ID

41535

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. 10/6/20 10/6/20 -
  2. 11/2/20 11/2/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 2, 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 - Scleroderma or Morphea; Dermatomyositis or Polymyositis; Diabetes mellitus Type I (Report Final and Annex Report 2 Final)

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
Scleroderma or Morphea
Description

Scleroderma or Morphea

Alias
UMLS CUI-1
C1527383
UMLS CUI-2
C0011644
Scleroderma or Morphea Diagnosis
Description

Scleroderma or Morphea Diagnosis

Data type

integer

Alias
UMLS CUI [1]
C1527383
UMLS CUI [2]
C0011644
UMLS CUI [3]
C0011900
Specify other diagnosis
Description

Specify other diagnosis

Data type

text

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

In case of serious adverse event

Data type

integer

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

In case of non-serious adverse event

Data type

integer

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

Date of final diagnosis:

Data type

date

Alias
UMLS CUI [1,1]
C2316983
UMLS CUI [1,2]
C1546485
Scleroderma or Morphea - Signs and Symptoms
Description

Scleroderma or Morphea - Signs and Symptoms

Alias
UMLS CUI-1
C1527383
UMLS CUI-2
C0011644
UMLS CUI-3
C0037088
Scleroderma or Morphea - Signs and Symptoms
Description

Scleroderma or Morphea - Signs and Symptoms

Data type

integer

Alias
UMLS CUI [1]
C1527383
UMLS CUI [2]
C0011644
UMLS CUI [3]
C0037088
Scleroderma or Morphea - Specify neurological disorders
Description

Scleroderma or Morphea - Specify neurological disorders

Data type

text

Alias
UMLS CUI [1]
C1527383
UMLS CUI [2]
C0011644
UMLS CUI [3]
C0027765
Scleroderma or Morphea - Signs and Symptoms present
Description

Scleroderma or Morphea - Signs and Symptoms present

Data type

text

Alias
UMLS CUI [1]
C1527383
UMLS CUI [2]
C0011644
UMLS CUI [3,1]
C0037088
UMLS CUI [3,2]
C0150312
Scleroderma or Morphea - Signs and Symptoms start date
Description

Scleroderma or Morphea - Signs and Symptoms start date

Data type

date

Alias
UMLS CUI [1]
C1527383
UMLS CUI [2]
C0011644
UMLS CUI [3,1]
C0037088
UMLS CUI [3,2]
C0808070
Scleroderma or Morphea - Signs and Symptoms end date
Description

Scleroderma or Morphea - Signs and Symptoms end date

Data type

date

Alias
UMLS CUI [1]
C1527383
UMLS CUI [2]
C0011644
UMLS CUI [3,1]
C0037088
UMLS CUI [3,2]
C0806020
Scleroderma or Morphea - Signs and Symptoms continuing at end of study
Description

Scleroderma or Morphea - Signs and Symptoms continuing at end of study

Data type

integer

Alias
UMLS CUI [1]
C1527383
UMLS CUI [2]
C0011644
UMLS CUI [3]
C0037088
UMLS CUI [4,1]
C0549178
UMLS CUI [4,2]
C0444496
Scleroderma or Morphea - Other signs and symptoms
Description

Scleroderma or Morphea - Other signs and symptoms

Alias
UMLS CUI-1
C1527383
UMLS CUI-3
C0011644
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
Scleroderma or Morphea - Other signs and symptoms
Description

Scleroderma or Morphea - Other signs and symptoms

Alias
UMLS CUI-1
C1527383
UMLS CUI-3
C0011644
UMLS CUI-4
C0037088
UMLS CUI-5
C0205394
Scleroderma or Morphea - Other signs and symptoms
Description

Scleroderma or Morphea - Other signs and symptoms

Data type

text

Alias
UMLS CUI [1]
C1527383
UMLS CUI [2]
C0011644
UMLS CUI [3,1]
C0037088
UMLS CUI [3,2]
C0205394
Scleroderma or Morphea - Other signs and symptoms start date
Description

Scleroderma or Morphea - Other signs and symptoms start date

Data type

date

Alias
UMLS CUI [1]
C1527383
UMLS CUI [2]
C0011644
UMLS CUI [3,1]
C0037088
UMLS CUI [3,2]
C0205394
UMLS CUI [4]
C0808070
Scleroderma or Morphea - Other signs and symptoms end date
Description

Scleroderma or Morphea - Other signs and symptoms end date

Data type

date

Alias
UMLS CUI [1]
C1527383
UMLS CUI [2]
C0011644
UMLS CUI [3,1]
C0037088
UMLS CUI [3,2]
C0205394
UMLS CUI [4]
C0806020
Scleroderma or Morphea - Other signs and symptoms continuing at end of study
Description

Scleroderma or Morphea - Other signs and symptoms continuing at end of study

Data type

integer

Alias
UMLS CUI [1]
C1527383
UMLS CUI [2]
C0011644
UMLS CUI [3,1]
C0037088
UMLS CUI [3,2]
C0205394
UMLS CUI [4,1]
C0549178
UMLS CUI [4,2]
C0444496
Scleroderma or Morphea - Diagnostic Test Results
Description

Scleroderma or Morphea - Diagnostic Test Results

Alias
UMLS CUI-1
C1527383
UMLS CUI-3
C0011644
UMLS CUI-4
C0456984
UMLS CUI-5
C0430022
Scleroderma or Morphea - Test
Description

Scleroderma or Morphea - Test

Data type

integer

Alias
UMLS CUI [1]
C1527383
UMLS CUI [2]
C0011644
UMLS CUI [3]
C2826273
Scleroderma or Morphea - Test done
Description

Scleroderma or Morphea - Test done

Data type

text

Alias
UMLS CUI [1]
C1527383
UMLS CUI [2]
C0011644
UMLS CUI [3,1]
C0022885
UMLS CUI [3,2]
C1272695
Scleroderma or Morphea - Test date
Description

Scleroderma or Morphea - Test date

Data type

date

Alias
UMLS CUI [1]
C1527383
UMLS CUI [2]
C0011644
UMLS CUI [3]
C2826247
Scleroderma or Morphea - Test Result
Description

Scleroderma or Morphea - Test Result

Data type

float

Alias
UMLS CUI [1]
C1527383
UMLS CUI [2]
C0011644
UMLS CUI [3]
C0587081
Scleroderma or Morphea - Test Units
Description

Scleroderma or Morphea - Test Units

Data type

text

Alias
UMLS CUI [1]
C1527383
UMLS CUI [2]
C0011644
UMLS CUI [3]
C1519795
Scleroderma or Morphea - Low Norm
Description

Scleroderma or Morphea - Low Norm

Data type

float

Alias
UMLS CUI [1]
C1527383
UMLS CUI [2]
C0011644
UMLS CUI [3,1]
C0086715
UMLS CUI [3,2]
C0205251
Scleroderma or Morphea - High Norm
Description

Scleroderma or Morphea - High Norm

Data type

float

Alias
UMLS CUI [1]
C1527383
UMLS CUI [2]
C0011644
UMLS CUI [3,1]
C0086715
UMLS CUI [3,2]
C0205250
Scleroderma or Morphea - Other Diagnostic Test Results
Description

Scleroderma or Morphea - Other Diagnostic Test Results

Alias
UMLS CUI-1
C1527383
UMLS CUI-3
C0011644
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
Scleroderma or Morphea - Other Diagnostic Test Results
Description

