ID

41403

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

  1. 9/29/20 9/29/20 -
  2. 11/2/20 11/2/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 29, 2020

DOI

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License

Creative Commons BY 4.0

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

IMD Report - Rheumatic Diseases; Systemic Lupus Erythematosus or Cutaneous Lupus; Sjogren's Syndrome

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
Rheumatic Diseases
Description

Rheumatic Diseases

Alias
UMLS CUI-1
C3495832
Rheumatic Diseases Diagnosis
Description

Rheumatic Diseases Diagnosis

Data type

integer

Alias
UMLS CUI [1,1]
C3495832
UMLS CUI [1,2]
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
Rheumatic Diseases - Signs and Symptoms
Description

Rheumatic Diseases - Signs and Symptoms

Alias
UMLS CUI-1
C3495832
UMLS CUI-2
C0037088
Rheumatic Diseases - Signs and Symptoms
Description

Rheumatic Diseases - Signs and Symptoms

Data type

integer

Alias
UMLS CUI [1]
C3495832
UMLS CUI [2]
C0037088
Rheumatic diseases - Specify number of joints affected
Description

Rheumatic diseases - Specify number of joints affected

Data type

integer

Alias
UMLS CUI [1]
C3495832
UMLS CUI [2,1]
C0022417
UMLS CUI [2,2]
C0392760
UMLS CUI [3]
C0237753
Rheumatic diseases - Specify vascular disorders
Description

Rheumatic diseases - Specify vascular disorders

Data type

text

Alias
UMLS CUI [1]
C3495832
UMLS CUI [2]
C0042373
Rheumatic diseases - Specify cardiac disorders
Description

Rheumatic diseases - Specify cardiac disorders

Data type

text

Alias
UMLS CUI [1]
C3495832
UMLS CUI [2]
C0018799
Rheumatic diseases - Specify pulmonary disorders
Description

Rheumatic diseases - Specify pulmonary disorders

Data type

text

Alias
UMLS CUI [1]
C3495832
UMLS CUI [2]
C0024115
Rheumatic diseases - Specify renal disorders
Description

Rheumatic diseases - Specify renal disorders

Data type

text

Alias
UMLS CUI [1]
C3495832
UMLS CUI [2]
C0022658
Rheumatic diseases - Specify gastrointestinal disorders
Description

Rheumatic diseases - Specify gastrointestinal disorders

Data type

text

Alias
UMLS CUI [1]
C3495832
UMLS CUI [2]
C0017178
Rheumatic diseases - Specify hematological disorders
Description

Rheumatic diseases - Specify hematological disorders

Data type

text

Alias
UMLS CUI [1]
C3495832
UMLS CUI [2]
C0018939
Rheumatic diseases - Signs and Symptoms present
Description

Rheumatic diseases - Signs and Symptoms present

Data type

text

Alias
UMLS CUI [1]
C3495832
UMLS CUI [2,1]
C0037088
UMLS CUI [2,2]
C0150312
Rheumatic diseases - Signs and Symptoms start date
Description

Rheumatic diseases - Signs and Symptoms start date

Data type

date

Alias
UMLS CUI [1]
C3495832
UMLS CUI [2,1]
C0037088
UMLS CUI [2,2]
C0808070
Rheumatic diseases - Signs and Symptoms end date
Description

Rheumatic diseases - Signs and Symptoms end date

Data type

date

Alias
UMLS CUI [1]
C3495832
UMLS CUI [2,1]
C0037088
UMLS CUI [2,2]
C0806020
Rheumatic diseases - Signs and Symptoms continuing at end of study
Description

Rheumatic diseases - Signs and Symptoms continuing at end of study

Data type

integer

Alias
UMLS CUI [1]
C3495832
UMLS CUI [2]
C0037088
UMLS CUI [3,1]
C0549178
UMLS CUI [3,2]
C0444496
Rheumatic diseases - Other signs and symptoms
Description

Rheumatic diseases - Other signs and symptoms

Alias
UMLS CUI-1
C3495832
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
Rheumatic diseases - Other signs and symptoms
Description

Rheumatic diseases - Other signs and symptoms

Alias
UMLS CUI-1
C3495832
UMLS CUI-2
C0037088
UMLS CUI-3
C0205394
Rheumatic diseases - Other signs and symptoms
Description

Rheumatic diseases - Other signs and symptoms

Data type

text

Alias
UMLS CUI [1]
C3495832
UMLS CUI [2,1]
C0037088
UMLS CUI [2,2]
C0205394
Rheumatic diseases - Other signs and symptoms start date
Description

Rheumatic diseases - Other signs and symptoms start date

Data type

date

Alias
UMLS CUI [1]
C3495832
UMLS CUI [2,1]
C0037088
UMLS CUI [2,2]
C0205394
UMLS CUI [3]
C0808070
Rheumatic diseases - Other signs and symptoms end date
Description

Rheumatic diseases - Other signs and symptoms end date

Data type

date

Alias
UMLS CUI [1]
C3495832
UMLS CUI [2,1]
C0037088
UMLS CUI [2,2]
C0205394
UMLS CUI [3]
C0806020
Rheumatic diseases - Other signs and symptoms continuing at end of study
Description

Rheumatic diseases - Other signs and symptoms continuing at end of study

Data type

integer

Alias
UMLS CUI [1]
C3495832
UMLS CUI [2,1]
C0037088
UMLS CUI [2,2]
C0205394
UMLS CUI [3,1]
C0549178
UMLS CUI [3,2]
C0444496
Rheumatic diseases - Diagnostic Test Results
Description

Rheumatic diseases - Diagnostic Test Results

Alias
UMLS CUI-1
C3495832
UMLS CUI-2
C0456984
UMLS CUI-3
C0430022
Rheumatic diseases - Test
Description

Rheumatic diseases - Test

Data type

integer

Alias
UMLS CUI [1]
C3495832
UMLS CUI [2]
C2826273
Rheumatic diseases - Test done
Description

Rheumatic diseases - Test done

Data type

text

Alias
UMLS CUI [1]
C3495832
UMLS CUI [2,1]
C0022885
UMLS CUI [2,2]
C1272695
Rheumatic diseases - Test date
Description

Rheumatic diseases - Test date

Data type

date

Alias
UMLS CUI [1]
C3495832
UMLS CUI [2]
C2826247
Rheumatic diseases - Test Result
Description

Rheumatic diseases - Test Result

Data type

float

Alias
UMLS CUI [1]
C3495832
UMLS CUI [2]
C0587081
Rheumatic diseases - Test Units
Description

Rheumatic diseases - Test Units

Data type

text

Alias
UMLS CUI [1]
C3495832
UMLS CUI [2]
C1519795
Rheumatic diseases - Low Norm
Description

Rheumatic diseases - Low Norm

Data type

float

Alias
UMLS CUI [1]
C3495832
UMLS CUI [2,1]
C0086715
UMLS CUI [2,2]
C0205251
Rheumatic diseases - High Norm
Description

Rheumatic diseases - High Norm

Data type

float

Alias
UMLS CUI [1]
C3495832
UMLS CUI [2,1]
C0086715
UMLS CUI [2,2]
C0205250
Rheumatic diseases - Other Diagnostic Test Results
Description

Rheumatic diseases - Other Diagnostic Test Results

Alias
UMLS CUI-1
C3495832
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
Rheumatic diseases - Other Diagnostic Test Results
Description

Rheumatic diseases - Other Diagnostic Test Results

Alias
UMLS CUI-1
C3495832
UMLS CUI-2
C0456984
UMLS CUI-3
C0430022
UMLS CUI-4
C0205394
Rheumatic diseases - Test
Description

Rheumatic diseases - Test

Data type

text

Alias
UMLS CUI [1]
C3495832
UMLS CUI [2]
C2826273
Rheumatic diseases - Test date
Description

