0 Évaluations

ID

42773

Description

ODM derived from http://clinicaltrials.gov/show/NCT00391287

Lien

http://clinicaltrials.gov/show/NCT00391287

Mots-clés

  1. 09/12/2013 09/12/2013 - Martin Dugas
  2. 17/09/2021 17/09/2021 -
Téléchargé le

17 septembre 2021

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Groupe Item commentaires pour :

Item commentaires pour :


    Aucun commentaire

    Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

    Eligibility NCT00391287 Pure Red-Cell Aplasia

    Eligibility

    1. StudyEvent: Eligibility
      1. Eligibility
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI 2011AA
    CL425202
    age at least 18 Years
    Description

    age at least 18 Years

    Type de données

    boolean

    Alias
    UMLS CUI 2011AA
    C0001779
    SNOMED CT 2011_0131
    397669002
    Patients with established CRF as an indication for the treatment of anemia
    Description

    Patients with established CRF as an indication for the treatment of anemia

    Type de données

    boolean

    Alias
    UMLS CUI 2011AA
    C0443211
    SNOMED CT 2011_0131
    263748003
    UMLS CUI 2011AA
    C0022661
    SNOMED CT 2011_0131
    90688005
    MedDRA 14.1
    10038444
    ICD-10-CM Version 2010
    N18.9
    ICD-9-CM Version 2011
    585.6
    UMLS CUI 2011AA
    C0011900
    SNOMED CT 2011_0131
    439401001
    LOINC Version 232
    MTHU008876
    UMLS CUI 2011AA
    CL335836
    UMLS CUI 2011AA
    C0039798
    UMLS CUI 2011AA
    C0002871
    SNOMED CT 2011_0131
    271737000
    MedDRA 14.1
    10002034
    LOINC Version 232
    MTHU020823
    ICD-10-CM Version 2010
    D64.9
    ICD-9-CM Version 2011
    285.9
    CTCAE 1105E
    E10010
    Patients who are receiving or are about to receive (within 1 month) a marketed erythropoietin product by the s.c. route of administration
    Description

    Patients who are receiving or are about to receive (within 1 month) a marketed erythropoietin product by the s.c. route of administration

    Type de données

    boolean

    Alias
    UMLS CUI 2011AA
    C1514756
    UMLS CUI 2011AA
    C0332285
    SNOMED CT 2011_0131
    18720000
    UMLS CUI 2011AA
    C0205447
    SNOMED CT 2011_0131
    38112003
    UMLS CUI 2011AA
    C0439231
    SNOMED CT 2011_0131
    258706009
    HL7 V3 2006_05
    MO
    UMLS CUI 2011AA
    C0014822
    SNOMED CT 2011_0131
    111167001
    LOINC Version 232
    MTHU004935
    UMLS CUI 2011AA
    C1522438
    SNOMED CT 2011_0131
    34206005
    HL7 V3 2006_05
    SubcutaneousRoute
    UMLS CUI 2011AA
    C1533734
    SNOMED CT 2011_0131
    416118004
    Patients who are likely to continue to receive s.c. erythropoietin product(s) for at least 1 year
    Description

    Patients who are likely to continue to receive s.c. erythropoietin product(s) for at least 1 year

    Type de données

    boolean

    Alias
    UMLS CUI 2011AA
    C0332148
    SNOMED CT 2011_0131
    2931005
    UMLS CUI 2011AA
    C0549178
    UMLS CUI 2011AA
    C1514756
    UMLS CUI 2011AA
    C1522438
    SNOMED CT 2011_0131
    34206005
    HL7 V3 2006_05
    SubcutaneousRoute
    UMLS CUI 2011AA
    C0014822
    SNOMED CT 2011_0131
    111167001
    LOINC Version 232
    MTHU004935
    UMLS CUI 2011AA
    C0205447
    SNOMED CT 2011_0131
    38112003
    UMLS CUI 2011AA
    C0439234
    SNOMED CT 2011_0131
    258707000
    HL7 V3 2006_05
    Y
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI 2011AA
    CL425201
    Patients with a history of pure red cell aplasia or aplastic anemia
    Description