Scleroderma or Morphea - Other Diagnostic Test Results

Alias
UMLS CUI-1
C1527383
UMLS CUI-3
C0011644
UMLS CUI-4
C0456984
UMLS CUI-5
C0430022
UMLS CUI-6
C0205394
Scleroderma or Morphea - Test
Description

Scleroderma or Morphea - Test

Data type

text

Alias
UMLS CUI [1]
C1527383
UMLS CUI [2]
C0011644
UMLS CUI [3]
C2826273
Scleroderma or Morphea - Test date
Description

Scleroderma or Morphea - Test date

Data type

date

Alias
UMLS CUI [1]
C1527383
UMLS CUI [2]
C0011644
UMLS CUI [3]
C2826247
Scleroderma or Morphea - Test Result
Description

Scleroderma or Morphea - Test Result

Data type

float

Alias
UMLS CUI [1]
C1527383
UMLS CUI [2]
C0011644
UMLS CUI [3]
C0587081
Scleroderma or Morphea - Test Units
Description

Scleroderma or Morphea - Test Units

Data type

text

Alias
UMLS CUI [1]
C1527383
UMLS CUI [2]
C0011644
UMLS CUI [3]
C1519795
Scleroderma or Morphea - Low Norm
Description

Scleroderma or Morphea - Low Norm

Data type

float

Alias
UMLS CUI [1]
C1527383
UMLS CUI [2]
C0011644
UMLS CUI [3,1]
C0086715
UMLS CUI [3,2]
C0205251
Scleroderma or Morphea - High Norm
Description

Scleroderma or Morphea - High Norm

Data type

float

Alias
UMLS CUI [1]
C1527383
UMLS CUI [2]
C0011644
UMLS CUI [3,1]
C0086715
UMLS CUI [3,2]
C0205250
Scleroderma or Morphea - Other diagnostic Procedure
Description

Scleroderma or Morphea - Other diagnostic Procedure

Alias
UMLS CUI-1
C1527383
UMLS CUI-3
C0011644
UMLS CUI-4
C0430022
UMLS CUI-5
C0205394
Describe any other diagnostic procedure supporting the diagnosis (Chest X-Ray, Chest CT scan, Echocardiography, Right heart catheterization, Oesophagraphy, Lung functional test, Skin biopsy, Intravital capillaroscopy, Hepatitic tests, 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]
C0202823
UMLS CUI [5]
C0013516
UMLS CUI [6]
C0189896
UMLS CUI [7]
C1318509
UMLS CUI [8]
C0024119
UMLS CUI [9]
C0150866
UMLS CUI [10,1]
C0430501
UMLS CUI [10,2]
C0596795
UMLS CUI [11,1]
C0019158
UMLS CUI [11,2]
C0022885
UMLS CUI [12]
C0242318
Dermatomyositis or Polymyositis
Description

Dermatomyositis or Polymyositis

Alias
UMLS CUI-1
C0011633
UMLS CUI-2
C0085655
Dermatomyositis or Polymyositis - Diagnosis
Description

Dermatomyositis or Polymyositis - Diagnosis

Data type

integer

Alias
UMLS CUI [1]
C0011633
UMLS CUI [2]
C0085655
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
Dermatomyositis or Polymyositis - Signs and symptoms (supporting the final diagnosis)
Description

Dermatomyositis or Polymyositis - Signs and symptoms (supporting the final diagnosis)

Alias
UMLS CUI-1
C0011633
UMLS CUI-3
C0085655
UMLS CUI-4
C0037088
UMLS CUI-5
C1546485
Dermatomyositis or Polymyositis - Signs and symptoms
Description

Dermatomyositis or Polymyositis - Signs and symptoms

Data type

integer

Alias
UMLS CUI [1]
C0011633
UMLS CUI [2]
C0085655
UMLS CUI [3]
C0037088
Dermatomyositis or Polymyositis - Specify localization of Gottron’s Papules
Description

Dermatomyositis or Polymyositis - Specify localization of Gottron’s Papules

Data type

text

Alias
UMLS CUI [1]
C0011633
UMLS CUI [2]
C0085655
UMLS CUI [3,1]
C0475264
UMLS CUI [3,2]
C0332563
Dermatomyositis or Polymyositis - Specify localization of erythema
Description

Dermatomyositis or Polymyositis - Specify localization of erythema

Data type

text

Alias
UMLS CUI [1]
C0011633
UMLS CUI [2]
C0085655
UMLS CUI [3,1]
C0475264
UMLS CUI [3,2]
C0041834
Dermatomyositis or Polymyositis - Specify localization of Arthritis
Description

Dermatomyositis or Polymyositis - Specify localization of Arthritis

Data type

text

Alias
UMLS CUI [1]
C0011633
UMLS CUI [2]
C0085655
UMLS CUI [3,1]
C0475264
UMLS CUI [3,2]
C0003864
Dermatomyositis or Polymyositis - Signs and symptoms present
Description

Dermatomyositis or Polymyositis - Signs and symptoms present

Data type

text

Alias
UMLS CUI [1]
C0011633
UMLS CUI [2]
C0085655
UMLS CUI [3]
C0037088
UMLS CUI [4]
C0150312
Dermatomyositis or Polymyositis - Signs and symptoms Start Date
Description

Dermatomyositis or Polymyositis - Signs and symptoms Start Date

Data type

date

Alias
UMLS CUI [1]
C0011633
UMLS CUI [2]
C0085655
UMLS CUI [3]
C0037088
UMLS CUI [4]
C0808070
Dermatomyositis or Polymyositis - Signs and symptoms End date
Description

Dermatomyositis or Polymyositis - Signs and symptoms End date

Data type

date

Alias
UMLS CUI [1]
C0011633
UMLS CUI [2]
C0085655
UMLS CUI [3]
C0037088
UMLS CUI [4]
C0806020
Dermatomyositis or Polymyositis - Signs and symptoms continuing at the end of study
Description

Dermatomyositis or Polymyositis - Signs and symptoms continuing at the end of study

Data type

integer

Alias
UMLS CUI [1]
C0011633
UMLS CUI [2]
C0085655
UMLS CUI [3]
C0037088
UMLS CUI [4,1]
C0549178
UMLS CUI [4,2]
C0444496
Dermatomyositis or Polymyositis - Other Signs and symptoms
Description

Dermatomyositis or Polymyositis - Other Signs and symptoms

Alias
UMLS CUI-1
C0011633
UMLS CUI-3
C0085655
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
Dermatomyositis or Polymyositis - Other Signs and symptoms
Description

Dermatomyositis or Polymyositis - Other Signs and symptoms

Alias
UMLS CUI-1
C0011633
UMLS CUI-3
C0085655
UMLS CUI-5
C0037088
UMLS CUI-6
C0205394
Dermatomyositis or Polymyositis - Other Signs and symptoms
Description

Dermatomyositis or Polymyositis - Other Signs and symptoms

Data type

text

Alias
UMLS CUI [1]
C0011633
UMLS CUI [2]
C0085655
UMLS CUI [3,1]
C0037088
UMLS CUI [3,2]
C0205394
Dermatomyositis or Polymyositis - Other Signs and symptoms Start Date
Description

Dermatomyositis or Polymyositis - Other Signs and symptoms Start Date

Data type

date

Alias
UMLS CUI [1]
C0011633
UMLS CUI [2]
C0085655
UMLS CUI [3,1]
C0037088
UMLS CUI [3,2]
C0205394
UMLS CUI [4]
C0808070
Dermatomyositis or Polymyositis - Other Signs and symptoms End Date
Description

