ID

12496

Description

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.

Keywords

Versions (1)
  1. 11/24/15 11/24/15 -
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November 24, 2015

DOI

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License

Creative Commons BY-NC 3.0
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Riliva_CRF_EudraCT - Nr. 2012-000108-13- Anamnesis DRKS00004652

German ( localization.languageCode.DE ) English

Anamnesis

2 forms  
Livedoid vasculitis anamnesis
Description

Livedoid vasculitis anamnesis

Alias
UMLS CUI-1
C0343081
UMLS CUI-2
C0025084
Occurrence of first symptoms:
Description

date symptom first

Data type

partialDate

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205435
Occurrence of first ulcer:
Description

date Ulcer first

Data type

partialDate

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0041582
UMLS CUI [1,3]
C0205435
Date of the first diagnosis:
Description

date diagnosis

Data type

partialDate

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0011900
Date of first anticoagulation therapy:
Description

date Anticoagulation Therapy

Data type

partialDate

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0003281
Number of relapses within the last 6 months:
Description

Relapse

Data type

integer

Alias
UMLS CUI [1]
C0035020
Occurrence of superficial vein thrombosis so far?
Description

Superficial vein thrombosis

Data type

boolean

Alias
UMLS CUI [1]
C0235511
Occurrence of deep vein thrombosis so far?
Description

Deep Vein Thrombosis

Data type

boolean

Alias
UMLS CUI [1]
C0149871
When yes, date of first occurrence?
Description

date

Data type

date

Alias
UMLS CUI [1]
C0011008
Location of venous thrombosis: Arm vein?
Description

Location Venous Thrombosis Arm vein

Data type

boolean

Alias
UMLS CUI [1,1]
C0450429
UMLS CUI [1,2]
C0042487
UMLS CUI [1,3]
C0226792
Location of venous thrombosis: lower extremity ?
Description

Location Venous Thrombosis lower extremity

Data type

boolean

Alias
UMLS CUI [1,1]
C0450429
UMLS CUI [1,2]
C0042487
UMLS CUI [1,3]
C0340707
Location of venous thrombosis: Iliac vein?
Description

Location Venous Thrombosis Iliac Vein

Data type

boolean

Alias
UMLS CUI [1,1]
C0450429
UMLS CUI [1,2]
C0042487
UMLS CUI [1,3]
C0020888
Location of venous thrombosis: Femoral vein?
Description

Location Venous Thrombosis Femoral vein

Data type

boolean

Alias
UMLS CUI [1,1]
C0450429
UMLS CUI [1,2]
C0042487
UMLS CUI [1,3]
C0015809
Location of venous thrombosis: Knee vein?
Description

Location Venous Thrombosis knee vein

Data type

boolean

Alias
UMLS CUI [1,1]
C0450429
UMLS CUI [1,2]
C0042487
UMLS CUI [1,3]
C1279596
Location of venous thrombosis: Hepatic portal vein?
Description

Location Venous Thrombosis Hepatic portal vein

Data type

boolean

Alias
UMLS CUI [1,1]
C0450429
UMLS CUI [1,2]
C0042487
UMLS CUI [1,3]
C0032718
Other locations:
Description

Location Venous Thrombosis

Data type

text

Alias
UMLS CUI [1,1]
C0450429
UMLS CUI [1,2]
C0042487
Occurrence of blood coagulation disorders?
Description

Blood Coagulation Disorders

Data type

text

Alias
UMLS CUI [1]
C0005779
Factor V Leiden mutation?
Description

Factor V Leiden

Data type

boolean

Alias
UMLS CUI [1]
C0380964
Deficiency of protein C and protein S?
Description

deficiency protein C; protein S

Data type

boolean

Alias
UMLS CUI [1,1]
C0011155
UMLS CUI [1,2]
C0033621
UMLS CUI [2]
C0072393
Prothrombin G20210A mutation?
Description

Prothrombin G20210A mutation

Data type

boolean

Alias
UMLS CUI [1]
C2584409
Hyperhomocysteinemia?
Description

hyperhomocysteinemia

Data type

boolean

Alias
UMLS CUI [1]
C0598608
Antithrombin III deficiency?
Description

Antithrombin III deficiency

Data type

boolean

Alias
UMLS CUI [1]
C0272375
Anticardiolipin antibodies?
Description

Anticardiolipin antibodies

Data type

boolean

Alias
UMLS CUI [1]
C0162596
Increased plasminogen activator inhibitor-1 levels (fibrinolysis disorder)?
Description

fibrinolysis disorder

Data type

boolean

Alias
UMLS CUI [1]
C0521803
Other:
Description

Other

Data type

text

Alias
UMLS CUI [1]
C0205394
Therapy of livedoid vasculitis
Description

Therapy of livedoid vasculitis

Alias
UMLS CUI-1
C0087111
UMLS CUI-2
C0343081
Heparin, this therapy must be discontinued at least 1 day prior to initiation of treatment (exclusion criteria)!
Description

