ID

41536

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

Versions (2)
  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

English

IMD Report - Autoimmune thyroid diseases; Addisons's disease; Inflammatory bowel diseases (Report Final and Annex Report 2 Final)

1 forms  
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
Autoimmune thyroid diseases
Description

Autoimmune thyroid diseases

Alias
UMLS CUI-1
C0178468
Autoimmune thyroid diseases Diagnosis
Description

Autoimmune thyroid diseases Diagnosis

Data type

integer

Alias
UMLS CUI [1]
C0178468
UMLS CUI [2]
C0011900
Specify other diagnosis
Description

Specify other diagnosis

Data type

text

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

In case of serious adverse event

Data type

integer

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

In case of non-serious adverse event

Data type

integer

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

Date of final diagnosis:

Data type

date

Alias
UMLS CUI [1,1]
C2316983
UMLS CUI [1,2]
C1546485
Autoimmune thyroid diseases - Signs and Symptoms
Description

Autoimmune thyroid diseases - Signs and Symptoms

Alias
UMLS CUI-1
C0178468
UMLS CUI-2
C0037088
Autoimmune thyroid diseases - Signs and Symptoms
Description

Autoimmune thyroid diseases - Signs and Symptoms

Data type

integer

Alias
UMLS CUI [1]
C0178468
UMLS CUI [2]
C0037088
Autoimmune thyroid diseases - Specify ophthalmopathy
Description

Autoimmune thyroid diseases - Specify ophthalmopathy

Data type

text

Alias
UMLS CUI [1]
C0178468
UMLS CUI [2]
C0015397
Autoimmune thyroid diseases - Specify blood pressure
Description

Autoimmune thyroid diseases - Specify blood pressure

Data type

text

Alias
UMLS CUI [1]
C0178468
UMLS CUI [2]
C0005823
Autoimmune thyroid diseases - Specify dermopathy
Description

Autoimmune thyroid diseases - Specify dermopathy

Data type

text

Alias
UMLS CUI [1]
C0178468
UMLS CUI [2]
C0037274
Autoimmune thyroid diseases - Signs and Symptoms present
Description

Autoimmune thyroid diseases - Signs and Symptoms present

Data type

text

Alias
UMLS CUI [1]
C0178468
UMLS CUI [2,1]
C0037088
UMLS CUI [2,2]
C0150312
Autoimmune thyroid diseases - Signs and Symptoms start date
Description

Autoimmune thyroid diseases - Signs and Symptoms start date

Data type

date

Alias
UMLS CUI [1]
C0178468
UMLS CUI [2,1]
C0037088
UMLS CUI [2,2]
C0808070
Autoimmune thyroid diseases - Signs and Symptoms end date
Description

Autoimmune thyroid diseases - Signs and Symptoms end date

Data type

date

Alias
UMLS CUI [1]
C0178468
UMLS CUI [2,1]
C0037088
UMLS CUI [2,2]
C0806020
Autoimmune thyroid diseases - Signs and Symptoms continuing at end of study
Description

Autoimmune thyroid diseases - Signs and Symptoms continuing at end of study

Data type

integer

Alias
UMLS CUI [1]
C0178468
UMLS CUI [2]
C0037088
UMLS CUI [3,1]
C0549178
UMLS CUI [3,2]
C0444496
Autoimmune thyroid diseases - Other signs and symptoms
Description

Autoimmune thyroid diseases - Other signs and symptoms

Alias
UMLS CUI-1
C0178468
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
Autoimmune thyroid diseases - Other signs and symptoms
Description

Autoimmune thyroid diseases - Other signs and symptoms

Alias
UMLS CUI-1
C0178468
UMLS CUI-2
C0037088
UMLS CUI-3
C0205394
Autoimmune thyroid diseases - Other signs and symptoms
Description

Autoimmune thyroid diseases - Other signs and symptoms

Data type

text

Alias
UMLS CUI [1]
C0178468
UMLS CUI [2,1]
C0037088
UMLS CUI [2,2]
C0205394
Autoimmune thyroid diseases - Other signs and symptoms start date
Description

Autoimmune thyroid diseases - Other signs and symptoms start date

Data type

date

Alias
UMLS CUI [1]
C0178468
UMLS CUI [2,1]
C0037088
UMLS CUI [2,2]
C0205394
UMLS CUI [3]
C0808070
Autoimmune thyroid diseases - Other signs and symptoms end date
Description

Autoimmune thyroid diseases - Other signs and symptoms end date

Data type

date

Alias
UMLS CUI [1]
C0178468
UMLS CUI [2,1]
C0037088
UMLS CUI [2,2]
C0205394
UMLS CUI [3]
C0806020
Autoimmune thyroid diseases - Other signs and symptoms continuing at end of study
Description

Autoimmune thyroid diseases - Other signs and symptoms continuing at end of study

Data type

integer

Alias
UMLS CUI [1]
C0178468
UMLS CUI [2,1]
C0037088
UMLS CUI [2,2]
C0205394
UMLS CUI [3,1]
C0549178
UMLS CUI [3,2]
C0444496
Autoimmune thyroid diseases - Diagnostic Test Results
Description

Autoimmune thyroid diseases - Diagnostic Test Results

Alias
UMLS CUI-1
C0178468
UMLS CUI-2
C0456984
UMLS CUI-3
C0430022
Autoimmune thyroid diseases - Test
Description

Autoimmune thyroid diseases - Test

Data type

integer

Alias
UMLS CUI [1]
C0178468
UMLS CUI [2]
C2826273
Autoimmune thyroid diseases - Test done
Description

Autoimmune thyroid diseases - Test done

Data type

text

Alias
UMLS CUI [1]
C0178468
UMLS CUI [2,1]
C0022885
UMLS CUI [2,2]
C1272695
Autoimmune thyroid diseases - Test date
Description

Autoimmune thyroid diseases - Test date

Data type

date

Alias
UMLS CUI [1]
C0178468
UMLS CUI [2]
C2826247
Autoimmune thyroid diseases - Test Result
Description

Autoimmune thyroid diseases - Test Result

Data type

float

Alias
UMLS CUI [1]
C0178468
UMLS CUI [2]
C0587081
Autoimmune thyroid diseases - Test Units
Description

Autoimmune thyroid diseases - Test Units

Data type

text

Alias
UMLS CUI [1]
C0178468
UMLS CUI [2]
C1519795
Autoimmune thyroid diseases - Low Norm
Description

Autoimmune thyroid diseases - Low Norm

Data type

float

Alias
UMLS CUI [1]
C0178468
UMLS CUI [2,1]
C0086715
UMLS CUI [2,2]
C0205251
Autoimmune thyroid diseases - High Norm
Description

Autoimmune thyroid diseases - High Norm

Data type

float

Alias
UMLS CUI [1]
C0178468
UMLS CUI [2,1]
C0086715
UMLS CUI [2,2]
C0205250
Autoimmune thyroid diseases - Other Diagnostic Test Results
Description

