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41536

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 (2)
  1. 10/6/20 10/6/20 -
  2. 11/2/20 11/2/20 -
Copyright Holder

GlaxoSmithKline

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November 2, 2020

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    Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162

    English

    IMD Report - Autoimmune thyroid diseases; Addisons's disease; Inflammatory bowel diseases (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
    Autoimmune thyroid diseases
    Description

    Autoimmune thyroid diseases

    Alias
    UMLS CUI-1
    C0178468
    Autoimmune thyroid diseases Diagnosis
    Description

    Autoimmune thyroid diseases Diagnosis

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0178468
    UMLS CUI [2]
    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
    Autoimmune thyroid diseases - Signs and Symptoms
    Description

    Autoimmune thyroid diseases - Signs and Symptoms

    Alias
    UMLS CUI-1
    C0178468
    UMLS CUI-2
    C0037088
    Autoimmune thyroid diseases - Signs and Symptoms
    Description

    Autoimmune thyroid diseases - Signs and Symptoms

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0178468
    UMLS CUI [2]
    C0037088
    Autoimmune thyroid diseases - Specify ophthalmopathy
    Description

    Autoimmune thyroid diseases - Specify ophthalmopathy

    Data type

    text

    Alias
    UMLS CUI [1]
    C0178468
    UMLS CUI [2]
    C0015397
    Autoimmune thyroid diseases - Specify blood pressure
    Description

    Autoimmune thyroid diseases - Specify blood pressure

    Data type

    text

    Alias
    UMLS CUI [1]
    C0178468
    UMLS CUI [2]
    C0005823
    Autoimmune thyroid diseases - Specify dermopathy
    Description

    Autoimmune thyroid diseases - Specify dermopathy

    Data type

    text

    Alias
    UMLS CUI [1]
    C0178468
    UMLS CUI [2]
    C0037274
    Autoimmune thyroid diseases - Signs and Symptoms present
    Description

    Autoimmune thyroid diseases - Signs and Symptoms present

    Data type

    text

    Alias
    UMLS CUI [1]
    C0178468
    UMLS CUI [2,1]
    C0037088
    UMLS CUI [2,2]
    C0150312
    Autoimmune thyroid diseases - Signs and Symptoms start date
    Description

    Autoimmune thyroid diseases - Signs and Symptoms start date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0178468
    UMLS CUI [2,1]
    C0037088
    UMLS CUI [2,2]
    C0808070
    Autoimmune thyroid diseases - Signs and Symptoms end date
    Description

    Autoimmune thyroid diseases - Signs and Symptoms end date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0178468
    UMLS CUI [2,1]
    C0037088
    UMLS CUI [2,2]
    C0806020
    Autoimmune thyroid diseases - Signs and Symptoms continuing at end of study
    Description

    Autoimmune thyroid diseases - Signs and Symptoms continuing at end of study

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0178468
    UMLS CUI [2]
    C0037088
    UMLS CUI [3,1]
    C0549178
    UMLS CUI [3,2]
    C0444496
    Autoimmune thyroid diseases - Other signs and symptoms
    Description

    Autoimmune thyroid diseases - Other signs and symptoms

    Alias
    UMLS CUI-1
    C0178468
    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
    Autoimmune thyroid diseases - Other signs and symptoms
    Description

    Autoimmune thyroid diseases - Other signs and symptoms

    Alias
    UMLS CUI-1
    C0178468
    UMLS CUI-2
    C0037088
    UMLS CUI-3
    C0205394
    Autoimmune thyroid diseases - Other signs and symptoms
    Description

    Autoimmune thyroid diseases - Other signs and symptoms

    Data type

    text

    Alias
    UMLS CUI [1]
    C0178468
    UMLS CUI [2,1]
    C0037088
    UMLS CUI [2,2]
    C0205394
    Autoimmune thyroid diseases - Other signs and symptoms start date
    Description

    Autoimmune thyroid diseases - Other signs and symptoms start date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0178468
    UMLS CUI [2,1]
    C0037088
    UMLS CUI [2,2]
    C0205394
    UMLS CUI [3]
    C0808070
    Autoimmune thyroid diseases - Other signs and symptoms end date
    Description

    Autoimmune thyroid diseases - Other signs and symptoms end date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0178468
    UMLS CUI [2,1]
    C0037088
    UMLS CUI [2,2]
    C0205394
    UMLS CUI [3]
    C0806020
    Autoimmune thyroid diseases - Other signs and symptoms continuing at end of study
    Description

    Autoimmune thyroid diseases - Other signs and symptoms continuing at end of study

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0178468
    UMLS CUI [2,1]
    C0037088
    UMLS CUI [2,2]
    C0205394
    UMLS CUI [3,1]
    C0549178
    UMLS CUI [3,2]
    C0444496
    Autoimmune thyroid diseases - Diagnostic Test Results
    Description

    Autoimmune thyroid diseases - Diagnostic Test Results

    Alias
    UMLS CUI-1
    C0178468
    UMLS CUI-2
    C0456984
    UMLS CUI-3
    C0430022
    Autoimmune thyroid diseases - Test
    Description

    Autoimmune thyroid diseases - Test

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0178468
    UMLS CUI [2]
    C2826273
    Autoimmune thyroid diseases - Test done
    Description

    Autoimmune thyroid diseases - Test done

    Data type

    text

    Alias
    UMLS CUI [1]
    C0178468
    UMLS CUI [2,1]
    C0022885
    UMLS CUI [2,2]
    C1272695
    Autoimmune thyroid diseases - Test date
    Description

    Autoimmune thyroid diseases - Test date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0178468
    UMLS CUI [2]
    C2826247
    Autoimmune thyroid diseases - Test Result
    Description

    Autoimmune thyroid diseases - Test Result

    Data type

    float

    Alias
    UMLS CUI [1]
    C0178468
    UMLS CUI [2]
    C0587081
    Autoimmune thyroid diseases - Test Units
    Description

    Autoimmune thyroid diseases - Test Units

    Data type

    text

    Alias
    UMLS CUI [1]
    C0178468
    UMLS CUI [2]
    C1519795
    Autoimmune thyroid diseases - Low Norm
    Description

    Autoimmune thyroid diseases - Low Norm

    Data type

    float

    Alias
    UMLS CUI [1]
    C0178468
    UMLS CUI [2,1]
    C0086715
    UMLS CUI [2,2]
    C0205251
    Autoimmune thyroid diseases - High Norm
    Description

    Autoimmune thyroid diseases - High Norm

    Data type

    float

    Alias
    UMLS CUI [1]
    C0178468
    UMLS CUI [2,1]
    C0086715
    UMLS CUI [2,2]
    C0205250
    Autoimmune thyroid diseases - Other Diagnostic Test Results
    Description

