0 Beoordelingen
ID

43459

Beschrijving

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

Link

http://clinicaltrials.gov/show/NCT00804856

Trefwoorden

Versies (3)
  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 -
Geüploaded op

20 september 2021

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

  • Nieuwste
  • Oudste
  • Populair
  • Nieuwste
    • Nieuwste
    • Oudste
    • Populair

    Geen commentaren

    U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

    Eligibility DRKS00003750 NCT00804856 Leukemia, Myeloid, Acute

    Duits Engels

    Eligibility

    1 Formulieren  
    1. StudyEvent: Eligibility
      1. Eligibility
    Einschlusskriterien
    Beschrijving

    Einschlusskriterien

    Alias
    UMLS CUI 2011AA
    CL425202 (undefined)
    Alter mindestens 18 Jahre
    Beschrijving

    age at least 18 Years

    Datatype

    boolean

    Alias
    UMLS CUI 2011AA
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    SNOMED CT 2011_0131
    397669002 (undefined)
    Male or female adult with relapsed/refractory AML ineligible for intensive treatment (phase I part only)
    Beschrijving

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

    Datatype

    boolean

    Alias
    UMLS CUI 2011AA
    C0086582 (Males)
    SNOMED
    10052007
    SNOMED CT 2011_0131
    248153007 (undefined)
    HL7 V3 2006_05
    M (undefined)
    UMLS CUI 2011AA
    C0086287 (Females)
    SNOMED
    1086007
    SNOMED CT 2011_0131
    248152002 (undefined)
    HL7 V3 2006_05
    F (undefined)
    UMLS CUI 2011AA
    C0001675 (Adult)
    SNOMED
    133936004
    LOINC
    LA13524-6
    SNOMED CT 2011_0131
    133936004 (undefined)
    UMLS CUI 2011AA
    C0278780 (recurrent adult acute myeloid leukemia)
    UMLS CUI 2011AA
    C0205269 (Unresponsive to Treatment)
    SNOMED
    20646008
    SNOMED CT 2011_0131
    20646008 (undefined)
    UMLS CUI 2011AA
    C0023467 (Leukemia, Myelocytic, Acute)
    SNOMED
    17788007
    SNOMED CT 2011_0131
    91861009 (undefined)
    MedDRA 14.1
    10000880 (undefined)
    ICD-10-CM Version 2010
    C92.0 (undefined)
    ICD-9-CM Version 2011
    205.0 (undefined)
    UMLS CUI 2011AA
    C0011900 (Diagnosis)
    SNOMED
    439401001
    LOINC
    LP30831-9
    SNOMED CT 2011_0131
    439401001 (undefined)
    LOINC Version 232
    MTHU008876 (undefined)
    UMLS CUI 2011AA
    C1518422 (Negation)
    LOINC
    LA21291-2
    UMLS CUI 2011AA
    C1548635 (Eligible)
    HL7 V3 2006_05
    ELG (undefined)
    UMLS CUI 2011AA
    C0085559 (intensive care)
    MedDRA 14.1
    10022519 (undefined)
    UMLS CUI 2011AA
    C0205390 (Phase)
    SNOMED
    21191007
    SNOMED CT 2011_0131
    21191007 (undefined)
    UMLS CUI 2011AA
    C0439068 (roman numeral upper case eye)
    SNOMED
    257469003
    SNOMED CT 2011_0131
    257469003 (undefined)
    Male or female adult with previously untreated AML ineligible for intensive treatment (phase IIa part only)
    Beschrijving

