ID

38422

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 (non-serious) adverse events, and is to be filled in as necessary during the study. An AE is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceuticalproduct and which does not necessarily have to have a causal relationship with this treatment. An Adverse Event (AE) can therefore be any unfavorable and unintended sign (including an abnormal laboratoryfinding, for example), symptoms, or disease temporally associated with the use of a medicinal product, whetheror not considered related to the medicinal product. For a given AE, if certain information (outcome, intensity etc.) is not known at the time of the initial completionof the form, this information will be completed as soon as it is known on the same form.

Link

https://clinicaltrials.gov/ct2/show/NCT00038961

Stichworte

Versionen (1)
  1. 17.10.19 17.10.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

17. Oktober 2019

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

Englisch

Adverse Event

1 Formulare  
  1. StudyEvent: ODM
    1. Adverse Event
Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722
Country No.
Beschreibung

Country No.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0454664
UMLS CUI [1,2]
C0600091
Centre No.
Beschreibung

Centre No.

Datentyp

integer

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Subject No.
Beschreibung

Clinical Trial Subject Unique Identifier

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Subject Initials
Beschreibung

Subject Initials

Datentyp

text

Alias
UMLS CUI [1,1]
C1997894
UMLS CUI [1,2]
C2986440
AE form No.
Beschreibung

The Form Number is a unique number which identifies each AE. This number will be further reported on another AE form in case of worsening, or on a the "SAE complementary or follow-up information" forms in case the event becomes serious

Datentyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0684224
UMLS CUI [1,3]
C0600091
None
Beschreibung

in the case no Adverse Event was reported during the clinical trial -> if so, skip the rest of this form

Datentyp

boolean

Alias
UMLS CUI [1]
C1963761
Initial AE form number
Beschreibung

Initial AE form number

Alias
UMLS CUI-1
C0205265
UMLS CUI-2
C0877248
UMLS CUI-3
C0684224
UMLS CUI-4
C0600091
Initial AE form number
Beschreibung

In case of worsening of an AE, or if the AE becomes serious, record the initial AE form number as the reference number,and indicate the date of worsening or the date the event became serious as the date of start

Datentyp

integer

Alias
UMLS CUI [1,1]
C0205265
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0684224
UMLS CUI [1,4]
C0600091
Adverse Event Diagnosis
Beschreibung

Adverse Event Diagnosis

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C0011900
Adverse Event Diagnosis
Beschreibung

Give the nature of the Adverse Event, whenever possible report a diagnosis or a syndrome. If no diagnosis ismade, list the symptoms on separate AE Forms. Death must be reported as the verbatim of an Adverse Event only in the case of death of unknown origin.Otherwise, it should be considered as the outcome of a given adverse event and death should be ticked in box 7. Record the site of the adverse event: surgical, procedural, injection or other

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0011900
AE site
Beschreibung

AE site

Datentyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1515974
Date and Time of Start of Event
Beschreibung

Date and Time of Start of Event

Alias
UMLS CUI-1
C2826806
Date and Time of Start of Event
Beschreibung

Report the complete date. If the day is not available, record at least the month and year. Report the date of aggravation of the event in the case of a pre-existing pathology. Pre-existing pathologies should be recorded on the corresponding page in the CRF. Report the date of aggravation of the event in the case of an aggravation of an AE previously reported or thedate the event became serious. Report the date of recurrence in the case of a new occurrence (except in case of an intermittent event).

Datentyp

partialDatetime

Alias
UMLS CUI [1]
C2826806
AE Intensity
Beschreibung

AE Intensity

Alias
UMLS CUI-1
C1710066
AE Intensity
Beschreibung

AE Intensity

Datentyp

integer

Alias
UMLS CUI [1]
C1710066
Relationship to Study Drug
Beschreibung

Relationship to Study Drug

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C0013230
UMLS CUI-3
C0439849
Is there a reasonable possibility that the AE was caused by study drug?
Beschreibung

According to the investigator's judgment

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
Action Taken with Study Drug
Beschreibung

Action Taken with Study Drug

Alias
UMLS CUI-1
C2826626
Has the event resulted in permanent Treatment discontinuation?
Beschreibung

AE resulted in permanent treatment discontinuation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C1444662
UMLS CUI [1,4]
C0205355
UMLS CUI [1,5]
C0087111
Corrective Treatment/Therapy
Beschreibung

Corrective Treatment/Therapy

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C0087111
Corrective Treatment/Therapy?
Beschreibung

