2011_0131
    26091008
    LOINC Version 232
    MTHU004883
    UMLS CUI 2011AA
    C0001899
    SNOMED CT 2011_0131
    56935002
    LOINC Version 232
    MTHU006766
    UMLS CUI 2011AA
    C1632851
    SNOMED CT 2011_0131
    417929005
    UMLS CUI 2011AA
    C1519815
    INR > 1.5 x ULN for subjects not on therapeutic vitamin K antagonists (phenprocoumon, warfarin).
    Descrição

    INR > 1.5 x ULN for subjects not on therapeutic vitamin K antagonists (phenprocoumon, warfarin).

    Tipo de dados

    boolean

    Alias
    UMLS CUI 2011AA
    C0525032
    SNOMED CT 2011_0131
    165581004
    MedDRA 14.1
    10022400
    UMLS CUI 2011AA
    C1519815
    UMLS CUI 2011AA
    C1518422
    UMLS CUI 2011AA
    C1611640
    SNOMED CT 2011_0131
    5487002
    HL7 V3 2006_05
    THER
    UMLS CUI 2011AA
    C1096489
    MedDRA 14.1
    10053755
    UMLS CUI 2011AA
    C0031444
    SNOMED CT 2011_0131
    59488002
    LOINC Version 232
    MTHU016364
    UMLS CUI 2011AA
    C0043031
    SNOMED CT 2011_0131
    48603004
    LOINC Version 232
    MTHU003212
    Bilirubin
    Descrição

    Bilirubin > 1.5 mg/dl.

    Tipo de dados

    boolean

    Alias
    UMLS CUI 2011AA
    C1278039
    SNOMED CT 2011_0131
    79706000
    LOINC Version 232
    1975-2
    Kreatinin im Serum
    Descrição

    Serum creatinine > 2.0 mg/dl.

    Tipo de dados

    boolean

    Alias
    UMLS CUI 2011AA
    C0201976
    SNOMED CT 2011_0131
    113075003
    MedDRA 14.1
    10040230
    LVEF (Left ventricular ejection fraction) < 50% in echocardiography or clinical congestive heart failure New York Heart Association (NYHA) grade III or IV.
    Descrição

    LVEF (Left ventricular ejection fraction) < 50% in echocardiography or clinical congestive heart failure New York Heart Association (NYHA) grade III or IV.

    Tipo de dados

    boolean

    Alias
    UMLS CUI 2011AA
    C0428772
    SNOMED CT 2011_0131
    250908004
    MedDRA 14.1
    10069170
    UMLS CUI 2011AA
    C0013516
    SNOMED CT 2011_0131
    40701008
    MedDRA 14.1
    10014116
    ICD-9-CM Version 2011
    88.72
    UMLS CUI 2011AA
    C0205210
    SNOMED CT 2011_0131
    58147004
    UMLS CUI 2011AA
    C0018802
    SNOMED CT 2011_0131
    42343007
    MedDRA 14.1
    10007559
    LOINC Version 232
    MTHU020787
    ICD-10-CM Version 2010
    I50.9
    ICD-9-CM Version 2011
    428.0
    UMLS CUI 2011AA
    C1319795
    SNOMED CT 2011_0131
    420913000
    MedDRA 14.1
    10064081
    UMLS CUI 2011AA
    C1319796
    SNOMED CT 2011_0131
    422293003
    MedDRA 14.1
    10064082
    Concomitant intercurrent illness, which would compromise the evaluation of efficacy or safety of the trial drug, e.g. active severe infection, unstable angina pectoris or cardiac arrhythmia.
    Descrição

    Concomitant intercurrent illness, which would compromise the evaluation of efficacy or safety of the trial drug, e.g. active severe infection, unstable angina pectoris or cardiac arrhythmia.