Autoimmune thyroid diseases - Other Diagnostic Test Results

Alias
UMLS CUI-1
C0178468
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
Autoimmune thyroid diseases - Other Diagnostic Test Results
Description

Autoimmune thyroid diseases - Other Diagnostic Test Results

Alias
UMLS CUI-1
C0178468
UMLS CUI-2
C0456984
UMLS CUI-3
C0430022
UMLS CUI-4
C0205394
Autoimmune thyroid diseases - Test
Description

Autoimmune thyroid diseases - Test

Data type

text

Alias
UMLS CUI [1]
C0178468
UMLS CUI [2]
C2826273
Autoimmune thyroid diseases - Test date
Description

Autoimmune thyroid diseases - Test date

Data type

date

Alias
UMLS CUI [1]
C0178468
UMLS CUI [2]
C2826247
Autoimmune thyroid diseases - Test Result
Description

Autoimmune thyroid diseases - Test Result

Data type

float

Alias
UMLS CUI [1]
C0178468
UMLS CUI [2]
C0587081
Autoimmune thyroid diseases - Test Units
Description

Autoimmune thyroid diseases - Test Units

Data type

text

Alias
UMLS CUI [1]
C0178468
UMLS CUI [2]
C1519795
Autoimmune thyroid diseases - Low Norm
Description

Autoimmune thyroid diseases - Low Norm

Data type

float

Alias
UMLS CUI [1]
C0178468
UMLS CUI [2,1]
C0086715
UMLS CUI [2,2]
C0205251
Autoimmune thyroid diseases - High Norm
Description

Autoimmune thyroid diseases - High Norm

Data type

float

Alias
UMLS CUI [1]
C0178468
UMLS CUI [2,1]
C0086715
UMLS CUI [2,2]
C0205250
Autoimmune thyroid diseases - Other diagnostic Procedure
Description

Autoimmune thyroid diseases - Other diagnostic Procedure

Alias
UMLS CUI-1
C0178468
UMLS CUI-2
C0430022
UMLS CUI-3
C0205394
Describe any other diagnostic procedure supporting the diagnosis (Thyroid scintigraphy, sonography)
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]
C0860843
UMLS CUI [4]
C0041618
Addison's disease
Description

Addison's disease

Alias
UMLS CUI-1
C0001403
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
Addison's disease - Signs and symptoms (supporting the final diagnosis)
Description

Addison's disease - Signs and symptoms (supporting the final diagnosis)

Alias
UMLS CUI-1
C0001403
UMLS CUI-2
C0037088
UMLS CUI-3
C1546485
Addison's disease - Signs and symptoms
Description

Addison's disease - Signs and symptoms

Data type

integer

Alias
UMLS CUI [1]
C0001403
UMLS CUI [2]
C0037088
Addison's disease - Signs and symptoms present
Description

Addison's disease - Signs and symptoms present

Data type

text

Alias
UMLS CUI [1]
C0001403
UMLS CUI [2]
C0037088
UMLS CUI [3]
C0150312
Addison's disease - Signs and symptoms Start Date
Description

Addison's disease - Signs and symptoms Start Date

Data type

date

Alias
UMLS CUI [1]
C0001403
UMLS CUI [2]
C0037088
UMLS CUI [3]
C0808070
Addison's disease - Signs and symptoms End date
Description

Addison's disease - Signs and symptoms End date

Data type

date

Alias
UMLS CUI [1]
C0001403
UMLS CUI [2]
C0037088
UMLS CUI [3]
C0806020
Addison's disease - Signs and symptoms continuing at the end of study
Description

Addison's disease - Signs and symptoms continuing at the end of study

Data type

integer

Alias
UMLS CUI [1]
C0001403
UMLS CUI [2]
C0037088
UMLS CUI [3,1]
C0549178
UMLS CUI [3,2]
C0444496
Addison's disease - Other Signs and symptoms
Description

Addison's disease - Other Signs and symptoms

Alias
UMLS CUI-1
C0001403
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
Addison's disease - Other Signs and symptoms
Description

Addison's disease - Other Signs and symptoms

Alias
UMLS CUI-1
C0001403
UMLS CUI-2
C0037088
UMLS CUI-3
C0205394
Addison's disease - Other Signs and symptoms
Description

Addison's disease - Other Signs and symptoms

Data type

text

Alias
UMLS CUI [1]
C0001403
UMLS CUI [2,1]
C0037088
UMLS CUI [2,2]
C0205394
Addison's disease - Other Signs and symptoms Start Date
Description

Addison's disease - Other Signs and symptoms Start Date

Data type

date

Alias
UMLS CUI [1]
C0001403
UMLS CUI [2,1]
C0037088
UMLS CUI [2,2]
C0205394
UMLS CUI [3]
C0808070
Addison's disease - Other Signs and symptoms End Date
Description

Addison's disease - Other Signs and symptoms End Date

Data type

date

Alias
UMLS CUI [1]
C0001403
UMLS CUI [2,1]
C0037088
UMLS CUI [2,2]
C0205394
UMLS CUI [3]
C0806020
Addison's disease - Other signs and symptoms continuing at the end of study
Description

Addison's disease - Other signs and symptoms continuing at the end of study

Data type

text

Alias
UMLS CUI [1]
C0001403
UMLS CUI [2,1]
C0037088
UMLS CUI [2,2]
C0205394
UMLS CUI [3,1]
C0549178
UMLS CUI [3,2]
C0444496
Addison's disease - Diagnostic Test Results
Description

Addison's disease - Diagnostic Test Results

Alias
UMLS CUI-1
C0001403
UMLS CUI-2
C0085655
UMLS CUI-3
C0456984
Addison's disease - Test
Description

Addison's disease - Test

Data type

integer

Alias
UMLS CUI [1]
C0001403
UMLS CUI [2]
C2826273
Addison's disease - Test done
Description

Addison's disease - Test done

Data type

text

Alias
UMLS CUI [1]
C0001403
UMLS CUI [2,1]
C0022885
UMLS CUI [2,2]
C1272695
Addison's disease - Test date
Description

Addison's disease - Test date

Data type

date

Alias
UMLS CUI [1]
C0001403
UMLS CUI [2]
C2826247
Addison's disease - Test Result
Description

Addison's disease - Test Result

Data type

float

Alias
UMLS CUI [1]
C0001403
UMLS CUI [2]
C0587081
Addison's disease - Test Units
Description

Addison's disease - Test Units

Data type

text

Alias
UMLS CUI [1]
C0001403
UMLS CUI [2]
C1519795
Addison's disease - Low Norm
Description

Addison's disease - Low Norm

Data type

float

Alias
UMLS CUI [1]
C0001403
UMLS CUI [2,1]
C0086715
UMLS CUI [2,2]
C0205251
Addison's disease - High Norm
Description

