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ID

44592

Beschreibung

ODM derived from http://clinicaltrials.gov/show/NCT01018069

Link

http://clinicaltrials.gov/show/NCT01018069

Stichworte

  1. 07.12.13 07.12.13 - Martin Dugas
  2. 17.04.14 17.04.14 - Julian Varghese
  3. 27.09.21 27.09.21 -
Hochgeladen am

27. September 2021

DOI

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    Eligibility NCT01018069 Leukemia

    Eligibility

    1. StudyEvent: Eligibility
      1. Eligibility
    Einschlusskriterien
    Beschreibung

    Einschlusskriterien

    Alias
    UMLS CUI 2011AA
    CL425202
    Alter mindestens 18 Jahre
    Beschreibung

    age at least 18 Years

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0001779
    SNOMED CT 2011_0131
    397669002
    Patients with AML, except those with APL (acute promyelocytic leukemia), failing a single standard dose cytarabine based frontline induction regimen. The diagnosis of refractory AML is based on the presence of either > 10% blasts in marrow or blood or 5-10% blasts in either site together with cytopenia (Hb < 10 g/dL, or platelets < 100 x 109/L, or neutrophil count < 1.0 x 109/L).
    Beschreibung

    Patients with AML, except those with APL (acute promyelocytic leukemia), failing a single standard dose cytarabine based frontline induction regimen. The diagnosis of refractory AML is based on the presence of either > 10% blasts in marrow or blood or 5-10% blasts in either site together with cytopenia (Hb < 10 g/dL, or platelets < 100 x 109/L, or neutrophil count < 1.0 x 109/L).

    Datentyp

    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
    C0011900
    SNOMED CT 2011_0131
    439401001
    LOINC Version 232
    MTHU008876
    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
    UMLS CUI 2011AA
    C0231175
    UMLS CUI 2011AA
    C0205171
    SNOMED CT 2011_0131
    50607009
    UMLS CUI 2011AA
    C2828392
    UMLS CUI 2011AA
    C0178602
    SNOMED CT 2011_0131
    260911001
    UMLS CUI 2011AA
    C0010711
    SNOMED CT 2011_0131
    89265009
    UMLS CUI 2011AA
    C0600558
    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
    UMLS CUI 2011AA
    C0010828
    SNOMED CT 2011_0131
    50820005
    MedDRA 14.1
    10066274
    UMLS CUI 2011AA
    C0019046
    SNOMED CT 2011_0131
    38082009
    MedDRA 14.1
    10019481
    LOINC Version 232
    LP14449-0
    UMLS CUI 2011AA
    C0005821
    SNOMED CT 2011_0131
    16378004
    LOINC Version 232
    MTHU002432
    UMLS CUI 2011AA
    C0200633
    SNOMED CT 2011_0131
    30630007
    MedDRA 14.1
    10029363
    ECOG Status <=2
    Beschreibung

    Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of <=2.

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C1520224
    SNOMED CT 2011_0131
    424122007
    Male, or female patients who are post-menopausal (amenorrheic for at least 12 months), or surgically or biologically sterile.
    Beschreibung

    Male, or female patients who are post-menopausal (amenorrheic for at least 12 months), or surgically or biologically sterile.

    Datentyp

    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
    C0232970
    SNOMED CT 2011_0131
    76498008
    UMLS CUI 2011AA
    C0002453
    SNOMED CT 2011_0131
    14302001
    MedDRA 14.1
    10001928
    ICD-10-CM Version 2010
    N91.2
    ICD-9-CM Version 2011
    626.0
    UMLS CUI 2011AA
    C0543467
    SNOMED CT 2011_0131
    83578000
    MedDRA 14.1
    10051332
    LOINC Version 232
    MTHU000079
    UMLS CUI 2011AA
    C0205460
    SNOMED CT 2011_0131
    12893009
    UMLS CUI 2011AA
    C0021359
    SNOMED CT 2011_0131
    8619003
    MedDRA 14.1
    10021926
    Patients must have adequate organ and immune function as indicated by the following laboratory values:
    Beschreibung

    Patients must have adequate organ and immune function as indicated by the following laboratory values:

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0205411
    SNOMED CT 2011_0131
    88323005
    UMLS CUI 2011AA
    C0678852
    UMLS CUI 2011AA
    C1817756
    SNOMED CT 2011_0131
    106183005
    UMLS CUI 2011AA
    C1444656
    SNOMED CT 2011_0131
    410535002
    UMLS CUI 2011AA
    C0332282
    SNOMED CT 2011_0131
    255260001
    UMLS CUI 2011AA
    C0022877
    SNOMED CT 2011_0131
    261904005
    LOINC Version 232
    MTHU029808
    UMLS CUI 2011AA
    C1522609
    Parameter Laboratory Values Serum creatinine; ≤2.0 mg/dL (≤ 177 μmol/L Total Bilirubin ≤2.0 mg/dL (≤ 34 μmol/L) AST (SGOT) and ALT (SGPT) ≤3 X ULN
    Beschreibung

    Parameter Laboratory Values Serum creatinine; ≤2.0 mg/dL (≤ 177 μmol/L Total Bilirubin ≤2.0 mg/dL (≤ 34 μmol/L) AST (SGOT) and ALT (SGPT) ≤3 X ULN

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0201976
    SNOMED CT 2011_0131
    113075003
    MedDRA 14.1
    10040230
    UMLS CUI 2011AA
    C0201913
    SNOMED CT 2011_0131
    359986008
    MedDRA 14.1
    10004696
    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
    C1519815
    The patient must understand, be able and willing and likely to fully comply with study procedures, including scheduled follow-up, and restrictions.
    Beschreibung

    The patient must understand, be able and willing and likely to fully comply with study procedures, including scheduled follow-up, and restrictions.

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C1273101
    SNOMED CT 2011_0131
    395659009
    UMLS CUI 2011AA
    C1321605
    SNOMED CT 2011_0131
    405078008
    UMLS CUI 2011AA
    C0680734
    UMLS CUI 2011AA
    C1522577
    UMLS CUI 2011AA
    CL357089
    Ausschlusskriterien
    Beschreibung

    Ausschlusskriterien

    Alias
    UMLS CUI 2011AA
    CL425201
    Clinical evidence of ongoing grade 3 or 4 non-hematological toxicities from the initial standard dose cytarabine-based induction chemotherapy
    Beschreibung

    Clinical evidence of ongoing grade 3 or 4 non-hematological toxicities from the initial standard dose cytarabine-based induction chemotherapy

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0549178
    UMLS CUI 2011AA
    C1518422
    UMLS CUI 2011AA
    C0205488
    SNOMED CT 2011_0131
    57407000
    UMLS CUI 2011AA
    C2826262
    UMLS CUI 2011AA
    C0205449
    SNOMED CT 2011_0131
    421291004
    UMLS CUI 2011AA
    C0205450
    SNOMED CT 2011_0131
    9362000
    UMLS CUI 2011AA
    C0010711
    SNOMED CT 2011_0131
    89265009
    UMLS CUI 2011AA
    C0205263
    SNOMED CT 2011_0131
    16404004
    UMLS CUI 2011AA
    C0392920
    SNOMED CT 2011_0131
    150415003
    Patients with a prior history of peripheral neuropathy of grade >= 2.
    Beschreibung

    Patients with a prior history of peripheral neuropathy of grade >= 2.

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    CL421546
    SNOMED CT 2011_0131
    392521001
    UMLS CUI 2011AA
    C0031117
    MedDRA 14.1
    10029331
    ICD-10-CM Version 2010
    G64
    ICD-9-CM Version 2011
    350-359.99
    UMLS CUI 2011AA
    C0441800
    SNOMED CT 2011_0131
    258349007
    LOINC Version 232
    MTHU003112
    Clinical evidence of active CNS leukemic involvement.
    Beschreibung

    Clinical evidence of active CNS leukemic involvement.

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0205177
    SNOMED CT 2011_0131
    55561003
    UMLS CUI 2011AA
    C1332884
    SNOMED CT 2011_0131
    10067299
    UMLS CUI 2011AA
    C1314939
    SNOMED CT 2011_0131
    248448006
    Active and uncontrolled infection. Patients with an infection who are under active treatment with antibiotics and whose infections are controlled may be entered to the study.
    Beschreibung

    Active and uncontrolled infection. Patients with an infection who are under active treatment with antibiotics and whose infections are controlled may be entered to the study.

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0009450
    Current evidence of invasive fungal infection (blood or tissue culture).
    Beschreibung

    Current evidence of invasive fungal infection (blood or tissue culture).

