0 Bewertungen
ID

43377

Beschreibung

ODM derived from http://clinicaltrials.gov/show/NCT00560794

Link

http://clinicaltrials.gov/show/NCT00560794

Stichworte

Versionen (3)
  1. 10.12.13 10.12.13 - Martin Dugas
  2. 14.04.14 14.04.14 - Julian Varghese
  3. 20.09.21 20.09.21 -
Hochgeladen am

20. September 2021

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

  • Neueste
  • Älteste
  • Beliebt
  • Neueste
    • Neueste
    • Älteste
    • Beliebt

    Keine Kommentare

    Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

    Eligibility NCT00560794 Acute Lymphoblastic Leukemia

    Deutsch Englisch

    Eligibility

    1 Formulare  
    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
    B-precursor ALL patients in complete hematological remission with molecular failure or molecular relapse starting at any time after consolidation I of front-line therapy within GMALL standards or at any time outside GMALL standards.
    Beschreibung

    B-precursor ALL patients in complete hematological remission with molecular failure or molecular relapse starting at any time after consolidation I of front-line therapy within GMALL standards or at any time outside GMALL standards.

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C1292769
    SNOMED CT 2011_0131
    128823009
    MedDRA 14.1
    10003890
    UMLS CUI 2011AA
    C0011900
    SNOMED CT 2011_0131
    439401001
    LOINC Version 232
    MTHU008876
    UMLS CUI 2011AA
    C0677874
    SNOMED CT 2011_0131
    103338009
    UMLS CUI 2011AA
    C0205488
    SNOMED CT 2011_0131
    57407000
    UMLS CUI 2011AA
    CL414625
    UMLS CUI 2011AA
    C0277556
    SNOMED CT 2011_0131
    58184002
    UMLS CUI 2011AA
    C0231174
    SNOMED CT 2011_0131
    76797004
    UMLS CUI 2011AA
    C0702116
    SNOMED CT 2011_0131
    9656002
    UMLS CUI 2011AA
    C1708063
    Patients must have a molecular marker for evaluation of minimal residual disease which is either Bcr/abl at any detection level or individual rearrangements of immunoglobulin or TCR-genes measured by an assay with a sensitivity of minimum 10-4: At least one individual marker at a quantitative level 10-4.
    Beschreibung

    Patients must have a molecular marker for evaluation of minimal residual disease which is either Bcr/abl at any detection level or individual rearrangements of immunoglobulin or TCR-genes measured by an assay with a sensitivity of minimum 10-4: At least one individual marker at a quantitative level 10-4.

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0005516
    UMLS CUI 2011AA
    C0220825
    UMLS CUI 2011AA
    C0242596
    UMLS CUI 2011AA
    C0004891
    SNOMED CT 2011_0131
    56564003
    LOINC Version 232
    MTHU021298
    UMLS CUI 2011AA
    C1511790
    UMLS CUI 2011AA
    C0456079
    SNOMED CT 2011_0131
    276625007
    UMLS CUI 2011AA
    CL370615
    UMLS CUI 2011AA
    C1511695
    UMLS CUI 2011AA
    C0021027
    SNOMED CT 2011_0131
    399771004
    HL7 V3 2006_05
    14
    UMLS CUI 2011AA
    C0524889
    UMLS CUI 2011AA
    C0444706
    SNOMED CT 2011_0131
    258104002
    UMLS CUI 2011AA
    C1510438
    SNOMED CT 2011_0131
    272392009
    UMLS CUI 2011AA
    C0036667
    UMLS CUI 2011AA
    C1524031
    UMLS CUI 2011AA
    C0392762
    SNOMED CT 2011_0131
    30766002
    ECOG Status < 2
    Beschreibung

    ECOG Performance Status < 2

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C1520224
    SNOMED CT 2011_0131
    424122007
    Ability to understand and willingness to sign a written informed consent
    Beschreibung

    Ability to understand and willingness to sign a written informed consent

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0021430
    Signed and dated written informed consent is available
    Beschreibung

    Signed and dated written informed consent is available

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0021430
    Ausschlusskriterien
    Beschreibung

    Ausschlusskriterien

    Alias
    UMLS CUI 2011AA
    CL425201
    Current extra medullar involvement
    Beschreibung

    Current extra medullar involvement

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0521116
    SNOMED CT 2011_0131
    15240007
    UMLS CUI 2011AA
    C1517060
    UMLS CUI 2011AA
    C1314939
    SNOMED CT 2011_0131
    248448006
    History of or current relevant CNS pathology (except migraine/headache and/or previous infiltration of cerebrospinal fluid (CSF) by ALL)
    Beschreibung

    History of or current relevant CNS pathology (except migraine/headache and/or previous infiltration of cerebrospinal fluid (CSF) by ALL)

