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43475

Beschreibung

ODM derived from http://clinicaltrials.gov/show/NCT00823173

Link

http://clinicaltrials.gov/show/NCT00823173

Stichworte

Versionen (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 -
Hochgeladen am

20. September 2021

DOI

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    Eligibility NCT00823173 Anterior Uveitis

    Deutsch Englisch

    Eligibility

    1 Formulare  
    1. StudyEvent: Eligibility
      1. Eligibility
    Einschlusskriterien
    Beschreibung

    Einschlusskriterien

    Alias
    UMLS CUI 2011AA
    CL425202
    Alter mindestens 18 Jahre
    Beschreibung

    age at least 18 Years

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0001779
    SNOMED CT 2011_0131
    397669002
    Signed and dated informed consent.
    Beschreibung

    Signed and dated informed consent.

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0021430
    Patients with the typical presentation of HLA-B27 positive AAU (unilateral, painful anterior uveitis of sudden onset).
    Beschreibung

    Patients with the typical presentation of HLA-B27 positive AAU (unilateral, painful anterior uveitis of sudden onset).

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0019740
    SNOMED CT 2011_0131
    34453005
    LOINC Version 232
    MTHU012533
    UMLS CUI 2011AA
    CL415097
    UMLS CUI 2011AA
    C0701807
    SNOMED CT 2011_0131
    4927003
    ICD-10-CM Version 2010
    H20.0
    UMLS CUI 2011AA
    C0011900
    SNOMED CT 2011_0131
    439401001
    LOINC Version 232
    MTHU008876
    UMLS CUI 2011AA
    C0205092
    SNOMED CT 2011_0131
    66459002
    UMLS CUI 2011AA
    CL414713
    UMLS CUI 2011AA
    C0042165
    SNOMED CT 2011_0131
    410692006
    MedDRA 14.1
    10046852
    UMLS CUI 2011AA
    C1272517
    SNOMED CT 2011_0131
    385315009
    2+ anterior chamber cells according to the SUN Working Group criteria, as assessed by slit lamp biomicroscopy.
    Beschreibung

    2+ anterior chamber cells according to the SUN Working Group criteria, as assessed by slit lamp biomicroscopy.

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C2827735
    UMLS CUI 2011AA
    C0423282
    SNOMED CT 2011_0131
    246993000
    MedDRA 14.1
    10053781
    UMLS CUI 2011AA
    C0332290
    SNOMED CT 2011_0131
    385433004
    UMLS CUI 2011AA
    C0038136
    UMLS CUI 2011AA
    C0042164
    SNOMED CT 2011_0131
    128473001
    MedDRA 14.1
    10046851
    ICD-10-CM Version 2010
    H20.9
    CTCAE 1105E
    E10442
    UMLS CUI 2011AA
    C0600281
    UMLS CUI 2011AA
    CL414621
    UMLS CUI 2011AA
    C0582103
    SNOMED CT 2011_0131
    225886003
    UMLS CUI 2011AA
    C0183355
    SNOMED CT 2011_0131
    397247004
    Start of the typical first symptoms of the current attack, defined as the point in time when the patient felt the first sensation of the attack, within the last 72 hours before initiation of treatment with the study medication.
    Beschreibung

    Start of the typical first symptoms of the current attack, defined as the point in time when the patient felt the first sensation of the attack, within the last 72 hours before initiation of treatment with the study medication.

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0205435
    SNOMED CT 2011_0131
    255216001
    UMLS CUI 2011AA
    C1457887
    LOINC Version 232
    MTHU021540
    ICD-9-CM Version 2011
    780-789.99
    UMLS CUI 2011AA
    C1304680
    SNOMED CT 2011_0131
    216299002
    UMLS CUI 2011AA
    C0332152
    SNOMED CT 2011_0131
    288556008
    UMLS CUI 2011AA
    C2348558
    UMLS CUI 2011AA
    C0013227
    Negative pregnancy test for females of childbearing potential (pre menopausal, <2 years post-menopausal, not surgically sterile).
    Beschreibung

    Negative pregnancy test for females of childbearing potential (pre menopausal, <2 years post-menopausal, not surgically sterile).

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0427780
    SNOMED CT 2011_0131
    250425007
    MedDRA 14.1
    10036574
    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
    C0279752
    UMLS CUI 2011AA
    C0232970
    SNOMED CT 2011_0131
    76498008
    Patients with a negative QuantiFERON TB Gold test result.
    Beschreibung

    Patients with a negative QuantiFERON TB Gold test result.

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C1875713
    UMLS CUI 2011AA
    C1334932
    Patients who currently have no clinically apparent symptoms of an HLA B27 associated acute extraocular disorder requiring systemic immunosuppressive therapy.
    Beschreibung

    Patients who currently have no clinically apparent symptoms of an HLA B27 associated acute extraocular disorder requiring systemic immunosuppressive therapy.

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C1518422
    UMLS CUI 2011AA
    C0019740
    SNOMED CT 2011_0131
    34453005
    LOINC Version 232
    MTHU012533
    UMLS CUI 2011AA
    C0332281
    SNOMED CT 2011_0131
    47429007
    UMLS CUI 2011AA
    C0241886
    UMLS CUI 2011AA
    C0012634
    SNOMED CT 2011_0131
    64572001
    UMLS CUI 2011AA
    C1514873
    UMLS CUI 2011AA
    C0205373
    SNOMED CT 2011_0131
    31099001
    UMLS CUI 2011AA
    C0021079
    SNOMED CT 2011_0131
    86553008
    Patients who are willing and able to cooperate with study requirements.
    Beschreibung

    Patients who are willing and able to cooperate with study requirements.

