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ID
12496
Descrição
Study documentation part: Anamnesis. This is a phase II multicenter trial with Rivaroxaban in the treatment of livedoid vasculopathy assessing the pain on a visual analog scale (VAS). Principal Investigator PD Dr. Tobias Görge, University Hospital of Münster. EudraCT - Nr. 2012-000108-13.
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- 24/11/2015 24/11/2015 -
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24 novembre 2015
DOI
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Licença
Creative Commons BY-NC 3.0
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Riliva_CRF_EudraCT - Nr. 2012-000108-13- Anamnesis DRKS00004652
Similar models
Anamnesis
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Livedoid vasculitis anamnesis
C0343081 (UMLS CUI-1)
C0025084 (UMLS CUI-2)
C0025084 (UMLS CUI-2)
date symptom first
Item
Occurrence of first symptoms:
partialDate
C0011008 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205435 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,2])
C0205435 (UMLS CUI [1,3])
date Ulcer first
Item
Occurrence of first ulcer:
partialDate
C0011008 (UMLS CUI [1,1])
C0041582 (UMLS CUI [1,2])
C0205435 (UMLS CUI [1,3])
C0041582 (UMLS CUI [1,2])
C0205435 (UMLS CUI [1,3])
date diagnosis
Item
Date of the first diagnosis:
partialDate
C0011008 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
date Anticoagulation Therapy
Item
Date of first anticoagulation therapy:
partialDate
C0011008 (UMLS CUI [1,1])
C0003281 (UMLS CUI [1,2])
C0003281 (UMLS CUI [1,2])
Relapse
Item
Number of relapses within the last 6 months:
integer
C0035020 (UMLS CUI [1])
Superficial vein thrombosis
Item
Occurrence of superficial vein thrombosis so far?
boolean
C0235511 (UMLS CUI [1])
Deep Vein Thrombosis
Item
Occurrence of deep vein thrombosis so far?
boolean
C0149871 (UMLS CUI [1])
date
Item
When yes, date of first occurrence?
date
C0011008 (UMLS CUI [1])
Location Venous Thrombosis Arm vein
Item
Location of venous thrombosis: Arm vein?
boolean
C0450429 (UMLS CUI [1,1])
C0042487 (UMLS CUI [1,2])
C0226792 (UMLS CUI [1,3])
C0042487 (UMLS CUI [1,2])
C0226792 (UMLS CUI [1,3])
Location Venous Thrombosis lower extremity
Item
Location of venous thrombosis: lower extremity ?
boolean
C0450429 (UMLS CUI [1,1])
C0042487 (UMLS CUI [1,2])
C0340707 (UMLS CUI [1,3])
C0042487 (UMLS CUI [1,2])
C0340707 (UMLS CUI [1,3])
Location Venous Thrombosis Iliac Vein
Item
Location of venous thrombosis: Iliac vein?
boolean
C0450429 (UMLS CUI [1,1])
C0042487 (UMLS CUI [1,2])
C0020888 (UMLS CUI [1,3])
C0042487 (UMLS CUI [1,2])
C0020888 (UMLS CUI [1,3])
Location Venous Thrombosis Femoral vein
Item
Location of venous thrombosis: Femoral vein?
boolean
C0450429 (UMLS CUI [1,1])
C0042487 (UMLS CUI [1,2])
C0015809 (UMLS CUI [1,3])
C0042487 (UMLS CUI [1,2])
C0015809 (UMLS CUI [1,3])
Location Venous Thrombosis knee vein
Item
Location of venous thrombosis: Knee vein?
boolean
C0450429 (UMLS CUI [1,1])
C0042487 (UMLS CUI [1,2])
C1279596 (UMLS CUI [1,3])
C0042487 (UMLS CUI [1,2])
C1279596 (UMLS CUI [1,3])
Location Venous Thrombosis Hepatic portal vein
Item
Location of venous thrombosis: Hepatic portal vein?