Rheumatic diseases - Test date

Data type

date

Alias
UMLS CUI [1]
C3495832
UMLS CUI [2]
C2826247
Rheumatic diseases - Test Result
Description

Rheumatic diseases - Test Result

Data type

float

Alias
UMLS CUI [1]
C3495832
UMLS CUI [2]
C0587081
Rheumatic diseases - Test Units
Description

Rheumatic diseases - Test Units

Data type

text

Alias
UMLS CUI [1]
C3495832
UMLS CUI [2]
C1519795
Rheumatic diseases - Low Norm
Description

Rheumatic diseases - Low Norm

Data type

float

Alias
UMLS CUI [1]
C3495832
UMLS CUI [2,1]
C0086715
UMLS CUI [2,2]
C0205251
Rheumatic diseases - High Norm
Description

Rheumatic diseases - High Norm

Data type

float

Alias
UMLS CUI [1]
C3495832
UMLS CUI [2,1]
C0086715
UMLS CUI [2,2]
C0205250
Rheumatic diseases - Other diagnostic Procedure
Description

Rheumatic diseases - Other diagnostic Procedure

Alias
UMLS CUI-1
C3495832
UMLS CUI-2
C0430022
UMLS CUI-3
C0205394
Describe any other diagnostic procedure supporting the diagnosis (Radiographic evidence of RA, CT scan, MRI, Infectious investigations, HLA typing)
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 [3,1]
C1962945
UMLS CUI [3,2]
C0003873
UMLS CUI [3,3]
C3887511
UMLS CUI [4]
C0040405
UMLS CUI [5]
C0024485
UMLS CUI [6,1]
C1261322
UMLS CUI [6,2]
C3714514
UMLS CUI [7]
C0242318
Systemic Lupus Erythematosus or Cutaneous Lupus
Description

Systemic Lupus Erythematosus or Cutaneous Lupus

Alias
UMLS CUI-1
C0024141
UMLS CUI-2
C0746306
Systemic Lupus Erythematosus or Cutaneous Lupus - Diagnosis
Description

Systemic Lupus Erythematosus or Cutaneous Lupus - Diagnosis

Data type

integer

Alias
UMLS CUI [1]
C0024141
UMLS CUI [2]
C0746306
UMLS CUI [3]
C0011900
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
Systemic Lupus Erythematosus or Cutaneous Lupus - Signs and symptoms (supporting the final diagnosis)
Description

Systemic Lupus Erythematosus or Cutaneous Lupus - Signs and symptoms (supporting the final diagnosis)

Alias
UMLS CUI-1
C0024141
UMLS CUI-2
C0746306
UMLS CUI-3
C0037088
UMLS CUI-4
C1546485
Systemic Lupus Erythematosus or Cutaneous Lupus - Signs and symptoms
Description

Systemic Lupus Erythematosus or Cutaneous Lupus - Signs and symptoms

Data type

integer

Alias
UMLS CUI [1]
C0024141
UMLS CUI [2]
C0746306
UMLS CUI [3]
C0037088
Systemic Lupus Erythematosus or Cutaneous Lupus - Signs and symptoms present
Description

Systemic Lupus Erythematosus or Cutaneous Lupus - Signs and symptoms present

Data type

text

Alias
UMLS CUI [1]
C0024141
UMLS CUI [2]
C0746306
UMLS CUI [3]
C0037088
UMLS CUI [4]
C0150312
Systemic Lupus Erythematosus or Cutaneous Lupus - Signs and symptoms Start Date
Description

Systemic Lupus Erythematosus or Cutaneous Lupus - Signs and symptoms Start Date

Data type

date

Alias
UMLS CUI [1]
C0024141
UMLS CUI [2]
C0746306
UMLS CUI [3]
C0037088
UMLS CUI [4]
C0808070
Systemic Lupus Erythematosus or Cutaneous Lupus - Signs and symptoms End date
Description

Systemic Lupus Erythematosus or Cutaneous Lupus - Signs and symptoms End date

Data type

date

Alias
UMLS CUI [1]
C0024141
UMLS CUI [2]
C0746306
UMLS CUI [3]
C0037088
UMLS CUI [4]
C0806020
Systemic Lupus Erythematosus or Cutaneous Lupus - Signs and symptoms continuing at the end of study
Description

Systemic Lupus Erythematosus or Cutaneous Lupus - Signs and symptoms continuing at the end of study

Data type

integer

Alias
UMLS CUI [1]
C0024141
UMLS CUI [2]
C0746306
UMLS CUI [3]
C0037088
UMLS CUI [4,1]
C0549178
UMLS CUI [4,2]
C0444496
Systemic Lupus Erythematosus or Cutaneous Lupus - Other Signs and symptoms
Description

Systemic Lupus Erythematosus or Cutaneous Lupus - Other Signs and symptoms

Alias
UMLS CUI-1
C0024141
UMLS CUI-3
C0746306
UMLS CUI-4
C0037088
UMLS CUI-5
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
Systemic Lupus Erythematosus or Cutaneous Lupus - Other Signs and symptoms
Description

Systemic Lupus Erythematosus or Cutaneous Lupus - Other Signs and symptoms

Alias
UMLS CUI-1
C0024141
UMLS CUI-3
C0746306
UMLS CUI-4
C0037088
UMLS CUI-5
C0205394
Systemic Lupus Erythematosus or Cutaneous Lupus - Other Signs and symptoms
Description

Systemic Lupus Erythematosus or Cutaneous Lupus - Other Signs and symptoms

Data type

text

Alias
UMLS CUI [1]
C0024141
UMLS CUI [2]
C0746306
UMLS CUI [3,1]
C0037088
UMLS CUI [3,2]
C0205394
Systemic Lupus Erythematosus or Cutaneous Lupus - Other Signs and symptoms Start Date
Description

Systemic Lupus Erythematosus or Cutaneous Lupus - Other Signs and symptoms Start Date

Data type

date

Alias
UMLS CUI [1]
C0024141
UMLS CUI [2]
C0746306
UMLS CUI [3,1]
C0037088
UMLS CUI [3,2]
C0205394
UMLS CUI [4]
C0808070
Systemic Lupus Erythematosus or Cutaneous Lupus - Other Signs and symptoms End Date
Description

Systemic Lupus Erythematosus or Cutaneous Lupus - Other Signs and symptoms End Date

Data type

date

Alias
UMLS CUI [1]
C0024141
UMLS CUI [2]
C0746306
UMLS CUI [3,1]
C0037088
UMLS CUI [3,2]
C0205394
UMLS CUI [4]
C0806020
Systemic Lupus Erythematosus or Cutaneous Lupus - Diagnostic Test Results
Description

Systemic Lupus Erythematosus or Cutaneous Lupus - Diagnostic Test Results

Alias
UMLS CUI-1
C0024141
UMLS CUI-3
C0746306
UMLS CUI-4
C0456984
Systemic Lupus Erythematosus or Cutaneous Lupus - Test
Description

Systemic Lupus Erythematosus or Cutaneous Lupus - Test

Data type

integer

Alias
UMLS CUI [1]
C0024141
UMLS CUI [2]
C0746306
UMLS CUI [3]
C2826273
Systemic Lupus Erythematosus or Cutaneous Lupus - Test done
Description

Systemic Lupus Erythematosus or Cutaneous Lupus - Test done

Data type

text

Alias
UMLS CUI [1]
C0024141
UMLS CUI [2]
C0746306
UMLS CUI [3,1]
C0022885
UMLS CUI [3,2]
C1272695
Systemic Lupus Erythematosus or Cutaneous Lupus - Test date
Description

Systemic Lupus Erythematosus or Cutaneous Lupus - Test date

Data type

date

Alias
UMLS CUI [1]
C0024141
UMLS CUI [2]
C0746306
UMLS CUI [3]
C2826247
Systemic Lupus Erythematosus or Cutaneous Lupus - Test Result
Description

