ID

31490

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. 8/28/18 8/28/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 28, 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

SAE Complementary Information Form

1 forms  
Serious Adverse Event
Description

Serious Adverse Event

Alias
UMLS CUI-1
C1519255
Date of Birth
Description

Patient Date of Birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Age
Description

Age

Data type

integer

Alias
UMLS CUI [1]
C0001779
Sex
Description

Gender

Data type

text

Alias
UMLS CUI [1]
C0079399
Race
Description

Racial group

Data type

text

Alias
UMLS CUI [1]
C0034510
Height
Description

Body Height

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Description

Body Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Detailed Description
Description

Serious Adverse Event; description

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0678257
Study Drug - Treatment Number
Description

Study Drug, Identifier

Data type

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0600091
Date and of the FIRST administration of Study Drug
Description

Study Drug, Date and Time of First Study Treatment

Data type

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C3899436
Date and of the LAST administration of Study Drug
Description

Study Drug, Date and Time of last Study Treatment

Data type

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C3469597
UMLS CUI [1,3]
C1517741
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Study drug ongoing (at the time of report)
Description

Experimental drug; Administration of medication; Continuous

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C3469597
UMLS CUI [1,3]
C0549178
In case of Hospitalization: Date of admission
Description

serious adverse event; hospitalization; admission date

Data type

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1708385
UMLS CUI [1,3]
C1302393
Previous and concomitant Medications
Description

Serious Adverse Event, Pharmaceutical Preparations, Previous; Serious Adverse Event, Concomitant Agent

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0205156
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C2347852
Medical History and Concomitant Diseases
Description

Serious Adverse Event; Medical History; Concomitant Diseases

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0262926
UMLS CUI [1,3]
C0243087
SAE Follow-Up Information
Description

SAE Follow-Up Information

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C1522577
Adverse Event
Description

Serious Adverse Event

Data type

text

Alias
UMLS CUI [1]
C1519255
Date of Evaluation
Description

Serious Adverse Event; Date of Evaluation

Data type

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0220825
UMLS CUI [1,3]
C0011008
Additional Information and Comments
Description

Serious Adverse Event; Additional Information, Comments

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1546922
UMLS CUI [1,3]
C0947611
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Similar models

SAE Complementary Information Form

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Serious Adverse Event
C1519255 (UMLS CUI-1)
Patient Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Age
Item
Age
integer
C0001779 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Gender
Code List
Sex
CL Item
Male (Male)
CL Item
Female (Female)
Item
Race
text
C0034510 (UMLS CUI [1])
Racial group
Code List
Race
CL Item
Caucasian (Caucasian)
CL Item
Black (Black)
CL Item
Asian, Oriental (Asian, Oriental)
CL Item
Other (Other)
Body Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Body Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Serious Adverse Event; description
Item
Detailed Description
text
C1519255 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Study Drug, Identifier
Item
Study Drug - Treatment Number
integer
C0304229 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Study Drug, Date and Time of First Study Treatment
Item
Date and of the FIRST administration of Study Drug
datetime
C0304229 (UMLS CUI [1,1])
C3899436 (UMLS CUI [1,2])
Study Drug, Date and Time of last Study Treatment
Item
Date and of the LAST administration of Study Drug
datetime
C0304229 (UMLS CUI [1,1])
C3469597 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Experimental drug; Administration of medication; Continuous
Item
Study drug ongoing (at the time of report)
boolean
C0304229 (UMLS CUI [1,1])
C3469597 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
serious adverse event; hospitalization; admission date
Item
In case of Hospitalization: Date of admission
date
C1519255 (UMLS CUI [1,1])
C1708385 (UMLS CUI [1,2])
C1302393 (UMLS CUI [1,3])
Serious Adverse Event, Pharmaceutical Preparations, Previous; Serious Adverse Event, Concomitant Agent
Item
Previous and concomitant Medications
boolean
C1519255 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2,1])
C2347852 (UMLS CUI [2,2])
Serious Adverse Event; Medical History; Concomitant Diseases
Item
Medical History and Concomitant Diseases
boolean
C1519255 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0243087 (UMLS CUI [1,3])
Item Group
SAE Follow-Up Information
C1519255 (UMLS CUI-1)
C1522577 (UMLS CUI-2)
Serious Adverse Event
Item
Adverse Event
text
C1519255 (UMLS CUI [1])
Serious Adverse Event; Date of Evaluation
Item
Date of Evaluation
date
C1519255 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Serious Adverse Event; Additional Information, Comments
Item
Additional Information and Comments
text
C1519255 (UMLS CUI [1,1])
C1546922 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
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