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0600109
    SNOMED CT 2011_0131
    225466006
    UMLS CUI 2011AA
    C0085732
    SNOMED CT 2011_0131
    371150009
    UMLS CUI 2011AA
    C0392337
    UMLS CUI 2011AA
    C0008976
    SNOMED CT 2011_0131
    110465008
    UMLS CUI 2011AA
    C1514873
    Ausschlusskriterien
    Beschreibung

    Ausschlusskriterien

    Alias
    UMLS CUI 2011AA
    CL425201
    IOP elevation requiring therapy.
    Beschreibung

    IOP elevation requiring therapy.

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0234708
    SNOMED CT 2011_0131
    112222000
    MedDRA 14.1
    10022806
    UMLS CUI 2011AA
    C1514873
    UMLS CUI 2011AA
    C0039798
    Uncontrolled diabetes mellitus and diabetic retinopathy.
    Beschreibung

    Uncontrolled diabetes mellitus and diabetic retinopathy.

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0205318
    SNOMED CT 2011_0131
    19032002
    UMLS CUI 2011AA
    C0011849
    SNOMED CT 2011_0131
    191044006
    UMLS CUI 2011AA
    C0011884
    SNOMED CT 2011_0131
    4855003
    MedDRA 14.1
    10012689
    LOINC Version 232
    MTHU020818
    ICD-9-CM Version 2011
    362.0
    Patients with a single eye or a pinhole Snellen visual acuity 20/200 or worse in the non study eye.
    Beschreibung

    Patients with a single eye or a pinhole Snellen visual acuity 20/200 or worse in the non study eye.

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0205171
    SNOMED CT 2011_0131
    50607009
    UMLS CUI 2011AA
    C0015392
    SNOMED CT 2011_0131
    81745001
    LOINC Version 232
    MTHU000064
    UMLS CUI 2011AA
    C0450042
    SNOMED CT 2011_0131
    257492003
    UMLS CUI 2011AA
    C1827708
    SNOMED CT 2011_0131
    422673001
    UMLS CUI 2011AA
    C1518422
    UMLS CUI 2011AA
    C0008976
    SNOMED CT 2011_0131
    110465008
    UMLS CUI 2011AA
    C0015392
    SNOMED CT 2011_0131
    81745001
    LOINC Version 232
    MTHU000064
    Zellen in der Augenvorderkammer <= 1+
    Beschreibung

    Patients with <= 1+ anterior chamber cells.

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0423282
    SNOMED CT 2011_0131
    246993000
    MedDRA 14.1
    10053781
    Patients with 3+ or 4+ anterior chamber cells or hypopyon.
    Beschreibung

    Patients with 3+ or 4+ anterior chamber cells or hypopyon.

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C2827736
    UMLS CUI 2011AA
    C2827737
    UMLS CUI 2011AA
    C0423282
    SNOMED CT 2011_0131
    246993000
    MedDRA 14.1
    10053781
    UMLS CUI 2011AA
    C0020641
    SNOMED CT 2011_0131
    87807004
    MedDRA 14.1
    10021086
    ICD-10-CM Version 2010
    H20.05
    ICD-9-CM Version 2011
    364.05
    Patients in whom the time of the beginning of the current attack can not be determined.
    Beschreibung

    Patients in whom the time of the beginning of the current attack can not be determined.

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0439547
    SNOMED CT 2011_0131
    272105005
    UMLS CUI 2011AA
    C0439659
    SNOMED CT 2011_0131
    246062003
    LOINC Version 232
    MTHU026300
    UMLS CUI 2011AA
    C0521116
    SNOMED CT 2011_0131
    15240007
    UMLS CUI 2011AA
    C1304680
    SNOMED CT 2011_0131
    216299002
    UMLS CUI 2011AA
    C0439673
    SNOMED CT 2011_0131
    261665006
    Patients exhibiting corneal ulceration or a history of recurrent herpetic keratitis or clinical evidence of herpetic dermatitis.
    Beschreibung

    Patients exhibiting corneal ulceration or a history of recurrent herpetic keratitis or clinical evidence of herpetic dermatitis.

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0010043
    SNOMED CT 2011_0131
    91514001
    MedDRA 14.1
    10011060
    ICD-10-CM Version 2010
    H16.0
    ICD-9-CM Version 2011
    370.0
    CTCAE 1105E
    E10359
    UMLS CUI 2011AA
    CL421546
    SNOMED CT 2011_0131
    392521001
    UMLS CUI 2011AA
    C1274320
    SNOMED CT 2011_0131
    402891002
    UMLS CUI 2011AA
    C0332120
    SNOMED CT 2011_0131
    18669006
    UMLS CUI 2011AA
    C1262170
    MedDRA 14.1
    10062639
    Patients currently treated with topical corticosteroids.
    Beschreibung

    Patients currently treated with topical corticosteroids.

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C2827774
    UMLS CUI 2011AA
    C0304604
    SNOMED CT 2011_0131
    331645009
    Patients treated with systemic immunosuppressive therapy within the last 2 months.
    Beschreibung

    Patients treated with systemic immunosuppressive therapy within the last 2 months.