    Autoimmune thyroid diseases - Other Diagnostic Test Results

    Alias
    UMLS CUI-1
    C0178468
    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
    Autoimmune thyroid diseases - Other Diagnostic Test Results
    Description

    Autoimmune thyroid diseases - Other Diagnostic Test Results

    Alias
    UMLS CUI-1
    C0178468
    UMLS CUI-2
    C0456984
    UMLS CUI-3
    C0430022
    UMLS CUI-4
    C0205394
    Autoimmune thyroid diseases - Test
    Description

    Autoimmune thyroid diseases - Test

    Data type

    text

    Alias
    UMLS CUI [1]
    C0178468
    UMLS CUI [2]
    C2826273
    Autoimmune thyroid diseases - Test date
    Description

    Autoimmune thyroid diseases - Test date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0178468
    UMLS CUI [2]
    C2826247
    Autoimmune thyroid diseases - Test Result
    Description

    Autoimmune thyroid diseases - Test Result

    Data type

    float

    Alias
    UMLS CUI [1]
    C0178468
    UMLS CUI [2]
    C0587081
    Autoimmune thyroid diseases - Test Units
    Description

    Autoimmune thyroid diseases - Test Units

    Data type

    text

    Alias
    UMLS CUI [1]
    C0178468
    UMLS CUI [2]
    C1519795
    Autoimmune thyroid diseases - Low Norm
    Description

    Autoimmune thyroid diseases - Low Norm

    Data type

    float

    Alias
    UMLS CUI [1]
    C0178468
    UMLS CUI [2,1]
    C0086715
    UMLS CUI [2,2]
    C0205251
    Autoimmune thyroid diseases - High Norm
    Description

    Autoimmune thyroid diseases - High Norm

    Data type

    float

    Alias
    UMLS CUI [1]
    C0178468
    UMLS CUI [2,1]
    C0086715
    UMLS CUI [2,2]
    C0205250
    Autoimmune thyroid diseases - Other diagnostic Procedure
    Description

    Autoimmune thyroid diseases - Other diagnostic Procedure

    Alias
    UMLS CUI-1
    C0178468
    UMLS CUI-2
    C0430022
    UMLS CUI-3
    C0205394
    Describe any other diagnostic procedure supporting the diagnosis (Thyroid scintigraphy, sonography)
    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]
    C0860843
    UMLS CUI [4]
    C0041618
    Addison's disease
    Description

    Addison's disease

    Alias
    UMLS CUI-1
    C0001403
    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
    Addison's disease - Signs and symptoms (supporting the final diagnosis)
    Description

    Addison's disease - Signs and symptoms (supporting the final diagnosis)

    Alias
    UMLS CUI-1
    C0001403
    UMLS CUI-2
    C0037088
    UMLS CUI-3
    C1546485
    Addison's disease - Signs and symptoms
    Description

    Addison's disease - Signs and symptoms

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0001403
    UMLS CUI [2]
    C0037088
    Addison's disease - Signs and symptoms present
    Description

    Addison's disease - Signs and symptoms present

    Data type

    text

    Alias
    UMLS CUI [1]
    C0001403
    UMLS CUI [2]
    C0037088
    UMLS CUI [3]
    C0150312
    Addison's disease - Signs and symptoms Start Date
    Description

    Addison's disease - Signs and symptoms Start Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0001403
    UMLS CUI [2]
    C0037088
    UMLS CUI [3]
    C0808070
    Addison's disease - Signs and symptoms End date
    Description

    Addison's disease - Signs and symptoms End date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0001403
    UMLS CUI [2]
    C0037088
    UMLS CUI [3]
    C0806020
    Addison's disease - Signs and symptoms continuing at the end of study
    Description

    Addison's disease - Signs and symptoms continuing at the end of study

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0001403
    UMLS CUI [2]
    C0037088
    UMLS CUI [3,1]
    C0549178
    UMLS CUI [3,2]
    C0444496
    Addison's disease - Other Signs and symptoms
    Description

    Addison's disease - Other Signs and symptoms

    Alias
    UMLS CUI-1
    C0001403
    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
    Addison's disease - Other Signs and symptoms
    Description

    Addison's disease - Other Signs and symptoms

    Alias
    UMLS CUI-1
    C0001403
    UMLS CUI-2
    C0037088
    UMLS CUI-3
    C0205394
    Addison's disease - Other Signs and symptoms
    Description

    Addison's disease - Other Signs and symptoms

    Data type

    text

    Alias
    UMLS CUI [1]
    C0001403
    UMLS CUI [2,1]
    C0037088
    UMLS CUI [2,2]
    C0205394
    Addison's disease - Other Signs and symptoms Start Date
    Description

    Addison's disease - Other Signs and symptoms Start Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0001403
    UMLS CUI [2,1]
    C0037088
    UMLS CUI [2,2]
    C0205394
    UMLS CUI [3]
    C0808070
    Addison's disease - Other Signs and symptoms End Date
    Description

    Addison's disease - Other Signs and symptoms End Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0001403
    UMLS CUI [2,1]
    C0037088
    UMLS CUI [2,2]
    C0205394
    UMLS CUI [3]
    C0806020
    Addison's disease - Other signs and symptoms continuing at the end of study
    Description

    Addison's disease - Other signs and symptoms continuing at the end of study

    Data type

    text

    Alias
    UMLS CUI [1]
    C0001403
    UMLS CUI [2,1]
    C0037088
    UMLS CUI [2,2]
    C0205394
    UMLS CUI [3,1]
    C0549178
    UMLS CUI [3,2]
    C0444496
    Addison's disease - Diagnostic Test Results
    Description

    Addison's disease - Diagnostic Test Results

    Alias
    UMLS CUI-1
    C0001403
    UMLS CUI-2
    C0085655
    UMLS CUI-3
    C0456984
    Addison's disease - Test
    Description

    Addison's disease - Test

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0001403
    UMLS CUI [2]
    C2826273
    Addison's disease - Test done
    Description

    Addison's disease - Test done

    Data type

    text

    Alias
    UMLS CUI [1]
    C0001403
    UMLS CUI [2,1]
    C0022885
    UMLS CUI [2,2]
    C1272695
    Addison's disease - Test date
    Description

    Addison's disease - Test date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0001403
    UMLS CUI [2]
    C2826247
    Addison's disease - Test Result
    Description

    Addison's disease - Test Result

    Data type

    float

    Alias
    UMLS CUI [1]
    C0001403
    UMLS CUI [2]
    C0587081
    Addison's disease - Test Units
    Description

    Addison's disease - Test Units

    Data type

    text

    Alias
    UMLS CUI [1]
    C0001403
    UMLS CUI [2]
    C1519795
    Addison's disease - Low Norm
    Description