    Patients with a history of pure red cell aplasia or aplastic anemia

    Type de données

    boolean

    Alias
    UMLS CUI 2011AA
    CL421546
    SNOMED CT 2011_0131
    392521001
    UMLS CUI 2011AA
    C0034902
    SNOMED CT 2011_0131
    50715003
    MedDRA 14.1
    10002965
    UMLS CUI 2011AA
    C0002874
    SNOMED CT 2011_0131
    306058006
    MedDRA 14.1
    10002967
    ICD-10-CM Version 2010
    D61.9
    ICD-9-CM Version 2011
    284.9
    Patients who are experiencing unexplained loss or lack of effect to a recombinant erythropoietin product ongoing at the time of enrollment
    Description

    Patients who are experiencing unexplained loss or lack of effect to a recombinant erythropoietin product ongoing at the time of enrollment

    Type de données

    boolean

    Alias
    UMLS CUI 2011AA
    C0596545
    UMLS CUI 2011AA
    C1705492
    UMLS CUI 2011AA
    C0681841
    LOINC Version 232
    MTHU013812
    UMLS CUI 2011AA
    C1517945
    UMLS CUI 2011AA
    C0332197
    SNOMED CT 2011_0131
    2667000
    UMLS CUI 2011AA
    C1280500
    SNOMED CT 2011_0131
    253861007
    UMLS CUI 2011AA
    C0376541
    UMLS CUI 2011AA
    C0549178
    UMLS CUI 2011AA
    C0439547
    SNOMED CT 2011_0131
    272105005
    UMLS CUI 2011AA
    C1516879
    Patients who have had prior recombinant erythropoietin treatment whose anemia had never responded (primary lack of efficacy)
    Description

    Patients who have had prior recombinant erythropoietin treatment whose anemia had never responded (primary lack of efficacy)

    Type de données

    boolean

    Alias
    UMLS CUI 2011AA
    C0332152
    SNOMED CT 2011_0131
    288556008
    UMLS CUI 2011AA
    C0376541
    UMLS CUI 2011AA
    C0039798
    UMLS CUI 2011AA
    C0002871
    SNOMED CT 2011_0131
    271737000
    MedDRA 14.1
    10002034
    LOINC Version 232
    MTHU020823
    ICD-10-CM Version 2010
    D64.9
    ICD-9-CM Version 2011
    285.9
    CTCAE 1105E
    E10010
    UMLS CUI 2011AA
    C0438286
    SNOMED CT 2011_0131
    266721009
    MedDRA 14.1
    10063670
    UMLS CUI 2011AA
    CL414904
    UMLS CUI 2011AA
    C0332197
    SNOMED CT 2011_0131
    2667000
    UMLS CUI 2011AA
    C1280519
    SNOMED CT 2011_0131
    255403003
    Patients with a history of EPO antibodies prior to enrollment
    Description

    Patients with a history of EPO antibodies prior to enrollment

    Type de données

    boolean

    Alias
    UMLS CUI 2011AA
    CL421546
    SNOMED CT 2011_0131
    392521001
    UMLS CUI 2011AA
    C0014822
    SNOMED CT 2011_0131
    111167001
    LOINC Version 232
    MTHU004935
    UMLS CUI 2011AA
    C0003241
    SNOMED CT 2011_0131
    68498002
    LOINC Version 232
    MTHU003502
    UMLS CUI 2011AA
    C0332152
    SNOMED CT 2011_0131
    288556008
    UMLS CUI 2011AA
    C1516879
    Subjects who are currently receiving immunosuppressive medication (e.g., cyclosporine, tacrolimus, sirolimus, mycophenolic mofetil, azathioprine, or monoclonal antibodies) or corticosteroids at a dose corresponding to >15 mg/day prednisolone
    Description

    Subjects who are currently receiving immunosuppressive medication (e.g., cyclosporine, tacrolimus, sirolimus, mycophenolic mofetil, azathioprine, or monoclonal antibodies) or corticosteroids at a dose corresponding to >15 mg/day prednisolone

