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Subcutaneous fondaparinux sodium for prevention of venous thromboembolic events; Study ID: 104619 - Visit 02

- 22.10.18 - 1 Formular, 5 Itemgruppen, 35 Datenelemente, 1 Sprache
Itemgruppen: Experimental Drug, Dosage, Hematology finding, Biochemistry, Venography, Prophylactic treatment, Mechanical Methods; Physical therapy
Study ID: 104619 Clinical Study ID: 63129 Study Title:A multinational, randomized, double-blind comparison of once daily subcutaneous fondaparinux sodium with placebo for the prevention of venous thromboembolic events in acutely ill medical patients (ARTEMIS). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fondaparinux sodium Trade Name: Arixtra Study Indication: Thrombosis, Venous

Fondaparinux in Addition to Intermittent Pneumatic Compression in Abdominal Surgery Patients at VTE Risk - NCT00038961 - Mandatory Venography Adjudication

- 16.09.19 - 1 Formular, 5 Itemgruppen, 15 Datenelemente, 1 Sprache
Itemgruppen: Administrative documentation, Mandatory Venography Adjudication, Venography Adjudication Results, Overall assessment, Adjudicators
Study ID: 103414 Clinical Study ID: 103414 Study Title: A Multicenter, Randomized, Double-blind, Parallel Group Trial to Demonstrate the Efficacy of Fondaparinux Sodium in Association With Intermittent Pneumatic Compression (IPC) Versus IPC Used Alone for the Prevention of Venous Thromboembolic Events in Subjects at Increased Risk Undergoing Major Abdominal surgery Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00038961 https://clinicaltrials.gov/ct2/show/NCT00038961 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Fondaparinux Sodium Trade Name: Fondaparinux Sodium Study Indication: Thrombosis This phase III placebo-controlled trial studies the efficacy and safety of Fondaparinux as an additional prevention measure of venous thromboembolic events (VTE) in patients above the age of 40 with intermediate or high VTE risk undergoing abdominal surgery. The study consists of a Screening Visit (Visit 0), the baseline visit on Day 1, the day of the surgery (Visit 1), the treatment period (denoted in its entirety as Visit 2) consisting of administration of Fondaparinux (2.5mg subcutaneously once daily) or placebo starting on Day 1 and continuing at least up to Day 5, possibly up to Day 9, in parallel to intermittent pneumatic compression and possibly elastic stockings, followed by a mandatory bilateral venography no longer than 24 hours after study drug cessation, and finally a Follow-up Visit (Visit 3) on Day 30 +/- 2. This form contains information on the adjudication of the mandatory venography which is performed between Day 5 and 10 (not more than one day after the last study drug dose), i.e. Visit 2, to check for asymptomatic deep vein thrombosis, and is recorded in a seperate form.

Riliva_CRF_EudraCT - Nr. 2012-000108-13- Anamnesis DRKS00004652 - Anamnesis

- 24.11.15 - 2 Formulare, 5 Itemgruppen, 66 Datenelemente, 2 Sprachen
Itemgruppen: Livedoid vasculitis anamnesis, Therapy Livedoid vasculitis, Comorbidities chronic, Family anamnesis Livedoid vasculitis, Blood Coagulation Disorders
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.

Laboratory values

1 Itemgruppe 32 Datenelemente

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