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ID

43462

Beschreibung

ODM derived from http://clinicaltrials.gov/show/NCT00804856

Link

http://clinicaltrials.gov/show/NCT00804856

Stichworte

  1. 09.12.13 09.12.13 - Martin Dugas
  2. 16.04.14 16.04.14 - Julian Varghese
  3. 20.09.21 20.09.21 -
Hochgeladen am

20. September 2021

DOI

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Lizenz

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    Eligibility DRKS00003750 NCT00812799 Allergic Rhinoconjunctivitis

    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
    Male or female adult with relapsed/refractory AML ineligible for intensive treatment (phase I part only)
    Beschreibung

    Male or female adult with relapsed/refractory AML ineligible for intensive treatment (phase I part only)

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0001675
    SNOMED CT 2011_0131
    133936004
    UMLS CUI 2011AA
    C0278780
    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
    C0011900
    SNOMED CT 2011_0131
    439401001
    LOINC Version 232
    MTHU008876
    UMLS CUI 2011AA
    C1518422
    UMLS CUI 2011AA
    C1548635
    HL7 V3 2006_05
    ELG
    UMLS CUI 2011AA
    C0085559
    MedDRA 14.1
    10022519
    UMLS CUI 2011AA
    C0205390
    SNOMED CT 2011_0131
    21191007
    UMLS CUI 2011AA
    C0439068
    SNOMED CT 2011_0131
    257469003
    Male or female adult with previously untreated AML ineligible for intensive treatment (phase IIa part only)
    Beschreibung

    Male or female adult with previously untreated AML ineligible for intensive treatment (phase IIa part only)

    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
    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
    C1518422
    UMLS CUI 2011AA
    C1548635
    HL7 V3 2006_05
    ELG
    UMLS CUI 2011AA
    C0085559
    MedDRA 14.1
    10022519
    UMLS CUI 2011AA
    C1706446
    Confirmed diagnosis of AML according to the WHO definition (except for acute promyelocytic leukaemia, APL)
    Beschreibung

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

    Datentyp

    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
    C0332290
    SNOMED CT 2011_0131
    385433004
    UMLS CUI 2011AA
    C0451584
    SNOMED CT 2011_0131
    273931002
    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 eligible for LD-Ara-C treatment
    Beschreibung

    Patient is eligible for LD-Ara-C treatment

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C1548635
    HL7 V3 2006_05
    ELG
    UMLS CUI 2011AA
    C1708745
    UMLS CUI 2011AA
    C0010711
    SNOMED CT 2011_0131
    89265009
    UMLS CUI 2011AA
    C0039798
    Life expectancy > 3 months
    Beschreibung

    Life expectancy > 3 months

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0023671
    Eastern co-operative oncology group (ECOG, R01-0787) performance score <=2 at screening
    Beschreibung

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

    Datentyp

    boolean

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

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

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0021430
    Ausschlusskriterien
    Beschreibung

    Ausschlusskriterien

    Alias
    UMLS CUI 2011AA
    CL425201
    Previously untreated AML (phase I part only)
    Beschreibung

    Previously untreated AML (phase I part only)

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0205156
    Relapsed or treatment refractory AML (phase IIa part only)
    Beschreibung

    Relapsed or treatment refractory AML (phase IIa part only)

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0278780
    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
    C1706446
    Patient with APL (AML subtype M3 according to the French-American-British (FAB) classification)
    Beschreibung

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

    Datentyp

    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
    C0457329
    SNOMED CT 2011_0131
    278165002
    Hypersensitivity to one of the trial drugs or the excipients
    Beschreibung

    Hypersensitivity to one of the trial drugs or the excipients

    Datentyp

    boolean

    Alias
    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
    C0015237
    SNOMED CT 2011_0131
    360215002
    Other malignancy requiring treatment
    Beschreibung

    Other malignancy requiring treatment

    Datentyp

    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
    Symptomatic central nervous system involvement
    Beschreibung

    Symptomatic central nervous system involvement

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0231220
    SNOMED CT 2011_0131
    264931009
    UMLS CUI 2011AA
    C1269563
    SNOMED CT 2011_0131
    278199004
    UMLS CUI 2011AA
    C1314939
    SNOMED CT 2011_0131
    248448006
    Clinically relevant QT prolongation (e.g. long QT syndrome, QTcF>470 ms)
    Beschreibung