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0205373
    SNOMED CT 2011_0131
    31099001
    UMLS CUI 2011AA
    C0021079
    SNOMED CT 2011_0131
    86553008
    Patients treated with a systemically administered TNF-alpha inhibitor within the last 2 months.
    Beschreibung

    Patients treated with a systemically administered TNF-alpha inhibitor within the last 2 months.

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0205373
    SNOMED CT 2011_0131
    31099001
    UMLS CUI 2011AA
    C1521801
    UMLS CUI 2011AA
    C1562242
    SNOMED CT 2011_0131
    416897008
    Pregnant or breast-feeding women or women of childbearing potential, who with their partners refuse to use 2 reliable methods of contraception (including 1 barrier method) during the study.
    Beschreibung

    Pregnant or breast-feeding women or women of childbearing potential, who with their partners refuse to use 2 reliable methods of contraception (including 1 barrier method) during the study.

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0043210
    SNOMED CT 2011_0131
    224526002
    UMLS CUI 2011AA
    C0032961
    SNOMED CT 2011_0131
    289908002
    MedDRA 14.1
    10036556
    LOINC Version 232
    MTHU035048
    UMLS CUI 2011AA
    C0006147
    MedDRA 14.1
    10006247
    UMLS CUI 2011AA
    C1148523
    UMLS CUI 2011AA
    C0237399
    UMLS CUI 2011AA
    C0682323
    SNOMED CT 2011_0131
    262043009
    HL7 V3 2006_05
    SIGOTHR
    UMLS CUI 2011AA
    C1705116
    SNOMED CT 2011_0131
    443390004
    UMLS CUI 2011AA
    C0700589
    SNOMED CT 2011_0131
    146680009
    MedDRA 14.1
    10010808
    UMLS CUI 2011AA
    C0004764
    SNOMED CT 2011_0131
    225370004
    Male patients with a female partner who could become pregnant and who refuse, with their partner, to use 2 reliable methods of contraception (including 1 barrier method) during the study.
    Beschreibung

    Male patients with a female partner who could become pregnant and who refuse, with their partner, to use 2 reliable methods of contraception (including 1 barrier method) during the study.

    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
    C0682323
    SNOMED CT 2011_0131
    262043009
    HL7 V3 2006_05
    SIGOTHR
    UMLS CUI 2011AA
    C1148523
    UMLS CUI 2011AA
    C0237399
    UMLS CUI 2011AA
    C1705116
    SNOMED CT 2011_0131
    443390004
    UMLS CUI 2011AA
    C0700589
    SNOMED CT 2011_0131
    146680009
    MedDRA 14.1
    10010808
    UMLS CUI 2011AA
    C0004764
    SNOMED CT 2011_0131
    225370004
    Patients whose clinical presentation is suggestive for an active bacterial, viral or fungal infection anywhere in the body.
    Beschreibung

    Patients whose clinical presentation is suggestive for an active bacterial, viral or fungal infection anywhere in the body.

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0750491
    SNOMED CT 2011_0131
    415684004
    UMLS CUI 2011AA
    C0004623
    SNOMED CT 2011_0131
    87628006
    MedDRA 14.1
    10060945
    ICD-10-CM Version 2010
    A49.9
    UMLS CUI 2011AA
    C0042769
    SNOMED CT 2011_0131
    34014006
    MedDRA 14.1
    10047461
    ICD-10-CM Version 2010
    B34.9
    UMLS CUI 2011AA
    C0026946
    SNOMED CT 2011_0131
    3218000
    MedDRA 14.1
    10017533
    ICD-10-CM Version 2010
    B35-B49
    ICD-9-CM Version 2011
    110-118.99
    Patients with history of recurrent infections, or a clinical presentation suggestive of a chronic infection requiring antimicrobial therapy (e.g. syphilis) including active episodes of serious viral infections by, e.g. herpes simplex, herpes zoster, cytomegalic or hepatitis viruses or clinical signs of fungal infections, such as histoplasmosis, aspergillosis or coccidiomycosis.
    Beschreibung

    Patients with history of recurrent infections, or a clinical presentation suggestive of a chronic infection requiring antimicrobial therapy (e.g. syphilis) including active episodes of serious viral infections by, e.g. herpes simplex, herpes zoster, cytomegalic or hepatitis viruses or clinical signs of fungal infections, such as histoplasmosis, aspergillosis or coccidiomycosis.

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    CL421546
    SNOMED CT 2011_0131
    392521001
    UMLS CUI 2011AA
    C0239998
    MedDRA 14.1
    10067860
    UMLS CUI 2011AA
    C0750491
    SNOMED CT 2011_0131
    415684004
    UMLS CUI 2011AA
    C0151317
    SNOMED CT 2011_0131
    177010002
    UMLS CUI 2011AA
    C1514873
    UMLS CUI 2011AA
    C1136254
    SNOMED CT 2011_0131
    250428009
    LOINC Version 232
    MTHU014499
    UMLS CUI 2011AA
    C0039128
    SNOMED CT 2011_0131
    76272004
    MedDRA 14.1
    10062120
    ICD-10-CM Version 2010
    A53.9
    ICD-9-CM Version 2011
    097.9
    UMLS CUI 2011AA
    C0019348
    SNOMED CT 2011_0131
    88594005
    MedDRA 14.1
    10019948
    ICD-10-CM Version 2010
    B00
    ICD-9-CM Version 2011
    054
    UMLS CUI 2011AA
    C0019360
    SNOMED CT 2011_0131
    4740000
    MedDRA 14.1
    10019974
    ICD-10-CM Version 2010
    B02
    ICD-9-CM Version 2011
    53
    UMLS CUI 2011AA
    C0010825
    SNOMED CT 2011_0131
    407444007
    MedDRA 14.1
    10009701
    LOINC Version 232
    MTHU033986
    UMLS CUI 2011AA
    C0019186
    UMLS CUI 2011AA
    C0019655
    SNOMED CT 2011_0131
    12962009
    MedDRA 14.1
    10020141
    ICD-10-CM Version 2010
    B39.9
    ICD-9-CM Version 2011
    115.90
    UMLS CUI 2011AA
    C0004030
    SNOMED CT 2011_0131
    65553006
    MedDRA 14.1
    10003488
    ICD-10-CM Version 2010
    B44
    ICD-9-CM Version 2011
    117.3
    UMLS CUI 2011AA
    C0262426
    Patients presenting with higher intraocular pressure in the uveitic eye than in the contralateral eye.
    Beschreibung