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    CL421546
    SNOMED CT 2011_0131
    392521001
    UMLS CUI 2011AA
    C0521116
    SNOMED CT 2011_0131
    15240007
    UMLS CUI 2011AA
    C2347946
    UMLS CUI 2011AA
    C0007682
    SNOMED CT 2011_0131
    23853001
    MedDRA 14.1
    10007943
    ICD-10-CM Version 2010
    G96.9
    UMLS CUI 2011AA
    C1554961
    HL7 V3 2006_05
    E
    UMLS CUI 2011AA
    C0149931
    SNOMED CT 2011_0131
    37796009
    MedDRA 14.1
    10027599
    ICD-10-CM Version 2010
    G43
    ICD-9-CM Version 2011
    346
    UMLS CUI 2011AA
    C0018681
    SNOMED CT 2011_0131
    25064002
    MedDRA 14.1
    10019211
    LOINC Version 232
    MTHU020860
    ICD-10-CM Version 2010
    R51
    ICD-9-CM Version 2011
    784.0
    CTCAE 1105E
    E12678
    UMLS CUI 2011AA
    C0205156
    SNOMED CT 2011_0131
    9130008
    UMLS CUI 2011AA
    C0332448
    SNOMED CT 2011_0131
    47351003
    UMLS CUI 2011AA
    C0007806
    SNOMED CT 2011_0131
    65216001
    LOINC Version 232
    MTHU001311
    HL7 V3 2006_05
    CSF
    UMLS CUI 2011AA
    C0023449
    SNOMED CT 2011_0131
    91857003, 128822004
    MedDRA 14.1
    10060390
    ICD-10-CM Version 2010
    C91.0
    ICD-9-CM Version 2011
    204.0
    Current infiltration of cerebrospinal fluid by ALL
    Beschreibung

    Current infiltration of cerebrospinal fluid by ALL

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0521116
    SNOMED CT 2011_0131
    15240007
    UMLS CUI 2011AA
    C0332448
    SNOMED CT 2011_0131
    47351003
    UMLS CUI 2011AA
    C0007806
    SNOMED CT 2011_0131
    65216001
    LOINC Version 232
    MTHU001311
    HL7 V3 2006_05
    CSF
    UMLS CUI 2011AA
    C0023449
    SNOMED CT 2011_0131
    91857003, 128822004
    MedDRA 14.1
    10060390
    ICD-10-CM Version 2010
    C91.0
    ICD-9-CM Version 2011
    204.0
    History of or current autoimmune disease
    Beschreibung

    History of or current autoimmune disease

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    CL421546
    SNOMED CT 2011_0131
    392521001
    UMLS CUI 2011AA
    C0521116
    SNOMED CT 2011_0131
    15240007
    UMLS CUI 2011AA
    C0004364
    SNOMED CT 2011_0131
    85828009
    MedDRA 14.1
    10061664
    ICD-10-CM Version 2010
    M30-M36
    CTCAE 1105E
    E11258
    Autologous stem cell transplantation within 6 weeks prior to study entry
    Beschreibung

    Autologous stem cell transplantation within 6 weeks prior to study entry

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C1831743
    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
    C2348558
    Any prior allogeneic stem cell transplantation
    Beschreibung

    Any prior allogeneic stem cell transplantation

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C2242529
    Cancer chemotherapy within 4 weeks prior to study treatment (except for intrathecal prophylaxis and/or low dose maintenance therapy such as vincalkaloids, mercaptopurine, methotrexate, steroids)
    Beschreibung

    Cancer chemotherapy within 4 weeks prior to study treatment (except for intrathecal prophylaxis and/or low dose maintenance therapy such as vincalkaloids, mercaptopurine, methotrexate, steroids)

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0392920
    SNOMED CT 2011_0131
    150415003
    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
    C0008976
    SNOMED CT 2011_0131
    110465008
    UMLS CUI 2011AA
    C0039798
    UMLS CUI 2011AA
    C1554961
    HL7 V3 2006_05
    E
    UMLS CUI 2011AA
    C0205527
    SNOMED CT 2011_0131
    72607000
    UMLS CUI 2011AA
    C0199176
    SNOMED CT 2011_0131
    360271000
    MedDRA 14.1
    10036898
    UMLS CUI 2011AA
    C1708745
    UMLS CUI 2011AA
    C0677908
    SNOMED CT 2011_0131
    314122007
    UMLS CUI 2011AA
    C0042672
    SNOMED CT 2011_0131
    61864009
    UMLS CUI 2011AA
    C0000618
    SNOMED CT 2011_0131
    386835005
    LOINC Version 232
    MTHU002562
    UMLS CUI 2011AA
    C0025677
    SNOMED CT 2011_0131
    387381009
    LOINC Version 232
    MTHU005020
    UMLS CUI 2011AA
    C0038317
    SNOMED CT 2011_0131
    116566001
    Radiotherapy within 4 weeks prior to study treatment
    Beschreibung

    Radiotherapy within 4 weeks prior to study treatment

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0034619
    UMLS CUI 2011AA
    C0439231
    SNOMED CT 2011_0131
    258706009
    HL7 V3 2006_05
    MO
    UMLS CUI 2011AA
    C0332152
    SNOMED CT 2011_0131
    288556008
    UMLS CUI 2011AA
    C0008976
    SNOMED CT 2011_0131
    110465008
    UMLS CUI 2011AA
    C0039798
    Therapy with monoclonal antibodies (Rituximab, MabCampath) within 6 weeks prior to study treatment
    Beschreibung

    Therapy with monoclonal antibodies (Rituximab, MabCampath) within 6 weeks prior to study treatment

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0039798
    UMLS CUI 2011AA
    C0003250
    SNOMED CT 2011_0131
    49616005
    UMLS CUI 2011AA
    C0732355
    SNOMED CT 2011_0131
    386919002
    UMLS CUI 2011AA
    C0383429
    SNOMED CT 2011_0131
    391864003
    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
    C0008976
    SNOMED CT 2011_0131
    110465008
    UMLS CUI 2011AA
    C0039798
    Known hypersensitivity to immunoglobulins or to any other component of the study drug formulation
    Beschreibung

    Known hypersensitivity to immunoglobulins or to any other component of the study drug formulation

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0205309
    SNOMED CT 2011_0131
    36692007
    UMLS CUI 2011AA
    C0020517
    SNOMED CT 2011_0131
    418634005
    ICD-10-CM Version 2010
    T78.40
    UMLS CUI 2011AA
    C0021027
    SNOMED CT 2011_0131
    399771004
    HL7 V3 2006_05
    14
    UMLS CUI 2011AA
    C0205394
    SNOMED CT 2011_0131
    74964007
    UMLS CUI 2011AA
    C1705248
    UMLS CUI 2011AA
    C0008976
    SNOMED CT 2011_0131
    110465008
    UMLS CUI 2011AA
    C1705957
    Presence of human anti-murine antibodies (HAMA)
    Beschreibung

    Presence of human anti-murine antibodies (HAMA)

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0150312
    SNOMED CT 2011_0131
    52101004
    UMLS CUI 2011AA
    C1291910
    SNOMED CT 2011_0131
    115628002
    LOINC Version 232
    MTHU003865
    Abnormal bone marrow, renal or hepatic function
    Beschreibung

    Abnormal bone marrow, renal or hepatic function

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0205161
    SNOMED CT 2011_0131
    263654008
    UMLS CUI 2011AA
    C0005953
    SNOMED CT 2011_0131
    14016003
    LOINC Version 232
    MTHU016536
    UMLS CUI 2011AA
    C0151746
    SNOMED CT 2011_0131
    39539005
    MedDRA 14.1
    10013902
    UMLS CUI 2011AA
    C0086565
    SNOMED CT 2011_0131
    75183008
    MedDRA 14.1
    10019670
    Indication for a hypercoagulative state
    Beschreibung

    Indication for a hypercoagulative state

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    CL335836
    UMLS CUI 2011AA
    C0398623
    MedDRA 14.1
    10020608
    History of malignancy other than ALL within 5 years prior to study entry, with the exception of basal cell carcinoma of the skin or cervix carcinoma in situ
    Beschreibung

    History of malignancy other than ALL within 5 years prior to study entry, with the exception of basal cell carcinoma of the skin or cervix carcinoma in situ

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    CL421546
    SNOMED CT 2011_0131
    392521001
    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
    CL411789
    UMLS CUI 2011AA
    C0023449
    SNOMED CT 2011_0131
    91857003, 128822004
    MedDRA 14.1
    10060390
    ICD-10-CM Version 2010
    C91.0
    ICD-9-CM Version 2011
    204.0
    UMLS CUI 2011AA
    C0439234
    SNOMED CT 2011_0131
    258707000
    HL7 V3 2006_05
    Y
    UMLS CUI 2011AA
    C0332152
    SNOMED CT 2011_0131
    288556008
    UMLS CUI 2011AA
    C2348558
    UMLS CUI 2011AA
    C1554961
    HL7 V3 2006_05
    E
    UMLS CUI 2011AA
    C0007117
    SNOMED CT 2011_0131
    1338007
    MedDRA 14.1
    10004146
    UMLS CUI 2011AA
    C0851140
    SNOMED CT 2011_0131
    92564006
    MedDRA 14.1
    10061809
    ICD-10-CM Version 2010
    D06.9
    ICD-9-CM Version 2011
    233.1
    Active severe infection, any other concurrent disease or medical condition that are deemed to interfere with the conduct of the study as judged by the investigator
    Beschreibung

