0 Evaluaciones
ID

41537

Descripción

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

Palabras clave

Versiones (2)
  1. 7/10/20 7/10/20 -
  2. 3/11/20 3/11/20 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

3 de noviembre de 2020

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

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

    Inglés

    IMD Report - Coeliac Disease; Antiphospholipid Syndrome; Autoimmune Haemolytic Anaemia (Report Final and Annex Report 2 Final)

    1 formularios  
    Administrative
    Descripción

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    Centre Number
    Descripción

    Centre Number

    Tipo de datos

    text

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

    Patient Number

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2348585
    Coeliac disease
    Descripción

    Coeliac disease

    Alias
    UMLS CUI-1
    C0007570
    Please specify related adverse event: SAE Case No.
    Descripción

    In case of serious adverse event

    Tipo de datos

    integer

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

    In case of non-serious adverse event

    Tipo de datos

    integer

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

    Date of final diagnosis:

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C2316983
    UMLS CUI [1,2]
    C1546485
    Coeliac disease - Signs and Symptoms
    Descripción

    Coeliac disease - Signs and Symptoms

    Alias
    UMLS CUI-1
    C0007570
    UMLS CUI-3
    C0037088
    Coeliac disease - Signs and Symptoms
    Descripción

    Coeliac disease - Signs and Symptoms

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0007570
    UMLS CUI [2]
    C0037088
    Coeliac disease - Signs and Symptoms present
    Descripción

    Coeliac disease - Signs and Symptoms present

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0007570
    UMLS CUI [2,1]
    C0037088
    UMLS CUI [2,2]
    C0150312
    Coeliac disease - Signs and Symptoms start date
    Descripción

    Coeliac disease - Signs and Symptoms start date

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C0007570
    UMLS CUI [2,1]
    C0037088
    UMLS CUI [2,2]
    C0808070
    Coeliac disease - Signs and Symptoms end date
    Descripción

    Coeliac disease - Signs and Symptoms end date

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C0007570
    UMLS CUI [2,1]
    C0037088
    UMLS CUI [2,2]
    C0806020
    Coeliac disease - Signs and Symptoms continuing at end of study
    Descripción

    Coeliac disease - Signs and Symptoms continuing at end of study

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0007570
    UMLS CUI [2]
    C0037088
    UMLS CUI [3,1]
    C0549178
    UMLS CUI [3,2]
    C0444496
    Coeliac disease - Other signs and symptoms
    Descripción

    Coeliac disease - Other signs and symptoms

    Alias
    UMLS CUI-1
    C0007570
    UMLS CUI-2
    C0037088
    UMLS CUI-3
    C0205394
    If any other signs and symptoms, please tick the box and complete below
    Descripción

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

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0037088
    UMLS CUI [1,2]
    C0205394
    Coeliac disease - Other signs and symptoms
    Descripción

    Coeliac disease - Other signs and symptoms

    Alias
    UMLS CUI-1
    C0007570
    UMLS CUI-2
    C0037088
    UMLS CUI-3
    C0205394
    Coeliac disease - Other signs and symptoms
    Descripción

    Coeliac disease - Other signs and symptoms

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0007570
    UMLS CUI [2,1]
    C0037088
    UMLS CUI [2,2]
    C0205394
    Coeliac disease - Other signs and symptoms start date
    Descripción

    Coeliac disease - Other signs and symptoms start date

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C0007570
    UMLS CUI [2,1]
    C0037088
    UMLS CUI [2,2]
    C0205394
    UMLS CUI [3]
    C0808070
    Coeliac disease - Other signs and symptoms end date
    Descripción

    Coeliac disease - Other signs and symptoms end date

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C0007570
    UMLS CUI [2,1]
    C0037088
    UMLS CUI [2,2]
    C0205394
    UMLS CUI [3]
    C0806020
    Coeliac disease - Other signs and symptoms continuing at end of study
    Descripción

    Coeliac disease - Other signs and symptoms continuing at end of study

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0007570
    UMLS CUI [2,1]
    C0037088
    UMLS CUI [2,2]
    C0205394
    UMLS CUI [3,1]
    C0549178
    UMLS CUI [3,2]
    C0444496
    Coeliac disease - Diagnostic Test Results
    Descripción

    Coeliac disease - Diagnostic Test Results

    Alias
    UMLS CUI-1
    C0007570
    UMLS CUI-2
    C0456984
    UMLS CUI-3
    C0430022
    Coeliac disease - Test
    Descripción

    Coeliac disease - Test

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0007570
    UMLS CUI [2]
    C2826273
    Coeliac disease - Test done
    Descripción

    Coeliac disease - Test done

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0007570
    UMLS CUI [2,1]
    C0022885
    UMLS CUI [2,2]
    C1272695
    Coeliac disease - Test date
    Descripción

    Coeliac disease - Test date

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C0007570
    UMLS CUI [2]
    C2826247
    Coeliac disease - Test Result
    Descripción

    Coeliac disease - Test Result

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0007570
    UMLS CUI [2]
    C0587081
    Coeliac disease - Test Units
    Descripción

    Coeliac disease - Test Units

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0007570
    UMLS CUI [2]
    C1519795
    Coeliac disease - Low Norm
    Descripción

    Coeliac disease - Low Norm

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0007570
    UMLS CUI [2,1]
    C0086715
    UMLS CUI [2,2]
    C0205251
    Coeliac disease - High Norm
    Descripción

    Coeliac disease - High Norm

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0007570
    UMLS CUI [2,1]
    C0086715
    UMLS CUI [2,2]
    C0205250
    Coeliac disease - Other Diagnostic Test Results
    Descripción

    Coeliac disease - Other Diagnostic Test Results

    Alias
    UMLS CUI-1
    C0007570
    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
    Descripción

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

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0456984
    UMLS CUI [1,2]
    C0430022
    UMLS CUI [1,3]
    C0205394
    Coeliac disease - Other Diagnostic Test Results
    Descripción

    Coeliac disease - Other Diagnostic Test Results

    Alias
    UMLS CUI-1
    C0007570
    UMLS CUI-2
    C0456984
    UMLS CUI-3
    C0430022
    UMLS CUI-4
    C0205394
    Coeliac disease - Test
    Descripción

    Coeliac disease - Test

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0007570
    UMLS CUI [2]
    C2826273
    Coeliac disease - Test date
    Descripción

    Coeliac disease - Test date

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C0007570
    UMLS CUI [2]
    C2826247
    Coeliac disease - Test Result
    Descripción

    Coeliac disease - Test Result

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0007570
    UMLS CUI [2]
    C0587081
    Coeliac disease - Test Units
    Descripción

    Coeliac disease - Test Units

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0007570
    UMLS CUI [2]
    C1519795
    Coeliac disease - Low Norm
    Descripción

