ID

31319

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

Bleeding Report

1 forms  
  1. StudyEvent: ODM
    1. Bleeding 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
Bleeding
Description

Bleeding

Alias
UMLS CUI-1
C0019080
Onset of bleeding - date
Description

Hemorrhage; date of onset

Data type

date

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C0574845
Onset of bleeding - time
Description

Hemorrhage; start time

Data type

time

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C1301880
Onset of bleeding - related AE report #
Description

Hemorrhage; AE report number

Data type

integer

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0684224
UMLS CUI [1,4]
C0237753
Cessation of bleeding - date
Description

Hemorrhage, end date

Data type

date

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C0806020
Cessation of bleeding - time
Description

Hemorrhage, end time

Data type

time

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C1522314
Clinically overt bleeding meeting criteria for major bleed
Description

major bleed

Data type

text

Alias
UMLS CUI [1]
C3160769
Minor bleeding: any other clinically overt bleeding not meeting major bleeding definition
Description

Minor bleeding

Data type

boolean

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C0205165
Was this bleeding event associated with any of the following?
Description

hemorrhage; associated event

Data type

text

Alias
UMLS CUI [1]
C1560575
Site/source
Description

Hemorrhage; Site/Source

Data type

text

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C1515974
UMLS CUI [2,1]
C0019080
UMLS CUI [2,2]
C0449416
Was blood transfusion required?
Description

hemorrhage; blood transfusion

Data type

text

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C0005841
Hemoglobin drop associated with bleeding episode - prior to bleeding episode - date of sample
Description

Hemorrhage; Hemoglobin Before; Collection of blood specimen for laboratory procedure, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C0019046
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C0005834
UMLS CUI [1,5]
C0011008
Hemoglobin drop associated with bleeding episode - prior to bleeding episode - time of sample
Description

Hemorrhage; Hemoglobin Before; Collection of blood specimen for laboratory procedure, time

Data type

time

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C0019046
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C0005834
UMLS CUI [1,5]
C0040223
Hemoglobin drop associated with bleeding episode - prior to bleeding episode
Description

Hemorrhage; Hemoglobin Before

Data type

float

Measurement units
  • g/dL
Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C0019046
UMLS CUI [1,3]
C0332152
g/dL
Hemoglobin drop associated with bleeding episode - prior to bleeding episode - hematocrit
Description

Hemorrhage; hematocrit Before

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C0518014
UMLS CUI [1,3]
C0332152
%
Hemoglobin drop associated with bleeding episode - lowest value - date of sample
Description

Hemorrhage; Hemoglobin minimum; Collection of blood specimen for laboratory procedure, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C0019046
UMLS CUI [1,3]
C1524031
UMLS CUI [1,4]
C0005834
UMLS CUI [1,5]
C0011008
Hemoglobin drop associated with bleeding episode - lowest value - time of sample
Description

Hemorrhage; Hemoglobin minimum; Collection of blood specimen for laboratory procedure, time

Data type

time

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C0019046
UMLS CUI [1,3]
C1524031
UMLS CUI [1,4]
C0005834
UMLS CUI [1,5]
C0040223
Hemoglobin drop associated with bleeding episode - lowest value - time of sample
Description

Hemorrhage; Hemoglobin minimum; Collection of blood specimen for laboratory procedure, time

Data type

time

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C0019046
UMLS CUI [1,3]
C1524031
UMLS CUI [1,4]
C0005834
UMLS CUI [1,5]
C0040223
Hemoglobin drop associated with bleeding episode - lowest value
Description

Hemorrhage; Hemoglobin minimum

Data type

float

Measurement units
  • g/dL
Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C0019046
UMLS CUI [1,3]
C1524031
g/dL
Hemoglobin drop associated with bleeding episode - lowest value
Description

Hemorrhage; hemoglobin minimum; hematocrit

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C0019046
UMLS CUI [1,3]
C1524031
UMLS CUI [1,4]
C0518014
%
Were any of the following investigations performed?
Description

hemorrhage; investigations

Data type

text

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C0841577
Indicate whether any of the following medications were taken by the patient within 24 hrs of this bleeding event?
Description

hemorrhage; medications; within 24 hrs

Data type

text

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C4035156
Indicate whether any of the following medications were taken by the patient within 5 days of this bleeding event?
Description

hemorrhage; medications

Data type

text

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C0013227
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Similar models

Bleeding Report

1 forms
  1. StudyEvent: ODM
    1. Bleeding 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
Bleeding
C0019080 (UMLS CUI-1)
Hemorrhage; date of onset
Item
Onset of bleeding - date
date
C0019080 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
Hemorrhage; start time
Item
Onset of bleeding - time
time
C0019080 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Hemorrhage; AE report number
Item
Onset of bleeding - related AE report #
integer
C0019080 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0684224 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,4])
Hemorrhage, end date
Item
Cessation of bleeding - date
date
C0019080 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Hemorrhage, end time
Item
Cessation of bleeding - time
time
C0019080 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Item
Clinically overt bleeding meeting criteria for major bleed
text
C3160769 (UMLS CUI [1])
major bleed
Code List
Clinically overt bleeding meeting criteria for major bleed
CL Item
No (No)
CL Item
Yes - Fatal bleed (Yes - Fatal bleed)
CL Item
Yes- Symptomatic intracranial hemorrhage (Yes- Symptomatic intracranial hemorrhage)
CL Item
Yes - Drop in hemoglobin of at least 3 g/dL (with each unit counting for 1.0 g/dL) (Yes - Drop in hemoglobin of at least 3 g/dL (with each unit counting for 1.0 g/dL))
CL Item
Yes - Requiring transfusion of 2 or more units of blood (Yes - Requiring transfusion of 2 or more units of blood)
CL Item
Yes - Retroperitoneal hemorrhage (Yes - Retroperitoneal hemorrhage)
CL Item
Yes - Intraocular bleeding leading to significant vision loss (Yes - Intraocular bleeding leading to significant vision loss)
Minor bleeding
Item
Minor bleeding: any other clinically overt bleeding not meeting major bleeding definition
boolean
C0019080 (UMLS CUI [1,1])
C0205165 (UMLS CUI [1,2])
Item
Was this bleeding event associated with any of the following?
text
C1560575 (UMLS CUI [1])
hemorrhage; associated event
Code List
Was this bleeding event associated with any of the following?
CL Item
Index PCI (Index PCI)
CL Item
Repeat PCI (Repeat PCI)
CL Item
CABG surgery (CABG surgery)
CL Item
Coronary angiography (Coronary angiography)
CL Item
Other surgery (Other surgery)
CL Item
Other (specify) (Other (specify))
Item
Site/source
text
C0019080 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0019080 (UMLS CUI [2,1])
C0449416 (UMLS CUI [2,2])
Hemorrhage; Site/Source
Code List
Site/source
CL Item
Hematuria (Hematuria)
CL Item
Hemoptysis (Hemoptysis)
CL Item
Puncture site (Puncture site)
CL Item
Epistaxis (Epistaxis)
CL Item
Gastrointestinal (Gastrointestinal)
CL Item
Injection site (Injection site)
CL Item
Cardiac tamponade (Cardiac tamponade)
CL Item
Other (specify) (Other (specify))
Item
Was blood transfusion required?
text
C0019080 (UMLS CUI [1,1])
C0005841 (UMLS CUI [1,2])
hemorrhage; blood transfusion
Code List
Was blood transfusion required?
CL Item
No (No)
CL Item
Yes (give number of units) (Yes (give number of units))
Hemorrhage; Hemoglobin Before; Collection of blood specimen for laboratory procedure, Date in time
Item
Hemoglobin drop associated with bleeding episode - prior to bleeding episode - date of sample
date
C0019080 (UMLS CUI [1,1])
C0019046 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0005834 (UMLS CUI [1,4])
C0011008 (UMLS CUI [1,5])
Hemorrhage; Hemoglobin Before; Collection of blood specimen for laboratory procedure, time
Item
Hemoglobin drop associated with bleeding episode - prior to bleeding episode - time of sample
time
C0019080 (UMLS CUI [1,1])
C0019046 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0005834 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Hemorrhage; Hemoglobin Before
Item
Hemoglobin drop associated with bleeding episode - prior to bleeding episode
float
C0019080 (UMLS CUI [1,1])
C0019046 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
Hemorrhage; hematocrit Before
Item
Hemoglobin drop associated with bleeding episode - prior to bleeding episode - hematocrit
integer
C0019080 (UMLS CUI [1,1])
C0518014 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
Hemorrhage; Hemoglobin minimum; Collection of blood specimen for laboratory procedure, Date in time
Item
Hemoglobin drop associated with bleeding episode - lowest value - date of sample
date
C0019080 (UMLS CUI [1,1])
C0019046 (UMLS CUI [1,2])
C1524031 (UMLS CUI [1,3])
C0005834 (UMLS CUI [1,4])
C0011008 (UMLS CUI [1,5])
Hemorrhage; Hemoglobin minimum; Collection of blood specimen for laboratory procedure, time
Item
Hemoglobin drop associated with bleeding episode - lowest value - time of sample
time
C0019080 (UMLS CUI [1,1])
C0019046 (UMLS CUI [1,2])
C1524031 (UMLS CUI [1,3])
C0005834 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Hemorrhage; Hemoglobin minimum; Collection of blood specimen for laboratory procedure, time
Item
Hemoglobin drop associated with bleeding episode - lowest value - time of sample
time
C0019080 (UMLS CUI [1,1])
C0019046 (UMLS CUI [1,2])
C1524031 (UMLS CUI [1,3])
C0005834 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Hemorrhage; Hemoglobin minimum
Item
Hemoglobin drop associated with bleeding episode - lowest value
float
C0019080 (UMLS CUI [1,1])
C0019046 (UMLS CUI [1,2])
C1524031 (UMLS CUI [1,3])
Hemorrhage; hemoglobin minimum; hematocrit
Item
Hemoglobin drop associated with bleeding episode - lowest value
integer
C0019080 (UMLS CUI [1,1])
C0019046 (UMLS CUI [1,2])
C1524031 (UMLS CUI [1,3])
C0518014 (UMLS CUI [1,4])
Item
Were any of the following investigations performed?
text
C0019080 (UMLS CUI [1,1])
C0841577 (UMLS CUI [1,2])
hemorrhage; investigations
Code List
Were any of the following investigations performed?
CL Item
CT Scan (CT Scan)
CL Item
MRI (MRI)
CL Item
Ultrasound (Ultrasound)
CL Item
Endoscopy (Endoscopy)
Item
Indicate whether any of the following medications were taken by the patient within 24 hrs of this bleeding event?
text
C0019080 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C4035156 (UMLS CUI [1,3])
hemorrhage; medications; within 24 hrs
Code List
Indicate whether any of the following medications were taken by the patient within 24 hrs of this bleeding event?
CL Item
GPIIb/IIIa antagonists (GPIIb/IIIa antagonists)
CL Item
Oral anticoagulants (Oral anticoagulants)
CL Item
Hirudin (Hirudin)
CL Item
Bivalirudin (Bivalirudin)
CL Item
open label UFH (open label UFH)
CL Item
LMWH (LMWH)
CL Item
Study drug (Study drug)
Item
Indicate whether any of the following medications were taken by the patient within 5 days of this bleeding event?
text
C0019080 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
hemorrhage; medications; within 24 hrs
Code List
Indicate whether any of the following medications were taken by the patient within 5 days of this bleeding event?
CL Item
ASA (ASA)
CL Item
Clopidogrel (Clopidogrel)
CL Item
Ticlopidine (Ticlopidine)
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