Systemic Lupus Erythematosus or Cutaneous Lupus - Test Result

Data type

float

Alias
UMLS CUI [1]
C0024141
UMLS CUI [2]
C0746306
UMLS CUI [3]
C0587081
Systemic Lupus Erythematosus or Cutaneous Lupus - Test Units
Description

Systemic Lupus Erythematosus or Cutaneous Lupus - Test Units

Data type

text

Alias
UMLS CUI [1]
C0024141
UMLS CUI [2]
C0746306
UMLS CUI [3]
C1519795
Systemic Lupus Erythematosus or Cutaneous Lupus - Low Norm
Description

Systemic Lupus Erythematosus or Cutaneous Lupus - Low Norm

Data type

float

Alias
UMLS CUI [1]
C0024141
UMLS CUI [2]
C0746306
UMLS CUI [3,1]
C0086715
UMLS CUI [3,2]
C0205251
Systemic Lupus Erythematosus or Cutaneous Lupus - High Norm
Description

Systemic Lupus Erythematosus or Cutaneous Lupus - High Norm

Data type

float

Alias
UMLS CUI [1]
C0024141
UMLS CUI [2]
C0746306
UMLS CUI [3,1]
C0086715
UMLS CUI [3,2]
C0205250
Systemic Lupus Erythematosus or Cutaneous Lupus - Other Diagnostic Test Results
Description

Systemic Lupus Erythematosus or Cutaneous Lupus - Other Diagnostic Test Results

Alias
UMLS CUI-1
C0024141
UMLS CUI-3
C0746306
UMLS CUI-4
C0456984
UMLS CUI-5
C0430022
UMLS CUI-6
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
Systemic Lupus Erythematosus or Cutaneous Lupus - Other Diagnostic Test Results
Description

Systemic Lupus Erythematosus or Cutaneous Lupus - Other Diagnostic Test Results

Alias
UMLS CUI-1
C0024141
UMLS CUI-3
C0746306
UMLS CUI-4
C0456984
UMLS CUI-5
C0430022
UMLS CUI-6
C0205394
Systemic Lupus Erythematosus or Cutaneous Lupus - Test
Description

Systemic Lupus Erythematosus or Cutaneous Lupus - Test

Data type

text

Alias
UMLS CUI [1]
C0024141
UMLS CUI [2]
C0746306
UMLS CUI [3]
C2826273
Systemic Lupus Erythematosus or Cutaneous Lupus - Test date
Description

Systemic Lupus Erythematosus or Cutaneous Lupus - Test date

Data type

date

Alias
UMLS CUI [1]
C0024141
UMLS CUI [2]
C0746306
UMLS CUI [3]
C2826247
Systemic Lupus Erythematosus or Cutaneous Lupus - Test Result
Description

Systemic Lupus Erythematosus or Cutaneous Lupus - Test Result

Data type

float

Alias
UMLS CUI [1]
C0024141
UMLS CUI [2]
C0746306
UMLS CUI [3]
C0587081
Systemic Lupus Erythematosus or Cutaneous Lupus - Test Units
Description

Systemic Lupus Erythematosus or Cutaneous Lupus - Test Units

Data type

text

Alias
UMLS CUI [1]
C0024141
UMLS CUI [2]
C0746306
UMLS CUI [3]
C1519795
Systemic Lupus Erythematosus or Cutaneous Lupus - Low Norm
Description

Systemic Lupus Erythematosus or Cutaneous Lupus - Low Norm

Data type

float

Alias
UMLS CUI [1]
C0024141
UMLS CUI [2]
C0746306
UMLS CUI [3,1]
C0086715
UMLS CUI [3,2]
C0205251
Systemic Lupus Erythematosus or Cutaneous Lupus - High Norm
Description

Systemic Lupus Erythematosus or Cutaneous Lupus - High Norm

Data type

float

Alias
UMLS CUI [1]
C0024141
UMLS CUI [2]
C0746306
UMLS CUI [3,1]
C0086715
UMLS CUI [3,2]
C0205250
Systemic Lupus Erythematosus or Cutaneous Lupus - Other diagnostic Procedure
Description

Systemic Lupus Erythematosus or Cutaneous Lupus - Other diagnostic Procedure

Alias
UMLS CUI-1
C0024141
UMLS CUI-3
C0746306
UMLS CUI-4
C0430022
UMLS CUI-5
C0205394
Describe any other diagnostic procedure supporting the diagnosis (Chest x-ray, Joint xRay, Brain MRI/MRA, Echocardiography, Lumbar puncture, Renal biopsy, Skin biopsy, HLA typing)
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 [4,1]
C0043309
UMLS CUI [4,2]
C0022417
UMLS CUI [5]
C0412675
UMLS CUI [6]
C0013516
UMLS CUI [7]
C0037943
UMLS CUI [8]
C0194073
UMLS CUI [9]
C0150866
UMLS CUI [10]
C0242318
Sjogren's Syndrome
Description

Sjogren's Syndrome

Alias
UMLS CUI-1
C1527336
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
Sjogren's Syndrome - Signs and symptoms (supporting the final diagnosis)
Description

Sjogren's Syndrome - Signs and symptoms (supporting the final diagnosis)

Alias
UMLS CUI-1
C1527336
UMLS CUI-2
C0037088
UMLS CUI-3
C1546485
Sjogren's Syndrome - Signs and symptoms
Description

(supporting the final diagnosis)

Data type

integer

Alias
UMLS CUI [1]
C1527336
UMLS CUI [2]
C0037088
Sjogren's Syndrome - Signs and symptoms present
Description

Sjogren's Syndrome - Signs and symptoms present

Data type

text

Alias
UMLS CUI [1]
C1527336
UMLS CUI [2]
C0037088
UMLS CUI [3]
C0150312
Sjogren's Syndrome - Signs and symptoms Start Date
Description

Sjogren's Syndrome - Signs and symptoms Start Date

Data type

date

Alias
UMLS CUI [1]
C1527336
UMLS CUI [2]
C0037088
UMLS CUI [3]
C0808070
Sjogren's Syndrome - Signs and symptoms End date
Description

Sjogren's Syndrome - Signs and symptoms End date

Data type

date

Alias
UMLS CUI [1]
C1527336
UMLS CUI [2]
C0037088
UMLS CUI [3]
C0806020
Sjogren's Syndrome - Signs and symptoms continuing at the end of study
Description

Sjogren's Syndrome - Signs and symptoms continuing at the end of study

Data type

integer

Alias
UMLS CUI [1]
C1527336
UMLS CUI [2]
C0037088
UMLS CUI [3,1]
C0549178
UMLS CUI [3,2]
C0444496
Sjogren's Syndrome - Other Signs and symptoms
Description

Sjogren's Syndrome - Other Signs and symptoms

Alias
UMLS CUI-1
C1527336
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
Sjogren's Syndrome - Other Signs and symptoms
Description

Sjogren's Syndrome - Other Signs and symptoms

Alias
UMLS CUI-1
C1527336
UMLS CUI-2
C0037088
UMLS CUI-3
C0205394
Sjogren's Syndrome - Other Signs and symptoms
Description

Sjogren's Syndrome - Other Signs and symptoms

Data type

text

Alias
UMLS CUI [1]
C1527336
UMLS CUI [2,1]
C0037088
UMLS CUI [2,2]
C0205394
Sjogren's Syndrome - Other Signs and symptoms Start Date
Description

Sjogren's Syndrome - Other Signs and symptoms Start Date

Data type

date

Alias
UMLS CUI [1]
C1527336
UMLS CUI [2,1]
C0037088
UMLS CUI [2,2]
C0205394
UMLS CUI [3]
C0808070
Sjogren's Syndrome - Other Signs and symptoms End Date
Description