Heparin

Data type

boolean

Alias
UMLS CUI [1]
C0019134
Treatment start Date:
Description

TreatmentStartDate

Data type

date

Alias
UMLS CUI [1]
C3173309
Treatment End Date:
Description

TreatmentEndDate

Data type

date

Alias
UMLS CUI [1]
C1531784
Response to treatment:
Description

treatment response

Data type

text

Alias
UMLS CUI [1]
C0521982
Non-steroidal anti-inflammatory drug (NSAID),this therapy must be discontinued at least 1 day prior to initiation of treatment (exclusion criteria)!
Description

Anti-Inflammatory Agents, Non-Steroidal

Data type

boolean

Alias
UMLS CUI [1]
C0003211
Treatment start Date:
Description

TreatmentStartDate

Data type

date

Alias
UMLS CUI [1]
C3173309
Treatment End Date:
Description

TreatmentEndDate

Data type

date

Alias
UMLS CUI [1]
C1531784
Response to treatment:
Description

treatment response

Data type

text

Alias
UMLS CUI [1]
C0521982
Antiplatelet agents,this therapy must be discontinued at least 1 day prior to initiation of treatment (exclusion criteria)!
Description

Antiplatelet Agents

Data type

boolean

Alias
UMLS CUI [1]
C0085826
Treatment start Date:
Description

TreatmentStartDate

Data type

date

Alias
UMLS CUI [1]
C3173309
Treatment End Date:
Description

TreatmentEndDate

Data type

date

Alias
UMLS CUI [1]
C1531784
Response to treatment:
Description

treatment response

Data type

text

Alias
UMLS CUI [1]
C0521982
Vitamin K antagonist, this therapy must be discontinued at least. 7 days before the start of therapy (exclusion criterion)!
Description

Treatment with Vitamin K antagonist

Data type

boolean

Alias
UMLS CUI [1]
C1096489
Treatment start Date:
Description

TreatmentStartDate

Data type

date

Alias
UMLS CUI [1]
C3173309
Treatment End Date:
Description

TreatmentEndDate

Data type

date

Alias
UMLS CUI [1]
C1531784
Response to treatment:
Description

treatment response

Data type

text

Alias
UMLS CUI [1]
C0521982
Immunoglobulins:
Description

Immunoglobulins

Data type

boolean

Alias
UMLS CUI [1]
C0021027
Treatment start Date:
Description

TreatmentStartDate

Data type

date

Alias
UMLS CUI [1]
C3173309
Treatment End Date:
Description

TreatmentEndDate

Data type

date

Alias
UMLS CUI [1]
C1531784
Response to treatment:
Description

treatment response

Data type

text

Alias
UMLS CUI [1]
C0521982
Steroids:
Description

Steroide

Data type

boolean

Alias
UMLS CUI [1]
C0038317
Treatment start Date:
Description

TreatmentStartDate

Data type

date

Alias
UMLS CUI [1]
C3173309
Treatment End Date:
Description

TreatmentEndDate

Data type

date

Alias
UMLS CUI [1]
C1531784
Response to treatment:
Description

treatment response

Data type

text

Alias
UMLS CUI [1]
C0521982
Other:
Description

Other

Data type

text

Alias
UMLS CUI [1]
C0205394
Treatment start Date:
Description

TreatmentStartDate

Data type

date

Alias
UMLS CUI [1]
C3173309
Treatment End Date:
Description

TreatmentEndDate

Data type

date

Alias
UMLS CUI [1]
C1531784
Response to treatment:
Description

treatment response

Data type

text

Alias
UMLS CUI [1]
C0521982
Chronic comorbidities
Description

Chronic comorbidities

Alias
UMLS CUI-1
C0009488
UMLS CUI-2
C0205191
Chronic comorbidities
Description

Comorbidities chronic

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205191
Disease
Description

disease

Data type

text

Alias
UMLS CUI [1]
C0012634
Disease start date:
Description

date

Data type

date

Livedoid vasculitis family anamnesis
Description

Livedoid vasculitis family anamnesis

Alias
UMLS CUI-1
C0343081
UMLS CUI-2
C0025084
UMLS CUI-3
C0015576
Occurrence of livedoid vasculitis by own children and parents ?
Description

Livedoid vasculitis

Data type

text

Alias
UMLS CUI [1]
C0343081
Occurrence of livedoid vasculitis by grandparents, grandchildren, siblings ?
Description

Livedoid vasculitis

Data type

text

Alias
UMLS CUI [1]
C0343081
Occurrence of livedoid vasculitis by uncle, aunt, nephew, niece?
Description

Livedoid vasculitis

Data type

text

Alias
UMLS CUI [1]
C0343081
Blood coagulation disorders in family
Description

Blood coagulation disorders in family

Alias
UMLS CUI-1
C0005779
Factor V Leiden mutation?
Description

Factor V Leiden

Data type

text

Alias
UMLS CUI [1]
C0380964
Deficiency of protein C and protein S?
Description

deficiency protein C; protein S

Data type

text

Alias
UMLS CUI [1,1]
C0011155
UMLS CUI [1,2]
C0033621
UMLS CUI [2]
C0072393
Prothrombin G20210A mutation?
Description