    Patients presenting with higher intraocular pressure in the uveitic eye than in the contralateral eye.

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0578862
    SNOMED CT 2011_0131
    302157000
    UMLS CUI 2011AA
    C0042164
    SNOMED CT 2011_0131
    128473001
    MedDRA 14.1
    10046851
    ICD-10-CM Version 2010
    H20.9
    CTCAE 1105E
    E10442
    UMLS CUI 2011AA
    C0015392
    SNOMED CT 2011_0131
    81745001
    LOINC Version 232
    MTHU000064
    UMLS CUI 2011AA
    C0439093
    SNOMED CT 2011_0131
    276140008
    HL7 V3 2006_05
    GT
    UMLS CUI 2011AA
    C0441988
    SNOMED CT 2011_0131
    255209002
    UMLS CUI 2011AA
    C0015392
    SNOMED CT 2011_0131
    81745001
    LOINC Version 232
    MTHU000064
    Patients with known carrier status of human immunodeficiency virus, hepatitis B or hepatitis C.
    Beschreibung

    Patients with known carrier status of human immunodeficiency virus, hepatitis B or hepatitis C.

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C0449439
    SNOMED CT 2011_0131
    246098006
    UMLS CUI 2011AA
    C0019682
    SNOMED CT 2011_0131
    19030005
    UMLS CUI 2011AA
    C0019163
    SNOMED CT 2011_0131
    66071002
    MedDRA 14.1
    10019731
    UMLS CUI 2011AA
    C0019196
    SNOMED CT 2011_0131
    50711007
    MedDRA 14.1
    10019744
    ICD-10-CM Version 2010
    B19.20
    ICD-9-CM Version 2011
    070.7
    Patients with a history of demyelinating disease (multiple sclerosis) or optic neuritis.
    Beschreibung

    Patients with a history of demyelinating disease (multiple sclerosis) or optic neuritis.

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    CL421546
    SNOMED CT 2011_0131
    392521001
    UMLS CUI 2011AA
    C0011304
    SNOMED CT 2011_0131
    32693004
    MedDRA 14.1
    10012305
    UMLS CUI 2011AA
    C0026769
    SNOMED CT 2011_0131
    24700007
    MedDRA 14.1
    10028245
    LOINC Version 232
    MTHU020805
    ICD-10-CM Version 2010
    G35
    ICD-9-CM Version 2011
    340
    UMLS CUI 2011AA
    C0029134
    SNOMED CT 2011_0131
    66760008
    MedDRA 14.1
    10030942
    ICD-10-CM Version 2010
    H46.9
    ICD-9-CM Version 2011
    377.30
    Patients with positive or unclear QuantiFERON TB Gold test result or history of high risk exposure to Mycobacterium tuberculosis.
    Beschreibung

    Patients with positive or unclear QuantiFERON TB Gold test result or history of high risk exposure to Mycobacterium tuberculosis.

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    C1875713
    UMLS CUI 2011AA
    C1335447
    UMLS CUI 2011AA
    CL427836
    UMLS CUI 2011AA
    C0587081
    SNOMED CT 2011_0131
    118246004
    UMLS CUI 2011AA
    C0332167
    SNOMED CT 2011_0131
    15508007
    UMLS CUI 2011AA
    C2732789
    SNOMED CT 2011_0131
    444507004
    Patients with known coexisting malignancy.
    Beschreibung

    Patients with known coexisting malignancy.

    Datentyp

    boolean

    Alias
    UMLS CUI 2011AA
    CL415222
    UMLS CUI 2011AA
    C0006826
    SNOMED CT 2011_0131
    363346000
    MedDRA 14.1
    10028997
    LOINC Version 232
    MTHU010328
    ICD-10-CM Version 2010
    C00-C96
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    Ähnliche Modelle