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

    Datatype

    boolean

    Alias
    UMLS CUI 2011AA
    C0086582 (Males)
    SNOMED
    10052007
    SNOMED CT 2011_0131
    248153007 (undefined)
    HL7 V3 2006_05
    M (undefined)
    UMLS CUI 2011AA
    C0086287 (Females)
    SNOMED
    1086007
    SNOMED CT 2011_0131
    248152002 (undefined)
    HL7 V3 2006_05
    F (undefined)
    UMLS CUI 2011AA
    C0001675 (Adult)
    SNOMED
    133936004
    LOINC
    LA13524-6
    SNOMED CT 2011_0131
    133936004 (undefined)
    UMLS CUI 2011AA
    C0205156 (Previous)
    SNOMED
    9130008
    LOINC
    LP21061-4
    SNOMED CT 2011_0131
    9130008 (undefined)
    UMLS CUI 2011AA
    C1518422 (Negation)
    LOINC
    LA21291-2
    UMLS CUI 2011AA
    CL415147 (undefined)
    UMLS CUI 2011AA
    C0023467 (Leukemia, Myelocytic, Acute)
    SNOMED
    17788007
    SNOMED CT 2011_0131
    91861009 (undefined)
    MedDRA 14.1
    10000880 (undefined)
    ICD-10-CM Version 2010
    C92.0 (undefined)
    ICD-9-CM Version 2011
    205.0 (undefined)
    UMLS CUI 2011AA
    C1518422 (Negation)
    LOINC
    LA21291-2
    UMLS CUI 2011AA
    C1548635 (Eligible)
    HL7 V3 2006_05
    ELG (undefined)
    UMLS CUI 2011AA
    C0085559 (intensive care)
    MedDRA 14.1
    10022519 (undefined)
    UMLS CUI 2011AA
    C1706446 (Trial Phase 2A)
    Confirmed diagnosis of AML according to the WHO definition (except for acute promyelocytic leukaemia, APL)
    Beschrijving

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

    Datatype

    boolean

    Alias
    UMLS CUI 2011AA
    C0750484 (Confirmation)
    LOINC
    LA15290-2
    UMLS CUI 2011AA
    C0011900 (Diagnosis)
    SNOMED
    439401001
    LOINC
    LP30831-9
    SNOMED CT 2011_0131
    439401001 (undefined)
    LOINC Version 232
    MTHU008876 (undefined)
    UMLS CUI 2011AA
    C0023467 (Leukemia, Myelocytic, Acute)
    SNOMED
    17788007
    SNOMED CT 2011_0131
    91861009 (undefined)
    MedDRA 14.1
    10000880 (undefined)
    ICD-10-CM Version 2010
    C92.0 (undefined)
    ICD-9-CM Version 2011
    205.0 (undefined)
    UMLS CUI 2011AA
    C0332290 (Consistent with)
    SNOMED
    385433004
    SNOMED CT 2011_0131
    385433004 (undefined)
    UMLS CUI 2011AA
    C0451584 (World Health Organization (WHO) classification of impairments, disabilities and handicap scale)
    SNOMED
    273931002
    SNOMED CT 2011_0131
    273931002 (undefined)
    UMLS CUI 2011AA
    C1554961 (exception - ResponseLevel)
    HL7 V3 2006_05
    E (undefined)
    UMLS CUI 2011AA
    C0023487 (Acute Promyelocytic Leukemia)
    SNOMED
    110004001
    SNOMED CT 2011_0131
    110004001 (undefined)
    MedDRA 14.1
    10001019 (undefined)
    ICD-10-CM Version 2010
    C92.4 (undefined)
    Patient is eligible for LD-Ara-C treatment
    Beschrijving

    Patient is eligible for LD-Ara-C treatment

    Datatype

    boolean

    Alias
    UMLS CUI 2011AA
    C1548635 (Eligible)
    HL7 V3 2006_05
    ELG (undefined)
    UMLS CUI 2011AA
    C1708745 (Low-Dose Treatment)
    UMLS CUI 2011AA
    C0010711 (cytarabine)
    SNOMED
    89265009
    SNOMED CT 2011_0131
    89265009 (undefined)
    UMLS CUI 2011AA
    C0039798 (therapeutic aspects)
    Life expectancy > 3 months
    Beschrijving