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0205281
    SNOMED CT 2011_0131
    10179008
    UMLS CUI 2011AA
    C0026946
    SNOMED CT 2011_0131
    3218000
    MedDRA 14.1
    10017533
    ICD-10-CM Version 2010
    B35-B49
    ICD-9-CM Version 2011
    110-118.99
    UMLS CUI 2011AA
    C0200949
    SNOMED CT 2011_0131
    30088009
    MedDRA 14.1
    10005485
    ICD-9-CM Version 2011
    90.52
    UMLS CUI 2011AA
    C0040284
    SNOMED CT 2011_0131
    77601007
    Current evidence of an active second malignancy except for non-melanoma skin cancer.
    Beschreibung

    Current evidence of an active second malignancy except for non-melanoma skin cancer.

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0205177
    SNOMED CT 2011_0131
    55561003
    UMLS CUI 2011AA
    C0085183
    UMLS CUI 2011AA
    C1554961
    HL7 V3 2006_05
    E
    UMLS CUI 2011AA
    C0699893
    MedDRA 14.1
    10040810
    Uncontrolled medical problems, unrelated to the malignancy, or of sufficient severity that in the opinion of the investigator, impair a patient's ability to give informed consent or unacceptably reduce the safety of the proposed treatment.
    Beschreibung

    Uncontrolled medical problems, unrelated to the malignancy, or of sufficient severity that in the opinion of the investigator, impair a patient's ability to give informed consent or unacceptably reduce the safety of the proposed treatment.

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C1522577
    Neurological or psychiatric disorders that would interfere with consent or study follow-up.
    Beschreibung

    Neurological or psychiatric disorders that would interfere with consent or study follow-up.

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0021430
    Known or suspected intolerance or hypersensitivity to the study drugs [or closely related compounds] or any of their stated ingredients. Study drugs being the antisense, cytarabine and idarubicin.
    Beschreibung

    Known or suspected intolerance or hypersensitivity to the study drugs [or closely related compounds] or any of their stated ingredients. Study drugs being the antisense, cytarabine and idarubicin.

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C1744706
    UMLS CUI 2011AA
    C0020517
    SNOMED CT 2011_0131
    418634005
    ICD-10-CM Version 2010
    T78.40
    UMLS CUI 2011AA
    C0304229
    SNOMED CT 2011_0131
    902003
    UMLS CUI 2011AA
    CL414967
    UMLS CUI 2011AA
    C0079925
    UMLS CUI 2011AA
    C0010711
    SNOMED CT 2011_0131
    89265009
    UMLS CUI 2011AA
    C0020789
    SNOMED CT 2011_0131
    372539000
    History of alcohol or other substance abuse within the last year.
    Beschreibung

    History of alcohol or other substance abuse within the last year.

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0085762
    Use of another investigational agent within the last 14 days prior to enrolment. Patients who have received a previous antisense agent in the last 90 days will be excluded.
    Beschreibung

    Use of another investigational agent within the last 14 days prior to enrolment. Patients who have received a previous antisense agent in the last 90 days will be excluded.

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C1524063
    SNOMED CT 2011_0131
    260676000
    UMLS CUI 2011AA
    C0205394
    SNOMED CT 2011_0131
    74964007
    UMLS CUI 2011AA
    C0013230
    UMLS CUI 2011AA
    C0205448
    SNOMED CT 2011_0131
    19338005
    UMLS CUI 2011AA
    C0439230
    SNOMED CT 2011_0131
    258705008
    HL7 V3 2006_05
    WK
    UMLS CUI 2011AA
    C0332152
    SNOMED CT 2011_0131
    288556008
    UMLS CUI 2011AA
    C1516879
    Female patients who are pregnant, lactating, or with a positive pregnancy test at screening must be excluded.
    Beschreibung

    Female patients who are pregnant, lactating, or with a positive pregnancy test at screening must be excluded.

