ID
41987
Beschrijving
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
Trefwoorden
Versies (2)
- 17-10-19 17-10-19 -
- 15-03-21 15-03-21 - Dr. rer. medic Philipp Neuhaus
Houder van rechten
GlaxoSmithKline
Geüploaded op
15 maart 2021
DOI
Voor een aanvraag inloggen.
Licentie
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
Beschrijving
Demographic Information
Alias
- UMLS CUI-1
- C1704791
Beschrijving
Record Date of Birth or Age
Datatype
date
Alias
- UMLS CUI [1]
- C0421451
Beschrijving
Record Date of Birth or Age
Datatype
integer
Alias
- UMLS CUI [1]
- C0001779
Beschrijving
Gender
Datatype
text
Alias
- UMLS CUI [1]
- C0079399
Beschrijving
Race
Datatype
text
Alias
- UMLS CUI [1]
- C0034510
Beschrijving
Height
Datatype
integer
Maateenheden
- cm
Alias
- UMLS CUI [1]
- C0005890
Beschrijving
Weight
Datatype
float
Maateenheden
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschrijving
Detailed Description
Alias
- UMLS CUI-1
- C0678257
Beschrijving
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.
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0678257
Beschrijving
Study Drug
Alias
- UMLS CUI-1
- C0304229
Beschrijving
Treatment number
Datatype
integer
Alias
- UMLS CUI [1]
- C1522541
Beschrijving
Date/Time first administration of study drug
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C3899436
Beschrijving
Date/Time last administration of study drug before SAE
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C3899434
- UMLS CUI [1,3]
- C0332152
- UMLS CUI [1,4]
- C1519255
Beschrijving
If No, provide a copy of the end of treatment form
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0549178
Beschrijving
In Case of Hospitalization
Alias
- UMLS CUI-1
- C0019993
Beschrijving
In Case of Death
Alias
- UMLS CUI-1
- C0011065
Beschrijving
Previous and Concomitant Medication
Alias
- UMLS CUI-1
- C0205156
- UMLS CUI-2
- C0013227
- UMLS CUI-3
- C2347852
Beschrijving
Medical History and Concomitant Disease
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0243087
Beschrijving
SAE Follow-Up Information Form
Alias
- UMLS CUI-1
- C1533716
- UMLS CUI-2
- C1519255
- UMLS CUI-3
- C1522577
Beschrijving
Adverse Event
Datatype
text
Alias
- UMLS CUI [1]
- C0877248
Beschrijving
Date of Evaluation
Datatype
date
Alias
- UMLS CUI [1]
- C2985720
Beschrijving
Additional information and Comments
Datatype
text
Alias
- UMLS CUI [1]
- C1546922
- UMLS CUI [2]
- C0947611
Beschrijving
Investigator & Monitor
Alias
- UMLS CUI-1
- C0008961
- UMLS CUI-2
- C1708968
Beschrijving
Investigator name
Datatype
text
Alias
- UMLS CUI [1]
- C2826892
Beschrijving
Date of report
Datatype
date
Alias
- UMLS CUI [1]
- C1302584
Beschrijving
Investigator's signature
Datatype
text
Alias
- UMLS CUI [1]
- C2346576
Beschrijving
Monitor's name
Datatype
text
Alias
- UMLS CUI [1,1]
- C0027365
- UMLS CUI [1,2]
- C1708968
Beschrijving
Monitor date of receipt
Datatype
date
Alias
- UMLS CUI [1,1]
- C2985846
- UMLS CUI [1,2]
- C1708968
Beschrijving
PV date of receipt
Datatype
date
Alias
- UMLS CUI [1,1]
- C3178990
- UMLS CUI [1,2]
- C2985846
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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])