    Life expectancy > 3 months

    Datatype

    boolean

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

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

    Datatype

    boolean

    Alias
    UMLS CUI 2011AA
    C1828127 (ECOG performance status finding)
    SNOMED
    424122007
    SNOMED CT 2011_0131
    424122007 (undefined)
    UMLS CUI 2011AA
    C1409616 (Special screening finding)
    Signed written informed consent consistent with international conference on harmonisation, good clinical practice (ICH-GCP) and local legislation
    Beschrijving

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

    Datatype

    boolean

    Alias
    UMLS CUI 2011AA
    C0021430 (Informed Consent)
    Ausschlusskriterien
    Beschrijving

    Ausschlusskriterien

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

    Previously untreated AML (phase I part only)

    Datatype

    boolean

    Alias
    UMLS CUI 2011AA
    C0205156 (Previous)
    SNOMED
    9130008
    LOINC
    LP21061-4
    SNOMED CT 2011_0131
    9130008 (undefined)
    UMLS CUI 2011AA
    C1518422 (Negation)
    LOINC
    LA21291-2
    UMLS CUI 2011AA
    CL415147 (undefined)
    UMLS CUI 2011AA
    C0205390 (Phase)
    SNOMED
    21191007
    SNOMED CT 2011_0131
    21191007 (undefined)
    UMLS CUI 2011AA
    C0439068 (roman numeral upper case eye)
    SNOMED
    257469003
    SNOMED CT 2011_0131
    257469003 (undefined)
    Relapsed or treatment refractory AML (phase IIa part only)
    Beschrijving

    Relapsed or treatment refractory AML (phase IIa part only)

    Datatype

    boolean

    Alias
    UMLS CUI 2011AA
    C0278780 (recurrent adult acute myeloid leukemia)
    UMLS CUI 2011AA
    C0205269 (Unresponsive to Treatment)
    SNOMED
    20646008
    SNOMED CT 2011_0131
    20646008 (undefined)
    UMLS CUI 2011AA
    C0023467 (Leukemia, Myelocytic, Acute)
    SNOMED
    17788007
    SNOMED CT 2011_0131
    91861009 (undefined)
    MedDRA 14.1
    10000880 (undefined)
    ICD-10-CM Version 2010
    C92.0 (undefined)
    ICD-9-CM Version 2011
    205.0 (undefined)
    UMLS CUI 2011AA
    C1706446 (Trial Phase 2A)
    Patient with APL (AML subtype M3 according to the French-American-British (FAB) classification)
    Beschrijving

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

    Datatype

    boolean

    Alias
    UMLS CUI 2011AA
    C0023487 (Acute Promyelocytic Leukemia)
    SNOMED
    110004001
    SNOMED CT 2011_0131
    110004001 (undefined)
    MedDRA 14.1
    10001019 (undefined)
    ICD-10-CM Version 2010
    C92.4 (undefined)
    UMLS CUI 2011AA
    C0023467 (Leukemia, Myelocytic, Acute)
    SNOMED
    17788007
    SNOMED CT 2011_0131
    91861009 (undefined)
    MedDRA 14.1
    10000880 (undefined)
    ICD-10-CM Version 2010
    C92.0 (undefined)
    ICD-9-CM Version 2011
    205.0 (undefined)
    UMLS CUI 2011AA
    C0457329 (FAB type M3)
    SNOMED
    278165002
    SNOMED CT 2011_0131
    278165002 (undefined)
    Hypersensitivity to one of the trial drugs or the excipients
    Beschrijving

    Hypersensitivity to one of the trial drugs or the excipients

    Datatype

    boolean

    Alias
    UMLS CUI 2011AA
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    SNOMED CT 2011_0131
    418634005 (undefined)
    ICD-10-CM Version 2010
    T78.40 (undefined)
    UMLS CUI 2011AA
    C0304229 (Experimental drug)
    SNOMED CT 2011_0131
    902003 (undefined)
    UMLS CUI 2011AA
    C0015237 (Pharmaceutical Excipient)
    SNOMED
    43747001
    SNOMED CT 2011_0131
    360215002 (undefined)
    Other malignancy requiring treatment
    Beschrijving

