0 Avaliações
ID

5024

Descrição

ODM derived from http://clinicaltrials.gov/show/NCT00875667

Link

http://clinicaltrials.gov/show/NCT00875667

Palavras-chave

Versões (2)
  1. 09/12/2013 09/12/2013 - Martin Dugas
  2. 16/04/2014 16/04/2014 - Julian Varghese
Transferido a

16 de abril de 2014

DOI

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Licença

Creative Commons BY 4.0
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    Eligibility DRKS00003810 NCT00875667 Mantle Cell Lymphoma

    Alemão Inglês

    Eligibility

    1 Formulários  
    1. StudyEvent: Eligibility
      1. Eligibility
    Einschlusskriterien
    Descrição

    Einschlusskriterien

    Alias
    UMLS CUI 2011AA
    CL425202
    Alter mindestens 18 Jahre
    Descrição

    age at least 18 Years

    Tipo de dados

    boolean

    Alias
    UMLS CUI 2011AA
    C0001779
    SNOMED CT 2011_0131
    397669002
    Biopsy proven mantle cell lymphoma
    Descrição

    Biopsy proven mantle cell lymphoma

    Tipo de dados

    boolean

    Alias
    UMLS CUI 2011AA
    C0005558
    SNOMED CT 2011_0131
    86273004
    MedDRA 14.1
    10004720
    LOINC Version 232
    MTHU028106
    UMLS CUI 2011AA
    C0456369
    SNOMED CT 2011_0131
    277025001
    UMLS CUI 2011AA
    C0334634
    SNOMED CT 2011_0131
    443487006
    MedDRA 14.1
    10061275
    ICD-10-CM Version 2010
    C83.1
    ICD-9-CM Version 2011
    200.4
    UMLS CUI 2011AA
    C0011900
    SNOMED CT 2011_0131
    439401001
    LOINC Version 232
    MTHU008876
    Patients who have progressed or relapsed after or are refractory to at least one, and up to three prior chemotherapy regimens, and who have documented progressive disease.
    Descrição

    Patients who have progressed or relapsed after or are refractory to at least one, and up to three prior chemotherapy regimens, and who have documented progressive disease.

    Tipo de dados

    boolean

    Alias
    UMLS CUI 2011AA
    C0242656
    SNOMED CT 2011_0131
    246453008
    MedDRA 14.1
    10061818
    UMLS CUI 2011AA
    C0277556
    SNOMED CT 2011_0131
    58184002
    UMLS CUI 2011AA
    C0205269
    SNOMED CT 2011_0131
    20646008
    UMLS CUI 2011AA
    C1514457
    UMLS CUI 2011AA
    C1301725
    SNOMED CT 2011_0131
    397934002
    UMLS CUI 2011AA
    C1335499
    ECOG performance score 0,1, or 2
    Descrição

    ECOG performance score 0,1, or 2

    Tipo de dados

    boolean

    Alias
    UMLS CUI 2011AA
    C1520224
    Willing to follow pregnancy precaution
    Descrição

    Willing to follow pregnancy precaution

    Tipo de dados

    boolean

    Alias
    UMLS CUI 2011AA
    C0600109
    SNOMED CT 2011_0131
    225466006
    UMLS CUI 2011AA
    C0032961
    SNOMED CT 2011_0131
    289908002
    MedDRA 14.1
    10036556
    LOINC Version 232
    MTHU035048
    UMLS CUI 2011AA
    C1882442
    Ausschlusskriterien
    Descrição

    Ausschlusskriterien

    Alias
    UMLS CUI 2011AA
    CL425201
    abnormale Laborbefunde
    Descrição

    Any of the following laboratory abnormalities

    Tipo de dados

    boolean

    Alias
    UMLS CUI 2011AA
    C0438215
    SNOMED CT 2011_0131
    165346000
    MedDRA 14.1
    10023547
    Absolute Neutrophil Count, ANC
    Descrição

    Absolute neutrophil count (ANC)<1,500 cells/mm^3 (1.5 x 10^9/L)

    Tipo de dados

    boolean

    Alias
    UMLS CUI 2011AA
    C0948762
    MedDRA 14.1
    10052033
    Thrombozyten
    Descrição