boolean
C0450429 (UMLS CUI [1,1])
C0042487 (UMLS CUI [1,2])
C0032718 (UMLS CUI [1,3])
C0042487 (UMLS CUI [1,2])
C0032718 (UMLS CUI [1,3])
Location Venous Thrombosis
Item
Other locations:
text
C0450429 (UMLS CUI [1,1])
C0042487 (UMLS CUI [1,2])
C0042487 (UMLS CUI [1,2])
Item
Occurrence of blood coagulation disorders?
text
C0005779 (UMLS CUI [1])
CL Item
yes (1)
CL Item
no (2)
CL Item
unknown (3)
Factor V Leiden
Item
Factor V Leiden mutation?
boolean
C0380964 (UMLS CUI [1])
deficiency protein C; protein S
Item
Deficiency of protein C and protein S?
boolean
C0011155 (UMLS CUI [1,1])
C0033621 (UMLS CUI [1,2])
C0072393 (UMLS CUI [2])
C0033621 (UMLS CUI [1,2])
C0072393 (UMLS CUI [2])
Prothrombin G20210A mutation
Item
Prothrombin G20210A mutation?
boolean
C2584409 (UMLS CUI [1])
hyperhomocysteinemia
Item
Hyperhomocysteinemia?
boolean
C0598608 (UMLS CUI [1])
Antithrombin III deficiency
Item
Antithrombin III deficiency?
boolean
C0272375 (UMLS CUI [1])
Anticardiolipin antibodies
Item
Anticardiolipin antibodies?
boolean
C0162596 (UMLS CUI [1])
fibrinolysis disorder
Item
Increased plasminogen activator inhibitor-1 levels (fibrinolysis disorder)?
boolean
C0521803 (UMLS CUI [1])
Other
Item
Other:
text
C0205394 (UMLS CUI [1])
Item Group
Therapy of livedoid vasculitis
C0087111 (UMLS CUI-1)
C0343081 (UMLS CUI-2)
C0343081 (UMLS CUI-2)
Heparin
Item
Heparin, this therapy must be discontinued at least 1 day prior to initiation of treatment (exclusion criteria)!
boolean
C0019134 (UMLS CUI [1])
TreatmentStartDate
Item
Treatment start Date:
date
C3173309 (UMLS CUI [1])
TreatmentEndDate
Item
Treatment End Date:
date
C1531784 (UMLS CUI [1])
CL Item
excellent (1)
CL Item
good (2)
CL Item
moderate (3)
CL Item
poor (4)
CL Item
not at all (5)
CL Item
unknown (6)
Anti-Inflammatory Agents, Non-Steroidal
Item
Non-steroidal anti-inflammatory drug (NSAID),this therapy must be discontinued at least 1 day prior to initiation of treatment (exclusion criteria)!
boolean
C0003211 (UMLS CUI [1])
TreatmentStartDate
Item
Treatment start Date:
date
C3173309 (UMLS CUI [1])
TreatmentEndDate
Item
Treatment End Date:
date
C1531784 (UMLS CUI [1])
CL Item
excellent (1)
CL Item
good (2)
CL Item
moderate (3)
CL Item
poor (4)
CL Item
not at all (5)
CL Item
unknown (6)
Antiplatelet Agents
Item
Antiplatelet agents,this therapy must be discontinued at least 1 day prior to initiation of treatment (exclusion criteria)!
boolean
C0085826 (UMLS CUI [1])
TreatmentStartDate
Item
Treatment start Date:
date
C3173309 (UMLS CUI [1])
TreatmentEndDate
Item
Treatment End Date:
date
C1531784 (UMLS CUI [1])
CL Item
excellent (1)
CL Item
good (2)
CL Item
moderate (3)
CL Item
poor (4)
CL Item
not at all (5)
CL Item
unknown (6)
Treatment with Vitamin K antagonist
Item
Vitamin K antagonist, this therapy must be discontinued at least. 7 days before the start of therapy (exclusion criterion)!