    Other malignancy requiring treatment

    Datatype

    boolean

    Alias
    UMLS CUI 2011AA
    C0205394 (Other)
    SNOMED
    74964007
    LOINC
    LP21049-9
    SNOMED CT 2011_0131
    74964007 (undefined)
    UMLS CUI 2011AA
    C0006826 (Malignant Neoplasms)
    SNOMED
    363346000
    LOINC
    LP100805-3
    SNOMED CT 2011_0131
    363346000 (undefined)
    MedDRA 14.1
    10028997 (undefined)
    LOINC Version 232
    MTHU010328 (undefined)
    ICD-10-CM Version 2010
    C00-C96 (undefined)
    UMLS CUI 2011AA
    C1514873 (Requirement)
    UMLS CUI 2011AA
    C0039798 (therapeutic aspects)
    Symptomatic central nervous system involvement
    Beschrijving

    Symptomatic central nervous system involvement

    Datatype

    boolean

    Alias
    UMLS CUI 2011AA
    C0231220 (Symptomatic)
    SNOMED
    264931009
    LOINC
    LA17766-9
    SNOMED CT 2011_0131
    264931009 (undefined)
    UMLS CUI 2011AA
    C1269563 (Entire central nervous system)
    SNOMED
    278199004
    SNOMED CT 2011_0131
    278199004 (undefined)
    UMLS CUI 2011AA
    C1314939 (Involvement with)
    SNOMED
    248448006
    LOINC
    LA26536-5
    SNOMED CT 2011_0131
    248448006 (undefined)
    Clinically relevant QT prolongation (e.g. long QT syndrome, QTcF>470 ms)
    Beschrijving

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

    Datatype

    boolean

    Alias
    UMLS CUI 2011AA
    C0205210 (Clinical)
    SNOMED
    58147004
    SNOMED CT 2011_0131
    58147004 (undefined)
    UMLS CUI 2011AA
    C2347946 (Relevance)
    UMLS CUI 2011AA
    C0151878 (Prolonged QT interval)
    SNOMED
    111975006
    SNOMED CT 2011_0131
    111975006 (undefined)
    MedDRA 14.1
    10014387 (undefined)
    CTCAE 1105E
    E12146 (undefined)
    UMLS CUI 2011AA
    C0023976 (Long QT Syndrome)
    SNOMED
    9651007
    SNOMED CT 2011_0131
    9651007 (undefined)
    MedDRA 14.1
    10024803 (undefined)
    ICD-10-CM Version 2010
    I45.81 (undefined)
    ICD-9-CM Version 2011
    426.82 (undefined)
    UMLS CUI 2011AA
    C1882513 (QTcF - Fridericia's Correction Formula)
    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
    Beschrijving

    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

    Datatype

    boolean

    Alias
    UMLS CUI 2011AA
    C0004002 (Aspartate Transaminase)
    SNOMED
    26091008
    SNOMED CT 2011_0131
    26091008 (undefined)
    LOINC Version 232
    MTHU004883 (undefined)
    UMLS CUI 2011AA
    C0001899 (Alanine Transaminase)
    SNOMED
    56935002
    SNOMED CT 2011_0131
    56935002 (undefined)
    LOINC Version 232
    MTHU006766 (undefined)
    UMLS CUI 2011AA
    C1519815 (Upper Limit of Normal)
    UMLS CUI 2011AA
    C0023418 (leukemia)
    SNOMED
    93143009
    SNOMED CT 2011_0131
    93143009 (undefined)
    MedDRA 14.1
    10024288 (undefined)
    ICD-10-CM Version 2010
    C95.9 (undefined)
    ICD-9-CM Version 2011
    208.9 (undefined)
    UMLS CUI 2011AA
    C0023884 (Liver)
    SNOMED
    10200004
    LOINC
    LP29289-3
    SNOMED CT 2011_0131
    10200004 (undefined)
    LOINC Version 232
    MTHU002039 (undefined)
    UMLS CUI 2011AA
    C1314939 (Involvement with)
    SNOMED
    248448006
    LOINC
    LA26536-5
    SNOMED CT 2011_0131
    248448006 (undefined)
    Prothrombin time (PT) > 1.5 x ULN for subjects not on therapeutic vitamin K antagonists (phenprocoumon, warfarin)
    Beschrijving