    Platelet count < 60,000/mm^3 (60 x 10^9/L)

    Tipo de dados

    boolean

    Alias
    UMLS CUI 2011AA
    C1287267
    SNOMED CT 2011_0131
    365632008
    LOINC Version 232
    777-3
    Serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) >3.0 x upper limit or normal (ULN), except patients with documented liver involvement by lymphoma
    Descrição

    Serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) >3.0 x upper limit or normal (ULN), except patients with documented liver involvement by lymphoma

    Tipo de dados

    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
    C1554961
    HL7 V3 2006_05
    E
    UMLS CUI 2011AA
    C0441932
    SNOMED CT 2011_0131
    258322007
    UMLS CUI 2011AA
    C0024299
    SNOMED CT 2011_0131
    21964009
    MedDRA 14.1
    10025310
    ICD-10-CM Version 2010
    C85.9
    Serum total bilirubin > 1.5 x ULN, except in case of Gilbert's Syndrome and documented liver involvement by lymphoma.
    Descrição

    Serum total bilirubin > 1.5 x ULN, except in case of Gilbert's Syndrome and documented liver involvement by lymphoma.

    Tipo de dados

    boolean

    Alias
    UMLS CUI 2011AA
    C1278039
    SNOMED CT 2011_0131
    313840000
    MedDRA 14.1
    10040162
    UMLS CUI 2011AA
    C1519815
    UMLS CUI 2011AA
    C1554961
    HL7 V3 2006_05
    E
    UMLS CUI 2011AA
    C0017551
    SNOMED CT 2011_0131
    27503000
    MedDRA 14.1
    10018267
    ICD-10-CM Version 2010
    E80.4
    UMLS CUI 2011AA
    C0441932
    SNOMED CT 2011_0131
    258322007
    UMLS CUI 2011AA
    C0024299
    SNOMED CT 2011_0131
    21964009
    MedDRA 14.1
    10025310
    ICD-10-CM Version 2010
    C85.9
    Estimation of creatinine clearance by Cockcroft-Gault formula (procedure)
    Descrição

    Calculated creatinine clearance (Cockcroft-Gault formula) of < 30 mL/min

    Tipo de dados

    boolean

    Alias
    UMLS CUI 2011AA
    C2711451
    SNOMED CT 2011_0131
    442407001
    History of active CNS lymphoma within the previous 3 months
    Descrição

    History of active CNS lymphoma within the previous 3 months

    Tipo de dados

    boolean

    Alias
    UMLS CUI 2011AA
    CL421546
    SNOMED CT 2011_0131
    392521001
    UMLS CUI 2011AA
    C0205177
    SNOMED CT 2011_0131
    55561003
    UMLS CUI 2011AA
    C0280803
    SNOMED CT 2011_0131
    307649006
    MedDRA 14.1
    10007953
    ICD-9-CM Version 2011
    200.5
    Subjects not willing to take DVT prophylaxis
    Descrição

    Subjects not willing to take DVT prophylaxis

    Tipo de dados

    boolean

    Alias
    UMLS CUI 2011AA
    C1518422
    UMLS CUI 2011AA
    C0600109
    SNOMED CT 2011_0131
    225466006
    UMLS CUI 2011AA
    C0853245
    MedDRA 14.1
    10013880
    Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are sero-positive because of hepatitis B virus vaccine are eligible
    Descrição

    Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are sero-positive because of hepatitis B virus vaccine are eligible