    Datentyp

    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
    C2828358
    UMLS CUI 2011AA
    C0240802
    SNOMED CT 2011_0131
    250423000
    MedDRA 14.1
    10036575
    UMLS CUI 2011AA
    C1409616

    Ähnliche Modelle

    Eligibility

    1. StudyEvent: Eligibility
      1. Eligibility
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    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)
    Patients with AML, except those with APL (acute promyelocytic leukemia), failing a single standard dose cytarabine based frontline induction regimen. The diagnosis of refractory AML is based on the presence of either > 10% blasts in marrow or blood or 5-10% blasts in either site together with cytopenia (Hb < 10 g/dL, or platelets < 100 x 109/L, or neutrophil count < 1.0 x 109/L).
    Item
    Patients with AML, except those with APL (acute promyelocytic leukemia), failing a single standard dose cytarabine based frontline induction regimen. The diagnosis of refractory AML is based on the presence of either > 10% blasts in marrow or blood or 5-10% blasts in either site together with cytopenia (Hb < 10 g/dL, or platelets < 100 x 109/L, or neutrophil count < 1.0 x 109/L).
    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)
    C0011900 (UMLS CUI 2011AA)
    439401001 (SNOMED CT 2011_0131)
    MTHU008876 (LOINC Version 232)
    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)
    C0231175 (UMLS CUI 2011AA)
    C0205171 (UMLS CUI 2011AA)
    50607009 (SNOMED CT 2011_0131)
    C2828392 (UMLS CUI 2011AA)
    C0178602 (UMLS CUI 2011AA)
    260911001 (SNOMED CT 2011_0131)
    C0010711 (UMLS CUI 2011AA)
    89265009 (SNOMED CT 2011_0131)
    C0600558 (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)
    C0010828 (UMLS CUI 2011AA)
    50820005 (SNOMED CT 2011_0131)
    10066274 (MedDRA 14.1)
    C0019046 (UMLS CUI 2011AA)
    38082009 (SNOMED CT 2011_0131)
    10019481 (MedDRA 14.1)
    LP14449-0 (LOINC Version 232)
    C0005821 (UMLS CUI 2011AA)
    16378004 (SNOMED CT 2011_0131)
    MTHU002432 (LOINC Version 232)
    C0200633 (UMLS CUI 2011AA)
    30630007 (SNOMED CT 2011_0131)
    10029363 (MedDRA 14.1)
    Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of <=2.
    Item
    ECOG Status <=2
    boolean
    C1520224 (UMLS CUI 2011AA)
    424122007 (SNOMED CT 2011_0131)
    Male, or female patients who are post-menopausal (amenorrheic for at least 12 months), or surgically or biologically sterile.
    Item
    Male, or female patients who are post-menopausal (amenorrheic for at least 12 months), or surgically or biologically sterile.
    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)
    C0232970 (UMLS CUI 2011AA)
    76498008 (SNOMED CT 2011_0131)
    C0002453 (UMLS CUI 2011AA)
    14302001 (SNOMED CT 2011_0131)
    10001928 (MedDRA 14.1)
    N91.2 (ICD-10-CM Version 2010)
    626.0 (ICD-9-CM Version 2011)
    C0543467 (UMLS CUI 2011AA)
    83578000 (SNOMED CT 2011_0131)
    10051332 (MedDRA 14.1)
    MTHU000079 (LOINC Version 232)
    C0205460 (UMLS CUI 2011AA)
    12893009 (SNOMED CT 2011_0131)
    C0021359 (UMLS CUI 2011AA)
    8619003 (SNOMED CT 2011_0131)
    10021926 (MedDRA 14.1)
    Patients must have adequate organ and immune function as indicated by the following laboratory values:
    Item
    Patients must have adequate organ and immune function as indicated by the following laboratory values:
    boolean
    C0205411 (UMLS CUI 2011AA)
    88323005 (SNOMED CT 2011_0131)
    C0678852 (UMLS CUI 2011AA)
    C1817756 (UMLS CUI 2011AA)
    106183005 (SNOMED CT 2011_0131)
    C1444656 (UMLS CUI 2011AA)
    410535002 (SNOMED CT 2011_0131)
    C0332282 (UMLS CUI 2011AA)
    255260001 (SNOMED CT 2011_0131)
    C0022877 (UMLS CUI 2011AA)