    Clinically relevant QT prolongation (e.g. long QT syndrome, QTcF>470 ms)

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0205210
    SNOMED CT 2011_0131
    58147004
    UMLS CUI 2011AA
    C2347946
    UMLS CUI 2011AA
    C0151878
    SNOMED CT 2011_0131
    111975006
    MedDRA 14.1
    10014387
    CTCAE 1105E
    E12146
    UMLS CUI 2011AA
    C0023976
    SNOMED CT 2011_0131
    9651007
    MedDRA 14.1
    10024803
    ICD-10-CM Version 2010
    I45.81
    ICD-9-CM Version 2011
    426.82
    UMLS CUI 2011AA
    C1882513
    Aspartate amino transferase (AST) or alanine amino transferase (ALT) > 2.5 times the upper limit of normal (ULN), or AST or ALT > 5 times the ULN in case of known leukaemia liver involvement
    Beschreibung

    Aspartate amino transferase (AST) or alanine amino transferase (ALT) > 2.5 times the upper limit of normal (ULN), or AST or ALT > 5 times the ULN in case of known leukaemia liver involvement

    Datentyp

    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
    C1519815
    UMLS CUI 2011AA
    C0023418
    SNOMED CT 2011_0131
    93143009
    MedDRA 14.1
    10024288
    ICD-10-CM Version 2010
    C95.9
    ICD-9-CM Version 2011
    208.9
    UMLS CUI 2011AA
    C0023884
    SNOMED CT 2011_0131
    10200004
    LOINC Version 232
    MTHU002039
    UMLS CUI 2011AA
    C1314939
    SNOMED CT 2011_0131
    248448006
    Prothrombin time (PT) > 1.5 x ULN for subjects not on therapeutic vitamin K antagonists (phenprocoumon, warfarin)
    Beschreibung

    Prothrombin time (PT) > 1.5 x ULN for subjects not on therapeutic vitamin K antagonists (phenprocoumon, warfarin)

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    CL434069
    UMLS CUI 2011AA
    C1519815
    UMLS CUI 2011AA
    C1518422
    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
    Beschreibung

    Bilirubin > 1.5 mg/dl (> 26 mcmol/L)

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0011221
    SNOMED CT 2011_0131
    79706000
    LOINC Version 232
    1975-2
    Kreatinin im Serum
    Beschreibung

    Serum creatinine > 2.0 mg/dl

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0201976
    SNOMED CT 2011_0131
    113075003
    MedDRA 14.1
    10040230
    Concomitant intercurrent illness, which would compromise the evaluation of efficacy or safety of the trial drug, e.g. active severe infection, unstable angina pectoris, cardiac arrhythmia or severe heart failure/cardiac insufficiency.
    Beschreibung

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

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    CL415222
    UMLS CUI 2011AA
    C0277557
    SNOMED CT 2011_0131
    88472004
    UMLS CUI 2011AA
    C0221099
    SNOMED CT 2011_0131
    260379002
    UMLS CUI 2011AA
    C0013175
    SNOMED CT 2011_0131
    185922005
    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
    UMLS CUI 2011AA
    C0018801
    SNOMED CT 2011_0131
    155374007
    MedDRA 14.1
    10019279
    ICD-9-CM Version 2011
    428
    CTCAE 1105E
    E10124
    Psychiatric illness or social situation that would limit compliance with trial requirements
    Beschreibung

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

    Datentyp

    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
    C0449295
    SNOMED CT 2011_0131
    246175000
    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
    Beschreibung

    Concomitant therapy, which is considered relevant for the evaluation of the efficacy or safety of the trial drug

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C1707479
    UMLS CUI 2011AA
    C2347946
    UMLS CUI 2011AA
    C0013175
    SNOMED CT 2011_0131
    185922005
    Contraindications for cytarabine treatment according to the SPC
    Beschreibung

    Contraindications for cytarabine treatment according to the SPC

    Datentyp

    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
    C0332290
    SNOMED CT 2011_0131
    385433004
    UMLS CUI 2011AA
    C1709515
    Female patients of childbearing potential who are sexually active and unwilling to use a medically acceptable method of contraception during the trial, i.e. combination of two forms of effective contraception (hormonal contraception, intrauterine device, condom with spermicide, etc.).
    Beschreibung

    Female patients of childbearing potential who are sexually active and unwilling to use a medically acceptable method of contraception during the trial, i.e. combination of two forms of effective contraception (hormonal contraception, intrauterine device, condom with spermicide, etc.).