    Eligibility

    1 Formulare
    1. StudyEvent: Eligibility
      1. Eligibility
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Einschlusskriterien
    CL425202 (UMLS CUI 2011AA)
    age at least 18 Years
    Item
    Alter mindestens 18 Jahre
    boolean
    C0001779 (UMLS CUI 2011AA)
    397669002 (SNOMED CT 2011_0131)
    Signed and dated informed consent.
    Item
    Signed and dated informed consent.
    boolean
    C0021430 (UMLS CUI 2011AA)
    Patients with the typical presentation of HLA-B27 positive AAU (unilateral, painful anterior uveitis of sudden onset).
    Item
    Patients with the typical presentation of HLA-B27 positive AAU (unilateral, painful anterior uveitis of sudden onset).
    boolean
    C0019740 (UMLS CUI 2011AA)
    34453005 (SNOMED CT 2011_0131)
    MTHU012533 (LOINC Version 232)
    CL415097 (UMLS CUI 2011AA)
    C0701807 (UMLS CUI 2011AA)
    4927003 (SNOMED CT 2011_0131)
    H20.0 (ICD-10-CM Version 2010)
    C0011900 (UMLS CUI 2011AA)
    439401001 (SNOMED CT 2011_0131)
    MTHU008876 (LOINC Version 232)
    C0205092 (UMLS CUI 2011AA)
    66459002 (SNOMED CT 2011_0131)
    CL414713 (UMLS CUI 2011AA)
    C0042165 (UMLS CUI 2011AA)
    410692006 (SNOMED CT 2011_0131)
    10046852 (MedDRA 14.1)
    C1272517 (UMLS CUI 2011AA)
    385315009 (SNOMED CT 2011_0131)
    2+ anterior chamber cells according to the SUN Working Group criteria, as assessed by slit lamp biomicroscopy.
    Item
    2+ anterior chamber cells according to the SUN Working Group criteria, as assessed by slit lamp biomicroscopy.
    boolean
    C2827735 (UMLS CUI 2011AA)
    C0423282 (UMLS CUI 2011AA)
    246993000 (SNOMED CT 2011_0131)
    10053781 (MedDRA 14.1)
    C0332290 (UMLS CUI 2011AA)
    385433004 (SNOMED CT 2011_0131)
    C0038136 (UMLS CUI 2011AA)
    C0042164 (UMLS CUI 2011AA)
    128473001 (SNOMED CT 2011_0131)
    10046851 (MedDRA 14.1)
    H20.9 (ICD-10-CM Version 2010)
    E10442 (CTCAE 1105E)
    C0600281 (UMLS CUI 2011AA)
    CL414621 (UMLS CUI 2011AA)
    C0582103 (UMLS CUI 2011AA)
    225886003 (SNOMED CT 2011_0131)
    C0183355 (UMLS CUI 2011AA)
    397247004 (SNOMED CT 2011_0131)
    Start of the typical first symptoms of the current attack, defined as the point in time when the patient felt the first sensation of the attack, within the last 72 hours before initiation of treatment with the study medication.
    Item
    Start of the typical first symptoms of the current attack, defined as the point in time when the patient felt the first sensation of the attack, within the last 72 hours before initiation of treatment with the study medication.
    boolean
    C0205435 (UMLS CUI 2011AA)
    255216001 (SNOMED CT 2011_0131)
    C1457887 (UMLS CUI 2011AA)
    MTHU021540 (LOINC Version 232)
    780-789.99 (ICD-9-CM Version 2011)
    C1304680 (UMLS CUI 2011AA)
    216299002 (SNOMED CT 2011_0131)
    C0332152 (UMLS CUI 2011AA)
    288556008 (SNOMED CT 2011_0131)
    C2348558 (UMLS CUI 2011AA)
    C0013227 (UMLS CUI 2011AA)
    Negative pregnancy test for females of childbearing potential (pre menopausal, <2 years post-menopausal, not surgically sterile).
    Item
    Negative pregnancy test for females of childbearing potential (pre menopausal, <2 years post-menopausal, not surgically sterile).
    boolean
    C0427780 (UMLS CUI 2011AA)
    250425007 (SNOMED CT 2011_0131)
    10036574 (MedDRA 14.1)
    C0086287 (UMLS CUI 2011AA)
    248152002 (SNOMED CT 2011_0131)
    F (HL7 V3 2006_05)
    C1148523 (UMLS CUI 2011AA)
    C0237399 (UMLS CUI 2011AA)
    C0279752 (UMLS CUI 2011AA)
    C0232970 (UMLS CUI 2011AA)
    76498008 (SNOMED CT 2011_0131)
    Patients with a negative QuantiFERON TB Gold test result.
    Item
    Patients with a negative QuantiFERON TB Gold test result.
    boolean
    C1875713 (UMLS CUI 2011AA)
    C1334932 (UMLS CUI 2011AA)
    Patients who currently have no clinically apparent symptoms of an HLA B27 associated acute extraocular disorder requiring systemic immunosuppressive therapy.
    Item
    Patients who currently have no clinically apparent symptoms of an HLA B27 associated acute extraocular disorder requiring systemic immunosuppressive therapy.
    boolean
    C1518422 (UMLS CUI 2011AA)
    C0019740 (UMLS CUI 2011AA)
    34453005 (SNOMED CT 2011_0131)
    MTHU012533 (LOINC Version 232)
    C0332281 (UMLS CUI 2011AA)
