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
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
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
Constipation (15)
CL Item
Gastroesophageal reflux (17)
CL Item
Precordial chest pain (due to pulmonary hypertension) (19)
CL Item
Dry persistent cough (20)
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
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
Red blood cells (7)
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
LMW proteinuria (14)
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-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
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)
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
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)
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
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 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
Red blood cells (7)
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
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
Polydypsia / Thrist (2)
CL Item
Blurred vision (5)
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
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 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
Red blood cells (7)
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
LMW proteinuria (23)
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
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])