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0086287
    SNOMED CT 2011_0131
    248152002
    HL7 V3 2006_05
    F
    UMLS CUI 2011AA
    C1148523
    UMLS CUI 2011AA
    C0237399
    UMLS CUI 2011AA
    C0241028
    SNOMED CT 2011_0131
    228453005
    MedDRA 14.1
    10066098
    UMLS CUI 2011AA
    C0558080
    SNOMED CT 2011_0131
    225465005
    UMLS CUI 2011AA
    C0700589
    SNOMED CT 2011_0131
    146680009
    MedDRA 14.1
    10010808
    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
    Male patients with partners of childbearing potential who are unwilling to use condoms in combination with a second medically acceptable method of contraception during the trial
    Beschreibung

    Male patients with partners of childbearing potential who are unwilling to use condoms in combination with a second medically acceptable method of contraception during the trial

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0086582
    SNOMED CT 2011_0131
    248153007
    HL7 V3 2006_05
    M
    UMLS CUI 2011AA
    C0682323
    SNOMED CT 2011_0131
    262043009
    HL7 V3 2006_05
    SIGOTHR
    UMLS CUI 2011AA
    C1148523
    UMLS CUI 2011AA
    C0237399
    UMLS CUI 2011AA
    C0558080
    SNOMED CT 2011_0131
    225465005
    UMLS CUI 2011AA
    C1524063
    SNOMED CT 2011_0131
    260676000
    UMLS CUI 2011AA
    C0677582
    UMLS CUI 2011AA
    C1947911
    UMLS CUI 2011AA
    C0205436
    SNOMED CT 2011_0131
    81170007
    UMLS CUI 2011AA
    C0025663
    SNOMED CT 2011_0131
    260686004
    LOINC Version 232
    MTHU024654
    UMLS CUI 2011AA
    C0700589
    SNOMED CT 2011_0131
    146680009
    MedDRA 14.1
    10010808
    Pregnant or nursing female patients
    Beschreibung