Sjogren's Syndrome - Other Signs and symptoms End Date

Data type

date

Alias
UMLS CUI [1]
C1527336
UMLS CUI [2,1]
C0037088
UMLS CUI [2,2]
C0205394
UMLS CUI [3]
C0806020
Sjogren's Syndrome - Diagnostic Test Results
Description

Sjogren's Syndrome - Diagnostic Test Results

Alias
UMLS CUI-1
C1527336
UMLS CUI-2
C0456984
Sjogren's Syndrome - Test
Description

Sjogren's Syndrome - Test

Data type

integer

Alias
UMLS CUI [1]
C1527336
UMLS CUI [2]
C2826273
Sjogren's Syndrome - Test done
Description

Sjogren's Syndrome - Test done

Data type

text

Alias
UMLS CUI [1]
C1527336
UMLS CUI [2,1]
C0022885
UMLS CUI [2,2]
C1272695
Sjogren's Syndrome - Test date
Description

Sjogren's Syndrome - Test date

Data type

date

Alias
UMLS CUI [1]
C1527336
UMLS CUI [2]
C2826247
Sjogren's Syndrome - Test Result
Description

Sjogren's Syndrome - Test Result

Data type

float

Alias
UMLS CUI [1]
C1527336
UMLS CUI [2]
C0587081
Sjogren's Syndrome - Test Units
Description

Sjogren's Syndrome - Test Units

Data type

text

Alias
UMLS CUI [1]
C1527336
UMLS CUI [2]
C1519795
Sjogren's Syndrome - Low Norm
Description

Sjogren's Syndrome - Low Norm

Data type

float

Alias
UMLS CUI [1]
C1527336
UMLS CUI [2,1]
C0086715
UMLS CUI [2,2]
C0205251
Sjogren's Syndrome - High Norm
Description

Sjogren's Syndrome - High Norm

Data type

float

Alias
UMLS CUI [1]
C1527336
UMLS CUI [2,1]
C0086715
UMLS CUI [2,2]
C0205250
Sjogren's Syndrome - Other Diagnostic Test Results
Description

Sjogren's Syndrome - Other Diagnostic Test Results

Alias
UMLS CUI-1
C1527336
UMLS CUI-2
C0456984
UMLS CUI-3
C0430022
UMLS CUI-4
C0205394
If any other diagnostic test results are available (i.e. Serological viral hepatitic tests, Serological liver enzymes), 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
UMLS CUI [2,1]
C0042721
UMLS CUI [2,2]
C0205473
UMLS CUI [2,3]
C0022885
UMLS CUI [3,1]
C1287351
UMLS CUI [3,2]
C0205473
Sjogren's Syndrome - Other Diagnostic Test Results
Description

Sjogren's Syndrome - Other Diagnostic Test Results

Alias
UMLS CUI-1
C1527336
UMLS CUI-2
C0456984
UMLS CUI-3
C0430022
UMLS CUI-4
C0205394
Sjogren's Syndrome - Test
Description

Sjogren's Syndrome - Test

Data type

text

Alias
UMLS CUI [1]
C1527336
UMLS CUI [2]
C2826273
Sjogren's Syndrome - Test date
Description

Sjogren's Syndrome - Test date

Data type

date

Alias
UMLS CUI [1]
C1527336
UMLS CUI [2]
C2826247
Sjogren's Syndrome - Test Result
Description

Sjogren's Syndrome - Test Result

Data type

float

Alias
UMLS CUI [1]
C1527336
UMLS CUI [2]
C0587081
Sjogren's Syndrome - Test Units
Description

Sjogren's Syndrome - Test Units

Data type

text

Alias
UMLS CUI [1]
C1527336
UMLS CUI [2]
C1519795
Sjogren's Syndrome - Low Norm
Description

Sjogren's Syndrome - Low Norm

Data type

float

Alias
UMLS CUI [1]
C1527336
UMLS CUI [2,1]
C0086715
UMLS CUI [2,2]
C0205251
Sjogren's Syndrome - High Norm
Description

Sjogren's Syndrome - High Norm

Data type

float

Alias
UMLS CUI [1]
C1527336
UMLS CUI [2,1]
C0086715
UMLS CUI [2,2]
C0205250
Sjogren's Syndrome - Other diagnostic Procedure
Description

Sjogren's Syndrome - Other diagnostic Procedure

Alias
UMLS CUI-1
C1527336
UMLS CUI-2
C0430022
UMLS CUI-3
C0205394
Describe any other diagnostic procedure supporting the diagnosis (Shirmer test, Sialography, Salivary gland scintigraphy, Ultranography of salivary gland, Magnetic resonance sialography, Minor salivary gland biopsy, Conjunctiva rose bengal staining, HLA typing)
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]
C3846158
UMLS CUI [4]
C1659593
UMLS CUI [5,1]
C0036098
UMLS CUI [5,2]
C0034606
UMLS CUI [6,1]
C0036098
UMLS CUI [6,2]
C3846158
UMLS CUI [7,1]
C0024485
UMLS CUI [7,2]
C1659593
UMLS CUI [8]
C0842619
UMLS CUI [9,1]
C1321948
UMLS CUI [9,2]
C0009758
UMLS CUI [10]
C0242318

Similar models

IMD Report - Rheumatic Diseases; Systemic Lupus Erythematosus or Cutaneous Lupus; Sjogren's Syndrome

