ID
41987
Beskrivning
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.
Länk
https://clinicaltrials.gov/ct2/show/NCT00038961
Nyckelord
Versioner (2)
- 2019-10-17 2019-10-17 -
- 2021-03-15 2021-03-15 - Dr. rer. medic Philipp Neuhaus
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
15 mars 2021
DOI
För en begäran logga in.
Licens
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
Beskrivning
Demographic Information
Alias
- UMLS CUI-1
- C1704791
Beskrivning
Record Date of Birth or Age
Datatyp
date
Alias
- UMLS CUI [1]
- C0421451
Beskrivning
Record Date of Birth or Age
Datatyp
integer
Alias
- UMLS CUI [1]
- C0001779
Beskrivning
Gender
Datatyp
text
Alias
- UMLS CUI [1]
- C0079399
Beskrivning
Race
Datatyp
text
Alias
- UMLS CUI [1]
- C0034510
Beskrivning
Height
Datatyp
integer
Måttenheter
- cm
Alias
- UMLS CUI [1]
- C0005890
Beskrivning
Weight
Datatyp
float
Måttenheter
- kg
Alias
- UMLS CUI [1]
- C0005910
Beskrivning
Detailed Description
Alias
- UMLS CUI-1
- C0678257
Beskrivning
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.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0678257
Beskrivning
Study Drug
Alias
- UMLS CUI-1
- C0304229
Beskrivning
Treatment number
Datatyp
integer
Alias
- UMLS CUI [1]
- C1522541
Beskrivning
Date/Time first administration of study drug
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C3899436
Beskrivning
Date/Time last administration of study drug before SAE
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C3899434
- UMLS CUI [1,3]
- C0332152
- UMLS CUI [1,4]
- C1519255
Beskrivning
If No, provide a copy of the end of treatment form
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0549178
Beskrivning
In Case of Hospitalization
Alias
- UMLS CUI-1
- C0019993
Beskrivning
In Case of Death
Alias
- UMLS CUI-1
- C0011065
Beskrivning
Previous and Concomitant Medication
Alias
- UMLS CUI-1
- C0205156
- UMLS CUI-2
- C0013227
- UMLS CUI-3
- C2347852
Beskrivning
Medical History and Concomitant Disease
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0243087
Beskrivning
SAE Follow-Up Information Form
Alias
- UMLS CUI-1
- C1533716
- UMLS CUI-2
- C1519255
- UMLS CUI-3
- C1522577
Beskrivning
Adverse Event
Datatyp
text
Alias
- UMLS CUI [1]
- C0877248
Beskrivning
Date of Evaluation
Datatyp
date
Alias
- UMLS CUI [1]
- C2985720
Beskrivning
Additional information and Comments
Datatyp
text
Alias
- UMLS CUI [1]
- C1546922
- UMLS CUI [2]
- C0947611
Beskrivning
Investigator & Monitor
Alias
- UMLS CUI-1
- C0008961
- UMLS CUI-2
- C1708968
Beskrivning
Investigator name
Datatyp
text
Alias
- UMLS CUI [1]
- C2826892
Beskrivning
Date of report
Datatyp
date
Alias
- UMLS CUI [1]
- C1302584
Beskrivning
Investigator's signature
Datatyp
text
Alias
- UMLS CUI [1]
- C2346576
Beskrivning
Monitor's name
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0027365
- UMLS CUI [1,2]
- C1708968
Beskrivning
Monitor date of receipt
Datatyp
date
Alias
- UMLS CUI [1,1]
- C2985846
- UMLS CUI [1,2]
- C1708968
Beskrivning
PV date of receipt
Datatyp
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])