boolean
C1096489 (UMLS CUI [1])
TreatmentStartDate
Item
Treatment start Date:
date
C3173309 (UMLS CUI [1])
TreatmentEndDate
Item
Treatment End Date:
date
C1531784 (UMLS CUI [1])
CL Item
excellent (1)
CL Item
good (2)
CL Item
moderate (3)
CL Item
poor (4)
CL Item
not at all (5)
CL Item
unknown (6)
Immunoglobulins
Item
Immunoglobulins:
boolean
C0021027 (UMLS CUI [1])
TreatmentStartDate
Item
Treatment start Date:
date
C3173309 (UMLS CUI [1])
TreatmentEndDate
Item
Treatment End Date:
date
C1531784 (UMLS CUI [1])
CL Item
excellent (1)
CL Item
good (2)
CL Item
moderate (3)
CL Item
poor (4)
CL Item
not at all (5)
CL Item
unknown (6)
Steroide
Item
Steroids:
boolean
C0038317 (UMLS CUI [1])
TreatmentStartDate
Item
Treatment start Date:
date
C3173309 (UMLS CUI [1])
TreatmentEndDate
Item
Treatment End Date:
date
C1531784 (UMLS CUI [1])
CL Item
excellent (1)
CL Item
good (2)
CL Item
moderate (3)
CL Item
poor (4)
CL Item
not at all (5)
CL Item
unknown (6)
Other
Item
Other:
text
C0205394 (UMLS CUI [1])
TreatmentStartDate
Item
Treatment start Date:
date
C3173309 (UMLS CUI [1])
TreatmentEndDate
Item
Treatment End Date:
date
C1531784 (UMLS CUI [1])
CL Item
excellent (1)
CL Item
good (2)
CL Item
moderate (3)
CL Item
poor (4)
CL Item
not at all (5)
CL Item
unknown (6)
Comorbidities chronic
Item
Chronic comorbidities
boolean
C0009488 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,2])
disease
Item
Disease
text
C0012634 (UMLS CUI [1])
date
Item
Disease start date:
date
Item Group
Livedoid vasculitis family anamnesis
C0343081 (UMLS CUI-1)
C0025084 (UMLS CUI-2)
C0015576 (UMLS CUI-3)
C0025084 (UMLS CUI-2)
C0015576 (UMLS CUI-3)
Item
Occurrence of livedoid vasculitis by own children and parents ?
text
C0343081 (UMLS CUI [1])
CL Item
unknown (1)
CL Item
no (2)
CL Item
yes, male (3)
CL Item
yes, female (4)
Item
Occurrence of livedoid vasculitis by grandparents, grandchildren, siblings ?
text
C0343081 (UMLS CUI [1])
Code List
Occurrence of livedoid vasculitis by grandparents, grandchildren, siblings ?
CL Item
unknown (1)
CL Item
no (2)
CL Item
yes, male (3)
CL Item
yes, female (4)
Item
Occurrence of livedoid vasculitis by uncle, aunt, nephew, niece?
text
C0343081 (UMLS CUI [1])
CL Item
unknown (1)
CL Item
no (2)
CL Item
yes, male (3)
CL Item
yes, female (4)
CL Item
yes (1)
CL Item
no (2)
CL Item
unknown (3)
Item
Deficiency of protein C and protein S?
text
C0011155 (UMLS CUI [1,1])
C0033621 (UMLS CUI [1,2])
C0072393 (UMLS CUI [2])
C0033621 (UMLS CUI [1,2])
C0072393 (UMLS CUI [2])
CL Item
yes (1)
CL Item
no (2)
CL Item
unknown (3)
CL Item
yes (1)
CL Item
no (2)
CL Item
unknown (3)
CL Item
yes (1)
CL Item
no (2)
CL Item
unknown (3)
CL Item
yes (1)
CL Item
no (2)
CL Item
unknown (3)
CL Item
yes (1)
CL Item
no (2)
CL Item
unknown (3)
Item
Increased plasminogen activator inhibitor-1 levels (fibrinolysis disorder)?
text
C0521803 (UMLS CUI [1])
Code List
Increased plasminogen activator inhibitor-1 levels (fibrinolysis disorder)?
CL Item
yes (1)
CL Item
no (2)
CL Item
unknown (3)
Other
Item
Other:
text
C0205394 (UMLS CUI [1])