Dermatomyositis or Polymyositis - Other Signs and symptoms End Date

Data type

date

Alias
UMLS CUI [1]
C0011633
UMLS CUI [2]
C0085655
UMLS CUI [3,1]
C0037088
UMLS CUI [3,2]
C0205394
UMLS CUI [4]
C0806020
Dermatomyositis or Polymyositis - Other signs and symptoms continuing at the end of study
Description

Dermatomyositis or Polymyositis - Other signs and symptoms continuing at the end of study

Data type

text

Alias
UMLS CUI [1]
C0011633
UMLS CUI [2]
C0085655
UMLS CUI [3,1]
C0037088
UMLS CUI [3,2]
C0205394
UMLS CUI [4,1]
C0549178
UMLS CUI [4,2]
C0444496
Dermatomyositis or Polymyositis - Diagnostic Test Results
Description

Dermatomyositis or Polymyositis - Diagnostic Test Results

Alias
UMLS CUI-1
C0011633
UMLS CUI-3
C0085655
UMLS CUI-4
C0456984
Dermatomyositis or Polymyositis - Test
Description

Dermatomyositis or Polymyositis - Test

Data type

integer

Alias
UMLS CUI [1]
C0011633
UMLS CUI [2]
C0085655
UMLS CUI [3]
C2826273
Dermatomyositis or Polymyositis - Test done
Description

Dermatomyositis or Polymyositis - Test done

Data type

text

Alias
UMLS CUI [1]
C0011633
UMLS CUI [2]
C0085655
UMLS CUI [3,1]
C0022885
UMLS CUI [3,2]
C1272695
Dermatomyositis or Polymyositis - Test date
Description

Dermatomyositis or Polymyositis - Test date

Data type

date

Alias
UMLS CUI [1]
C0011633
UMLS CUI [2]
C0085655
UMLS CUI [3]
C2826247
Dermatomyositis or Polymyositis - Test Result
Description

Dermatomyositis or Polymyositis - Test Result

Data type

float

Alias
UMLS CUI [1]
C0011633
UMLS CUI [2]
C0085655
UMLS CUI [3]
C0587081
Dermatomyositis or Polymyositis - Test Units
Description

Dermatomyositis or Polymyositis - Test Units

Data type

text

Alias
UMLS CUI [1]
C0011633
UMLS CUI [2]
C0085655
UMLS CUI [3]
C1519795
Dermatomyositis or Polymyositis - Low Norm
Description

Dermatomyositis or Polymyositis - Low Norm

Data type

float

Alias
UMLS CUI [1]
C0011633
UMLS CUI [2]
C0085655
UMLS CUI [3,1]
C0086715
UMLS CUI [3,2]
C0205251
Dermatomyositis or Polymyositis - High Norm
Description

Dermatomyositis or Polymyositis - High Norm

Data type

float

Alias
UMLS CUI [1]
C0011633
UMLS CUI [2]
C0085655
UMLS CUI [3,1]
C0086715
UMLS CUI [3,2]
C0205250
Dermatomyositis or Polymyositis - Other Diagnostic Test Results
Description

Dermatomyositis or Polymyositis - Other Diagnostic Test Results

Alias
UMLS CUI-1
C0011633
UMLS CUI-2
C0085655
UMLS CUI-3
C0456984
UMLS CUI-4
C0430022
UMLS CUI-5
C0205394
If any other diagnostic test results are available, please tick the box and complete below
Description

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

Data type

integer

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

Dermatomyositis or Polymyositis - Other Diagnostic Test Results

Alias
UMLS CUI-1
C0011633
UMLS CUI-2
C0085655
UMLS CUI-3
C0456984
UMLS CUI-4
C0430022
UMLS CUI-5
C0205394
Dermatomyositis or Polymyositis - Test
Description

Dermatomyositis or Polymyositis - Test

Data type

text

Alias
UMLS CUI [1]
C0011633
UMLS CUI [2]
C0085655
UMLS CUI [3]
C2826273
Dermatomyositis or Polymyositis - Test date
Description

Dermatomyositis or Polymyositis - Test date

Data type

date

Alias
UMLS CUI [1]
C0011633
UMLS CUI [2]
C0085655
UMLS CUI [3]
C2826247
Dermatomyositis or Polymyositis - Test Result
Description

Dermatomyositis or Polymyositis - Test Result

Data type

float

Alias
UMLS CUI [1]
C0011633
UMLS CUI [2]
C0085655
UMLS CUI [3]
C0587081
Dermatomyositis or Polymyositis - Test Units
Description

Dermatomyositis or Polymyositis - Test Units

Data type

text

Alias
UMLS CUI [1]
C0011633
UMLS CUI [2]
C0085655
UMLS CUI [3]
C1519795
Dermatomyositis or Polymyositis - Low Norm
Description

Dermatomyositis or Polymyositis - Low Norm

Data type

float

Alias
UMLS CUI [1]
C0011633
UMLS CUI [2]
C0085655
UMLS CUI [3,1]
C0086715
UMLS CUI [3,2]
C0205251
Dermatomyositis or Polymyositis - High Norm
Description

Dermatomyositis or Polymyositis - High Norm

Data type

float

Alias
UMLS CUI [1]
C0011633
UMLS CUI [2]
C0085655
UMLS CUI [3,1]
C0086715
UMLS CUI [3,2]
C0205250
Dermatomyositis or Polymyositis - Other diagnostic Procedure
Description

Dermatomyositis or Polymyositis - Other diagnostic Procedure

Alias
UMLS CUI-1
C0011633
UMLS CUI-3
C0085655
UMLS CUI-4
C0430022
UMLS CUI-5
C0205394
Describe any other diagnostic procedure supporting the diagnosis (Muscle MRI, Electromyography, Muscle Ultra sound, Skin biopsy, CT scan, Chest x-Ray, Barium enema)
Description

Describe any other diagnostic procedure supporting the diagnosis

Data type

text

Alias
UMLS CUI [1,1]
C0430022
UMLS CUI [1,2]
C0205394
UMLS CUI [2]
C0011900
UMLS CUI [3]
C0024485
UMLS CUI [4]
C0026845
UMLS CUI [5]
C0013839
UMLS CUI [6,1]
C1456803
UMLS CUI [6,2]
C0026845
UMLS CUI [7]
C0150866
UMLS CUI [8]
C0040405
UMLS CUI [9]
C0039985
UMLS CUI [10]
C0203075
Diabetes mellitus type I
Description

Diabetes mellitus type I

Alias
UMLS CUI-1
C0011854
Diabetes mellitus type I - Diagnosis
Description

Please tick appropriate diagnosis

Data type

integer

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0011900
Diabetes mellitus type I - Specify other diagnosis
Description

Diabetes mellitus type I - Specify other diagnosis

Data type

text

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2,1]
C0011900
UMLS CUI [2,2]
C0205394
Please specify related adverse event: SAE Case No.
Description

In case of serious adverse event

Data type

integer

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

In case of non-serious adverse event

Data type

text

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

Date of final diagnosis:

Data type

date

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

Diabetes mellitus type I - Signs and symptoms (supporting the final diagnosis)

Alias
UMLS CUI-1
C0011854
UMLS CUI-2
C0037088
UMLS CUI-3
C1546485
Diabetes mellitus type I - Signs and symptoms
Description

(supporting the final diagnosis)

Data type

integer

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0037088
Diabetes mellitus type I - Signs and symptoms present
Description

Diabetes mellitus type I - Signs and symptoms present

Data type

text

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0037088
UMLS CUI [3]
C0150312
Diabetes mellitus type I - Signs and symptoms Start Date
Description