    Coeliac disease - Low Norm

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0007570
    UMLS CUI [2,1]
    C0086715
    UMLS CUI [2,2]
    C0205251
    Coeliac disease - High Norm
    Descripción

    Coeliac disease - High Norm

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0007570
    UMLS CUI [2,1]
    C0086715
    UMLS CUI [2,2]
    C0205250
    Coeliac disease - Other diagnostic Procedure
    Descripción

    Coeliac disease - Other diagnostic Procedure

    Alias
    UMLS CUI-1
    C0007570
    UMLS CUI-2
    C0430022
    UMLS CUI-3
    C0205394
    Describe any other diagnostic procedure supporting the diagnosis (X-Ray: Small bowel barium studies, Duodenal Endoscopy, Biopsy, Oral tolerance tests, HLA typing)
    Descripción

    Describe any other diagnostic procedure supporting the diagnosis

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0430022
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [2]
    C0011900
    UMLS CUI [3,1]
    C0043309
    UMLS CUI [3,2]
    C0021852
    UMLS CUI [3,3]
    C0004749
    UMLS CUI [4,1]
    C0014245
    UMLS CUI [4,2]
    C0013303
    UMLS CUI [5]
    C0005558
    UMLS CUI [6]
    C0029161
    UMLS CUI [7]
    C0242318
    Antiphospholipid Syndrome
    Descripción

    Antiphospholipid Syndrome

    Alias
    UMLS CUI-1
    C0085278
    Please specify related adverse event: SAE Case No.
    Descripción

    In case of serious adverse event

    Tipo de datos

    integer

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

    In case of non-serious adverse event

    Tipo de datos

    integer

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

    Date of final diagnosis:

    Tipo de datos

    date

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

    Antiphospholipid Syndrome - Signs and symptoms (supporting the final diagnosis)

    Alias
    UMLS CUI-1
    C0085278
    UMLS CUI-2
    C0037088
    UMLS CUI-3
    C1546485
    Antiphospholipid Syndrome - Signs and symptoms
    Descripción

    Antiphospholipid Syndrome - Signs and symptoms

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0085278
    UMLS CUI [2]
    C0037088
    Antiphospholipid Syndrome - Signs and symptoms present
    Descripción

    Antiphospholipid Syndrome - Signs and symptoms present

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0085278
    UMLS CUI [2]
    C0037088
    UMLS CUI [3]
    C0150312
    Antiphospholipid Syndrome - Signs and symptoms Start Date
    Descripción

    Antiphospholipid Syndrome - Signs and symptoms Start Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C0085278
    UMLS CUI [2]
    C0037088
    UMLS CUI [3]
    C0808070
    Antiphospholipid Syndrome - Signs and symptoms End date
    Descripción

    Antiphospholipid Syndrome - Signs and symptoms End date

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C0085278
    UMLS CUI [2]
    C0037088
    UMLS CUI [3]
    C0806020
    Antiphospholipid Syndrome - Signs and symptoms continuing at the end of study
    Descripción

    Antiphospholipid Syndrome - Signs and symptoms continuing at the end of study

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0085278
    UMLS CUI [2]
    C0037088
    UMLS CUI [3,1]
    C0549178
    UMLS CUI [3,2]
    C0444496
    Antiphospholipid Syndrome - Other Signs and symptoms
    Descripción

    Antiphospholipid Syndrome - Other Signs and symptoms

    Alias
    UMLS CUI-1
    C0085278
    UMLS CUI-2
    C0037088
    UMLS CUI-3
    C0205394
    If any other signs and symptoms, please tick the box and complete below
    Descripción

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

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0037088
    UMLS CUI [1,2]
    C0205394
    Antiphospholipid Syndrome - Other Signs and symptoms
    Descripción

    Antiphospholipid Syndrome - Other Signs and symptoms

    Alias
    UMLS CUI-1
    C0085278
    UMLS CUI-2
    C0037088
    UMLS CUI-3
    C0205394
    Antiphospholipid Syndrome - Other Signs and symptoms
    Descripción

    Antiphospholipid Syndrome - Other Signs and symptoms

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0085278
    UMLS CUI [2,1]
    C0037088
    UMLS CUI [2,2]
    C0205394
    Antiphospholipid Syndrome - Other Signs and symptoms Start Date
    Descripción

    Antiphospholipid Syndrome - Other Signs and symptoms Start Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C0085278
    UMLS CUI [2,1]
    C0037088
    UMLS CUI [2,2]
    C0205394
    UMLS CUI [3]
    C0808070
    Antiphospholipid Syndrome - Other Signs and symptoms End Date
    Descripción

    Antiphospholipid Syndrome - Other Signs and symptoms End Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C0085278
    UMLS CUI [2,1]
    C0037088
    UMLS CUI [2,2]
    C0205394
    UMLS CUI [3]
    C0806020
    Antiphospholipid Syndrome - Other signs and symptoms continuing at the end of study
    Descripción

    Antiphospholipid Syndrome - Other signs and symptoms continuing at the end of study

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0085278
    UMLS CUI [2,1]
    C0037088
    UMLS CUI [2,2]
    C0205394
    UMLS CUI [3,1]
    C0549178
    UMLS CUI [3,2]
    C0444496
    Antiphospholipid Syndrome - Diagnostic Test Results
    Descripción

    Antiphospholipid Syndrome - Diagnostic Test Results

    Alias
    UMLS CUI-1
    C0085278
    UMLS CUI-2
    C0085655
    UMLS CUI-3
    C0456984
    Antiphospholipid Syndrome - Test
    Descripción

    Antiphospholipid Syndrome - Test

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0085278
    UMLS CUI [2]
    C2826273
    Antiphospholipid Syndrome - Test done
    Descripción

    Antiphospholipid Syndrome - Test done

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0085278
    UMLS CUI [2,1]
    C0022885
    UMLS CUI [2,2]
    C1272695
    Antiphospholipid Syndrome - Test date
    Descripción

    Antiphospholipid Syndrome - Test date

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C0085278
    UMLS CUI [2]
    C2826247
    Antiphospholipid Syndrome - Test Result
    Descripción

    Antiphospholipid Syndrome - Test Result

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0085278
    UMLS CUI [2]
    C0587081
    Antiphospholipid Syndrome - Test Units
    Descripción

    Antiphospholipid Syndrome - Test Units

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0085278
    UMLS CUI [2]
    C1519795
    Antiphospholipid Syndrome - Low Norm
    Descripción

    Antiphospholipid Syndrome - Low Norm

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0085278
    UMLS CUI [2,1]
    C0086715
    UMLS CUI [2,2]
    C0205251
    Antiphospholipid Syndrome - High Norm
    Descripción

    Antiphospholipid Syndrome - High Norm

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0085278
    UMLS CUI [2,1]
    C0086715
    UMLS CUI [2,2]
    C0205250
    Antiphospholipid Syndrome - Other Diagnostic Test Results
    Descripción