Addison's disease - High Norm

Data type

float

Alias
UMLS CUI [1]
C0001403
UMLS CUI [2,1]
C0086715
UMLS CUI [2,2]
C0205250
Addison's disease - Other Diagnostic Test Results
Description

Addison's disease - Other Diagnostic Test Results

Alias
UMLS CUI-1
C0001403
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
Addison's disease - Other Diagnostic Test Results
Description

Addison's disease - Other Diagnostic Test Results

Alias
UMLS CUI-1
C0001403
UMLS CUI-2
C0456984
UMLS CUI-3
C0430022
UMLS CUI-4
C0205394
Addison's disease - Test
Description

Addison's disease - Test

Data type

text

Alias
UMLS CUI [1]
C0001403
UMLS CUI [2]
C2826273
Addison's disease - Test date
Description

Addison's disease - Test date

Data type

date

Alias
UMLS CUI [1]
C0001403
UMLS CUI [2]
C2826247
Addison's disease - Test Result
Description

Addison's disease - Test Result

Data type

float

Alias
UMLS CUI [1]
C0001403
UMLS CUI [2]
C0587081
Addison's disease - Test Units
Description

Addison's disease - Test Units

Data type

text

Alias
UMLS CUI [1]
C0001403
UMLS CUI [2]
C1519795
Addison's disease - Low Norm
Description

Addison's disease - Low Norm

Data type

float

Alias
UMLS CUI [1]
C0001403
UMLS CUI [2,1]
C0086715
UMLS CUI [2,2]
C0205251
Addison's disease - High Norm
Description

Addison's disease - High Norm

Data type

float

Alias
UMLS CUI [1]
C0001403
UMLS CUI [2,1]
C0086715
UMLS CUI [2,2]
C0205250
Addison's disease - Other diagnostic Procedure
Description

Addison's disease - Other diagnostic Procedure

Alias
UMLS CUI-1
C0001403
UMLS CUI-2
C0430022
UMLS CUI-3
C0205394
Describe any other diagnostic procedure supporting the diagnosis (Chest x-Ray, Abdominal CT scan, Thyroid scintigraphy, sonography)
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]
C0412620
UMLS CUI [5]
C0860843
UMLS CUI [6]
C0041618
Inflammatory bowel diseases
Description

Inflammatory bowel diseases

Alias
UMLS CUI-1
C0021390
Inflammatory bowel diseases - Diagnosis
Description

Please tick appropriate diagnosis

Data type

integer

Alias
UMLS CUI [1,1]
C0021390
UMLS CUI [1,2]
C0011900
Inflammatory bowel diseases - Specify other diagnosis
Description

Inflammatory bowel diseases - Specify other diagnosis

Data type

text

Alias
UMLS CUI [1]
C0021390
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
Inflammatory bowel diseases - Signs and symptoms (supporting the final diagnosis)
Description

Inflammatory bowel diseases - Signs and symptoms (supporting the final diagnosis)

Alias
UMLS CUI-1
C0021390
UMLS CUI-2
C0037088
UMLS CUI-3
C1546485
Inflammatory bowel diseases - Signs and symptoms
Description

(supporting the final diagnosis)

Data type

integer

Alias
UMLS CUI [1]
C0021390
UMLS CUI [2]
C0037088
Inflammatory bowel diseases - Signs and symptoms present
Description

Inflammatory bowel diseases - Signs and symptoms present

Data type

text

Alias
UMLS CUI [1]
C0021390
UMLS CUI [2]
C0037088
UMLS CUI [3]
C0150312
Inflammatory bowel diseases - Signs and symptoms Start Date
Description

Inflammatory bowel diseases - Signs and symptoms Start Date

Data type

date

Alias
UMLS CUI [1]
C0021390
UMLS CUI [2]
C0037088
UMLS CUI [3]
C0808070
Inflammatory bowel diseases - Signs and symptoms End date
Description

Inflammatory bowel diseases - Signs and symptoms End date

Data type

date

Alias
UMLS CUI [1]
C0021390
UMLS CUI [2]
C0037088
UMLS CUI [3]
C0806020
Inflammatory bowel diseases - Signs and symptoms continuing at the end of study
Description

Inflammatory bowel diseases - Signs and symptoms continuing at the end of study

Data type

integer

Alias
UMLS CUI [1]
C0021390
UMLS CUI [2]
C0037088
UMLS CUI [3,1]
C0549178
UMLS CUI [3,2]
C0444496
Inflammatory bowel diseases - Other Signs and symptoms
Description

Inflammatory bowel diseases - Other Signs and symptoms

Alias
UMLS CUI-1
C0021390
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
Inflammatory bowel diseases - Other Signs and symptoms
Description

Inflammatory bowel diseases - Other Signs and symptoms

Alias
UMLS CUI-1
C0021390
UMLS CUI-2
C0037088
UMLS CUI-3
C0205394
Inflammatory bowel diseases - Other Signs and symptoms
Description

Inflammatory bowel diseases - Other Signs and symptoms

Data type

text

Alias
UMLS CUI [1]
C0021390
UMLS CUI [2,1]
C0037088
UMLS CUI [2,2]
C0205394
Inflammatory bowel diseases - Other Signs and symptoms Start Date
Description

Inflammatory bowel diseases - Other Signs and symptoms Start Date

Data type

date

Alias
UMLS CUI [1]
C0021390
UMLS CUI [2,1]
C0037088
UMLS CUI [2,2]
C0205394
UMLS CUI [3]
C0808070
Inflammatory bowel diseases - Other Signs and symptoms End Date
Description

Inflammatory bowel diseases - Other Signs and symptoms End Date

Data type

date

Alias
UMLS CUI [1]
C0021390
UMLS CUI [2,1]
C0037088
UMLS CUI [2,2]
C0205394
UMLS CUI [3]
C0806020
Inflammatory bowel diseases - Other signs and symptoms continuing at the end of study
Description

Inflammatory bowel diseases - Other signs and symptoms continuing at the end of study

Data type

text

Alias
UMLS CUI [1]
C0021390
UMLS CUI [2,1]
C0037088
UMLS CUI [2,2]
C0205394
UMLS CUI [3,1]
C0549178
UMLS CUI [3,2]
C0444496
Inflammatory bowel diseases - Diagnostic Test Results
Description

Inflammatory bowel diseases - Diagnostic Test Results

Alias
UMLS CUI-1
C0021390
UMLS CUI-2
C0456984
Inflammatory bowel diseases - Test
Description

Inflammatory bowel diseases - Test

Data type

integer

Alias
UMLS CUI [1]
C0021390
UMLS CUI [2]
C2826273
Inflammatory bowel diseases - Test done
Description