Diabetes mellitus type I - Signs and symptoms Start Date

Data type

date

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0037088
UMLS CUI [3]
C0808070
Diabetes mellitus type I - Signs and symptoms End date
Description

Diabetes mellitus type I - Signs and symptoms End date

Data type

date

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0037088
UMLS CUI [3]
C0806020
Diabetes mellitus type I - Signs and symptoms continuing at the end of study
Description

Diabetes mellitus type I - Signs and symptoms continuing at the end of study

Data type

integer

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0037088
UMLS CUI [3,1]
C0549178
UMLS CUI [3,2]
C0444496
Diabetes mellitus type I - Other Signs and symptoms
Description

Diabetes mellitus type I - Other Signs and symptoms

Alias
UMLS CUI-1
C0011854
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
Diabetes mellitus type I - Other Signs and symptoms
Description

Diabetes mellitus type I - Other Signs and symptoms

Alias
UMLS CUI-1
C0011854
UMLS CUI-2
C0037088
UMLS CUI-3
C0205394
Diabetes mellitus type I - Other Signs and symptoms
Description

Diabetes mellitus type I - Other Signs and symptoms

Data type

text

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2,1]
C0037088
UMLS CUI [2,2]
C0205394
Diabetes mellitus type I - Other Signs and symptoms Start Date
Description

Diabetes mellitus type I - Other Signs and symptoms Start Date

Data type

date

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2,1]
C0037088
UMLS CUI [2,2]
C0205394
UMLS CUI [3]
C0808070
Diabetes mellitus type I - Other Signs and symptoms End Date
Description

Diabetes mellitus type I - Other Signs and symptoms End Date

Data type

date

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2,1]
C0037088
UMLS CUI [2,2]
C0205394
UMLS CUI [3]
C0806020
Diabetes mellitus type I - Other signs and symptoms continuing at the end of study
Description

Diabetes mellitus type I - Other signs and symptoms continuing at the end of study

Data type

text

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2,1]
C0037088
UMLS CUI [2,2]
C0205394
UMLS CUI [3,1]
C0549178
UMLS CUI [3,2]
C0444496
Diabetes mellitus type I - Diagnostic Test Results
Description

Diabetes mellitus type I - Diagnostic Test Results

Alias
UMLS CUI-1
C0011854
UMLS CUI-2
C0456984
Diabetes mellitus type I - Test
Description

Diabetes mellitus type I - Test

Data type

integer

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C2826273
Diabetes mellitus type I - Test done
Description

Diabetes mellitus type I - Test done

Data type

text

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2,1]
C0022885
UMLS CUI [2,2]
C1272695
Diabetes mellitus type I - Test date
Description

Diabetes mellitus type I - Test date

Data type

date

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C2826247
Diabetes mellitus type I - Test Result
Description

Diabetes mellitus type I - Test Result

Data type

float

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0587081
Diabetes mellitus type I - Test Units
Description

Diabetes mellitus type I - Test Units

Data type

text

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C1519795
Diabetes mellitus type I - Low Norm
Description

Diabetes mellitus type I - Low Norm

Data type

float

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2,1]
C0086715
UMLS CUI [2,2]
C0205251
Diabetes mellitus type I - High Norm
Description

Diabetes mellitus type I - High Norm

Data type

float

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2,1]
C0086715
UMLS CUI [2,2]
C0205250
Diabetes mellitus type I - Other Diagnostic Test Results
Description

Diabetes mellitus type I - Other Diagnostic Test Results

Alias
UMLS CUI-1
C0011854
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
Diabetes mellitus type I - Other Diagnostic Test Results
Description

Diabetes mellitus type I - Other Diagnostic Test Results

Alias
UMLS CUI-1
C0011854
UMLS CUI-2
C0456984
UMLS CUI-3
C0430022
UMLS CUI-4
C0205394
Diabetes mellitus type I - Test
Description

Diabetes mellitus type I - Test

Data type

text

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C2826273
Diabetes mellitus type I - Test date
Description

Diabetes mellitus type I - Test date

Data type

date

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C2826247
Diabetes mellitus type I - Test Result
Description

Diabetes mellitus type I - Test Result

Data type

float

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0587081
Diabetes mellitus type I - Test Units
Description

Diabetes mellitus type I - Test Units

Data type

text

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C1519795
Diabetes mellitus type I - Low Norm
Description

Diabetes mellitus type I - Low Norm

Data type

float

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2,1]
C0086715
UMLS CUI [2,2]
C0205251
Diabetes mellitus type I - High Norm
Description

Diabetes mellitus type I - High Norm

Data type

float

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2,1]
C0086715
UMLS CUI [2,2]
C0205250
Diabetes mellitus type I - Other diagnostic Procedure
Description

Diabetes mellitus type I - Other diagnostic Procedure

Alias
UMLS CUI-1
C0011854
UMLS CUI-2
C0430022
UMLS CUI-3
C0205394
Describe any other diagnostic procedure supporting the diagnosis (Thyroid tests, other…)
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]
C0040130

Similar models

IMD Report - Scleroderma or Morphea; Dermatomyositis or Polymyositis; Diabetes mellitus Type I (Report Final and Annex Report 2 Final)