    Tipo de dados

    boolean

    Alias
    UMLS CUI 2011AA
    C0243087
    UMLS CUI 2011AA
    C0277557
    SNOMED CT 2011_0131
    88472004
    UMLS CUI 2011AA
    C0221099
    SNOMED CT 2011_0131
    260379002
    UMLS CUI 2011AA
    C0220825
    UMLS CUI 2011AA
    C1280519
    SNOMED CT 2011_0131
    255403003
    UMLS CUI 2011AA
    C0036043
    UMLS CUI 2011AA
    C0008976
    SNOMED CT 2011_0131
    110465008
    UMLS CUI 2011AA
    C0013227
    UMLS CUI 2011AA
    C0205177
    SNOMED CT 2011_0131
    55561003
    UMLS CUI 2011AA
    C0205082
    SNOMED CT 2011_0131
    24484000
    UMLS CUI 2011AA
    C0009450
    SNOMED CT 2011_0131
    257551009
    MedDRA 14.1
    10021789
    UMLS CUI 2011AA
    C0002965
    SNOMED CT 2011_0131
    4557003
    MedDRA 14.1
    10002388
    ICD-10-CM Version 2010
    I20.0
    ICD-9-CM Version 2011
    411.1
    UMLS CUI 2011AA
    C0003811
    SNOMED CT 2011_0131
    44808001
    MedDRA 14.1
    10003119
    ICD-9-CM Version 2011
    427.9
    Psychiatric illness or social situation that would limit compliance with trial requirements.
    Descrição

    Psychiatric illness or social situation that would limit compliance with trial requirements.

    Tipo de dados

    boolean

    Alias
    UMLS CUI 2011AA
    C0004936
    SNOMED CT 2011_0131
    74732009
    MedDRA 14.1
    10037174
    ICD-10-CM Version 2010
    F99
    ICD-9-CM Version 2011
    290-319.99
    UMLS CUI 2011AA
    C0851364
    MedDRA 14.1
    10041244
    UMLS CUI 2011AA
    C0439801
    SNOMED CT 2011_0131
    255469002
    UMLS CUI 2011AA
    C1321605
    SNOMED CT 2011_0131
    405078008
    UMLS CUI 2011AA
    C0008976
    SNOMED CT 2011_0131
    110465008
    UMLS CUI 2011AA
    C1514873
    Concomitant therapy, which is considered relevant for the evaluation of the efficacy or safety of the trial drug (i.e. other chemo- or immunotherapy, see also section 4.2.2).
    Descrição

    Concomitant therapy, which is considered relevant for the evaluation of the efficacy or safety of the trial drug (i.e. other chemo- or immunotherapy, see also section 4.2.2).

    Tipo de dados

    boolean

    Alias
    UMLS CUI 2011AA
    C1707479
    UMLS CUI 2011AA
    C0022423
    SNOMED CT 2011_0131
    61254005
    UMLS CUI 2011AA
    C2347946
    UMLS CUI 2011AA
    C0220825
    UMLS CUI 2011AA
    C1280519
    SNOMED CT 2011_0131
    255403003
    UMLS CUI 2011AA
    C0036043
    UMLS CUI 2011AA
    C0008976
    SNOMED CT 2011_0131
    110465008
    UMLS CUI 2011AA
    C0013227
    UMLS CUI 2011AA
    C0205394
    SNOMED CT 2011_0131
    74964007
    UMLS CUI 2011AA
    C0392920
    SNOMED CT 2011_0131
    150415003
    UMLS CUI 2011AA
    C0021083
    SNOMED CT 2011_0131
    146638005
    Contraindications for cytarabine treatment according to the summary of product characteristics (SPC).
    Descrição

    Contraindications for cytarabine treatment according to the summary of product characteristics (SPC).