    Type de données

    boolean

    Alias
    UMLS CUI 2011AA
    C0521116
    SNOMED CT 2011_0131
    15240007
    UMLS CUI 2011AA
    C1514756
    UMLS CUI 2011AA
    C0021081
    SNOMED CT 2011_0131
    372823004, 69431002
    UMLS CUI 2011AA
    C0010592
    SNOMED CT 2011_0131
    387467008
    LOINC Version 232
    MTHU005140
    UMLS CUI 2011AA
    C0085149
    SNOMED CT 2011_0131
    386975001
    LOINC Version 232
    MTHU001849
    UMLS CUI 2011AA
    C0072980
    SNOMED CT 2011_0131
    387014003
    LOINC Version 232
    MTHU013897
    UMLS CUI 2011AA
    C0026933
    SNOMED CT 2011_0131
    409330005
    UMLS CUI 2011AA
    C0209368
    SNOMED CT 2011_0131
    386976000
    UMLS CUI 2011AA
    C0004482
    SNOMED CT 2011_0131
    372574004
    LOINC Version 232
    MTHU006794
    UMLS CUI 2011AA
    C0003250
    SNOMED CT 2011_0131
    49616005
    UMLS CUI 2011AA
    C0001617
    SNOMED CT 2011_0131
    79440004
    UMLS CUI 2011AA
    C0178602
    SNOMED CT 2011_0131
    260911001
    UMLS CUI 2011AA
    CL415123
    UMLS CUI 2011AA
    C0439228
    SNOMED CT 2011_0131
    258703001
    HL7 V3 2006_05
    D
    UMLS CUI 2011AA
    C0032950
    SNOMED CT 2011_0131
    116601002
    LOINC Version 232
    MTHU003522
    Subjects whose first s.c. exposure to any erythropoietin product was >1 year prior to enrollment
    Description

    Subjects whose first s.c. exposure to any erythropoietin product was >1 year prior to enrollment

    Type de données

    boolean

    Alias
    UMLS CUI 2011AA
    C0205435
    SNOMED CT 2011_0131
    255216001
    UMLS CUI 2011AA
    C1522438
    SNOMED CT 2011_0131
    34206005
    HL7 V3 2006_05
    SubcutaneousRoute
    UMLS CUI 2011AA
    C0332157
    SNOMED CT 2011_0131
    24932003
    UMLS CUI 2011AA
    C0014822
    SNOMED CT 2011_0131
    111167001
    LOINC Version 232
    MTHU004935
    UMLS CUI 2011AA
    CL384738
    UMLS CUI 2011AA
    C0205447
    SNOMED CT 2011_0131
    38112003
    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
    C1516879