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
Scleroderma or Morphea
C1527383 (UMLS CUI-1)
C0011644 (UMLS CUI-2)
Item
Scleroderma or Morphea Diagnosis
integer
C1527383 (UMLS CUI [1])
C0011644 (UMLS CUI [2])
C0011900 (UMLS CUI [3])
Code List
Scleroderma or Morphea Diagnosis
CL Item
Scleroderma (1)
CL Item
Morphea (2)
CL Item
Other, specify (3)
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
Scleroderma or Morphea - Signs and Symptoms
C1527383 (UMLS CUI-1)
C0011644 (UMLS CUI-2)
C0037088 (UMLS CUI-3)
Item
Scleroderma or Morphea - Signs and Symptoms
integer
C1527383 (UMLS CUI [1])
C0011644 (UMLS CUI [2])
C0037088 (UMLS CUI [3])
Code List
Scleroderma or Morphea - Signs and Symptoms
CL Item
Fatigue (1)
CL Item
Fever (2)
CL Item
Weight loss (3)
CL Item
Proximal scleroderma (symmetric thickening, tightening, and induration of the skin) - Fingers and metacarpophalangeal joints (4)
CL Item
Proximal scleroderma (symmetric thickening, tightening, and induration of the skin) - Metatarsophalangeal joints (5)
CL Item
Proximal scleroderma (symmetric thickening, tightening, and induration of the skin) - Face (6)
CL Item
Proximal scleroderma (symmetric thickening, tightening, and induration of the skin) - Neck (7)
CL Item
Proximal scleroderma (symmetric thickening, tightening, and induration of the skin) - Trunk (8)
CL Item
Digital pitting scars or loss of substance from the finger pad (9)
CL Item
Bibasilar pulmonary fibrosis (bilateral reticular pattern of linear or lineonodular densities most pronounced in basilar portions of the lungs, diffuse mottling or a honeycomb lung on X-ray) (10)
CL Item
Diffuse pruritus (11)
CL Item
Pigmentation changes (12)
CL Item
Raynaud’s phenomenon (13)
CL Item
Diarrhea (14)
CL Item
Constipation (15)
CL Item
Dyspesia (16)
CL Item
Gastroesophageal reflux (17)
CL Item
Dyspnea (18)
CL Item
Precordial chest pain (due to pulmonary hypertension) (19)
CL Item
Dry persistent cough (20)
CL Item
Palpitation (21)
CL Item
Arthralgia (22)
CL Item
Myalgia (23)
CL Item
Muscle weakness (24)
CL Item
Carpal tunnel syndrome (25)
CL Item
Renal crisis (26)
CL Item
Salivary production decreased (27)
CL Item
Neurological disorders: specify (28)
Scleroderma or Morphea - Specify neurological disorders
Item
Scleroderma or Morphea - Specify neurological disorders
text
C1527383 (UMLS CUI [1])
C0011644 (UMLS CUI [2])
C0027765 (UMLS CUI [3])
Item
Scleroderma or Morphea - Signs and Symptoms present
text
C1527383 (UMLS CUI [1])
C0011644 (UMLS CUI [2])
C0037088 (UMLS CUI [3,1])
C0150312 (UMLS CUI [3,2])
Code List
Scleroderma or Morphea - Signs and Symptoms present
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
CL Item
Not Applicable (NA)
Scleroderma or Morphea - Signs and Symptoms start date
Item
Scleroderma or Morphea - Signs and Symptoms start date
date
C1527383 (UMLS CUI [1])
C0011644 (UMLS CUI [2])
C0037088 (UMLS CUI [3,1])
C0808070 (UMLS CUI [3,2])
Scleroderma or Morphea - Signs and Symptoms end date
Item
Scleroderma or Morphea - Signs and Symptoms end date
date
C1527383 (UMLS CUI [1])
C0011644 (UMLS CUI [2])
C0037088 (UMLS CUI [3,1])
C0806020 (UMLS CUI [3,2])
Item
Scleroderma or Morphea - Signs and Symptoms continuing at end of study
integer
C1527383 (UMLS CUI [1])
C0011644 (UMLS CUI [2])
C0037088 (UMLS CUI [3])
C0549178 (UMLS CUI [4,1])
C0444496 (UMLS CUI [4,2])
Code List
Scleroderma or Morphea - Signs and Symptoms continuing at end of study
CL Item
Continuing at end of study (1)
Item Group
Scleroderma or Morphea - Other signs and symptoms
C1527383 (UMLS CUI-1)
C0011644 (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
Scleroderma or Morphea - Other signs and symptoms
C1527383 (UMLS CUI-1)
C0011644 (UMLS CUI-3)
C0037088 (UMLS CUI-4)
C0205394 (UMLS CUI-5)
Scleroderma or Morphea - Other signs and symptoms
Item
Scleroderma or Morphea - Other signs and symptoms
text
C1527383 (UMLS CUI [1])
C0011644 (UMLS CUI [2])
C0037088 (UMLS CUI [3,1])
C0205394 (UMLS CUI [3,2])
Scleroderma or Morphea - Other signs and symptoms start date
Item
Scleroderma or Morphea - Other signs and symptoms start date
date
C1527383 (UMLS CUI [1])
C0011644 (UMLS CUI [2])
C0037088 (UMLS CUI [3,1])
C0205394 (UMLS CUI [3,2])
C0808070 (UMLS CUI [4])
Scleroderma or Morphea - Other signs and symptoms end date
Item
Scleroderma or Morphea - Other signs and symptoms end date
date
C1527383 (UMLS CUI [1])
C0011644 (UMLS CUI [2])
C0037088 (UMLS CUI [3,1])
C0205394 (UMLS CUI [3,2])
C0806020 (UMLS CUI [4])
Item
Scleroderma or Morphea - Other signs and symptoms continuing at end of study
integer
C1527383 (UMLS CUI [1])
C0011644 (UMLS CUI [2])
C0037088 (UMLS CUI [3,1])
C0205394 (UMLS CUI [3,2])
C0549178 (UMLS CUI [4,1])
C0444496 (UMLS CUI [4,2])
Code List
Scleroderma or Morphea - Other signs and symptoms continuing at end of study
CL Item
Continuing at end of study (1)
Item Group
Scleroderma or Morphea - Diagnostic Test Results
C1527383 (UMLS CUI-1)
C0011644 (UMLS CUI-3)
C0456984 (UMLS CUI-4)
C0430022 (UMLS CUI-5)
Item
Scleroderma or Morphea - Test
integer
C1527383 (UMLS CUI [1])
C0011644 (UMLS CUI [2])
C2826273 (UMLS CUI [3])
Code List
Scleroderma or Morphea - 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-topoisomerase I (scl-70) (18)
CL Item
Anti-centromere (19)
CL Item
Anti-U3 RNP (ribonucleoprotein) (20)
CL Item
Anti-fibrillarin (21)
CL Item
Anti-ThRMP (22)
CL Item
Anti-PM-scl (23)
CL Item
Anti-endothelial cell (AECA) (24)
CL Item
Anti-fibrillin (FBN1) (25)
CL Item
Anti–matrix metalloproteinase (MMP)–1 anti–MMP-3 (26)
CL Item
Anti–platelet-derived growth factor receptor (PDGFr) (27)
Item
Scleroderma or Morphea - Test done
text
C1527383 (UMLS CUI [1])
C0011644 (UMLS CUI [2])
C0022885 (UMLS CUI [3,1])
C1272695 (UMLS CUI [3,2])
Code List
Scleroderma or Morphea - Test done
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
CL Item
Not Applicable (NA)
Scleroderma or Morphea - Test date
Item
Scleroderma or Morphea - Test date
date
C1527383 (UMLS CUI [1])
C0011644 (UMLS CUI [2])
C2826247 (UMLS CUI [3])
Scleroderma or Morphea - Test Result
Item
Scleroderma or Morphea - Test Result
float
C1527383 (UMLS CUI [1])
C0011644 (UMLS CUI [2])
C0587081 (UMLS CUI [3])
Scleroderma or Morphea - Test Units
Item