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
Rheumatic Diseases
C3495832 (UMLS CUI-1)
Item
Rheumatic Diseases Diagnosis
integer
C3495832 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Code List
Rheumatic Diseases Diagnosis
CL Item
Rheumatoid arthritis (1)
CL Item
Juvenile rheumatoid arthritis (2)
CL Item
Polymyalgia rheumatica (3)
CL Item
Reactive arthritis (4)
CL Item
Reiter ‘s syndrome (5)
CL Item
Ankylosing spondylitis (6)
CL Item
Psoriatic arthritis (7)
CL Item
Undifferenciated spondylarthropathy (8)
CL Item
Other, specify (9)
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
Rheumatic Diseases - Signs and Symptoms
C3495832 (UMLS CUI-1)
C0037088 (UMLS CUI-2)
Item
Rheumatic Diseases - Signs and Symptoms
integer
C3495832 (UMLS CUI [1])
C0037088 (UMLS CUI [2])
Code List
Rheumatic Diseases - Signs and Symptoms
CL Item
Joints affected, specify number (1, 2, 3, 4 or ≥ 5) (1)
CL Item
Large joints affected (2)
CL Item
Small joints affected (3)
CL Item
Arthritis of hand (4)
CL Item
Arthritis symmetric (5)
CL Item
Arthritis asymmetric (6)
CL Item
Sacroiliitis (7)
CL Item
Spondylitis (8)
CL Item
Joint swelling (9)
CL Item
Joint stiffness (10)
CL Item
Morning stiffness (11)
CL Item
Enthesitis (12)
CL Item
Dactylitis (13)
CL Item
Nail lesions (14)
CL Item
Rheumatoid nodules (15)
CL Item
Fever (16)
CL Item
Weight loss (17)
CL Item
Swelling of lymph glands (18)
CL Item
Evanescent rash on trunk & extremities (19)
CL Item
Uveitis, iridocyclitis (20)
CL Item
Conjonctivitis (21)
CL Item
Psoriasis (22)
CL Item
Keratoderma blennorrhagica on palms and soles (23)
CL Item
Oral ulcers (24)
CL Item
Urogenital infection (25)
CL Item
Gastrointestinal infection (26)
CL Item
Vascular disorders, specify (27)
CL Item
Cardiac disorders, specify (28)
CL Item
Pulmonary disorders, specify (29)
CL Item
Renal disorders, specify (30)
CL Item
Gastrointestinal disorders, specify (31)
CL Item
Hematological disorders, specify (32)
Item
Rheumatic diseases - Specify number of joints affected
integer
C3495832 (UMLS CUI [1])
C0022417 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0237753 (UMLS CUI [3])
Code List
Rheumatic diseases - Specify number of joints affected
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
>=5 (5)
Rheumatic diseases - Specify vascular disorders
Item
Rheumatic diseases - Specify vascular disorders
text
C3495832 (UMLS CUI [1])
C0042373 (UMLS CUI [2])
Rheumatic diseases - Specify cardiac disorders
Item
Rheumatic diseases - Specify cardiac disorders
text
C3495832 (UMLS CUI [1])
C0018799 (UMLS CUI [2])
Rheumatic diseases - Specify pulmonary disorders
Item
Rheumatic diseases - Specify pulmonary disorders
text
C3495832 (UMLS CUI [1])
C0024115 (UMLS CUI [2])
Rheumatic diseases - Specify renal disorders
Item
Rheumatic diseases - Specify renal disorders
text
C3495832 (UMLS CUI [1])
C0022658 (UMLS CUI [2])
Rheumatic diseases - Specify gastrointestinal disorders
Item
Rheumatic diseases - Specify gastrointestinal disorders
text
C3495832 (UMLS CUI [1])
C0017178 (UMLS CUI [2])
Rheumatic diseases - Specify hematological disorders
Item
Rheumatic diseases - Specify hematological disorders
text
C3495832 (UMLS CUI [1])
C0018939 (UMLS CUI [2])
Item
Rheumatic diseases - Signs and Symptoms present
text
C3495832 (UMLS CUI [1])
C0037088 (UMLS CUI [2,1])
C0150312 (UMLS CUI [2,2])
Code List
Rheumatic diseases - Signs and Symptoms present
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
CL Item
Not Applicable (NA)
Rheumatic diseases - Signs and Symptoms start date
Item
Rheumatic diseases - Signs and Symptoms start date
date
C3495832 (UMLS CUI [1])
C0037088 (UMLS CUI [2,1])
C0808070 (UMLS CUI [2,2])
Rheumatic diseases - Signs and Symptoms end date
Item
Rheumatic diseases - Signs and Symptoms end date
date
C3495832 (UMLS CUI [1])
C0037088 (UMLS CUI [2,1])
C0806020 (UMLS CUI [2,2])
Item
Rheumatic diseases - Signs and Symptoms continuing at end of study
integer
C3495832 (UMLS CUI [1])
C0037088 (UMLS CUI [2])
C0549178 (UMLS CUI [3,1])
C0444496 (UMLS CUI [3,2])
Code List
Rheumatic diseases - Signs and Symptoms continuing at end of study
CL Item
Continuing at end of study (1)
Item Group
Rheumatic diseases - Other signs and symptoms
C3495832 (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])
Code List
If any other signs and symptoms, please tick the box and complete below
CL Item
Other signs and symptoms (1)
Item Group
Rheumatic diseases - Other signs and symptoms
C3495832 (UMLS CUI-1)
C0037088 (UMLS CUI-2)
C0205394 (UMLS CUI-3)
Rheumatic diseases - Other signs and symptoms
Item
Rheumatic diseases - Other signs and symptoms
text
C3495832 (UMLS CUI [1])
C0037088 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
Rheumatic diseases - Other signs and symptoms start date
Item
Rheumatic diseases - Other signs and symptoms start date
date
C3495832 (UMLS CUI [1])
C0037088 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0808070 (UMLS CUI [3])
Rheumatic diseases - Other signs and symptoms end date
Item
Rheumatic diseases - Other signs and symptoms end date
date
C3495832 (UMLS CUI [1])
C0037088 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0806020 (UMLS CUI [3])
Item
Rheumatic diseases - Other signs and symptoms continuing at end of study
integer
C3495832 (UMLS CUI [1])
C0037088 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0549178 (UMLS CUI [3,1])
C0444496 (UMLS CUI [3,2])
Code List
Rheumatic diseases - Other signs and symptoms continuing at end of study
CL Item
Continuing at end of study (1)
Item Group
Rheumatic diseases - Diagnostic Test Results
C3495832 (UMLS CUI-1)
C0456984 (UMLS CUI-2)
C0430022 (UMLS CUI-3)
Item
Rheumatic diseases - Test
integer
C3495832 (UMLS CUI [1])
C2826273 (UMLS CUI [2])
Code List
Rheumatic 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
Rheumatoid Factor (RF) (11)
CL Item
Anti-cyclic citrullinated peptide antibodies (12)
CL Item
(anti-CCP) (13)
CL Item
Anti-nuclear antibodies (ANA) (14)
Item
Rheumatic diseases - Test done
text
C3495832 (UMLS CUI [1])
C0022885 (UMLS CUI [2,1])
C1272695 (UMLS CUI [2,2])
Code List
Rheumatic diseases - Test done
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
CL Item
Not Applicable (NA)
Rheumatic diseases - Test date
Item
Rheumatic diseases - Test date
date
C3495832 (UMLS CUI [1])
C2826247 (UMLS CUI [2])
Rheumatic diseases - Test Result
Item
Rheumatic diseases - Test Result
float