    Tipo de dados

    boolean

    Alias
    UMLS CUI 2011AA
    C1301624
    SNOMED CT 2011_0131
    397745006
    UMLS CUI 2011AA
    C0010711
    SNOMED CT 2011_0131
    89265009
    UMLS CUI 2011AA
    C0039798
    UMLS CUI 2011AA
    C0680240
    UMLS CUI 2011AA
    C1709515
    Patients who are sexually active and unwilling to use a medically acceptable method of contraception during the trial (hormonal contraception, intrauterine device, condom with spermicide, etc.).
    Descrição

    Patients who are sexually active and unwilling to use a medically acceptable method of contraception during the trial (hormonal contraception, intrauterine device, condom with spermicide, etc.).

    Tipo de dados

    boolean

    Alias
    UMLS CUI 2011AA
    C0241028
    SNOMED CT 2011_0131
    228453005
    MedDRA 14.1
    10066098
    UMLS CUI 2011AA
    C0030705
    SNOMED CT 2011_0131
    116154003
    UMLS CUI 2011AA
    C1518422
    UMLS CUI 2011AA
    C0600109
    SNOMED CT 2011_0131
    225466006
    UMLS CUI 2011AA
    C1524063
    SNOMED CT 2011_0131
    260676000
    UMLS CUI 2011AA
    C0700589
    SNOMED CT 2011_0131
    146680009
    MedDRA 14.1
    10010808
    UMLS CUI 2011AA
    C0347984
    SNOMED CT 2011_0131
    371881003
    UMLS CUI 2011AA
    C0008976
    SNOMED CT 2011_0131
    110465008
    UMLS CUI 2011AA
    CL424941
    UMLS CUI 2011AA
    C0021900
    SNOMED CT 2011_0131
    268460000
    MedDRA 14.1
    10022745
    UMLS CUI 2011AA
    C0677582
    UMLS CUI 2011AA
    C0037862
    SNOMED CT 2011_0131
    425484006
    Pregnant or nursing female patients.
    Descrição

    Pregnant or nursing female patients.

    Tipo de dados

    boolean

    Alias
    UMLS CUI 2011AA
    C0086287
    SNOMED CT 2011_0131
    248152002
    HL7 V3 2006_05
    F
    UMLS CUI 2011AA
    C0549206
    MedDRA 14.1
    10036586
    UMLS CUI 2011AA
    C0006147
    MedDRA 14.1
    10006247
    Patient unable to comply with the protocol.
    Descrição

    Patient unable to comply with the protocol.

    Tipo de dados

    boolean

    Alias
    UMLS CUI 2011AA
    C1321605
    SNOMED CT 2011_0131
    371151008
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    Eligibility