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

    Datatype

    boolean

    Alias
    UMLS CUI 2011AA
    CL434069 (undefined)
    UMLS CUI 2011AA
    C1519815 (Upper Limit of Normal)
    UMLS CUI 2011AA
    C1518422 (Negation)
    LOINC
    LA21291-2
    UMLS CUI 2011AA
    C1096489 (Treatment with Vitamin K antagonist)
    MedDRA 14.1
    10053755 (undefined)
    UMLS CUI 2011AA
    C0031444 (phenprocoumon)
    SNOMED
    59488002
    SNOMED CT 2011_0131
    59488002 (undefined)
    LOINC Version 232
    MTHU016364 (undefined)
    UMLS CUI 2011AA
    C0043031 (warfarin)
    SNOMED
    48603004
    SNOMED CT 2011_0131
    48603004 (undefined)
    LOINC Version 232
    MTHU003212 (undefined)
    Bilirubin
    Beschrijving

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

    Datatype

    boolean

    Alias
    UMLS CUI 2011AA
    C0011221 (Delta Bilirubin)
    SNOMED CT 2011_0131
    79706000 (undefined)
    LOINC Version 232
    1975-2 (undefined)
    Kreatinin im Serum
    Beschrijving

    Serum creatinine > 2.0 mg/dl

    Datatype

    boolean

    Alias
    UMLS CUI 2011AA
    C0201976 (Creatinine measurement, serum (procedure))
    SNOMED
    113075003
    SNOMED CT 2011_0131
    113075003 (undefined)
    MedDRA 14.1
    10040230 (undefined)
    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.
    Beschrijving

    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.

    Datatype

    boolean

    Alias
    UMLS CUI 2011AA
    CL415222 (undefined)
    UMLS CUI 2011AA
    C0277557 (Intercurrent disease)
    SNOMED
    88472004
    SNOMED CT 2011_0131
    88472004 (undefined)
    UMLS CUI 2011AA
    C0221099 (Impaired)
    SNOMED
    260379002
    LOINC
    LA13035-3
    SNOMED CT 2011_0131
    260379002 (undefined)
    UMLS CUI 2011AA
    C0013175 (Drug Evaluation)
    SNOMED
    185922005
    SNOMED CT 2011_0131
    185922005 (undefined)
    UMLS CUI 2011AA
    C0205082 (Severe (severity modifier))
    SNOMED
    24484000
    LOINC
    LA6750-9
    SNOMED CT 2011_0131
    24484000 (undefined)
    UMLS CUI 2011AA
    C0009450 (Communicable Diseases)
    SNOMED
    189822004
    SNOMED CT 2011_0131
    257551009 (undefined)
    MedDRA 14.1
    10021789 (undefined)
    UMLS CUI 2011AA
    C0002965 (Angina, Unstable)
    SNOMED
    4557003
    SNOMED CT 2011_0131
    4557003 (undefined)
    MedDRA 14.1
    10002388 (undefined)
    ICD-10-CM Version 2010
    I20.0 (undefined)
    ICD-9-CM Version 2011
    411.1 (undefined)
    UMLS CUI 2011AA
    C0003811 (Cardiac Arrhythmia)
    SNOMED
    698247007
    LOINC
    LA7414-1
    SNOMED CT 2011_0131
    44808001 (undefined)
    MedDRA 14.1
    10003119 (undefined)
    ICD-9-CM Version 2011
    427.9 (undefined)
    UMLS CUI 2011AA
    C0018801 (Heart failure)
    SNOMED
    84114007
    LOINC
    LP269421-6
    SNOMED CT 2011_0131
    155374007 (undefined)
    MedDRA 14.1
    10019279 (undefined)
    ICD-9-CM Version 2011
    428 (undefined)
    CTCAE 1105E
    E10124 (undefined)
    Psychiatric illness or social situation that would limit compliance with trial requirements
    Beschrijving