Inflammatory bowel diseases - Test done

Data type

text

Alias
UMLS CUI [1]
C0021390
UMLS CUI [2,1]
C0022885
UMLS CUI [2,2]
C1272695
Inflammatory bowel diseases - Test date
Description

Inflammatory bowel diseases - Test date

Data type

date

Alias
UMLS CUI [1]
C0021390
UMLS CUI [2]
C2826247
Inflammatory bowel diseases - Test Result
Description

Inflammatory bowel diseases - Test Result

Data type

float

Alias
UMLS CUI [1]
C0021390
UMLS CUI [2]
C0587081
Inflammatory bowel diseases - Test Units
Description

Inflammatory bowel diseases - Test Units

Data type

text

Alias
UMLS CUI [1]
C0021390
UMLS CUI [2]
C1519795
Inflammatory bowel diseases - Low Norm
Description

Inflammatory bowel diseases - Low Norm

Data type

float

Alias
UMLS CUI [1]
C0021390
UMLS CUI [2,1]
C0086715
UMLS CUI [2,2]
C0205251
Inflammatory bowel diseases - High Norm
Description

Inflammatory bowel diseases - High Norm

Data type

float

Alias
UMLS CUI [1]
C0021390
UMLS CUI [2,1]
C0086715
UMLS CUI [2,2]
C0205250
Inflammatory bowel diseases - Other Diagnostic Test Results
Description

Inflammatory bowel diseases - Other Diagnostic Test Results

Alias
UMLS CUI-1
C0021390
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]
C04569840
UMLS CUI [1,2]
C0430022
UMLS CUI [1,3]
C0205394
Inflammatory bowel diseases - Other Diagnostic Test Results
Description

Inflammatory bowel diseases - Other Diagnostic Test Results

Alias
UMLS CUI-1
C0021390
UMLS CUI-2
C0456984
UMLS CUI-3
C0430022
UMLS CUI-4
C0205394
Inflammatory bowel diseases - Test
Description

Inflammatory bowel diseases - Test

Data type

text

Alias
UMLS CUI [1]
C0021390
UMLS CUI [2]
C2826273
Inflammatory bowel diseases - Test date
Description

Inflammatory bowel diseases - Test date

Data type

date

Alias
UMLS CUI [1]
C0021390
UMLS CUI [2]
C2826247
Inflammatory bowel diseases - Test Result
Description

Inflammatory bowel diseases - Test Result

Data type

float

Alias
UMLS CUI [1]
C0021390
UMLS CUI [2]
C0587081
Inflammatory bowel diseases - Test Units
Description

Inflammatory bowel diseases - Test Units

Data type

text

Alias
UMLS CUI [1]
C0021390
UMLS CUI [2]
C1519795
Inflammatory bowel diseases - Low Norm
Description

Inflammatory bowel diseases - Low Norm

Data type

float

Alias
UMLS CUI [1]
C0021390
UMLS CUI [2,1]
C0086715
UMLS CUI [2,2]
C0205251
Inflammatory bowel diseases - High Norm
Description

Inflammatory bowel diseases - High Norm

Data type

float

Alias
UMLS CUI [1]
C0021390
UMLS CUI [2,1]
C0086715
UMLS CUI [2,2]
C0205250
Inflammatory bowel diseases - Other diagnostic Procedure
Description

Inflammatory bowel diseases - Other diagnostic Procedure

Alias
UMLS CUI-1
C0021390
UMLS CUI-2
C0430022
UMLS CUI-3
C0205394
Describe any other diagnostic procedure supporting the diagnosis (Abdominal X-ray, Upper Gastrointestinal Small Bowel Follow Through (UGI-SBFT), Barium enema, Endoscopy / colonoscopy, Biopsy, Others)
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]
C0034573
UMLS CUI [4]
C0203063
UMLS CUI [5]
C0203075
UMLS CUI [6,1]
C0014245
UMLS CUI [6,2]
C0009378
UMLS CUI [7]
C0005558
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Similar models

IMD Report - Autoimmune thyroid diseases; Addisons's disease; Inflammatory bowel diseases (Report Final and Annex Report 2 Final)