    Antiphospholipid Syndrome - Other Diagnostic Test Results

    Alias
    UMLS CUI-1
    C0085278
    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
    Descripción

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

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0456984
    UMLS CUI [1,2]
    C0430022
    UMLS CUI [1,3]
    C0205394
    Antiphospholipid Syndrome - Other Diagnostic Test Results
    Descripción

    Antiphospholipid Syndrome - Other Diagnostic Test Results

    Alias
    UMLS CUI-1
    C0085278
    UMLS CUI-2
    C0456984
    UMLS CUI-3
    C0430022
    UMLS CUI-4
    C0205394
    Antiphospholipid Syndrome - Test
    Descripción

    Antiphospholipid Syndrome - Test

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0085278
    UMLS CUI [2]
    C2826273
    Antiphospholipid Syndrome - Test date
    Descripción

    Antiphospholipid Syndrome - Test date

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C0085278
    UMLS CUI [2]
    C2826247
    Antiphospholipid Syndrome - Test Result
    Descripción

    Antiphospholipid Syndrome - Test Result

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0085278
    UMLS CUI [2]
    C0587081
    Antiphospholipid Syndrome - Test Units
    Descripción

    Antiphospholipid Syndrome - Test Units

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0085278
    UMLS CUI [2]
    C1519795
    Antiphospholipid Syndrome - Low Norm
    Descripción

    Antiphospholipid Syndrome - Low Norm

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0085278
    UMLS CUI [2,1]
    C0086715
    UMLS CUI [2,2]
    C0205251
    Antiphospholipid Syndrome - High Norm
    Descripción

    Antiphospholipid Syndrome - High Norm

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0085278
    UMLS CUI [2,1]
    C0086715
    UMLS CUI [2,2]
    C0205250
    Antiphospholipid Syndrome - Other diagnostic Procedure
    Descripción

    Antiphospholipid Syndrome - Other diagnostic Procedure

    Alias
    UMLS CUI-1
    C0085278
    UMLS CUI-2
    C0430022
    UMLS CUI-3
    C0205394
    Describe any other diagnostic procedure supporting the diagnosis (Doppler ultrasound, Brain CT scan, Brain MRI, Chest CT scan, Abdomen CT scan, Cardiac echocardiography, Biopsy)
    Descripción

    Describe any other diagnostic procedure supporting the diagnosis

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0430022
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [2]
    C0011900
    UMLS CUI [3]
    C0162481
    UMLS CUI [4]
    C0412585
    UMLS CUI [5]
    C0412675
    UMLS CUI [6]
    C0202823
    UMLS CUI [7]
    C0412620
    UMLS CUI [8]
    C0013516
    UMLS CUI [9]
    C0005558
    Autoimmune Haemolytic Anaemia
    Descripción

    Autoimmune Haemolytic Anaemia

    Alias
    UMLS CUI-1
    C0002880
    Please specify related adverse event: SAE Case No.
    Descripción

    In case of serious adverse event

    Tipo de datos

    integer

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

    In case of non-serious adverse event

    Tipo de datos

    text

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

    Date of final diagnosis:

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C2316983
    UMLS CUI [1,2]
    C1546485
    Autoimmune Haemolytic Anaemia - Signs and symptoms (supporting the final diagnosis)
    Descripción

    Autoimmune Haemolytic Anaemia - Signs and symptoms (supporting the final diagnosis)

    Alias
    UMLS CUI-1
    C0002880
    UMLS CUI-2
    C0037088
    UMLS CUI-3
    C1546485
    Autoimmune Haemolytic Anaemia - Signs and symptoms
    Descripción

    Autoimmune Haemolytic Anaemia - Signs and symptoms

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0002880
    UMLS CUI [2]
    C0037088
    Autoimmune Haemolytic Anaemia - Specify Arthritis
    Descripción

    Autoimmune Haemolytic Anaemia - Specify Arthritis

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0002880
    UMLS CUI [2]
    C0003864
    Autoimmune Haemolytic Anaemia - Signs and symptoms present
    Descripción

    Autoimmune Haemolytic Anaemia - Signs and symptoms present

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0002880
    UMLS CUI [2]
    C0037088
    UMLS CUI [3]
    C0150312
    Autoimmune Haemolytic Anaemia - Signs and symptoms Start Date
    Descripción

    Autoimmune Haemolytic Anaemia - Signs and symptoms Start Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C0002880
    UMLS CUI [2]
    C0037088
    UMLS CUI [3]
    C0808070
    Autoimmune Haemolytic Anaemia - Signs and symptoms End date
    Descripción

    Autoimmune Haemolytic Anaemia - Signs and symptoms End date

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C0002880
    UMLS CUI [2]
    C0037088
    UMLS CUI [3]
    C0806020
    Autoimmune Haemolytic Anaemia - Signs and symptoms continuing at the end of study
    Descripción

    Autoimmune Haemolytic Anaemia - Signs and symptoms continuing at the end of study

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0002880
    UMLS CUI [2]
    C0037088
    UMLS CUI [3,1]
    C0549178
    UMLS CUI [3,2]
    C0444496
    Autoimmune Haemolytic Anaemia - Other Signs and symptoms
    Descripción

    Autoimmune Haemolytic Anaemia - Other Signs and symptoms

    Alias
    UMLS CUI-1
    C0002880
    UMLS CUI-2
    C0037088
    UMLS CUI-3
    C0205394
    If any other signs and symptoms, please tick the box and complete below
    Descripción

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

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0037088
    UMLS CUI [1,2]
    C0205394
    Autoimmune Haemolytic Anaemia - Other Signs and symptoms
    Descripción

    Autoimmune Haemolytic Anaemia - Other Signs and symptoms

    Alias
    UMLS CUI-1
    C0002880
    UMLS CUI-2
    C0037088
    UMLS CUI-3
    C0205394
    Autoimmune Haemolytic Anaemia - Other Signs and symptoms
    Descripción

    Autoimmune Haemolytic Anaemia - Other Signs and symptoms

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0002880
    UMLS CUI [2,1]
    C0037088
    UMLS CUI [2,2]
    C0205394
    Autoimmune Haemolytic Anaemia - Other Signs and symptoms Start Date
    Descripción

    Autoimmune Haemolytic Anaemia - Other Signs and symptoms Start Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C0002880
    UMLS CUI [2,1]
    C0037088
    UMLS CUI [2,2]
    C0205394
    UMLS CUI [3]
    C0808070
    Autoimmune Haemolytic Anaemia - Other Signs and symptoms End Date
    Descripción

    Autoimmune Haemolytic Anaemia - Other Signs and symptoms End Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C0002880
    UMLS CUI [2,1]
    C0037088
    UMLS CUI [2,2]
    C0205394
    UMLS CUI [3]
    C0806020
    Autoimmune Haemolytic Anaemia - Other signs and symptoms continuing at the end of study
    Descripción