    1 Formulários
    1. StudyEvent: Eligibility
      1. Eligibility
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    Einschlusskriterien
    CL425202 (UMLS CUI 2011AA)
    age at least 18 Years
    Item
    Alter mindestens 18 Jahre
    boolean
    C0001779 (UMLS CUI 2011AA)
    397669002 (SNOMED CT 2011_0131)
    Male or female adult with previously untreated acute myeloid leukaemia (AML)
    Item
    Male or female adult with previously untreated acute myeloid leukaemia (AML)
    boolean
    C0086582 (UMLS CUI 2011AA)
    248153007 (SNOMED CT 2011_0131)
    M (HL7 V3 2006_05)
    C0086287 (UMLS CUI 2011AA)
    248152002 (SNOMED CT 2011_0131)
    F (HL7 V3 2006_05)
    C0001675 (UMLS CUI 2011AA)
    133936004 (SNOMED CT 2011_0131)
    C0205156 (UMLS CUI 2011AA)
    9130008 (SNOMED CT 2011_0131)
    C1518422 (UMLS CUI 2011AA)
    CL415147 (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)
    Confirmed diagnosis of AML according to the WHO definition (except for acute promyelocytic leukaemia, APL)
    Item
    Confirmed diagnosis of AML according to the WHO definition (except for acute promyelocytic leukaemia, APL)
    boolean
    C0750484 (UMLS CUI 2011AA)
    C0011900 (UMLS CUI 2011AA)
    439401001 (SNOMED CT 2011_0131)
    MTHU008876 (LOINC Version 232)
    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)
    C0680240 (UMLS CUI 2011AA)
    C0043237 (UMLS CUI 2011AA)
    C1704788 (UMLS CUI 2011AA)
    C1554961 (UMLS CUI 2011AA)
    E (HL7 V3 2006_05)
    C0023487 (UMLS CUI 2011AA)
    110004001 (SNOMED CT 2011_0131)
    10001019 (MedDRA 14.1)
    C92.4 (ICD-10-CM Version 2010)
    Patient is considered ineligible for intensive treatment
    Item
    Patient is considered ineligible for intensive treatment
    boolean
    C0022423 (UMLS CUI 2011AA)
    61254005 (SNOMED CT 2011_0131)
    C0030705 (UMLS CUI 2011AA)
    116154003 (SNOMED CT 2011_0131)
    C1518422 (UMLS CUI 2011AA)
    C1548635 (UMLS CUI 2011AA)
    ELG (HL7 V3 2006_05)
    C0522510 (UMLS CUI 2011AA)
    103370009 (SNOMED CT 2011_0131)
    C0039798 (UMLS CUI 2011AA)
    Patient is eligible for low-dose cytarabine (LD-Ara-C) treatment
    Item
    Patient is eligible for low-dose cytarabine (LD-Ara-C) treatment
    boolean
    C0030705 (UMLS CUI 2011AA)
    116154003 (SNOMED CT 2011_0131)
    C1548635 (UMLS CUI 2011AA)
    C1708745 (UMLS CUI 2011AA)
    C0010711 (UMLS CUI 2011AA)
    89265009 (SNOMED CT 2011_0131)
    Life expectancy > 3 months
    Item
    Life expectancy > 3 months
    boolean
    C0023671 (UMLS CUI 2011AA)
    LP75025-4 (LOINC Version 232)
    C2825406 (UMLS CUI 2011AA)
    C0439234 (UMLS CUI 2011AA)
    258707000 (SNOMED CT 2011_0131)
    Y (HL7 V3 2006_05)
    Eastern co-operative oncology group (ECOG, R01-0787) performance score <=2 at screening
    Item
    Eastern co-operative oncology group (ECOG, R01-0787) performance score <=2 at screening
    boolean
    C1828127 (UMLS CUI 2011AA)
    424122007 (SNOMED CT 2011_0131)
    C1520224 (UMLS CUI 2011AA)
    423740007 (SNOMED CT 2011_0131)
    10067961 (MedDRA 14.1)
    C1409616 (UMLS CUI 2011AA)
    Signed written informed consent consistent with international conference on harmonisation good clinical practice (ICH-GCP) and local legislation
    Item
