Centre number
Item
Centre number:
integer
Assessment Date
Item
Date of renewed assessment of the inclusion and the exclusion criteria:
date
C2985720 (UMLS CUI [1])
Livedoid vasculitis
Item
1) Secured livedo vasculopathy
boolean
C0343081 (UMLS CUI [1])
age
Item
2) Age ≥ 18 years and ≤ 80 years
boolean
C0001779 (UMLS CUI [1])
Visual Analog Pain Scale
Item
3) 40 points on the pain VAS at least one day within the last 7 days before beginning therapy
boolean
C0042815 (UMLS CUI [1])
contraception
Item
4)In women: secured contraception (Requirement: Pearl Index <1) (in case of men please choose "No")
boolean
C0700589 (UMLS CUI [1])
communication skills
Item
5) Adequate communication skills in the German language
boolean
C0870313 (UMLS CUI [1])
informed consent
Item
6) Patient must be able to recognize the nature, significance and scope of the clinical trial and to align his will hereafter
boolean
C0021430 (UMLS CUI [1])
intervention study
Item
1) Participation in another intervention study within the last 30 days before beginning therapy
boolean
C1096775 (UMLS CUI [1])
Drug Allergy
Item
2) Known allergy to the study medication
boolean
C0013182 (UMLS CUI [1])
Intolerance or malabsorption of glucose-galactose
Item
3) Known problems of galactose intolerance, deficit of lactase or glucose-galactose malabsorption
boolean
C0865194 (UMLS CUI [1])
pregnancy
Item
4) Pregnancy
boolean
C0549206 (UMLS CUI [1])
Lactation
Item
5) Lactation
boolean
C0006147 (UMLS CUI [1])
creatinine clearance
Item
6) Known renal impairment (creatinine clearance <30ml/min)
boolean
C0812399 (UMLS CUI [1])
Child-Pugh score
Item
7) Known liver disease (Child-Pugh score B and C)
boolean
C3854424 (UMLS CUI [1])
Gastrointestinal ulcer
Item
8) Known ulcerative gastrointestinal disorders within the last 30 days prior to initiation of therapy or during
boolean
C0237938 (UMLS CUI [1])
arterial hypertension severe
Item
9) Uncontrolled, severe arterial hypertension
boolean
C0020538 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Heart Valve Prosthesis
Item
10) Artificial heart valves
boolean
C0018825 (UMLS CUI [1])
Acute pulmonary embolism
Item
11) Acute pulmonary embolism
boolean
C2882221 (UMLS CUI [1])
bronchiectasis
Item
12) Known bronchiectasis or pulmonary bleeding
boolean
C0006267 (UMLS CUI [1])
retinopathy vascular
Item
13) Known vascular retinopathy
boolean
C0035309 (UMLS CUI [1,1])
C1801960 (UMLS CUI [1,2])
Cerebral Hemorrhage
Item
14) Intracranial or intracerebral haemorrhage within the last 30 days before beginning of therapy or during therapy
boolean
C2937358 (UMLS CUI [1])
neurological surgery; eye surgery
Item
15) Brain, spinal cord or eye surgery within the last 30 days before beginning of therapy or during therapy
boolean
C0524850 (UMLS CUI [1])
C0038901 (UMLS CUI [2])
epidural anaesthesia
Item
16) Spinal or epidural anaesthesia or puncture within the last 2 weeks before beginning of therapy or during therapy
boolean
C0002913 (UMLS CUI [1])
Heparin therapy systemic
Item
17) Application of systemic heparin within 1 day before beginning of therapy
boolean
C0522794 (UMLS CUI [1])
C0205373 (UMLS CUI [2])
Nonsteroidal anti-inflammatory drug
Item
18) Intake of NSARs or thrombocyte aggregation inhibitors within 1 day before beginning of therapy or during therapy
boolean
C0003211 (UMLS CUI [1])
vitamin-K-antagonist therapy; dabigatran
Item
19) Intake of vitamin-K-antagonists (marcumar, warfarin) and/or thrombin inhibitor (dabigatran) within 7 days before beginning of therapy or during therapy
boolean
C1096489 (UMLS CUI [1])
C2348066 (UMLS CUI [2])
CYP3A4 inducers
Item
20) Concomitant use of CYP3A4 inducers (e.g. rifampicin, phenytoin, carbamazepine, phenobarbital or St. John’s Wort)
boolean
C3850041 (UMLS CUI [1])
ketoconazole; itraconazole
Item
21) Concomitant systemic treatment with azole-antimycotics (such as ketoconazole, itraconazole, voriconazole and posaconazole)
boolean
C0022625 (UMLS CUI [1])
C0064113 (UMLS CUI [2])
HIV-protease inhibitors
Item
22) Concomitant systemic treatment with HIV-protease inhibitors (e.g. ritonavir)
boolean
C0162714 (UMLS CUI [1])
dronedarone
Item
23) Concomitant systemic treatment with dronedarone
boolean
C0766326 (UMLS CUI [1])
malignant neoplasms; Bleeding Risk
Item
24) Presence of malignant neoplasms at high risk of bleeding
boolean
C0006826 (UMLS CUI [1])
C3251812 (UMLS CUI [2])
brain or spinal injury
Item
25) Recent brain or spinal injury
boolean
C1402439 (UMLS CUI [1])
Esophageal Varices
Item
26) Known or suspected oesophageal varices
boolean
C0014867 (UMLS CUI [1])
arteriovenous malformation
Item
27) Known arteriovenous malformations
boolean
C0450109 (UMLS CUI [1,1])
C0302142 (UMLS CUI [1,2])
Aneurysm vascular
Item
28) Known vascular aneurysms
boolean
Abnormality Intraspinal
Item
29) Known major intraspinal or intracerebral vascular abnormalities
boolean
C1704258 (UMLS CUI [1,1])
C1283188 (UMLS CUI [1,2])
date
Item
Date of urine pregnancy test:
date
C0011008 (UMLS CUI [1])
Item
Result of urine pregnancy test:
text
C2826772 (UMLS CUI [1])
Code List
Result of urine pregnancy test:
CL Item
not performed as the subject is male (3)
Other
Item
Please mention details when other:
text
C0205394 (UMLS CUI [1])
Item
Patient meets all the inclusion criteria and none of the exclusion criteria is present:
text
C1512693 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
Code List
Patient meets all the inclusion criteria and none of the exclusion criteria is present:
CL Item
Yes, approval for treatment with study medication according to the study protocol (1)
CL Item
No, end of study (Screening failure) (2)