C3495832 (UMLS CUI [1])
C0587081 (UMLS CUI [2])
Rheumatic diseases - Test Units
Item
Rheumatic diseases - Test Units
text
C3495832 (UMLS CUI [1])
C1519795 (UMLS CUI [2])
Rheumatic diseases - Low Norm
Item
Rheumatic diseases - Low Norm
float
C3495832 (UMLS CUI [1])
C0086715 (UMLS CUI [2,1])
C0205251 (UMLS CUI [2,2])
Rheumatic diseases - High Norm
Item
Rheumatic diseases - High Norm
float
C3495832 (UMLS CUI [1])
C0086715 (UMLS CUI [2,1])
C0205250 (UMLS CUI [2,2])
Item Group
Rheumatic diseases - Other Diagnostic Test Results
C3495832 (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])
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
Rheumatic diseases - Other Diagnostic Test Results
C3495832 (UMLS CUI-1)
C0456984 (UMLS CUI-2)
C0430022 (UMLS CUI-3)
C0205394 (UMLS CUI-4)
Rheumatic diseases - Test
Item
Rheumatic diseases - Test
text
C3495832 (UMLS CUI [1])
C2826273 (UMLS CUI [2])
Rheumatic diseases - Test date
Item
Rheumatic diseases - Test date
date
C3495832 (UMLS CUI [1])
C2826247 (UMLS CUI [2])
Rheumatic diseases - Test Result
Item
Rheumatic diseases - Test Result
float
C3495832 (UMLS CUI [1])
C0587081 (UMLS CUI [2])
Rheumatic diseases - Test Units
Item
Rheumatic diseases - Test Units
text
C3495832 (UMLS CUI [1])
C1519795 (UMLS CUI [2])
Rheumatic diseases - Low Norm
Item
Rheumatic diseases - Low Norm
float
C3495832 (UMLS CUI [1])
C0086715 (UMLS CUI [2,1])
C0205251 (UMLS CUI [2,2])
Rheumatic diseases - High Norm
Item
Rheumatic diseases - High Norm
float
C3495832 (UMLS CUI [1])
C0086715 (UMLS CUI [2,1])
C0205250 (UMLS CUI [2,2])
Item Group
Rheumatic diseases - Other diagnostic Procedure
C3495832 (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 (Radiographic evidence of RA, CT scan, MRI, Infectious investigations, HLA typing)
text
C0430022 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0011900 (UMLS CUI [2])
C1962945 (UMLS CUI [3,1])
C0003873 (UMLS CUI [3,2])
C3887511 (UMLS CUI [3,3])
C0040405 (UMLS CUI [4])
C0024485 (UMLS CUI [5])
C1261322 (UMLS CUI [6,1])
C3714514 (UMLS CUI [6,2])
C0242318 (UMLS CUI [7])
Item Group
Systemic Lupus Erythematosus or Cutaneous Lupus
C0024141 (UMLS CUI-1)
C0746306 (UMLS CUI-2)
Item
Systemic Lupus Erythematosus or Cutaneous Lupus - Diagnosis
integer
C0024141 (UMLS CUI [1])
C0746306 (UMLS CUI [2])
C0011900 (UMLS CUI [3])
Code List
Systemic Lupus Erythematosus or Cutaneous Lupus - Diagnosis
CL Item
Cutaneous lupus erythematosus (1)
CL Item
Systemic lupus erythematosus (2)
CL Item
Other, specify (3)
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
Systemic Lupus Erythematosus or Cutaneous Lupus - Signs and symptoms (supporting the final diagnosis)
C0024141 (UMLS CUI-1)
C0746306 (UMLS CUI-2)
C0037088 (UMLS CUI-3)
C1546485 (UMLS CUI-4)
Item
Systemic Lupus Erythematosus or Cutaneous Lupus - Signs and symptoms
integer
C0024141 (UMLS CUI [1])
C0746306 (UMLS CUI [2])
C0037088 (UMLS CUI [3])
Code List
Systemic Lupus Erythematosus or Cutaneous Lupus - Signs and symptoms
CL Item
Fatigue (1)
CL Item
Fever (2)
CL Item
Weight loss (3)
CL Item
Butterfly rash (4)
CL Item
Photosensitivity (Unusual skin reaction to light exposure) (5)
CL Item
Discoid rash (Raised rimmed lesions with keratotic scaling and follicular plugging) (6)
CL Item
Arthritis (small joints of hands, wrists, knee) (7)
CL Item
Migratory asymmetric pain (8)
CL Item
Oral ulcers (Oral or nasopharyngeal, usually painless; palate is most specific) (9)
CL Item
Pleurisy (10)
CL Item
Pericarditis (11)
CL Item
Seizures (12)
CL Item
Psychosis (13)
CL Item
Edema (14)
CL Item
Hypertension (15)
CL Item
Raynaud’s phenomenon (16)
Item
Systemic Lupus Erythematosus or Cutaneous Lupus - Signs and symptoms present
text
C0024141 (UMLS CUI [1])
C0746306 (UMLS CUI [2])
C0037088 (UMLS CUI [3])
C0150312 (UMLS CUI [4])
Code List
Systemic Lupus Erythematosus or Cutaneous Lupus - Signs and symptoms present
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
CL Item
Not Applicable (NA)
Systemic Lupus Erythematosus or Cutaneous Lupus - Signs and symptoms Start Date
Item
Systemic Lupus Erythematosus or Cutaneous Lupus - Signs and symptoms Start Date
date
C0024141 (UMLS CUI [1])
C0746306 (UMLS CUI [2])
C0037088 (UMLS CUI [3])
C0808070 (UMLS CUI [4])
Systemic Lupus Erythematosus or Cutaneous Lupus - Signs and symptoms End date
Item
Systemic Lupus Erythematosus or Cutaneous Lupus - Signs and symptoms End date
date
C0024141 (UMLS CUI [1])
C0746306 (UMLS CUI [2])
C0037088 (UMLS CUI [3])
C0806020 (UMLS CUI [4])
Item
Systemic Lupus Erythematosus or Cutaneous Lupus - Signs and symptoms continuing at the end of study
integer
C0024141 (UMLS CUI [1])
C0746306 (UMLS CUI [2])
C0037088 (UMLS CUI [3])
C0549178 (UMLS CUI [4,1])
C0444496 (UMLS CUI [4,2])
Code List
Systemic Lupus Erythematosus or Cutaneous Lupus - Signs and symptoms continuing at the end of study
CL Item
Continuing at end of study (1)
Item Group
Systemic Lupus Erythematosus or Cutaneous Lupus - Other Signs and symptoms
C0024141 (UMLS CUI-1)
C0746306 (UMLS CUI-3)
C0037088 (UMLS CUI-4)
C0205394 (UMLS CUI-5)
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])
Code List
If any other signs and symptoms, please tick the box and complete below
CL Item
Other signs and symptoms (1)
Item Group
Systemic Lupus Erythematosus or Cutaneous Lupus - Other Signs and symptoms
C0024141 (UMLS CUI-1)
C0746306 (UMLS CUI-3)
C0037088 (UMLS CUI-4)
C0205394 (UMLS CUI-5)
Systemic Lupus Erythematosus or Cutaneous Lupus - Other Signs and symptoms
Item
Systemic Lupus Erythematosus or Cutaneous Lupus - Other Signs and symptoms
text
C0024141 (UMLS CUI [1])
C0746306 (UMLS CUI [2])
C0037088 (UMLS CUI [3,1])
C0205394 (UMLS CUI [3,2])
Systemic Lupus Erythematosus or Cutaneous Lupus - Other Signs and symptoms Start Date
Item
Systemic Lupus Erythematosus or Cutaneous Lupus - Other Signs and symptoms Start Date
date
C0024141 (UMLS CUI [1])
C0746306 (UMLS CUI [2])
C0037088 (UMLS CUI [3,1])
C0205394 (UMLS CUI [3,2])
C0808070 (UMLS CUI [4])
Systemic Lupus Erythematosus or Cutaneous Lupus - Other Signs and symptoms End Date
Item
Systemic Lupus Erythematosus or Cutaneous Lupus - Other Signs and symptoms End Date
date
C0024141 (UMLS CUI [1])
C0746306 (UMLS CUI [2])
C0037088 (UMLS CUI [3,1])
C0205394 (UMLS CUI [3,2])
C0806020 (UMLS CUI [4])
Item Group
Systemic Lupus Erythematosus or Cutaneous Lupus - Diagnostic Test Results
C0024141 (UMLS CUI-1)
C0746306 (UMLS CUI-3)