Scleroderma or Morphea - Test Units
text
C1527383 (UMLS CUI [1])
C0011644 (UMLS CUI [2])
C1519795 (UMLS CUI [3])
Scleroderma or Morphea - Low Norm
Item
Scleroderma or Morphea - Low Norm
float
C1527383 (UMLS CUI [1])
C0011644 (UMLS CUI [2])
C0086715 (UMLS CUI [3,1])
C0205251 (UMLS CUI [3,2])
Scleroderma or Morphea - High Norm
Item
Scleroderma or Morphea - High Norm
float
C1527383 (UMLS CUI [1])
C0011644 (UMLS CUI [2])
C0086715 (UMLS CUI [3,1])
C0205250 (UMLS CUI [3,2])
Item Group
Scleroderma or Morphea - Other Diagnostic Test Results
C1527383 (UMLS CUI-1)
C0011644 (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
Scleroderma or Morphea - Other Diagnostic Test Results
C1527383 (UMLS CUI-1)
C0011644 (UMLS CUI-3)
C0456984 (UMLS CUI-4)
C0430022 (UMLS CUI-5)
C0205394 (UMLS CUI-6)
Scleroderma or Morphea - Test
Item
Scleroderma or Morphea - Test
text
C1527383 (UMLS CUI [1])
C0011644 (UMLS CUI [2])
C2826273 (UMLS CUI [3])
Scleroderma or Morphea - Test date
Item
Scleroderma or Morphea - Test date
date
C1527383 (UMLS CUI [1])
C0011644 (UMLS CUI [2])
C2826247 (UMLS CUI [3])
Scleroderma or Morphea - Test Result
Item
Scleroderma or Morphea - Test Result
float
C1527383 (UMLS CUI [1])
C0011644 (UMLS CUI [2])
C0587081 (UMLS CUI [3])
Scleroderma or Morphea - Test Units
Item
Scleroderma or Morphea - Test Units
text
C1527383 (UMLS CUI [1])
C0011644 (UMLS CUI [2])
C1519795 (UMLS CUI [3])
Scleroderma or Morphea - Low Norm
Item
Scleroderma or Morphea - Low Norm
float
C1527383 (UMLS CUI [1])
C0011644 (UMLS CUI [2])
C0086715 (UMLS CUI [3,1])
C0205251 (UMLS CUI [3,2])
Scleroderma or Morphea - High Norm
Item
Scleroderma or Morphea - High Norm
float
C1527383 (UMLS CUI [1])
C0011644 (UMLS CUI [2])
C0086715 (UMLS CUI [3,1])
C0205250 (UMLS CUI [3,2])
Item Group
Scleroderma or Morphea - Other diagnostic Procedure
C1527383 (UMLS CUI-1)
C0011644 (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, Chest CT scan, Echocardiography, Right heart catheterization, Oesophagraphy, Lung functional test, Skin biopsy, Intravital capillaroscopy, Hepatitic tests, HLA typing)
text
C0430022 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0011900 (UMLS CUI [2])
C0039985 (UMLS CUI [3])
C0202823 (UMLS CUI [4])
C0013516 (UMLS CUI [5])
C0189896 (UMLS CUI [6])
C1318509 (UMLS CUI [7])
C0024119 (UMLS CUI [8])
C0150866 (UMLS CUI [9])
C0430501 (UMLS CUI [10,1])
C0596795 (UMLS CUI [10,2])
C0019158 (UMLS CUI [11,1])
C0022885 (UMLS CUI [11,2])
C0242318 (UMLS CUI [12])
Item Group
Dermatomyositis or Polymyositis
C0011633 (UMLS CUI-1)
C0085655 (UMLS CUI-2)
Item
Dermatomyositis or Polymyositis - Diagnosis
integer
C0011633 (UMLS CUI [1])
C0085655 (UMLS CUI [2])
C0011900 (UMLS CUI [3])
Code List
Dermatomyositis or Polymyositis - Diagnosis
CL Item
Dermatomyositis (1)
CL Item
Polymyositis (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
Dermatomyositis or Polymyositis - Signs and symptoms (supporting the final diagnosis)
C0011633 (UMLS CUI-1)
C0085655 (UMLS CUI-3)
C0037088 (UMLS CUI-4)
C1546485 (UMLS CUI-5)
Item
Dermatomyositis or Polymyositis - Signs and symptoms
integer
C0011633 (UMLS CUI [1])
C0085655 (UMLS CUI [2])
C0037088 (UMLS CUI [3])
Code List
Dermatomyositis or Polymyositis - Signs and symptoms
CL Item
Gottron’s Papules (slightly elevated violacious papules), specify localization (1)
CL Item
Heliotropic rash (symmetric erythematous rash w/wo edema on periorbital skin) (2)
CL Item
Periungual telangectases (3)
CL Item
“Mechanic’s hands” (dry and crackled skin of palms and fingers) (4)
CL Item
Erythema specify localisation (5)
CL Item
Arthralgia (6)
CL Item
Join swelling (7)
CL Item
Arthritis, specify localization (8)
CL Item
Muscle weakness symmetric (9)
CL Item
Muscle weakness asymmetric (10)
CL Item
Muscle weakness proximal (11)
CL Item
Muscle weakness distal (12)
CL Item
Depigmentation (13)
CL Item
Hyperpigmentation (14)
CL Item
Subcutaneous calcifications (15)
CL Item
Dyspnea (16)
CL Item
Dysphagia (17)
CL Item
Arrhythmia (18)
CL Item
Dysphonia (19)
Dermatomyositis or Polymyositis - Specify localization of Gottron’s Papules
Item
Dermatomyositis or Polymyositis - Specify localization of Gottron’s Papules
text
C0011633 (UMLS CUI [1])
C0085655 (UMLS CUI [2])
C0475264 (UMLS CUI [3,1])
C0332563 (UMLS CUI [3,2])
Dermatomyositis or Polymyositis - Specify localization of erythema
Item
Dermatomyositis or Polymyositis - Specify localization of erythema
text
C0011633 (UMLS CUI [1])
C0085655 (UMLS CUI [2])
C0475264 (UMLS CUI [3,1])
C0041834 (UMLS CUI [3,2])
Dermatomyositis or Polymyositis - Specify localization of Arthritis
Item
Dermatomyositis or Polymyositis - Specify localization of Arthritis
text
C0011633 (UMLS CUI [1])
C0085655 (UMLS CUI [2])
C0475264 (UMLS CUI [3,1])
C0003864 (UMLS CUI [3,2])
Item
Dermatomyositis or Polymyositis - Signs and symptoms present
text
C0011633 (UMLS CUI [1])
C0085655 (UMLS CUI [2])
C0037088 (UMLS CUI [3])
C0150312 (UMLS CUI [4])
Code List
Dermatomyositis or Polymyositis - Signs and symptoms present
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
CL Item
Not Applicable (NA)
Dermatomyositis or Polymyositis - Signs and symptoms Start Date
Item
Dermatomyositis or Polymyositis - Signs and symptoms Start Date
date
C0011633 (UMLS CUI [1])
C0085655 (UMLS CUI [2])
C0037088 (UMLS CUI [3])
C0808070 (UMLS CUI [4])
Dermatomyositis or Polymyositis - Signs and symptoms End date
Item
Dermatomyositis or Polymyositis - Signs and symptoms End date
date
C0011633 (UMLS CUI [1])
C0085655 (UMLS CUI [2])
C0037088 (UMLS CUI [3])
C0806020 (UMLS CUI [4])
Item
Dermatomyositis or Polymyositis - Signs and symptoms continuing at the end of study
integer
C0011633 (UMLS CUI [1])
C0085655 (UMLS CUI [2])
C0037088 (UMLS CUI [3])
C0549178 (UMLS CUI [4,1])
C0444496 (UMLS CUI [4,2])
Code List
Dermatomyositis or Polymyositis - Signs and symptoms continuing at the end of study
CL Item
Continuing at end of study (1)
Item Group
Dermatomyositis or Polymyositis - Other Signs and symptoms
C0011633 (UMLS CUI-1)
C0085655 (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
Dermatomyositis or Polymyositis - Other Signs and symptoms
C0011633 (UMLS CUI-1)
C0085655 (UMLS CUI-3)
C0037088 (UMLS CUI-5)
C0205394 (UMLS CUI-6)
Dermatomyositis or Polymyositis - Other Signs and symptoms