    Tipo de dados

    boolean

    Alias
    UMLS CUI 2011AA
    C0521143
    SNOMED CT 2011_0131
    4879001
    UMLS CUI 2011AA
    C0205177
    SNOMED CT 2011_0131
    55561003
    UMLS CUI 2011AA
    C0042769
    SNOMED CT 2011_0131
    34014006
    MedDRA 14.1
    10047461
    ICD-10-CM Version 2010
    B34.9
    UMLS CUI 2011AA
    C0019682
    SNOMED CT 2011_0131
    19030005
    UMLS CUI 2011AA
    C0019169
    SNOMED CT 2011_0131
    81665004
    UMLS CUI 2011AA
    C0220847
    SNOMED CT 2011_0131
    62944002
    MedDRA 14.1
    10019752
    UMLS CUI 2011AA
    C1548635
    HL7 V3 2006_05
    ELG
    UMLS CUI 2011AA
    C0521143
    SNOMED CT 2011_0131
    4879001
    UMLS CUI 2011AA
    CL420107
    UMLS CUI 2011AA
    C0062527
    SNOMED CT 2011_0131
    396424005
    HL7 V3 2006_05
    45
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    Similar models

    Eligibility

    1 Formulários
    1. StudyEvent: Eligibility
      1. Eligibility
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    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)
    Biopsy proven mantle cell lymphoma
    Item
    Biopsy proven mantle cell lymphoma
    boolean
    C0005558 (UMLS CUI 2011AA)
    86273004 (SNOMED CT 2011_0131)
    10004720 (MedDRA 14.1)
    MTHU028106 (LOINC Version 232)
    C0456369 (UMLS CUI 2011AA)
    277025001 (SNOMED CT 2011_0131)
    C0334634 (UMLS CUI 2011AA)
    443487006 (SNOMED CT 2011_0131)
    10061275 (MedDRA 14.1)
    C83.1 (ICD-10-CM Version 2010)
    200.4 (ICD-9-CM Version 2011)
    C0011900 (UMLS CUI 2011AA)
    439401001 (SNOMED CT 2011_0131)
    MTHU008876 (LOINC Version 232)
    Patients who have progressed or relapsed after or are refractory to at least one, and up to three prior chemotherapy regimens, and who have documented progressive disease.
    Item
    Patients who have progressed or relapsed after or are refractory to at least one, and up to three prior chemotherapy regimens, and who have documented progressive disease.
    boolean
    C0242656 (UMLS CUI 2011AA)
    246453008 (SNOMED CT 2011_0131)
    10061818 (MedDRA 14.1)
    C0277556 (UMLS CUI 2011AA)
    58184002 (SNOMED CT 2011_0131)
    C0205269 (UMLS CUI 2011AA)
    20646008 (SNOMED CT 2011_0131)
    C1514457 (UMLS CUI 2011AA)
    C1301725 (UMLS CUI 2011AA)
    397934002 (SNOMED CT 2011_0131)
    C1335499 (UMLS CUI 2011AA)
    ECOG performance score 0,1, or 2
    Item
    ECOG performance score 0,1, or 2
    boolean
    C1520224 (UMLS CUI 2011AA)
    Willing to follow pregnancy precaution
    Item
    Willing to follow pregnancy precaution
    boolean
    C0600109 (UMLS CUI 2011AA)
    225466006 (SNOMED CT 2011_0131)
    C0032961 (UMLS CUI 2011AA)
    289908002 (SNOMED CT 2011_0131)
    10036556 (MedDRA 14.1)
    MTHU035048 (LOINC Version 232)
    C1882442 (UMLS CUI 2011AA)
    Item Group
    Ausschlusskriterien
    CL425201 (UMLS CUI 2011AA)
    Any of the following laboratory abnormalities
    Item
    abnormale Laborbefunde
    boolean
    C0438215 (UMLS CUI 2011AA)
    165346000 (SNOMED CT 2011_0131)
    10023547 (MedDRA 14.1)
    Absolute neutrophil count (ANC)<1,500 cells/mm^3 (1.5 x 10^9/L)
    Item
    Absolute Neutrophil Count, ANC
    boolean
    C0948762 (UMLS CUI 2011AA)
    10052033 (MedDRA 14.1)
    Platelet count < 60,000/mm^3 (60 x 10^9/L)
    Item
    Thrombozyten
    boolean
    C1287267 (UMLS CUI 2011AA)
    365632008 (SNOMED CT 2011_0131)