C0456984 (UMLS CUI-4)
Item
Systemic Lupus Erythematosus or Cutaneous Lupus - Test
integer
C0024141 (UMLS CUI [1])
C0746306 (UMLS CUI [2])
C2826273 (UMLS CUI [3])
Code List
Systemic Lupus Erythematosus or Cutaneous Lupus - 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 urea nitrogen (11)
CL Item
Serum creatinine (12)
CL Item
Albuminuria (13)
CL Item
LMW proteinuria (14)
CL Item
Hematuria (15)
CL Item
Urine Red blood cell cast (16)
CL Item
Serum complement C3 (17)
CL Item
Serum complement C4 (18)
CL Item
Serum complement CH50 (19)
CL Item
Coombs test (20)
CL Item
Anti-nuclear antibodies (ANA) (21)
CL Item
Anti-dsDNA (22)
CL Item
Anti-Extractable nuclear antigen antibodies (anti-ENA) (23)
CL Item
Anti-Sm (24)
CL Item
Anti-nucleosomes (25)
CL Item
Anti-histone (26)
CL Item
Anti-SSA (Ro) (27)
CL Item
Anti-SSB (La) (28)
CL Item
Anti-ribosomal P (29)
CL Item
Anti-RNP (30)
CL Item
Anticardiolipin (ELISA) IgG (31)
CL Item
Anticardiolipin (ELISA) IgM (32)
CL Item
Anti-beta 2 glycoprotein I (33)
CL Item
Anti-prothrombin (34)
CL Item
Anti-neutophil cytoplasmic autoantibodies (ANCAs) (35)
CL Item
Anti-C1q (36)
CL Item
Rheumatoid factor (RF) (37)
Item
Systemic Lupus Erythematosus or Cutaneous Lupus - Test done
text
C0024141 (UMLS CUI [1])
C0746306 (UMLS CUI [2])
C0022885 (UMLS CUI [3,1])
C1272695 (UMLS CUI [3,2])
Code List
Systemic Lupus Erythematosus or Cutaneous Lupus - Test done
CL Item
Yes  (Y)
CL Item
No  (N)
CL Item
Unknown  (U)
CL Item
Not Applicable (NA)
Systemic Lupus Erythematosus or Cutaneous Lupus - Test date
Item
Systemic Lupus Erythematosus or Cutaneous Lupus - Test date
date
C0024141 (UMLS CUI [1])
C0746306 (UMLS CUI [2])
C2826247 (UMLS CUI [3])
Systemic Lupus Erythematosus or Cutaneous Lupus - Test Result
Item
Systemic Lupus Erythematosus or Cutaneous Lupus - Test Result
float
C0024141 (UMLS CUI [1])
C0746306 (UMLS CUI [2])
C0587081 (UMLS CUI [3])
Systemic Lupus Erythematosus or Cutaneous Lupus - Test Units
Item
Systemic Lupus Erythematosus or Cutaneous Lupus - Test Units
text
C0024141 (UMLS CUI [1])
C0746306 (UMLS CUI [2])
C1519795 (UMLS CUI [3])
Systemic Lupus Erythematosus or Cutaneous Lupus - Low Norm
Item
Systemic Lupus Erythematosus or Cutaneous Lupus - Low Norm
float
C0024141 (UMLS CUI [1])
C0746306 (UMLS CUI [2])
C0086715 (UMLS CUI [3,1])
C0205251 (UMLS CUI [3,2])
Systemic Lupus Erythematosus or Cutaneous Lupus - High Norm
Item
Systemic Lupus Erythematosus or Cutaneous Lupus - High Norm
float
C0024141 (UMLS CUI [1])
C0746306 (UMLS CUI [2])
C0086715 (UMLS CUI [3,1])
C0205250 (UMLS CUI [3,2])
Item Group
Systemic Lupus Erythematosus or Cutaneous Lupus - Other Diagnostic Test Results
C0024141 (UMLS CUI-1)
C0746306 (UMLS CUI-3)
C0456984 (UMLS CUI-4)
C0430022 (UMLS CUI-5)
C0205394 (UMLS CUI-6)
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])
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
Systemic Lupus Erythematosus or Cutaneous Lupus - Other Diagnostic Test Results
C0024141 (UMLS CUI-1)
C0746306 (UMLS CUI-3)
C0456984 (UMLS CUI-4)
C0430022 (UMLS CUI-5)
C0205394 (UMLS CUI-6)
Systemic Lupus Erythematosus or Cutaneous Lupus - Test
Item
Systemic Lupus Erythematosus or Cutaneous Lupus - Test
text
C0024141 (UMLS CUI [1])
C0746306 (UMLS CUI [2])
C2826273 (UMLS CUI [3])
Systemic Lupus Erythematosus or Cutaneous Lupus - Test date
Item
Systemic Lupus Erythematosus or Cutaneous Lupus - Test date
date
C0024141 (UMLS CUI [1])
C0746306 (UMLS CUI [2])
C2826247 (UMLS CUI [3])
Systemic Lupus Erythematosus or Cutaneous Lupus - Test Result
Item
Systemic Lupus Erythematosus or Cutaneous Lupus - Test Result
float
C0024141 (UMLS CUI [1])
C0746306 (UMLS CUI [2])
C0587081 (UMLS CUI [3])
Systemic Lupus Erythematosus or Cutaneous Lupus - Test Units
Item
Systemic Lupus Erythematosus or Cutaneous Lupus - Test Units
text
C0024141 (UMLS CUI [1])
C0746306 (UMLS CUI [2])
C1519795 (UMLS CUI [3])
Systemic Lupus Erythematosus or Cutaneous Lupus - Low Norm
Item
Systemic Lupus Erythematosus or Cutaneous Lupus - Low Norm
float
C0024141 (UMLS CUI [1])
C0746306 (UMLS CUI [2])
C0086715 (UMLS CUI [3,1])
C0205251 (UMLS CUI [3,2])
Systemic Lupus Erythematosus or Cutaneous Lupus - High Norm
Item
Systemic Lupus Erythematosus or Cutaneous Lupus - High Norm
float
C0024141 (UMLS CUI [1])
C0746306 (UMLS CUI [2])
C0086715 (UMLS CUI [3,1])
C0205250 (UMLS CUI [3,2])
Item Group
Systemic Lupus Erythematosus or Cutaneous Lupus - Other diagnostic Procedure
C0024141 (UMLS CUI-1)
C0746306 (UMLS CUI-3)
C0430022 (UMLS CUI-4)
C0205394 (UMLS CUI-5)
Describe any other diagnostic procedure supporting the diagnosis
Item
Describe any other diagnostic procedure supporting the diagnosis (Chest x-ray, Joint xRay, Brain MRI/MRA, Echocardiography, Lumbar puncture, Renal biopsy, Skin biopsy, HLA typing)
text
C0430022 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0011900 (UMLS CUI [2])
C0039985 (UMLS CUI [3])
C0043309 (UMLS CUI [4,1])
C0022417 (UMLS CUI [4,2])
C0412675 (UMLS CUI [5])
C0013516 (UMLS CUI [6])
C0037943 (UMLS CUI [7])
C0194073 (UMLS CUI [8])
C0150866 (UMLS CUI [9])
C0242318 (UMLS CUI [10])
Item Group
Sjogren's Syndrome
C1527336 (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
Sjogren's Syndrome - Signs and symptoms (supporting the final diagnosis)
C1527336 (UMLS CUI-1)
C0037088 (UMLS CUI-2)
C1546485 (UMLS CUI-3)
Item
Sjogren's Syndrome - Signs and symptoms
integer
C1527336 (UMLS CUI [1])
C0037088 (UMLS CUI [2])
Code List
Sjogren's Syndrome - Signs and symptoms
CL Item
Dry mouth (xerostomia) (1)
CL Item
Frequent carries (2)
CL Item
Oral candidiasis (3)
CL Item
Dry eyes (xerophalmia) (4)
CL Item
Blepharitis (5)
CL Item
Parotid gland enlargement (6)
CL Item
Parotidis (7)
CL Item
Dry cough (xerotrachea) (8)
CL Item
Nasal dryness (9)
CL Item
Atrophic rhinitis (10)
CL Item
Difficulty with swallowing (11)
CL Item
Raynaud’s phenomenon (12)
CL Item
Palpable purpura (13)
CL Item
Vaginal dryness (14)
CL Item
Skin dryness (15)
CL Item
Erhythema of nose and cheeks (16)
CL Item
Annular erythematous rash on face and neck (17)
CL Item
Vasculitis purpura (18)
CL Item
2-3 mm lesions on lower extremities (19)
CL Item
Urticarial vasculitis (20)
CL Item
Erythema multiforme–like lesions (21)
CL Item
Digital vasculitis (22)
CL Item
Petechiae (23)
CL Item
Erythema nodosum (24)
CL Item
Annular erythematous plaques (25)
CL Item
Arthritis (26)
CL Item
Joint pain (27)
CL Item
Joint swelling (28)
CL Item