    47429007 (SNOMED CT 2011_0131)
    C0241886 (UMLS CUI 2011AA)
    C0012634 (UMLS CUI 2011AA)
    64572001 (SNOMED CT 2011_0131)
    C1514873 (UMLS CUI 2011AA)
    C0205373 (UMLS CUI 2011AA)
    31099001 (SNOMED CT 2011_0131)
    C0021079 (UMLS CUI 2011AA)
    86553008 (SNOMED CT 2011_0131)
    Patients who are willing and able to cooperate with study requirements.
    Item
    Patients who are willing and able to cooperate with study requirements.
    boolean
    C0600109 (UMLS CUI 2011AA)
    225466006 (SNOMED CT 2011_0131)
    C0085732 (UMLS CUI 2011AA)
    371150009 (SNOMED CT 2011_0131)
    C0392337 (UMLS CUI 2011AA)
    C0008976 (UMLS CUI 2011AA)
    110465008 (SNOMED CT 2011_0131)
    C1514873 (UMLS CUI 2011AA)
    Item Group
    Ausschlusskriterien
    CL425201 (UMLS CUI 2011AA)
    IOP elevation requiring therapy.
    Item
    IOP elevation requiring therapy.
    boolean
    C0234708 (UMLS CUI 2011AA)
    112222000 (SNOMED CT 2011_0131)
    10022806 (MedDRA 14.1)
    C1514873 (UMLS CUI 2011AA)
    C0039798 (UMLS CUI 2011AA)
    Uncontrolled diabetes mellitus and diabetic retinopathy.
    Item
    Uncontrolled diabetes mellitus and diabetic retinopathy.
    boolean
    C0205318 (UMLS CUI 2011AA)
    19032002 (SNOMED CT 2011_0131)
    C0011849 (UMLS CUI 2011AA)
    191044006 (SNOMED CT 2011_0131)
    C0011884 (UMLS CUI 2011AA)
    4855003 (SNOMED CT 2011_0131)
    10012689 (MedDRA 14.1)
    MTHU020818 (LOINC Version 232)
    362.0 (ICD-9-CM Version 2011)
    Patients with a single eye or a pinhole Snellen visual acuity 20/200 or worse in the non study eye.
    Item
    Patients with a single eye or a pinhole Snellen visual acuity 20/200 or worse in the non study eye.
    boolean
    C0205171 (UMLS CUI 2011AA)
    50607009 (SNOMED CT 2011_0131)
    C0015392 (UMLS CUI 2011AA)
    81745001 (SNOMED CT 2011_0131)
    MTHU000064 (LOINC Version 232)
    C0450042 (UMLS CUI 2011AA)
    257492003 (SNOMED CT 2011_0131)
    C1827708 (UMLS CUI 2011AA)
    422673001 (SNOMED CT 2011_0131)
    C1518422 (UMLS CUI 2011AA)
    C0008976 (UMLS CUI 2011AA)
    110465008 (SNOMED CT 2011_0131)
    C0015392 (UMLS CUI 2011AA)
    81745001 (SNOMED CT 2011_0131)
    MTHU000064 (LOINC Version 232)
    Patients with <= 1+ anterior chamber cells.
    Item
    Zellen in der Augenvorderkammer <= 1+
    boolean
    C0423282 (UMLS CUI 2011AA)
    246993000 (SNOMED CT 2011_0131)
    10053781 (MedDRA 14.1)
    Patients with 3+ or 4+ anterior chamber cells or hypopyon.
    Item
    Patients with 3+ or 4+ anterior chamber cells or hypopyon.
    boolean
    C2827736 (UMLS CUI 2011AA)
    C2827737 (UMLS CUI 2011AA)
    C0423282 (UMLS CUI 2011AA)
    246993000 (SNOMED CT 2011_0131)
    10053781 (MedDRA 14.1)
    C0020641 (UMLS CUI 2011AA)
    87807004 (SNOMED CT 2011_0131)
    10021086 (MedDRA 14.1)
    H20.05 (ICD-10-CM Version 2010)
    364.05 (ICD-9-CM Version 2011)
    Patients in whom the time of the beginning of the current attack can not be determined.
    Item
    Patients in whom the time of the beginning of the current attack can not be determined.
    boolean
    C0439547 (UMLS CUI 2011AA)
    272105005 (SNOMED CT 2011_0131)
    C0439659 (UMLS CUI 2011AA)
    246062003 (SNOMED CT 2011_0131)
    MTHU026300 (LOINC Version 232)
    C0521116 (UMLS CUI 2011AA)
    15240007 (SNOMED CT 2011_0131)
    C1304680 (UMLS CUI 2011AA)
    216299002 (SNOMED CT 2011_0131)
    C0439673 (UMLS CUI 2011AA)
    261665006 (SNOMED CT 2011_0131)
    Patients exhibiting corneal ulceration or a history of recurrent herpetic keratitis or clinical evidence of herpetic dermatitis.
    Item
    Patients exhibiting corneal ulceration or a history of recurrent herpetic keratitis or clinical evidence of herpetic dermatitis.
    boolean
    C0010043 (UMLS CUI 2011AA)
    91514001 (SNOMED CT 2011_0131)
    10011060 (MedDRA 14.1)
    H16.0 (ICD-10-CM Version 2010)
    370.0 (ICD-9-CM Version 2011)
    E10359 (CTCAE 1105E)
    CL421546 (UMLS CUI 2011AA)
    392521001 (SNOMED CT 2011_0131)
    C1274320 (UMLS CUI 2011AA)
    402891002 (SNOMED CT 2011_0131)
    C0332120 (UMLS CUI 2011AA)
    18669006 (SNOMED CT 2011_0131)
    C1262170 (UMLS CUI 2011AA)
    10062639 (MedDRA 14.1)
    Patients currently treated with topical corticosteroids.
    Item
    Patients currently treated with topical corticosteroids.
    boolean
    C2827774 (UMLS CUI 2011AA)
