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ID

41533

Description

Study ID: 111476 Clinical Study ID: 111476 Study Title: An open, single-arm trial to assess the clinical activity of recMAGE-A3 + AS15 in patients with unresectable MAGE-A3-positive metastatic cutaneous melanoma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00942162 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Antigen-Specific Cancer Immunotherapeutic Study Indication: Melanoma

Keywords

Versions (5)
  1. 9/28/20 9/28/20 -
  2. 9/28/20 9/28/20 -
  3. 9/29/20 9/29/20 -
  4. 9/29/20 9/29/20 -
  5. 11/2/20 11/2/20 -
Copyright Holder

GlaxoSmithKline

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November 2, 2020

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Creative Commons BY 4.0
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    Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162

    English

    Immune Mediated Disease Report; General Medical History; Relevant Risk Factors; Neurological Events; Myasthenia Gravis; Uveitis (Report Final and Annex Report 2 Final)

    1 forms  
    Administrative
    Description

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    Centre Number
    Description

    Centre Number

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0600091
    UMLS CUI [1,2]
    C0019994
    Patient Number
    Description

    Patient Number

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    IMD Report
    Description

    IMD Report

    Alias
    UMLS CUI-1
    C0012634
    UMLS CUI-2
    C4330477
    UMLS CUI-3
    C0684224
    Has any confirmed or probable Immune Mediated Disease occurred during the study?
    Description

    Has any confirmed or probable Immune Mediated Disease occurred during the study?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C4330477
    If Immune Mediated Diasease occured during study, tick the disease category
    Description

    If Immune Mediated Diasease occured during study, tick the disease category

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C4330477
    UMLS CUI [2]
    C2745955
    UMLS CUI [3]
    C0683312
    General Medical History
    Description

    General Medical History

    Alias
    UMLS CUI-1
    C0262926
    Are you aware of any pre-existing conditions present in Patient or in close family (father, mother or sister/brother) prior the start of the study?
    Description

    Are you aware of any pre-existing conditions present in Patient or in close family (father, mother or sister/brother) prior the start of the study?

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0521987
    UMLS CUI [2]
    C0030705
    UMLS CUI [3]
    C0086282
    UMLS CUI [4]
    C0015671
    UMLS CUI [5]
    C0026591
    UMLS CUI [6]
    C0337514
    UMLS CUI [7]
    C0337527
    General Medical History
    Description

    General Medical History

    Alias
    UMLS CUI-1
    C0262926
    Diagnosis
    Description

    Diagnosis

    Data type

    text

    Alias
    UMLS CUI [1]
    C0011900
    Pre-existing conditions present in Patient or in close family
    Description

    Pre-existing conditions present in Patient or in close family

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0521987
    UMLS CUI [2]
    C0030705
    UMLS CUI [3]
    C0086282
    Diagnosis status
    Description

    Diagnosis status

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0011900
    UMLS CUI [1,2]
    C0449438
    Relevant risk factors
    Description

    Relevant risk factors

    Alias
    UMLS CUI-1
    C0035648
    Are you aware of any other pre-existing conditions in other family members or of relevant risk factors (occupational, life style,…) in the Patient?
    Description

    Are you aware of any other pre-existing conditions in other family members or of relevant risk factors (occupational, life style,…) in the Patient?

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0521987
    UMLS CUI [2,1]
    C0086282
    UMLS CUI [2,2]
    C0205394
    UMLS CUI [3]
    C0035648
    UMLS CUI [4]
    C0014006
    UMLS CUI [5]
    C0023676
    Pre-existing conditions or Risk factors details
    Description

    Pre-existing conditions or Risk factors details

    Data type

    text

    Alias
    UMLS CUI [1]
    C0521987
    UMLS CUI [2]
    C0035648
    UMLS CUI [3]
    C1522508
    Neurological Events
    Description

    Neurological Events

    Alias
    UMLS CUI-1
    C0027763
    UMLS CUI-2
    C0877248
    Neurological Event Diagnosis
    Description

    Neurological Event Diagnosis

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0027763
    UMLS CUI [1,2]
    C0877248
    UMLS CUI [1,3]
    C0011900
    Specify other diagnosis
    Description

    Specify other diagnosis

    Data type

    text

    Alias
    UMLS CUI [1]
    C0011900
    UMLS CUI [2,1]
    C0205394
    UMLS CUI [2,2]
    C2348235
    Please specify related adverse event: SAE Case No.
    Description

    In case of serious adverse event

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0237753
    Please specify related adverse event: AE No.
    Description

    In case of non-serious adverse event

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C0237753
    Date of final diagnosis:
    Description

    Date of final diagnosis:

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2316983
    UMLS CUI [1,2]
    C1546485
    Neurological Events - Signs and Symptoms
    Description

    Neurological Events - Signs and Symptoms

    Alias
    UMLS CUI-1
    C0027763
    UMLS CUI-2
    C0877248
    UMLS CUI-3
    C0037088
    Neurological Events - Signs and Symptoms
    Description

    Neurological Events - Signs and Symptoms

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0027763
    UMLS CUI [1,2]
    C0877248
    UMLS CUI [2]
    C0037088
    Neurological Events - Signs and Symptoms present
    Description

    Neurological Events - Signs and Symptoms present

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0027763
    UMLS CUI [1,2]
    C0877248
    UMLS CUI [2,1]
    C0037088
    UMLS CUI [2,2]
    C0150312
    Neurological Events - Signs and Symptoms start date
    Description

    Neurological Events - Signs and Symptoms start date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0027763
    UMLS CUI [1,2]
    C0877248
    UMLS CUI [2,1]
    C0037088
    UMLS CUI [2,2]
    C0808070
    Neurological Events - Signs and Symptoms end date
    Description

    Neurological Events - Signs and Symptoms end date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0027763
    UMLS CUI [1,2]
    C0877248
    UMLS CUI [2,1]
    C0037088
    UMLS CUI [2,2]
    C0806020
    Neurological Events - Signs and Symptoms continuing at end of study
    Description

    Neurological Events - Signs and Symptoms continuing at end of study

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0027763
    UMLS CUI [1,2]
    C0877248
    UMLS CUI [2]
    C0037088
    UMLS CUI [3,1]
    C0549178
    UMLS CUI [3,2]
    C0444496
    Neurological Events - Signs and Symptoms - Seizures
    Description

    Neurological Events - Signs and Symptoms - Seizures

    Alias
    UMLS CUI-1
    C0027763
    UMLS CUI-2
    C0877248
    UMLS CUI-3
    C0037088
    UMLS CUI-4
    C0036572
    Neurological Events - Specify seizures
    Description

    Neurological Events - Specify seizures

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0027763
    UMLS CUI [1,2]
    C0877248
    UMLS CUI [2,1]
    C0036572
    UMLS CUI [2,2]
    C2348235
    Neurological Events - Number of seizure episodes
    Description

    Neurological Events - Number of seizure episodes

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0027763
    UMLS CUI [1,2]
    C0877248
    UMLS CUI [2,1]
    C0036572
    UMLS CUI [2,2]
    C4086638
    Neurological Events - Duration of longest seizure episode
    Description

    Neurological Events - Duration of longest seizure episode

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0027763
    UMLS CUI [1,2]
    C0877248
    UMLS CUI [2]
    C0449238
    UMLS CUI [3,1]
    C0332189
    UMLS CUI [3,2]
    C1522425
    UMLS CUI [4]
    C0036572
    Neurological Events - Signs and Symptoms
    Description

    Neurological Events - Signs and Symptoms

    Alias
    UMLS CUI-1
    C0027763
    UMLS CUI-2
    C0877248
    UMLS CUI-3
    C0037088
    Neurological Events - Signs and Symptoms
    Description

    Neurological Events - Signs and Symptoms

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0027763
    UMLS CUI [1,2]
    C0877248
    UMLS CUI [2]
    C0037088
    Specify Hyperreflexia
    Description

    Specify Hyperreflexia

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0151889
    UMLS CUI [1,2]
    C2348235
    Specify deep tendon reflexes
    Description

    Specify deep tendon reflexes

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0034929
    UMLS CUI [1,2]
    C0039508
    UMLS CUI [1,3]
    C0205125
    Specify Bowel dysfunction
    Description

    Specify Bowel dysfunction

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2004461
    UMLS CUI [1,2]
    C2348235
    Specify Pain in limbs
    Description

    Specify Pain in limbs

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0015385
    UMLS CUI [1,2]
    C0030193
    UMLS CUI [1,3]
    C2348235
    Specify Myelitis Transverse, lesion level
    Description

    Specify Myelitis Transverse, lesion level

    Data type

    text

    Alias
    UMLS CUI [1]
    C0026976
    UMLS CUI [2]
    C0221198
    UMLS CUI [3]
    C2348235
    Neurological Events - Signs and symptoms present
    Description

    Neurological Events - Signs and symptoms present

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0027763
    UMLS CUI [1,2]
    C0877248
    UMLS CUI [2,1]
    C0037088
    UMLS CUI [2,2]
    C0150312
    Neurological Events - Signs and symptoms start date
    Description

    Neurological Events - Signs and symptoms start date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0027763
    UMLS CUI [1,2]
    C0877248
    UMLS CUI [2,1]
    C0037088
    UMLS CUI [2,2]
    C0808070
    Neurological Events - Signs and symptoms end date
    Description

    Neurological Events - Signs and symptoms end date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0027763
    UMLS CUI [1,2]
    C0877248
    UMLS CUI [2,1]
    C0037088
    UMLS CUI [2,2]
    C0806020
    Neurological Events - Signs and symptoms continuing at end of study
    Description

    Neurological Events - Signs and symptoms continuing at end of study

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0027763
    UMLS CUI [1,2]
    C0877248
    UMLS CUI [2]
    C0037088
    UMLS CUI [3,1]
    C0549178
    UMLS CUI [3,2]
    C0444496
    Neurological Events - Other signs and symptoms
    Description