If yes, specify

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0087111
Specify AE Treatment/Therapy
Beschreibung

if applicable

Datentyp

text

Alias
UMLS CUI [1,1]
C1521902
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0087111
Outcome at the time of the last observation
Beschreibung

Outcome at the time of the last observation

Alias
UMLS CUI-1
C1705586
Outcome at the time of the last observation
Beschreibung

Select one, specify recovered, sequelae and death. Definitions: Recovering: If the event is still reported but improving. Unknown: must be used only for lost to follow-up subject

Datentyp

integer

Alias
UMLS CUI [1]
C1705586
Date of recovery
Beschreibung

if applicable

Datentyp

date

Alias
UMLS CUI [1,1]
C0237820
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0877248
Time of recovery
Beschreibung

if applicable, optional

Datentyp

time

Alias
UMLS CUI [1,1]
C0237820
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0040223
Specify AE sequelae
Beschreibung

if applicable

Datentyp

text

Alias
UMLS CUI [1,1]
C1521902
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0243088
Date of death
Beschreibung

if applicable

Datentyp

date

Alias
UMLS CUI [1]
C1148348
Time of death
Beschreibung

if applicable, optional

Datentyp

time

Alias
UMLS CUI [1]
C1301931
Seriousness Criteria
Beschreibung

Seriousness Criteria

Alias
UMLS CUI-1
C1710056
Seriousness Criteria?
Beschreibung

If Yes, complete this section and the SAE complementary information form (select all items in this itemgroup that apply)

Datentyp

boolean

Alias
UMLS CUI [1]
C1710056
Resulting in death
Beschreibung

AE resulting in death

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0011065
Life-threatening
Beschreibung

"life-threatening" event refers to an event in which the subject was at risk of death at the time of the eventand not to an event which hypothetically would have caused death if it were more severe

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C2826244
Requiring/prolonging hospitalization
Beschreibung

AE requiring/prolonging hospitalization

Datentyp

boolean

Alias
UMLS CUI [1]
C2826664
Persistent/significant disability/incapacity
Beschreibung

AE Persistent/significant disability/incapacity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2347488
UMLS CUI [1,2]
C0877248
Congenital anomaly/birth defect
Beschreibung

AE Congenital anomaly/birth defect

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0000768
UMLS CUI [1,2]
C0877248
Other medically important event
Beschreibung

"Other medically important event": According to medical judgment of the investigator, " events that may not be immediately life-threatening or result in death but may jeopardize the subject's health or may require intervention to prevent one of the other seriousness criteria".

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C1710056
Investigator & Monitor
Beschreibung

Investigator & Monitor

Alias
UMLS CUI-1
C0008961
UMLS CUI-2
C1708968
Investigator name
Beschreibung

Investigator name

Datentyp

text

Alias
UMLS CUI [1]
C2826892
Date of report
Beschreibung

Date of report

Datentyp

date

Alias
UMLS CUI [1]
C1302584
Investigator's signature
Beschreibung

Investigator's signature

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Monitor's name
Beschreibung

Monitor's name

Datentyp

text

Alias
UMLS CUI [1,1]
C0027365
UMLS CUI [1,2]
C1708968
Monitor date of receipt
Beschreibung

Monitor date of receipt

Datentyp

date

Alias
UMLS CUI [1,1]
C2985846
UMLS CUI [1,2]
C1708968
PV corporate date of receipt
Beschreibung

PV date of receipt

Datentyp

date

Alias
UMLS CUI [1,1]
C3178990
UMLS CUI [1,2]
C2985846
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Ähnliche Modelle