    C0304604 (UMLS CUI 2011AA)
    331645009 (SNOMED CT 2011_0131)
    Patients treated with systemic immunosuppressive therapy within the last 2 months.
    Item
    Patients treated with systemic immunosuppressive therapy within the last 2 months.
    boolean
    C0205373 (UMLS CUI 2011AA)
    31099001 (SNOMED CT 2011_0131)
    C0021079 (UMLS CUI 2011AA)
    86553008 (SNOMED CT 2011_0131)
    Patients treated with a systemically administered TNF-alpha inhibitor within the last 2 months.
    Item
    Patients treated with a systemically administered TNF-alpha inhibitor within the last 2 months.
    boolean
    C0205373 (UMLS CUI 2011AA)
    31099001 (SNOMED CT 2011_0131)
    C1521801 (UMLS CUI 2011AA)
    C1562242 (UMLS CUI 2011AA)
    416897008 (SNOMED CT 2011_0131)
    Pregnant or breast-feeding women or women of childbearing potential, who with their partners refuse to use 2 reliable methods of contraception (including 1 barrier method) during the study.
    Item
    Pregnant or breast-feeding women or women of childbearing potential, who with their partners refuse to use 2 reliable methods of contraception (including 1 barrier method) during the study.
    boolean
    C0043210 (UMLS CUI 2011AA)
    224526002 (SNOMED CT 2011_0131)
    C0032961 (UMLS CUI 2011AA)
    289908002 (SNOMED CT 2011_0131)
    10036556 (MedDRA 14.1)
    MTHU035048 (LOINC Version 232)
    C0006147 (UMLS CUI 2011AA)
    10006247 (MedDRA 14.1)
    C1148523 (UMLS CUI 2011AA)
    C0237399 (UMLS CUI 2011AA)
    C0682323 (UMLS CUI 2011AA)
    262043009 (SNOMED CT 2011_0131)
    SIGOTHR (HL7 V3 2006_05)
    C1705116 (UMLS CUI 2011AA)
    443390004 (SNOMED CT 2011_0131)
    C0700589 (UMLS CUI 2011AA)
    146680009 (SNOMED CT 2011_0131)
    10010808 (MedDRA 14.1)
    C0004764 (UMLS CUI 2011AA)
    225370004 (SNOMED CT 2011_0131)
    Male patients with a female partner who could become pregnant and who refuse, with their partner, to use 2 reliable methods of contraception (including 1 barrier method) during the study.
    Item
    Male patients with a female partner who could become pregnant and who refuse, with their partner, to use 2 reliable methods of contraception (including 1 barrier method) during the study.
    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)
    C0682323 (UMLS CUI 2011AA)
    262043009 (SNOMED CT 2011_0131)
    SIGOTHR (HL7 V3 2006_05)
    C1148523 (UMLS CUI 2011AA)
    C0237399 (UMLS CUI 2011AA)
    C1705116 (UMLS CUI 2011AA)
    443390004 (SNOMED CT 2011_0131)
    C0700589 (UMLS CUI 2011AA)
    146680009 (SNOMED CT 2011_0131)
    10010808 (MedDRA 14.1)
    C0004764 (UMLS CUI 2011AA)
    225370004 (SNOMED CT 2011_0131)
    Patients whose clinical presentation is suggestive for an active bacterial, viral or fungal infection anywhere in the body.
    Item
    Patients whose clinical presentation is suggestive for an active bacterial, viral or fungal infection anywhere in the body.
    boolean
    C0750491 (UMLS CUI 2011AA)
    415684004 (SNOMED CT 2011_0131)
    C0004623 (UMLS CUI 2011AA)
    87628006 (SNOMED CT 2011_0131)
    10060945 (MedDRA 14.1)
    A49.9 (ICD-10-CM Version 2010)
    C0042769 (UMLS CUI 2011AA)
    34014006 (SNOMED CT 2011_0131)
    10047461 (MedDRA 14.1)
    B34.9 (ICD-10-CM Version 2010)
    C0026946 (UMLS CUI 2011AA)
    3218000 (SNOMED CT 2011_0131)
    10017533 (MedDRA 14.1)
    B35-B49 (ICD-10-CM Version 2010)
    110-118.99 (ICD-9-CM Version 2011)
    Patients with history of recurrent infections, or a clinical presentation suggestive of a chronic infection requiring antimicrobial therapy (e.g. syphilis) including active episodes of serious viral infections by, e.g. herpes simplex, herpes zoster, cytomegalic or hepatitis viruses or clinical signs of fungal infections, such as histoplasmosis, aspergillosis or coccidiomycosis.
    Item
    Patients with history of recurrent infections, or a clinical presentation suggestive of a chronic infection requiring antimicrobial therapy (e.g. syphilis) including active episodes of serious viral infections by, e.g. herpes simplex, herpes zoster, cytomegalic or hepatitis viruses or clinical signs of fungal infections, such as histoplasmosis, aspergillosis or coccidiomycosis.
    boolean
    CL421546 (UMLS CUI 2011AA)
    392521001 (SNOMED CT 2011_0131)
    C0239998 (UMLS CUI 2011AA)
    10067860 (MedDRA 14.1)