    Autoimmune Haemolytic Anaemia - Other signs and symptoms continuing at the end of study

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0002880
    UMLS CUI [2,1]
    C0037088
    UMLS CUI [2,2]
    C0205394
    UMLS CUI [3,1]
    C0549178
    UMLS CUI [3,2]
    C0444496
    Autoimmune Haemolytic Anaemia - Diagnostic Test Results
    Descripción

    Autoimmune Haemolytic Anaemia - Diagnostic Test Results

    Alias
    UMLS CUI-1
    C0002880
    UMLS CUI-2
    C0456984
    Autoimmune Haemolytic Anaemia - Test
    Descripción

    Autoimmune Haemolytic Anaemia - Test

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0002880
    UMLS CUI [2]
    C2826273
    Autoimmune Haemolytic Anaemia - Test done
    Descripción

    Autoimmune Haemolytic Anaemia - Test done

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0002880
    UMLS CUI [2,1]
    C0022885
    UMLS CUI [2,2]
    C1272695
    Autoimmune Haemolytic Anaemia - Test date
    Descripción

    Autoimmune Haemolytic Anaemia - Test date

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C0002880
    UMLS CUI [2]
    C2826247
    Autoimmune Haemolytic Anaemia - Test Result
    Descripción

    Autoimmune Haemolytic Anaemia - Test Result

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0002880
    UMLS CUI [2]
    C0587081
    Autoimmune Haemolytic Anaemia - Test Units
    Descripción

    Autoimmune Haemolytic Anaemia - Test Units

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0002880
    UMLS CUI [2]
    C1519795
    Autoimmune Haemolytic Anaemia - Low Norm
    Descripción

    Autoimmune Haemolytic Anaemia - Low Norm

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0002880
    UMLS CUI [2,1]
    C0086715
    UMLS CUI [2,2]
    C0205251
    Autoimmune Haemolytic Anaemia - High Norm
    Descripción

    Autoimmune Haemolytic Anaemia - High Norm

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0002880
    UMLS CUI [2,1]
    C0086715
    UMLS CUI [2,2]
    C0205250
    Autoimmune Haemolytic Anaemia - Other Diagnostic Test Results
    Descripción

    Autoimmune Haemolytic Anaemia - Other Diagnostic Test Results

    Alias
    UMLS CUI-1
    C0002880
    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
    Descripción

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

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0456984
    UMLS CUI [1,2]
    C0430022
    UMLS CUI [1,3]
    C0205394
    Autoimmune Haemolytic Anaemia - Other Diagnostic Test Results
    Descripción

    Autoimmune Haemolytic Anaemia - Other Diagnostic Test Results

    Alias
    UMLS CUI-1
    C0002880
    UMLS CUI-2
    C0456984
    UMLS CUI-3
    C0430022
    UMLS CUI-4
    C0205394
    Autoimmune Haemolytic Anaemia - Test
    Descripción

    Autoimmune Haemolytic Anaemia - Test

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0002880
    UMLS CUI [2]
    C2826273
    Autoimmune Haemolytic Anaemia - Test date
    Descripción

    Autoimmune Haemolytic Anaemia - Test date

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C0002880
    UMLS CUI [2]
    C2826247
    Autoimmune Haemolytic Anaemia - Test Result
    Descripción

    Autoimmune Haemolytic Anaemia - Test Result

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0002880
    UMLS CUI [2]
    C0587081
    Autoimmune Haemolytic Anaemia - Test Units
    Descripción

    Autoimmune Haemolytic Anaemia - Test Units

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0002880
    UMLS CUI [2]
    C1519795
    Autoimmune Haemolytic Anaemia - Low Norm
    Descripción

    Autoimmune Haemolytic Anaemia - Low Norm

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0002880
    UMLS CUI [2,1]
    C0086715
    UMLS CUI [2,2]
    C0205251
    Autoimmune Haemolytic Anaemia - High Norm
    Descripción

    Autoimmune Haemolytic Anaemia - High Norm

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0002880
    UMLS CUI [2,1]
    C0086715
    UMLS CUI [2,2]
    C0205250
    Autoimmune Haemolytic Anaemia - Other diagnostic Procedure
    Descripción

    Autoimmune Haemolytic Anaemia - Other diagnostic Procedure

    Alias
    UMLS CUI-1
    C0002880
    UMLS CUI-2
    C0430022
    UMLS CUI-3
    C0205394
    Describe any other diagnostic procedure supporting the diagnosis (Marrow biopsy, Chest X-ray, Abdominal ultrasound, serology for CMV, EBV, Mycoplasma)
    Descripción

    Describe any other diagnostic procedure supporting the diagnosis

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0430022
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [2]
    C0011900
    UMLS CUI [3]
    C0005954
    UMLS CUI [4]
    C0039985
    UMLS CUI [5,1]
    C1456803
    UMLS CUI [5,2]
    C0000726
    UMLS CUI [6,1]
    C0010825
    UMLS CUI [6,2]
    C0036743
    UMLS CUI [7]
    C0014644
    UMLS CUI [8]
    C0026934
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    Similar models

    IMD Report - Coeliac Disease; Antiphospholipid Syndrome; Autoimmune Haemolytic Anaemia (Report Final and Annex Report 2 Final)

