Informazione:
Errore:
ID
41538
Descrizione
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
versioni (2)
- 12/10/20 12/10/20 -
- 03/11/20 03/11/20 -
Titolare del copyright
GlaxoSmithKline
Caricato su
3 novembre 2020
DOI
Per favore, per richiedere un accesso.
Licenza
Creative Commons BY 4.0
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Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162
IMD Report - Idiopathic Thrombocytopenic Purpura; Pernicious Anaemia; Vasculitis (Report Final and Annex Report 2 Final)
Similar models
IMD Report - Idiopathic Thrombocytopenic Purpura; Pernicious Anaemia; Vasculitis (Report Final and Annex Report 2 Final)
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Centre Number
Item
Centre Number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
C0019994 (UMLS CUI [1,2])
Patient Number
Item
Patient Number
text
C2348585 (UMLS CUI [1])
Item Group
Idiopathic Thrombocytopenic Purpura
C0857305 (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])
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])
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])
C1546485 (UMLS CUI [1,2])
Item Group
Idiopathic Thrombocytopenic Purpura - Signs and Symptoms
C0857305 (UMLS CUI-1)
C0037088 (UMLS CUI-2)
C0037088 (UMLS CUI-2)
Item
Idiopathic Thrombocytopenic Purpura - Signs and Symptoms
integer
C0857305 (UMLS CUI [1])
C0037088 (UMLS CUI [2])
C0037088 (UMLS CUI [2])
CL Item
Abrupt onset (1)
CL Item
Gradual onset (2)
CL Item
Purpura (3)
CL Item
Bruising (4)
CL Item
Non palpable petachiae (5)
CL Item
Epistaxis (bleeding from nose) (6)
CL Item
Gingival bleeding (7)
CL Item
Gastro-intestinal bleeding (8)
CL Item
Intra-cranial bleeding (9)
CL Item
Other bleeding, specify (10)
CL Item
Menorrhagia (11)
Idiopathic Thrombocytopenic Purpura - Specify other bleeding
Item
Idiopathic Thrombocytopenic Purpura - Specify other bleeding
text
C0857305 (UMLS CUI [1])
C0019080 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0019080 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
Item
Idiopathic Thrombocytopenic Purpura - Signs and Symptoms present
text
C0857305 (UMLS CUI [1])
C0037088 (UMLS CUI [2,1])
C0150312 (UMLS CUI [2,2])
C0037088 (UMLS CUI [2,1])
C0150312 (UMLS CUI [2,2])
Code List
Idiopathic Thrombocytopenic Purpura - Signs and Symptoms present
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
CL Item
Not Applicable (NA)
Idiopathic Thrombocytopenic Purpura - Signs and Symptoms start date
Item
Idiopathic Thrombocytopenic Purpura - Signs and Symptoms start date
date
C0857305 (UMLS CUI [1])
C0037088 (UMLS CUI [2,1])
C0808070 (UMLS CUI [2,2])
C0037088 (UMLS CUI [2,1])
C0808070 (UMLS CUI [2,2])
Idiopathic Thrombocytopenic Purpura - Signs and Symptoms end date
Item
Idiopathic Thrombocytopenic Purpura - Signs and Symptoms end date
date
C0857305 (UMLS CUI [1])
C0037088 (UMLS CUI [2,1])
C0806020 (UMLS CUI [2,2])
C0037088 (UMLS CUI [2,1])
C0806020 (UMLS CUI [2,2])
Item
Idiopathic Thrombocytopenic Purpura - Signs and Symptoms continuing at end of study
integer
C0857305 (UMLS CUI [1])
C0037088 (UMLS CUI [2])
C0549178 (UMLS CUI [3,1])
C0444496 (UMLS CUI [3,2])
C0037088 (UMLS CUI [2])
C0549178 (UMLS CUI [3,1])
C0444496 (UMLS CUI [3,2])
Code List
Idiopathic Thrombocytopenic Purpura - Signs and Symptoms continuing at end of study
CL Item
Continuing at end of study (1)
Item Group
Idiopathic Thrombocytopenic Purpura - Other signs and symptoms
C0857305 (UMLS CUI-1)
C0037088 (UMLS CUI-2)
C0205394 (UMLS CUI-3)
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])
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
Idiopathic Thrombocytopenic Purpura - Other signs and symptoms
C0857305 (UMLS CUI-1)
C0037088 (UMLS CUI-2)
C0205394 (UMLS CUI-3)
C0037088 (UMLS CUI-2)
C0205394 (UMLS CUI-3)
Idiopathic Thrombocytopenic Purpura - Other signs and symptoms
Item
Idiopathic Thrombocytopenic Purpura - Other signs and symptoms
text
C0857305 (UMLS CUI [1])
C0037088 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0037088 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
Idiopathic Thrombocytopenic Purpura - Other signs and symptoms start date
Item
Idiopathic Thrombocytopenic Purpura - Other signs and symptoms start date
date
C0857305 (UMLS CUI [1])
C0037088 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0808070 (UMLS CUI [3])
C0037088 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0808070 (UMLS CUI [3])
Idiopathic Thrombocytopenic Purpura - Other signs and symptoms end date
Item
Idiopathic Thrombocytopenic Purpura - Other signs and symptoms end date
date
C0857305 (UMLS CUI [1])
C0037088 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0806020 (UMLS CUI [3])
C0037088 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0806020 (UMLS CUI [3])
Item
Idiopathic Thrombocytopenic Purpura - Other signs and symptoms continuing at end of study
integer
C0857305 (UMLS CUI [1])
C0037088 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0549178 (UMLS CUI [3,1])
C0444496 (UMLS CUI [3,2])
C0037088 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0549178 (UMLS CUI [3,1])
C0444496 (UMLS CUI [3,2])
Code List
Idiopathic Thrombocytopenic Purpura - Other signs and symptoms continuing at end of study
CL Item
Continuing at end of study (1)
Item Group
Idiopathic Thrombocytopenic Purpura - Diagnostic Test Results
C0857305 (UMLS CUI-1)
C0456984 (UMLS CUI-2)
C0430022 (UMLS CUI-3)
C0456984 (UMLS CUI-2)
C0430022 (UMLS CUI-3)
Item
Idiopathic Thrombocytopenic Purpura - Test
integer
C0857305 (UMLS CUI [1])
C2826273 (UMLS CUI [2])
C2826273 (UMLS CUI [2])
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
Prothrombine time (PT) (11)
CL Item
Activated partial thromboplastine time (APTT) (12)
CL Item
Serum anti-platelet antibodies (13)
CL Item
Anticardiolipin (ELISA) IgM (14)
CL Item
Anticardiolipin (ELISA) IgG (15)
CL Item
Anti-beta 2 glycoprotein I (16)
CL Item
Anti-prothrombin (17)
Item
Idiopathic Thrombocytopenic Purpura - Test done
text
C0857305 (UMLS CUI [1])
C0022885 (UMLS CUI [2,1])
C1272695 (UMLS CUI [2,2])
C0022885 (UMLS CUI [2,1])
C1272695 (UMLS CUI [2,2])
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
CL Item
Not Applicable (NA)
Idiopathic Thrombocytopenic Purpura - Test date
Item
Idiopathic Thrombocytopenic Purpura - Test date
date
C0857305 (UMLS CUI [1])
C2826247 (UMLS CUI [2])
C2826247 (UMLS CUI [2])
Idiopathic Thrombocytopenic Purpura - Test Result
Item
Idiopathic Thrombocytopenic Purpura - Test Result
float
C0857305 (UMLS CUI [1])
C0587081 (UMLS CUI [2])
C0587081 (UMLS CUI [2])
Idiopathic Thrombocytopenic Purpura - Test Units
Item
Idiopathic Thrombocytopenic Purpura - Test Units
text
C0857305 (UMLS CUI [1])
C1519795 (UMLS CUI [2])
C1519795 (UMLS CUI [2])
Idiopathic Thrombocytopenic Purpura - Low Norm
Item
Idiopathic Thrombocytopenic Purpura - Low Norm
float
C0857305 (UMLS CUI [1])
C0086715 (UMLS CUI [2,1])
C0205251 (UMLS CUI [2,2])
C0086715 (UMLS CUI [2,1])
C0205251 (UMLS CUI [2,2])
Idiopathic Thrombocytopenic Purpura - High Norm
Item
Idiopathic Thrombocytopenic Purpura - High Norm
float
C0857305 (UMLS CUI [1])
C0086715 (UMLS CUI [2,1])
C0205250 (UMLS CUI [2,2])
C0086715 (UMLS CUI [2,1])
C0205250 (UMLS CUI [2,2])
Item Group
Idiopathic Thrombocytopenic Purpura - Other Diagnostic Test Results
C0857305 (UMLS CUI-1)
C0456984 (UMLS CUI-2)
C0430022 (UMLS CUI-3)
C0205394 (UMLS CUI-4)
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])
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
Idiopathic Thrombocytopenic Purpura - Other Diagnostic Test Results
C0857305 (UMLS CUI-1)
C0456984 (UMLS CUI-2)
C0430022 (UMLS CUI-3)
C0205394 (UMLS CUI-4)
C0456984 (UMLS CUI-2)
C0430022 (UMLS CUI-3)
C0205394 (UMLS CUI-4)
Idiopathic Thrombocytopenic Purpura - Test
Item
Idiopathic Thrombocytopenic Purpura - Test
text
C0857305 (UMLS CUI [1])
C2826273 (UMLS CUI [2])
C2826273 (UMLS CUI [2])
Idiopathic Thrombocytopenic Purpura - Test date
Item
Idiopathic Thrombocytopenic Purpura - Test date
date
C0857305 (UMLS CUI [1])
C2826247 (UMLS CUI [2])
C2826247 (UMLS CUI [2])
Idiopathic Thrombocytopenic Purpura - Test Result
Item
Idiopathic Thrombocytopenic Purpura - Test Result
float
C0857305 (UMLS CUI [1])
C0587081 (UMLS CUI [2])
C0587081 (UMLS CUI [2])
Idiopathic Thrombocytopenic Purpura - Test Units
Item
Idiopathic Thrombocytopenic Purpura - Test Units
text
C0857305 (UMLS CUI [1])
C1519795 (UMLS CUI [2])
C1519795 (UMLS CUI [2])
Idiopathic Thrombocytopenic Purpura - Low Norm
Item
Idiopathic Thrombocytopenic Purpura - Low Norm
float
C0857305 (UMLS CUI [1])
C0086715 (UMLS CUI [2,1])
C0205251 (UMLS CUI [2,2])
C0086715 (UMLS CUI [2,1])
C0205251 (UMLS CUI [2,2])
Idiopathic Thrombocytopenic Purpura - High Norm
Item
Idiopathic Thrombocytopenic Purpura - High Norm
float
C0857305 (UMLS CUI [1])
C0086715 (UMLS CUI [2,1])
C0205250 (UMLS CUI [2,2])
C0086715 (UMLS CUI [2,1])
C0205250 (UMLS CUI [2,2])
Item Group
Idiopathic Thrombocytopenic Purpura - Other diagnostic Procedure
C0857305 (UMLS CUI-1)
C0430022 (UMLS CUI-2)
C0205394 (UMLS CUI-3)
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
text
C0430022 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0011900 (UMLS CUI [2])
C0205394 (UMLS CUI [1,2])
C0011900 (UMLS CUI [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])
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])
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])
C1546485 (UMLS CUI [1,2])
Item Group
Pernicious Anaemia - Signs and symptoms
C0002892 (UMLS CUI-1)
C0037088 (UMLS CUI-2)
C1546485 (UMLS CUI-3)
C0037088 (UMLS CUI-2)
C1546485 (UMLS CUI-3)
Item
Pernicious Anaemia - Signs and symptoms
text
C0002892 (UMLS CUI [1])
C0037088 (UMLS CUI [2])
C0037088 (UMLS CUI [2])
CL Item
Lemon-yellow waxy pallor (Lemon-yellow waxy pallor)
CL Item
Beefy, red, smooth tongue (Beefy, red, smooth tongue)
CL Item
Poor feeding (Poor feeding)
CL Item
Weight loss (Weight loss)
CL Item
Low grade fever (Low grade fever)
CL Item
Paresthesia (Paresthesia)
CL Item
Ataxia (Ataxia)
CL Item
Vision deterioration (Vision deterioration)
CL Item
Hearing deterioration (Hearing deterioration)
CL Item
Abnormal mentation (Abnormal mentation)
CL Item
Vertigos (Vertigos)
CL Item
Palpitation, tachycardia (Palpitation, tachycardia)
CL Item
Dyspnea, tachypnea (Dyspnea, tachypnea)
CL Item
Congestive heart failure (Congestive heart failure)
Item
Pernicious Anaemia - Signs and symptoms present
text
C0002892 (UMLS CUI [1])
C0037088 (UMLS CUI [2])
C0150312 (UMLS CUI [3])
C0037088 (UMLS CUI [2])
C0150312 (UMLS CUI [3])
Code List
Pernicious Anaemia - Signs and symptoms present
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
CL Item
Not Applicable (NA)
Pernicious Anaemia - Signs and symptoms Start Date
Item
Pernicious Anaemia - Signs and symptoms Start Date
date
C0002892 (UMLS CUI [1])
C0037088 (UMLS CUI [2])
C0808070 (UMLS CUI [3])
C0037088 (UMLS CUI [2])
C0808070 (UMLS CUI [3])
Pernicious Anaemia - Signs and symptoms End date
Item
Pernicious Anaemia - Signs and symptoms End date
date
C0002892 (UMLS CUI [1])
C0037088 (UMLS CUI [2])
C0806020 (UMLS CUI [3])
C0037088 (UMLS CUI [2])
C0806020 (UMLS CUI [3])
Item
Pernicious Anaemia - Signs and symptoms continuing at the end of study
integer
C0002892 (UMLS CUI [1])
C0037088 (UMLS CUI [2])
C0549178 (UMLS CUI [3,1])
C0444496 (UMLS CUI [3,2])
C0037088 (UMLS CUI [2])
C0549178 (UMLS CUI [3,1])
C0444496 (UMLS CUI [3,2])
Code List
Pernicious Anaemia - Signs and symptoms continuing at the end of study
CL Item
Continuing at end of study (1)
Item Group
Pernicious Anaemia - Other Signs and symptoms
C0002892 (UMLS CUI-1)
C0037088 (UMLS CUI-2)
C0205394 (UMLS CUI-3)
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])
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
Pernicious Anaemia - Other Signs and symptoms
C0002892 (UMLS CUI-1)
C0037088 (UMLS CUI-2)
C0205394 (UMLS CUI-3)
C0037088 (UMLS CUI-2)
C0205394 (UMLS CUI-3)
Pernicious Anaemia - Other Signs and symptoms
Item
Pernicious Anaemia - Other Signs and symptoms
text
C0002892 (UMLS CUI [1])
C0037088 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0037088 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
Pernicious Anaemia - Other Signs and symptoms Start Date
Item
Pernicious Anaemia - Other Signs and symptoms Start Date
date
C0002892 (UMLS CUI [1])
C0037088 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0808070 (UMLS CUI [3])
C0037088 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0808070 (UMLS CUI [3])
Pernicious Anaemia - Other Signs and symptoms End Date
Item
Pernicious Anaemia - Other Signs and symptoms End Date
date
C0002892 (UMLS CUI [1])
C0037088 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0806020 (UMLS CUI [3])
C0037088 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0806020 (UMLS CUI [3])
Item
Pernicious Anaemia - Other signs and symptoms continuing at the end of study
text
C0002892 (UMLS CUI [1])
C0037088 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0549178 (UMLS CUI [3,1])
C0444496 (UMLS CUI [3,2])
C0037088 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0549178 (UMLS CUI [3,1])
C0444496 (UMLS CUI [3,2])
Code List
Pernicious Anaemia - Other signs and symptoms continuing at the end of study
CL Item
Continuing at end of study (1)
Item Group
Pernicious Anaemia - Diagnostic Test Results
C0002892 (UMLS CUI-1)
C0430022 (UMLS CUI-2)
C0456984 (UMLS CUI-3)
C0430022 (UMLS CUI-2)
C0456984 (UMLS CUI-3)
Item
Pernicious Anaemia - Test
integer
C0002892 (UMLS CUI [1])
C2826273 (UMLS CUI [2])
C2826273 (UMLS CUI [2])
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
Mean corpuscular volume (MCV) (11)
CL Item
Mean corpuscular hemoglobin concentration (MCHC) (12)
CL Item
Reticulocytosis (13)
CL Item
Serum antiparietal cell antibodies (14)
CL Item
Serum antiintrinsic factor antibodies (15)
CL Item
Serum cobalamin (B-12) levels (16)
Item
Pernicious Anaemia - Test done
text
C0002892 (UMLS CUI [1])
C0022885 (UMLS CUI [2,1])
C1272695 (UMLS CUI [2,2])
C0022885 (UMLS CUI [2,1])
C1272695 (UMLS CUI [2,2])
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
CL Item
Not Applicable (NA)
Pernicious Anaemia - Test date
Item
Pernicious Anaemia - Test date
date
C0002892 (UMLS CUI [1])
C2826247 (UMLS CUI [2])
C2826247 (UMLS CUI [2])
Pernicious Anaemia - Test Result
Item
Pernicious Anaemia - Test Result
float
C0002892 (UMLS CUI [1])
C0587081 (UMLS CUI [2])
C0587081 (UMLS CUI [2])
Pernicious Anaemia - Test Units
Item
Pernicious Anaemia - Test Units
text
C0002892 (UMLS CUI [1])
C1519795 (UMLS CUI [2])
C1519795 (UMLS CUI [2])
Pernicious Anaemia - Low Norm
Item
Pernicious Anaemia - Low Norm
float
C0002892 (UMLS CUI [1])
C0086715 (UMLS CUI [2,1])
C0205251 (UMLS CUI [2,2])
C0086715 (UMLS CUI [2,1])
C0205251 (UMLS CUI [2,2])
Pernicious Anaemia - High Norm
Item
Pernicious Anaemia - High Norm
float
C0002892 (UMLS CUI [1])
C0086715 (UMLS CUI [2,1])
C0205250 (UMLS CUI [2,2])
C0086715 (UMLS CUI [2,1])
C0205250 (UMLS CUI [2,2])
Item Group
Pernicious Anaemia - Other Diagnostic Test Results
C0002892 (UMLS CUI-1)
C0456984 (UMLS CUI-2)
C0430022 (UMLS CUI-3)
C0205394 (UMLS CUI-4)
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])
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
Pernicious Anaemia - Other Diagnostic Test Results
C0002892 (UMLS CUI-1)
C0456984 (UMLS CUI-2)
C0430022 (UMLS CUI-3)
C0205394 (UMLS CUI-4)
C0456984 (UMLS CUI-2)
C0430022 (UMLS CUI-3)
C0205394 (UMLS CUI-4)
Pernicious Anaemia - Test
Item
Pernicious Anaemia - Test
text
C0002892 (UMLS CUI [1])
C2826273 (UMLS CUI [2])
C2826273 (UMLS CUI [2])
Pernicious Anaemia - Test date
Item
Pernicious Anaemia - Test date
date
C0002892 (UMLS CUI [1])
C2826247 (UMLS CUI [2])
C2826247 (UMLS CUI [2])
Pernicious Anaemia - Test Result
Item
Pernicious Anaemia - Test Result
float
C0002892 (UMLS CUI [1])
C0587081 (UMLS CUI [2])
C0587081 (UMLS CUI [2])
Pernicious Anaemia - Test Units
Item
Pernicious Anaemia - Test Units
text
C0002892 (UMLS CUI [1])
C1519795 (UMLS CUI [2])
C1519795 (UMLS CUI [2])
Pernicious Anaemia - Low Norm
Item
Pernicious Anaemia - Low Norm
float
C0002892 (UMLS CUI [1])
C0086715 (UMLS CUI [2,1])
C0205251 (UMLS CUI [2,2])
C0086715 (UMLS CUI [2,1])
C0205251 (UMLS CUI [2,2])
Pernicious Anaemia - High Norm
Item
Pernicious Anaemia - High Norm
float
C0002892 (UMLS CUI [1])
C0086715 (UMLS CUI [2,1])
C0205250 (UMLS CUI [2,2])
C0086715 (UMLS CUI [2,1])
C0205250 (UMLS CUI [2,2])
Item Group
Pernicious Anaemia - Other diagnostic Procedure
C0002892 (UMLS CUI-1)
C0430022 (UMLS CUI-2)
C0205394 (UMLS CUI-3)
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 (Gastric secretions, Gastric biopsy, Schilling test, Marrow biopsy)
text
C0430022 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0011900 (UMLS CUI [2])
C1704242 (UMLS CUI [3,1])
C0036537 (UMLS CUI [3,2])
C1704242 (UMLS CUI [4,1])
C0005558 (UMLS CUI [4,2])
C0036313 (UMLS CUI [5])
C0005954 (UMLS CUI [6])
C0205394 (UMLS CUI [1,2])
C0011900 (UMLS CUI [2])
C1704242 (UMLS CUI [3,1])
C0036537 (UMLS CUI [3,2])
C1704242 (UMLS CUI [4,1])
C0005558 (UMLS CUI [4,2])
C0036313 (UMLS CUI [5])
C0005954 (UMLS CUI [6])
Item
Vasculitis - Diagnosis
integer
C0042384 (UMLS CUI [1])
C0011900 (UMLS CUI [2])
C0011900 (UMLS CUI [2])
CL Item
Leukocytoclastic vasculitis (1)
CL Item
PAN (periarteritis nodosa) (2)
CL Item
Microscopic polyangiitis (3)
CL Item
Wegener’s granulomatosis (4)
CL Item
Henoch-Schonlein purpura (5)
CL Item
Churg Strauss syndrome (6)
CL Item
Kawasaki disease (7)
CL Item
Temporal arteritis (8)
CL Item
Takayasu’s arteritis (9)
CL Item
Giant cell arteritis (10)
CL Item
Horton’s arteritis (11)
CL Item
Behcet disease (12)
CL Item
Other, specify (13)
Vasculitis - Specify other diagnosis
Item
Vasculitis - Specify other diagnosis
text
C0042384 (UMLS CUI [1])
C0011900 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
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])
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])
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])
C1546485 (UMLS CUI [1,2])
Item Group
Vasculitis - Signs and symptoms
C0042384 (UMLS CUI-1)
C0037088 (UMLS CUI-2)
C1546485 (UMLS CUI-3)
C0037088 (UMLS CUI-2)
C1546485 (UMLS CUI-3)
Item
Vasculitis - Signs and symptoms
integer
C0042384 (UMLS CUI [1])
C0037088 (UMLS CUI [2])
C0037088 (UMLS CUI [2])
CL Item
Weakness (1)
CL Item
Malaise (2)
CL Item
Fever (3)
CL Item
Weight loss (4)
CL Item
Anorexia (5)
CL Item
Abdominal pain (6)
CL Item
Myalgia (7)
CL Item
Headache (8)
CL Item
Hypertension (9)
CL Item
Macules (10)
CL Item
Papules (11)
CL Item
Vesicules (12)
CL Item
Purpura (13)
CL Item
Palpable purpura (14)
CL Item
Nodules (15)
CL Item
Nodular temporal artery (16)
CL Item
Ulcers (17)
CL Item
Rash (18)
CL Item
Urticaria (19)
CL Item
Raynaud phenomenon (20)
CL Item
Erythema of oral cavity, lips, palms (21)
CL Item
Desquamation of fingertips (22)
CL Item
Arthralgia (23)
CL Item
Arthritis, specify (24)
CL Item
Renal failure (25)
CL Item
Upper respiratory disorder (sinusitis…) (26)
CL Item
Lower respiratory disorder (27)
CL Item
Asthma (28)
CL Item
Eye disorders, specify (29)
CL Item
Peripheral neuropathy (30)
CL Item
Optic neuritis (31)
CL Item
Cerebral vascular accident (32)
CL Item
Mental status disorder (33)
CL Item
Seizure (34)
CL Item
Lymphadenopathy (35)
CL Item
Cervical adenitis (36)
CL Item
Cardiac failure (37)
CL Item
Myocardial infarctus (38)
CL Item
Pericarditis (39)
CL Item
Cardiomyopathy (40)
CL Item
Peripheral pulse Upper leg (41)
CL Item
Peripheral pulse Lower leg (42)
CL Item
Coronary artery aneurysm (43)
CL Item
Signs of previous infection (44)
Vasculitis - Specify Arthritis
Item
Vasculitis - Specify Arthritis
text
C0042384 (UMLS CUI [1])
C0003864 (UMLS CUI [2])
C0003864 (UMLS CUI [2])
Vasculitis - Specify eye disorders
Item
Vasculitis - Specify eye disorders
text
C0042384 (UMLS CUI [1])
C0015397 (UMLS CUI [2])
C0015397 (UMLS CUI [2])
Item
Vasculitis - Signs and symptoms present
text
C0042384 (UMLS CUI [1])
C0037088 (UMLS CUI [2])
C0150312 (UMLS CUI [3])
C0037088 (UMLS CUI [2])
C0150312 (UMLS CUI [3])
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
CL Item
Not Applicable (NA)
Vasculitis - Signs and symptoms Start Date
Item
Vasculitis - Signs and symptoms Start Date
date
C0042384 (UMLS CUI [1])
C0037088 (UMLS CUI [2])
C0808070 (UMLS CUI [3])
C0037088 (UMLS CUI [2])
C0808070 (UMLS CUI [3])
Vasculitis - Signs and symptoms End date
Item
Vasculitis - Signs and symptoms End date
date
C0042384 (UMLS CUI [1])
C0037088 (UMLS CUI [2])
C0806020 (UMLS CUI [3])
C0037088 (UMLS CUI [2])
C0806020 (UMLS CUI [3])
Item
Vasculitis - Signs and symptoms continuing at the end of study
integer
C0042384 (UMLS CUI [1])
C0037088 (UMLS CUI [2])
C0549178 (UMLS CUI [3,1])
C0444496 (UMLS CUI [3,2])
C0037088 (UMLS CUI [2])
C0549178 (UMLS CUI [3,1])
C0444496 (UMLS CUI [3,2])
Code List
Vasculitis - Signs and symptoms continuing at the end of study
CL Item
Continuing at end of study (1)
Item Group
Vasculitis - Other Signs and symptoms
C0042384 (UMLS CUI-1)
C0037088 (UMLS CUI-2)
C0205394 (UMLS CUI-3)
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])
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
Vasculitis - Other Signs and symptoms
C0042384 (UMLS CUI-1)
C0037088 (UMLS CUI-2)
C0205394 (UMLS CUI-3)
C0037088 (UMLS CUI-2)
C0205394 (UMLS CUI-3)
Vasculitis - Other Signs and symptoms
Item
Vasculitis - Other Signs and symptoms
text
C0042384 (UMLS CUI [1])
C0037088 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0037088 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
Vasculitis - Other Signs and symptoms Start Date
Item
Vasculitis - Other Signs and symptoms Start Date
date
C0042384 (UMLS CUI [1])
C0037088 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0808070 (UMLS CUI [3])
C0037088 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0808070 (UMLS CUI [3])
Vasculitis - Other Signs and symptoms End Date
Item
Vasculitis - Other Signs and symptoms End Date
date
C0042384 (UMLS CUI [1])
C0037088 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0806020 (UMLS CUI [3])
C0037088 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0806020 (UMLS CUI [3])
Item
Vasculitis - Other signs and symptoms continuing at the end of study
text
C0042384 (UMLS CUI [1])
C0037088 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0549178 (UMLS CUI [3,1])
C0444496 (UMLS CUI [3,2])
C0037088 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0549178 (UMLS CUI [3,1])
C0444496 (UMLS CUI [3,2])
Code List
Vasculitis - Other signs and symptoms continuing at the end of study
CL Item
Continuing at end of study (1)
Item Group
Vasculitis - Diagnostic Test Results
C0042384 (UMLS CUI-1)
C0456984 (UMLS CUI-2)
C0456984 (UMLS CUI-2)
CL Item
White Blood Cells (1)
CL Item
Neutrophils (2)
CL Item
Lymphocytes (3)
CL Item
Monocytes (4)
CL Item
Eosinophils (5)
CL Item
Basophils (6)
CL Item
Red blood cells (7)
CL Item
Platelets (8)
CL Item
Erythrocyte sedimentation rate (ESR) (9)
CL Item
Serum C-reactive protein (CRP) (10)
CL Item
Serum urea nitrogen (11)
CL Item
Serum creatinine (12)
CL Item
Serum albumin (13)
CL Item
Serum IgG (14)
CL Item
Serum IgA (15)
CL Item
Serum IgM (16)
CL Item
Serum cryoglobulin (17)
CL Item
Serum creatine kinase (CK) (18)
CL Item
Alanine amino Transferase (ALT) (19)
CL Item
Aspartate amino Transferase (AST) (20)
CL Item
Perinuclear-ANCA (21)
CL Item
Cytoplasmic-ANCA (22)
CL Item
ANCA undetermined (23)
CL Item
Rheumatoid Factor (RF) (24)
CL Item
Anti-nuclear antibodies (ANA) (25)
CL Item
Albuminuria (26)
CL Item
LMW proteinuria (27)
CL Item
Hematuria (28)
CL Item
RBC casts (29)
CL Item
Stool leucocytes (30)
CL Item
Stool blood (31)
Item
Vasculitis - Test done
text
C0042384 (UMLS CUI [1])
C0022885 (UMLS CUI [2,1])
C1272695 (UMLS CUI [2,2])
C0022885 (UMLS CUI [2,1])
C1272695 (UMLS CUI [2,2])
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
CL Item
Not Applicable (NA)
Vasculitis - Test date
Item
Vasculitis - Test date
date
C0042384 (UMLS CUI [1])
C2826247 (UMLS CUI [2])
C2826247 (UMLS CUI [2])
Vasculitis - Test Result
Item
Vasculitis - Test Result
float
C0042384 (UMLS CUI [1])
C0587081 (UMLS CUI [2])
C0587081 (UMLS CUI [2])
Vasculitis - Test Units
Item
Vasculitis - Test Units
text
C0042384 (UMLS CUI [1])
C1519795 (UMLS CUI [2])
C1519795 (UMLS CUI [2])
Vasculitis - Low Norm
Item
Vasculitis - Low Norm
float
C0042384 (UMLS CUI [1])
C0086715 (UMLS CUI [2,1])
C0205251 (UMLS CUI [2,2])
C0086715 (UMLS CUI [2,1])
C0205251 (UMLS CUI [2,2])
Vasculitis - High Norm
Item
Vasculitis - High Norm
float
C0042384 (UMLS CUI [1])
C0086715 (UMLS CUI [2,1])
C0205250 (UMLS CUI [2,2])
C0086715 (UMLS CUI [2,1])
C0205250 (UMLS CUI [2,2])
Item Group
Vasculitis - Other Diagnostic Test Results
C0042384 (UMLS CUI-1)
C0456984 (UMLS CUI-2)
C0430022 (UMLS CUI-3)
C0205394 (UMLS CUI-4)
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])
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
Vasculitis - Other Diagnostic Test Results (i.e. Serological viral hepatic tests, Serological liver enzymes)
C0042384 (UMLS CUI-1)
C0456984 (UMLS CUI-2)
C0430022 (UMLS CUI-3)
C0205394 (UMLS CUI-4)
C0205473 (UMLS CUI-5)
C0019158 (UMLS CUI-6)
C1287351 (UMLS CUI-7)
C0456984 (UMLS CUI-2)
C0430022 (UMLS CUI-3)
C0205394 (UMLS CUI-4)
C0205473 (UMLS CUI-5)
C0019158 (UMLS CUI-6)
C1287351 (UMLS CUI-7)
Vasculitis - Test
Item
Vasculitis - Test
text
C0042384 (UMLS CUI [1])
C2826273 (UMLS CUI [2])
C2826273 (UMLS CUI [2])
Vasculitis - Test date
Item
Vasculitis - Test date
date
C0042384 (UMLS CUI [1])
C2826247 (UMLS CUI [2])
C2826247 (UMLS CUI [2])
Vasculitis - Test Result
Item
Vasculitis - Test Result
float
C0042384 (UMLS CUI [1])
C0587081 (UMLS CUI [2])
C0587081 (UMLS CUI [2])
Vasculitis - Test Units
Item
Vasculitis - Test Units
text
C0042384 (UMLS CUI [1])
C1519795 (UMLS CUI [2])
C1519795 (UMLS CUI [2])
Vasculitis - Low Norm
Item
Vasculitis - Low Norm
float
C0042384 (UMLS CUI [1])
C0086715 (UMLS CUI [2,1])
C0205251 (UMLS CUI [2,2])
C0086715 (UMLS CUI [2,1])
C0205251 (UMLS CUI [2,2])
Vasculitis - High Norm
Item
Vasculitis - High Norm
float
C0042384 (UMLS CUI [1])
C0086715 (UMLS CUI [2,1])
C0205250 (UMLS CUI [2,2])
C0086715 (UMLS CUI [2,1])
C0205250 (UMLS CUI [2,2])
Item Group
Vasculitis - Other diagnostic Procedure
C0042384 (UMLS CUI-1)
C0430022 (UMLS CUI-2)
C0205394 (UMLS CUI-3)
C0011900 (UMLS CUI-4)
C0430022 (UMLS CUI-2)
C0205394 (UMLS CUI-3)
C0011900 (UMLS CUI-4)
Vasculitis - Describe any other diagnostic procedure supporting the diagnosis
Item
Vasculitis - Describe any other diagnostic procedure supporting the diagnosis (Biopsies of affected organ, Pulmonary X-Ray, Angiography, Others)
text
C0430022 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0011900 (UMLS CUI [2])
C0005558 (UMLS CUI [3,1])
C0178784 (UMLS CUI [3,2])
C0392760 (UMLS CUI [3,3])
C0039985 (UMLS CUI [4,1])
C2709248 (UMLS CUI [4,2])
C0002978 (UMLS CUI [5])
C0205394 (UMLS CUI [6])
C0205394 (UMLS CUI [1,2])
C0011900 (UMLS CUI [2])
C0005558 (UMLS CUI [3,1])
C0178784 (UMLS CUI [3,2])
C0392760 (UMLS CUI [3,3])
C0039985 (UMLS CUI [4,1])
C2709248 (UMLS CUI [4,2])
C0002978 (UMLS CUI [5])
C0205394 (UMLS CUI [6])
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