ID
41987
Beschreibung
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
Stichworte
Versionen (2)
- 17.10.19 17.10.19 -
- 15.03.21 15.03.21 - Dr. rer. medic Philipp Neuhaus
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
15. März 2021
DOI
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Lizenz
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
Beschreibung
Demographic Information
Alias
- UMLS CUI-1
- C1704791
Beschreibung
Record Date of Birth or Age
Datentyp
date
Alias
- UMLS CUI [1]
- C0421451
Beschreibung
Record Date of Birth or Age
Datentyp
integer
Alias
- UMLS CUI [1]
- C0001779
Beschreibung
Gender
Datentyp
text
Alias
- UMLS CUI [1]
- C0079399
Beschreibung
Race
Datentyp
text
Alias
- UMLS CUI [1]
- C0034510
Beschreibung
Height
Datentyp
integer
Maßeinheiten
- cm
Alias
- UMLS CUI [1]
- C0005890
Beschreibung
Weight
Datentyp
float
Maßeinheiten
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschreibung
Detailed Description
Alias
- UMLS CUI-1
- C0678257
Beschreibung
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.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0678257
Beschreibung
Study Drug
Alias
- UMLS CUI-1
- C0304229
Beschreibung
Treatment number
Datentyp
integer
Alias
- UMLS CUI [1]
- C1522541
Beschreibung
Date/Time first administration of study drug
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C3899436
Beschreibung
Date/Time last administration of study drug before SAE
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C3899434
- UMLS CUI [1,3]
- C0332152
- UMLS CUI [1,4]
- C1519255
Beschreibung
If No, provide a copy of the end of treatment form
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0549178
Beschreibung
In Case of Hospitalization
Alias
- UMLS CUI-1
- C0019993
Beschreibung
In Case of Death
Alias
- UMLS CUI-1
- C0011065
Beschreibung
Previous and Concomitant Medication
Alias
- UMLS CUI-1
- C0205156
- UMLS CUI-2
- C0013227
- UMLS CUI-3
- C2347852
Beschreibung
Medical History and Concomitant Disease
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0243087
Beschreibung
SAE Follow-Up Information Form
Alias
- UMLS CUI-1
- C1533716
- UMLS CUI-2
- C1519255
- UMLS CUI-3
- C1522577
Beschreibung
Adverse Event
Datentyp
text
Alias
- UMLS CUI [1]
- C0877248
Beschreibung
Date of Evaluation
Datentyp
date
Alias
- UMLS CUI [1]
- C2985720
Beschreibung
Additional information and Comments
Datentyp
text
Alias
- UMLS CUI [1]
- C1546922
- UMLS CUI [2]
- C0947611
Beschreibung
Investigator & Monitor
Alias
- UMLS CUI-1
- C0008961
- UMLS CUI-2
- C1708968
Beschreibung
Investigator name
Datentyp
text
Alias
- UMLS CUI [1]
- C2826892
Beschreibung
Date of report
Datentyp
date
Alias
- UMLS CUI [1]
- C1302584
Beschreibung
Investigator's signature
Datentyp
text
Alias
- UMLS CUI [1]
- C2346576
Beschreibung
Monitor's name
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0027365
- UMLS CUI [1,2]
- C1708968
Beschreibung
Monitor date of receipt
Datentyp
date
Alias
- UMLS CUI [1,1]
- C2985846
- UMLS CUI [1,2]
- C1708968
Beschreibung
PV date of receipt
Datentyp
date
Alias
- UMLS CUI [1,1]
- C3178990
- UMLS CUI [1,2]
- C2985846
Ähnliche Modelle
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])