ID
41987
Descripción
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 serious adverse events, and is to be filled in as necessary during the study, in addition to the AE form, and consists of a complimentary part and a follow-up part.
Link
https://clinicaltrials.gov/ct2/show/NCT00038961
Palabras clave
Versiones (2)
- 17/10/19 17/10/19 -
- 15/3/21 15/3/21 - Dr. rer. medic Philipp Neuhaus
Titular de derechos de autor
GlaxoSmithKline
Subido en
15 de marzo de 2021
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
Creative Commons BY-NC 3.0
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Fondaparinux in Addition to Intermittent Pneumatic Compression in Abdominal Surgery Patients at VTE Risk - NCT00038961
Serious Adverse Event
- StudyEvent: ODM
Descripción
Demographic Information
Alias
- UMLS CUI-1
- C1704791
Descripción
Record Date of Birth or Age
Tipo de datos
date
Alias
- UMLS CUI [1]
- C0421451
Descripción
Record Date of Birth or Age
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0001779
Descripción
Gender
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0079399
Descripción
Race
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0034510
Descripción
Height
Tipo de datos
integer
Unidades de medida
- cm
Alias
- UMLS CUI [1]
- C0005890
Descripción
Weight
Tipo de datos
float
Unidades de medida
- kg
Alias
- UMLS CUI [1]
- C0005910
Descripción
Detailed Description
Alias
- UMLS CUI-1
- C0678257
Descripción
including complementary investigations Report the AE form verbatim (AE diagnosis) and give complete and detailed description and circumstances of the event. If relevant, give results of complementary investigation, laboratory tests, etc.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0678257
Descripción
Study Drug
Alias
- UMLS CUI-1
- C0304229
Descripción
Treatment number
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C1522541
Descripción
Date/Time first administration of study drug
Tipo de datos
datetime
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C3899436
Descripción
Date/Time last administration of study drug before SAE
Tipo de datos
datetime
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C3899434
- UMLS CUI [1,3]
- C0332152
- UMLS CUI [1,4]
- C1519255
Descripción
If No, provide a copy of the end of treatment form
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0549178
Descripción
In Case of Hospitalization
Alias
- UMLS CUI-1
- C0019993
Descripción
In Case of Death
Alias
- UMLS CUI-1
- C0011065
Descripción
Previous and Concomitant Medication
Alias
- UMLS CUI-1
- C0205156
- UMLS CUI-2
- C0013227
- UMLS CUI-3
- C2347852
Descripción
Medical History and Concomitant Disease
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0243087
Descripción
SAE Follow-Up Information Form
Alias
- UMLS CUI-1
- C1533716
- UMLS CUI-2
- C1519255
- UMLS CUI-3
- C1522577
Descripción
Adverse Event
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0877248
Descripción
Date of Evaluation
Tipo de datos
date
Alias
- UMLS CUI [1]
- C2985720
Descripción
Additional information and Comments
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1546922
- UMLS CUI [2]
- C0947611
Descripción
Investigator & Monitor
Alias
- UMLS CUI-1
- C0008961
- UMLS CUI-2
- C1708968
Descripción
Investigator name
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2826892
Descripción
Date of report
Tipo de datos
date
Alias
- UMLS CUI [1]
- C1302584
Descripción
Investigator's signature
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2346576
Descripción
Monitor's name
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0027365
- UMLS CUI [1,2]
- C1708968
Descripción
Monitor date of receipt
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C2985846
- UMLS CUI [1,2]
- C1708968
Descripción
PV date of receipt
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C3178990
- UMLS CUI [1,2]
- C2985846
Similar models
Serious Adverse Event
- StudyEvent: ODM
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
C2986440 (UMLS CUI [1,2])
C0684224 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
C0678257 (UMLS CUI [1,2])
C3899436 (UMLS CUI [1,2])
C3899434 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,4])
C0549178 (UMLS CUI [1,2])
C0013227 (UMLS CUI-2)
C2347852 (UMLS CUI-3)
C0013227 (UMLS CUI [1,2])
C2347852 (UMLS CUI [2])
C0243087 (UMLS CUI-2)
C0243087 (UMLS CUI [2])
C1519255 (UMLS CUI-2)
C1522577 (UMLS CUI-3)
C0947611 (UMLS CUI [2])
C1708968 (UMLS CUI-2)
C1708968 (UMLS CUI [1,2])
C1708968 (UMLS CUI [1,2])
C2985846 (UMLS CUI [1,2])