    Similar models

    Eligibility

    1. StudyEvent: Eligibility
      1. Eligibility
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    Inclusion Criteria
    CL425202 (UMLS CUI 2011AA)
    age at least 18 Years
    Item
    age at least 18 Years
    boolean
    C0001779 (UMLS CUI 2011AA)
    397669002 (SNOMED CT 2011_0131)
    Patients with established CRF as an indication for the treatment of anemia
    Item
    Patients with established CRF as an indication for the treatment of anemia
    boolean
    C0443211 (UMLS CUI 2011AA)
    263748003 (SNOMED CT 2011_0131)
    C0022661 (UMLS CUI 2011AA)
    90688005 (SNOMED CT 2011_0131)
    10038444 (MedDRA 14.1)
    N18.9 (ICD-10-CM Version 2010)
    585.6 (ICD-9-CM Version 2011)
    C0011900 (UMLS CUI 2011AA)
    439401001 (SNOMED CT 2011_0131)
    MTHU008876 (LOINC Version 232)
    CL335836 (UMLS CUI 2011AA)
    C0039798 (UMLS CUI 2011AA)
    C0002871 (UMLS CUI 2011AA)
    271737000 (SNOMED CT 2011_0131)
    10002034 (MedDRA 14.1)
    MTHU020823 (LOINC Version 232)
    D64.9 (ICD-10-CM Version 2010)
    285.9 (ICD-9-CM Version 2011)
    E10010 (CTCAE 1105E)
    Patients who are receiving or are about to receive (within 1 month) a marketed erythropoietin product by the s.c. route of administration
    Item
    Patients who are receiving or are about to receive (within 1 month) a marketed erythropoietin product by the s.c. route of administration
    boolean
    C1514756 (UMLS CUI 2011AA)
    C0332285 (UMLS CUI 2011AA)
    18720000 (SNOMED CT 2011_0131)
    C0205447 (UMLS CUI 2011AA)
    38112003 (SNOMED CT 2011_0131)
    C0439231 (UMLS CUI 2011AA)
    258706009 (SNOMED CT 2011_0131)
    MO (HL7 V3 2006_05)
    C0014822 (UMLS CUI 2011AA)
    111167001 (SNOMED CT 2011_0131)
    MTHU004935 (LOINC Version 232)
    C1522438 (UMLS CUI 2011AA)
    34206005 (SNOMED CT 2011_0131)
    SubcutaneousRoute (HL7 V3 2006_05)
    C1533734 (UMLS CUI 2011AA)
    416118004 (SNOMED CT 2011_0131)
    Patients who are likely to continue to receive s.c. erythropoietin product(s) for at least 1 year
    Item
    Patients who are likely to continue to receive s.c. erythropoietin product(s) for at least 1 year
    boolean
    C0332148 (UMLS CUI 2011AA)
    2931005 (SNOMED CT 2011_0131)
    C0549178 (UMLS CUI 2011AA)
    C1514756 (UMLS CUI 2011AA)
    C1522438 (UMLS CUI 2011AA)
    34206005 (SNOMED CT 2011_0131)
    SubcutaneousRoute (HL7 V3 2006_05)
    C0014822 (UMLS CUI 2011AA)
    111167001 (SNOMED CT 2011_0131)
    MTHU004935 (LOINC Version 232)
    C0205447 (UMLS CUI 2011AA)
    38112003 (SNOMED CT 2011_0131)
    C0439234 (UMLS CUI 2011AA)
    258707000 (SNOMED CT 2011_0131)
    Y (HL7 V3 2006_05)
    Item Group
    Exclusion Criteria
    CL425201 (UMLS CUI 2011AA)
    Patients with a history of pure red cell aplasia or aplastic anemia
    Item
    Patients with a history of pure red cell aplasia or aplastic anemia
    boolean
    CL421546 (UMLS CUI 2011AA)
    392521001 (SNOMED CT 2011_0131)
    C0034902 (UMLS CUI 2011AA)
    50715003 (SNOMED CT 2011_0131)
    10002965 (MedDRA 14.1)
    C0002874 (UMLS CUI 2011AA)
    306058006 (SNOMED CT 2011_0131)
    10002967 (MedDRA 14.1)
    D61.9 (ICD-10-CM Version 2010)
    284.9 (ICD-9-CM Version 2011)
    Patients who are experiencing unexplained loss or lack of effect to a recombinant erythropoietin product ongoing at the time of enrollment
    Item
    Patients who are experiencing unexplained loss or lack of effect to a recombinant erythropoietin product ongoing at the time of enrollment
    boolean
    C0596545 (UMLS CUI 2011AA)
    C1705492 (UMLS CUI 2011AA)
    C0681841 (UMLS CUI 2011AA)
    MTHU013812 (LOINC Version 232)
    C1517945 (UMLS CUI 2011AA)
    C0332197 (UMLS CUI 2011AA)
    2667000 (SNOMED CT 2011_0131)
    C1280500 (UMLS CUI 2011AA)
    253861007 (SNOMED CT 2011_0131)
    C0376541 (UMLS CUI 2011AA)
    C0549178 (UMLS CUI 2011AA)
    C0439547 (UMLS CUI 2011AA)
    272105005 (SNOMED CT 2011_0131)
    C1516879 (UMLS CUI 2011AA)