Prothrombin G20210A mutation

Data type

text

Alias
UMLS CUI [1]
C2584409
Hyperhomocysteinemia?
Description

Hyperhomocysteinemia

Data type

text

Alias
UMLS CUI [1]
C0598608
Antithrombin III deficiency?
Description

Antithrombin III deficiency

Data type

text

Alias
UMLS CUI [1]
C0272375
Anticardiolipin antibodies?
Description

Anticardiolipin antibodies

Data type

text

Alias
UMLS CUI [1]
C0162596
Increased plasminogen activator inhibitor-1 levels (fibrinolysis disorder)?
Description

fibrinolysis disorder

Data type

text

Alias
UMLS CUI [1]
C0521803
Other:
Description

Other

Data type

text

Alias
UMLS CUI [1]
C0205394
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Similar models

Anamnesis

2 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Livedoid vasculitis anamnesis
C0343081 (UMLS CUI-1)
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])
date Ulcer first
Item
Occurrence of first ulcer:
partialDate
C0011008 (UMLS CUI [1,1])
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])
date Anticoagulation Therapy
Item
Date of first anticoagulation therapy:
partialDate
C0011008 (UMLS CUI [1,1])
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])
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])
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])
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])
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])
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])
Location Venous Thrombosis
Item
Other locations:
text
C0450429 (UMLS CUI [1,1])
C0042487 (UMLS CUI [1,2])
Item
Occurrence of blood coagulation disorders?
text
C0005779 (UMLS CUI [1])
Blood Coagulation Disorders
Code List
Occurrence of blood coagulation disorders?
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])
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)
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])
Item
Response to treatment:
text
C0521982 (UMLS CUI [1])
treatment response
Code List
Response to treatment:
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])
Item
Response to treatment:
text
C0521982 (UMLS CUI [1])
treatment response
Code List
Response to treatment:
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])
Item
Response to treatment:
text
C0521982 (UMLS CUI [1])
treatment response
Code List
Response to treatment:
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])
Item
Response to treatment:
text
C0521982 (UMLS CUI [1])
treatment response
Code List
Response to treatment:
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])
Item
Response to treatment:
text
C0521982 (UMLS CUI [1])
treatment response
Code List
Response to treatment:
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])
Item
Response to treatment:
text
C0521982 (UMLS CUI [1])
treatment response
Code List
Response to treatment:
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])
Item
Response to treatment:
text
C0521982 (UMLS CUI [1])
treatment response
Code List
Response to treatment:
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)
Item Group
Chronic comorbidities
C0009488 (UMLS CUI-1)
C0205191 (UMLS CUI-2)
Comorbidities chronic
Item
Chronic comorbidities
boolean
C0009488 (UMLS CUI [1,1])
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)
Item
Occurrence of livedoid vasculitis by own children and parents ?
text
C0343081 (UMLS CUI [1])
Livedoid vasculitis
Code List
Occurrence of livedoid vasculitis by own children and parents ?
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])
Livedoid vasculitis
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])
Livedoid vasculitis
Code List
Occurrence of livedoid vasculitis by uncle, aunt, nephew, niece?
CL Item
unknown (1)
CL Item
no (2)
CL Item
yes, male (3)
CL Item
yes, female (4)
Item Group
Blood coagulation disorders in family
C0005779 (UMLS CUI-1)
Item
Factor V Leiden mutation?
text
C0380964 (UMLS CUI [1])
Factor V Leiden
Code List
Factor V Leiden mutation?
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])
deficiency protein C; protein S
Code List
Deficiency of protein C and protein S?
CL Item
yes (1)
CL Item
no (2)
CL Item
unknown (3)
Item
Prothrombin G20210A mutation?
text
C2584409 (UMLS CUI [1])
Prothrombin G20210A mutation
Code List
Prothrombin G20210A mutation?
CL Item
yes (1)
CL Item
no (2)
CL Item
unknown (3)
Item
Hyperhomocysteinemia?
text
C0598608 (UMLS CUI [1])
Hyperhomocysteinemia
Code List
Hyperhomocysteinemia?
CL Item
yes (1)
CL Item
no (2)
CL Item
unknown (3)
Item
Antithrombin III deficiency?
text
C0272375 (UMLS CUI [1])
Antithrombin III deficiency
Code List
Antithrombin III deficiency?
CL Item
yes (1)
CL Item
no (2)
CL Item
unknown (3)
Item
Anticardiolipin antibodies?
text
C0162596 (UMLS CUI [1])
Anticardiolipin antibodies
Code List
Anticardiolipin antibodies?
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])
fibrinolysis disorder
Code List
Increased plasminogen activator inhibitor-1 levels (fibrinolysis disorder)?
CL Item
yes (1)
CL Item
no (2)
CL Item
unknown (3)
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C0205394 (UMLS CUI [1])
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