    Addison's disease - Low Norm

    Data type

    float

    Alias
    UMLS CUI [1]
    C0001403
    UMLS CUI [2,1]
    C0086715
    UMLS CUI [2,2]
    C0205251
    Addison's disease - High Norm
    Description

    Addison's disease - High Norm

    Data type

    float

    Alias
    UMLS CUI [1]
    C0001403
    UMLS CUI [2,1]
    C0086715
    UMLS CUI [2,2]
    C0205250
    Addison's disease - Other Diagnostic Test Results
    Description

    Addison's disease - Other Diagnostic Test Results

    Alias
    UMLS CUI-1
    C0001403
    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
    Addison's disease - Other Diagnostic Test Results
    Description

    Addison's disease - Other Diagnostic Test Results

    Alias
    UMLS CUI-1
    C0001403
    UMLS CUI-2
    C0456984
    UMLS CUI-3
    C0430022
    UMLS CUI-4
    C0205394
    Addison's disease - Test
    Description

    Addison's disease - Test

    Data type

    text

    Alias
    UMLS CUI [1]
    C0001403
    UMLS CUI [2]
    C2826273
    Addison's disease - Test date
    Description

    Addison's disease - Test date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0001403
    UMLS CUI [2]
    C2826247
    Addison's disease - Test Result
    Description

    Addison's disease - Test Result

    Data type

    float

    Alias
    UMLS CUI [1]
    C0001403
    UMLS CUI [2]
    C0587081
    Addison's disease - Test Units
    Description

    Addison's disease - Test Units

    Data type

    text

    Alias
    UMLS CUI [1]
    C0001403
    UMLS CUI [2]
    C1519795
    Addison's disease - Low Norm
    Description

    Addison's disease - Low Norm

    Data type

    float

    Alias
    UMLS CUI [1]
    C0001403
    UMLS CUI [2,1]
    C0086715
    UMLS CUI [2,2]
    C0205251
    Addison's disease - High Norm
    Description

    Addison's disease - High Norm

    Data type

    float

    Alias
    UMLS CUI [1]
    C0001403
    UMLS CUI [2,1]
    C0086715
    UMLS CUI [2,2]
    C0205250
    Addison's disease - Other diagnostic Procedure
    Description

    Addison's disease - Other diagnostic Procedure

    Alias
    UMLS CUI-1
    C0001403
    UMLS CUI-2
    C0430022
    UMLS CUI-3
    C0205394
    Describe any other diagnostic procedure supporting the diagnosis (Chest x-Ray, Abdominal CT scan, Thyroid scintigraphy, sonography)
    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]
    C0412620
    UMLS CUI [5]
    C0860843
    UMLS CUI [6]
    C0041618
    Inflammatory bowel diseases
    Description

    Inflammatory bowel diseases

    Alias
    UMLS CUI-1
    C0021390
    Inflammatory bowel diseases - Diagnosis
    Description

    Please tick appropriate diagnosis

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0021390
    UMLS CUI [1,2]
    C0011900
    Inflammatory bowel diseases - Specify other diagnosis
    Description

    Inflammatory bowel diseases - Specify other diagnosis

    Data type

    text

    Alias
    UMLS CUI [1]
    C0021390
    UMLS CUI [2,1]
    C0011900
    UMLS CUI [2,2]
    C0205394
    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
    Inflammatory bowel diseases - Signs and symptoms (supporting the final diagnosis)
    Description

    Inflammatory bowel diseases - Signs and symptoms (supporting the final diagnosis)

    Alias
    UMLS CUI-1
    C0021390
    UMLS CUI-2
    C0037088
    UMLS CUI-3
    C1546485
    Inflammatory bowel diseases - Signs and symptoms
    Description

    (supporting the final diagnosis)

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0021390
    UMLS CUI [2]
    C0037088
    Inflammatory bowel diseases - Signs and symptoms present
    Description

    Inflammatory bowel diseases - Signs and symptoms present

    Data type

    text

    Alias
    UMLS CUI [1]
    C0021390
    UMLS CUI [2]
    C0037088
    UMLS CUI [3]
    C0150312
    Inflammatory bowel diseases - Signs and symptoms Start Date
    Description

    Inflammatory bowel diseases - Signs and symptoms Start Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0021390
    UMLS CUI [2]
    C0037088
    UMLS CUI [3]
    C0808070
    Inflammatory bowel diseases - Signs and symptoms End date
    Description

    Inflammatory bowel diseases - Signs and symptoms End date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0021390
    UMLS CUI [2]
    C0037088
    UMLS CUI [3]
    C0806020
    Inflammatory bowel diseases - Signs and symptoms continuing at the end of study
    Description

    Inflammatory bowel diseases - Signs and symptoms continuing at the end of study

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0021390
    UMLS CUI [2]
    C0037088
    UMLS CUI [3,1]
    C0549178
    UMLS CUI [3,2]
    C0444496
    Inflammatory bowel diseases - Other Signs and symptoms
    Description

    Inflammatory bowel diseases - Other Signs and symptoms

    Alias
    UMLS CUI-1
    C0021390
    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
    Inflammatory bowel diseases - Other Signs and symptoms
    Description

    Inflammatory bowel diseases - Other Signs and symptoms

    Alias
    UMLS CUI-1
    C0021390
    UMLS CUI-2
    C0037088
    UMLS CUI-3
    C0205394
    Inflammatory bowel diseases - Other Signs and symptoms
    Description

    Inflammatory bowel diseases - Other Signs and symptoms

    Data type

    text

    Alias
    UMLS CUI [1]
    C0021390
    UMLS CUI [2,1]
    C0037088
    UMLS CUI [2,2]
    C0205394
    Inflammatory bowel diseases - Other Signs and symptoms Start Date
    Description

    Inflammatory bowel diseases - Other Signs and symptoms Start Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0021390
    UMLS CUI [2,1]
    C0037088
    UMLS CUI [2,2]
    C0205394
    UMLS CUI [3]
    C0808070
    Inflammatory bowel diseases - Other Signs and symptoms End Date
    Description

    Inflammatory bowel diseases - Other Signs and symptoms End Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0021390
    UMLS CUI [2,1]
    C0037088
    UMLS CUI [2,2]
    C0205394
    UMLS CUI [3]
    C0806020
    Inflammatory bowel diseases - Other signs and symptoms continuing at the end of study
    Description

    Inflammatory bowel diseases - Other signs and symptoms continuing at the end of study

    Data type

    text

    Alias
    UMLS CUI [1]
    C0021390
    UMLS CUI [2,1]
    C0037088
    UMLS CUI [2,2]
    C0205394
    UMLS CUI [3,1]
    C0549178
    UMLS CUI [3,2]
    C0444496
    Inflammatory bowel diseases - Diagnostic Test Results
    Description

    Inflammatory bowel diseases - Diagnostic Test Results

    Alias
    UMLS CUI-1
    C0021390
    UMLS CUI-2
    C0456984
    Inflammatory bowel diseases - Test
    Description