    777-3 (LOINC Version 232)
    Serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) >3.0 x upper limit or normal (ULN), except patients with documented liver involvement by lymphoma
    Item
    Serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) >3.0 x upper limit or normal (ULN), except patients with documented liver involvement by lymphoma
    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)
    C1554961 (UMLS CUI 2011AA)
    E (HL7 V3 2006_05)
    C0441932 (UMLS CUI 2011AA)
    258322007 (SNOMED CT 2011_0131)
    C0024299 (UMLS CUI 2011AA)
    21964009 (SNOMED CT 2011_0131)
    10025310 (MedDRA 14.1)
    C85.9 (ICD-10-CM Version 2010)
    Serum total bilirubin > 1.5 x ULN, except in case of Gilbert's Syndrome and documented liver involvement by lymphoma.
    Item
    Serum total bilirubin > 1.5 x ULN, except in case of Gilbert's Syndrome and documented liver involvement by lymphoma.
    boolean
    C1278039 (UMLS CUI 2011AA)
    313840000 (SNOMED CT 2011_0131)
    10040162 (MedDRA 14.1)
    C1519815 (UMLS CUI 2011AA)
    C1554961 (UMLS CUI 2011AA)
    E (HL7 V3 2006_05)
    C0017551 (UMLS CUI 2011AA)
    27503000 (SNOMED CT 2011_0131)
    10018267 (MedDRA 14.1)
    E80.4 (ICD-10-CM Version 2010)
    C0441932 (UMLS CUI 2011AA)
    258322007 (SNOMED CT 2011_0131)
    C0024299 (UMLS CUI 2011AA)
    21964009 (SNOMED CT 2011_0131)
    10025310 (MedDRA 14.1)
    C85.9 (ICD-10-CM Version 2010)
    Calculated creatinine clearance (Cockcroft-Gault formula) of < 30 mL/min
    Item
    Estimation of creatinine clearance by Cockcroft-Gault formula (procedure)
    boolean
    C2711451 (UMLS CUI 2011AA)
    442407001 (SNOMED CT 2011_0131)
    History of active CNS lymphoma within the previous 3 months
    Item
    History of active CNS lymphoma within the previous 3 months
    boolean
    CL421546 (UMLS CUI 2011AA)
    392521001 (SNOMED CT 2011_0131)
    C0205177 (UMLS CUI 2011AA)
    55561003 (SNOMED CT 2011_0131)
    C0280803 (UMLS CUI 2011AA)
    307649006 (SNOMED CT 2011_0131)
    10007953 (MedDRA 14.1)
    200.5 (ICD-9-CM Version 2011)
    Subjects not willing to take DVT prophylaxis
    Item
    Subjects not willing to take DVT prophylaxis
    boolean
    C1518422 (UMLS CUI 2011AA)
    C0600109 (UMLS CUI 2011AA)
    225466006 (SNOMED CT 2011_0131)
    C0853245 (UMLS CUI 2011AA)
    10013880 (MedDRA 14.1)
    Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are sero-positive because of hepatitis B virus vaccine are eligible
    Item
    Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are sero-positive because of hepatitis B virus vaccine are eligible
    boolean
    C0521143 (UMLS CUI 2011AA)
    4879001 (SNOMED CT 2011_0131)
    C0205177 (UMLS CUI 2011AA)
    55561003 (SNOMED CT 2011_0131)
    C0042769 (UMLS CUI 2011AA)
    34014006 (SNOMED CT 2011_0131)
    10047461 (MedDRA 14.1)
    B34.9 (ICD-10-CM Version 2010)
    C0019682 (UMLS CUI 2011AA)
    19030005 (SNOMED CT 2011_0131)
    C0019169 (UMLS CUI 2011AA)
    81665004 (SNOMED CT 2011_0131)
    C0220847 (UMLS CUI 2011AA)
    62944002 (SNOMED CT 2011_0131)
    10019752 (MedDRA 14.1)
    C1548635 (UMLS CUI 2011AA)
    ELG (HL7 V3 2006_05)
    C0521143 (UMLS CUI 2011AA)
    4879001 (SNOMED CT 2011_0131)
    CL420107 (UMLS CUI 2011AA)
    C0062527 (UMLS CUI 2011AA)
    396424005 (SNOMED CT 2011_0131)
    45 (HL7 V3 2006_05)
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