Information:
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ID
12498
Description
Study documentation part: Adverse event. 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 (2)
- 11/24/15 11/24/15 -
- 11/24/15 11/24/15 - Julian Varghese
Uploaded on
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- Adverse event DRKS00004652
Riliva_CRF_EudraCT - Nr. 2012-000108-13- Adverse event
- StudyEvent: ODM
Similar models
Riliva_CRF_EudraCT - Nr. 2012-000108-13- Adverse event
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Adverse event
Item
Adverse event
text
C0877248 (UMLS CUI [1])
Start date
Item
Start date of adverse event
date
C0808070 (UMLS CUI [1])
Serious Adverse Event
Item
Serious Adverse Event
boolean
C1519255 (UMLS CUI [1])
CL Item
slight, no effect on daily activities (e.g, cooking, shopping) (1)
CL Item
moderate, daily activity impaired (2)
CL Item
severe, daily activity not possible (3)
Item
Relation to study medication
text
C0013227 (UMLS CUI [1,1])
C0869014 (UMLS CUI [1,2])
C0869014 (UMLS CUI [1,2])
CL Item
no reasonable connection (1)
CL Item
reasonable connection (2)
Item
Measures taken regarding study medication
text
C0013227 (UMLS CUI [1,1])
C0079809 (UMLS CUI [1,2])
C0079809 (UMLS CUI [1,2])
CL Item
none (1)
CL Item
dose reduction (2)
CL Item
dose increase (3)
CL Item
temporarily stopped (4)
CL Item
ultimately stopped (5)
CL Item
unknown (6)
CL Item
not applicable (7)
Adverse Event Caused Study Discontinuation
Item
Adverse event leading to study discontinuation
boolean
C2826233 (UMLS CUI [1])
Adverse Event End Date
Item
Adverse event end date
date
C2697886 (UMLS CUI [1])
CL Item
restored (1)
CL Item
improved (2)
CL Item
still not improved (3)
CL Item
restored with permanent damage (4)
CL Item
death (5)
CL Item
unknown (6)