    Patients who have had prior recombinant erythropoietin treatment whose anemia had never responded (primary lack of efficacy)
    Item
    Patients who have had prior recombinant erythropoietin treatment whose anemia had never responded (primary lack of efficacy)
    boolean
    C0332152 (UMLS CUI 2011AA)
    288556008 (SNOMED CT 2011_0131)
    C0376541 (UMLS CUI 2011AA)
    C0039798 (UMLS CUI 2011AA)
    C0002871 (UMLS CUI 2011AA)
    271737000 (SNOMED CT 2011_0131)
    10002034 (MedDRA 14.1)
    MTHU020823 (LOINC Version 232)
    D64.9 (ICD-10-CM Version 2010)
    285.9 (ICD-9-CM Version 2011)
    E10010 (CTCAE 1105E)
    C0438286 (UMLS CUI 2011AA)
    266721009 (SNOMED CT 2011_0131)
    10063670 (MedDRA 14.1)
    CL414904 (UMLS CUI 2011AA)
    C0332197 (UMLS CUI 2011AA)
    2667000 (SNOMED CT 2011_0131)
    C1280519 (UMLS CUI 2011AA)
    255403003 (SNOMED CT 2011_0131)
    Patients with a history of EPO antibodies prior to enrollment
    Item
    Patients with a history of EPO antibodies prior to enrollment
    boolean
    CL421546 (UMLS CUI 2011AA)
    392521001 (SNOMED CT 2011_0131)
    C0014822 (UMLS CUI 2011AA)
    111167001 (SNOMED CT 2011_0131)
    MTHU004935 (LOINC Version 232)
    C0003241 (UMLS CUI 2011AA)
    68498002 (SNOMED CT 2011_0131)
    MTHU003502 (LOINC Version 232)
    C0332152 (UMLS CUI 2011AA)
    288556008 (SNOMED CT 2011_0131)
    C1516879 (UMLS CUI 2011AA)
    Subjects who are currently receiving immunosuppressive medication (e.g., cyclosporine, tacrolimus, sirolimus, mycophenolic mofetil, azathioprine, or monoclonal antibodies) or corticosteroids at a dose corresponding to >15 mg/day prednisolone
    Item
    Subjects who are currently receiving immunosuppressive medication (e.g., cyclosporine, tacrolimus, sirolimus, mycophenolic mofetil, azathioprine, or monoclonal antibodies) or corticosteroids at a dose corresponding to >15 mg/day prednisolone
    boolean
    C0521116 (UMLS CUI 2011AA)
    15240007 (SNOMED CT 2011_0131)
    C1514756 (UMLS CUI 2011AA)
    C0021081 (UMLS CUI 2011AA)
    372823004, 69431002 (SNOMED CT 2011_0131)
    C0010592 (UMLS CUI 2011AA)
    387467008 (SNOMED CT 2011_0131)
    MTHU005140 (LOINC Version 232)
    C0085149 (UMLS CUI 2011AA)
    386975001 (SNOMED CT 2011_0131)
    MTHU001849 (LOINC Version 232)
    C0072980 (UMLS CUI 2011AA)
    387014003 (SNOMED CT 2011_0131)
    MTHU013897 (LOINC Version 232)
    C0026933 (UMLS CUI 2011AA)
    409330005 (SNOMED CT 2011_0131)
    C0209368 (UMLS CUI 2011AA)
    386976000 (SNOMED CT 2011_0131)
    C0004482 (UMLS CUI 2011AA)
    372574004 (SNOMED CT 2011_0131)
    MTHU006794 (LOINC Version 232)
    C0003250 (UMLS CUI 2011AA)
    49616005 (SNOMED CT 2011_0131)
    C0001617 (UMLS CUI 2011AA)
    79440004 (SNOMED CT 2011_0131)
    C0178602 (UMLS CUI 2011AA)
    260911001 (SNOMED CT 2011_0131)
    CL415123 (UMLS CUI 2011AA)
    C0439228 (UMLS CUI 2011AA)
    258703001 (SNOMED CT 2011_0131)
    D (HL7 V3 2006_05)
    C0032950 (UMLS CUI 2011AA)
    116601002 (SNOMED CT 2011_0131)
    MTHU003522 (LOINC Version 232)
    Subjects whose first s.c. exposure to any erythropoietin product was >1 year prior to enrollment
    Item
    Subjects whose first s.c. exposure to any erythropoietin product was >1 year prior to enrollment
    boolean
    C0205435 (UMLS CUI 2011AA)
    255216001 (SNOMED CT 2011_0131)
    C1522438 (UMLS CUI 2011AA)
    34206005 (SNOMED CT 2011_0131)
    SubcutaneousRoute (HL7 V3 2006_05)
    C0332157 (UMLS CUI 2011AA)
    24932003 (SNOMED CT 2011_0131)
    C0014822 (UMLS CUI 2011AA)
    111167001 (SNOMED CT 2011_0131)
    MTHU004935 (LOINC Version 232)
    CL384738 (UMLS CUI 2011AA)
    C0205447 (UMLS CUI 2011AA)
    38112003 (SNOMED CT 2011_0131)
    C0439234 (UMLS CUI 2011AA)
    258707000 (SNOMED CT 2011_0131)
    Y (HL7 V3 2006_05)
    C0332152 (UMLS CUI 2011AA)
    288556008 (SNOMED CT 2011_0131)
    C1516879 (UMLS CUI 2011AA)

    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