ID

31820

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. 10/1/18 10/1/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 1, 2018

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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

Visit 00

1 forms  
  1. StudyEvent: ODM
    1. Visit 00
Demography
Description

Demography

Alias
UMLS CUI-1
C0011298
Date of consent
Description

Informed Consent Date

Data type

date

Alias
UMLS CUI [1]
C2985782
Date of birth
Description

Patient Date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Sex
Description

Gender

Data type

text

Alias
UMLS CUI [1]
C0079399
Race
Description

Racial group

Data type

text

Alias
UMLS CUI [1]
C0034510
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
Height
Description

Body Height

Data type

integer

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

Body Weight

Data type

float

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

Pregnancy Test

Alias
UMLS CUI-1
C0032976
Not done
Description

Pregnancy Test; Not done

Data type

boolean

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C1272696
Date and Time of Sampling
Description

Pregnancy Test; Sampling; Date in Time; Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Result
Description

Pregnancy Test finding

Data type

text

Alias
UMLS CUI [1]
C0427777
Specific Medical History/Risk Factors for VTE
Description

Specific Medical History/Risk Factors for VTE

Alias
UMLS CUI-1
C0262926
UMLS CUI-3
C0035648
UMLS CUI-4
C1861172
VTE
Description

Medical History; VTE

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C1861172
PE
Description

Medical History; Pulmonary Embolism

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0034065
Stroke
Description

Medical History; Cerebrovascular accident

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0038454
Myocardial Infarction
Description

Medical History; Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0027051
Prior major surgery or trauma within the last 12 months
Description

Medical History, major surgery, within the last year; Medical History, Major injury, within the last year

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0679637
UMLS CUI [1,3]
C3842283
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0332677
UMLS CUI [2,3]
C3842283
Neoplastic disease
Description

Medical History; Neoplastic disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C1882062
Inflammatory Bowel Disease
Description

Medical History; Inflammatory Bowel Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0021390
Chronic Obstructive Pulmonary Disease
Description

Medical History; Chronic Obstructive Airway Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0024117
Immobilization
Description

Medical History; Immobilization

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0020944
Oral contraceptive use
Description

Medical History; contraceptives, oral; use of

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0009905
UMLS CUI [1,3]
C1524063
Varicose veins
Description

Medical History; History of Varicose veins

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0455534
Prothrombotic states
Description

Medical History; State; Before; Thrombosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C1442792
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C0040053
Congestive Heart Failure
Description

Medical History; Congestive Heart Failure

Data type

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0018802
Past medical or surgical history
Description

Past medical or surgical history

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0489540
Past medical or surgical history
Description

Medical History; History of surgical procedures

Data type

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0489540
Persistence of symptoms
Description

Medical history; history of surgical procedures; Symptoms, persistent

Data type

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0489540
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205322
Hematology
Description

Hematology

Alias
UMLS CUI-1
C0474523
Laboratory Name
Description

Hematology finding; Performing Laboratory

Data type

text

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C1882331
Date and time of sampling
Description

Hematology finding; Collection of blood specimen for laboratory procedure; Date in time; Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0005834
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Platelet
Description

Hematology finding; Finding of Platelet Count

Data type

float

Measurement units
  • 10^9/L
Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C1287267
10^9/L
Hemoglobin
Description

Hematology finding; Hemoglobin

Data type

float

Measurement units
  • g/dL
Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0019046
g/dL
Biochemistry
Description

Biochemistry

Alias
UMLS CUI-1
C0005477
Laboratory Name
Description

Biochemistry; Performing Laboratory

Data type

text

Alias
UMLS CUI [1,1]
C0005477
UMLS CUI [1,2]
C1882331
Date and time of sampling
Description

Biochemistry; Collection of blood specimen for laboratory procedure; Date in time; Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0005477
UMLS CUI [1,2]
C0005834
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Creatinine
Description

Biochemistry; Creatinine measurement

Data type

float

Measurement units
  • mg/dL
Alias
UMLS CUI [1,1]
C0005477
UMLS CUI [1,2]
C0201976
mg/dL
AST
Description

Biochemistry; Aspartate aminotransferase measurement

Data type

float

Measurement units
  • UL
Alias
UMLS CUI [1,1]
C0005477
UMLS CUI [1,2]
C0201899
UL
ALT
Description

Biochemistry; Alanine aminotransferase measurement

Data type

float

Measurement units
  • UL
Alias
UMLS CUI [1,1]
C0005477
UMLS CUI [1,2]
C0201836
UL
Total Bilirubin
Description

Biochemistry; Bilirubin, total measurement

Data type

float

Measurement units
  • mg/dL
Alias
UMLS CUI [1,1]
C0005477
UMLS CUI [1,2]
C0201913
mg/dL
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Similar models