    Signed written informed consent consistent with international conference on harmonisation good clinical practice (ICH-GCP) and local legislation
    boolean
    C1561610 (UMLS CUI 2011AA)
    C0600657 (UMLS CUI 2011AA)
    Item Group
    Ausschlusskriterien
    CL425201 (UMLS CUI 2011AA)
    Patient with APL (AML subtype M3 according to the French-American-British (FAB) classification).
    Item
    Patient with APL (AML subtype M3 according to the French-American-British (FAB) classification).
    boolean
    C0023487 (UMLS CUI 2011AA)
    110004001 (SNOMED CT 2011_0131)
    10001019 (MedDRA 14.1)
    C92.4 (ICD-10-CM Version 2010)
    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)
    C0449560 (UMLS CUI 2011AA)
    260837004 (SNOMED CT 2011_0131)
    C0680240 (UMLS CUI 2011AA)
    CL421536 (UMLS CUI 2011AA)
    Relapsed or treatment refractory AML.
    Item
    Relapsed or treatment refractory AML.
    boolean
    C0278780 (UMLS CUI 2011AA)
    C0039798 (UMLS CUI 2011AA)
    C0205269 (UMLS CUI 2011AA)
    20646008 (SNOMED CT 2011_0131)
    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)
    Hypersensitivity to one of the trial drugs or the excipients.
    Item
    Hypersensitivity to one of the trial drugs or the excipients.
    boolean
    C0020517 (UMLS CUI 2011AA)
    418634005 (SNOMED CT 2011_0131)
    T78.40 (ICD-10-CM Version 2010)
    C0008976 (UMLS CUI 2011AA)
    110465008 (SNOMED CT 2011_0131)
    C0013227 (UMLS CUI 2011AA)
    C0015237 (UMLS CUI 2011AA)
    360215002 (SNOMED CT 2011_0131)
    Other malignancy requiring treatment.
    Item
    Other malignancy requiring treatment.
    boolean
    C0205394 (UMLS CUI 2011AA)
    74964007 (SNOMED CT 2011_0131)
    C0006826 (UMLS CUI 2011AA)
    363346000 (SNOMED CT 2011_0131)
    10028997 (MedDRA 14.1)
    MTHU010328 (LOINC Version 232)
    C00-C96 (ICD-10-CM Version 2010)
    C1514873 (UMLS CUI 2011AA)
    C0039798 (UMLS CUI 2011AA)
    Known central nervous system involvement.
    Item
    Known central nervous system involvement.
    boolean
    C0205309 (UMLS CUI 2011AA)
    36692007 (SNOMED CT 2011_0131)
    C0449389 (UMLS CUI 2011AA)
    260766009 (SNOMED CT 2011_0131)
    Aspartate amino transferase (AST) or alanine amino transferase (ALT) > 2.5 times the upper limit of normal (ULN).
    Item
    Aspartate amino transferase (AST) or alanine amino transferase (ALT) > 2.5 times the upper limit of normal (ULN).
    boolean
    C0004002 (UMLS CUI 2011AA)
    26091008 (SNOMED CT 2011_0131)
    MTHU004883 (LOINC Version 232)
    C0001899 (UMLS CUI 2011AA)
    56935002 (SNOMED CT 2011_0131)
    MTHU006766 (LOINC Version 232)
    C1632851 (UMLS CUI 2011AA)
    417929005 (SNOMED CT 2011_0131)
    C1519815 (UMLS CUI 2011AA)
    INR > 1.5 x ULN for subjects not on therapeutic vitamin K antagonists (phenprocoumon, warfarin).
    Item
    INR > 1.5 x ULN for subjects not on therapeutic vitamin K antagonists (phenprocoumon, warfarin).
    boolean
    C0525032 (UMLS CUI 2011AA)
    165581004 (SNOMED CT 2011_0131)
    10022400 (MedDRA 14.1)
    C1519815 (UMLS CUI 2011AA)
    C1518422 (UMLS CUI 2011AA)
    C1611640 (UMLS CUI 2011AA)
    5487002 (SNOMED CT 2011_0131)
    THER (HL7 V3 2006_05)
    C1096489 (UMLS CUI 2011AA)
    10053755 (MedDRA 14.1)
    C0031444 (UMLS CUI 2011AA)
    59488002 (SNOMED CT 2011_0131)