    Inflammatory bowel diseases - Test

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0021390
    UMLS CUI [2]
    C2826273
    Inflammatory bowel diseases - Test done
    Description

    Inflammatory bowel diseases - Test done

    Data type

    text

    Alias
    UMLS CUI [1]
    C0021390
    UMLS CUI [2,1]
    C0022885
    UMLS CUI [2,2]
    C1272695
    Inflammatory bowel diseases - Test date
    Description

    Inflammatory bowel diseases - Test date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0021390
    UMLS CUI [2]
    C2826247
    Inflammatory bowel diseases - Test Result
    Description

    Inflammatory bowel diseases - Test Result

    Data type

    float

    Alias
    UMLS CUI [1]
    C0021390
    UMLS CUI [2]
    C0587081
    Inflammatory bowel diseases - Test Units
    Description

    Inflammatory bowel diseases - Test Units

    Data type

    text

    Alias
    UMLS CUI [1]
    C0021390
    UMLS CUI [2]
    C1519795
    Inflammatory bowel diseases - Low Norm
    Description

    Inflammatory bowel diseases - Low Norm

    Data type

    float

    Alias
    UMLS CUI [1]
    C0021390
    UMLS CUI [2,1]
    C0086715
    UMLS CUI [2,2]
    C0205251
    Inflammatory bowel diseases - High Norm
    Description

    Inflammatory bowel diseases - High Norm

    Data type

    float

    Alias
    UMLS CUI [1]
    C0021390
    UMLS CUI [2,1]
    C0086715
    UMLS CUI [2,2]
    C0205250
    Inflammatory bowel diseases - Other Diagnostic Test Results
    Description

    Inflammatory bowel diseases - Other Diagnostic Test Results

    Alias
    UMLS CUI-1
    C0021390
    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]
    C04569840
    UMLS CUI [1,2]
    C0430022
    UMLS CUI [1,3]
    C0205394
    Inflammatory bowel diseases - Other Diagnostic Test Results
    Description

    Inflammatory bowel diseases - Other Diagnostic Test Results

    Alias
    UMLS CUI-1
    C0021390
    UMLS CUI-2
    C0456984
    UMLS CUI-3
    C0430022
    UMLS CUI-4
    C0205394
    Inflammatory bowel diseases - Test
    Description

    Inflammatory bowel diseases - Test

    Data type

    text

    Alias
    UMLS CUI [1]
    C0021390
    UMLS CUI [2]
    C2826273
    Inflammatory bowel diseases - Test date
    Description

    Inflammatory bowel diseases - Test date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0021390
    UMLS CUI [2]
    C2826247
    Inflammatory bowel diseases - Test Result
    Description

    Inflammatory bowel diseases - Test Result

    Data type

    float

    Alias
    UMLS CUI [1]
    C0021390
    UMLS CUI [2]
    C0587081
    Inflammatory bowel diseases - Test Units
    Description

    Inflammatory bowel diseases - Test Units

    Data type

    text

    Alias
    UMLS CUI [1]
    C0021390
    UMLS CUI [2]
    C1519795
    Inflammatory bowel diseases - Low Norm
    Description

    Inflammatory bowel diseases - Low Norm

    Data type

    float

    Alias
    UMLS CUI [1]
    C0021390
    UMLS CUI [2,1]
    C0086715
    UMLS CUI [2,2]
    C0205251
    Inflammatory bowel diseases - High Norm
    Description

    Inflammatory bowel diseases - High Norm

    Data type

    float

    Alias
    UMLS CUI [1]
    C0021390
    UMLS CUI [2,1]
    C0086715
    UMLS CUI [2,2]
    C0205250
    Inflammatory bowel diseases - Other diagnostic Procedure
    Description

    Inflammatory bowel diseases - Other diagnostic Procedure

    Alias
    UMLS CUI-1
    C0021390
    UMLS CUI-2
    C0430022
    UMLS CUI-3
    C0205394
    Describe any other diagnostic procedure supporting the diagnosis (Abdominal X-ray, Upper Gastrointestinal Small Bowel Follow Through (UGI-SBFT), Barium enema, Endoscopy / colonoscopy, Biopsy, Others)
    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]
    C0034573
    UMLS CUI [4]
    C0203063
    UMLS CUI [5]
    C0203075
    UMLS CUI [6,1]
    C0014245
    UMLS CUI [6,2]
    C0009378
    UMLS CUI [7]
    C0005558
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    Similar models