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    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
    Coeliac disease
    C0007570 (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
    Coeliac disease - Signs and Symptoms
    C0007570 (UMLS CUI-1)
    C0037088 (UMLS CUI-3)
    Item
    Coeliac disease - Signs and Symptoms
    integer
    C0007570 (UMLS CUI [1])
    C0037088 (UMLS CUI [2])
    Signs and Symptoms
    Code List
    Coeliac disease - Signs and Symptoms
    CL Item
    Diarrhea (1)
    CL Item
    Protuberant and tympanic abdomen (2)
    CL Item
    Evidence of weight loss (3)
    CL Item
    Orthostatic hypotension (4)
    CL Item
    Peripheral edema (5)
    CL Item
    Ecchymoses (6)
    CL Item
    Fatigue (7)
    CL Item
    Mood change (8)
    CL Item
    Hyperkeratosis (9)
    CL Item
    Dermatitis herpetiformis (10)
    CL Item
    Cheilosis and glossitis (11)
    CL Item
    Evidence of peripheral neuropathy (12)
    CL Item
    Symptoms exacerbation with gluten-containing diet (13)
    Item
    Coeliac disease - Signs and Symptoms present
    text
    C0007570 (UMLS CUI [1])
    C0037088 (UMLS CUI [2,1])
    C0150312 (UMLS CUI [2,2])
    Signs and symptoms present
    Code List
    Coeliac disease - Signs and Symptoms present
    CL Item
    Yes (Y)
    CL Item
    No (N)
    CL Item
    Unknown (U)
    CL Item
    Not Applicable (NA)
    Coeliac disease - Signs and Symptoms start date
    Item
    Coeliac disease - Signs and Symptoms start date
    date
    C0007570 (UMLS CUI [1])
    C0037088 (UMLS CUI [2,1])
    C0808070 (UMLS CUI [2,2])
    Coeliac disease - Signs and Symptoms end date
    Item
    Coeliac disease - Signs and Symptoms end date
    date
    C0007570 (UMLS CUI [1])
    C0037088 (UMLS CUI [2,1])
    C0806020 (UMLS CUI [2,2])
    Item
    Coeliac disease - Signs and Symptoms continuing at end of study
    integer
    C0007570 (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
    Coeliac disease - Signs and Symptoms continuing at end of study
    CL Item
    Continuing at end of study (1)
    Item Group
    Coeliac disease - Other signs and symptoms
    C0007570 (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
    Coeliac disease - Other signs and symptoms
    C0007570 (UMLS CUI-1)
    C0037088 (UMLS CUI-2)
    C0205394 (UMLS CUI-3)
    Coeliac disease - Other signs and symptoms
    Item
    Coeliac disease - Other signs and symptoms
    text
    C0007570 (UMLS CUI [1])
    C0037088 (UMLS CUI [2,1])
    C0205394 (UMLS CUI [2,2])
    Coeliac disease - Other signs and symptoms start date
    Item
    Coeliac disease - Other signs and symptoms start date
    date
    C0007570 (UMLS CUI [1])
    C0037088 (UMLS CUI [2,1])
    C0205394 (UMLS CUI [2,2])
    C0808070 (UMLS CUI [3])
    Coeliac disease - Other signs and symptoms end date
    Item
    Coeliac disease - Other signs and symptoms end date
    date
    C0007570 (UMLS CUI [1])
    C0037088 (UMLS CUI [2,1])
    C0205394 (UMLS CUI [2,2])
    C0806020 (UMLS CUI [3])
    Item
    Coeliac disease - Other signs and symptoms continuing at end of study
    integer
    C0007570 (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
    Coeliac disease - Other signs and symptoms continuing at end of study
    CL Item
    Continuing at end of study (1)
    Item Group
    Coeliac disease - Diagnostic Test Results
    C0007570 (UMLS CUI-1)
    C0456984 (UMLS CUI-2)
    C0430022 (UMLS CUI-3)
    Item
    Coeliac disease - Test
    integer
    C0007570 (UMLS CUI [1])
    C2826273 (UMLS CUI [2])
    Test
    Code List
    Coeliac 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 anti-tissue transglutaminase (tTG) IgA (11)
    CL Item
    Serum anti-endomysial antibody IgA (12)
    CL Item
    Serum anti-gliadin antibodies (AGA) IgA (13)
    CL Item
    Serum anti-gliadin antibodies (AGA) IgG (14)
    CL Item
    Serum sodium (15)
    CL Item
    Serum chloride (16)
    CL Item
    Serum calcium (17)
    CL Item
    Serum proteins (18)
    CL Item
    Prothrombin time (PT) (19)
    CL Item
    Stool leucocytes (20)
    CL Item
    Stool blood (21)
    Item
    Coeliac disease - Test done
    text
    C0007570 (UMLS CUI [1])
    C0022885 (UMLS CUI [2,1])
    C1272695 (UMLS CUI [2,2])
    Test done
    Code List
    Coeliac disease - Test done
    CL Item
    Yes (Y)
    CL Item
    No (N)
    CL Item
    Unknown (U)
    CL Item
    Not Applicable (NA)
    Coeliac disease - Test date
    Item
    Coeliac disease - Test date
    date
    C0007570 (UMLS CUI [1])
    C2826247 (UMLS CUI [2])
    Coeliac disease - Test Result
    Item
    Coeliac disease - Test Result
    float
    C0007570 (UMLS CUI [1])
    C0587081 (UMLS CUI [2])
    Coeliac disease - Test Units
    Item
    Coeliac disease - Test Units
    text
    C0007570 (UMLS CUI [1])
    C1519795 (UMLS CUI [2])
    Coeliac disease - Low Norm
    Item
    Coeliac disease - Low Norm
    float
    C0007570 (UMLS CUI [1])
    C0086715 (UMLS CUI [2,1])
    C0205251 (UMLS CUI [2,2])
    Coeliac disease - High Norm
    Item
    Coeliac disease - High Norm
    float
    C0007570 (UMLS CUI [1])
    C0086715 (UMLS CUI [2,1])
    C0205250 (UMLS CUI [2,2])
    Item Group
    Coeliac disease - Other Diagnostic Test Results
    C0007570 (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
    Coeliac disease - Other Diagnostic Test Results
    C0007570 (UMLS CUI-1)
    C0456984 (UMLS CUI-2)
    C0430022 (UMLS CUI-3)
    C0205394 (UMLS CUI-4)
    Coeliac disease - Test
    Item
    Coeliac disease - Test
    text
    C0007570 (UMLS CUI [1])
    C2826273 (UMLS CUI [2])
    Coeliac disease - Test date
    Item
    Coeliac disease - Test date
    date
    C0007570 (UMLS CUI [1])
    C2826247 (UMLS CUI [2])
    Coeliac disease - Test Result
    Item
    Coeliac disease - Test Result
    float
    C0007570 (UMLS CUI [1])
    C0587081 (UMLS CUI [2])