1 forms
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
Autoimmune thyroid diseases
C0178468 (UMLS CUI-1)
Item
Autoimmune thyroid diseases Diagnosis
integer
C0178468 (UMLS CUI [1])
C0011900 (UMLS CUI [2])
Neurological Event Diagnosis
Code List
Autoimmune thyroid diseases Diagnosis
CL Item
Grave-Basedow disease (1)
CL Item
Hashimoto thyroiditis (2)
CL Item
Autoimmune thyroiditis (3)
CL Item
Other, specify (4)
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
Autoimmune thyroid diseases - Signs and Symptoms
C0178468 (UMLS CUI-1)
C0037088 (UMLS CUI-2)
Item
Autoimmune thyroid diseases - Signs and Symptoms
integer
C0178468 (UMLS CUI [1])
C0037088 (UMLS CUI [2])
Signs and Symptoms
Code List
Autoimmune thyroid diseases - Signs and Symptoms
CL Item
Thyroid enlargement (1)
CL Item
Thyroid nodules (2)
CL Item
Fatigue (3)
CL Item
Weight loss (4)
CL Item
Heat intolerance (5)
CL Item
Cold intolerance (6)
CL Item
Tachycardia, Palpitation (7)
CL Item
Bradycardia (8)
CL Item
Nervousness (9)
CL Item
Tremor (10)
CL Item
Depression (11)
CL Item
Hyperactive tendon reflex (12)
CL Item
Peripheral neuropathy (13)
CL Item
Skeletal weakness (14)
CL Item
Skin warm, moist, fine (15)
CL Item
Sweating (16)
CL Item
Dry skin (17)
CL Item
Fine hair, alopecia (18)
CL Item
Onycholysis (19)
CL Item
Pretibial myxedema (20)
CL Item
Polyuria, polydipsia (21)
CL Item
Constipation (22)
CL Item
Ophthalmopathy, specify (23)
CL Item
Periorbital oedema (24)
CL Item
Puffy face (25)
CL Item
Peripheral oedema (26)
CL Item
Blood pressure, specify (27)
CL Item
Dermopathy, specify (28)
Autoimmune thyroid diseases - Specify ophthalmopathy
Item
Autoimmune thyroid diseases - Specify ophthalmopathy
text
C0178468 (UMLS CUI [1])
C0015397 (UMLS CUI [2])
Autoimmune thyroid diseases - Specify blood pressure
Item
Autoimmune thyroid diseases - Specify blood pressure
text
C0178468 (UMLS CUI [1])
C0005823 (UMLS CUI [2])
Autoimmune thyroid diseases - Specify dermopathy
Item
Autoimmune thyroid diseases - Specify dermopathy
text
C0178468 (UMLS CUI [1])
C0037274 (UMLS CUI [2])
Item
Autoimmune thyroid diseases - Signs and Symptoms present
text
C0178468 (UMLS CUI [1])
C0037088 (UMLS CUI [2,1])
C0150312 (UMLS CUI [2,2])
Signs and symptoms present
Code List
Autoimmune thyroid diseases - Signs and Symptoms present
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
CL Item
Not Applicable (NA)
Autoimmune thyroid diseases - Signs and Symptoms start date
Item
Autoimmune thyroid diseases - Signs and Symptoms start date
date
C0178468 (UMLS CUI [1])
C0037088 (UMLS CUI [2,1])
C0808070 (UMLS CUI [2,2])
Autoimmune thyroid diseases - Signs and Symptoms end date
Item
Autoimmune thyroid diseases - Signs and Symptoms end date
date
C0178468 (UMLS CUI [1])
C0037088 (UMLS CUI [2,1])
C0806020 (UMLS CUI [2,2])
Item
Autoimmune thyroid diseases - Signs and Symptoms continuing at end of study
integer
C0178468 (UMLS CUI [1])
C0037088 (UMLS CUI [2])
C0549178 (UMLS CUI [3,1])
C0444496 (UMLS CUI [3,2])
Signs and symptoms continuing at end of study
Code List
Autoimmune thyroid diseases - Signs and Symptoms continuing at end of study
CL Item
Continuing at end of study (1)
Item Group
Autoimmune thyroid diseases - Other signs and symptoms
C0178468 (UMLS CUI-1)
C0037088 (UMLS CUI-2)
C0205394 (UMLS CUI-3)
Item
If any other signs and symptoms, please tick the box and complete below
integer
C0037088 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
If any other signs and symptoms, please tick the box and complete below
Code List
If any other signs and symptoms, please tick the box and complete below
CL Item
Other signs and symptoms (1)
Item Group
Autoimmune thyroid diseases - Other signs and symptoms
C0178468 (UMLS CUI-1)
C0037088 (UMLS CUI-2)
C0205394 (UMLS CUI-3)
Autoimmune thyroid diseases - Other signs and symptoms
Item
Autoimmune thyroid diseases - Other signs and symptoms
text
C0178468 (UMLS CUI [1])
C0037088 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
Autoimmune thyroid diseases - Other signs and symptoms start date
Item
Autoimmune thyroid diseases - Other signs and symptoms start date
date
C0178468 (UMLS CUI [1])
C0037088 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0808070 (UMLS CUI [3])
Autoimmune thyroid diseases - Other signs and symptoms end date
Item
Autoimmune thyroid diseases - Other signs and symptoms end date
date
C0178468 (UMLS CUI [1])
C0037088 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0806020 (UMLS CUI [3])
Item
Autoimmune thyroid diseases - Other signs and symptoms continuing at end of study
integer
C0178468 (UMLS CUI [1])
C0037088 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0549178 (UMLS CUI [3,1])
C0444496 (UMLS CUI [3,2])
Signs and symptoms continuing at end of study
Code List
Autoimmune thyroid diseases - Other signs and symptoms continuing at end of study
CL Item
Continuing at end of study (1)
Item Group
Autoimmune thyroid diseases - Diagnostic Test Results
C0178468 (UMLS CUI-1)
C0456984 (UMLS CUI-2)
C0430022 (UMLS CUI-3)
Item
Autoimmune thyroid diseases - Test
integer
C0178468 (UMLS CUI [1])
C2826273 (UMLS CUI [2])
Test
Code List
Autoimmune thyroid diseases - Test
CL Item
White Blood Cells (1)
CL Item
Neutrophils (2)
CL Item
Lymphocytes (3)
CL Item
Monocytes (4)
CL Item
Eosinophils (5)
CL Item
Basophils (6)
CL Item
Red blood cells (7)
CL Item
Platelets (8)
CL Item
Erythrocyte sedimentation rate (ESR) (9)
CL Item
Serum C-reactive protein (CRP) (10)
CL Item
Thyroxin Total T4 (11)
CL Item
Thyroxin Free T4 (12)
CL Item
TSH (13)
CL Item
Anti-thyroglobulin autoantibodies (14)
CL Item
Anti-thyroid peroxidase autoantibodies (15)
CL Item
Anti-TSH-Receptor autoantibodies (16)
Item
Autoimmune thyroid diseases - Test done
text
C0178468 (UMLS CUI [1])
C0022885 (UMLS CUI [2,1])
C1272695 (UMLS CUI [2,2])
Test done
Code List
Autoimmune thyroid diseases - Test done
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
CL Item
Not Applicable (NA)
Autoimmune thyroid diseases - Test date
Item
Autoimmune thyroid diseases - Test date
date
C0178468 (UMLS CUI [1])
C2826247 (UMLS CUI [2])
Autoimmune thyroid diseases - Test Result
Item
Autoimmune thyroid diseases - Test Result
float
C0178468 (UMLS CUI [1])