Morning stiffness (29)
CL Item
Poly-articular arthritis (30)
CL Item
Symmetric arthritis (31)
CL Item
Peripheral sensory neuropathy symmetric (32)
CL Item
Peripheral sensory neuropathy asymmetric (33)
CL Item
Cranial neuropathy (34)
CL Item
Fatigue (35)
CL Item
Gastro-intestinal symptoms (36)
CL Item
Pulmonary symptoms (37)
CL Item
Renal disorders (38)
Item
Sjogren's Syndrome - Signs and symptoms present
text
C1527336 (UMLS CUI [1])
C0037088 (UMLS CUI [2])
C0150312 (UMLS CUI [3])
Code List
Sjogren's Syndrome - Signs and symptoms present
CL Item
Yes  (Y)
CL Item
No  (N)
CL Item
Unknown  (U)
CL Item
Not Applicable (NA)
Sjogren's Syndrome - Signs and symptoms Start Date
Item
Sjogren's Syndrome - Signs and symptoms Start Date
date
C1527336 (UMLS CUI [1])
C0037088 (UMLS CUI [2])
C0808070 (UMLS CUI [3])
Sjogren's Syndrome - Signs and symptoms End date
Item
Sjogren's Syndrome - Signs and symptoms End date
date
C1527336 (UMLS CUI [1])
C0037088 (UMLS CUI [2])
C0806020 (UMLS CUI [3])
Item
Sjogren's Syndrome - Signs and symptoms continuing at the end of study
integer
C1527336 (UMLS CUI [1])
C0037088 (UMLS CUI [2])
C0549178 (UMLS CUI [3,1])
C0444496 (UMLS CUI [3,2])
Code List
Sjogren's Syndrome - Signs and symptoms continuing at the end of study
CL Item
Continuing at end of study (1)
Item Group
Sjogren's Syndrome - Other Signs and symptoms
C1527336 (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])
Code List
If any other signs and symptoms, please tick the box and complete below
CL Item
Other signs and symptoms (1)
Item Group
Sjogren's Syndrome - Other Signs and symptoms
C1527336 (UMLS CUI-1)
C0037088 (UMLS CUI-2)
C0205394 (UMLS CUI-3)
Sjogren's Syndrome - Other Signs and symptoms
Item
Sjogren's Syndrome - Other Signs and symptoms
text
C1527336 (UMLS CUI [1])
C0037088 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
Sjogren's Syndrome - Other Signs and symptoms Start Date
Item
Sjogren's Syndrome - Other Signs and symptoms Start Date
date
C1527336 (UMLS CUI [1])
C0037088 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0808070 (UMLS CUI [3])
Sjogren's Syndrome - Other Signs and symptoms End Date
Item
Sjogren's Syndrome - Other Signs and symptoms End Date
date
C1527336 (UMLS CUI [1])
C0037088 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0806020 (UMLS CUI [3])
Item Group
Sjogren's Syndrome - Diagnostic Test Results
C1527336 (UMLS CUI-1)
C0456984 (UMLS CUI-2)
Item
Sjogren's Syndrome - Test
integer
C1527336 (UMLS CUI [1])
C2826273 (UMLS CUI [2])
Code List
Sjogren's 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
Serum urea nitrogen (11)
CL Item
Serum creatinine (12)
CL Item
Albuminuria (13)
CL Item
LMW proteinuria (14)
CL Item
Hematuria (15)
CL Item
Rheumatoid factor (RF) (16)
CL Item
Anti-nuclear antibodies (ANA) (17)
CL Item
Anti-SSA (Ro) (18)
CL Item
Anti-SSB (La) (19)
CL Item
Anti-alpha-fondrin antibodies (20)
CL Item
Anti-dsDNA (21)
CL Item
Anticardiolipin (ELISA) IgG (22)
CL Item
Anticardiolipin (ELISA) IgM (23)
CL Item
Anti-beta 2 glycoprotein I (24)
CL Item
Anti-prothrombin (25)
Item
Sjogren's Syndrome - Test done
text
C1527336 (UMLS CUI [1])
C0022885 (UMLS CUI [2,1])
C1272695 (UMLS CUI [2,2])
Code List
Sjogren's Syndrome - Test done
CL Item
Yes  (Y)
CL Item
No  (N)
CL Item
Unknown  (U)
CL Item
Not Applicable (NA)
Sjogren's Syndrome - Test date
Item
Sjogren's Syndrome - Test date
date
C1527336 (UMLS CUI [1])
C2826247 (UMLS CUI [2])
Sjogren's Syndrome - Test Result
Item
Sjogren's Syndrome - Test Result
float
C1527336 (UMLS CUI [1])
C0587081 (UMLS CUI [2])
Sjogren's Syndrome - Test Units
Item
Sjogren's Syndrome - Test Units
text
C1527336 (UMLS CUI [1])
C1519795 (UMLS CUI [2])
Sjogren's Syndrome - Low Norm
Item
Sjogren's Syndrome - Low Norm
float
C1527336 (UMLS CUI [1])
C0086715 (UMLS CUI [2,1])
C0205251 (UMLS CUI [2,2])
Sjogren's Syndrome - High Norm
Item
Sjogren's Syndrome - High Norm
float
C1527336 (UMLS CUI [1])
C0086715 (UMLS CUI [2,1])
C0205250 (UMLS CUI [2,2])
Item Group
Sjogren's Syndrome - Other Diagnostic Test Results
C1527336 (UMLS CUI-1)
C0456984 (UMLS CUI-2)
C0430022 (UMLS CUI-3)
C0205394 (UMLS CUI-4)
Item
If any other diagnostic test results are available (i.e. Serological viral hepatitic tests, Serological liver enzymes), please tick the box and complete below
integer
C0456984 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0042721 (UMLS CUI [2,1])
C0205473 (UMLS CUI [2,2])
C0022885 (UMLS CUI [2,3])
C1287351 (UMLS CUI [3,1])
C0205473 (UMLS CUI [3,2])
Code List
If any other diagnostic test results are available (i.e. Serological viral hepatitic tests, Serological liver enzymes), please tick the box and complete below
CL Item
Other diagnostic test results available (1)
Item Group
Sjogren's Syndrome - Other Diagnostic Test Results
C1527336 (UMLS CUI-1)
C0456984 (UMLS CUI-2)
C0430022 (UMLS CUI-3)
C0205394 (UMLS CUI-4)
Sjogren's Syndrome - Test
Item
Sjogren's Syndrome - Test
text
C1527336 (UMLS CUI [1])
C2826273 (UMLS CUI [2])
Sjogren's Syndrome - Test date
Item
Sjogren's Syndrome - Test date
date
C1527336 (UMLS CUI [1])
C2826247 (UMLS CUI [2])
Sjogren's Syndrome - Test Result
Item
Sjogren's Syndrome - Test Result
float
C1527336 (UMLS CUI [1])
C0587081 (UMLS CUI [2])
Sjogren's Syndrome - Test Units
Item
Sjogren's Syndrome - Test Units
text
C1527336 (UMLS CUI [1])
C1519795 (UMLS CUI [2])
Sjogren's Syndrome - Low Norm
Item
Sjogren's Syndrome - Low Norm
float
C1527336 (UMLS CUI [1])
C0086715 (UMLS CUI [2,1])
C0205251 (UMLS CUI [2,2])
Sjogren's Syndrome - High Norm
Item
Sjogren's Syndrome - High Norm
float
C1527336 (UMLS CUI [1])
C0086715 (UMLS CUI [2,1])
C0205250 (UMLS CUI [2,2])
Item Group
Sjogren's Syndrome - Other diagnostic Procedure
C1527336 (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 (Shirmer test, Sialography, Salivary gland scintigraphy, Ultranography of salivary gland, Magnetic resonance sialography, Minor salivary gland biopsy, Conjunctiva rose bengal staining, HLA typing)
text
C0430022 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0011900 (UMLS CUI [2])
C3846158 (UMLS CUI [3])
C1659593 (UMLS CUI [4])
C0036098 (UMLS CUI [5,1])
C0034606 (UMLS CUI [5,2])
C0036098 (UMLS CUI [6,1])
C3846158 (UMLS CUI [6,2])
C0024485 (UMLS CUI [7,1])
C1659593 (UMLS CUI [7,2])
C0842619 (UMLS CUI [8])
C1321948 (UMLS CUI [9,1])
C0009758 (UMLS CUI [9,2])
C0242318 (UMLS CUI [10])

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