    Active severe infection, any other concurrent disease or medical condition that are deemed to interfere with the conduct of the study as judged by the investigator

    Datentyp

    boolean

    Alias
    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
    C0205420
    SNOMED CT 2011_0131
    68405009
    UMLS CUI 2011AA
    C0012634
    SNOMED CT 2011_0131
    64572001
    UMLS CUI 2011AA
    C1699700
    HL7 V3 2006_05
    MEDCCAT
    UMLS CUI 2011AA
    C0521102
    SNOMED CT 2011_0131
    78235001
    UMLS CUI 2011AA
    C0750729
    SNOMED CT 2011_0131
    288524001
    UMLS CUI 2011AA
    C0008976
    SNOMED CT 2011_0131
    110465008
    UMLS CUI 2011AA
    C0022423
    SNOMED CT 2011_0131
    61254005
    UMLS CUI 2011AA
    CL102947
    Known infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus (HbsAg positive) or hepatitis C virus (anti-HCV positive
    Beschreibung

    Known infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus (HbsAg positive) or hepatitis C virus (anti-HCV positive

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0205309
    SNOMED CT 2011_0131
    36692007
    UMLS CUI 2011AA
    C0019693
    SNOMED CT 2011_0131
    86406008
    MedDRA 14.1
    10020161
    LOINC Version 232
    MTHU020829
    ICD-10-CM Version 2010
    B20
    ICD-9-CM Version 2011
    042
    UMLS CUI 2011AA
    C0151317
    SNOMED CT 2011_0131
    177010002
    UMLS CUI 2011AA
    C0019169
    SNOMED CT 2011_0131
    81665004
    UMLS CUI 2011AA
    C0149709
    SNOMED CT 2011_0131
    165806002
    MedDRA 14.1
    10019742
    UMLS CUI 2011AA
    C0220847
    SNOMED CT 2011_0131
    62944002
    MedDRA 14.1
    10019752
    UMLS CUI 2011AA
    C0281863
    MedDRA 14.1
    10019747
    Pregnant or nursing women
    Beschreibung

    Pregnant or nursing women

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0043210
    SNOMED CT 2011_0131
    224526002
    UMLS CUI 2011AA
    C0549206
    MedDRA 14.1
    10036586
    UMLS CUI 2011AA
    C0006147
    MedDRA 14.1
    10006247
    Women of childbearing potential not willing to use an effective form of contraception during participation in the study and at least 3 months thereafter or male patients not willing to ensure effective contraception dur-ing participation in the study and at least three months thereafter
    Beschreibung

    Women of childbearing potential not willing to use an effective form of contraception during participation in the study and at least 3 months thereafter or male patients not willing to ensure effective contraception dur-ing participation in the study and at least three months thereafter

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0043210
    SNOMED CT 2011_0131
    224526002
    UMLS CUI 2011AA
    C1148523
    UMLS CUI 2011AA
    C0237399
    UMLS CUI 2011AA
    C1518422
    UMLS CUI 2011AA
    C0600109
    SNOMED CT 2011_0131
    225466006
    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
    C0679823
    HL7 V3 2006_05
    PART
    UMLS CUI 2011AA
    C0008976
    SNOMED CT 2011_0131
    110465008
    UMLS CUI 2011AA
    C0439231
    SNOMED CT 2011_0131
    258706009
    HL7 V3 2006_05
    MO
    UMLS CUI 2011AA
    C0231290
    SNOMED CT 2011_0131
    237679004
    UMLS CUI 2011AA
    CL414906
    UMLS CUI 2011AA
    C0086582
    SNOMED CT 2011_0131
    248153007
    HL7 V3 2006_05
    M
    UMLS CUI 2011AA
    C1518422
    UMLS CUI 2011AA
    C0600109
    SNOMED CT 2011_0131
    225466006
    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
    C0679823
    HL7 V3 2006_05
    PART
    UMLS CUI 2011AA
    C0008976
    SNOMED CT 2011_0131
    110465008
    UMLS CUI 2011AA
    C0439231
    SNOMED CT 2011_0131
    258706009
    UMLS CUI 2011AA
    C0231290
    SNOMED CT 2011_0131
    237679004
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Eligibility