    IMD Report - Autoimmune thyroid diseases; Addisons's disease; Inflammatory bowel diseases (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
    Autoimmune thyroid diseases
    C0178468 (UMLS CUI-1)
    Item
    Autoimmune thyroid diseases Diagnosis
    integer
    C0178468 (UMLS CUI [1])
    C0011900 (UMLS CUI [2])
    Neurological Event Diagnosis
    Code List
    Autoimmune thyroid diseases Diagnosis
    CL Item
    Grave-Basedow disease (1)
    CL Item
    Hashimoto thyroiditis (2)
    CL Item
    Autoimmune thyroiditis (3)
    CL Item
    Other, specify (4)
    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
    Autoimmune thyroid diseases - Signs and Symptoms
    C0178468 (UMLS CUI-1)
    C0037088 (UMLS CUI-2)
    Item
    Autoimmune thyroid diseases - Signs and Symptoms
    integer
    C0178468 (UMLS CUI [1])
    C0037088 (UMLS CUI [2])
    Signs and Symptoms
    Code List
    Autoimmune thyroid diseases - Signs and Symptoms
    CL Item
    Thyroid enlargement (1)
    CL Item
    Thyroid nodules (2)
    CL Item
    Fatigue (3)
    CL Item
    Weight loss (4)
    CL Item
    Heat intolerance (5)
    CL Item
    Cold intolerance (6)
    CL Item
    Tachycardia, Palpitation (7)
    CL Item
    Bradycardia (8)
    CL Item
    Nervousness (9)
    CL Item
    Tremor (10)
    CL Item
    Depression (11)
    CL Item
    Hyperactive tendon reflex (12)
    CL Item
    Peripheral neuropathy (13)
    CL Item
    Skeletal weakness (14)
    CL Item
    Skin warm, moist, fine (15)
    CL Item
    Sweating (16)
    CL Item
    Dry skin (17)
    CL Item
    Fine hair, alopecia (18)
    CL Item
    Onycholysis (19)
    CL Item
    Pretibial myxedema (20)
    CL Item
    Polyuria, polydipsia (21)
    CL Item
    Constipation (22)
    CL Item
    Ophthalmopathy, specify (23)
    CL Item
    Periorbital oedema (24)
    CL Item
    Puffy face (25)
    CL Item
    Peripheral oedema (26)
    CL Item
    Blood pressure, specify (27)
    CL Item
    Dermopathy, specify (28)
    Autoimmune thyroid diseases - Specify ophthalmopathy
    Item
    Autoimmune thyroid diseases - Specify ophthalmopathy
    text
    C0178468 (UMLS CUI [1])
    C0015397 (UMLS CUI [2])
    Autoimmune thyroid diseases - Specify blood pressure
    Item
    Autoimmune thyroid diseases - Specify blood pressure
    text
    C0178468 (UMLS CUI [1])
    C0005823 (UMLS CUI [2])
    Autoimmune thyroid diseases - Specify dermopathy
    Item
    Autoimmune thyroid diseases - Specify dermopathy
    text
    C0178468 (UMLS CUI [1])
    C0037274 (UMLS CUI [2])
    Item
    Autoimmune thyroid diseases - Signs and Symptoms present
    text
    C0178468 (UMLS CUI [1])
    C0037088 (UMLS CUI [2,1])
    C0150312 (UMLS CUI [2,2])
    Signs and symptoms present
    Code List
    Autoimmune thyroid diseases - Signs and Symptoms present
    CL Item
    Yes (Y)
    CL Item
    No (N)
    CL Item
    Unknown (U)
    CL Item
    Not Applicable (NA)
    Autoimmune thyroid diseases - Signs and Symptoms start date
    Item
    Autoimmune thyroid diseases - Signs and Symptoms start date
    date
    C0178468 (UMLS CUI [1])
    C0037088 (UMLS CUI [2,1])
    C0808070 (UMLS CUI [2,2])
    Autoimmune thyroid diseases - Signs and Symptoms end date
    Item
    Autoimmune thyroid diseases - Signs and Symptoms end date
    date
    C0178468 (UMLS CUI [1])
    C0037088 (UMLS CUI [2,1])
    C0806020 (UMLS CUI [2,2])
    Item
    Autoimmune thyroid diseases - Signs and Symptoms continuing at end of study
    integer
    C0178468 (UMLS CUI [1])
    C0037088 (UMLS CUI [2])
    C0549178 (UMLS CUI [3,1])
    C0444496 (UMLS CUI [3,2])
    Signs and symptoms continuing at end of study
    Code List
    Autoimmune thyroid diseases - Signs and Symptoms continuing at end of study
    CL Item
    Continuing at end of study (1)
    Item Group
    Autoimmune thyroid diseases - Other signs and symptoms
    C0178468 (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
    Autoimmune thyroid diseases - Other signs and symptoms
    C0178468 (UMLS CUI-1)
    C0037088 (UMLS CUI-2)
    C0205394 (UMLS CUI-3)
    Autoimmune thyroid diseases - Other signs and symptoms
    Item
    Autoimmune thyroid diseases - Other signs and symptoms
    text
    C0178468 (UMLS CUI [1])
    C0037088 (UMLS CUI [2,1])
    C0205394 (UMLS CUI [2,2])
    Autoimmune thyroid diseases - Other signs and symptoms start date
    Item
    Autoimmune thyroid diseases - Other signs and symptoms start date
    date
    C0178468 (UMLS CUI [1])
    C0037088 (UMLS CUI [2,1])
    C0205394 (UMLS CUI [2,2])
    C0808070 (UMLS CUI [3])
    Autoimmune thyroid diseases - Other signs and symptoms end date
    Item
    Autoimmune thyroid diseases - Other signs and symptoms end date
    date
    C0178468 (UMLS CUI [1])
    C0037088 (UMLS CUI [2,1])
    C0205394 (UMLS CUI [2,2])
    C0806020 (UMLS CUI [3])
    Item
    Autoimmune thyroid diseases - Other signs and symptoms continuing at end of study
    integer
    C0178468 (UMLS CUI [1])
    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
    Autoimmune thyroid diseases - Other signs and symptoms continuing at end of study
    CL Item
    Continuing at end of study (1)
    Item Group
    Autoimmune thyroid diseases - Diagnostic Test Results
    C0178468 (UMLS CUI-1)
    C0456984 (UMLS CUI-2)
    C0430022 (UMLS CUI-3)
    Item
    Autoimmune thyroid diseases - Test
    integer
    C0178468 (UMLS CUI [1])
    C2826273 (UMLS CUI [2])
    Test
    Code List
    Autoimmune thyroid diseases - 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
    Thyroxin Total T4 (11)
    CL Item
    Thyroxin Free T4 (12)
    CL Item
    TSH (13)
    CL Item
    Anti-thyroglobulin autoantibodies (14)
    CL Item
    Anti-thyroid peroxidase autoantibodies (15)
    CL Item
    Anti-TSH-Receptor autoantibodies (16)
    Item
    Autoimmune thyroid diseases - Test done
    text
    C0178468 (UMLS CUI [1])
    C0022885 (UMLS CUI [2,1])
    C1272695 (UMLS CUI [2,2])
    Test done
    Code List
    Autoimmune thyroid diseases - Test done
    CL Item
    Yes (Y)
    CL Item
    No (N)
    CL Item
    Unknown (U)
    CL Item
    Not Applicable (NA)
