ID

32564

Description

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

Keywords

Versions (1)
  1. 11/6/18 11/6/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 6, 2018

DOI

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License

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

English

Adverse Event Form

1 forms  
  1. StudyEvent: ODM
    1. Adverse Event Form
Adverse Events
Description

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
Description

Adverse event; number

Data type

integer

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

Adverse event, diagnosis

Data type

text

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

Adverse event, Site

Data type

text

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

Adverse event Start Date

Data type

date

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

Adverse event Start time

Data type

time

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

Adverse event; new experimental drug; relationship

Data type

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?
Description

undefined item

Data type

boolean

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

Adverse event; investigational new drug; relationship

Data type

boolean

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

Adverse event; Corrective treatment

Data type

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
Description

Adverse event; Outcome

Data type

text

Alias
UMLS CUI [1]
C1705586
Seriousness Criteria
Description

Adverse event; seriousness

Data type

text

Alias
UMLS CUI [1]
C2985919
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Similar models

Adverse Event Form

1 forms
  1. StudyEvent: ODM
    1. Adverse Event Form
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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