C0587081 (UMLS CUI [2])
Autoimmune thyroid diseases - Test Units
Item
Autoimmune thyroid diseases - Test Units
text
C0178468 (UMLS CUI [1])
C1519795 (UMLS CUI [2])
Autoimmune thyroid diseases - Low Norm
Item
Autoimmune thyroid diseases - Low Norm
float
C0178468 (UMLS CUI [1])
C0086715 (UMLS CUI [2,1])
C0205251 (UMLS CUI [2,2])
Autoimmune thyroid diseases - High Norm
Item
Autoimmune thyroid diseases - High Norm
float
C0178468 (UMLS CUI [1])
C0086715 (UMLS CUI [2,1])
C0205250 (UMLS CUI [2,2])
Item Group
Autoimmune thyroid diseases - Other Diagnostic Test Results
C0178468 (UMLS CUI-1)
C0456984 (UMLS CUI-2)
C0430022 (UMLS CUI-3)
C0205394 (UMLS CUI-4)
Item
If any other diagnostic test results are available, please tick the box and complete below
integer
C0456984 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
If any other diagnostic test results are available, please tick the box and complete below
Code List
If any other diagnostic test results are available, please tick the box and complete below
CL Item
Other diagnostic test results available (1)
Item Group
Autoimmune thyroid diseases - Other Diagnostic Test Results
C0178468 (UMLS CUI-1)
C0456984 (UMLS CUI-2)
C0430022 (UMLS CUI-3)
C0205394 (UMLS CUI-4)
Autoimmune thyroid diseases - Test
Item
Autoimmune thyroid diseases - Test
text
C0178468 (UMLS CUI [1])
C2826273 (UMLS CUI [2])
Autoimmune thyroid diseases - Test date
Item
Autoimmune thyroid diseases - Test date
date
C0178468 (UMLS CUI [1])
C2826247 (UMLS CUI [2])
Autoimmune thyroid diseases - Test Result
Item
Autoimmune thyroid diseases - Test Result
float
C0178468 (UMLS CUI [1])
C0587081 (UMLS CUI [2])
Autoimmune thyroid diseases - Test Units
Item
Autoimmune thyroid diseases - Test Units
text
C0178468 (UMLS CUI [1])
C1519795 (UMLS CUI [2])
Autoimmune thyroid diseases - Low Norm
Item
Autoimmune thyroid diseases - Low Norm
float
C0178468 (UMLS CUI [1])
C0086715 (UMLS CUI [2,1])
C0205251 (UMLS CUI [2,2])
Autoimmune thyroid diseases - High Norm
Item
Autoimmune thyroid diseases - High Norm
float
C0178468 (UMLS CUI [1])
C0086715 (UMLS CUI [2,1])
C0205250 (UMLS CUI [2,2])
Item Group
Autoimmune thyroid diseases - Other diagnostic Procedure
C0178468 (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 scintigraphy, sonography)
text
C0430022 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0011900 (UMLS CUI [2])
C0860843 (UMLS CUI [3])
C0041618 (UMLS CUI [4])
Item Group
Addison's disease
C0001403 (UMLS CUI-1)
Please specify related adverse event: SAE Case No.
Item
Please specify related adverse event: SAE Case No.
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Please specify related adverse event: AE No.
Item
Please specify related adverse event: AE No.
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Date of final diagnosis:
Item
Date of final diagnosis:
date
C2316983 (UMLS CUI [1,1])
C1546485 (UMLS CUI [1,2])
Item Group
Addison's disease - Signs and symptoms (supporting the final diagnosis)
C0001403 (UMLS CUI-1)
C0037088 (UMLS CUI-2)
C1546485 (UMLS CUI-3)
Item
Addison's disease - Signs and symptoms
integer
C0001403 (UMLS CUI [1])
C0037088 (UMLS CUI [2])
Myasthenia Gravis - Signs and symptoms
Code List
Addison's disease - Signs and symptoms
CL Item
Skin hyperpigmentation (1)
CL Item
Mucous membranes hyperpigmentation (2)
CL Item
Vitiligo (3)
CL Item
Hair loss (4)
CL Item
Progressive weakness (5)
CL Item
Fatigue (6)
CL Item
Poor appetite (7)
CL Item
Weight loss (8)
CL Item
Nausea (9)
CL Item
Vomiting (10)
CL Item
Diarrhea (11)
CL Item
Hypotension (12)
CL Item
Orthostasis (13)
CL Item
Dehydratation (14)
Item
Addison's disease - Signs and symptoms present
text
C0001403 (UMLS CUI [1])
C0037088 (UMLS CUI [2])
C0150312 (UMLS CUI [3])
Myasthenia Gravis - Signs and symptoms present
Code List
Addison's disease - Signs and symptoms present
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
CL Item
Not Applicable (NA)
Addison's disease - Signs and symptoms Start Date
Item
Addison's disease - Signs and symptoms Start Date
date
C0001403 (UMLS CUI [1])
C0037088 (UMLS CUI [2])
C0808070 (UMLS CUI [3])
Addison's disease - Signs and symptoms End date
Item
Addison's disease - Signs and symptoms End date
date
C0001403 (UMLS CUI [1])
C0037088 (UMLS CUI [2])
C0806020 (UMLS CUI [3])
Item
Addison's disease - Signs and symptoms continuing at the end of study
integer
C0001403 (UMLS CUI [1])
C0037088 (UMLS CUI [2])
C0549178 (UMLS CUI [3,1])
C0444496 (UMLS CUI [3,2])
Myasthenia Gravis - Signs and symptoms continuing at the end of study
Code List
Addison's disease - Signs and symptoms continuing at the end of study
CL Item
Continuing at end of study (1)
Item Group
Addison's disease - Other Signs and symptoms
C0001403 (UMLS CUI-1)
C0037088 (UMLS CUI-2)
C0205394 (UMLS CUI-3)
Item
If any other signs and symptoms, please tick the box and complete below
integer
C0037088 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
If any other signs and symptoms, please tick the box and complete below
Code List
If any other signs and symptoms, please tick the box and complete below
CL Item
Other signs and symptoms (1)
Item Group
Addison's disease - Other Signs and symptoms
C0001403 (UMLS CUI-1)
C0037088 (UMLS CUI-2)
C0205394 (UMLS CUI-3)
Addison's disease - Other Signs and symptoms
Item
Addison's disease - Other Signs and symptoms
text
C0001403 (UMLS CUI [1])
C0037088 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
Addison's disease - Other Signs and symptoms Start Date
Item
Addison's disease - Other Signs and symptoms Start Date
date
C0001403 (UMLS CUI [1])
C0037088 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0808070 (UMLS CUI [3])
Addison's disease - Other Signs and symptoms End Date
Item
Addison's disease - Other Signs and symptoms End Date
date
C0001403 (UMLS CUI [1])
C0037088 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0806020 (UMLS CUI [3])
Item
Addison's disease - Other signs and symptoms continuing at the end of study
text
C0001403 (UMLS CUI [1])
C0037088 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0549178 (UMLS CUI [3,1])
C0444496 (UMLS CUI [3,2])
Addison's disease - Other signs and symptoms continuing at the end of study
Code List