    Autoimmune thyroid diseases - Test date
    Item
    Autoimmune thyroid diseases - Test date
    date
    C0178468 (UMLS CUI [1])
    C2826247 (UMLS CUI [2])
    Autoimmune thyroid diseases - Test Result
    Item
    Autoimmune thyroid diseases - Test Result
    float
    C0178468 (UMLS CUI [1])
    C0587081 (UMLS CUI [2])
    Autoimmune thyroid diseases - Test Units
    Item
    Autoimmune thyroid diseases - Test Units
    text
    C0178468 (UMLS CUI [1])
    C1519795 (UMLS CUI [2])
    Autoimmune thyroid diseases - Low Norm
    Item
    Autoimmune thyroid diseases - Low Norm
    float
    C0178468 (UMLS CUI [1])
    C0086715 (UMLS CUI [2,1])
    C0205251 (UMLS CUI [2,2])
    Autoimmune thyroid diseases - High Norm
    Item
    Autoimmune thyroid diseases - High Norm
    float
    C0178468 (UMLS CUI [1])
    C0086715 (UMLS CUI [2,1])
    C0205250 (UMLS CUI [2,2])
    Item Group
    Autoimmune thyroid diseases - Other Diagnostic Test Results
    C0178468 (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
    Autoimmune thyroid diseases - Other Diagnostic Test Results
    C0178468 (UMLS CUI-1)
    C0456984 (UMLS CUI-2)
    C0430022 (UMLS CUI-3)
    C0205394 (UMLS CUI-4)
    Autoimmune thyroid diseases - Test
    Item
    Autoimmune thyroid diseases - Test
    text
    C0178468 (UMLS CUI [1])
    C2826273 (UMLS CUI [2])
    Autoimmune thyroid diseases - Test date
    Item
    Autoimmune thyroid diseases - Test date
    date
    C0178468 (UMLS CUI [1])
    C2826247 (UMLS CUI [2])
    Autoimmune thyroid diseases - Test Result
    Item
    Autoimmune thyroid diseases - Test Result
    float
    C0178468 (UMLS CUI [1])
    C0587081 (UMLS CUI [2])
    Autoimmune thyroid diseases - Test Units
    Item
    Autoimmune thyroid diseases - Test Units
    text
    C0178468 (UMLS CUI [1])
    C1519795 (UMLS CUI [2])
    Autoimmune thyroid diseases - Low Norm
    Item
    Autoimmune thyroid diseases - Low Norm
    float
    C0178468 (UMLS CUI [1])
    C0086715 (UMLS CUI [2,1])
    C0205251 (UMLS CUI [2,2])
    Autoimmune thyroid diseases - High Norm
    Item
    Autoimmune thyroid diseases - High Norm
    float
    C0178468 (UMLS CUI [1])
    C0086715 (UMLS CUI [2,1])
    C0205250 (UMLS CUI [2,2])
    Item Group
    Autoimmune thyroid diseases - Other diagnostic Procedure
    C0178468 (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 (Thyroid scintigraphy, sonography)
    text
    C0430022 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C0011900 (UMLS CUI [2])
    C0860843 (UMLS CUI [3])
    C0041618 (UMLS CUI [4])
    Item Group
    Addison's disease
    C0001403 (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
    Addison's disease - Signs and symptoms (supporting the final diagnosis)
    C0001403 (UMLS CUI-1)
    C0037088 (UMLS CUI-2)
    C1546485 (UMLS CUI-3)
    Item
    Addison's disease - Signs and symptoms
    integer
    C0001403 (UMLS CUI [1])
    C0037088 (UMLS CUI [2])
    Myasthenia Gravis - Signs and symptoms
    Code List
    Addison's disease - Signs and symptoms
    CL Item
    Skin hyperpigmentation (1)
    CL Item
    Mucous membranes hyperpigmentation (2)
    CL Item
    Vitiligo (3)
    CL Item
    Hair loss (4)
    CL Item
    Progressive weakness (5)
    CL Item
    Fatigue (6)
    CL Item
    Poor appetite (7)
    CL Item
    Weight loss (8)
    CL Item
    Nausea (9)
    CL Item
    Vomiting (10)
    CL Item
    Diarrhea (11)
    CL Item
    Hypotension (12)
    CL Item
    Orthostasis (13)
    CL Item
    Dehydratation (14)
    Item
    Addison's disease - Signs and symptoms present
    text
    C0001403 (UMLS CUI [1])
    C0037088 (UMLS CUI [2])
    C0150312 (UMLS CUI [3])
    Myasthenia Gravis - Signs and symptoms present
    Code List
    Addison's disease - Signs and symptoms present
    CL Item
    Yes (Y)
    CL Item
    No (N)
    CL Item
    Unknown (U)
    CL Item
    Not Applicable (NA)
    Addison's disease - Signs and symptoms Start Date
    Item
    Addison's disease - Signs and symptoms Start Date
    date
    C0001403 (UMLS CUI [1])
    C0037088 (UMLS CUI [2])
    C0808070 (UMLS CUI [3])
    Addison's disease - Signs and symptoms End date
    Item
    Addison's disease - Signs and symptoms End date
    date
    C0001403 (UMLS CUI [1])
    C0037088 (UMLS CUI [2])
    C0806020 (UMLS CUI [3])
    Item
    Addison's disease - Signs and symptoms continuing at the end of study
    integer
    C0001403 (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
    Addison's disease - Signs and symptoms continuing at the end of study
    CL Item
    Continuing at end of study (1)
    Item Group
    Addison's disease - Other Signs and symptoms
    C0001403 (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
    Addison's disease - Other Signs and symptoms
    C0001403 (UMLS CUI-1)
    C0037088 (UMLS CUI-2)
    C0205394 (UMLS CUI-3)
    Addison's disease - Other Signs and symptoms
    Item
    Addison's disease - Other Signs and symptoms
    text
    C0001403 (UMLS CUI [1])
    C0037088 (UMLS CUI [2,1])
    C0205394 (UMLS CUI [2,2])
    Addison's disease - Other Signs and symptoms Start Date
    Item
    Addison's disease - Other Signs and symptoms Start Date
    date
    C0001403 (UMLS CUI [1])
    C0037088 (UMLS CUI [2,1])
    C0205394 (UMLS CUI [2,2])
    C0808070 (UMLS CUI [3])
    Addison's disease - Other Signs and symptoms End Date
    Item
    Addison's disease - Other Signs and symptoms End Date
    date
    C0001403 (UMLS CUI [1])
    C0037088 (UMLS CUI [2,1])
    C0205394 (UMLS CUI [2,2])
    C0806020 (UMLS CUI [3])
    Item
    Addison's disease - Other signs and symptoms continuing at the end of study
    text
    C0001403 (UMLS CUI [1])
    C0037088 (UMLS CUI [2,1])
    C0205394 (UMLS CUI [2,2])
    C0549178 (UMLS CUI [3,1])
    C0444496 (UMLS CUI [3,2])
    Addison's disease - Other signs and symptoms continuing at the end of study
    Code List
    Addison's disease - Other signs and symptoms continuing at the end of study
    CL Item
    Continuing at end of study (1)
    Item Group
    Addison's disease - Diagnostic Test Results
    C0001403 (UMLS CUI-1)
    C0085655 (UMLS CUI-2)