    MTHU016364 (LOINC Version 232)
    C0043031 (UMLS CUI 2011AA)
    48603004 (SNOMED CT 2011_0131)
    MTHU003212 (LOINC Version 232)
    Bilirubin > 1.5 mg/dl.
    Item
    Bilirubin
    boolean
    C1278039 (UMLS CUI 2011AA)
    79706000 (SNOMED CT 2011_0131)
    1975-2 (LOINC Version 232)
    Serum creatinine > 2.0 mg/dl.
    Item
    Kreatinin im Serum
    boolean
    C0201976 (UMLS CUI 2011AA)
    113075003 (SNOMED CT 2011_0131)
    10040230 (MedDRA 14.1)
    LVEF (Left ventricular ejection fraction) < 50% in echocardiography or clinical congestive heart failure New York Heart Association (NYHA) grade III or IV.
    Item
    LVEF (Left ventricular ejection fraction) < 50% in echocardiography or clinical congestive heart failure New York Heart Association (NYHA) grade III or IV.
    boolean
    C0428772 (UMLS CUI 2011AA)
    250908004 (SNOMED CT 2011_0131)
    10069170 (MedDRA 14.1)
    C0013516 (UMLS CUI 2011AA)
    40701008 (SNOMED CT 2011_0131)
    10014116 (MedDRA 14.1)
    88.72 (ICD-9-CM Version 2011)
    C0205210 (UMLS CUI 2011AA)
    58147004 (SNOMED CT 2011_0131)
    C0018802 (UMLS CUI 2011AA)
    42343007 (SNOMED CT 2011_0131)
    10007559 (MedDRA 14.1)
    MTHU020787 (LOINC Version 232)
    I50.9 (ICD-10-CM Version 2010)
    428.0 (ICD-9-CM Version 2011)
    C1319795 (UMLS CUI 2011AA)
    420913000 (SNOMED CT 2011_0131)
    10064081 (MedDRA 14.1)
    C1319796 (UMLS CUI 2011AA)
    422293003 (SNOMED CT 2011_0131)
    10064082 (MedDRA 14.1)
    Concomitant intercurrent illness, which would compromise the evaluation of efficacy or safety of the trial drug, e.g. active severe infection, unstable angina pectoris or cardiac arrhythmia.
    Item
    Concomitant intercurrent illness, which would compromise the evaluation of efficacy or safety of the trial drug, e.g. active severe infection, unstable angina pectoris or cardiac arrhythmia.
    boolean
    C0243087 (UMLS CUI 2011AA)
    C0277557 (UMLS CUI 2011AA)
    88472004 (SNOMED CT 2011_0131)
    C0221099 (UMLS CUI 2011AA)
    260379002 (SNOMED CT 2011_0131)
    C0220825 (UMLS CUI 2011AA)
    C1280519 (UMLS CUI 2011AA)
    255403003 (SNOMED CT 2011_0131)
    C0036043 (UMLS CUI 2011AA)
    C0008976 (UMLS CUI 2011AA)
    110465008 (SNOMED CT 2011_0131)
    C0013227 (UMLS CUI 2011AA)
    C0205177 (UMLS CUI 2011AA)
    55561003 (SNOMED CT 2011_0131)
    C0205082 (UMLS CUI 2011AA)
    24484000 (SNOMED CT 2011_0131)
    C0009450 (UMLS CUI 2011AA)
    257551009 (SNOMED CT 2011_0131)
    10021789 (MedDRA 14.1)
    C0002965 (UMLS CUI 2011AA)
    4557003 (SNOMED CT 2011_0131)
    10002388 (MedDRA 14.1)
    I20.0 (ICD-10-CM Version 2010)
    411.1 (ICD-9-CM Version 2011)
    C0003811 (UMLS CUI 2011AA)
    44808001 (SNOMED CT 2011_0131)
    10003119 (MedDRA 14.1)
    427.9 (ICD-9-CM Version 2011)
    Psychiatric illness or social situation that would limit compliance with trial requirements.
    Item
    Psychiatric illness or social situation that would limit compliance with trial requirements.
    boolean
    C0004936 (UMLS CUI 2011AA)
    74732009 (SNOMED CT 2011_0131)
    10037174 (MedDRA 14.1)
    F99 (ICD-10-CM Version 2010)
    290-319.99 (ICD-9-CM Version 2011)
    C0851364 (UMLS CUI 2011AA)
    10041244 (MedDRA 14.1)
    C0439801 (UMLS CUI 2011AA)
    255469002 (SNOMED CT 2011_0131)