Addison's disease - Other signs and symptoms continuing at the end of study
CL Item
Continuing at end of study (1)
Item Group
Addison's disease - Diagnostic Test Results
C0001403 (UMLS CUI-1)
C0085655 (UMLS CUI-2)
C0456984 (UMLS CUI-3)
Item
Addison's disease - Test
integer
C0001403 (UMLS CUI [1])
C2826273 (UMLS CUI [2])
Test
Code List
Addison's disease - Test
CL Item
White Blood Cells (1)
CL Item
Neutrophils (2)
CL Item
Lymphocytes (3)
CL Item
Monocytes (4)
CL Item
Eosinophils (5)
CL Item
Basophils (6)
CL Item
Red blood cells (7)
CL Item
Platelets (8)
CL Item
Erythrocyte sedimentation rate (ESR) (9)
CL Item
Serum C-reactive protein (CRP) (10)
CL Item
Serum cortisol (11)
CL Item
ACTH stimulation test (12)
CL Item
Serum sodium (13)
CL Item
Serum chloride (14)
CL Item
Serum calcium (15)
CL Item
Serum acidosis (16)
CL Item
Serum urea nitrogen (17)
CL Item
Serum creatinine (18)
CL Item
Serum glycemia (19)
CL Item
Serum prolactin (20)
CL Item
Thyroxin Total T4 (21)
CL Item
Thyroxin Free T4 (22)
CL Item
TSH (23)
CL Item
Anti-adrenal autoantibodies (24)
CL Item
Anti-thyroglobulin autoantibodies (25)
CL Item
Anti-thyroid peroxidase autoantibodies (26)
CL Item
Anti-TSH-Receptor autoantibodies (27)
Item
Addison's disease - Test done
text
C0001403 (UMLS CUI [1])
C0022885 (UMLS CUI [2,1])
C1272695 (UMLS CUI [2,2])
Test done
Code List
Addison's disease - Test done
CL Item
Yes  (Y)
CL Item
No  (N)
CL Item
Unknown  (U)
CL Item
Not Applicable (NA)
Addison's disease - Test date
Item
Addison's disease - Test date
date
C0001403 (UMLS CUI [1])
C2826247 (UMLS CUI [2])
Addison's disease - Test Result
Item
Addison's disease - Test Result
float
C0001403 (UMLS CUI [1])
C0587081 (UMLS CUI [2])
Addison's disease - Test Units
Item
Addison's disease - Test Units
text
C0001403 (UMLS CUI [1])
C1519795 (UMLS CUI [2])
Addison's disease - Low Norm
Item
Addison's disease - Low Norm
float
C0001403 (UMLS CUI [1])
C0086715 (UMLS CUI [2,1])
C0205251 (UMLS CUI [2,2])
Addison's disease - High Norm
Item
Addison's disease - High Norm
float
C0001403 (UMLS CUI [1])
C0086715 (UMLS CUI [2,1])
C0205250 (UMLS CUI [2,2])
Item Group
Addison's disease - Other Diagnostic Test Results
C0001403 (UMLS CUI-1)
C0456984 (UMLS CUI-2)
C0430022 (UMLS CUI-3)
C0205394 (UMLS CUI-4)
Item
If any other diagnostic test results are available, please tick the box and complete below
integer
C0456984 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
If any other diagnostic test results are available, please tick the box and complete below
Code List
If any other diagnostic test results are available, please tick the box and complete below
CL Item
Other diagnostic test results available (1)
Item Group
Addison's disease - Other Diagnostic Test Results
C0001403 (UMLS CUI-1)
C0456984 (UMLS CUI-2)
C0430022 (UMLS CUI-3)
C0205394 (UMLS CUI-4)
Addison's disease - Test
Item
Addison's disease - Test
text
C0001403 (UMLS CUI [1])
C2826273 (UMLS CUI [2])
Addison's disease - Test date
Item
Addison's disease - Test date
date
C0001403 (UMLS CUI [1])
C2826247 (UMLS CUI [2])
Addison's disease - Test Result
Item
Addison's disease - Test Result
float
C0001403 (UMLS CUI [1])
C0587081 (UMLS CUI [2])
Addison's disease - Test Units
Item
Addison's disease - Test Units
text
C0001403 (UMLS CUI [1])
C1519795 (UMLS CUI [2])
Addison's disease - Low Norm
Item
Addison's disease - Low Norm
float
C0001403 (UMLS CUI [1])
C0086715 (UMLS CUI [2,1])
C0205251 (UMLS CUI [2,2])
Addison's disease - High Norm
Item
Addison's disease - High Norm
float
C0001403 (UMLS CUI [1])
C0086715 (UMLS CUI [2,1])
C0205250 (UMLS CUI [2,2])
Item Group
Addison's disease - Other diagnostic Procedure
C0001403 (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 (Chest x-Ray, Abdominal CT scan, Thyroid scintigraphy, sonography)
text
C0430022 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0011900 (UMLS CUI [2])
C0039985 (UMLS CUI [3])
C0412620 (UMLS CUI [4])
C0860843 (UMLS CUI [5])
C0041618 (UMLS CUI [6])
Item Group
Inflammatory bowel diseases
C0021390 (UMLS CUI-1)
Item
Inflammatory bowel diseases - Diagnosis
integer
C0021390 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Diabetes mellitus type I - Diagnosis
Code List
Inflammatory bowel diseases - Diagnosis
CL Item
Crohn’s disease (1)
CL Item
Ulcerative colitis (2)
CL Item
Ulcerative proctitis (3)
CL Item
Other, specify (4)
Inflammatory bowel diseases - Specify other diagnosis
Item
Inflammatory bowel diseases - Specify other diagnosis
text
C0021390 (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
Inflammatory bowel diseases - Signs and symptoms (supporting the final diagnosis)
C0021390 (UMLS CUI-1)
C0037088 (UMLS CUI-2)
C1546485 (UMLS CUI-3)
Item
Inflammatory bowel diseases - Signs and symptoms
integer
C0021390 (UMLS CUI [1])
C0037088 (UMLS CUI [2])
Uveitis - Signs and symptoms
Code List
Inflammatory bowel diseases - Signs and symptoms
CL Item
Diarrhea (1)
CL Item
Bloody diarrhea (2)
CL Item
Abdominal pain (3)
CL Item
Intestinal obstruction (4)
CL Item
Right lower quadrant mass (5)
CL Item
Perianal disease (6)
CL Item
Fistulae (7)
CL Item
Weight loss (8)
CL Item
Fever (9)
CL Item
Anorexia (10)
CL Item
Fatigue (11)
CL Item
Short stature (12)
CL Item
Delayed puberty (13)
CL Item
Erythema nodosum (14)
CL Item
Pyoderma gangrenosum (15)
CL Item
Ankylosing spondilitis (16)
CL Item
Sacroiliitis (17)
CL Item
Peripheral arthritis asymmetric (18)
CL Item
Peripheral arthritis symmetric (19)
CL Item
Ocular involvement (e.g. uveitis) (20)
CL Item
Primary sclerosing cholangitis (21)
Item
Inflammatory bowel diseases - Signs and symptoms present
text
C0021390 (UMLS CUI [1])
C0037088 (UMLS CUI [2])
C0150312 (UMLS CUI [3])
Myasthenia Gravis - Signs and symptoms present
Code List
Inflammatory bowel diseases - Signs and symptoms present
CL Item
Yes  (Y)
CL Item
No  (N)
CL Item
Unknown  (U)
CL Item
Not Applicable (NA)
Inflammatory bowel diseases - Signs and symptoms Start Date
Item
Inflammatory bowel diseases - Signs and symptoms Start Date
date
C0021390 (UMLS CUI [1])
C0037088 (UMLS CUI [2])
C0808070 (UMLS CUI [3])
Inflammatory bowel diseases - Signs and symptoms End date
Item
Inflammatory bowel diseases - Signs and symptoms End date
date
C0021390 (UMLS CUI [1])