    C0456984 (UMLS CUI-3)
    Item
    Addison's disease - Test
    integer
    C0001403 (UMLS CUI [1])
    C2826273 (UMLS CUI [2])
    Test
    Code List
    Addison's disease - 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
    Serum cortisol (11)
    CL Item
    ACTH stimulation test (12)
    CL Item
    Serum sodium (13)
    CL Item
    Serum chloride (14)
    CL Item
    Serum calcium (15)
    CL Item
    Serum acidosis (16)
    CL Item
    Serum urea nitrogen (17)
    CL Item
    Serum creatinine (18)
    CL Item
    Serum glycemia (19)
    CL Item
    Serum prolactin (20)
    CL Item
    Thyroxin Total T4 (21)
    CL Item
    Thyroxin Free T4 (22)
    CL Item
    TSH (23)
    CL Item
    Anti-adrenal autoantibodies (24)
    CL Item
    Anti-thyroglobulin autoantibodies (25)
    CL Item
    Anti-thyroid peroxidase autoantibodies (26)
    CL Item
    Anti-TSH-Receptor autoantibodies (27)
    Item
    Addison's disease - Test done
    text
    C0001403 (UMLS CUI [1])
    C0022885 (UMLS CUI [2,1])
    C1272695 (UMLS CUI [2,2])
    Test done
    Code List
    Addison's disease - Test done
    CL Item
    Yes  (Y)
    CL Item
    No  (N)
    CL Item
    Unknown  (U)
    CL Item
    Not Applicable (NA)
    Addison's disease - Test date
    Item
    Addison's disease - Test date
    date
    C0001403 (UMLS CUI [1])
    C2826247 (UMLS CUI [2])
    Addison's disease - Test Result
    Item
    Addison's disease - Test Result
    float
    C0001403 (UMLS CUI [1])
    C0587081 (UMLS CUI [2])
    Addison's disease - Test Units
    Item
    Addison's disease - Test Units
    text
    C0001403 (UMLS CUI [1])
    C1519795 (UMLS CUI [2])
    Addison's disease - Low Norm
    Item
    Addison's disease - Low Norm
    float
    C0001403 (UMLS CUI [1])
    C0086715 (UMLS CUI [2,1])
    C0205251 (UMLS CUI [2,2])
    Addison's disease - High Norm
    Item
    Addison's disease - High Norm
    float
    C0001403 (UMLS CUI [1])
    C0086715 (UMLS CUI [2,1])
    C0205250 (UMLS CUI [2,2])
    Item Group
    Addison's disease - Other Diagnostic Test Results
    C0001403 (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
    Addison's disease - Other Diagnostic Test Results
    C0001403 (UMLS CUI-1)
    C0456984 (UMLS CUI-2)
    C0430022 (UMLS CUI-3)
    C0205394 (UMLS CUI-4)
    Addison's disease - Test
    Item
    Addison's disease - Test
    text
    C0001403 (UMLS CUI [1])
    C2826273 (UMLS CUI [2])
    Addison's disease - Test date
    Item
    Addison's disease - Test date
    date
    C0001403 (UMLS CUI [1])
    C2826247 (UMLS CUI [2])
    Addison's disease - Test Result
    Item
    Addison's disease - Test Result
    float
    C0001403 (UMLS CUI [1])
    C0587081 (UMLS CUI [2])
    Addison's disease - Test Units
    Item
    Addison's disease - Test Units
    text
    C0001403 (UMLS CUI [1])
    C1519795 (UMLS CUI [2])
    Addison's disease - Low Norm
    Item
    Addison's disease - Low Norm
    float
    C0001403 (UMLS CUI [1])
    C0086715 (UMLS CUI [2,1])
    C0205251 (UMLS CUI [2,2])
    Addison's disease - High Norm
    Item
    Addison's disease - High Norm
    float
    C0001403 (UMLS CUI [1])
    C0086715 (UMLS CUI [2,1])
    C0205250 (UMLS CUI [2,2])
    Item Group
    Addison's disease - Other diagnostic Procedure
    C0001403 (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, Abdominal CT scan, Thyroid scintigraphy, sonography)
    text
    C0430022 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C0011900 (UMLS CUI [2])
    C0039985 (UMLS CUI [3])
    C0412620 (UMLS CUI [4])
    C0860843 (UMLS CUI [5])
    C0041618 (UMLS CUI [6])
    Item Group
    Inflammatory bowel diseases
    C0021390 (UMLS CUI-1)
    Item
    Inflammatory bowel diseases - Diagnosis
    integer
    C0021390 (UMLS CUI [1,1])
    C0011900 (UMLS CUI [1,2])
    Diabetes mellitus type I - Diagnosis
    Code List
    Inflammatory bowel diseases - Diagnosis
    CL Item
    Crohn’s disease (1)
    CL Item
    Ulcerative colitis (2)
    CL Item
    Ulcerative proctitis (3)
    CL Item
    Other, specify (4)
    Inflammatory bowel diseases - Specify other diagnosis
    Item
    Inflammatory bowel diseases - Specify other diagnosis
    text
    C0021390 (UMLS CUI [1])
    C0011900 (UMLS CUI [2,1])
    C0205394 (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.
    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
    Inflammatory bowel diseases - Signs and symptoms (supporting the final diagnosis)
    C0021390 (UMLS CUI-1)
    C0037088 (UMLS CUI-2)
    C1546485 (UMLS CUI-3)
    Item
    Inflammatory bowel diseases - Signs and symptoms
    integer
    C0021390 (UMLS CUI [1])
    C0037088 (UMLS CUI [2])
    Uveitis - Signs and symptoms
    Code List
    Inflammatory bowel diseases - Signs and symptoms
    CL Item
    Diarrhea (1)
    CL Item
    Bloody diarrhea (2)
    CL Item
    Abdominal pain (3)
    CL Item
    Intestinal obstruction (4)
    CL Item
    Right lower quadrant mass (5)
    CL Item
    Perianal disease (6)
    CL Item
    Fistulae (7)
    CL Item
    Weight loss (8)
    CL Item
    Fever (9)
    CL Item
    Anorexia (10)
    CL Item
    Fatigue (11)
    CL Item
    Short stature (12)
    CL Item
    Delayed puberty (13)
    CL Item
    Erythema nodosum (14)
    CL Item
    Pyoderma gangrenosum (15)
    CL Item
    Ankylosing spondilitis (16)
    CL Item
    Sacroiliitis (17)
    CL Item
    Peripheral arthritis asymmetric (18)
    CL Item
    Peripheral arthritis symmetric (19)
    CL Item
    Ocular involvement (e.g. uveitis) (20)
    CL Item
    Primary sclerosing cholangitis (21)
    Item
    Inflammatory bowel diseases - Signs and symptoms present
    text
    C0021390 (UMLS CUI [1])
    C0037088 (UMLS CUI [2])
    C0150312 (UMLS CUI [3])
    Myasthenia Gravis - Signs and symptoms present
    Code List
    Inflammatory bowel diseases - Signs and symptoms present
    CL Item
    Yes  (Y)
    CL Item
    No  (N)
    CL Item
    Unknown  (U)
    CL Item
    Not Applicable (NA)
    Inflammatory bowel diseases - Signs and symptoms Start Date
    Item
    Inflammatory bowel diseases - Signs and symptoms Start Date
    date
    C0021390 (UMLS CUI [1])
    C0037088 (UMLS CUI [2])
    C0808070 (UMLS CUI [3])
    Inflammatory bowel diseases - Signs and symptoms End date
    Item
    Inflammatory bowel diseases - Signs and symptoms End date
    date
    C0021390 (UMLS CUI [1])
    C0037088 (UMLS CUI [2])
    C0806020 (UMLS CUI [3])
    Item
    Inflammatory bowel diseases - Signs and symptoms continuing at the end of study
    integer
    C0021390 (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
    Inflammatory bowel diseases - Signs and symptoms continuing at the end of study
    CL Item
    Continuing at end of study (1)
    Item Group
    Inflammatory bowel diseases - Other Signs and symptoms
    C0021390 (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
    Inflammatory bowel diseases - Other Signs and symptoms
    C0021390 (UMLS CUI-1)
    C0037088 (UMLS CUI-2)
    C0205394 (UMLS CUI-3)
    Inflammatory bowel diseases - Other Signs and symptoms
    Item
    Inflammatory bowel diseases - Other Signs and symptoms
    text
    C0021390 (UMLS CUI [1])
    C0037088 (UMLS CUI [2,1])
    C0205394 (UMLS CUI [2,2])
    Inflammatory bowel diseases - Other Signs and symptoms Start Date
    Item
    Inflammatory bowel diseases - Other Signs and symptoms Start Date
    date
    C0021390 (UMLS CUI [1])
    C0037088 (UMLS CUI [2,1])
    C0205394 (UMLS CUI [2,2])
    C0808070 (UMLS CUI [3])
    Inflammatory bowel diseases - Other Signs and symptoms End Date
    Item
    Inflammatory bowel diseases - Other Signs and symptoms End Date
    date
    C0021390 (UMLS CUI [1])
    C0037088 (UMLS CUI [2,1])
    C0205394 (UMLS CUI [2,2])
    C0806020 (UMLS CUI [3])
    Item
    Inflammatory bowel diseases - Other signs and symptoms continuing at the end of study
    text
    C0021390 (UMLS CUI [1])
    C0037088 (UMLS CUI [2,1])
    C0205394 (UMLS CUI [2,2])
    C0549178 (UMLS CUI [3,1])
    C0444496 (UMLS CUI [3,2])
    Inflammatory bowel diseases - Other signs and symptoms continuing at the end of study
    Code List
    Inflammatory bowel diseases - Other signs and symptoms continuing at the end of study
    CL Item
    Continuing at end of study (1)
    Item Group
    Inflammatory bowel diseases - Diagnostic Test Results
    C0021390 (UMLS CUI-1)
    C0456984 (UMLS CUI-2)
    Item
    Inflammatory bowel diseases - Test
    integer
    C0021390 (UMLS CUI [1])
    C2826273 (UMLS CUI [2])
    Myasthenia Gravis - Test
    Code List
    Inflammatory bowel diseases - 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
    Serum iron (11)
    CL Item
    Serum albumin (12)
    CL Item
    Perinuclear-ANCA (13)
    CL Item
    Cytoplasmic-ANCA (14)
    CL Item
    Anti-myeloperoxidase autoantibodies (15)
    CL Item
    Anti-proteinase 3 autoantibodies (16)
    CL Item
    Anti-S. cerevisiae antibodies (ASCA) (17)
    CL Item
    Stool guiac (18)
    CL Item
    Stool leucocytes (19)
    CL Item
    Stool blood (20)
    Item
    Inflammatory bowel diseases - Test done
    text
    C0021390 (UMLS CUI [1])
    C0022885 (UMLS CUI [2,1])
    C1272695 (UMLS CUI [2,2])
    Myasthenia Gravis - Test done
    Code List
    Inflammatory bowel diseases - Test done
    CL Item
    Yes  (Y)
    CL Item
    No  (N)
    CL Item
    Unknown  (U)
    CL Item
    Not Applicable (NA)
    Inflammatory bowel diseases - Test date
    Item
    Inflammatory bowel diseases - Test date
    date
    C0021390 (UMLS CUI [1])
    C2826247 (UMLS CUI [2])
    Inflammatory bowel diseases - Test Result
    Item
    Inflammatory bowel diseases - Test Result
    float
    C0021390 (UMLS CUI [1])
    C0587081 (UMLS CUI [2])
    Inflammatory bowel diseases - Test Units
    Item
    Inflammatory bowel diseases - Test Units
    text
    C0021390 (UMLS CUI [1])
    C1519795 (UMLS CUI [2])
    Inflammatory bowel diseases - Low Norm
    Item
    Inflammatory bowel diseases - Low Norm
    float
    C0021390 (UMLS CUI [1])
    C0086715 (UMLS CUI [2,1])
    C0205251 (UMLS CUI [2,2])
    Inflammatory bowel diseases - High Norm
    Item
    Inflammatory bowel diseases - High Norm
    float
    C0021390 (UMLS CUI [1])
    C0086715 (UMLS CUI [2,1])
    C0205250 (UMLS CUI [2,2])
    Item Group
    Inflammatory bowel diseases - Other Diagnostic Test Results
    C0021390 (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
    C04569840 (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
    Inflammatory bowel diseases - Other Diagnostic Test Results
    C0021390 (UMLS CUI-1)
    C0456984 (UMLS CUI-2)
    C0430022 (UMLS CUI-3)
    C0205394 (UMLS CUI-4)
    Inflammatory bowel diseases - Test
    Item
    Inflammatory bowel diseases - Test
    text
    C0021390 (UMLS CUI [1])
    C2826273 (UMLS CUI [2])
    Inflammatory bowel diseases - Test date
    Item
    Inflammatory bowel diseases - Test date
    date
    C0021390 (UMLS CUI [1])
    C2826247 (UMLS CUI [2])
    Inflammatory bowel diseases - Test Result
    Item
    Inflammatory bowel diseases - Test Result
    float
    C0021390 (UMLS CUI [1])
    C0587081 (UMLS CUI [2])
    Inflammatory bowel diseases - Test Units
    Item
    Inflammatory bowel diseases - Test Units
    text
    C0021390 (UMLS CUI [1])
    C1519795 (UMLS CUI [2])
    Inflammatory bowel diseases - Low Norm
    Item
    Inflammatory bowel diseases - Low Norm
    float
    C0021390 (UMLS CUI [1])
    C0086715 (UMLS CUI [2,1])
    C0205251 (UMLS CUI [2,2])
    Inflammatory bowel diseases - High Norm
    Item
    Inflammatory bowel diseases - High Norm
    float
    C0021390 (UMLS CUI [1])
    C0086715 (UMLS CUI [2,1])
    C0205250 (UMLS CUI [2,2])
    Item Group
    Inflammatory bowel diseases - Other diagnostic Procedure
    C0021390 (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 (Abdominal X-ray, Upper Gastrointestinal Small Bowel Follow Through (UGI-SBFT), Barium enema, Endoscopy / colonoscopy, Biopsy, Others)
    text
    C0430022 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C0011900 (UMLS CUI [2])
    C0034573 (UMLS CUI [3])
    C0203063 (UMLS CUI [4])
    C0203075 (UMLS CUI [5])
    C0014245 (UMLS CUI [6,1])
    C0009378 (UMLS CUI [6,2])
    C0005558 (UMLS CUI [7])
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