ID

31490

Beskrivning

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

Nyckelord

Versioner (1)
  1. 2018-08-28 2018-08-28 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

28 augusti 2018

DOI

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Creative Commons BY-NC 3.0
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Subcutaneous fondaparinux sodium for prevention of venous thromboembolic events; Study ID: 104619

Engelsk

SAE Complementary Information Form

1 Formulär  
Serious Adverse Event
Beskrivning

Serious Adverse Event

Alias
UMLS CUI-1
C1519255
Date of Birth
Beskrivning

Patient Date of Birth

Datatyp

date

Alias
UMLS CUI [1]
C0421451
Age
Beskrivning

Age

Datatyp

integer

Alias
UMLS CUI [1]
C0001779
Sex
Beskrivning

Gender

Datatyp

text

Alias
UMLS CUI [1]
C0079399
Race
Beskrivning

Racial group

Datatyp

text

Alias
UMLS CUI [1]
C0034510
Height
Beskrivning

Body Height

Datatyp

integer

Måttenheter
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Beskrivning

Body Weight

Datatyp

float

Måttenheter
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Detailed Description
Beskrivning

Serious Adverse Event; description

Datatyp

text

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

Study Drug, Identifier

Datatyp

integer

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

Study Drug, Date and Time of First Study Treatment

Datatyp

datetime

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

Study Drug, Date and Time of last Study Treatment

Datatyp

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)
Beskrivning

Experimental drug; Administration of medication; Continuous

Datatyp

boolean

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

serious adverse event; hospitalization; admission date

Datatyp

date

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

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

Datatyp

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
Beskrivning

Serious Adverse Event; Medical History; Concomitant Diseases

Datatyp

boolean

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

SAE Follow-Up Information

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

Serious Adverse Event

Datatyp

text

Alias
UMLS CUI [1]
C1519255
Date of Evaluation
Beskrivning

Serious Adverse Event; Date of Evaluation

Datatyp

date

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

Serious Adverse Event; Additional Information, Comments

Datatyp

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 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

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