C0037088 (UMLS CUI [2])
C0806020 (UMLS CUI [3])
Item
Inflammatory bowel diseases - Signs and symptoms continuing at the end of study
integer
C0021390 (UMLS CUI [1])
C0037088 (UMLS CUI [2])
C0549178 (UMLS CUI [3,1])
C0444496 (UMLS CUI [3,2])
Myasthenia Gravis - Signs and symptoms continuing at the end of study
Code List
Inflammatory bowel diseases - Signs and symptoms continuing at the end of study
CL Item
Continuing at end of study (1)
Item Group
Inflammatory bowel diseases - Other Signs and symptoms
C0021390 (UMLS CUI-1)
C0037088 (UMLS CUI-2)
C0205394 (UMLS CUI-3)
Item
If any other signs and symptoms, please tick the box and complete below
integer
C0037088 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
If any other signs and symptoms, please tick the box and complete below
Code List
If any other signs and symptoms, please tick the box and complete below
CL Item
Other signs and symptoms (1)
Item Group
Inflammatory bowel diseases - Other Signs and symptoms
C0021390 (UMLS CUI-1)
C0037088 (UMLS CUI-2)
C0205394 (UMLS CUI-3)
Inflammatory bowel diseases - Other Signs and symptoms
Item
Inflammatory bowel diseases - Other Signs and symptoms
text
C0021390 (UMLS CUI [1])
C0037088 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
Inflammatory bowel diseases - Other Signs and symptoms Start Date
Item
Inflammatory bowel diseases - Other Signs and symptoms Start Date
date
C0021390 (UMLS CUI [1])
C0037088 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0808070 (UMLS CUI [3])
Inflammatory bowel diseases - Other Signs and symptoms End Date
Item
Inflammatory bowel diseases - Other Signs and symptoms End Date
date
C0021390 (UMLS CUI [1])
C0037088 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0806020 (UMLS CUI [3])
Item
Inflammatory bowel diseases - Other signs and symptoms continuing at the end of study
text
C0021390 (UMLS CUI [1])
C0037088 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0549178 (UMLS CUI [3,1])
C0444496 (UMLS CUI [3,2])
Inflammatory bowel diseases - Other signs and symptoms continuing at the end of study
Code List
Inflammatory bowel diseases - Other signs and symptoms continuing at the end of study
CL Item
Continuing at end of study (1)
Item Group
Inflammatory bowel diseases - Diagnostic Test Results
C0021390 (UMLS CUI-1)
C0456984 (UMLS CUI-2)
Item
Inflammatory bowel diseases - Test
integer
C0021390 (UMLS CUI [1])
C2826273 (UMLS CUI [2])
Myasthenia Gravis - Test
Code List
Inflammatory bowel diseases - Test
CL Item
White Blood Cells (1)
CL Item
Neutrophils (2)
CL Item
Lymphocytes (3)
CL Item
Monocytes (4)
CL Item
Eosinophils (5)
CL Item
Basophils (6)
CL Item
Red blood cells (7)
CL Item
Platelets (8)
CL Item
Erythrocyte sedimentation rate (ESR) (9)
CL Item
Serum C-reactive protein (CRP) (10)
CL Item
Serum iron (11)
CL Item
Serum albumin (12)
CL Item
Perinuclear-ANCA (13)
CL Item
Cytoplasmic-ANCA (14)
CL Item
Anti-myeloperoxidase autoantibodies (15)
CL Item
Anti-proteinase 3 autoantibodies (16)
CL Item
Anti-S. cerevisiae antibodies (ASCA) (17)
CL Item
Stool guiac (18)
CL Item
Stool leucocytes (19)
CL Item
Stool blood (20)
Item
Inflammatory bowel diseases - Test done
text
C0021390 (UMLS CUI [1])
C0022885 (UMLS CUI [2,1])
C1272695 (UMLS CUI [2,2])
Myasthenia Gravis - Test done
Code List
Inflammatory bowel diseases - Test done
CL Item
Yes  (Y)
CL Item
No  (N)
CL Item
Unknown  (U)
CL Item
Not Applicable (NA)
Inflammatory bowel diseases - Test date
Item
Inflammatory bowel diseases - Test date
date
C0021390 (UMLS CUI [1])
C2826247 (UMLS CUI [2])
Inflammatory bowel diseases - Test Result
Item
Inflammatory bowel diseases - Test Result
float
C0021390 (UMLS CUI [1])
C0587081 (UMLS CUI [2])
Inflammatory bowel diseases - Test Units
Item
Inflammatory bowel diseases - Test Units
text
C0021390 (UMLS CUI [1])
C1519795 (UMLS CUI [2])
Inflammatory bowel diseases - Low Norm
Item
Inflammatory bowel diseases - Low Norm
float
C0021390 (UMLS CUI [1])
C0086715 (UMLS CUI [2,1])
C0205251 (UMLS CUI [2,2])
Inflammatory bowel diseases - High Norm
Item
Inflammatory bowel diseases - High Norm
float
C0021390 (UMLS CUI [1])
C0086715 (UMLS CUI [2,1])
C0205250 (UMLS CUI [2,2])
Item Group
Inflammatory bowel diseases - Other Diagnostic Test Results
C0021390 (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
C04569840 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
If any other diagnostic test results are available, please tick the box and complete below
Code List
If any other diagnostic test results are available please tick the box and complete below
CL Item
Other diagnostic test results available (1)
Item Group
Inflammatory bowel diseases - Other Diagnostic Test Results
C0021390 (UMLS CUI-1)
C0456984 (UMLS CUI-2)
C0430022 (UMLS CUI-3)
C0205394 (UMLS CUI-4)
Inflammatory bowel diseases - Test
Item
Inflammatory bowel diseases - Test
text
C0021390 (UMLS CUI [1])
C2826273 (UMLS CUI [2])
Inflammatory bowel diseases - Test date
Item
Inflammatory bowel diseases - Test date
date
C0021390 (UMLS CUI [1])
C2826247 (UMLS CUI [2])
Inflammatory bowel diseases - Test Result
Item
Inflammatory bowel diseases - Test Result
float
C0021390 (UMLS CUI [1])
C0587081 (UMLS CUI [2])
Inflammatory bowel diseases - Test Units
Item
Inflammatory bowel diseases - Test Units
text
C0021390 (UMLS CUI [1])
C1519795 (UMLS CUI [2])
Inflammatory bowel diseases - Low Norm
Item
Inflammatory bowel diseases - Low Norm
float
C0021390 (UMLS CUI [1])
C0086715 (UMLS CUI [2,1])
C0205251 (UMLS CUI [2,2])
Inflammatory bowel diseases - High Norm
Item
Inflammatory bowel diseases - High Norm
float
C0021390 (UMLS CUI [1])
C0086715 (UMLS CUI [2,1])
C0205250 (UMLS CUI [2,2])
Item Group
Inflammatory bowel diseases - Other diagnostic Procedure
C0021390 (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 (Abdominal X-ray, Upper Gastrointestinal Small Bowel Follow Through (UGI-SBFT), Barium enema, Endoscopy / colonoscopy, Biopsy, Others)
text
C0430022 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0011900 (UMLS CUI [2])
C0034573 (UMLS CUI [3])
C0203063 (UMLS CUI [4])
C0203075 (UMLS CUI [5])
C0014245 (UMLS CUI [6,1])
C0009378 (UMLS CUI [6,2])
C0005558 (UMLS CUI [7])
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