Item
Dermatomyositis or Polymyositis - Other Signs and symptoms
text
C0011633 (UMLS CUI [1])
C0085655 (UMLS CUI [2])
C0037088 (UMLS CUI [3,1])
C0205394 (UMLS CUI [3,2])
Dermatomyositis or Polymyositis - Other Signs and symptoms Start Date
Item
Dermatomyositis or Polymyositis - Other Signs and symptoms Start Date
date
C0011633 (UMLS CUI [1])
C0085655 (UMLS CUI [2])
C0037088 (UMLS CUI [3,1])
C0205394 (UMLS CUI [3,2])
C0808070 (UMLS CUI [4])
Dermatomyositis or Polymyositis - Other Signs and symptoms End Date
Item
Dermatomyositis or Polymyositis - Other Signs and symptoms End Date
date
C0011633 (UMLS CUI [1])
C0085655 (UMLS CUI [2])
C0037088 (UMLS CUI [3,1])
C0205394 (UMLS CUI [3,2])
C0806020 (UMLS CUI [4])
Item
Dermatomyositis or Polymyositis - Other signs and symptoms continuing at the end of study
text
C0011633 (UMLS CUI [1])
C0085655 (UMLS CUI [2])
C0037088 (UMLS CUI [3,1])
C0205394 (UMLS CUI [3,2])
C0549178 (UMLS CUI [4,1])
C0444496 (UMLS CUI [4,2])
Code List
Dermatomyositis or Polymyositis - Other signs and symptoms continuing at the end of study
CL Item
Continuing at end of study (1)
Item Group
Dermatomyositis or Polymyositis - Diagnostic Test Results
C0011633 (UMLS CUI-1)
C0085655 (UMLS CUI-3)
C0456984 (UMLS CUI-4)
Item
Dermatomyositis or Polymyositis - Test
integer
C0011633 (UMLS CUI [1])
C0085655 (UMLS CUI [2])
C2826273 (UMLS CUI [3])
Code List
Dermatomyositis or Polymyositis - 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 creatine kinase (CK) (11)
CL Item
Serum aldolase (12)
CL Item
Aspartate amino Transferase (AST) (13)
CL Item
Serum lactic deshydrogenase (LDH) (14)
CL Item
Anti-nuclear antibodies (ANA) (15)
CL Item
Anti-Mi-2 autoantibodies (16)
CL Item
Anti-Jo-A (antihistidyl transfer RNA [t-RNA] synthetase) autoantibodies (17)
CL Item
Anti-signal recognition protein (SRP) (18)
CL Item
Anti-PM-Scl autoantibodies (19)
CL Item
Anti-Ku autoantibodies (20)
Item
Dermatomyositis or Polymyositis - Test done
text
C0011633 (UMLS CUI [1])
C0085655 (UMLS CUI [2])
C0022885 (UMLS CUI [3,1])
C1272695 (UMLS CUI [3,2])
Code List
Dermatomyositis or Polymyositis - Test done
CL Item
Yes  (Y)
CL Item
No  (N)
CL Item
Unknown  (U)
CL Item
Not Applicable (NA)
Dermatomyositis or Polymyositis - Test date
Item
Dermatomyositis or Polymyositis - Test date
date
C0011633 (UMLS CUI [1])
C0085655 (UMLS CUI [2])
C2826247 (UMLS CUI [3])
Dermatomyositis or Polymyositis - Test Result
Item
Dermatomyositis or Polymyositis - Test Result
float
C0011633 (UMLS CUI [1])
C0085655 (UMLS CUI [2])
C0587081 (UMLS CUI [3])
Dermatomyositis or Polymyositis - Test Units
Item
Dermatomyositis or Polymyositis - Test Units
text
C0011633 (UMLS CUI [1])
C0085655 (UMLS CUI [2])
C1519795 (UMLS CUI [3])
Dermatomyositis or Polymyositis - Low Norm
Item
Dermatomyositis or Polymyositis - Low Norm
float
C0011633 (UMLS CUI [1])
C0085655 (UMLS CUI [2])
C0086715 (UMLS CUI [3,1])
C0205251 (UMLS CUI [3,2])
Dermatomyositis or Polymyositis - High Norm
Item
Dermatomyositis or Polymyositis - High Norm
float
C0011633 (UMLS CUI [1])
C0085655 (UMLS CUI [2])
C0086715 (UMLS CUI [3,1])
C0205250 (UMLS CUI [3,2])
Item Group
Dermatomyositis or Polymyositis - Other Diagnostic Test Results
C0011633 (UMLS CUI-1)
C0085655 (UMLS CUI-2)
C0456984 (UMLS CUI-3)
C0430022 (UMLS CUI-4)
C0205394 (UMLS CUI-5)
Item
If any other diagnostic test results are available, please tick the box and complete below
integer
C0456984 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
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
Dermatomyositis or Polymyositis - Other Diagnostic Test Results
C0011633 (UMLS CUI-1)
C0085655 (UMLS CUI-2)
C0456984 (UMLS CUI-3)
C0430022 (UMLS CUI-4)
C0205394 (UMLS CUI-5)
Dermatomyositis or Polymyositis - Test
Item
Dermatomyositis or Polymyositis - Test
text
C0011633 (UMLS CUI [1])
C0085655 (UMLS CUI [2])
C2826273 (UMLS CUI [3])
Dermatomyositis or Polymyositis - Test date
Item
Dermatomyositis or Polymyositis - Test date
date
C0011633 (UMLS CUI [1])
C0085655 (UMLS CUI [2])
C2826247 (UMLS CUI [3])
Dermatomyositis or Polymyositis - Test Result
Item
Dermatomyositis or Polymyositis - Test Result
float
C0011633 (UMLS CUI [1])
C0085655 (UMLS CUI [2])
C0587081 (UMLS CUI [3])
Dermatomyositis or Polymyositis - Test Units
Item
Dermatomyositis or Polymyositis - Test Units
text
C0011633 (UMLS CUI [1])
C0085655 (UMLS CUI [2])
C1519795 (UMLS CUI [3])
Dermatomyositis or Polymyositis - Low Norm
Item
Dermatomyositis or Polymyositis - Low Norm
float
C0011633 (UMLS CUI [1])
C0085655 (UMLS CUI [2])
C0086715 (UMLS CUI [3,1])
C0205251 (UMLS CUI [3,2])
Dermatomyositis or Polymyositis - High Norm
Item
Dermatomyositis or Polymyositis - High Norm
float
C0011633 (UMLS CUI [1])
C0085655 (UMLS CUI [2])
C0086715 (UMLS CUI [3,1])
C0205250 (UMLS CUI [3,2])
Item Group
Dermatomyositis or Polymyositis - Other diagnostic Procedure
C0011633 (UMLS CUI-1)
C0085655 (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 (Muscle MRI, Electromyography, Muscle Ultra sound, Skin biopsy, CT scan, Chest x-Ray, Barium enema)
text
C0430022 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0011900 (UMLS CUI [2])
C0024485 (UMLS CUI [3])
C0026845 (UMLS CUI [4])
C0013839 (UMLS CUI [5])
C1456803 (UMLS CUI [6,1])
C0026845 (UMLS CUI [6,2])
C0150866 (UMLS CUI [7])
C0040405 (UMLS CUI [8])
C0039985 (UMLS CUI [9])
C0203075 (UMLS CUI [10])
Item Group
Diabetes mellitus type I
C0011854 (UMLS CUI-1)
Item
Diabetes mellitus type I - Diagnosis
integer
C0011854 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Code List
Diabetes mellitus type I - Diagnosis
CL Item
Insulin dependent diabetes mellitus (Diabetes Type I) (1)
CL Item
Other, specify: (2)
Diabetes mellitus type I - Specify other diagnosis
Item
Diabetes mellitus type I - Specify other diagnosis
text
C0011854 (UMLS CUI [1])
C0011900 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
Please specify related adverse event: SAE Case No.
Item
Please specify related adverse event: SAE Case No.
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Please specify related adverse event: AE No.
Item
Please specify related adverse event: AE No.
text
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Date of final diagnosis:
Item