    261904005 (SNOMED CT 2011_0131)
    MTHU029808 (LOINC Version 232)
    C1522609 (UMLS CUI 2011AA)
    Parameter Laboratory Values Serum creatinine; ≤2.0 mg/dL (≤ 177 μmol/L Total Bilirubin ≤2.0 mg/dL (≤ 34 μmol/L) AST (SGOT) and ALT (SGPT) ≤3 X ULN
    Item
    Parameter Laboratory Values Serum creatinine; ≤2.0 mg/dL (≤ 177 μmol/L Total Bilirubin ≤2.0 mg/dL (≤ 34 μmol/L) AST (SGOT) and ALT (SGPT) ≤3 X ULN
    boolean
    C0201976 (UMLS CUI 2011AA)
    113075003 (SNOMED CT 2011_0131)
    10040230 (MedDRA 14.1)
    C0201913 (UMLS CUI 2011AA)
    359986008 (SNOMED CT 2011_0131)
    10004696 (MedDRA 14.1)
    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)
    C1519815 (UMLS CUI 2011AA)
    The patient must understand, be able and willing and likely to fully comply with study procedures, including scheduled follow-up, and restrictions.
    Item
    The patient must understand, be able and willing and likely to fully comply with study procedures, including scheduled follow-up, and restrictions.
    boolean
    C1273101 (UMLS CUI 2011AA)
    395659009 (SNOMED CT 2011_0131)
    C1321605 (UMLS CUI 2011AA)
    405078008 (SNOMED CT 2011_0131)
    C0680734 (UMLS CUI 2011AA)
    C1522577 (UMLS CUI 2011AA)
    CL357089 (UMLS CUI 2011AA)
    Item Group
    Ausschlusskriterien
    CL425201 (UMLS CUI 2011AA)
    Clinical evidence of ongoing grade 3 or 4 non-hematological toxicities from the initial standard dose cytarabine-based induction chemotherapy
    Item
    Clinical evidence of ongoing grade 3 or 4 non-hematological toxicities from the initial standard dose cytarabine-based induction chemotherapy
    boolean
    C0549178 (UMLS CUI 2011AA)
    C1518422 (UMLS CUI 2011AA)
    C0205488 (UMLS CUI 2011AA)
    57407000 (SNOMED CT 2011_0131)
    C2826262 (UMLS CUI 2011AA)
    C0205449 (UMLS CUI 2011AA)
    421291004 (SNOMED CT 2011_0131)
    C0205450 (UMLS CUI 2011AA)
    9362000 (SNOMED CT 2011_0131)
    C0010711 (UMLS CUI 2011AA)
    89265009 (SNOMED CT 2011_0131)
    C0205263 (UMLS CUI 2011AA)
    16404004 (SNOMED CT 2011_0131)
    C0392920 (UMLS CUI 2011AA)
    150415003 (SNOMED CT 2011_0131)
    Patients with a prior history of peripheral neuropathy of grade >= 2.
    Item
    Patients with a prior history of peripheral neuropathy of grade >= 2.
    boolean
    CL421546 (UMLS CUI 2011AA)
    392521001 (SNOMED CT 2011_0131)
    C0031117 (UMLS CUI 2011AA)
    10029331 (MedDRA 14.1)
    G64 (ICD-10-CM Version 2010)
    350-359.99 (ICD-9-CM Version 2011)
    C0441800 (UMLS CUI 2011AA)
    258349007 (SNOMED CT 2011_0131)
    MTHU003112 (LOINC Version 232)
    Clinical evidence of active CNS leukemic involvement.
    Item
    Clinical evidence of active CNS leukemic involvement.
    boolean
    C0205177 (UMLS CUI 2011AA)
    55561003 (SNOMED CT 2011_0131)
    C1332884 (UMLS CUI 2011AA)
    10067299 (SNOMED CT 2011_0131)
    C1314939 (UMLS CUI 2011AA)
    248448006 (SNOMED CT 2011_0131)
    Active and uncontrolled infection. Patients with an infection who are under active treatment with antibiotics and whose infections are controlled may be entered to the study.
    Item
    Active and uncontrolled infection. Patients with an infection who are under active treatment with antibiotics and whose infections are controlled may be entered to the study.
    boolean
    C0009450 (UMLS CUI 2011AA)
    Current evidence of invasive fungal infection (blood or tissue culture).
    Item
    Current evidence of invasive fungal infection (blood or tissue culture).
    boolean
    C0205281 (UMLS CUI 2011AA)
    10179008 (SNOMED CT 2011_0131)
    C0026946 (UMLS CUI 2011AA)
    3218000 (SNOMED CT 2011_0131)
    10017533 (MedDRA 14.1)
    B35-B49 (ICD-10-CM Version 2010)
    110-118.99 (ICD-9-CM Version 2011)
    C0200949 (UMLS CUI 2011AA)