Visit 00

1 forms
  1. StudyEvent: ODM
    1. Visit 00
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Demography
C0011298 (UMLS CUI-1)
Informed Consent Date
Item
Date of consent
date
C2985782 (UMLS CUI [1])
Patient Date of birth
Item
Date of birth
date
C0421451 (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 (specify) (Other (specify))
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Body Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Body Weight
Item
Body Weight
float
C0005910 (UMLS CUI [1])
Item Group
Pregnancy Test
C0032976 (UMLS CUI-1)
Pregnancy Test; Not done
Item
Not done
boolean
C0032976 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
Pregnancy Test; Sampling; Date in Time; Time
Item
Date and Time of Sampling
datetime
C0032976 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
Result
text
C0427777 (UMLS CUI [1])
Pregnancy Test finding
Code List
Result
CL Item
Positive (Positive)
CL Item
Negative (Negative)
Item Group
Specific Medical History/Risk Factors for VTE
C0262926 (UMLS CUI-1)
C0035648 (UMLS CUI-3)
C1861172 (UMLS CUI-4)
Medical History; VTE
Item
VTE
boolean
C0262926 (UMLS CUI [1,1])
C1861172 (UMLS CUI [1,2])
Medical History; Pulmonary Embolism
Item
PE
boolean
C0262926 (UMLS CUI [1,1])
C0034065 (UMLS CUI [1,2])
Medical History; Cerebrovascular accident
Item
Stroke
boolean
C0262926 (UMLS CUI [1,1])
C0038454 (UMLS CUI [1,2])
Medical History; Myocardial Infarction
Item
Myocardial Infarction
boolean
C0262926 (UMLS CUI [1,1])
C0027051 (UMLS CUI [1,2])
Medical History, major surgery, within the last year; Medical History, Major injury, within the last year
Item
Prior major surgery or trauma within the last 12 months
boolean
C0262926 (UMLS CUI [1,1])
C0679637 (UMLS CUI [1,2])
C3842283 (UMLS CUI [1,3])
C0262926 (UMLS CUI [2,1])
C0332677 (UMLS CUI [2,2])
C3842283 (UMLS CUI [2,3])
Medical History; Neoplastic disease
Item
Neoplastic disease
boolean
C0262926 (UMLS CUI [1,1])
C1882062 (UMLS CUI [1,2])
Medical History; Inflammatory Bowel Disease
Item
Inflammatory Bowel Disease
boolean
C0262926 (UMLS CUI [1,1])
C0021390 (UMLS CUI [1,2])
Medical History; Chronic Obstructive Airway Disease
Item
Chronic Obstructive Pulmonary Disease
boolean
C0262926 (UMLS CUI [1,1])
C0024117 (UMLS CUI [1,2])
Medical History; Immobilization
Item
Immobilization
boolean
C0262926 (UMLS CUI [1,1])
C0020944 (UMLS CUI [1,2])
Medical History; contraceptives, oral; use of
Item
Oral contraceptive use
boolean
C0262926 (UMLS CUI [1,1])
C0009905 (UMLS CUI [1,2])
C1524063 (UMLS CUI [1,3])
Medical History; History of Varicose veins
Item
Varicose veins
boolean
C0262926 (UMLS CUI [1,1])
C0455534 (UMLS CUI [1,2])
Medical History; State; Before; Thrombosis
Item
Prothrombotic states
boolean
C0262926 (UMLS CUI [1,1])
C1442792 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0040053 (UMLS CUI [1,4])
Item
Congestive Heart Failure
text
C0262926 (UMLS CUI [1,1])
C0018802 (UMLS CUI [1,2])
Medical History; Congestive Heart Failure
Code List
Congestive Heart Failure
CL Item
No (No)
CL Item
Yes, grade I (Yes, grade I)
CL Item
Yes, grade II (Yes, grade II)
CL Item
Yes, grade III (Yes, grade III)
CL Item
Yes, grade IV (Yes, grade IV)
Item Group
Past medical or surgical history
C0262926 (UMLS CUI-1)
C0489540 (UMLS CUI-2)
Medical History; History of surgical procedures
Item
Past medical or surgical history
text
C0262926 (UMLS CUI [1,1])
C0489540 (UMLS CUI [1,2])
Item
Persistence of symptoms
text
C0262926 (UMLS CUI [1,1])
C0489540 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205322 (UMLS CUI [1,4])
Medical history; history of surgical procedures; Symptoms, persistent
Code List
Persistence of symptoms
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Not applicable (Not applicable)
Item Group
Hematology
C0474523 (UMLS CUI-1)
Hematology finding; Performing Laboratory
Item
Laboratory Name
text
C0474523 (UMLS CUI [1,1])
C1882331 (UMLS CUI [1,2])
Hematology finding; Collection of blood specimen for laboratory procedure; Date in time; Time
Item
Date and time of sampling
datetime
C0474523 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Hematology finding; Finding of Platelet Count
Item
Platelet
float
C0474523 (UMLS CUI [1,1])
C1287267 (UMLS CUI [1,2])
Hematology finding; Hemoglobin
Item
Hemoglobin
float
C0474523 (UMLS CUI [1,1])
C0019046 (UMLS CUI [1,2])
Item Group
Biochemistry
C0005477 (UMLS CUI-1)
Biochemistry; Performing Laboratory
Item
Laboratory Name
text
C0005477 (UMLS CUI [1,1])
C1882331 (UMLS CUI [1,2])
Biochemistry; Collection of blood specimen for laboratory procedure; Date in time; Time
Item
Date and time of sampling
datetime
C0005477 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Biochemistry; Creatinine measurement
Item
Creatinine
float
C0005477 (UMLS CUI [1,1])
C0201976 (UMLS CUI [1,2])
Biochemistry; Aspartate aminotransferase measurement
Item
AST
float
C0005477 (UMLS CUI [1,1])
C0201899 (UMLS CUI [1,2])
Biochemistry; Alanine aminotransferase measurement
Item
ALT
float
C0005477 (UMLS CUI [1,1])
C0201836 (UMLS CUI [1,2])
Biochemistry; Bilirubin, total measurement
Item
Total Bilirubin
float
C0005477 (UMLS CUI [1,1])
C0201913 (UMLS CUI [1,2])
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