Date of final diagnosis:
date
C2316983 (UMLS CUI [1,1])
C1546485 (UMLS CUI [1,2])
Item Group
Diabetes mellitus type I - Signs and symptoms (supporting the final diagnosis)
C0011854 (UMLS CUI-1)
C0037088 (UMLS CUI-2)
C1546485 (UMLS CUI-3)
Item
Diabetes mellitus type I - Signs and symptoms
integer
C0011854 (UMLS CUI [1])
C0037088 (UMLS CUI [2])
Code List
Diabetes mellitus type I - Signs and symptoms
CL Item
Weight loss (1)
CL Item
Polydypsia / Thrist (2)
CL Item
Polyphagia (3)
CL Item
Polyuria (4)
CL Item
Blurred vision (5)
CL Item
Ketoacidosis (6)
CL Item
Gastrointestinal symptoms (7)
CL Item
Peripheral neuropathy (8)
Item
Diabetes mellitus type I - Signs and symptoms present
text
C0011854 (UMLS CUI [1])
C0037088 (UMLS CUI [2])
C0150312 (UMLS CUI [3])
Code List
Diabetes mellitus type I - Signs and symptoms present
CL Item
Yes  (Y)
CL Item
No  (N)
CL Item
Unknown  (U)
CL Item
Not Applicable (NA)
Diabetes mellitus type I - Signs and symptoms Start Date
Item
Diabetes mellitus type I - Signs and symptoms Start Date
date
C0011854 (UMLS CUI [1])
C0037088 (UMLS CUI [2])
C0808070 (UMLS CUI [3])
Diabetes mellitus type I - Signs and symptoms End date
Item
Diabetes mellitus type I - Signs and symptoms End date
date
C0011854 (UMLS CUI [1])
C0037088 (UMLS CUI [2])
C0806020 (UMLS CUI [3])
Item
Diabetes mellitus type I - Signs and symptoms continuing at the end of study
integer
C0011854 (UMLS CUI [1])
C0037088 (UMLS CUI [2])
C0549178 (UMLS CUI [3,1])
C0444496 (UMLS CUI [3,2])
Code List
Diabetes mellitus type I - Signs and symptoms continuing at the end of study
CL Item
Continuing at end of study (1)
Item Group
Diabetes mellitus type I - Other Signs and symptoms
C0011854 (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
Diabetes mellitus type I - Other Signs and symptoms
C0011854 (UMLS CUI-1)
C0037088 (UMLS CUI-2)
C0205394 (UMLS CUI-3)
Diabetes mellitus type I - Other Signs and symptoms
Item
Diabetes mellitus type I - Other Signs and symptoms
text
C0011854 (UMLS CUI [1])
C0037088 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
Diabetes mellitus type I - Other Signs and symptoms Start Date
Item
Diabetes mellitus type I - Other Signs and symptoms Start Date
date
C0011854 (UMLS CUI [1])
C0037088 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0808070 (UMLS CUI [3])
Diabetes mellitus type I - Other Signs and symptoms End Date
Item
Diabetes mellitus type I - Other Signs and symptoms End Date
date
C0011854 (UMLS CUI [1])
C0037088 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0806020 (UMLS CUI [3])
Item
Diabetes mellitus type I - Other signs and symptoms continuing at the end of study
text
C0011854 (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
Diabetes mellitus type I - Other signs and symptoms continuing at the end of study
CL Item
Continuing at end of study (1)
Item Group
Diabetes mellitus type I - Diagnostic Test Results
C0011854 (UMLS CUI-1)
C0456984 (UMLS CUI-2)
Item
Diabetes mellitus type I - Test
integer
C0011854 (UMLS CUI [1])
C2826273 (UMLS CUI [2])
Code List
Diabetes mellitus type I - 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 sodium (11)
CL Item
Serum chloride (12)
CL Item
Serum calcium (13)
CL Item
Serum glucose (14)
CL Item
Anti-insulin autoantibodies (IAA) (15)
CL Item
Anti-glutamic acid decarboxylase (GAD) autoantibodies (16)
CL Item
Anti-Tyrosine phosphatase-like IA2antibodies (17)
CL Item
Anti-islet cell antibodies (18)
CL Item
Glycosylated Hb (HbA1c) (19)
CL Item
Insulin or c-peptide level (20)
CL Item
Oral glucose tolerance test with insulin level (21)
CL Item
Albuminuria (22)
CL Item
LMW proteinuria (23)
CL Item
Hematuria (24)
CL Item
Glucosuria (25)
Item
Diabetes mellitus type I - Test done
text
C0011854 (UMLS CUI [1])
C0022885 (UMLS CUI [2,1])
C1272695 (UMLS CUI [2,2])
Code List
Diabetes mellitus type I - Test done
CL Item
Yes  (Y)
CL Item
No  (N)
CL Item
Unknown  (U)
CL Item
Not Applicable (NA)
Diabetes mellitus type I - Test date
Item
Diabetes mellitus type I - Test date
date
C0011854 (UMLS CUI [1])
C2826247 (UMLS CUI [2])
Diabetes mellitus type I - Test Result
Item
Diabetes mellitus type I - Test Result
float
C0011854 (UMLS CUI [1])
C0587081 (UMLS CUI [2])
Diabetes mellitus type I - Test Units
Item
Diabetes mellitus type I - Test Units
text
C0011854 (UMLS CUI [1])
C1519795 (UMLS CUI [2])
Diabetes mellitus type I - Low Norm
Item
Diabetes mellitus type I - Low Norm
float
C0011854 (UMLS CUI [1])
C0086715 (UMLS CUI [2,1])
C0205251 (UMLS CUI [2,2])
Diabetes mellitus type I - High Norm
Item
Diabetes mellitus type I - High Norm
float
C0011854 (UMLS CUI [1])
C0086715 (UMLS CUI [2,1])
C0205250 (UMLS CUI [2,2])
Item Group
Diabetes mellitus type I - Other Diagnostic Test Results
C0011854 (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
Diabetes mellitus type I - Other Diagnostic Test Results
C0011854 (UMLS CUI-1)
C0456984 (UMLS CUI-2)
C0430022 (UMLS CUI-3)
C0205394 (UMLS CUI-4)
Diabetes mellitus type I - Test
Item
Diabetes mellitus type I - Test
text
C0011854 (UMLS CUI [1])
C2826273 (UMLS CUI [2])
Diabetes mellitus type I - Test date
Item
Diabetes mellitus type I - Test date
date
C0011854 (UMLS CUI [1])
C2826247 (UMLS CUI [2])
Diabetes mellitus type I - Test Result
Item
Diabetes mellitus type I - Test Result
float
C0011854 (UMLS CUI [1])
C0587081 (UMLS CUI [2])
Diabetes mellitus type I - Test Units
Item
Diabetes mellitus type I - Test Units
text
C0011854 (UMLS CUI [1])
C1519795 (UMLS CUI [2])
Diabetes mellitus type I - Low Norm
Item
Diabetes mellitus type I - Low Norm
float
C0011854 (UMLS CUI [1])
C0086715 (UMLS CUI [2,1])
C0205251 (UMLS CUI [2,2])
Diabetes mellitus type I - High Norm
Item
Diabetes mellitus type I - High Norm
float
C0011854 (UMLS CUI [1])
C0086715 (UMLS CUI [2,1])
C0205250 (UMLS CUI [2,2])
Item Group
Diabetes mellitus type I - Other diagnostic Procedure
C0011854 (UMLS CUI-1)
C0430022 (UMLS CUI-2)
C0205394 (UMLS CUI-3)
Describe any other diagnostic procedure supporting the diagnosis
Item
Describe any other diagnostic procedure supporting the diagnosis (Thyroid tests, other…)
text
C0430022 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0011900 (UMLS CUI [2])
C0040130 (UMLS CUI [3])

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