    1 Formulare
    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)
    B-precursor ALL patients in complete hematological remission with molecular failure or molecular relapse starting at any time after consolidation I of front-line therapy within GMALL standards or at any time outside GMALL standards.
    Item
    B-precursor ALL patients in complete hematological remission with molecular failure or molecular relapse starting at any time after consolidation I of front-line therapy within GMALL standards or at any time outside GMALL standards.
    boolean
    C1292769 (UMLS CUI 2011AA)
    128823009 (SNOMED CT 2011_0131)
    10003890 (MedDRA 14.1)
    C0011900 (UMLS CUI 2011AA)
    439401001 (SNOMED CT 2011_0131)
    MTHU008876 (LOINC Version 232)
    C0677874 (UMLS CUI 2011AA)
    103338009 (SNOMED CT 2011_0131)
    C0205488 (UMLS CUI 2011AA)
    57407000 (SNOMED CT 2011_0131)
    CL414625 (UMLS CUI 2011AA)
    C0277556 (UMLS CUI 2011AA)
    58184002 (SNOMED CT 2011_0131)
    C0231174 (UMLS CUI 2011AA)
    76797004 (SNOMED CT 2011_0131)
    C0702116 (UMLS CUI 2011AA)
    9656002 (SNOMED CT 2011_0131)
    C1708063 (UMLS CUI 2011AA)
    Patients must have a molecular marker for evaluation of minimal residual disease which is either Bcr/abl at any detection level or individual rearrangements of immunoglobulin or TCR-genes measured by an assay with a sensitivity of minimum 10-4: At least one individual marker at a quantitative level 10-4.
    Item
    Patients must have a molecular marker for evaluation of minimal residual disease which is either Bcr/abl at any detection level or individual rearrangements of immunoglobulin or TCR-genes measured by an assay with a sensitivity of minimum 10-4: At least one individual marker at a quantitative level 10-4.
    boolean
    C0005516 (UMLS CUI 2011AA)
    C0220825 (UMLS CUI 2011AA)
    C0242596 (UMLS CUI 2011AA)
    C0004891 (UMLS CUI 2011AA)
    56564003 (SNOMED CT 2011_0131)
    MTHU021298 (LOINC Version 232)
    C1511790 (UMLS CUI 2011AA)
    C0456079 (UMLS CUI 2011AA)
    276625007 (SNOMED CT 2011_0131)
    CL370615 (UMLS CUI 2011AA)
    C1511695 (UMLS CUI 2011AA)
    C0021027 (UMLS CUI 2011AA)
    399771004 (SNOMED CT 2011_0131)
    14 (HL7 V3 2006_05)
    C0524889 (UMLS CUI 2011AA)
    C0444706 (UMLS CUI 2011AA)
    258104002 (SNOMED CT 2011_0131)
    C1510438 (UMLS CUI 2011AA)
    272392009 (SNOMED CT 2011_0131)
    C0036667 (UMLS CUI 2011AA)
    C1524031 (UMLS CUI 2011AA)
    C0392762 (UMLS CUI 2011AA)
    30766002 (SNOMED CT 2011_0131)
    ECOG Performance Status < 2
    Item
    ECOG Status < 2
    boolean
    C1520224 (UMLS CUI 2011AA)
    424122007 (SNOMED CT 2011_0131)
    Ability to understand and willingness to sign a written informed consent
    Item
    Ability to understand and willingness to sign a written informed consent
    boolean
    C0021430 (UMLS CUI 2011AA)
    Signed and dated written informed consent is available
    Item
    Signed and dated written informed consent is available
    boolean
    C0021430 (UMLS CUI 2011AA)
    Item Group
    Ausschlusskriterien
    CL425201 (UMLS CUI 2011AA)
    Current extra medullar involvement
    Item
    Current extra medullar involvement
    boolean
    C0521116 (UMLS CUI 2011AA)
    15240007 (SNOMED CT 2011_0131)
    C1517060 (UMLS CUI 2011AA)
    C1314939 (UMLS CUI 2011AA)
    248448006 (SNOMED CT 2011_0131)
    History of or current relevant CNS pathology (except migraine/headache and/or previous infiltration of cerebrospinal fluid (CSF) by ALL)
    Item
    History of or current relevant CNS pathology (except migraine/headache and/or previous infiltration of cerebrospinal fluid (CSF) by ALL)
    boolean
    CL421546 (UMLS CUI 2011AA)
    392521001 (SNOMED CT 2011_0131)
    C0521116 (UMLS CUI 2011AA)
    15240007 (SNOMED CT 2011_0131)
