ID

31325

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

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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

SAE Complementary Report

1 forms  
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
Serious advert event
Description

Serious advert event

Alias
UMLS CUI-1
C1519255
Date of Onset of SAE
Description

Serious advert event; date of onset

Data type

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0574845
Time of Onset of SAE
Description

Serious advert event; time of onset

Data type

time

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1301880
Detailed description of the serious adverse event
Description

Serious advert event; description

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0678257
List relevant concomitant medications (report name only) taken within 30 days of this SAE: (exclude treatment for SAE)
Description

Serious advert event; concomitant medications

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
List relevant medical history
Description

Medical History; Serious advert events

Data type

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C1519255
List relevant concomitant diseases
Description

Concomitant diseases; Serious advert events

Data type

text

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C1519255
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Similar models

SAE Complementary Report

1 forms
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
Serious advert event
C1519255 (UMLS CUI-1)
Serious advert event; date of onset
Item
Date of Onset of SAE
date
C1519255 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
Serious advert event; time of onset
Item
Time of Onset of SAE
time
C1519255 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Serious advert event; description
Item
Detailed description of the serious adverse event
text
C1519255 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Serious advert event; concomitant medications
Item
List relevant concomitant medications (report name only) taken within 30 days of this SAE: (exclude treatment for SAE)
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Medical History; Serious advert events
Item
List relevant medical history
text
C0262926 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Concomitant diseases; Serious advert events
Item
List relevant concomitant diseases
text
C0009488 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
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