    Neurological Events - Other signs and symptoms

    Alias
    UMLS CUI-1
    C0027763
    UMLS CUI-2
    C0877248
    UMLS CUI-3
    C0037088
    UMLS CUI-4
    C0205394
    If any other signs and symptoms, please tick the box and complete below
    Description

    If any other signs and symptoms, please tick the box and complete below

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0037088
    UMLS CUI [1,2]
    C0205394
    Neurological Events - Other signs and symptoms
    Description

    Neurological Events - Other signs and symptoms

    Alias
    UMLS CUI-1
    C0027763
    UMLS CUI-2
    C0877248
    UMLS CUI-3
    C0037088
    UMLS CUI-4
    C0205394
    Neurological Events - Other signs and symptoms
    Description

    Neurological Events - Other signs and symptoms

    Data type

    text

    Alias
    UMLS CUI [1]
    C0027763
    UMLS CUI [2,1]
    C0877248
    UMLS CUI [2,2]
    C0205394
    Neurological Events - Other signs and symptoms start date
    Description

    Neurological Events - Other signs and symptoms start date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0027763
    UMLS CUI [2,1]
    C0877248
    UMLS CUI [2,2]
    C0205394
    UMLS CUI [3]
    C0808070
    Neurological Events - Other signs and symptoms end date
    Description

    Neurological Events - Other signs and symptoms end date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0027763
    UMLS CUI [1,2]
    C0877248
    UMLS CUI [2,1]
    C0037088
    UMLS CUI [2,2]
    C0205394
    UMLS CUI [3]
    C0806020
    Neurological Events - Other signs and symptoms continuing at end of study
    Description

    Neurological Events - Other signs and symptoms continuing at end of study

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0027763
    UMLS CUI [1,2]
    C0877248
    UMLS CUI [2,1]
    C0037088
    UMLS CUI [2,2]
    C0205394
    UMLS CUI [3,1]
    C0549178
    UMLS CUI [3,2]
    C0444496
    Neurological Events - Diagnostic Test Results
    Description

    Neurological Events - Diagnostic Test Results

    Alias
    UMLS CUI-1
    C0027763
    UMLS CUI-2
    C0877248
    UMLS CUI-3
    C0456984
    UMLS CUI-4
    C0430022
    Neurological Events - Test
    Description

    Neurological Events - Test

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0027763
    UMLS CUI [1,2]
    C0877248
    UMLS CUI [2]
    C2826273
    Neurological Events - Test done
    Description

    Neurological Events - Test done

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0027763
    UMLS CUI [1,2]
    C0877248
    UMLS CUI [2,1]
    C0022885
    UMLS CUI [2,2]
    C1272695
    Neurological Events - Test date
    Description

    Neurological Events - Test date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0027763
    UMLS CUI [1,2]
    C0877248
    UMLS CUI [2]
    C2826247
    Neurological Events - Test Result
    Description

    Neurological Events - Test Result

    Data type

    float

    Alias
    UMLS CUI [1,1]
    C0027763
    UMLS CUI [1,2]
    C0877248
    UMLS CUI [2]
    C0587081
    Neurological Events - Test Units
    Description

    Neurological Events - Test Units

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0027763
    UMLS CUI [1,2]
    C0877248
    UMLS CUI [2]
    C1519795
    Neurological Events - Low Norm
    Description

    Neurological Events - Low Norm

    Data type

    float

    Alias
    UMLS CUI [1,1]
    C0027763
    UMLS CUI [1,2]
    C0877248
    UMLS CUI [2,1]
    C0086715
    UMLS CUI [2,2]
    C0205251
    Neurological Events - High Norm
    Description

    Neurological Events - High Norm

    Data type

    float

    Alias
    UMLS CUI [1,1]
    C0027763
    UMLS CUI [1,2]
    C0877248
    UMLS CUI [2,1]
    C0086715
    UMLS CUI [2,2]
    C0205250
    Neurological Events - Other Diagnostic Test Results
    Description

    Neurological Events - Other Diagnostic Test Results

    Alias
    UMLS CUI-1
    C0027763
    UMLS CUI-2
    C0877248
    UMLS CUI-3
    C0456984
    UMLS CUI-4
    C0430022
    UMLS CUI-5
    C0205394
    If any other diagnostic test results are available, please tick the box and complete below
    Description

    If any other diagnostic test results are available, please tick the box and complete below

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0456984
    UMLS CUI [1,2]
    C0430022
    UMLS CUI [1,3]
    C0205394
    Neurological Events - Other Diagnostic Test Results
    Description

    Neurological Events - Other Diagnostic Test Results

    Alias
    UMLS CUI-1
    C0027763
    UMLS CUI-2
    C0877248
    UMLS CUI-3
    C0456984
    UMLS CUI-4
    C0430022
    UMLS CUI-5
    C0205394
    Neurological Events - Test
    Description

    Neurological Events - Test

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0027763
    UMLS CUI [1,2]
    C0877248
    UMLS CUI [2]
    C2826273
    Neurological Events - Test date
    Description

    Neurological Events - Test date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0027763
    UMLS CUI [1,2]
    C0877248
    UMLS CUI [2]
    C2826247
    Neurological Events - Test Result
    Description

    Neurological Events - Test Result

    Data type

    float

    Alias
    UMLS CUI [1,1]
    C0027763
    UMLS CUI [1,2]
    C0877248
    UMLS CUI [2]
    C0587081
    Neurological Events - Test Units
    Description

    Neurological Events - Test Units

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0027763
    UMLS CUI [1,2]
    C0877248
    UMLS CUI [2]
    C1519795
    Neurological Events - Low Norm
    Description

    Neurological Events - Low Norm

    Data type

    float

    Alias
    UMLS CUI [1,1]
    C0027763
    UMLS CUI [1,2]
    C0877248
    UMLS CUI [2,1]
    C0086715
    UMLS CUI [2,2]
    C0205251
    Neurological Events - High Norm
    Description

    Neurological Events - High Norm

    Data type

    float

    Alias
    UMLS CUI [1,1]
    C0027763
    UMLS CUI [1,2]
    C0877248
    UMLS CUI [2,1]
    C0086715
    UMLS CUI [2,2]
    C0205250
    Neurological Events - Other diagnostic Procedure
    Description

    Neurological Events - Other diagnostic Procedure

    Alias
    UMLS CUI-1
    C0027763
    UMLS CUI-2
    C0877248
    UMLS CUI-3
    C0430022
    UMLS CUI-4
    C0205394
    Describe any other diagnostic procedure supporting the diagnosis (Magnetic Resonance Image, Evoqued Potential Tests, Ophtalmologic examination, Electrophysiologic examination, Myelography, CT scan, Viral serology, Tests for bacterial infections)
    Description

    Describe any other diagnostic procedure supporting the diagnosis

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0430022
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [2]
    C0011900
    UMLS CUI [3]
    C0024485
    UMLS CUI [4]
    C0015214
    UMLS CUI [5,1]
    C0029087
    UMLS CUI [5,2]
    C0031809
    UMLS CUI [6,1]
    C0013865
    UMLS CUI [6,2]
    C0031809
    UMLS CUI [7]
    C0026995
    UMLS CUI [8]
    C0040405
    UMLS CUI [9,1]
    C0036743
    UMLS CUI [9,2]
    C0521026
    UMLS CUI [10,1]
    C0004623
    UMLS CUI [10,2]
    C0022885
    Myasthenia Gravis
    Description

    Myasthenia Gravis

    Alias
    UMLS CUI-1
    C0026896
    Please specify related adverse event: SAE Case No.
    Description

    In case of serious adverse event

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0237753
    Please specify related adverse event: AE No.
    Description

    In case of non-serious adverse event

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C0237753
    Date of final diagnosis:
    Description

    Date of final diagnosis:

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2316983
    UMLS CUI [1,2]
    C1546485
    Myasthenia Gravis - Signs and symptoms (supporting the final diagnosis)
    Description

    Myasthenia Gravis - Signs and symptoms (supporting the final diagnosis)

    Alias
    UMLS CUI-1
    C0026896
    UMLS CUI-2
    C0037088
    UMLS CUI-3
    C1546485
    Myasthenia Gravis - Signs and symptoms
    Description

    Myasthenia Gravis - Signs and symptoms

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0026896
    UMLS CUI [2]
    C0037088
    Myasthenia Gravis - Signs and symptoms present
    Description

    Myasthenia Gravis - Signs and symptoms present

    Data type

    text

    Alias
    UMLS CUI [1]
    C0026896
    UMLS CUI [2]
    C0037088
    UMLS CUI [3]
    C0150312
    Myasthenia Gravis - Signs and symptoms Start Date
    Description

    Myasthenia Gravis - Signs and symptoms Start Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0026896
    UMLS CUI [2]
    C0037088
    UMLS CUI [3]
    C0808070
    Myasthenia Gravis - Signs and symptoms End date
    Description

    Myasthenia Gravis - Signs and symptoms End date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0026896
    UMLS CUI [2]
    C0037088
    UMLS CUI [3]
    C0806020
    Myasthenia Gravis - Signs and symptoms continuing at the end of study
    Description

    Myasthenia Gravis - Signs and symptoms continuing at the end of study

    Data type

    text

    Alias
    UMLS CUI [1]
    C0026896
    UMLS CUI [2]
    C0037088
    UMLS CUI [3,1]
    C0549178
    UMLS CUI [3,2]
    C0444496
    Myasthenia Gravis - Other Signs and symptoms
    Description

    Myasthenia Gravis - Other Signs and symptoms

    Alias
    UMLS CUI-1
    C0026896
    UMLS CUI-2
    C0037088
    UMLS CUI-3
    C0205394
    If any other signs and symptoms, please tick the box and complete below
    Description

    If any other signs and symptoms, please tick the box and complete below

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0037088
    UMLS CUI [1,2]
    C0205394
    Myasthenia Gravis - Other Signs and symptoms
    Description

    Myasthenia Gravis - Other Signs and symptoms

    Alias
    UMLS CUI-1
    C0026896
    UMLS CUI-2
    C0037088
    UMLS CUI-3
    C0205394
    Myasthenia Gravis - Other Signs and symptoms
    Description

    Myasthenia Gravis - Other Signs and symptoms

    Data type

    text

    Alias
    UMLS CUI [1]
    C0026896
    UMLS CUI [2,1]
    C0037088
    UMLS CUI [2,2]
    C0205394
    Myasthenia Gravis - Other Signs and symptoms Start Date
    Description

    Myasthenia Gravis - Other Signs and symptoms Start Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0026896
    UMLS CUI [2,1]
    C0037088
    UMLS CUI [2,2]
    C0205394
    UMLS CUI [3]
    C0808070
    Myasthenia Gravis - Other Signs and symptoms End Date
    Description

    Myasthenia Gravis - Other Signs and symptoms End Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0026896
    UMLS CUI [2,1]
    C0037088
    UMLS CUI [2,2]
    C0205394
    UMLS CUI [3]
    C0806020
    Myasthenia Gravis - Diagnostic Test Results
    Description

    Myasthenia Gravis - Diagnostic Test Results

    Alias
    UMLS CUI-1
    C0026896
    UMLS CUI-2
    C0456984
    Myasthenia Gravis - Test
    Description

    Myasthenia Gravis - Test

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0026896
    UMLS CUI [2]
    C2826273
    Myasthenia Gravis - Test done
    Description

    Myasthenia Gravis - Test done

    Data type

    text

    Alias
    UMLS CUI [1]
    C0026896
    UMLS CUI [2,1]
    C0022885
    UMLS CUI [2,2]
    C1272695
    Myasthenia Gravis - Test date
    Description

    Myasthenia Gravis - Test date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0026896
    UMLS CUI [2]
    C2826247
    Myasthenia Gravis - Test Result
    Description

    Myasthenia Gravis - Test Result

    Data type

    float

    Alias
    UMLS CUI [1]
    C0026896
    UMLS CUI [2]
    C0587081
    Myasthenia Gravis - Test Units
    Description

    Myasthenia Gravis - Test Units

    Data type

    text

    Alias
    UMLS CUI [1]
    C0026896
    UMLS CUI [2]
    C1519795
    Myasthenia Gravis - Low Norm
    Description

    Myasthenia Gravis - Low Norm

    Data type

    float

    Alias
    UMLS CUI [1]
    C0026896
    UMLS CUI [2,1]
    C0086715
    UMLS CUI [2,2]
    C0205251
    Myasthenia Gravis - High Norm
    Description

    Myasthenia Gravis - High Norm

    Data type

    float

    Alias
    UMLS CUI [1]
    C0026896
    UMLS CUI [2,1]
    C0086715
    UMLS CUI [2,2]
    C0205250
    Myasthenia Gravis - Other Diagnostic Test Results
    Description

    Myasthenia Gravis - Other Diagnostic Test Results

    Alias
    UMLS CUI-1
    C0026896
    UMLS CUI-2
    C0456984
    UMLS CUI-3
    C0430022
    UMLS CUI-4
    C0205394
    If any other diagnostic test results are available, please tick the box and complete below
    Description

    If any other diagnostic test results are available, please tick the box and complete below

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0456984
    UMLS CUI [1,2]
    C0430022
    UMLS CUI [1,3]
    C0205394
    Myasthenia Gravis - Other Diagnostic Test Results
    Description

    Myasthenia Gravis - Other Diagnostic Test Results

    Alias
    UMLS CUI-1
    C0026896
    UMLS CUI-2
    C0456984
    UMLS CUI-3
    C0430022
    UMLS CUI-4
    C0205394
    Myasthenia Gravis - Test
    Description

    Myasthenia Gravis - Test

    Data type

    text

    Alias
    UMLS CUI [1]
    C0026896
    UMLS CUI [2]
    C2826273
    Myasthenia Gravis - Test date
    Description

    Myasthenia Gravis - Test date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0026896
    UMLS CUI [2]
    C2826247
    Myasthenia Gravis - Test Result
    Description

    Myasthenia Gravis - Test Result

    Data type

    float

    Alias
    UMLS CUI [1]
    C0026896
    UMLS CUI [2]
    C0587081
    Myasthenia Gravis - Test Units
    Description

    Myasthenia Gravis - Test Units

    Data type

    text

    Alias
    UMLS CUI [1]
    C0026896
    UMLS CUI [2]
    C1519795
    Myasthenia Gravis - Low Norm
    Description

    Myasthenia Gravis - Low Norm

    Data type

    float

    Alias
    UMLS CUI [1]
    C0026896
    UMLS CUI [2,1]
    C0086715
    UMLS CUI [2,2]
    C0205251
    Myasthenia Gravis - High Norm
    Description

    Myasthenia Gravis - High Norm

    Data type

    float

    Alias
    UMLS CUI [1]
    C0026896
    UMLS CUI [2,1]
    C0086715
    UMLS CUI [2,2]
    C0205250
    Myasthenia Gravis - Other diagnostic Procedure
    Description

    Myasthenia Gravis - Other diagnostic Procedure

    Alias
    UMLS CUI-1
    C0026896
    UMLS CUI-2
    C0430022
    UMLS CUI-3
    C0205394
    Describe any other diagnostic procedure supporting the diagnosis (Chest x-ray, Chest CT scan, Electrodiagnositic studies, Repetitive nerve stimulation, Single-fiber electromyography)
    Description

    Describe any other diagnostic procedure supporting the diagnosis

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0430022
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [2]
    C0011900
    UMLS CUI [3]
    C0039985
    UMLS CUI [4]
    C0202823
    UMLS CUI [5]
    C0430874
    UMLS CUI [6]
    C0430810
    UMLS CUI [7]
    C0474789
    Uveitis
    Description

    Uveitis

    Alias
    UMLS CUI-1
    C0042164
    Please specify related adverse event: SAE Case No.
    Description

    In case of serious adverse event

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0237753
    Please specify related adverse event: AE No.
    Description

    In case of non-serious adverse event

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C0237753
    Date of final diagnosis:
    Description

    Date of final diagnosis:

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2316983
    UMLS CUI [1,2]
    C1546485
    Uveitis - Signs and symptoms (supporting the final diagnosis)
    Description

    Uveitis - Signs and symptoms (supporting the final diagnosis)

    Alias
    UMLS CUI-1
    C0042164
    UMLS CUI-2
    C0037088
    UMLS CUI-3
    C1546485
    Uveitis - Signs and symptoms
    Description

    Uveitis - Signs and symptoms

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0042164
    UMLS CUI [2]
    C0037088
    Uveitis - Specify nervous findings
    Description

    Uveitis - Specify nervous findings

    Data type

    text

    Alias
    UMLS CUI [1]
    C0042164
    UMLS CUI [2,1]
    C0027763
    UMLS CUI [2,2]
    C2607943
    Uveitis - Specify ear/ nose / throat findings
    Description

    Uveitis - Specify ear/ nose / throat findings

    Data type

    text

    Alias
    UMLS CUI [1]
    C0042164
    UMLS CUI [2]
    C0243095
    Uveitis - Specify gastrointestinal disorders
    Description

    Uveitis - Specify gastrointestinal disorders

    Data type

    text

    Alias
    UMLS CUI [1]
    C0042164
    UMLS CUI [2]
    C0017178
    Uveitis - Specify Pulmonary disorders
    Description

    Uveitis - Specify Pulmonary disorders

    Data type

    text

    Alias
    UMLS CUI [1]
    C0042164
    UMLS CUI [2]
    C0024115
    Uveitis - Specify genitourinary disoders
    Description

    Uveitis - Specify genitourinary disoders

    Data type

    text

    Alias
    UMLS CUI [1]
    C0042164
    UMLS CUI [2]
    C0042066
    Uveitis - Specify dermatologic disoders
    Description

    Uveitis - Specify dermatologic disoders

    Data type

    text

    Alias
    UMLS CUI [1]
    C0042164
    UMLS CUI [2]
    C0037274
    Uveitis - Specify musculoskeletal disoders
    Description

    Uveitis - Specify musculoskeletal disoders

    Data type

    text

    Alias
    UMLS CUI [1]
    C0042164
    UMLS CUI [2]
    C0026857
    Uveitis - Signs and symptoms present
    Description

    Uveitis - Signs and symptoms present

    Data type

    text

    Alias
    UMLS CUI [1]
    C0042164
    UMLS CUI [2]
    C0037088
    UMLS CUI [3]
    C0150312
    Uveitis - Signs and symptoms Start Date
    Description

    Uveitis - Signs and symptoms Start Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0042164
    UMLS CUI [2]
    C0037088
    UMLS CUI [3]
    C0808070
    Uveitis - Signs and symptoms End date
    Description

    Uveitis - Signs and symptoms End date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0042164
    UMLS CUI [2]
    C0037088
    UMLS CUI [3]
    C0806020
    Uveitis - Signs and symptoms continuing at the end of study
    Description

    Uveitis - Signs and symptoms continuing at the end of study

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0042164
    UMLS CUI [2]
    C0037088
    UMLS CUI [3,1]
    C0549178
    UMLS CUI [3,2]
    C0444496
    Uveitis - Other Signs and symptoms
    Description

    Uveitis - Other Signs and symptoms

    Alias
    UMLS CUI-1
    C0042164
    UMLS CUI-2
    C0037088
    UMLS CUI-3
    C0205394
    If any other signs and symptoms, please tick the box and complete below
    Description

    If any other signs and symptoms, please tick the box and complete below

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0037088
    UMLS CUI [1,2]
    C0205394
    Uveitis - Other Signs and symptoms
    Description

    Uveitis - Other Signs and symptoms

    Alias
    UMLS CUI-1
    C0042164
    UMLS CUI-2
    C0037088
    UMLS CUI-3
    C0205394
    Uveitis - Other Signs and symptoms
    Description

    Uveitis - Other Signs and symptoms

    Data type

    text

    Alias
    UMLS CUI [1]
    C0042164
    UMLS CUI [2,1]
    C0037088
    UMLS CUI [2,2]
    C0205394
    Uveitis - Other Signs and symptoms Start Date
    Description

    Uveitis - Other Signs and symptoms Start Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0042164
    UMLS CUI [2,1]
    C0037088
    UMLS CUI [2,2]
    C0205394
    UMLS CUI [3]
    C0808070
    Uveitis - Other Signs and symptoms End Date
    Description

    Uveitis - Other Signs and symptoms End Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0042164
    UMLS CUI [2,1]
    C0037088
    UMLS CUI [2,2]
    C0205394
    UMLS CUI [3]
    C0806020
    Uveitis - Diagnostic Test Results
    Description

    Uveitis - Diagnostic Test Results

    Alias
    UMLS CUI-1
    C0042164
    UMLS CUI-2
    C0456984
    Uveitis - Test
    Description

    Uveitis - Test

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0042164
    UMLS CUI [2]
    C2826273
    Uveitis - Test done
    Description

    Uveitis - Test done

    Data type

    text

    Alias
    UMLS CUI [1]
    C0042164
    UMLS CUI [2,1]
    C0022885
    UMLS CUI [2,2]
    C1272695
    Uveitis - Test date
    Description

    Uveitis - Test date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0042164
    UMLS CUI [2]
    C2826247
    Uveitis - Test Result
    Description

    Uveitis - Test Result

    Data type

    float

    Alias
    UMLS CUI [1]
    C0042164
    UMLS CUI [2]
    C0587081
    Uveitis - Test Units
    Description

    Uveitis - Test Units

    Data type

    text

    Alias
    UMLS CUI [1]
    C0042164
    UMLS CUI [2]
    C1519795
    Uveitis - Low Norm
    Description

    Uveitis - Low Norm

    Data type

    float

    Alias
    UMLS CUI [1]
    C0042164
    UMLS CUI [2,1]
    C0086715
    UMLS CUI [2,2]
    C0205251
    Uveitis - High Norm
    Description

    Uveitis - High Norm

    Data type

    float

    Alias
    UMLS CUI [1]
    C0042164
    UMLS CUI [2,1]
    C0086715
    UMLS CUI [2,2]
    C0205250
    Uveitis - Other Diagnostic Test Results
    Description

    Uveitis - Other Diagnostic Test Results

    Alias
    UMLS CUI-1
    C0042164
    UMLS CUI-2
    C0456984
    UMLS CUI-3
    C0430022
    UMLS CUI-4
    C0205394
    If any other diagnostic test results are available, please tick the box and complete below
    Description

    If any other diagnostic test results are available, please tick the box and complete below

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0456984
    UMLS CUI [1,2]
    C0430022
    UMLS CUI [1,3]
    C0205394
    Uveitis - Other Diagnostic Test Results
    Description

    Uveitis - Other Diagnostic Test Results

    Alias
    UMLS CUI-1
    C0042164
    UMLS CUI-2
    C0456984
    UMLS CUI-3
    C0430022
    UMLS CUI-4
    C0205394
    Uveitis - Test
    Description

    Uveitis - Test

    Data type

    text

    Alias
    UMLS CUI [1]
    C0042164
    UMLS CUI [2]
    C2826273
    Uveitis - Test date
    Description

    Uveitis - Test date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0042164
    UMLS CUI [2]
    C2826247
    Uveitis - Test Result
    Description

    Uveitis - Test Result

    Data type

    float

    Alias
    UMLS CUI [1]
    C0042164
    UMLS CUI [2]
    C0587081
    Uveitis - Test Units
    Description

    Uveitis - Test Units

    Data type

    text

    Alias
    UMLS CUI [1]
    C0042164
    UMLS CUI [2]
    C1519795
    Uveitis - Low Norm
    Description

    Uveitis - Low Norm

    Data type

    float

    Alias
    UMLS CUI [1]
    C0042164
    UMLS CUI [2,1]
    C0086715
    UMLS CUI [2,2]
    C0205251
    Uveitis - High Norm
    Description

    Uveitis - High Norm

    Data type

    float

    Alias
    UMLS CUI [1]
    C0042164
    UMLS CUI [2,1]
    C0086715
    UMLS CUI [2,2]
    C0205250
    Uveitis - Other diagnostic Procedure
    Description

    Uveitis - Other diagnostic Procedure

    Alias
    UMLS CUI-1
    C0042164
    UMLS CUI-2
    C0430022
    UMLS CUI-3
    C0205394
    Describe any other diagnostic procedure supporting the diagnosis (Slit-lamp photograph, Biomicroscopy)
    Description

    Describe any other diagnostic procedure supporting the diagnosis

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0430022
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [2]
    C0011900
    UMLS CUI [3]
    C0419360
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    Similar models

    Immune Mediated Disease Report; General Medical History; Relevant Risk Factors; Neurological Events; Myasthenia Gravis; Uveitis (Report Final and Annex Report 2 Final)

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative
    C1320722 (UMLS CUI-1)
    Centre Number
    Item
    Centre Number
    text
    C0600091 (UMLS CUI [1,1])
    C0019994 (UMLS CUI [1,2])
    Patient Number
    Item
    Patient Number
    text
    C2348585 (UMLS CUI [1])
    Item Group
    IMD Report
    C0012634 (UMLS CUI-1)
    C4330477 (UMLS CUI-2)
    C0684224 (UMLS CUI-3)
    Has any confirmed or probable Immune Mediated Disease occurred during the study?
    Item
    Has any confirmed or probable Immune Mediated Disease occurred during the study?
    boolean
    C0012634 (UMLS CUI [1,1])
    C4330477 (UMLS CUI [1,2])
    Item
    If Immune Mediated Diasease occured during study, tick the disease category
    text
    C0012634 (UMLS CUI [1,1])
    C4330477 (UMLS CUI [1,2])
    C2745955 (UMLS CUI [2])
    C0683312 (UMLS CUI [3])
    If Immune Mediated Diasease occured during study, tick the disease category
    Code List
    If Immune Mediated Diasease occured during study, tick the disease category
    CL Item
    Neurological events: Guillain-Barre syndrome, Multiple sclerosis, Optic neuritis, Myelitis Transverse, Demyelinating disease (1)
    CL Item
    Myasthenia gravis (2)
    CL Item
    Uveitis (3)
    CL Item
    Rheumatoid diseases: Rheumatoid arthritis, Juvenile rheumatoid arthritis, Polymyalgia rheumatica, Reactive arthritis, Reiter syndrome, Ankylosing spondilitis, Psoriasis arthritis, Undifferienciated spondylarthropathy (4)
    CL Item
    Systemic lupus erythematosus or Cutaneous lupus (5)
    CL Item
    Sjogren’s syndrome (6)
    CL Item
    Scleroderma or Morphea (7)
    CL Item
    Dermatomyositis or Polymyositis (8)
    CL Item
    Diabetes Mellitus type I (9)
    CL Item
    Autoimmune thyroid diseases: Grave-Basedow disease, Hashimoto thyroiditis, Autoimmune thyroiditis (10)
    CL Item
    Addison’s disease (11)
    CL Item
    Inflammatory bowel diseases: Crohn’s disease, Ulcerative colitis, Ulcerative proctitis (12)
    CL Item
    Coeliac disease (13)
    CL Item
    Antiphospholipid syndrome (14)
    CL Item
    Autoimmune haemolytic anaemia (15)
    CL Item
    Idiopathic thrombocytopenic purpura (16)
    CL Item
    Pernicious anaemia (17)
    CL Item
    Vasculitis: Leukocytoclatic vasculitis, Periarteritis nodosa, Microscopic polyangiitis, Wegener’s granulomatosis, Henoch-Schonlein purpura, Churg Strauss disease, Kawasaki disease, Temporal arteritis, Giant cell arteritis, Takayasu’s arteritis, (18)
    CL Item
    (Glomerulo)nephritis (19)
    CL Item
    Inflammatory skin diseases: Pemphigus, Bullous pemphigoid, Dermatitis herpetiformis, Stevens-Johnson syndrome, Psoriasis, Vitiligo, Raynaud’s phenomen, Raynaud disease, Erythema nodosum (20)
    CL Item
    Autoimmune myocarditis (21)
    CL Item
    Autoimmune liver disease: Autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis (22)
    CL Item
    Sarcoidosis (23)
    CL Item
    Other, specify (24)
    Item Group
    General Medical History
    C0262926 (UMLS CUI-1)
    Are you aware of any pre-existing conditions present in Patient or in close family (father, mother or sister/brother) prior the start of the study?
    Item
    Are you aware of any pre-existing conditions present in Patient or in close family (father, mother or sister/brother) prior the start of the study?
    boolean
    C0521987 (UMLS CUI [1])
    C0030705 (UMLS CUI [2])
    C0086282 (UMLS CUI [3])
    C0015671 (UMLS CUI [4])
    C0026591 (UMLS CUI [5])
    C0337514 (UMLS CUI [6])
    C0337527 (UMLS CUI [7])
    Item Group
    General Medical History
    C0262926 (UMLS CUI-1)
    Diagnosis
    Item
    Diagnosis
    text
    C0011900 (UMLS CUI [1])
    Item
    Pre-existing conditions present in Patient or in close family
    integer
    C0521987 (UMLS CUI [1])
    C0030705 (UMLS CUI [2])
    C0086282 (UMLS CUI [3])
    Pre-existing conditions present in Patient or in close family
    Code List
    Pre-existing conditions present in Patient or in close family
    CL Item
    Patient (1)
    CL Item
    Father (2)
    CL Item
    Mother (3)
    CL Item
    Sister/ Brother (4)
    Item
    Diagnosis status
    integer
    C0011900 (UMLS CUI [1,1])
    C0449438 (UMLS CUI [1,2])
    Diagnosis status
    Code List
    Diagnosis status
    CL Item
    Past (1)
    CL Item
    Current (2)
    Item Group
    Relevant risk factors
    C0035648 (UMLS CUI-1)
    Are you aware of any other pre-existing conditions in other family members or of relevant risk factors (occupational, life style,…) in the Patient?
    Item
    Are you aware of any other pre-existing conditions in other family members or of relevant risk factors (occupational, life style,…) in the Patient?
    boolean
    C0521987 (UMLS CUI [1])
    C0086282 (UMLS CUI [2,1])
    C0205394 (UMLS CUI [2,2])
    C0035648 (UMLS CUI [3])
    C0014006 (UMLS CUI [4])
    C0023676 (UMLS CUI [5])
    Pre-existing conditions or Risk factors details
    Item
    Pre-existing conditions or Risk factors details
    text
    C0521987 (UMLS CUI [1])
    C0035648 (UMLS CUI [2])
    C1522508 (UMLS CUI [3])
    Item Group
    Neurological Events
    C0027763 (UMLS CUI-1)
    C0877248 (UMLS CUI-2)
    Item
    Neurological Event Diagnosis
    integer
    C0027763 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    C0011900 (UMLS CUI [1,3])
    Neurological Event Diagnosis
    Code List
    Neurological Event Diagnosis
    CL Item
    Guillain-Barre syndrome (1)
    CL Item
    Multiple sclerosis (2)
    CL Item
    Optic neuritis (3)
    CL Item
    Myelitis Transverse (4)
    CL Item
    Demyelinating disease (5)
    CL Item
    Other, specify (6)
    Specify other diagnosis
    Item
    Specify other diagnosis
    text
    C0011900 (UMLS CUI [1])
    C0205394 (UMLS CUI [2,1])
    C2348235 (UMLS CUI [2,2])
    Please specify related adverse event: SAE Case No.
    Item
    Please specify related adverse event: SAE Case No.
    integer
    C1519255 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Please specify related adverse event: AE No.
    Item
    Please specify related adverse event: AE No.
    integer
    C1518404 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Date of final diagnosis:
    Item
    Date of final diagnosis:
    date
    C2316983 (UMLS CUI [1,1])
    C1546485 (UMLS CUI [1,2])
    Item Group
    Neurological Events - Signs and Symptoms
    C0027763 (UMLS CUI-1)
    C0877248 (UMLS CUI-2)
    C0037088 (UMLS CUI-3)
    Item
    Neurological Events - Signs and Symptoms
    integer
    C0027763 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    C0037088 (UMLS CUI [2])
    Signs and Symptoms
    Code List
    Neurological Events - Signs and Symptoms
    CL Item
    Headache (1)
    CL Item
    Neck stiffness (2)
    CL Item
    Photophobia (3)
    CL Item
    Lethargy (4)
    CL Item
    Decreased level of consciousness (5)
    CL Item
    Cognitive dysfunction (Attention spam, Concentration, Memory, Judgment) (6)
    CL Item
    Depression (7)
    CL Item
    Meningismus (8)
    CL Item
    Sensory loss, specify localisation (9)
    CL Item
    Paresthesia (10)
    CL Item
    Motor dysfunction onset acute (11)
    CL Item
    Motor dysfunction onset chronic (12)
    CL Item
    Motor dysfunction onset symmetric (13)
    CL Item
    Motor dysfunction onset asymmetric (14)
    CL Item
    Hemiparesis, specify localisation (15)
    CL Item
    Paraparesis, specify localisation (16)
    CL Item
    Paralysis, specify localisation (17)
    CL Item
    Respiratory muscle involvement (18)
    CL Item
    Spasticity, specify localisation (19)
    CL Item
    Muscle cramping secondary to spasticity (20)
    CL Item
    Seizures (21)
    Item
    Neurological Events - Signs and Symptoms present
    text
    C0027763 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    C0037088 (UMLS CUI [2,1])
    C0150312 (UMLS CUI [2,2])
    Signs and symptoms present
    Code List
    Neurological Events - Signs and Symptoms present
    CL Item
    Yes (Y)
    CL Item
    No (N)
    CL Item
    Unknown (U)
    CL Item
    Not Applicable (NA)
    Neurological Events - Signs and Symptoms start date
    Item
    Neurological Events - Signs and Symptoms start date
    date
    C0027763 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    C0037088 (UMLS CUI [2,1])
    C0808070 (UMLS CUI [2,2])
    Neurological Events - Signs and Symptoms end date
    Item
    Neurological Events - Signs and Symptoms end date
    date
    C0027763 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    C0037088 (UMLS CUI [2,1])
    C0806020 (UMLS CUI [2,2])
    Item
    Neurological Events - Signs and Symptoms continuing at end of study
    integer
    C0027763 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    C0037088 (UMLS CUI [2])
    C0549178 (UMLS CUI [3,1])
    C0444496 (UMLS CUI [3,2])
    Signs and symptoms continuing at end of study
    Code List
    Neurological Events - Signs and Symptoms continuing at end of study
    CL Item
    Continuing at end of study (1)
    Item Group
    Neurological Events - Signs and Symptoms - Seizures
    C0027763 (UMLS CUI-1)
    C0877248 (UMLS CUI-2)
    C0037088 (UMLS CUI-3)
    C0036572 (UMLS CUI-4)
    Item
    Neurological Events - Specify seizures
    integer
    C0027763 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    C0036572 (UMLS CUI [2,1])
    C2348235 (UMLS CUI [2,2])
    Specify seizures
    Code List
    Neurological Events - Specify seizures
    CL Item
    Focal (1)
    CL Item
    Generalised (2)
    CL Item
    Convulsive (3)
    CL Item
    Sensitive (4)
    Neurological Events - Number of seizure episodes
    Item
    Neurological Events - Number of seizure episodes
    integer
    C0027763 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    C0036572 (UMLS CUI [2,1])
    C4086638 (UMLS CUI [2,2])
    Neurological Events - Duration of longest seizure episode
    Item
    Neurological Events - Duration of longest seizure episode
    text
    C0027763 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    C0449238 (UMLS CUI [2])
    C0332189 (UMLS CUI [3,1])
    C1522425 (UMLS CUI [3,2])
    C0036572 (UMLS CUI [4])
    Item Group
    Neurological Events - Signs and Symptoms
    C0027763 (UMLS CUI-1)
    C0877248 (UMLS CUI-2)
    C0037088 (UMLS CUI-3)
    Item
    Neurological Events - Signs and Symptoms
    integer
    C0027763 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    C0037088 (UMLS CUI [2])
    Signs and Symptoms
    Code List
    Neurological Events - Signs and Symptoms
    CL Item
    Hyperreflexia, specify (1)
    CL Item
    Deep tendon reflexes, specify (2)
    CL Item
    Urinary retention (3)
    CL Item
    Urinary incontinence (4)
    CL Item
    Bowel dysfunction, specify (5)
    CL Item
    Sexual dysfunction (6)
    CL Item
    Disarthria (7)
    CL Item
    Unsteady gait, ataxia (8)
    CL Item
    Tremor (9)
    CL Item
    Coordination disturbance, dysmetria (10)
    CL Item
    Hearing impairment (11)
    CL Item
    Diplopia (12)
    CL Item
    Aphasia / dysphasia (13)
    CL Item
    Facial palsy unilateral (14)
    CL Item
    Facial palsy bilateral (15)
    CL Item
    Trigeminal neuralgia unilateral (16)
    CL Item
    Trigeminal neuralgia bilateral (17)
    CL Item
    Pain in limbs, specify (18)
    CL Item
    Orbital pain (19)
    CL Item
    Loss of vision (20)
    CL Item
    Central scotoma (21)
    CL Item
    Flashes of light (22)
    CL Item
    Color vision disturbed (23)
    CL Item
    Optic neuritis bilateral (24)
    CL Item
    Optic neuritis unilateral (25)
    CL Item
    Myelitis Transverse acute (26)
    CL Item
    Myelitis Transverse chronic (27)
    CL Item
    Myelitis Transverse partial (28)
    CL Item
    Myelitis Transverse total (29)
    CL Item
    Myelitis Transverse, lesion level, specify (30)
    CL Item
    Lhermitte sign (Neck flexion results in an electric shocklike feeling in the torso or extremities) (31)
    Specify Hyperreflexia
    Item
    Specify Hyperreflexia
    text
    C0151889 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    Specify deep tendon reflexes
    Item
    Specify deep tendon reflexes
    text
    C0034929 (UMLS CUI [1,1])
    C0039508 (UMLS CUI [1,2])
    C0205125 (UMLS CUI [1,3])
    Specify Bowel dysfunction
    Item
    Specify Bowel dysfunction
    text
    C2004461 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    Specify Pain in limbs
    Item
    Specify Pain in limbs
    text
    C0015385 (UMLS CUI [1,1])
    C0030193 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [1,3])
    Specify Myelitis Transverse, lesion level
    Item
    Specify Myelitis Transverse, lesion level
    text
    C0026976 (UMLS CUI [1])
    C0221198 (UMLS CUI [2])
    C2348235 (UMLS CUI [3])
    Item
    Neurological Events - Signs and symptoms present
    text
    C0027763 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    C0037088 (UMLS CUI [2,1])
    C0150312 (UMLS CUI [2,2])
    Signs and symptoms present
    Code List
    Neurological Events - Signs and symptoms present
    CL Item
    Yes  (Y)
    CL Item
    No  (N)
    CL Item
    Unknown  (U)
    CL Item
    Not Applicable (NA)
    Neurological Events - Signs and symptoms start date
    Item
    Neurological Events - Signs and symptoms start date
    date
    C0027763 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    C0037088 (UMLS CUI [2,1])
    C0808070 (UMLS CUI [2,2])
    Neurological Events - Signs and symptoms end date
    Item
    Neurological Events - Signs and symptoms end date
    date
    C0027763 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    C0037088 (UMLS CUI [2,1])
    C0806020 (UMLS CUI [2,2])
    Item
    Neurological Events - Signs and symptoms continuing at end of study
    integer
    C0027763 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    C0037088 (UMLS CUI [2])
    C0549178 (UMLS CUI [3,1])
    C0444496 (UMLS CUI [3,2])
    Signs and symptoms continuing at end of study
    Code List
    Neurological Events - Signs and symptoms continuing at end of study
    CL Item
    Continuing at end of study (1)
    Item Group
    Neurological Events - Other signs and symptoms
    C0027763 (UMLS CUI-1)
    C0877248 (UMLS CUI-2)
    C0037088 (UMLS CUI-3)
    C0205394 (UMLS CUI-4)
    Item
    If any other signs and symptoms, please tick the box and complete below
    integer
    C0037088 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    If any other signs and symptoms, please tick the box and complete below
    Code List
    If any other signs and symptoms, please tick the box and complete below
    CL Item
    Other signs and symptoms (1)
    Item Group
    Neurological Events - Other signs and symptoms
    C0027763 (UMLS CUI-1)
    C0877248 (UMLS CUI-2)
    C0037088 (UMLS CUI-3)
    C0205394 (UMLS CUI-4)
    Neurological Events - Other signs and symptoms
    Item
    Neurological Events - Other signs and symptoms
    text
    C0027763 (UMLS CUI [1])
    C0877248 (UMLS CUI [2,1])
    C0205394 (UMLS CUI [2,2])
    Neurological Events - Other signs and symptoms start date
    Item
    Neurological Events - Other signs and symptoms start date
    date
    C0027763 (UMLS CUI [1])
    C0877248 (UMLS CUI [2,1])
    C0205394 (UMLS CUI [2,2])
    C0808070 (UMLS CUI [3])
    Neurological Events - Other signs and symptoms end date
    Item
    Neurological Events - Other signs and symptoms end date
    date
    C0027763 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    C0037088 (UMLS CUI [2,1])
    C0205394 (UMLS CUI [2,2])
    C0806020 (UMLS CUI [3])
    Item
    Neurological Events - Other signs and symptoms continuing at end of study
    integer
    C0027763 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    C0037088 (UMLS CUI [2,1])
    C0205394 (UMLS CUI [2,2])
    C0549178 (UMLS CUI [3,1])
    C0444496 (UMLS CUI [3,2])
    Signs and symptoms continuing at end of study
    Code List
    Neurological Events - Other signs and symptoms continuing at end of study
    CL Item
    Continuing at end of study (1)
    Item Group
    Neurological Events - Diagnostic Test Results
    C0027763 (UMLS CUI-1)
    C0877248 (UMLS CUI-2)
    C0456984 (UMLS CUI-3)
    C0430022 (UMLS CUI-4)
    Item
    Neurological Events - Test
    integer
    C0027763 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    C2826273 (UMLS CUI [2])
    Test
    Code List
    Neurological Events - Test
    CL Item
    CSF Total protein (1)
    CL Item
    CSF IgG elevated (2)
    CL Item
    CSF Oligoclonal bands (3)
    CL Item
    CSF white blood cells (4)
    CL Item
    CSF lymphocytes (5)
    CL Item
    CSF neutrophyls (6)
    CL Item
    CSF Glucose (7)
    CL Item
    White Blood Cells (8)
    CL Item
    Neutrophils (9)
    CL Item
    Lymphocytes (10)
    CL Item
    Monocytes (11)
    CL Item
    Eosinophils (12)
    CL Item
    Basophils (13)
    CL Item
    Red blood cells (14)
    CL Item
    Platelets (15)
    CL Item
    Erythrocyte Sedimentation Rate (ESR) (16)
    CL Item
    Serum C-reactive protein (CRP) (17)
    CL Item
    Serum sodium (18)
    CL Item
    Serum chloride (19)
    CL Item
    Serum calcium (20)
    CL Item
    Serum magnesium (21)
    CL Item
    Alanine amino Transferase (ALT) (22)
    CL Item
    Aspartate amino Transferase (AST) (23)
    CL Item
    Alkaline Phosphatase (AP) (24)
    CL Item
    Rheumatoid factor (RF) (25)
    CL Item
    Anti-nuclear antibodies (ANA) (26)
    Item
    Neurological Events - Test done
    text
    C0027763 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    C0022885 (UMLS CUI [2,1])
    C1272695 (UMLS CUI [2,2])
    Test done
    Code List
    Neurological Events - Test done
    CL Item
    Yes (Y)
    CL Item
    No (N)
    CL Item
    Unknown (U)
    CL Item
    Not Applicable (NA)
    Neurological Events - Test date
    Item
    Neurological Events - Test date
    date
    C0027763 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    C2826247 (UMLS CUI [2])
    Neurological Events - Test Result
    Item
    Neurological Events - Test Result
    float
    C0027763 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    C0587081 (UMLS CUI [2])
    Neurological Events - Test Units
    Item
    Neurological Events - Test Units
    text
    C0027763 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    C1519795 (UMLS CUI [2])
    Neurological Events - Low Norm
    Item
    Neurological Events - Low Norm
    float
    C0027763 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    C0086715 (UMLS CUI [2,1])
    C0205251 (UMLS CUI [2,2])
    Neurological Events - High Norm
    Item
    Neurological Events - High Norm
    float
    C0027763 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    C0086715 (UMLS CUI [2,1])
    C0205250 (UMLS CUI [2,2])
    Item Group
    Neurological Events - Other Diagnostic Test Results
    C0027763 (UMLS CUI-1)
    C0877248 (UMLS CUI-2)
    C0456984 (UMLS CUI-3)
    C0430022 (UMLS CUI-4)
    C0205394 (UMLS CUI-5)
    Item
    If any other diagnostic test results are available, please tick the box and complete below
    integer
    C0456984 (UMLS CUI [1,1])
    C0430022 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    If any other diagnostic test results are available, please tick the box and complete below
    Code List
    If any other diagnostic test results are available, please tick the box and complete below
    CL Item
    Other diagnostic test results available (1)
    Item Group
    Neurological Events - Other Diagnostic Test Results
    C0027763 (UMLS CUI-1)
    C0877248 (UMLS CUI-2)
    C0456984 (UMLS CUI-3)
    C0430022 (UMLS CUI-4)
    C0205394 (UMLS CUI-5)
    Neurological Events - Test
    Item
    Neurological Events - Test
    text
    C0027763 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    C2826273 (UMLS CUI [2])
    Neurological Events - Test date
    Item
    Neurological Events - Test date
    date
    C0027763 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    C2826247 (UMLS CUI [2])
    Neurological Events - Test Result
    Item
    Neurological Events - Test Result
    float
    C0027763 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    C0587081 (UMLS CUI [2])
    Neurological Events - Test Units
    Item
    Neurological Events - Test Units
    text
    C0027763 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    C1519795 (UMLS CUI [2])
    Neurological Events - Low Norm
    Item
    Neurological Events - Low Norm
    float
    C0027763 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    C0086715 (UMLS CUI [2,1])
    C0205251 (UMLS CUI [2,2])
    Neurological Events - High Norm
    Item
    Neurological Events - High Norm
    float
    C0027763 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    C0086715 (UMLS CUI [2,1])
    C0205250 (UMLS CUI [2,2])
    Item Group
    Neurological Events - Other diagnostic Procedure
    C0027763 (UMLS CUI-1)
    C0877248 (UMLS CUI-2)
    C0430022 (UMLS CUI-3)
    C0205394 (UMLS CUI-4)
    Describe any other diagnostic procedure supporting the diagnosis
    Item
    Describe any other diagnostic procedure supporting the diagnosis (Magnetic Resonance Image, Evoqued Potential Tests, Ophtalmologic examination, Electrophysiologic examination, Myelography, CT scan, Viral serology, Tests for bacterial infections)
    text
    C0430022 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C0011900 (UMLS CUI [2])
    C0024485 (UMLS CUI [3])
    C0015214 (UMLS CUI [4])
    C0029087 (UMLS CUI [5,1])
    C0031809 (UMLS CUI [5,2])
    C0013865 (UMLS CUI [6,1])
    C0031809 (UMLS CUI [6,2])
    C0026995 (UMLS CUI [7])
    C0040405 (UMLS CUI [8])
    C0036743 (UMLS CUI [9,1])
    C0521026 (UMLS CUI [9,2])
    C0004623 (UMLS CUI [10,1])
    C0022885 (UMLS CUI [10,2])
    Item Group
    Myasthenia Gravis
    C0026896 (UMLS CUI-1)
    Please specify related adverse event: SAE Case No.
    Item
    Please specify related adverse event: SAE Case No.
    integer
    C1519255 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Please specify related adverse event: AE No.
    Item
    Please specify related adverse event: AE No.
    integer
    C1518404 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Date of final diagnosis:
    Item
    Date of final diagnosis:
    date
    C2316983 (UMLS CUI [1,1])
    C1546485 (UMLS CUI [1,2])
    Item Group
    Myasthenia Gravis - Signs and symptoms (supporting the final diagnosis)
    C0026896 (UMLS CUI-1)
    C0037088 (UMLS CUI-2)
    C1546485 (UMLS CUI-3)
    Item
    Myasthenia Gravis - Signs and symptoms
    integer
    C0026896 (UMLS CUI [1])
    C0037088 (UMLS CUI [2])
    Myasthenia Gravis - Signs and symptoms
    Code List
    Myasthenia Gravis - Signs and symptoms
    CL Item
    Muscle weakness symmetric (1)
    CL Item
    Muscle weakness asymmetric (2)
    CL Item
    Ptosis (3)
    CL Item
    Diplopia (4)
    CL Item
    Facial weakness (5)
    CL Item
    Mask-like face (6)
    CL Item
    Horizontal smile (7)
    CL Item
    Head extension and flexion weakness (8)
    CL Item
    Oropharyngeal muscle weakness (9)
    CL Item
    Dysphagia (10)
    CL Item
    Dysarthria (11)
    CL Item
    Upper limb muscle weakness (12)
    CL Item
    Lower limb muscle weakness (13)
    CL Item
    Axial muscle weakness (14)
    CL Item
    Respiratory muscle weakness (15)
    CL Item
    Difficult breathing (16)
    CL Item
    Hyperthyroidism (17)
    CL Item
    Rheumatoid arthritis (18)
    CL Item
    Scleroderma (19)
    CL Item
    Lupus (20)
    Item
    Myasthenia Gravis - Signs and symptoms present
    text
    C0026896 (UMLS CUI [1])
    C0037088 (UMLS CUI [2])
    C0150312 (UMLS CUI [3])
    Myasthenia Gravis - Signs and symptoms present
    Code List
    Myasthenia Gravis - Signs and symptoms present
    CL Item
    Yes (Y)
    CL Item
    No (N)
    CL Item
    Unknown (U)
    CL Item
    Not Applicable (NA)
    Myasthenia Gravis - Signs and symptoms Start Date
    Item
    Myasthenia Gravis - Signs and symptoms Start Date
    date
    C0026896 (UMLS CUI [1])
    C0037088 (UMLS CUI [2])
    C0808070 (UMLS CUI [3])
    Myasthenia Gravis - Signs and symptoms End date
    Item
    Myasthenia Gravis - Signs and symptoms End date
    date
    C0026896 (UMLS CUI [1])
    C0037088 (UMLS CUI [2])
    C0806020 (UMLS CUI [3])
    Item
    Myasthenia Gravis - Signs and symptoms continuing at the end of study
    text
    C0026896 (UMLS CUI [1])
    C0037088 (UMLS CUI [2])
    C0549178 (UMLS CUI [3,1])
    C0444496 (UMLS CUI [3,2])
    Myasthenia Gravis - Signs and symptoms continuing at the end of study
    Code List
    Myasthenia Gravis - Signs and symptoms continuing at the end of study
    CL Item
    Continuing at end of study (1)
    Item Group
    Myasthenia Gravis - Other Signs and symptoms
    C0026896 (UMLS CUI-1)
    C0037088 (UMLS CUI-2)
    C0205394 (UMLS CUI-3)
    Item
    If any other signs and symptoms, please tick the box and complete below
    integer
    C0037088 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    If any other signs and symptoms, please tick the box and complete below
    Code List
    If any other signs and symptoms, please tick the box and complete below
    CL Item
    Other signs and symptoms (1)
    Item Group
    Myasthenia Gravis - Other Signs and symptoms
    C0026896 (UMLS CUI-1)
    C0037088 (UMLS CUI-2)
    C0205394 (UMLS CUI-3)
    Myasthenia Gravis - Other Signs and symptoms
    Item
    Myasthenia Gravis - Other Signs and symptoms
    text
    C0026896 (UMLS CUI [1])
    C0037088 (UMLS CUI [2,1])
    C0205394 (UMLS CUI [2,2])
    Myasthenia Gravis - Other Signs and symptoms Start Date
    Item
    Myasthenia Gravis - Other Signs and symptoms Start Date
    date
    C0026896 (UMLS CUI [1])
    C0037088 (UMLS CUI [2,1])
    C0205394 (UMLS CUI [2,2])
    C0808070 (UMLS CUI [3])
    Myasthenia Gravis - Other Signs and symptoms End Date
    Item
    Myasthenia Gravis - Other Signs and symptoms End Date
    date
    C0026896 (UMLS CUI [1])
    C0037088 (UMLS CUI [2,1])
    C0205394 (UMLS CUI [2,2])
    C0806020 (UMLS CUI [3])
    Item Group
    Myasthenia Gravis - Diagnostic Test Results
    C0026896 (UMLS CUI-1)
    C0456984 (UMLS CUI-2)
    Item
    Myasthenia Gravis - Test
    integer
    C0026896 (UMLS CUI [1])
    C2826273 (UMLS CUI [2])
    Test
    Code List
    Myasthenia Gravis - Test
    CL Item
    White Blood Cells (1)
    CL Item
    Neutrophils (2)
    CL Item
    Lymphocytes (3)
    CL Item
    Monocytes (4)
    CL Item
    Eosinophils (5)
    CL Item
    Basophils (6)
    CL Item
    Red blood cells (7)
    CL Item
    Platelets (8)
    CL Item
    Erythrocyte sedimentation rate (ESR) (9)
    CL Item
    Serum C-reactive protein (CRP) (10)
    CL Item
    Anti-acetylcholine receptor antibodies (anti-AChRs) (11)
    CL Item
    Anti-Muscle Specific Kinase antibodies (anti-MuSK) (12)
    CL Item
    Striational autoantibodies (skeletal muscle Ab) (13)
    CL Item
    Thyroxine Total T4 (14)
    CL Item
    Thyroxine Free T4 (15)
    CL Item
    TSH (16)
    CL Item
    Anti-thyroglobulin autoantibodies (17)
    CL Item
    Anti-thyroid peroxidase autoantibodies (18)
    CL Item
    Anti-TSH-Receptor antoantibodies (19)
    CL Item
    Rheumatoid Factor (RF) (20)
    CL Item
    Anti-Nuclear Antibodies (ANA) (21)
    Item
    Myasthenia Gravis - Test done
    text
    C0026896 (UMLS CUI [1])
    C0022885 (UMLS CUI [2,1])
    C1272695 (UMLS CUI [2,2])
    Test done
    Code List
    Myasthenia Gravis - Test done
    CL Item
    Yes  (Y)
    CL Item
    No  (N)
    CL Item
    Unknown  (U)
    CL Item
    Not Applicable (NA)
    Myasthenia Gravis - Test date
    Item
    Myasthenia Gravis - Test date
    date
    C0026896 (UMLS CUI [1])
    C2826247 (UMLS CUI [2])
    Myasthenia Gravis - Test Result
    Item
    Myasthenia Gravis - Test Result
    float
    C0026896 (UMLS CUI [1])
    C0587081 (UMLS CUI [2])
    Myasthenia Gravis - Test Units
    Item
    Myasthenia Gravis - Test Units
    text
    C0026896 (UMLS CUI [1])
    C1519795 (UMLS CUI [2])
    Myasthenia Gravis - Low Norm
    Item
    Myasthenia Gravis - Low Norm
    float
    C0026896 (UMLS CUI [1])
    C0086715 (UMLS CUI [2,1])
    C0205251 (UMLS CUI [2,2])
    Myasthenia Gravis - High Norm
    Item
    Myasthenia Gravis - High Norm
    float
    C0026896 (UMLS CUI [1])
    C0086715 (UMLS CUI [2,1])
    C0205250 (UMLS CUI [2,2])
    Item Group
    Myasthenia Gravis - Other Diagnostic Test Results
    C0026896 (UMLS CUI-1)
    C0456984 (UMLS CUI-2)
    C0430022 (UMLS CUI-3)
    C0205394 (UMLS CUI-4)
    Item
    If any other diagnostic test results are available, please tick the box and complete below
    integer
    C0456984 (UMLS CUI [1,1])
    C0430022 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    If any other diagnostic test results are available, please tick the box and complete below
    Code List
    If any other diagnostic test results are available, please tick the box and complete below
    CL Item
    Other diagnostic test results available (1)
    Item Group
    Myasthenia Gravis - Other Diagnostic Test Results
    C0026896 (UMLS CUI-1)
    C0456984 (UMLS CUI-2)
    C0430022 (UMLS CUI-3)
    C0205394 (UMLS CUI-4)
    Myasthenia Gravis - Test
    Item
    Myasthenia Gravis - Test
    text
    C0026896 (UMLS CUI [1])
    C2826273 (UMLS CUI [2])
    Myasthenia Gravis - Test date
    Item
    Myasthenia Gravis - Test date
    date
    C0026896 (UMLS CUI [1])
    C2826247 (UMLS CUI [2])
    Myasthenia Gravis - Test Result
    Item
    Myasthenia Gravis - Test Result
    float
    C0026896 (UMLS CUI [1])
    C0587081 (UMLS CUI [2])
    Myasthenia Gravis - Test Units
    Item
    Myasthenia Gravis - Test Units
    text
    C0026896 (UMLS CUI [1])
    C1519795 (UMLS CUI [2])
    Myasthenia Gravis - Low Norm
    Item
    Myasthenia Gravis - Low Norm
    float
    C0026896 (UMLS CUI [1])
    C0086715 (UMLS CUI [2,1])
    C0205251 (UMLS CUI [2,2])
    Myasthenia Gravis - High Norm
    Item
    Myasthenia Gravis - High Norm
    float
    C0026896 (UMLS CUI [1])
    C0086715 (UMLS CUI [2,1])
    C0205250 (UMLS CUI [2,2])
    Item Group
    Myasthenia Gravis - Other diagnostic Procedure
    C0026896 (UMLS CUI-1)
    C0430022 (UMLS CUI-2)
    C0205394 (UMLS CUI-3)
    Describe any other diagnostic procedure supporting the diagnosis
    Item
    Describe any other diagnostic procedure supporting the diagnosis (Chest x-ray, Chest CT scan, Electrodiagnositic studies, Repetitive nerve stimulation, Single-fiber electromyography)
    text
    C0430022 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C0011900 (UMLS CUI [2])
    C0039985 (UMLS CUI [3])
    C0202823 (UMLS CUI [4])
    C0430874 (UMLS CUI [5])
    C0430810 (UMLS CUI [6])
    C0474789 (UMLS CUI [7])
    Item Group
    Uveitis
    C0042164 (UMLS CUI-1)
    Please specify related adverse event: SAE Case No.
    Item
    Please specify related adverse event: SAE Case No.
    integer
    C1519255 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Please specify related adverse event: AE No.
    Item
    Please specify related adverse event: AE No.
    text
    C1518404 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Date of final diagnosis:
    Item
    Date of final diagnosis:
    date
    C2316983 (UMLS CUI [1,1])
    C1546485 (UMLS CUI [1,2])
    Item Group
    Uveitis - Signs and symptoms (supporting the final diagnosis)
    C0042164 (UMLS CUI-1)
    C0037088 (UMLS CUI-2)
    C1546485 (UMLS CUI-3)
    Item
    Uveitis - Signs and symptoms
    integer
    C0042164 (UMLS CUI [1])
    C0037088 (UMLS CUI [2])
    Uveitis - Signs and symptoms
    Code List
    Uveitis - Signs and symptoms
    CL Item
    Eye redness (1)
    CL Item
    Eye pain (2)
    CL Item
    Impaired/blurred vision (3)
    CL Item
    Light sensitivity (4)
    CL Item
    Anterior uveitis (iritis, iridocyclitis, anterior cyclitis) (5)
    CL Item
    Intermediate uveitis (inflammation in the vitreousand/or retina) (6)
    CL Item
    Posterior uveitis (inflammation of the retina andthe choroid) (7)
    CL Item
    Panuveitis (8)
    CL Item
    Fever (9)
    CL Item
    Nervous findings, specify (10)
    CL Item
    Ear / nose / throat findings, specify (11)
    CL Item
    Gastrointestinal disoders, specify (12)
    CL Item
    Pulmonary disoders, specify (13)
    CL Item
    Genitourinary disoders, specify (14)
    CL Item
    Dermatologic disoders, specify (15)
    CL Item
    Musculoskeletal disoders, specify (16)
    Uveitis - Specify nervous findings
    Item
    Uveitis - Specify nervous findings
    text
    C0042164 (UMLS CUI [1])
    C0027763 (UMLS CUI [2,1])
    C2607943 (UMLS CUI [2,2])
    Uveitis - Specify ear/ nose / throat findings
    Item
    Uveitis - Specify ear/ nose / throat findings
    text
    C0042164 (UMLS CUI [1])
    C0243095 (UMLS CUI [2])
    Uveitis - Specify gastrointestinal disorders
    Item
    Uveitis - Specify gastrointestinal disorders
    text
    C0042164 (UMLS CUI [1])
    C0017178 (UMLS CUI [2])
    Uveitis - Specify Pulmonary disorders
    Item
    Uveitis - Specify Pulmonary disorders
    text
    C0042164 (UMLS CUI [1])
    C0024115 (UMLS CUI [2])
    Uveitis - Specify genitourinary disoders
    Item
    Uveitis - Specify genitourinary disoders
    text
    C0042164 (UMLS CUI [1])
    C0042066 (UMLS CUI [2])
    Uveitis - Specify dermatologic disoders
    Item
    Uveitis - Specify dermatologic disoders
    text
    C0042164 (UMLS CUI [1])
    C0037274 (UMLS CUI [2])
    Uveitis - Specify musculoskeletal disoders
    Item
    Uveitis - Specify musculoskeletal disoders
    text
    C0042164 (UMLS CUI [1])
    C0026857 (UMLS CUI [2])
    Item
    Uveitis - Signs and symptoms present
    text
    C0042164 (UMLS CUI [1])
    C0037088 (UMLS CUI [2])
    C0150312 (UMLS CUI [3])
    Myasthenia Gravis - Signs and symptoms present
    Code List
    Uveitis - Signs and symptoms present
    CL Item
    Yes  (Y)
    CL Item
    No  (N)
    CL Item
    Unknown  (U)
    CL Item
    Not Applicable (NA)
    Uveitis - Signs and symptoms Start Date
    Item
    Uveitis - Signs and symptoms Start Date
    date
    C0042164 (UMLS CUI [1])
    C0037088 (UMLS CUI [2])
    C0808070 (UMLS CUI [3])
    Uveitis - Signs and symptoms End date
    Item
    Uveitis - Signs and symptoms End date
    date
    C0042164 (UMLS CUI [1])
    C0037088 (UMLS CUI [2])
    C0806020 (UMLS CUI [3])
    Item
    Uveitis - Signs and symptoms continuing at the end of study
    integer
    C0042164 (UMLS CUI [1])
    C0037088 (UMLS CUI [2])
    C0549178 (UMLS CUI [3,1])
    C0444496 (UMLS CUI [3,2])
    Myasthenia Gravis - Signs and symptoms continuing at the end of study
    Code List
    Uveitis - Signs and symptoms continuing at the end of study
    CL Item
    Continuing at end of study (1)
    Item Group
    Uveitis - Other Signs and symptoms
    C0042164 (UMLS CUI-1)
    C0037088 (UMLS CUI-2)
    C0205394 (UMLS CUI-3)
    Item
    If any other signs and symptoms, please tick the box and complete below
    integer
    C0037088 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    If any other signs and symptoms, please tick the box and complete below
    Code List
    If any other signs and symptoms, please tick the box and complete below
    CL Item
    Other signs and symptoms (1)
    Item Group
    Uveitis - Other Signs and symptoms
    C0042164 (UMLS CUI-1)
    C0037088 (UMLS CUI-2)
    C0205394 (UMLS CUI-3)
    Uveitis - Other Signs and symptoms
    Item
    Uveitis - Other Signs and symptoms
    text
    C0042164 (UMLS CUI [1])
    C0037088 (UMLS CUI [2,1])
    C0205394 (UMLS CUI [2,2])
    Uveitis - Other Signs and symptoms Start Date
    Item
    Uveitis - Other Signs and symptoms Start Date
    date
    C0042164 (UMLS CUI [1])
    C0037088 (UMLS CUI [2,1])
    C0205394 (UMLS CUI [2,2])
    C0808070 (UMLS CUI [3])
    Uveitis - Other Signs and symptoms End Date
    Item
    Uveitis - Other Signs and symptoms End Date
    date
    C0042164 (UMLS CUI [1])
    C0037088 (UMLS CUI [2,1])
    C0205394 (UMLS CUI [2,2])
    C0806020 (UMLS CUI [3])
    Item Group
    Uveitis - Diagnostic Test Results
    C0042164 (UMLS CUI-1)
    C0456984 (UMLS CUI-2)
    Item
    Uveitis - Test
    integer
    C0042164 (UMLS CUI [1])
    C2826273 (UMLS CUI [2])
    Myasthenia Gravis - Test
    Code List
    Uveitis - Test
    CL Item
    White Blood Cells  (1)
    CL Item
    Neutrophils  (2)
    CL Item
    Lymphocytes  (3)
    CL Item
    Monocytes  (4)
    CL Item
    Eosinophils  (5)
    CL Item
    Basophils  (6)
    CL Item
    Red blood cells  (7)
    CL Item
    Platelets  (8)
    CL Item
    Erythrocyte sedimentation rate (ESR)  (9)
    CL Item
    Serum C-reactive protein (CRP) (10)
    Item
    Uveitis - Test done
    text
    C0042164 (UMLS CUI [1])
    C0022885 (UMLS CUI [2,1])
    C1272695 (UMLS CUI [2,2])
    Myasthenia Gravis - Test done
    Code List
    Uveitis - Test done
    CL Item
    Yes  (Y)
    CL Item
    No  (N)
    CL Item
    Unknown  (U)
    CL Item
    Not Applicable (NA)
    Uveitis - Test date
    Item
    Uveitis - Test date
    date
    C0042164 (UMLS CUI [1])
    C2826247 (UMLS CUI [2])
    Uveitis - Test Result
    Item
    Uveitis - Test Result
    float
    C0042164 (UMLS CUI [1])
    C0587081 (UMLS CUI [2])
    Uveitis - Test Units
    Item
    Uveitis - Test Units
    text
    C0042164 (UMLS CUI [1])
    C1519795 (UMLS CUI [2])
    Uveitis - Low Norm
    Item
    Uveitis - Low Norm
    float
    C0042164 (UMLS CUI [1])
    C0086715 (UMLS CUI [2,1])
    C0205251 (UMLS CUI [2,2])
    Uveitis - High Norm
    Item
    Uveitis - High Norm
    float
    C0042164 (UMLS CUI [1])
    C0086715 (UMLS CUI [2,1])
    C0205250 (UMLS CUI [2,2])
    Item Group
    Uveitis - Other Diagnostic Test Results
    C0042164 (UMLS CUI-1)
    C0456984 (UMLS CUI-2)
    C0430022 (UMLS CUI-3)
    C0205394 (UMLS CUI-4)
    Item
    If any other diagnostic test results are available, please tick the box and complete below
    integer
    C0456984 (UMLS CUI [1,1])
    C0430022 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    If any other diagnostic test results are available, please tick the box and complete below
    Code List
    If any other diagnostic test results are available, please tick the box and complete below
    CL Item
    Other diagnostic test results available (1)
    Item Group
    Uveitis - Other Diagnostic Test Results
    C0042164 (UMLS CUI-1)
    C0456984 (UMLS CUI-2)
    C0430022 (UMLS CUI-3)
    C0205394 (UMLS CUI-4)
    Uveitis - Test
    Item
    Uveitis - Test
    text
    C0042164 (UMLS CUI [1])
    C2826273 (UMLS CUI [2])
    Uveitis - Test date
    Item
    Uveitis - Test date
    date
    C0042164 (UMLS CUI [1])
    C2826247 (UMLS CUI [2])
    Uveitis - Test Result
    Item
    Uveitis - Test Result
    float
    C0042164 (UMLS CUI [1])
    C0587081 (UMLS CUI [2])
    Uveitis - Test Units
    Item
    Uveitis - Test Units
    text
    C0042164 (UMLS CUI [1])
    C1519795 (UMLS CUI [2])
    Uveitis - Low Norm
    Item
    Uveitis - Low Norm
    float
    C0042164 (UMLS CUI [1])
    C0086715 (UMLS CUI [2,1])
    C0205251 (UMLS CUI [2,2])
    Uveitis - High Norm
    Item
    Uveitis - High Norm
    float
    C0042164 (UMLS CUI [1])
    C0086715 (UMLS CUI [2,1])
    C0205250 (UMLS CUI [2,2])
    Item Group
    Uveitis - Other diagnostic Procedure
    C0042164 (UMLS CUI-1)
    C0430022 (UMLS CUI-2)
    C0205394 (UMLS CUI-3)
    Describe any other diagnostic procedure supporting the diagnosis
    Item
    Describe any other diagnostic procedure supporting the diagnosis (Slit-lamp photograph, Biomicroscopy)
    text
    C0430022 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C0011900 (UMLS CUI [2])
    C0419360 (UMLS CUI [3])
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