ID

31323

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

Stroke Report

1 forms  
  1. StudyEvent: ODM
    1. Stroke 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
Stroke
Description

Stroke

Alias
UMLS CUI-1
C0038454
Date of Stroke onset
Description

Cerebrovascular event; onset date

Data type

date

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0574845
Time of Stroke onset
Description

Cerebrovascular event; time of onset

Data type

time

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0449244
Was patient hospitalized at time of this stroke?
Description

Cerebrovascular event; Hospitalization

Data type

boolean

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0019993
Was patient hospitalized at time of this stroke?
Description

Cerebrovascular event; Hospitalization

Data type

boolean

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0019993
Symptoms
Description

Cerebrovascular event; Symptoms

Data type

text

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C1457887
Status
Description

Cerebrovascular event; status

Data type

text

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0018759
Body side/visual field affected
Description

Cerebrovascular event; effect

Data type

text

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C1879646
Was the patient on any antithrombotic medications within 24 hours prior to onset of stroke symptoms?
Description

Cerebrovascualr event; antithrombotic medications

Data type

text

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C1704311
Did the patient undergo an invasive procedure within the 24 hours prior to onset of stroke symptoms?
Description

Cerebrovascular event; invasive procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C1548804
Was CT Scan/MRI done to confirm diagnosis?
Description

Cerebrovascular event; Diagnostic Tests

Data type

text

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0086143
Final Diagnosis
Description

Cerebrovascular event; Final Diagnosis

Data type

text

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C1546485
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Similar models

Stroke Report

1 forms
  1. StudyEvent: ODM
    1. Stroke 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
Stroke
C0038454 (UMLS CUI-1)
Cerebrovascular event; onset date
Item
Date of Stroke onset
date
C0038454 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
Cerebrovascular event; time of onset
Item
Time of Stroke onset
time
C0038454 (UMLS CUI [1,1])
C0449244 (UMLS CUI [1,2])
Cerebrovascular event; Hospitalization
Item
Was patient hospitalized at time of this stroke?
boolean
C0038454 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
Cerebrovascular event; Hospitalization
Item
Was patient hospitalized at time of this stroke?
boolean
C0038454 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
Item
Symptoms
text
C0038454 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
Cerebrovascular event; Symptoms
Code List
Symptoms
CL Item
Change in cognition (Change in cognition)
CL Item
Change in level of consciousness (Change in level of consciousness)
CL Item
Ocular or visual symptoms (Ocular or visual symptoms)
CL Item
Weakness in face or limbs (Weakness in face or limbs)
CL Item
Sensory symtoms (Sensory symtoms)
CL Item
Dysarthria/Dysphasia (Dysarthria/Dysphasia)
CL Item
Dysphagia (Dysphagia)
CL Item
Other (specify) (Other (specify))
Item
Status
text
C0038454 (UMLS CUI [1,1])
C0018759 (UMLS CUI [1,2])
Cerebrovascular event; status
Code List
Status
CL Item
Full recovery from all symptoms (Full recovery from all symptoms)
CL Item
Persistent symptoms which do not limit patient’s functional status (Persistent symptoms which do not limit patient’s functional status)
CL Item
Some functional impairment but patient can manage all activities independently (Some functional impairment but patient can manage all activities independently)
CL Item
Patient needs help from another person to perform everyday activities (Patient needs help from another person to perform everyday activities)
CL Item
Patient incapacitated, unable to perform everyday activities even with help (Patient incapacitated, unable to perform everyday activities even with help)
CL Item
Death (Death)
Item
Body side/visual field affected
text
C0038454 (UMLS CUI [1,1])
C1879646 (UMLS CUI [1,2])
Cerebrovascular event; effect
Code List
Body side/visual field affected
CL Item
Right Body Side (Right Body Side)
CL Item
Right Visual Field (Right Visual Field)
CL Item
Left body Side (Left body Side)
CL Item
Left Visual Field (Left Visual Field)
CL Item
Other (specify) (Other (specify))
Item
Was the patient on any antithrombotic medications within 24 hours prior to onset of stroke symptoms?
text
C0038454 (UMLS CUI [1,1])
C1704311 (UMLS CUI [1,2])
Cerebrovascualr event; antithrombotic medications
Code List
Was the patient on any antithrombotic medications within 24 hours prior to onset of stroke symptoms?
CL Item
No (No)
CL Item
ASA (ASA)
CL Item
UFH (UFH)
CL Item
LMWH (LMWH)
CL Item
Clopidogrel (Clopidogrel)
CL Item
Ticlopidine (Ticlopidine)
CL Item
Other (specify) (Other (specify))
Cerebrovascular event; invasive procedure
Item
Did the patient undergo an invasive procedure within the 24 hours prior to onset of stroke symptoms?
boolean
C0038454 (UMLS CUI [1,1])
C1548804 (UMLS CUI [1,2])
Item
Was CT Scan/MRI done to confirm diagnosis?
text
C0038454 (UMLS CUI [1,1])
C0086143 (UMLS CUI [1,2])
Cerebrovascular event; Diagnostic Tests
Code List
Was CT Scan/MRI done to confirm diagnosis?
CL Item
No (No)
CL Item
CT Scan (CT Scan)
CL Item
MRI (MRI)
Item
Final Diagnosis
text
C0038454 (UMLS CUI [1,1])
C1546485 (UMLS CUI [1,2])
Cerebrovascular event; Diagnostic Tests
Code List
Final Diagnosis
CL Item
Ischemic stroke (definite confirmed by CT, MRI or autopsy) (Ischemic stroke (definite confirmed by CT, MRI or autopsy))
CL Item
Hemorrhagic stroke (definite, confirmed by CT, MRI, or autopsy) (Hemorrhagic stroke (definite, confirmed by CT, MRI, or autopsy))
CL Item
Uncertain of classification (Uncertain of classification)
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