    C0750491 (UMLS CUI 2011AA)
    415684004 (SNOMED CT 2011_0131)
    C0151317 (UMLS CUI 2011AA)
    177010002 (SNOMED CT 2011_0131)
    C1514873 (UMLS CUI 2011AA)
    C1136254 (UMLS CUI 2011AA)
    250428009 (SNOMED CT 2011_0131)
    MTHU014499 (LOINC Version 232)
    C0039128 (UMLS CUI 2011AA)
    76272004 (SNOMED CT 2011_0131)
    10062120 (MedDRA 14.1)
    A53.9 (ICD-10-CM Version 2010)
    097.9 (ICD-9-CM Version 2011)
    C0019348 (UMLS CUI 2011AA)
    88594005 (SNOMED CT 2011_0131)
    10019948 (MedDRA 14.1)
    B00 (ICD-10-CM Version 2010)
    054 (ICD-9-CM Version 2011)
    C0019360 (UMLS CUI 2011AA)
    4740000 (SNOMED CT 2011_0131)
    10019974 (MedDRA 14.1)
    B02 (ICD-10-CM Version 2010)
    53 (ICD-9-CM Version 2011)
    C0010825 (UMLS CUI 2011AA)
    407444007 (SNOMED CT 2011_0131)
    10009701 (MedDRA 14.1)
    MTHU033986 (LOINC Version 232)
    C0019186 (UMLS CUI 2011AA)
    C0019655 (UMLS CUI 2011AA)
    12962009 (SNOMED CT 2011_0131)
    10020141 (MedDRA 14.1)
    B39.9 (ICD-10-CM Version 2010)
    115.90 (ICD-9-CM Version 2011)
    C0004030 (UMLS CUI 2011AA)
    65553006 (SNOMED CT 2011_0131)
    10003488 (MedDRA 14.1)
    B44 (ICD-10-CM Version 2010)
    117.3 (ICD-9-CM Version 2011)
    C0262426 (UMLS CUI 2011AA)
    Patients presenting with higher intraocular pressure in the uveitic eye than in the contralateral eye.
    Item
    Patients presenting with higher intraocular pressure in the uveitic eye than in the contralateral eye.
    boolean
    C0578862 (UMLS CUI 2011AA)
    302157000 (SNOMED CT 2011_0131)
    C0042164 (UMLS CUI 2011AA)
    128473001 (SNOMED CT 2011_0131)
    10046851 (MedDRA 14.1)
    H20.9 (ICD-10-CM Version 2010)
    E10442 (CTCAE 1105E)
    C0015392 (UMLS CUI 2011AA)
    81745001 (SNOMED CT 2011_0131)
    MTHU000064 (LOINC Version 232)
    C0439093 (UMLS CUI 2011AA)
    276140008 (SNOMED CT 2011_0131)
    GT (HL7 V3 2006_05)
    C0441988 (UMLS CUI 2011AA)
    255209002 (SNOMED CT 2011_0131)
    C0015392 (UMLS CUI 2011AA)
    81745001 (SNOMED CT 2011_0131)
    MTHU000064 (LOINC Version 232)
    Patients with known carrier status of human immunodeficiency virus, hepatitis B or hepatitis C.
    Item
    Patients with known carrier status of human immunodeficiency virus, hepatitis B or hepatitis C.
    boolean
    C0449439 (UMLS CUI 2011AA)
    246098006 (SNOMED CT 2011_0131)
    C0019682 (UMLS CUI 2011AA)
    19030005 (SNOMED CT 2011_0131)
    C0019163 (UMLS CUI 2011AA)
    66071002 (SNOMED CT 2011_0131)
    10019731 (MedDRA 14.1)
    C0019196 (UMLS CUI 2011AA)
    50711007 (SNOMED CT 2011_0131)
    10019744 (MedDRA 14.1)
    B19.20 (ICD-10-CM Version 2010)
    070.7 (ICD-9-CM Version 2011)
    Patients with a history of demyelinating disease (multiple sclerosis) or optic neuritis.
    Item
    Patients with a history of demyelinating disease (multiple sclerosis) or optic neuritis.
    boolean
    CL421546 (UMLS CUI 2011AA)
    392521001 (SNOMED CT 2011_0131)
    C0011304 (UMLS CUI 2011AA)
    32693004 (SNOMED CT 2011_0131)
    10012305 (MedDRA 14.1)
    C0026769 (UMLS CUI 2011AA)
    24700007 (SNOMED CT 2011_0131)
    10028245 (MedDRA 14.1)
    MTHU020805 (LOINC Version 232)
    G35 (ICD-10-CM Version 2010)
    340 (ICD-9-CM Version 2011)
    C0029134 (UMLS CUI 2011AA)
    66760008 (SNOMED CT 2011_0131)
    10030942 (MedDRA 14.1)
    H46.9 (ICD-10-CM Version 2010)
    377.30 (ICD-9-CM Version 2011)
    Patients with positive or unclear QuantiFERON TB Gold test result or history of high risk exposure to Mycobacterium tuberculosis.
    Item
    Patients with positive or unclear QuantiFERON TB Gold test result or history of high risk exposure to Mycobacterium tuberculosis.
    boolean
    C1875713 (UMLS CUI 2011AA)
    C1335447 (UMLS CUI 2011AA)
    CL427836 (UMLS CUI 2011AA)
    C0587081 (UMLS CUI 2011AA)
    118246004 (SNOMED CT 2011_0131)
    C0332167 (UMLS CUI 2011AA)
    15508007 (SNOMED CT 2011_0131)
    C2732789 (UMLS CUI 2011AA)
    444507004 (SNOMED CT 2011_0131)
    Patients with known coexisting malignancy.
    Item
    Patients with known coexisting malignancy.
    boolean
    CL415222 (UMLS CUI 2011AA)
    C0006826 (UMLS CUI 2011AA)
    363346000 (SNOMED CT 2011_0131)
    10028997 (MedDRA 14.1)
    MTHU010328 (LOINC Version 232)
    C00-C96 (ICD-10-CM Version 2010)
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