ID
38086
Descrição
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 any death occuring during the study.
Link
https://clinicaltrials.gov/ct2/show/NCT00038961
Palavras-chave
Versões (1)
- 16/09/2019 16/09/2019 -
Titular dos direitos
GlaxoSmithKline
Transferido a
16 de setembro de 2019
DOI
Para um pedido faça login.
Licença
Creative Commons BY-NC 3.0
Comentários do modelo :
Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.
Comentários do grupo de itens para :
Comentários do item para :
Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.
Fondaparinux in Addition to Intermittent Pneumatic Compression in Abdominal Surgery Patients at VTE Risk - NCT00038961
Death Adjudication
- StudyEvent: ODM
Descrição
Death Adjudication Form
Alias
- UMLS CUI-1
- C0680730
- UMLS CUI-2
- C0011065
Descrição
Classification Status
Alias
- UMLS CUI-1
- C0008902
Descrição
Adjudicators
Alias
- UMLS CUI-1
- C0401783
Descrição
Adjudicator Signature 1
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C0401783
- UMLS CUI [1,2]
- C1519316
Descrição
Adjudicator Signature 2
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C0401783
- UMLS CUI [1,2]
- C1519316
Descrição
Date of adjudication
Tipo de dados
text
Alias
- UMLS CUI [1]
- C4740194
Similar models
Death Adjudication
- StudyEvent: ODM
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
C2986440 (UMLS CUI [1,2])
C0011065 (UMLS CUI-2)
C1516308 (UMLS CUI [1,2])
C0011065 (UMLS CUI [1,2])
C0011065 (UMLS CUI [1,2])
C1519316 (UMLS CUI [1,2])
C1519316 (UMLS CUI [1,2])