    C1321605 (UMLS CUI 2011AA)
    405078008 (SNOMED CT 2011_0131)
    C0008976 (UMLS CUI 2011AA)
    110465008 (SNOMED CT 2011_0131)
    C1514873 (UMLS CUI 2011AA)
    Concomitant therapy, which is considered relevant for the evaluation of the efficacy or safety of the trial drug (i.e. other chemo- or immunotherapy, see also section 4.2.2).
    Item
    Concomitant therapy, which is considered relevant for the evaluation of the efficacy or safety of the trial drug (i.e. other chemo- or immunotherapy, see also section 4.2.2).
    boolean
    C1707479 (UMLS CUI 2011AA)
    C0022423 (UMLS CUI 2011AA)
    61254005 (SNOMED CT 2011_0131)
    C2347946 (UMLS CUI 2011AA)
    C0220825 (UMLS CUI 2011AA)
    C1280519 (UMLS CUI 2011AA)
    255403003 (SNOMED CT 2011_0131)
    C0036043 (UMLS CUI 2011AA)
    C0008976 (UMLS CUI 2011AA)
    110465008 (SNOMED CT 2011_0131)
    C0013227 (UMLS CUI 2011AA)
    C0205394 (UMLS CUI 2011AA)
    74964007 (SNOMED CT 2011_0131)
    C0392920 (UMLS CUI 2011AA)
    150415003 (SNOMED CT 2011_0131)
    C0021083 (UMLS CUI 2011AA)
    146638005 (SNOMED CT 2011_0131)
    Contraindications for cytarabine treatment according to the summary of product characteristics (SPC).
    Item
    Contraindications for cytarabine treatment according to the summary of product characteristics (SPC).
    boolean
    C1301624 (UMLS CUI 2011AA)
    397745006 (SNOMED CT 2011_0131)
    C0010711 (UMLS CUI 2011AA)
    89265009 (SNOMED CT 2011_0131)
    C0039798 (UMLS CUI 2011AA)
    C0680240 (UMLS CUI 2011AA)
    C1709515 (UMLS CUI 2011AA)
    Patients who are sexually active and unwilling to use a medically acceptable method of contraception during the trial (hormonal contraception, intrauterine device, condom with spermicide, etc.).
    Item
    Patients who are sexually active and unwilling to use a medically acceptable method of contraception during the trial (hormonal contraception, intrauterine device, condom with spermicide, etc.).
    boolean
    C0241028 (UMLS CUI 2011AA)
    228453005 (SNOMED CT 2011_0131)
    10066098 (MedDRA 14.1)
    C0030705 (UMLS CUI 2011AA)
    116154003 (SNOMED CT 2011_0131)
    C1518422 (UMLS CUI 2011AA)
    C0600109 (UMLS CUI 2011AA)
    225466006 (SNOMED CT 2011_0131)
    C1524063 (UMLS CUI 2011AA)
    260676000 (SNOMED CT 2011_0131)
    C0700589 (UMLS CUI 2011AA)
    146680009 (SNOMED CT 2011_0131)
    10010808 (MedDRA 14.1)
    C0347984 (UMLS CUI 2011AA)
    371881003 (SNOMED CT 2011_0131)
    C0008976 (UMLS CUI 2011AA)
    110465008 (SNOMED CT 2011_0131)
    CL424941 (UMLS CUI 2011AA)
    C0021900 (UMLS CUI 2011AA)
    268460000 (SNOMED CT 2011_0131)
    10022745 (MedDRA 14.1)
    C0677582 (UMLS CUI 2011AA)
    C0037862 (UMLS CUI 2011AA)
    425484006 (SNOMED CT 2011_0131)
    Pregnant or nursing female patients.
    Item
    Pregnant or nursing female patients.
    boolean
    C0086287 (UMLS CUI 2011AA)
    248152002 (SNOMED CT 2011_0131)
    F (HL7 V3 2006_05)
    C0549206 (UMLS CUI 2011AA)
    10036586 (MedDRA 14.1)
    C0006147 (UMLS CUI 2011AA)
    10006247 (MedDRA 14.1)
    Patient unable to comply with the protocol.
    Item
    Patient unable to comply with the protocol.
    boolean
    C1321605 (UMLS CUI 2011AA)
    371151008 (SNOMED CT 2011_0131)
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