    30088009 (SNOMED CT 2011_0131)
    10005485 (MedDRA 14.1)
    90.52 (ICD-9-CM Version 2011)
    C0040284 (UMLS CUI 2011AA)
    77601007 (SNOMED CT 2011_0131)
    Current evidence of an active second malignancy except for non-melanoma skin cancer.
    Item
    Current evidence of an active second malignancy except for non-melanoma skin cancer.
    boolean
    C0205177 (UMLS CUI 2011AA)
    55561003 (SNOMED CT 2011_0131)
    C0085183 (UMLS CUI 2011AA)
    C1554961 (UMLS CUI 2011AA)
    E (HL7 V3 2006_05)
    C0699893 (UMLS CUI 2011AA)
    10040810 (MedDRA 14.1)
    Uncontrolled medical problems, unrelated to the malignancy, or of sufficient severity that in the opinion of the investigator, impair a patient's ability to give informed consent or unacceptably reduce the safety of the proposed treatment.
    Item
    Uncontrolled medical problems, unrelated to the malignancy, or of sufficient severity that in the opinion of the investigator, impair a patient's ability to give informed consent or unacceptably reduce the safety of the proposed treatment.
    boolean
    C1522577 (UMLS CUI 2011AA)
    Neurological or psychiatric disorders that would interfere with consent or study follow-up.
    Item
    Neurological or psychiatric disorders that would interfere with consent or study follow-up.
    boolean
    C0021430 (UMLS CUI 2011AA)
    Known or suspected intolerance or hypersensitivity to the study drugs [or closely related compounds] or any of their stated ingredients. Study drugs being the antisense, cytarabine and idarubicin.
    Item
    Known or suspected intolerance or hypersensitivity to the study drugs [or closely related compounds] or any of their stated ingredients. Study drugs being the antisense, cytarabine and idarubicin.
    boolean
    C1744706 (UMLS CUI 2011AA)
    C0020517 (UMLS CUI 2011AA)
    418634005 (SNOMED CT 2011_0131)
    T78.40 (ICD-10-CM Version 2010)
    C0304229 (UMLS CUI 2011AA)
    902003 (SNOMED CT 2011_0131)
    CL414967 (UMLS CUI 2011AA)
    C0079925 (UMLS CUI 2011AA)
    C0010711 (UMLS CUI 2011AA)
    89265009 (SNOMED CT 2011_0131)
    C0020789 (UMLS CUI 2011AA)
    372539000 (SNOMED CT 2011_0131)
    History of alcohol or other substance abuse within the last year.
    Item
    History of alcohol or other substance abuse within the last year.
    boolean
    C0085762 (UMLS CUI 2011AA)
    Use of another investigational agent within the last 14 days prior to enrolment. Patients who have received a previous antisense agent in the last 90 days will be excluded.
    Item
    Use of another investigational agent within the last 14 days prior to enrolment. Patients who have received a previous antisense agent in the last 90 days will be excluded.
    boolean
    C1524063 (UMLS CUI 2011AA)
    260676000 (SNOMED CT 2011_0131)
    C0205394 (UMLS CUI 2011AA)
    74964007 (SNOMED CT 2011_0131)
    C0013230 (UMLS CUI 2011AA)
    C0205448 (UMLS CUI 2011AA)
    19338005 (SNOMED CT 2011_0131)
    C0439230 (UMLS CUI 2011AA)
    258705008 (SNOMED CT 2011_0131)
    WK (HL7 V3 2006_05)
    C0332152 (UMLS CUI 2011AA)
    288556008 (SNOMED CT 2011_0131)
    C1516879 (UMLS CUI 2011AA)
    Female patients who are pregnant, lactating, or with a positive pregnancy test at screening must be excluded.
    Item
    Female patients who are pregnant, lactating, or with a positive pregnancy test at screening must be excluded.
    boolean
    C0086287 (UMLS CUI 2011AA)
    248152002 (SNOMED CT 2011_0131)
    F (HL7 V3 2006_05)
    C0549206 (UMLS CUI 2011AA)
    10036586 (MedDRA 14.1)
    C2828358 (UMLS CUI 2011AA)
    C0240802 (UMLS CUI 2011AA)
    250423000 (SNOMED CT 2011_0131)
    10036575 (MedDRA 14.1)
    C1409616 (UMLS CUI 2011AA)

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