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
Joint swelling (9)
CL Item
Joint stiffness (10)
CL Item
Morning stiffness (11)
CL Item
Nail lesions (14)
CL Item
Rheumatoid nodules (15)
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
Keratoderma blennorrhagica on palms and soles (23)
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
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
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
Red blood cells (7)
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-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
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
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
Pericarditis (11)
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
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
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
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
Anti-nuclear antibodies (ANA) (21)
CL Item
Anti-Extractable nuclear antigen antibodies (anti-ENA) (23)
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
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
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
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
Parotid gland enlargement (6)
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
Erythema nodosum (24)
CL Item
Annular erythematous plaques (25)
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
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
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
Sjogren's Syndrome - Other signs and symptoms continuing at the end of study
text
C1527336 (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
Sjogren's Syndrome - Other signs and symptoms continuing at the end of study
CL Item
Continuing at end of study (1)
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
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-SSA (Ro) (18)
CL Item
Anti-SSB (La) (19)
CL Item
Anti-alpha-fondrin antibodies (20)
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
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])