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

    Datatype

    boolean

    Alias
    UMLS CUI 2011AA
    C0004936 (Mental disorders)
    SNOMED
    74732009
    SNOMED CT 2011_0131
    74732009 (undefined)
    MedDRA 14.1
    10037174 (undefined)
    ICD-10-CM Version 2010
    F99 (undefined)
    ICD-9-CM Version 2011
    290-319.99 (undefined)
    UMLS CUI 2011AA
    C0851364 (Social circumstances)
    MedDRA 14.1
    10041244 (undefined)
    UMLS CUI 2011AA
    C0449295 (Limitation)
    SNOMED
    246175000
    SNOMED CT 2011_0131
    246175000 (undefined)
    UMLS CUI 2011AA
    C1321605 (Compliance behavior)
    SNOMED
    405078008
    SNOMED CT 2011_0131
    405078008 (undefined)
    UMLS CUI 2011AA
    C0008976 (Clinical Trials)
    SNOMED
    110465008
    LOINC
    LP231796-6
    SNOMED CT 2011_0131
    110465008 (undefined)
    UMLS CUI 2011AA
    C1514873 (Requirement)
    Concomitant therapy, which is considered relevant for the evaluation of the efficacy or safety of the trial drug
    Beschrijving

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

    Datatype

    boolean

    Alias
    UMLS CUI 2011AA
    C1707479 (Concomitant Therapy)
    UMLS CUI 2011AA
    C2347946 (Relevance)
    UMLS CUI 2011AA
    C0013175 (Drug Evaluation)
    SNOMED
    185922005
    SNOMED CT 2011_0131
    185922005 (undefined)
    Contraindications for cytarabine treatment according to the SPC
    Beschrijving

    Contraindications for cytarabine treatment according to the SPC

    Datatype

    boolean

    Alias
    UMLS CUI 2011AA
    C1301624 (Medical contraindication)
    SNOMED
    397745006
    LOINC
    LA27164-5
    SNOMED CT 2011_0131
    397745006 (undefined)
    UMLS CUI 2011AA
    C0010711 (cytarabine)
    SNOMED
    89265009
    SNOMED CT 2011_0131
    89265009 (undefined)
    UMLS CUI 2011AA
    C0039798 (therapeutic aspects)
    UMLS CUI 2011AA
    C0332290 (Consistent with)
    SNOMED
    385433004
    SNOMED CT 2011_0131
    385433004 (undefined)
    UMLS CUI 2011AA
    C1709515 (Pharmaceutical Product Characteristics)
    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.).
    Beschrijving

    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.).

    Datatype

    boolean

    Alias
    UMLS CUI 2011AA
    C0086287 (Females)
    SNOMED
    1086007
    SNOMED CT 2011_0131
    248152002 (undefined)
    HL7 V3 2006_05
    F (undefined)
    UMLS CUI 2011AA
    C1148523 (Childbirth)
    SNOMED
    386216000
    LOINC
    LA6607-1
    UMLS CUI 2011AA
    C0237399 (undefined)
    UMLS CUI 2011AA
    C0241028 (Sexually active)
    SNOMED
    228453005
    SNOMED CT 2011_0131
    228453005 (undefined)
    MedDRA 14.1
    10066098 (undefined)
    UMLS CUI 2011AA
    C0558080 (Unwilling)
    SNOMED
    225465005
    SNOMED CT 2011_0131
    225465005 (undefined)
    UMLS CUI 2011AA
    C0700589 (Contraceptive methods)
    SNOMED
    13197004
    SNOMED CT 2011_0131
    146680009 (undefined)
    MedDRA 14.1
    10010808 (undefined)
    UMLS CUI 2011AA
    CL424941 (undefined)
    UMLS CUI 2011AA
    C0021900 (Intrauterine Devices)
    SNOMED
    268460000
    SNOMED CT 2011_0131
    268460000 (undefined)
    MedDRA 14.1
    10022745 (undefined)
    UMLS CUI 2011AA
    C0677582 (Condoms, Unspecified)
    LOINC
    LA14543-5
    UMLS CUI 2011AA
    C0037862 (Spermatocidal Agents)
    SNOMED CT 2011_0131
    425484006 (undefined)
    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
    Beschrijving