    Coeliac disease - Test Units
    Item
    Coeliac disease - Test Units
    text
    C0007570 (UMLS CUI [1])
    C1519795 (UMLS CUI [2])
    Coeliac disease - Low Norm
    Item
    Coeliac disease - Low Norm
    float
    C0007570 (UMLS CUI [1])
    C0086715 (UMLS CUI [2,1])
    C0205251 (UMLS CUI [2,2])
    Coeliac disease - High Norm
    Item
    Coeliac disease - High Norm
    float
    C0007570 (UMLS CUI [1])
    C0086715 (UMLS CUI [2,1])
    C0205250 (UMLS CUI [2,2])
    Item Group
    Coeliac disease - Other diagnostic Procedure
    C0007570 (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 (X-Ray: Small bowel barium studies, Duodenal Endoscopy, Biopsy, Oral tolerance tests, HLA typing)
    text
    C0430022 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C0011900 (UMLS CUI [2])
    C0043309 (UMLS CUI [3,1])
    C0021852 (UMLS CUI [3,2])
    C0004749 (UMLS CUI [3,3])
    C0014245 (UMLS CUI [4,1])
    C0013303 (UMLS CUI [4,2])
    C0005558 (UMLS CUI [5])
    C0029161 (UMLS CUI [6])
    C0242318 (UMLS CUI [7])
    Item Group
    Antiphospholipid Syndrome
    C0085278 (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
    Antiphospholipid Syndrome - Signs and symptoms (supporting the final diagnosis)
    C0085278 (UMLS CUI-1)
    C0037088 (UMLS CUI-2)
    C1546485 (UMLS CUI-3)
    Item
    Antiphospholipid Syndrome - Signs and symptoms
    text
    C0085278 (UMLS CUI [1])
    C0037088 (UMLS CUI [2])
    Myasthenia Gravis - Signs and symptoms
    Code List
    Antiphospholipid Syndrome - Signs and symptoms
    CL Item
    Arterial thrombosis (1)
    CL Item
    Venous thrombosis (2)
    CL Item
    Small vessels thrombosis (3)
    CL Item
    Cerebral thrombosis (4)
    CL Item
    Coronary thrombosis (5)
    CL Item
    Pulmonary thrombosis (emboli or thrombosis) (6)
    CL Item
    Leg extremities thrombosis (7)
    CL Item
    Hepatic thrombosis (8)
    CL Item
    Renal thrombosis (9)
    CL Item
    Ocular thrombosis (10)
    CL Item
    Adrenal thrombosis (11)
    CL Item
    Pregnancy morbidity - 1 or more late term spontaneous abortion (> 10 weeks) (12)
    CL Item
    Pregnancy morbidity - 3 or more spontaneous abortions (< 10 weeks) (13)
    CL Item
    34 weeks) due to preeclampsia/eclampsia or severe placental deficiency (Pregnancy morbidity - Premature birth of normal neonate (<)
    Item
    Antiphospholipid Syndrome - Signs and symptoms present
    text
    C0085278 (UMLS CUI [1])
    C0037088 (UMLS CUI [2])
    C0150312 (UMLS CUI [3])
    Myasthenia Gravis - Signs and symptoms present
    Code List
    Antiphospholipid Syndrome - Signs and symptoms present
    CL Item
    Yes (Y)
    CL Item
    No (N)
    CL Item
    Unknown (U)
    CL Item
    Not Applicable (NA)
    Antiphospholipid Syndrome - Signs and symptoms Start Date
    Item
    Antiphospholipid Syndrome - Signs and symptoms Start Date
    date
    C0085278 (UMLS CUI [1])
    C0037088 (UMLS CUI [2])
    C0808070 (UMLS CUI [3])
    Antiphospholipid Syndrome - Signs and symptoms End date
    Item
    Antiphospholipid Syndrome - Signs and symptoms End date
    date
    C0085278 (UMLS CUI [1])
    C0037088 (UMLS CUI [2])
    C0806020 (UMLS CUI [3])
    Item
    Antiphospholipid Syndrome - Signs and symptoms continuing at the end of study
    integer
    C0085278 (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
    Antiphospholipid Syndrome - Signs and symptoms continuing at the end of study
    CL Item
    Continuing at end of study (1)
    Item Group
    Antiphospholipid Syndrome - Other Signs and symptoms
    C0085278 (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
    Antiphospholipid Syndrome - Other Signs and symptoms
    C0085278 (UMLS CUI-1)
    C0037088 (UMLS CUI-2)
    C0205394 (UMLS CUI-3)
    Antiphospholipid Syndrome - Other Signs and symptoms
    Item
    Antiphospholipid Syndrome - Other Signs and symptoms
    text
    C0085278 (UMLS CUI [1])
    C0037088 (UMLS CUI [2,1])
    C0205394 (UMLS CUI [2,2])
    Antiphospholipid Syndrome - Other Signs and symptoms Start Date
    Item
    Antiphospholipid Syndrome - Other Signs and symptoms Start Date
    date
    C0085278 (UMLS CUI [1])
    C0037088 (UMLS CUI [2,1])
    C0205394 (UMLS CUI [2,2])
    C0808070 (UMLS CUI [3])
    Antiphospholipid Syndrome - Other Signs and symptoms End Date
    Item
    Antiphospholipid Syndrome - Other Signs and symptoms End Date
    date
    C0085278 (UMLS CUI [1])
    C0037088 (UMLS CUI [2,1])
    C0205394 (UMLS CUI [2,2])
    C0806020 (UMLS CUI [3])
    Item
    Antiphospholipid Syndrome - Other signs and symptoms continuing at the end of study
    text
    C0085278 (UMLS CUI [1])
    C0037088 (UMLS CUI [2,1])
    C0205394 (UMLS CUI [2,2])
    C0549178 (UMLS CUI [3,1])
    C0444496 (UMLS CUI [3,2])
    Antiphospholipid Syndrome - Other signs and symptoms continuing at the end of study
    Code List
    Antiphospholipid Syndrome - Other signs and symptoms continuing at the end of study
    CL Item
    Continuing at end of study (1)
    Item Group
    Antiphospholipid Syndrome - Diagnostic Test Results
    C0085278 (UMLS CUI-1)
    C0085655 (UMLS CUI-2)
    C0456984 (UMLS CUI-3)
    Item
    Antiphospholipid Syndrome - Test
    integer
    C0085278 (UMLS CUI [1])
    C2826273 (UMLS CUI [2])
    Test
    Code List
    Antiphospholipid Syndrome - 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
    Activated partial thromboplastine time (APTT) (11)
    CL Item
    Prothrombine time (PT) (12)
    CL Item
    Dilute Russel viper venom time (DRVVT) (13)
    CL Item
    Lupus anticoagulant (14)
    CL Item
    Lupus antigoagulant (12 weeks apart) (15)
    CL Item
    Anti-cardiolipin antibodies (aCL) (16)
    CL Item
    Anti-cardiolipin antibodies (aCL)(12 weeks apart) (17)
    CL Item
    Anti-beta-2 glycoprotein I antibodies (18)
    CL Item
    Anti-beta-2 glycoprotein I antibodies(12 weeks apart) (19)
    CL Item
    Anti-phosphatidylserine antibodies (20)
    CL Item
    Anti-phosphatydilathanolamine antibodies (21)
    CL Item
    Anti-prothrombine antibodies (22)
    CL Item
    Anti-nuclear antibodies (ANA) (23)
    CL Item
    Anti-DNA antibodies (24)
    CL Item
    Rheumatoid factor (RF) (25)
    Item
    Antiphospholipid Syndrome - Test done
    text
    C0085278 (UMLS CUI [1])
    C0022885 (UMLS CUI [2,1])
    C1272695 (UMLS CUI [2,2])
    Test done
    Code List
    Antiphospholipid Syndrome - Test done
    CL Item
    Yes  (Y)
    CL Item
    No  (N)
    CL Item
    Unknown  (U)
    CL Item
    Not Applicable (NA)
    Antiphospholipid Syndrome - Test date
    Item
    Antiphospholipid Syndrome - Test date
    date
    C0085278 (UMLS CUI [1])
    C2826247 (UMLS CUI [2])
    Antiphospholipid Syndrome - Test Result
    Item
    Antiphospholipid Syndrome - Test Result
    float
    C0085278 (UMLS CUI [1])
    C0587081 (UMLS CUI [2])
    Antiphospholipid Syndrome - Test Units
    Item
    Antiphospholipid Syndrome - Test Units
    text
    C0085278 (UMLS CUI [1])
    C1519795 (UMLS CUI [2])
    Antiphospholipid Syndrome - Low Norm
    Item
    Antiphospholipid Syndrome - Low Norm
    float
    C0085278 (UMLS CUI [1])
    C0086715 (UMLS CUI [2,1])
    C0205251 (UMLS CUI [2,2])
    Antiphospholipid Syndrome - High Norm
    Item
    Antiphospholipid Syndrome - High Norm
    float
    C0085278 (UMLS CUI [1])
    C0086715 (UMLS CUI [2,1])
    C0205250 (UMLS CUI [2,2])
    Item Group
    Antiphospholipid Syndrome - Other Diagnostic Test Results
    C0085278 (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
    Antiphospholipid Syndrome - Other Diagnostic Test Results
    C0085278 (UMLS CUI-1)
    C0456984 (UMLS CUI-2)
    C0430022 (UMLS CUI-3)
    C0205394 (UMLS CUI-4)
    Antiphospholipid Syndrome - Test
    Item
    Antiphospholipid Syndrome - Test
    text
    C0085278 (UMLS CUI [1])
    C2826273 (UMLS CUI [2])
    Antiphospholipid Syndrome - Test date
    Item
    Antiphospholipid Syndrome - Test date
    date
    C0085278 (UMLS CUI [1])
    C2826247 (UMLS CUI [2])
    Antiphospholipid Syndrome - Test Result
    Item
    Antiphospholipid Syndrome - Test Result
    float
    C0085278 (UMLS CUI [1])
    C0587081 (UMLS CUI [2])
    Antiphospholipid Syndrome - Test Units
    Item
    Antiphospholipid Syndrome - Test Units
    text
    C0085278 (UMLS CUI [1])
    C1519795 (UMLS CUI [2])
    Antiphospholipid Syndrome - Low Norm
    Item
    Antiphospholipid Syndrome - Low Norm
    float
    C0085278 (UMLS CUI [1])
    C0086715 (UMLS CUI [2,1])
    C0205251 (UMLS CUI [2,2])
    Antiphospholipid Syndrome - High Norm
    Item
    Antiphospholipid Syndrome - High Norm
    float
    C0085278 (UMLS CUI [1])
    C0086715 (UMLS CUI [2,1])
    C0205250 (UMLS CUI [2,2])
    Item Group
    Antiphospholipid Syndrome - Other diagnostic Procedure
    C0085278 (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 (Doppler ultrasound, Brain CT scan, Brain MRI, Chest CT scan, Abdomen CT scan, Cardiac echocardiography, Biopsy)
    text
    C0430022 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C0011900 (UMLS CUI [2])
    C0162481 (UMLS CUI [3])
    C0412585 (UMLS CUI [4])
    C0412675 (UMLS CUI [5])
    C0202823 (UMLS CUI [6])
    C0412620 (UMLS CUI [7])
    C0013516 (UMLS CUI [8])
    C0005558 (UMLS CUI [9])
    Item Group
    Autoimmune Haemolytic Anaemia
    C0002880 (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
    Autoimmune Haemolytic Anaemia - Signs and symptoms (supporting the final diagnosis)
    C0002880 (UMLS CUI-1)
    C0037088 (UMLS CUI-2)
    C1546485 (UMLS CUI-3)
    Item
    Autoimmune Haemolytic Anaemia - Signs and symptoms
    integer
    C0002880 (UMLS CUI [1])
    C0037088 (UMLS CUI [2])
    Uveitis - Signs and symptoms
    Code List
    Autoimmune Haemolytic Anaemia - Signs and symptoms
    CL Item
    Palor with pale conjunctivae and fingernails (1)
    CL Item
    Fatigue (2)
    CL Item
    Dyspnea (3)
    CL Item
    Poor feeding (4)
    CL Item
    Acrocyanosis (5)
    CL Item
    Splenomegaly (6)
    CL Item
    Congestive heart failure (7)
    CL Item
    Hematuria (8)
    CL Item
    Leg ulcer (9)
    CL Item
    Fever (10)
    CL Item
    Lymphadenopathy (11)
    CL Item
    Rash (12)
    CL Item
    Butterfly malar rash (13)
    CL Item
    Arthritis, specify (14)
    Autoimmune Haemolytic Anaemia - Specify Arthritis
    Item
    Autoimmune Haemolytic Anaemia - Specify Arthritis
    text
    C0002880 (UMLS CUI [1])
    C0003864 (UMLS CUI [2])
    Item
    Autoimmune Haemolytic Anaemia - Signs and symptoms present
    text
    C0002880 (UMLS CUI [1])
    C0037088 (UMLS CUI [2])
    C0150312 (UMLS CUI [3])
    Myasthenia Gravis - Signs and symptoms present
    Code List
    Autoimmune Haemolytic Anaemia - Signs and symptoms present
    CL Item
    Yes  (Y)
    CL Item
    No  (N)
    CL Item
    Unknown  (U)
    CL Item
    Not Applicable (NA)
    Autoimmune Haemolytic Anaemia - Signs and symptoms Start Date
    Item
    Autoimmune Haemolytic Anaemia - Signs and symptoms Start Date
    date
    C0002880 (UMLS CUI [1])
    C0037088 (UMLS CUI [2])
    C0808070 (UMLS CUI [3])
    Autoimmune Haemolytic Anaemia - Signs and symptoms End date
    Item
    Autoimmune Haemolytic Anaemia - Signs and symptoms End date
    date
    C0002880 (UMLS CUI [1])
    C0037088 (UMLS CUI [2])
    C0806020 (UMLS CUI [3])
    Item
    Autoimmune Haemolytic Anaemia - Signs and symptoms continuing at the end of study
    integer
    C0002880 (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
    Autoimmune Haemolytic Anaemia - Signs and symptoms continuing at the end of study
    CL Item
    Continuing at end of study (1)
    Item Group
    Autoimmune Haemolytic Anaemia - Other Signs and symptoms
    C0002880 (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 Haemolytic Anaemia - Other Signs and symptoms
    C0002880 (UMLS CUI-1)
    C0037088 (UMLS CUI-2)
    C0205394 (UMLS CUI-3)
    Autoimmune Haemolytic Anaemia - Other Signs and symptoms
    Item
    Autoimmune Haemolytic Anaemia - Other Signs and symptoms
    text
    C0002880 (UMLS CUI [1])
    C0037088 (UMLS CUI [2,1])
    C0205394 (UMLS CUI [2,2])
    Autoimmune Haemolytic Anaemia - Other Signs and symptoms Start Date
    Item
    Autoimmune Haemolytic Anaemia - Other Signs and symptoms Start Date
    date
    C0002880 (UMLS CUI [1])
    C0037088 (UMLS CUI [2,1])
    C0205394 (UMLS CUI [2,2])
    C0808070 (UMLS CUI [3])
    Autoimmune Haemolytic Anaemia - Other Signs and symptoms End Date
    Item
    Autoimmune Haemolytic Anaemia - Other Signs and symptoms End Date
    date
    C0002880 (UMLS CUI [1])
    C0037088 (UMLS CUI [2,1])
    C0205394 (UMLS CUI [2,2])
    C0806020 (UMLS CUI [3])
    Item
    Autoimmune Haemolytic Anaemia - Other signs and symptoms continuing at the end of study
    text
    C0002880 (UMLS CUI [1])
    C0037088 (UMLS CUI [2,1])
    C0205394 (UMLS CUI [2,2])
    C0549178 (UMLS CUI [3,1])
    C0444496 (UMLS CUI [3,2])
    Autoimmune Haemolytic Anaemia - Other signs and symptoms continuing at the end of study
    Code List
    Autoimmune Haemolytic Anaemia - Other signs and symptoms continuing at the end of study
    CL Item
    Continuing at end of study (1)
    Item Group
    Autoimmune Haemolytic Anaemia - Diagnostic Test Results
    C0002880 (UMLS CUI-1)
    C0456984 (UMLS CUI-2)
    Item
    Autoimmune Haemolytic Anaemia - Test
    integer
    C0002880 (UMLS CUI [1])
    C2826273 (UMLS CUI [2])
    Myasthenia Gravis - Test
    Code List
    Autoimmune Haemolytic Anaemia - 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
    Mean corpuscular volume (MCV) (11)
    CL Item
    Mean corpuscular hemoglobin concentration (MCHC) (12)
    CL Item
    Reticulocytosis (13)
    CL Item
    Blood smear (14)
    CL Item
    Serum lactate deshydrogenase (LDH) (15)
    CL Item
    Serum bilirubin (16)
    CL Item
    Serum urobilinogen (17)
    CL Item
    Albuminuria (18)
    CL Item
    LMW proteinuria (19)
    CL Item
    Hematuria (20)
    CL Item
    Hemosiderinuremia (21)
    CL Item
    Direct antiglobulin test with anti-C3 (22)
    CL Item
    Direct antiglobulin test with anti-IgG (23)
    CL Item
    Direct Coombs test (patient’s RBC) (24)
    CL Item
    Indirect Coombs test (patient’s serum) (25)
    CL Item
    Cold agglutinin titer - Anti-I globulin (26)
    CL Item
    Cold agglutinin titer - Anti-i globulin (27)
    CL Item
    Cold agglutinin titer - Anti-P globulin (28)
    Item
    Autoimmune Haemolytic Anaemia - Test done
    text
    C0002880 (UMLS CUI [1])
    C0022885 (UMLS CUI [2,1])
    C1272695 (UMLS CUI [2,2])
    Myasthenia Gravis - Test done
    Code List
    Autoimmune Haemolytic Anaemia - Test done
    CL Item
    Yes  (Y)
    CL Item
    No  (N)
    CL Item
    Unknown  (U)
    CL Item
    Not Applicable (NA)
    Autoimmune Haemolytic Anaemia - Test date
    Item
    Autoimmune Haemolytic Anaemia - Test date
    date
    C0002880 (UMLS CUI [1])
    C2826247 (UMLS CUI [2])
    Autoimmune Haemolytic Anaemia - Test Result
    Item
    Autoimmune Haemolytic Anaemia - Test Result
    float
    C0002880 (UMLS CUI [1])
    C0587081 (UMLS CUI [2])
    Autoimmune Haemolytic Anaemia - Test Units
    Item
    Autoimmune Haemolytic Anaemia - Test Units
    text
    C0002880 (UMLS CUI [1])
    C1519795 (UMLS CUI [2])
    Autoimmune Haemolytic Anaemia - Low Norm
    Item
    Autoimmune Haemolytic Anaemia - Low Norm
    float
    C0002880 (UMLS CUI [1])
    C0086715 (UMLS CUI [2,1])
    C0205251 (UMLS CUI [2,2])
    Autoimmune Haemolytic Anaemia - High Norm
    Item
    Autoimmune Haemolytic Anaemia - High Norm
    float
    C0002880 (UMLS CUI [1])
    C0086715 (UMLS CUI [2,1])
    C0205250 (UMLS CUI [2,2])
    Item Group
    Autoimmune Haemolytic Anaemia - Other Diagnostic Test Results
    C0002880 (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 Haemolytic Anaemia - Other Diagnostic Test Results
    C0002880 (UMLS CUI-1)
    C0456984 (UMLS CUI-2)
    C0430022 (UMLS CUI-3)
    C0205394 (UMLS CUI-4)
    Autoimmune Haemolytic Anaemia - Test
    Item
    Autoimmune Haemolytic Anaemia - Test
    text
    C0002880 (UMLS CUI [1])
    C2826273 (UMLS CUI [2])
    Autoimmune Haemolytic Anaemia - Test date
    Item
    Autoimmune Haemolytic Anaemia - Test date
    date
    C0002880 (UMLS CUI [1])
    C2826247 (UMLS CUI [2])
    Autoimmune Haemolytic Anaemia - Test Result
    Item
    Autoimmune Haemolytic Anaemia - Test Result
    float
    C0002880 (UMLS CUI [1])
    C0587081 (UMLS CUI [2])
    Autoimmune Haemolytic Anaemia - Test Units
    Item
    Autoimmune Haemolytic Anaemia - Test Units
    text
    C0002880 (UMLS CUI [1])
    C1519795 (UMLS CUI [2])
    Autoimmune Haemolytic Anaemia - Low Norm
    Item
    Autoimmune Haemolytic Anaemia - Low Norm
    float
    C0002880 (UMLS CUI [1])
    C0086715 (UMLS CUI [2,1])
    C0205251 (UMLS CUI [2,2])
    Autoimmune Haemolytic Anaemia - High Norm
    Item
    Autoimmune Haemolytic Anaemia - High Norm
    float
    C0002880 (UMLS CUI [1])
    C0086715 (UMLS CUI [2,1])
    C0205250 (UMLS CUI [2,2])
    Item Group
    Autoimmune Haemolytic Anaemia - Other diagnostic Procedure
    C0002880 (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 (Marrow biopsy, Chest X-ray, Abdominal ultrasound, serology for CMV, EBV, Mycoplasma)
    text
    C0430022 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C0011900 (UMLS CUI [2])
    C0005954 (UMLS CUI [3])
    C0039985 (UMLS CUI [4])
    C1456803 (UMLS CUI [5,1])
    C0000726 (UMLS CUI [5,2])
    C0010825 (UMLS CUI [6,1])
    C0036743 (UMLS CUI [6,2])
    C0014644 (UMLS CUI [7])
    C0026934 (UMLS CUI [8])
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