    C2347946 (UMLS CUI 2011AA)
    C0007682 (UMLS CUI 2011AA)
    23853001 (SNOMED CT 2011_0131)
    10007943 (MedDRA 14.1)
    G96.9 (ICD-10-CM Version 2010)
    C1554961 (UMLS CUI 2011AA)
    E (HL7 V3 2006_05)
    C0149931 (UMLS CUI 2011AA)
    37796009 (SNOMED CT 2011_0131)
    10027599 (MedDRA 14.1)
    G43 (ICD-10-CM Version 2010)
    346 (ICD-9-CM Version 2011)
    C0018681 (UMLS CUI 2011AA)
    25064002 (SNOMED CT 2011_0131)
    10019211 (MedDRA 14.1)
    MTHU020860 (LOINC Version 232)
    R51 (ICD-10-CM Version 2010)
    784.0 (ICD-9-CM Version 2011)
    E12678 (CTCAE 1105E)
    C0205156 (UMLS CUI 2011AA)
    9130008 (SNOMED CT 2011_0131)
    C0332448 (UMLS CUI 2011AA)
    47351003 (SNOMED CT 2011_0131)
    C0007806 (UMLS CUI 2011AA)
    65216001 (SNOMED CT 2011_0131)
    MTHU001311 (LOINC Version 232)
    CSF (HL7 V3 2006_05)
    C0023449 (UMLS CUI 2011AA)
    91857003, 128822004 (SNOMED CT 2011_0131)
    10060390 (MedDRA 14.1)
    C91.0 (ICD-10-CM Version 2010)
    204.0 (ICD-9-CM Version 2011)
    Current infiltration of cerebrospinal fluid by ALL
    Item
    Current infiltration of cerebrospinal fluid by ALL
    boolean
    C0521116 (UMLS CUI 2011AA)
    15240007 (SNOMED CT 2011_0131)
    C0332448 (UMLS CUI 2011AA)
    47351003 (SNOMED CT 2011_0131)
    C0007806 (UMLS CUI 2011AA)
    65216001 (SNOMED CT 2011_0131)
    MTHU001311 (LOINC Version 232)
    CSF (HL7 V3 2006_05)
    C0023449 (UMLS CUI 2011AA)
    91857003, 128822004 (SNOMED CT 2011_0131)
    10060390 (MedDRA 14.1)
    C91.0 (ICD-10-CM Version 2010)
    204.0 (ICD-9-CM Version 2011)
    History of or current autoimmune disease
    Item
    History of or current autoimmune disease
    boolean
    CL421546 (UMLS CUI 2011AA)
    392521001 (SNOMED CT 2011_0131)
    C0521116 (UMLS CUI 2011AA)
    15240007 (SNOMED CT 2011_0131)
    C0004364 (UMLS CUI 2011AA)
    85828009 (SNOMED CT 2011_0131)
    10061664 (MedDRA 14.1)
    M30-M36 (ICD-10-CM Version 2010)
    E11258 (CTCAE 1105E)
    Autologous stem cell transplantation within 6 weeks prior to study entry
    Item
    Autologous stem cell transplantation within 6 weeks prior to study entry
    boolean
    C1831743 (UMLS CUI 2011AA)
    C0439230 (UMLS CUI 2011AA)
    258705008 (SNOMED CT 2011_0131)
    WK (HL7 V3 2006_05)
    C0332152 (UMLS CUI 2011AA)
    288556008 (SNOMED CT 2011_0131)
    C2348558 (UMLS CUI 2011AA)
    Any prior allogeneic stem cell transplantation
    Item
    Any prior allogeneic stem cell transplantation
    boolean
    C2242529 (UMLS CUI 2011AA)
    Cancer chemotherapy within 4 weeks prior to study treatment (except for intrathecal prophylaxis and/or low dose maintenance therapy such as vincalkaloids, mercaptopurine, methotrexate, steroids)
    Item
    Cancer chemotherapy within 4 weeks prior to study treatment (except for intrathecal prophylaxis and/or low dose maintenance therapy such as vincalkaloids, mercaptopurine, methotrexate, steroids)
    boolean
    C0392920 (UMLS CUI 2011AA)
    150415003 (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)
    C0008976 (UMLS CUI 2011AA)
    110465008 (SNOMED CT 2011_0131)
    C0039798 (UMLS CUI 2011AA)
    C1554961 (UMLS CUI 2011AA)
    E (HL7 V3 2006_05)
    C0205527 (UMLS CUI 2011AA)
    72607000 (SNOMED CT 2011_0131)
    C0199176 (UMLS CUI 2011AA)
    360271000 (SNOMED CT 2011_0131)
    10036898 (MedDRA 14.1)
    C1708745 (UMLS CUI 2011AA)
    C0677908 (UMLS CUI 2011AA)
    314122007 (SNOMED CT 2011_0131)
    C0042672 (UMLS CUI 2011AA)
    61864009 (SNOMED CT 2011_0131)
    C0000618 (UMLS CUI 2011AA)
    386835005 (SNOMED CT 2011_0131)
    MTHU002562 (LOINC Version 232)
    C0025677 (UMLS CUI 2011AA)
    387381009 (SNOMED CT 2011_0131)
    MTHU005020 (LOINC Version 232)
    C0038317 (UMLS CUI 2011AA)
    116566001 (SNOMED CT 2011_0131)
    Radiotherapy within 4 weeks prior to study treatment
    Item
    Radiotherapy within 4 weeks prior to study treatment
    boolean
    C0034619 (UMLS CUI 2011AA)
    C0439231 (UMLS CUI 2011AA)
    258706009 (SNOMED CT 2011_0131)
    MO (HL7 V3 2006_05)
    C0332152 (UMLS CUI 2011AA)
    288556008 (SNOMED CT 2011_0131)
    C0008976 (UMLS CUI 2011AA)
    110465008 (SNOMED CT 2011_0131)
    C0039798 (UMLS CUI 2011AA)
    Therapy with monoclonal antibodies (Rituximab, MabCampath) within 6 weeks prior to study treatment
    Item
    Therapy with monoclonal antibodies (Rituximab, MabCampath) within 6 weeks prior to study treatment
    boolean
    C0039798 (UMLS CUI 2011AA)
    C0003250 (UMLS CUI 2011AA)
    49616005 (SNOMED CT 2011_0131)
    C0732355 (UMLS CUI 2011AA)
    386919002 (SNOMED CT 2011_0131)
    C0383429 (UMLS CUI 2011AA)
    391864003 (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)
    C0008976 (UMLS CUI 2011AA)
    110465008 (SNOMED CT 2011_0131)
    C0039798 (UMLS CUI 2011AA)
    Known hypersensitivity to immunoglobulins or to any other component of the study drug formulation
    Item
    Known hypersensitivity to immunoglobulins or to any other component of the study drug formulation
    boolean
    C0205309 (UMLS CUI 2011AA)
    36692007 (SNOMED CT 2011_0131)
    C0020517 (UMLS CUI 2011AA)
    418634005 (SNOMED CT 2011_0131)
    T78.40 (ICD-10-CM Version 2010)
    C0021027 (UMLS CUI 2011AA)
    399771004 (SNOMED CT 2011_0131)
    14 (HL7 V3 2006_05)
    C0205394 (UMLS CUI 2011AA)
    74964007 (SNOMED CT 2011_0131)
    C1705248 (UMLS CUI 2011AA)
    C0008976 (UMLS CUI 2011AA)
    110465008 (SNOMED CT 2011_0131)
    C1705957 (UMLS CUI 2011AA)
    Presence of human anti-murine antibodies (HAMA)
    Item
    Presence of human anti-murine antibodies (HAMA)
    boolean
    C0150312 (UMLS CUI 2011AA)
    52101004 (SNOMED CT 2011_0131)
    C1291910 (UMLS CUI 2011AA)
    115628002 (SNOMED CT 2011_0131)
    MTHU003865 (LOINC Version 232)
    Abnormal bone marrow, renal or hepatic function
    Item
    Abnormal bone marrow, renal or hepatic function
    boolean
    C0205161 (UMLS CUI 2011AA)
    263654008 (SNOMED CT 2011_0131)
    C0005953 (UMLS CUI 2011AA)
    14016003 (SNOMED CT 2011_0131)
    MTHU016536 (LOINC Version 232)
    C0151746 (UMLS CUI 2011AA)
    39539005 (SNOMED CT 2011_0131)
    10013902 (MedDRA 14.1)
    C0086565 (UMLS CUI 2011AA)
    75183008 (SNOMED CT 2011_0131)
    10019670 (MedDRA 14.1)
    Indication for a hypercoagulative state
    Item
    Indication for a hypercoagulative state
    boolean
    CL335836 (UMLS CUI 2011AA)
    C0398623 (UMLS CUI 2011AA)
    10020608 (MedDRA 14.1)
    History of malignancy other than ALL within 5 years prior to study entry, with the exception of basal cell carcinoma of the skin or cervix carcinoma in situ
    Item
    History of malignancy other than ALL within 5 years prior to study entry, with the exception of basal cell carcinoma of the skin or cervix carcinoma in situ
    boolean
    CL421546 (UMLS CUI 2011AA)
    392521001 (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)
    CL411789 (UMLS CUI 2011AA)
    C0023449 (UMLS CUI 2011AA)
    91857003, 128822004 (SNOMED CT 2011_0131)
    10060390 (MedDRA 14.1)
    C91.0 (ICD-10-CM Version 2010)
    204.0 (ICD-9-CM Version 2011)
    C0439234 (UMLS CUI 2011AA)
    258707000 (SNOMED CT 2011_0131)
    Y (HL7 V3 2006_05)
    C0332152 (UMLS CUI 2011AA)
    288556008 (SNOMED CT 2011_0131)
    C2348558 (UMLS CUI 2011AA)
    C1554961 (UMLS CUI 2011AA)
    E (HL7 V3 2006_05)
    C0007117 (UMLS CUI 2011AA)
    1338007 (SNOMED CT 2011_0131)
    10004146 (MedDRA 14.1)
    C0851140 (UMLS CUI 2011AA)
    92564006 (SNOMED CT 2011_0131)
    10061809 (MedDRA 14.1)
    D06.9 (ICD-10-CM Version 2010)
    233.1 (ICD-9-CM Version 2011)
    Active severe infection, any other concurrent disease or medical condition that are deemed to interfere with the conduct of the study as judged by the investigator
    Item
    Active severe infection, any other concurrent disease or medical condition that are deemed to interfere with the conduct of the study as judged by the investigator
    boolean
    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)
    C0205420 (UMLS CUI 2011AA)
    68405009 (SNOMED CT 2011_0131)
    C0012634 (UMLS CUI 2011AA)
    64572001 (SNOMED CT 2011_0131)
    C1699700 (UMLS CUI 2011AA)
    MEDCCAT (HL7 V3 2006_05)
    C0521102 (UMLS CUI 2011AA)
    78235001 (SNOMED CT 2011_0131)
    C0750729 (UMLS CUI 2011AA)
    288524001 (SNOMED CT 2011_0131)
    C0008976 (UMLS CUI 2011AA)
    110465008 (SNOMED CT 2011_0131)
    C0022423 (UMLS CUI 2011AA)
    61254005 (SNOMED CT 2011_0131)
    CL102947 (UMLS CUI 2011AA)
    Known infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus (HbsAg positive) or hepatitis C virus (anti-HCV positive
    Item
    Known infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus (HbsAg positive) or hepatitis C virus (anti-HCV positive
    boolean
    C0205309 (UMLS CUI 2011AA)
    36692007 (SNOMED CT 2011_0131)
    C0019693 (UMLS CUI 2011AA)
    86406008 (SNOMED CT 2011_0131)
    10020161 (MedDRA 14.1)
    MTHU020829 (LOINC Version 232)
    B20 (ICD-10-CM Version 2010)
    042 (ICD-9-CM Version 2011)
    C0151317 (UMLS CUI 2011AA)
    177010002 (SNOMED CT 2011_0131)
    C0019169 (UMLS CUI 2011AA)
    81665004 (SNOMED CT 2011_0131)
    C0149709 (UMLS CUI 2011AA)
    165806002 (SNOMED CT 2011_0131)
    10019742 (MedDRA 14.1)
    C0220847 (UMLS CUI 2011AA)
    62944002 (SNOMED CT 2011_0131)
    10019752 (MedDRA 14.1)
    C0281863 (UMLS CUI 2011AA)
    10019747 (MedDRA 14.1)
    Pregnant or nursing women
    Item
    Pregnant or nursing women
    boolean
    C0043210 (UMLS CUI 2011AA)
    224526002 (SNOMED CT 2011_0131)
    C0549206 (UMLS CUI 2011AA)
    10036586 (MedDRA 14.1)
    C0006147 (UMLS CUI 2011AA)
    10006247 (MedDRA 14.1)
    Women of childbearing potential not willing to use an effective form of contraception during participation in the study and at least 3 months thereafter or male patients not willing to ensure effective contraception dur-ing participation in the study and at least three months thereafter
    Item
    Women of childbearing potential not willing to use an effective form of contraception during participation in the study and at least 3 months thereafter or male patients not willing to ensure effective contraception dur-ing participation in the study and at least three months thereafter
    boolean
    C0043210 (UMLS CUI 2011AA)
    224526002 (SNOMED CT 2011_0131)
    C1148523 (UMLS CUI 2011AA)
    C0237399 (UMLS CUI 2011AA)
    C1518422 (UMLS CUI 2011AA)
    C0600109 (UMLS CUI 2011AA)
    225466006 (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)
    C0679823 (UMLS CUI 2011AA)
    PART (HL7 V3 2006_05)
    C0008976 (UMLS CUI 2011AA)
    110465008 (SNOMED CT 2011_0131)
    C0439231 (UMLS CUI 2011AA)
    258706009 (SNOMED CT 2011_0131)
    MO (HL7 V3 2006_05)
    C0231290 (UMLS CUI 2011AA)
    237679004 (SNOMED CT 2011_0131)
    CL414906 (UMLS CUI 2011AA)
    C0086582 (UMLS CUI 2011AA)
    248153007 (SNOMED CT 2011_0131)
    M (HL7 V3 2006_05)
    C1518422 (UMLS CUI 2011AA)
    C0600109 (UMLS CUI 2011AA)
    225466006 (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)
    C0679823 (UMLS CUI 2011AA)
    PART (HL7 V3 2006_05)
    C0008976 (UMLS CUI 2011AA)
    110465008 (SNOMED CT 2011_0131)
    C0439231 (UMLS CUI 2011AA)
    258706009 (SNOMED CT 2011_0131)
    C0231290 (UMLS CUI 2011AA)
    237679004 (SNOMED CT 2011_0131)
    Zum Seitenanfang zurückkehren 

    Hilfe

    Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

    Zum Video