    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

    Datatype

    boolean

    Alias
    UMLS CUI 2011AA
    C0086582 (Males)
    SNOMED
    10052007
    SNOMED CT 2011_0131
    248153007 (undefined)
    HL7 V3 2006_05
    M (undefined)
    UMLS CUI 2011AA
    C0682323 (Partner in relationship)
    SNOMED
    262043009
    LOINC
    LP76013-9
    SNOMED CT 2011_0131
    262043009 (undefined)
    HL7 V3 2006_05
    SIGOTHR (undefined)
    UMLS CUI 2011AA
    C1148523 (Childbirth)
    SNOMED
    386216000
    LOINC
    LA6607-1
    UMLS CUI 2011AA
    C0237399 (undefined)
    UMLS CUI 2011AA
    C0558080 (Unwilling)
    SNOMED
    225465005
    SNOMED CT 2011_0131
    225465005 (undefined)
    UMLS CUI 2011AA
    C1524063 (Use of)
    SNOMED
    260676000
    SNOMED CT 2011_0131
    260676000 (undefined)
    UMLS CUI 2011AA
    C0677582 (Condoms, Unspecified)
    LOINC
    LA14543-5
    UMLS CUI 2011AA
    C1947911 (combination of objects)
    UMLS CUI 2011AA
    C0205436 (second (number))
    SNOMED
    81170007
    LOINC
    LP35057-6
    SNOMED CT 2011_0131
    81170007 (undefined)
    UMLS CUI 2011AA
    C0025663 (Methods)
    SNOMED
    260686004
    SNOMED CT 2011_0131
    260686004 (undefined)
    LOINC Version 232
    MTHU024654 (undefined)
    UMLS CUI 2011AA
    C0700589 (Contraceptive methods)
    SNOMED
    13197004
    SNOMED CT 2011_0131
    146680009 (undefined)
    MedDRA 14.1
    10010808 (undefined)
    Pregnant or nursing female patients
    Beschrijving

    Pregnant or nursing female patients

    Datatype

    boolean

    Alias
    UMLS CUI 2011AA
    C0549206 (Patient currently pregnant)
    SNOMED
    77386006
    LOINC
    LA14670-6
    MedDRA 14.1
    10036586 (undefined)
    UMLS CUI 2011AA
    C0006147 (Breast Feeding)
    SNOMED
    169741004
    LOINC
    LP420040-0
    MedDRA 14.1
    10006247 (undefined)
    UMLS CUI 2011AA
    C0086287 (Females)
    SNOMED
    1086007
    SNOMED CT 2011_0131
    248152002 (undefined)
    HL7 V3 2006_05
    F (undefined)
    Patient unable to comply with the protocol
    Beschrijving

    Patient unable to comply with the protocol

    Datatype

    boolean

    Alias
    UMLS CUI 2011AA
    C1321605 (Compliance behavior)
    SNOMED
    405078008
    Terug naar het begin van de pagina

    Similar models

    Eligibility

    1 Formulieren
    1. StudyEvent: Eligibility
      1. Eligibility
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    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
    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)
    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)
    9130008 (SNOMED CT 2011_0131)
    C1518422 (UMLS CUI 2011AA)
    CL415147 (UMLS CUI 2011AA)
    C0205390 (UMLS CUI 2011AA)
    21191007 (SNOMED CT 2011_0131)
    C0439068 (UMLS CUI 2011AA)
    257469003 (SNOMED CT 2011_0131)
    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)
    Terug naar het begin van de pagina 

    Help

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial