Informazione:
Errore:
ID
41537
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)
- 07/10/20 07/10/20 -
- 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 - Coeliac Disease; Antiphospholipid Syndrome; Autoimmune Haemolytic Anaemia (Report Final and Annex Report 2 Final)
Similar models
IMD Report - Coeliac Disease; Antiphospholipid Syndrome; Autoimmune Haemolytic Anaemia (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])
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
Coeliac disease - Signs and Symptoms
C0007570 (UMLS CUI-1)
C0037088 (UMLS CUI-3)
C0037088 (UMLS CUI-3)
Item
Coeliac disease - Signs and Symptoms
integer
C0007570 (UMLS CUI [1])
C0037088 (UMLS CUI [2])
C0037088 (UMLS CUI [2])
CL Item
Diarrhea (1)
CL Item
Protuberant and tympanic abdomen (2)
CL Item
Evidence of weight loss (3)
CL Item
Orthostatic hypotension (4)
CL Item
Peripheral edema (5)
CL Item
Ecchymoses (6)
CL Item
Fatigue (7)
CL Item
Mood change (8)
CL Item
Hyperkeratosis (9)
CL Item
Dermatitis herpetiformis (10)
CL Item
Cheilosis and glossitis (11)
CL Item
Evidence of peripheral neuropathy (12)
CL Item
Symptoms exacerbation with gluten-containing diet (13)
Item
Coeliac disease - Signs and Symptoms present
text
C0007570 (UMLS CUI [1])
C0037088 (UMLS CUI [2,1])
C0150312 (UMLS CUI [2,2])
C0037088 (UMLS CUI [2,1])
C0150312 (UMLS CUI [2,2])
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
CL Item
Not Applicable (NA)
Coeliac disease - Signs and Symptoms start date
Item
Coeliac disease - Signs and Symptoms start date
date
C0007570 (UMLS CUI [1])
C0037088 (UMLS CUI [2,1])
C0808070 (UMLS CUI [2,2])
C0037088 (UMLS CUI [2,1])
C0808070 (UMLS CUI [2,2])
Coeliac disease - Signs and Symptoms end date
Item
Coeliac disease - Signs and Symptoms end date
date
C0007570 (UMLS CUI [1])
C0037088 (UMLS CUI [2,1])
C0806020 (UMLS CUI [2,2])
C0037088 (UMLS CUI [2,1])
C0806020 (UMLS CUI [2,2])
Item
Coeliac disease - Signs and Symptoms continuing at end of study
integer
C0007570 (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
Coeliac disease - Signs and Symptoms continuing at end of study
CL Item
Continuing at end of study (1)
Item Group
Coeliac disease - Other signs and symptoms
C0007570 (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
Coeliac disease - Other signs and symptoms
C0007570 (UMLS CUI-1)
C0037088 (UMLS CUI-2)
C0205394 (UMLS CUI-3)
C0037088 (UMLS CUI-2)
C0205394 (UMLS CUI-3)
Coeliac disease - Other signs and symptoms
Item
Coeliac disease - Other signs and symptoms
text
C0007570 (UMLS CUI [1])
C0037088 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0037088 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
Coeliac disease - Other signs and symptoms start date
Item
Coeliac disease - Other signs and symptoms start date
date
C0007570 (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])
Coeliac disease - Other signs and symptoms end date
Item
Coeliac disease - Other signs and symptoms end date
date
C0007570 (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
Coeliac disease - Other signs and symptoms continuing at end of study
integer
C0007570 (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
Coeliac disease - Other signs and symptoms continuing at end of study
CL Item
Continuing at end of study (1)
Item Group
Coeliac disease - Diagnostic Test Results
C0007570 (UMLS CUI-1)
C0456984 (UMLS CUI-2)
C0430022 (UMLS CUI-3)
C0456984 (UMLS CUI-2)
C0430022 (UMLS CUI-3)
Item
Coeliac disease - Test
integer
C0007570 (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
Serum anti-tissue transglutaminase (tTG) IgA (11)
CL Item
Serum anti-endomysial antibody IgA (12)
CL Item
Serum anti-gliadin antibodies (AGA) IgA (13)
CL Item
Serum anti-gliadin antibodies (AGA) IgG (14)
CL Item
Serum sodium (15)
CL Item
Serum chloride (16)
CL Item
Serum calcium (17)
CL Item
Serum proteins (18)
CL Item
Prothrombin time (PT) (19)
CL Item
Stool leucocytes (20)
CL Item
Stool blood (21)
Item
Coeliac disease - Test done
text
C0007570 (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)
Coeliac disease - Test date
Item
Coeliac disease - Test date
date
C0007570 (UMLS CUI [1])
C2826247 (UMLS CUI [2])
C2826247 (UMLS CUI [2])
Coeliac disease - Test Result
Item
Coeliac disease - Test Result
float
C0007570 (UMLS CUI [1])
C0587081 (UMLS CUI [2])
C0587081 (UMLS CUI [2])
Coeliac disease - Test Units
Item
Coeliac disease - Test Units
text
C0007570 (UMLS CUI [1])
C1519795 (UMLS CUI [2])
C1519795 (UMLS CUI [2])
Coeliac disease - Low Norm
Item
Coeliac disease - Low Norm
float
C0007570 (UMLS CUI [1])
C0086715 (UMLS CUI [2,1])
C0205251 (UMLS CUI [2,2])
C0086715 (UMLS CUI [2,1])
C0205251 (UMLS CUI [2,2])
Coeliac disease - High Norm
Item
Coeliac disease - High Norm
float
C0007570 (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
Coeliac disease - Other Diagnostic Test Results
C0007570 (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
Coeliac disease - Other Diagnostic Test Results
C0007570 (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)
Coeliac disease - Test
Item
Coeliac disease - Test
text
C0007570 (UMLS CUI [1])
C2826273 (UMLS CUI [2])
C2826273 (UMLS CUI [2])
Coeliac disease - Test date
Item
Coeliac disease - Test date
date
C0007570 (UMLS CUI [1])
C2826247 (UMLS CUI [2])
C2826247 (UMLS CUI [2])
Coeliac disease - Test Result
Item
Coeliac disease - Test Result
float
C0007570 (UMLS CUI [1])
C0587081 (UMLS CUI [2])
C0587081 (UMLS CUI [2])
Coeliac disease - Test Units
Item
Coeliac disease - Test Units
text
C0007570 (UMLS CUI [1])
C1519795 (UMLS CUI [2])
C1519795 (UMLS CUI [2])
Coeliac disease - Low Norm
Item
Coeliac disease - Low Norm
float
C0007570 (UMLS CUI [1])
C0086715 (UMLS CUI [2,1])
C0205251 (UMLS CUI [2,2])
C0086715 (UMLS CUI [2,1])
C0205251 (UMLS CUI [2,2])
Coeliac disease - High Norm
Item
Coeliac disease - High Norm
float
C0007570 (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
Coeliac disease - Other diagnostic Procedure
C0007570 (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 (X-Ray: Small bowel barium studies, Duodenal Endoscopy, Biopsy, Oral tolerance tests, HLA typing)
text
C0430022 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0011900 (UMLS CUI [2])
C0043309 (UMLS CUI [3,1])
C0021852 (UMLS CUI [3,2])
C0004749 (UMLS CUI [3,3])
C0014245 (UMLS CUI [4,1])
C0013303 (UMLS CUI [4,2])
C0005558 (UMLS CUI [5])
C0029161 (UMLS CUI [6])
C0242318 (UMLS CUI [7])
C0205394 (UMLS CUI [1,2])
C0011900 (UMLS CUI [2])
C0043309 (UMLS CUI [3,1])
C0021852 (UMLS CUI [3,2])
C0004749 (UMLS CUI [3,3])
C0014245 (UMLS CUI [4,1])
C0013303 (UMLS CUI [4,2])
C0005558 (UMLS CUI [5])
C0029161 (UMLS CUI [6])
C0242318 (UMLS CUI [7])
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
Antiphospholipid Syndrome - Signs and symptoms (supporting the final diagnosis)
C0085278 (UMLS CUI-1)
C0037088 (UMLS CUI-2)
C1546485 (UMLS CUI-3)
C0037088 (UMLS CUI-2)
C1546485 (UMLS CUI-3)
Item
Antiphospholipid Syndrome - Signs and symptoms
text
C0085278 (UMLS CUI [1])
C0037088 (UMLS CUI [2])
C0037088 (UMLS CUI [2])
CL Item
Arterial thrombosis (1)
CL Item
Venous thrombosis (2)
CL Item
Small vessels thrombosis (3)
CL Item
Cerebral thrombosis (4)
CL Item
Coronary thrombosis (5)
CL Item
Pulmonary thrombosis (emboli or thrombosis) (6)
CL Item
Leg extremities thrombosis (7)
CL Item
Hepatic thrombosis (8)
CL Item
Renal thrombosis (9)
CL Item
Ocular thrombosis (10)
CL Item
Adrenal thrombosis (11)
CL Item
Pregnancy morbidity - 1 or more late term spontaneous abortion (> 10 weeks) (12)
CL Item
Pregnancy morbidity - 3 or more spontaneous abortions (< 10 weeks) (13)
CL Item
34 weeks) due to preeclampsia/eclampsia or severe placental deficiency (Pregnancy morbidity - Premature birth of normal neonate (<)
Item
Antiphospholipid Syndrome - Signs and symptoms present
text
C0085278 (UMLS CUI [1])
C0037088 (UMLS CUI [2])
C0150312 (UMLS CUI [3])
C0037088 (UMLS CUI [2])
C0150312 (UMLS CUI [3])
Code List
Antiphospholipid Syndrome - Signs and symptoms present
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
CL Item
Not Applicable (NA)
Antiphospholipid Syndrome - Signs and symptoms Start Date
Item
Antiphospholipid Syndrome - Signs and symptoms Start Date
date
C0085278 (UMLS CUI [1])
C0037088 (UMLS CUI [2])
C0808070 (UMLS CUI [3])
C0037088 (UMLS CUI [2])
C0808070 (UMLS CUI [3])
Antiphospholipid Syndrome - Signs and symptoms End date
Item
Antiphospholipid Syndrome - Signs and symptoms End date
date
C0085278 (UMLS CUI [1])
C0037088 (UMLS CUI [2])
C0806020 (UMLS CUI [3])
C0037088 (UMLS CUI [2])
C0806020 (UMLS CUI [3])
Item
Antiphospholipid Syndrome - Signs and symptoms continuing at the end of study
integer
C0085278 (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
Antiphospholipid Syndrome - Signs and symptoms continuing at the end of study
CL Item
Continuing at end of study (1)
Item Group
Antiphospholipid Syndrome - Other Signs and symptoms
C0085278 (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
Antiphospholipid Syndrome - Other Signs and symptoms
C0085278 (UMLS CUI-1)
C0037088 (UMLS CUI-2)
C0205394 (UMLS CUI-3)
C0037088 (UMLS CUI-2)
C0205394 (UMLS CUI-3)
Antiphospholipid Syndrome - Other Signs and symptoms
Item
Antiphospholipid Syndrome - Other Signs and symptoms
text
C0085278 (UMLS CUI [1])
C0037088 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0037088 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
Antiphospholipid Syndrome - Other Signs and symptoms Start Date
Item
Antiphospholipid Syndrome - Other Signs and symptoms Start Date
date
C0085278 (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])
Antiphospholipid Syndrome - Other Signs and symptoms End Date
Item
Antiphospholipid Syndrome - Other Signs and symptoms End Date
date
C0085278 (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
Antiphospholipid Syndrome - Other signs and symptoms continuing at the end of study
text
C0085278 (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
Antiphospholipid Syndrome - Other signs and symptoms continuing at the end of study
CL Item
Continuing at end of study (1)
Item Group
Antiphospholipid Syndrome - Diagnostic Test Results
C0085278 (UMLS CUI-1)
C0085655 (UMLS CUI-2)
C0456984 (UMLS CUI-3)
C0085655 (UMLS CUI-2)
C0456984 (UMLS CUI-3)
Item
Antiphospholipid Syndrome - Test
integer
C0085278 (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
Activated partial thromboplastine time (APTT) (11)
CL Item
Prothrombine time (PT) (12)
CL Item
Dilute Russel viper venom time (DRVVT) (13)
CL Item
Lupus anticoagulant (14)
CL Item
Lupus antigoagulant (12 weeks apart) (15)
CL Item
Anti-cardiolipin antibodies (aCL) (16)
CL Item
Anti-cardiolipin antibodies (aCL)(12 weeks apart) (17)
CL Item
Anti-beta-2 glycoprotein I antibodies (18)
CL Item
Anti-beta-2 glycoprotein I antibodies(12 weeks apart) (19)
CL Item
Anti-phosphatidylserine antibodies (20)
CL Item
Anti-phosphatydilathanolamine antibodies (21)
CL Item
Anti-prothrombine antibodies (22)
CL Item
Anti-nuclear antibodies (ANA) (23)
CL Item
Anti-DNA antibodies (24)
CL Item
Rheumatoid factor (RF) (25)
Item
Antiphospholipid Syndrome - Test done
text
C0085278 (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)
Antiphospholipid Syndrome - Test date
Item
Antiphospholipid Syndrome - Test date
date
C0085278 (UMLS CUI [1])
C2826247 (UMLS CUI [2])
C2826247 (UMLS CUI [2])
Antiphospholipid Syndrome - Test Result
Item
Antiphospholipid Syndrome - Test Result
float
C0085278 (UMLS CUI [1])
C0587081 (UMLS CUI [2])
C0587081 (UMLS CUI [2])
Antiphospholipid Syndrome - Test Units
Item
Antiphospholipid Syndrome - Test Units
text
C0085278 (UMLS CUI [1])
C1519795 (UMLS CUI [2])
C1519795 (UMLS CUI [2])
Antiphospholipid Syndrome - Low Norm
Item
Antiphospholipid Syndrome - Low Norm
float
C0085278 (UMLS CUI [1])
C0086715 (UMLS CUI [2,1])
C0205251 (UMLS CUI [2,2])
C0086715 (UMLS CUI [2,1])
C0205251 (UMLS CUI [2,2])
Antiphospholipid Syndrome - High Norm
Item
Antiphospholipid Syndrome - High Norm
float
C0085278 (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
Antiphospholipid Syndrome - Other Diagnostic Test Results
C0085278 (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
Antiphospholipid Syndrome - Other Diagnostic Test Results
C0085278 (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)
Antiphospholipid Syndrome - Test
Item
Antiphospholipid Syndrome - Test
text
C0085278 (UMLS CUI [1])
C2826273 (UMLS CUI [2])
C2826273 (UMLS CUI [2])
Antiphospholipid Syndrome - Test date
Item
Antiphospholipid Syndrome - Test date
date
C0085278 (UMLS CUI [1])
C2826247 (UMLS CUI [2])
C2826247 (UMLS CUI [2])
Antiphospholipid Syndrome - Test Result
Item
Antiphospholipid Syndrome - Test Result
float
C0085278 (UMLS CUI [1])
C0587081 (UMLS CUI [2])
C0587081 (UMLS CUI [2])
Antiphospholipid Syndrome - Test Units
Item
Antiphospholipid Syndrome - Test Units
text
C0085278 (UMLS CUI [1])
C1519795 (UMLS CUI [2])
C1519795 (UMLS CUI [2])
Antiphospholipid Syndrome - Low Norm
Item
Antiphospholipid Syndrome - Low Norm
float
C0085278 (UMLS CUI [1])
C0086715 (UMLS CUI [2,1])
C0205251 (UMLS CUI [2,2])
C0086715 (UMLS CUI [2,1])
C0205251 (UMLS CUI [2,2])
Antiphospholipid Syndrome - High Norm
Item
Antiphospholipid Syndrome - High Norm
float
C0085278 (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
Antiphospholipid Syndrome - Other diagnostic Procedure
C0085278 (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 (Doppler ultrasound, Brain CT scan, Brain MRI, Chest CT scan, Abdomen CT scan, Cardiac echocardiography, Biopsy)
text
C0430022 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0011900 (UMLS CUI [2])
C0162481 (UMLS CUI [3])
C0412585 (UMLS CUI [4])
C0412675 (UMLS CUI [5])
C0202823 (UMLS CUI [6])
C0412620 (UMLS CUI [7])
C0013516 (UMLS CUI [8])
C0005558 (UMLS CUI [9])
C0205394 (UMLS CUI [1,2])
C0011900 (UMLS CUI [2])
C0162481 (UMLS CUI [3])
C0412585 (UMLS CUI [4])
C0412675 (UMLS CUI [5])
C0202823 (UMLS CUI [6])
C0412620 (UMLS CUI [7])
C0013516 (UMLS CUI [8])
C0005558 (UMLS CUI [9])
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
Autoimmune Haemolytic Anaemia - Signs and symptoms (supporting the final diagnosis)
C0002880 (UMLS CUI-1)
C0037088 (UMLS CUI-2)
C1546485 (UMLS CUI-3)
C0037088 (UMLS CUI-2)
C1546485 (UMLS CUI-3)
Item
Autoimmune Haemolytic Anaemia - Signs and symptoms
integer
C0002880 (UMLS CUI [1])
C0037088 (UMLS CUI [2])
C0037088 (UMLS CUI [2])
CL Item
Palor with pale conjunctivae and fingernails (1)
CL Item
Fatigue (2)
CL Item
Dyspnea (3)
CL Item
Poor feeding (4)
CL Item
Acrocyanosis (5)
CL Item
Splenomegaly (6)
CL Item
Congestive heart failure (7)
CL Item
Hematuria (8)
CL Item
Leg ulcer (9)
CL Item
Fever (10)
CL Item
Lymphadenopathy (11)
CL Item
Rash (12)
CL Item
Butterfly malar rash (13)
CL Item
Arthritis, specify (14)
Autoimmune Haemolytic Anaemia - Specify Arthritis
Item
Autoimmune Haemolytic Anaemia - Specify Arthritis
text
C0002880 (UMLS CUI [1])
C0003864 (UMLS CUI [2])
C0003864 (UMLS CUI [2])
Item
Autoimmune Haemolytic Anaemia - Signs and symptoms present
text
C0002880 (UMLS CUI [1])
C0037088 (UMLS CUI [2])
C0150312 (UMLS CUI [3])
C0037088 (UMLS CUI [2])
C0150312 (UMLS CUI [3])
Code List
Autoimmune Haemolytic Anaemia - Signs and symptoms present
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
CL Item
Not Applicable (NA)
Autoimmune Haemolytic Anaemia - Signs and symptoms Start Date
Item
Autoimmune Haemolytic Anaemia - Signs and symptoms Start Date
date
C0002880 (UMLS CUI [1])
C0037088 (UMLS CUI [2])
C0808070 (UMLS CUI [3])
C0037088 (UMLS CUI [2])
C0808070 (UMLS CUI [3])
Autoimmune Haemolytic Anaemia - Signs and symptoms End date
Item
Autoimmune Haemolytic Anaemia - Signs and symptoms End date
date
C0002880 (UMLS CUI [1])
C0037088 (UMLS CUI [2])
C0806020 (UMLS CUI [3])
C0037088 (UMLS CUI [2])
C0806020 (UMLS CUI [3])
Item
Autoimmune Haemolytic Anaemia - Signs and symptoms continuing at the end of study
integer
C0002880 (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
Autoimmune Haemolytic Anaemia - Signs and symptoms continuing at the end of study
CL Item
Continuing at end of study (1)
Item Group
Autoimmune Haemolytic Anaemia - Other Signs and symptoms
C0002880 (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
Autoimmune Haemolytic Anaemia - Other Signs and symptoms
C0002880 (UMLS CUI-1)
C0037088 (UMLS CUI-2)
C0205394 (UMLS CUI-3)
C0037088 (UMLS CUI-2)
C0205394 (UMLS CUI-3)
Autoimmune Haemolytic Anaemia - Other Signs and symptoms
Item
Autoimmune Haemolytic Anaemia - Other Signs and symptoms
text
C0002880 (UMLS CUI [1])
C0037088 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0037088 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
Autoimmune Haemolytic Anaemia - Other Signs and symptoms Start Date
Item
Autoimmune Haemolytic Anaemia - Other Signs and symptoms Start Date
date
C0002880 (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])
Autoimmune Haemolytic Anaemia - Other Signs and symptoms End Date
Item
Autoimmune Haemolytic Anaemia - Other Signs and symptoms End Date
date
C0002880 (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
Autoimmune Haemolytic Anaemia - Other signs and symptoms continuing at the end of study
text
C0002880 (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
Autoimmune Haemolytic Anaemia - Other signs and symptoms continuing at the end of study
CL Item
Continuing at end of study (1)
Item Group
Autoimmune Haemolytic Anaemia - Diagnostic Test Results
C0002880 (UMLS CUI-1)
C0456984 (UMLS CUI-2)
C0456984 (UMLS CUI-2)
Item
Autoimmune Haemolytic Anaemia - Test
integer
C0002880 (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
Blood smear (14)
CL Item
Serum lactate deshydrogenase (LDH) (15)
CL Item
Serum bilirubin (16)
CL Item
Serum urobilinogen (17)
CL Item
Albuminuria (18)
CL Item
LMW proteinuria (19)
CL Item
Hematuria (20)
CL Item
Hemosiderinuremia (21)
CL Item
Direct antiglobulin test with anti-C3 (22)
CL Item
Direct antiglobulin test with anti-IgG (23)
CL Item
Direct Coombs test (patient’s RBC) (24)
CL Item
Indirect Coombs test (patient’s serum) (25)
CL Item
Cold agglutinin titer - Anti-I globulin (26)
CL Item
Cold agglutinin titer - Anti-i globulin (27)
CL Item
Cold agglutinin titer - Anti-P globulin (28)
Item
Autoimmune Haemolytic Anaemia - Test done
text
C0002880 (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)
Autoimmune Haemolytic Anaemia - Test date
Item
Autoimmune Haemolytic Anaemia - Test date
date
C0002880 (UMLS CUI [1])
C2826247 (UMLS CUI [2])
C2826247 (UMLS CUI [2])
Autoimmune Haemolytic Anaemia - Test Result
Item
Autoimmune Haemolytic Anaemia - Test Result
float
C0002880 (UMLS CUI [1])
C0587081 (UMLS CUI [2])
C0587081 (UMLS CUI [2])
Autoimmune Haemolytic Anaemia - Test Units
Item
Autoimmune Haemolytic Anaemia - Test Units
text
C0002880 (UMLS CUI [1])
C1519795 (UMLS CUI [2])
C1519795 (UMLS CUI [2])
Autoimmune Haemolytic Anaemia - Low Norm
Item
Autoimmune Haemolytic Anaemia - Low Norm
float
C0002880 (UMLS CUI [1])
C0086715 (UMLS CUI [2,1])
C0205251 (UMLS CUI [2,2])
C0086715 (UMLS CUI [2,1])
C0205251 (UMLS CUI [2,2])
Autoimmune Haemolytic Anaemia - High Norm
Item
Autoimmune Haemolytic Anaemia - High Norm
float
C0002880 (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
Autoimmune Haemolytic Anaemia - Other Diagnostic Test Results
C0002880 (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
Autoimmune Haemolytic Anaemia - Other Diagnostic Test Results
C0002880 (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)
Autoimmune Haemolytic Anaemia - Test
Item
Autoimmune Haemolytic Anaemia - Test
text
C0002880 (UMLS CUI [1])
C2826273 (UMLS CUI [2])
C2826273 (UMLS CUI [2])
Autoimmune Haemolytic Anaemia - Test date
Item
Autoimmune Haemolytic Anaemia - Test date
date
C0002880 (UMLS CUI [1])
C2826247 (UMLS CUI [2])
C2826247 (UMLS CUI [2])
Autoimmune Haemolytic Anaemia - Test Result
Item
Autoimmune Haemolytic Anaemia - Test Result
float
C0002880 (UMLS CUI [1])
C0587081 (UMLS CUI [2])
C0587081 (UMLS CUI [2])
Autoimmune Haemolytic Anaemia - Test Units
Item
Autoimmune Haemolytic Anaemia - Test Units
text
C0002880 (UMLS CUI [1])
C1519795 (UMLS CUI [2])
C1519795 (UMLS CUI [2])
Autoimmune Haemolytic Anaemia - Low Norm
Item
Autoimmune Haemolytic Anaemia - Low Norm
float
C0002880 (UMLS CUI [1])
C0086715 (UMLS CUI [2,1])
C0205251 (UMLS CUI [2,2])
C0086715 (UMLS CUI [2,1])
C0205251 (UMLS CUI [2,2])
Autoimmune Haemolytic Anaemia - High Norm
Item
Autoimmune Haemolytic Anaemia - High Norm
float
C0002880 (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
Autoimmune Haemolytic Anaemia - Other diagnostic Procedure
C0002880 (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 (Marrow biopsy, Chest X-ray, Abdominal ultrasound, serology for CMV, EBV, Mycoplasma)
text
C0430022 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0011900 (UMLS CUI [2])
C0005954 (UMLS CUI [3])
C0039985 (UMLS CUI [4])
C1456803 (UMLS CUI [5,1])
C0000726 (UMLS CUI [5,2])
C0010825 (UMLS CUI [6,1])
C0036743 (UMLS CUI [6,2])
C0014644 (UMLS CUI [7])
C0026934 (UMLS CUI [8])
C0205394 (UMLS CUI [1,2])
C0011900 (UMLS CUI [2])
C0005954 (UMLS CUI [3])
C0039985 (UMLS CUI [4])
C1456803 (UMLS CUI [5,1])
C0000726 (UMLS CUI [5,2])
C0010825 (UMLS CUI [6,1])
C0036743 (UMLS CUI [6,2])
C0014644 (UMLS CUI [7])
C0026934 (UMLS CUI [8])