ID

32564

Beskrivning

Study ID: 104619 Clinical Study ID: 63129 Study Title:A multinational, randomized, double-blind comparison of once daily subcutaneous fondaparinux sodium with placebo for the prevention of venous thromboembolic events in acutely ill medical patients (ARTEMIS). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fondaparinux sodium Trade Name: Arixtra Study Indication: Thrombosis, Venous

Nyckelord

Versioner (1)
  1. 2018-11-06 2018-11-06 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

6 november 2018

DOI

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Licens

Creative Commons BY-NC 3.0
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Subcutaneous fondaparinux sodium for prevention of venous thromboembolic events; Study ID: 104619

Engelsk

Adverse Event Form

1 Formulär  
  1. StudyEvent: ODM
    1. Adverse Event Form
Adverse Events
Beskrivning

Adverse Events

Alias
UMLS CUI-1
C0877248
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
Beskrivning

Adverse event; number

Datatyp

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
Adverse Event Diagnosis
Beskrivning

Adverse event, diagnosis

Datatyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0011900
AE Site
Beskrivning

Adverse event, Site

Datatyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1515974
Date of Start of the Event
Beskrivning

Adverse event Start Date

Datatyp

date

Alias
UMLS CUI [1]
C2697888
Time of Start of the Event
Beskrivning

Adverse event Start time

Datatyp

time

Alias
UMLS CUI [1]
C2697889
Is there a reasonable possibility that the AE was caused by study drug?
Beskrivning

Adverse event; new experimental drug; relationship

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
Has the event resulted in permanent Treatment discontinuation?
Beskrivning

undefined item

Datatyp

boolean

Is there a reasonable possibility that the AE was caused by study drug?
Beskrivning

Adverse event; investigational new drug; relationship

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
Corrective Treatment/Therapy
Beskrivning

Adverse event; Corrective treatment

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0719519
Outcome at the time of the last observation
Beskrivning

Adverse event; Outcome

Datatyp

text

Alias
UMLS CUI [1]
C1705586
Seriousness Criteria
Beskrivning

Adverse event; seriousness

Datatyp

text

Alias
UMLS CUI [1]
C2985919
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Similar models

Adverse Event Form

1 Formulär
  1. StudyEvent: ODM
    1. Adverse Event Form
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Adverse Events
C0877248 (UMLS CUI-1)
Adverse event; number
Item
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
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Adverse event, diagnosis
Item
Adverse Event Diagnosis
text
C0877248 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
AE Site
text
C0877248 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
Adverse event, Site
Code List
AE Site
CL Item
Surgical (Surgical)
CL Item
Procedural (Procedural)
CL Item
Injection (Injection)
CL Item
Other (Other)
Adverse event Start Date
Item
Date of Start of the Event
date
C2697888 (UMLS CUI [1])
Adverse event Start time
Item
Time of Start of the Event
time
C2697889 (UMLS CUI [1])
Adverse event; new experimental drug; relationship
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])
undefined item
Item
Has the event resulted in permanent Treatment discontinuation?
boolean
Adverse event; investigational new drug; relationship
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])
Adverse event; Corrective treatment
Item
Corrective Treatment/Therapy
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0719519 (UMLS CUI [1,3])
Item
Outcome at the time of the last observation
text
C1705586 (UMLS CUI [1])
Adverse event; Outcome
Code List
Outcome at the time of the last observation
CL Item
Recovered (give date and time of recovery) (Recovered (give date and time of recovery))
CL Item
Recovering (Recovering)
CL Item
Not recovered (Not recovered)
CL Item
Recovered with sequelae (specify sequelae) (Recovered with sequelae (specify sequelae))
CL Item
Fatal (give date and time of death) (Fatal (give date and time of death))
CL Item
Unknown (Unknown)
Item
Seriousness Criteria
text
C2985919 (UMLS CUI [1])
Adverse event; seriousness
Code List
Seriousness Criteria
CL Item
No (No)
CL Item
Yes - Resulting in death (Yes - Resulting in death)
CL Item
Yes - Life-threatening (Yes - Life-threatening)
CL Item
Yes - Requiring/prolonging hospitalization (Yes - Requiring/prolonging hospitalization)
CL Item
Yes - Persistent/significant disability/incapacity (Yes - Persistent/significant disability/incapacity)
CL Item
Yes - Congenital anomaly/birth defect (Yes - Congenital anomaly/birth defect)
CL Item
Yes - Other medically important event (Yes - Other medically important event)
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