    Pregnant or nursing female patients

    Datentyp

    boolean

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

    Patient unable to comply with the protocol

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C1321605

    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)
    Male or female adult with relapsed/refractory AML ineligible for intensive treatment (phase I part only)
    Item
    Male or female adult with relapsed/refractory AML ineligible for intensive treatment (phase I part only)
    boolean
    C0001675 (UMLS CUI 2011AA)
    133936004 (SNOMED CT 2011_0131)
    C0278780 (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)
    C0011900 (UMLS CUI 2011AA)
    439401001 (SNOMED CT 2011_0131)
    MTHU008876 (LOINC Version 232)
    C1518422 (UMLS CUI 2011AA)
    C1548635 (UMLS CUI 2011AA)
    ELG (HL7 V3 2006_05)
    C0085559 (UMLS CUI 2011AA)
    10022519 (MedDRA 14.1)
    C0205390 (UMLS CUI 2011AA)
    21191007 (SNOMED CT 2011_0131)
    C0439068 (UMLS CUI 2011AA)
    257469003 (SNOMED CT 2011_0131)
    Male or female adult with previously untreated AML ineligible for intensive treatment (phase IIa part only)
    Item
    Male or female adult with previously untreated AML ineligible for intensive treatment (phase IIa part only)
    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)
    C1518422 (UMLS CUI 2011AA)
    C1548635 (UMLS CUI 2011AA)
    ELG (HL7 V3 2006_05)
    C0085559 (UMLS CUI 2011AA)
    10022519 (MedDRA 14.1)
    C1706446 (UMLS CUI 2011AA)
    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)
    C0332290 (UMLS CUI 2011AA)
    385433004 (SNOMED CT 2011_0131)
    C0451584 (UMLS CUI 2011AA)
    273931002 (SNOMED CT 2011_0131)
    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 eligible for LD-Ara-C treatment
    Item
    Patient is eligible for LD-Ara-C treatment
    boolean
    C1548635 (UMLS CUI 2011AA)
    ELG (HL7 V3 2006_05)
    C1708745 (UMLS CUI 2011AA)
    C0010711 (UMLS CUI 2011AA)
    89265009 (SNOMED CT 2011_0131)
    C0039798 (UMLS CUI 2011AA)
    Life expectancy > 3 months
    Item
    Life expectancy > 3 months
    boolean
    C0023671 (UMLS CUI 2011AA)
    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)
    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
    C0021430 (UMLS CUI 2011AA)
    Item Group
    Ausschlusskriterien
    CL425201 (UMLS CUI 2011AA)
    Previously untreated AML (phase I part only)
    Item
    Previously untreated AML (phase I part only)
    boolean
    C0205156 (UMLS CUI 2011AA)
    Relapsed or treatment refractory AML (phase IIa part only)
    Item
    Relapsed or treatment refractory AML (phase IIa part only)
    boolean
    C0278780 (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)
    C1706446 (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)
    C0457329 (UMLS CUI 2011AA)
    278165002 (SNOMED CT 2011_0131)
    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)
    C0304229 (UMLS CUI 2011AA)
    902003 (SNOMED CT 2011_0131)
    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)
    Symptomatic central nervous system involvement
    Item
    Symptomatic central nervous system involvement
    boolean
    C0231220 (UMLS CUI 2011AA)
    264931009 (SNOMED CT 2011_0131)
    C1269563 (UMLS CUI 2011AA)
    278199004 (SNOMED CT 2011_0131)
    C1314939 (UMLS CUI 2011AA)
    248448006 (SNOMED CT 2011_0131)
    Clinically relevant QT prolongation (e.g. long QT syndrome, QTcF>470 ms)
    Item
    Clinically relevant QT prolongation (e.g. long QT syndrome, QTcF>470 ms)
    boolean
    C0205210 (UMLS CUI 2011AA)
    58147004 (SNOMED CT 2011_0131)
    C2347946 (UMLS CUI 2011AA)
    C0151878 (UMLS CUI 2011AA)
    111975006 (SNOMED CT 2011_0131)
    10014387 (MedDRA 14.1)
    E12146 (CTCAE 1105E)
    C0023976 (UMLS CUI 2011AA)
    9651007 (SNOMED CT 2011_0131)
    10024803 (MedDRA 14.1)
    I45.81 (ICD-10-CM Version 2010)
    426.82 (ICD-9-CM Version 2011)
    C1882513 (UMLS CUI 2011AA)
    Aspartate amino transferase (AST) or alanine amino transferase (ALT) > 2.5 times the upper limit of normal (ULN), or AST or ALT > 5 times the ULN in case of known leukaemia liver involvement
    Item
    Aspartate amino transferase (AST) or alanine amino transferase (ALT) > 2.5 times the upper limit of normal (ULN), or AST or ALT > 5 times the ULN in case of known leukaemia liver involvement
    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)
    C1519815 (UMLS CUI 2011AA)
    C0023418 (UMLS CUI 2011AA)
    93143009 (SNOMED CT 2011_0131)
    10024288 (MedDRA 14.1)
    C95.9 (ICD-10-CM Version 2010)
    208.9 (ICD-9-CM Version 2011)
    C0023884 (UMLS CUI 2011AA)
    10200004 (SNOMED CT 2011_0131)
    MTHU002039 (LOINC Version 232)
    C1314939 (UMLS CUI 2011AA)
    248448006 (SNOMED CT 2011_0131)
    Prothrombin time (PT) > 1.5 x ULN for subjects not on therapeutic vitamin K antagonists (phenprocoumon, warfarin)
    Item
    Prothrombin time (PT) > 1.5 x ULN for subjects not on therapeutic vitamin K antagonists (phenprocoumon, warfarin)
    boolean
    CL434069 (UMLS CUI 2011AA)
    C1519815 (UMLS CUI 2011AA)
    C1518422 (UMLS CUI 2011AA)
    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 (> 26 mcmol/L)
    Item
    Bilirubin
    boolean
    C0011221 (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)
    Concomitant intercurrent illness, which would compromise the evaluation of efficacy or safety of the trial drug, e.g. active severe infection, unstable angina pectoris, cardiac arrhythmia or severe heart failure/cardiac insufficiency.
    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, cardiac arrhythmia or severe heart failure/cardiac insufficiency.
    boolean
    CL415222 (UMLS CUI 2011AA)
    C0277557 (UMLS CUI 2011AA)
    88472004 (SNOMED CT 2011_0131)
    C0221099 (UMLS CUI 2011AA)
    260379002 (SNOMED CT 2011_0131)
    C0013175 (UMLS CUI 2011AA)
    185922005 (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)
    C0018801 (UMLS CUI 2011AA)
    155374007 (SNOMED CT 2011_0131)
    10019279 (MedDRA 14.1)
    428 (ICD-9-CM Version 2011)
    E10124 (CTCAE 1105E)
    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)
    C0449295 (UMLS CUI 2011AA)
    246175000 (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
    Item
    Concomitant therapy, which is considered relevant for the evaluation of the efficacy or safety of the trial drug
    boolean
    C1707479 (UMLS CUI 2011AA)
    C2347946 (UMLS CUI 2011AA)
    C0013175 (UMLS CUI 2011AA)
    185922005 (SNOMED CT 2011_0131)
    Contraindications for cytarabine treatment according to the SPC
    Item
    Contraindications for cytarabine treatment according to the SPC
    boolean
    C1301624 (UMLS CUI 2011AA)
    397745006 (SNOMED CT 2011_0131)
    C0010711 (UMLS CUI 2011AA)
    89265009 (SNOMED CT 2011_0131)
    C0039798 (UMLS CUI 2011AA)
    C0332290 (UMLS CUI 2011AA)
    385433004 (SNOMED CT 2011_0131)
    C1709515 (UMLS CUI 2011AA)
    Female patients of childbearing potential who are sexually active and unwilling to use a medically acceptable method of contraception during the trial, i.e. combination of two forms of effective contraception (hormonal contraception, intrauterine device, condom with spermicide, etc.).
    Item
    Female patients of childbearing potential who are sexually active and unwilling to use a medically acceptable method of contraception during the trial, i.e. combination of two forms of effective contraception (hormonal contraception, intrauterine device, condom with spermicide, etc.).
    boolean
    C0086287 (UMLS CUI 2011AA)
    248152002 (SNOMED CT 2011_0131)
    F (HL7 V3 2006_05)
    C1148523 (UMLS CUI 2011AA)
    C0237399 (UMLS CUI 2011AA)
    C0241028 (UMLS CUI 2011AA)
    228453005 (SNOMED CT 2011_0131)
    10066098 (MedDRA 14.1)
    C0558080 (UMLS CUI 2011AA)
    225465005 (SNOMED CT 2011_0131)
    C0700589 (UMLS CUI 2011AA)
    146680009 (SNOMED CT 2011_0131)
    10010808 (MedDRA 14.1)
    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)
    Male patients with partners of childbearing potential who are unwilling to use condoms in combination with a second medically acceptable method of contraception during the trial
    Item
    Male patients with partners of childbearing potential who are unwilling to use condoms in combination with a second medically acceptable method of contraception during the trial
    boolean
    C0086582 (UMLS CUI 2011AA)
    248153007 (SNOMED CT 2011_0131)
    M (HL7 V3 2006_05)
    C0682323 (UMLS CUI 2011AA)
    262043009 (SNOMED CT 2011_0131)
    SIGOTHR (HL7 V3 2006_05)
    C1148523 (UMLS CUI 2011AA)
    C0237399 (UMLS CUI 2011AA)
    C0558080 (UMLS CUI 2011AA)
    225465005 (SNOMED CT 2011_0131)
    C1524063 (UMLS CUI 2011AA)
    260676000 (SNOMED CT 2011_0131)
    C0677582 (UMLS CUI 2011AA)
    C1947911 (UMLS CUI 2011AA)
    C0205436 (UMLS CUI 2011AA)
    81170007 (SNOMED CT 2011_0131)
    C0025663 (UMLS CUI 2011AA)
    260686004 (SNOMED CT 2011_0131)
    MTHU024654 (LOINC Version 232)
    C0700589 (UMLS CUI 2011AA)
    146680009 (SNOMED CT 2011_0131)
    10010808 (MedDRA 14.1)
    Pregnant or nursing female patients
    Item
    Pregnant or nursing female patients
    boolean
    C0549206 (UMLS CUI 2011AA)
    10036586 (MedDRA 14.1)
    C0006147 (UMLS CUI 2011AA)
    10006247 (MedDRA 14.1)
    C0086287 (UMLS CUI 2011AA)
    248152002 (SNOMED CT 2011_0131)
    F (HL7 V3 2006_05)
    Patient unable to comply with the protocol
    Item
    Patient unable to comply with the protocol
    boolean
    C1321605 (UMLS CUI 2011AA)

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