Adverse Event

1 Formulare
  1. StudyEvent: ODM
    1. Adverse Event
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Country No.
Item
Country No.
integer
C0454664 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Centre No.
Item
Centre No.
integer
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Clinical Trial Subject Unique Identifier
Item
Subject No.
integer
C2348585 (UMLS CUI [1])
Subject Initials
Item
Subject Initials
text
C1997894 (UMLS CUI [1,1])
C2986440 (UMLS CUI [1,2])
AE form number
Item
AE form No.
integer
C0877248 (UMLS CUI [1,1])
C0684224 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
No Adverse Event
Item
None
boolean
C1963761 (UMLS CUI [1])
Item Group
Initial AE form number
C0205265 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C0684224 (UMLS CUI-3)
C0600091 (UMLS CUI-4)
Initial AE form number
Item
Initial AE form number
integer
C0205265 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0684224 (UMLS CUI [1,3])
C0600091 (UMLS CUI [1,4])
Item Group
Adverse Event Diagnosis
C0877248 (UMLS CUI-1)
C0011900 (UMLS CUI-2)
Adverse Event Diagnosis
Item
Adverse Event Diagnosis
text
C0877248 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
AE site
integer
C0877248 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
AE site
Code List
AE site
CL Item
Surgical (1)
CL Item
Procedural (2)
CL Item
Injection (3)
CL Item
Other (4)
Item Group
Date and Time of Start of Event
C2826806 (UMLS CUI-1)
AE Start Date/Time
Item
Date and Time of Start of Event
partialDatetime
C2826806 (UMLS CUI [1])
Item Group
AE Intensity
C1710066 (UMLS CUI-1)
Item
AE Intensity
integer
C1710066 (UMLS CUI [1])
AE Intensity
Code List
AE Intensity
CL Item
Mild: no modification of daily activities and/or does not require symptomatic treatment. (1)
CL Item
Moderate: hinders normal daily activities and/or requires symptomatic treatment. (2)
CL Item
Severe: does not allow daily activities and requires symptomatic treatment. (3)
Item Group
Relationship to Study Drug
C0877248 (UMLS CUI-1)
C0013230 (UMLS CUI-2)
C0439849 (UMLS CUI-3)
AE relationship to study drug?
Item
Is there a reasonable possibility that the AE was caused by study drug?
boolean
C0877248 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Item Group
Action Taken with Study Drug
C2826626 (UMLS CUI-1)
AE resulted in permanent treatment discontinuation
Item
Has the event resulted in permanent Treatment discontinuation?
boolean
C0877248 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C1444662 (UMLS CUI [1,3])
C0205355 (UMLS CUI [1,4])
C0087111 (UMLS CUI [1,5])
Item Group
Corrective Treatment/Therapy
C0877248 (UMLS CUI-1)
C0087111 (UMLS CUI-2)
AE Treatment/Therapy?
Item
Corrective Treatment/Therapy?
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Specify AE Treatment/Therapy
Item
Specify AE Treatment/Therapy
text
C1521902 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
Item Group
Outcome at the time of the last observation
C1705586 (UMLS CUI-1)
Item
Outcome at the time of the last observation
integer
C1705586 (UMLS CUI [1])
AE outcome
Code List
Outcome at the time of the last observation
CL Item
Recovered (1)
CL Item
Recovering (2)
CL Item
Not recovered (3)
CL Item
Recovered with sequelae (4)
CL Item
Fatal (5)
CL Item
Unknown (6)
AE Date of recovery
Item
Date of recovery
date
C0237820 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
AE Time of recovery
Item
Time of recovery
time
C0237820 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Specify AE sequelae
Item
Specify AE sequelae
text
C1521902 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0243088 (UMLS CUI [1,3])
Date of death
Item
Date of death
date
C1148348 (UMLS CUI [1])
Time of death
Item
Time of death
time
C1301931 (UMLS CUI [1])
Item Group
Seriousness Criteria
C1710056 (UMLS CUI-1)
Seriousness Criteria met?
Item
Seriousness Criteria?
boolean
C1710056 (UMLS CUI [1])
AE resulting in death
Item
Resulting in death
boolean
C0877248 (UMLS CUI [1,1])
C0011065 (UMLS CUI [1,2])
AE life-threatening
Item
Life-threatening
boolean
C0877248 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
AE requiring/prolonging hospitalization
Item
Requiring/prolonging hospitalization
boolean
C2826664 (UMLS CUI [1])
AE Persistent/significant disability/incapacity
Item
Persistent/significant disability/incapacity
boolean
C2347488 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
AE Congenital anomaly/birth defect
Item
Congenital anomaly/birth defect
boolean
C0000768 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Other medically important event
Item
Other medically important event
boolean
C0205394 (UMLS CUI [1,1])
C1710056 (UMLS CUI [1,2])
Item Group
Investigator & Monitor
C0008961 (UMLS CUI-1)
C1708968 (UMLS CUI-2)
Investigator name
Item
Investigator name
text
C2826892 (UMLS CUI [1])
Date of report
Item
Date of report
date
C1302584 (UMLS CUI [1])
Investigator's signature
Item
Investigator's signature
text
C2346576 (UMLS CUI [1])
Monitor's name
Item
Monitor's name
text
C0027365 (UMLS CUI [1,1])
C1708968 (UMLS CUI [1,2])
Monitor date of receipt
Item
Monitor date of receipt
date
C2985846 (UMLS CUI [1,1])
C1708968 (UMLS CUI [1,2])
PV date of receipt
Item
PV corporate date of receipt
date
C3178990 (UMLS CUI [1,1])
C2985846 (UMLS CUI [1,2])
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