ID

31324

Description

Study ID: 104574 Clinical Study ID: AR1104574 Study Title: A randomized blinded pilot trial of fondaparinux sodium (Arixtra®) versus unfractionated heparin in addition to standard therapy in a broad range of patients undergoing percutaneous coronary intervention (ASPIRE) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: fondaparinux sodium Trade Name: Arixtra Study Indication: Thromboembolism

Keywords

Versions (1)
  1. 8/13/18 8/13/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 13, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Fondaparinux sodium (Arixtra) versus unfractionated heparin with patients undergoing PCI; Clinical Study ID: AR1104574

English

Adverse Event Report

1 forms  
  1. StudyEvent: ODM
    1. Adverse Event Report
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Patient ID, Centre No.
Description

Patient ID; Centre Number

Data type

text

Alias
UMLS CUI [1,1]
C1269815
UMLS CUI [1,2]
C2825181
UMLS CUI [1,3]
C1300638
Patient ID, Envelope No.
Description

Patient ID; Envelope Number

Data type

text

Alias
UMLS CUI [1,1]
C1269815
UMLS CUI [1,2]
C2348585
Patient Initials
Description

Patient Initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Adverse event
Description

Adverse event

Alias
UMLS CUI-1
C0877248
Advere Event
Description

Adverse event

Data type

text

Alias
UMLS CUI [1]
C0877248
Date of Onset of Adverse Event (1st symptom)
Description

Adverse event; Date of onset

Data type

date

Alias
UMLS CUI [1]
C2985916
Time of Onset of Adverse Event (1st symptom)
Description

Adverse event; start time

Data type

time

Alias
UMLS CUI [1]
C2697889
Maximum Intensity
Description

Adverse event; maximum intensity

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0518690
Is there a reasonable possibility that the AE was caused by the study drug?
Description

Adverse event; Relationship; study drug

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0013230
Was study drug stopped due to this event?
Description

Adverse event; Relationship; study drug; action taken

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0013230
UMLS CUI [1,4]
C2826626
Corrective Therapies
Description

Adverse event; Relationship; study drug; corrective therapies

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0013230
UMLS CUI [1,4]
C0087111
UMLS CUI [1,5]
C0719519
Outcome of AE
Description

Adverse event; Outcome

Data type

text

Alias
UMLS CUI [1]
C1705586
Seriousness Criteria
Description

Adverse event; seriousness criteria

Data type

boolean

Alias
UMLS CUI [1]
C1710056
Date when event became serious
Description

Adverse event; seriousness; date

Data type

date

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C0808070
Time when event became serious
Description

Adverse event; seriousness; time

Data type

time

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C1301880
Seriousness criteria
Description

Adverse event; seriousness criteria

Data type

text

Alias
UMLS CUI [1]
C1710056
Clinically significant bleeding
Description

Adverse event; significan bleeding

Data type

boolean

Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C0019080
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Similar models

Adverse Event Report

1 forms
  1. StudyEvent: ODM
    1. Adverse Event Report
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Patient ID; Centre Number
Item
Patient ID, Centre No.
text
C1269815 (UMLS CUI [1,1])
C2825181 (UMLS CUI [1,2])
C1300638 (UMLS CUI [1,3])
Patient ID; Envelope Number
Item
Patient ID, Envelope No.
text
C1269815 (UMLS CUI [1,1])
C2348585 (UMLS CUI [1,2])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Item Group
Adverse event
C0877248 (UMLS CUI-1)
Adverse event
Item
Advere Event
text
C0877248 (UMLS CUI [1])
Adverse event; Date of onset
Item
Date of Onset of Adverse Event (1st symptom)
date
C2985916 (UMLS CUI [1])
Adverse event; start time
Item
Time of Onset of Adverse Event (1st symptom)
time
C2697889 (UMLS CUI [1])
Item
Maximum Intensity
text
C0877248 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Adverse event; maximum intensity
Code List
Maximum Intensity
CL Item
Mild (Mild)
CL Item
Moderate (Moderate)
CL Item
Severe (Severe)
Adverse event; Relationship; study drug
Item
Is there a reasonable possibility that the AE was caused by the study drug?
boolean
C0877248 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
Adverse event; Relationship; study drug; action taken
Item
Was study drug stopped due to this event?
boolean
C0877248 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
C2826626 (UMLS CUI [1,4])
Adverse event; Relationship; study drug; corrective therapies
Item
Corrective Therapies
boolean
C0877248 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
C0719519 (UMLS CUI [1,5])
Item
Outcome of AE
text
C1705586 (UMLS CUI [1])
Adverse event; Outcome
Code List
Outcome of AE
CL Item
Recovered without sequelae (give date of recovery) (Recovered without sequelae (give date of recovery))
CL Item
Recovered with sequelae (specify sequelae) (Recovered with sequelae (specify sequelae))
CL Item
Recovering (Recovering)
CL Item
Not recovered (Not recovered)
CL Item
Fatal (Fatal)
CL Item
Unknown (Unknown)
Adverse event; seriousness criteria
Item
Seriousness Criteria
boolean
C1710056 (UMLS CUI [1])
Adverse event; seriousness; date
Item
Date when event became serious
date
C1710056 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Adverse event; seriousness; time
Item
Time when event became serious
time
C1710056 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Item
Seriousness criteria
text
C1710056 (UMLS CUI [1])
Adverse event; seriousness criteria
Code List
Seriousness criteria
CL Item
Resulting in death (Resulting in death)
CL Item
Life threatening (Life threatening)
CL Item
Requiring or prolonging in-patient hospitalization (Requiring or prolonging in-patient hospitalization)
CL Item
Persistent or significant disability or incapacity (Persistent or significant disability or incapacity)
CL Item
Congenital anomaly/birth defect (Congenital anomaly/birth defect)
CL Item
Other (specify) (Other (specify))
Adverse event; significan bleeding
Item
Clinically significant bleeding
boolean
C1301880 (UMLS CUI [1,1])
C0019080 (UMLS CUI [1,2])
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