ID

32164

Beschreibung

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

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  1. 22.10.18 22.10.18 -
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GlaxoSmithKline

Hochgeladen am

22. Oktober 2018

DOI

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Subcutaneous fondaparinux sodium for prevention of venous thromboembolic events; Study ID: 104619

Englisch

Visit 02

1 Formulare  
  1. StudyEvent: ODM
    1. Visit 02
Study Drug Dosing
Beschreibung

Study Drug Dosing

Alias
UMLS CUI-1
C0178602
UMLS CUI-2
C0178602
Was study drug given?
Beschreibung

Experimental drug, Medication administered

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0806914
Date and Time of Dosing
Beschreibung

Pharmaceutical Preparation; Dosage; Date in time; Time

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Treatment Number
Beschreibung

Clinical Trial Subject Unique Identifier

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Indicate reason if not done or outside time window
Beschreibung

Administration procedure, Not Done, Indication; Administration procedure, Late, Indication

Datentyp

text

Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C1272696
UMLS CUI [1,3]
C0392360
UMLS CUI [2,1]
C1533734
UMLS CUI [2,2]
C0205087
UMLS CUI [2,3]
C0392360
Haematology
Beschreibung

Haematology

Alias
UMLS CUI-1
C0474523
Day 3
Beschreibung

Hematology finding

Datentyp

text

Alias
UMLS CUI [1]
C0474523
Laboratory Name/City
Beschreibung

Hematology finding, Performing Laboratory

Datentyp

text

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C1882331
Date and Time of Sampling
Beschreibung

Hematology finding; Sampling; Date in time; Time

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Test
Beschreibung

Hematology finding; Hematologic Tests

Datentyp

text

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0018941
Value
Beschreibung

Hematology finding; Numerical Value

Datentyp

float

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C1522609
Unit
Beschreibung

Hematology finding; Unit

Datentyp

text

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0439148
If other unit, specify
Beschreibung

Hematology finding; Unit, other

Datentyp

text

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0439148
UMLS CUI [1,3]
C0205394
Biochemistry
Beschreibung

Biochemistry

Alias
UMLS CUI-1
C0005477
Laboratory Name/City
Beschreibung

Biochemistry; Performing Laboratory

Datentyp

text

Alias
UMLS CUI [1,1]
C0005477
UMLS CUI [1,2]
C1882331
Date and Time of Sampling
Beschreibung

Biochemistry; Sampling; Date in time; Time

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0005477
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Test
Beschreibung

Biochemistry test

Datentyp

text

Alias
UMLS CUI [1]
C1655775
Value
Beschreibung

Biochemistry; Numerical Value

Datentyp

float

Alias
UMLS CUI [1,1]
C0005477
UMLS CUI [1,2]
C1522609
Unit
Beschreibung

Biochemistry; Unit

Datentyp

text

Alias
UMLS CUI [1,1]
C0005477
UMLS CUI [1,2]
C0439148
If other unit, specify
Beschreibung

Biochemistry; Unit; other

Datentyp

text

Alias
UMLS CUI [1,1]
C0005477
UMLS CUI [1,2]
C0439148
UMLS CUI [1,3]
C0205394
Mandatory Venography to Assess Asymptomatic DVT
Beschreibung

Mandatory Venography to Assess Asymptomatic DVT

Alias
UMLS CUI-1
C0031545
Not done
Beschreibung

Venography

Datentyp

boolean

Alias
UMLS CUI [1]
C0031545
Bilateral
Beschreibung

Venography, Bilateral

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0031545
UMLS CUI [1,2]
C0238767
Bilateral, Date performed
Beschreibung

Venography, Bilateral, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C0031545
UMLS CUI [1,2]
C0238767
UMLS CUI [1,3]
C0011008
Left Leg
Beschreibung

Venography, Structure of left lower leg

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0031545
UMLS CUI [1,2]
C0230443
Left Leg, Date performed
Beschreibung

Venography, Structure of left lower leg, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C0031545
UMLS CUI [1,2]
C0230443
UMLS CUI [1,3]
C0011008
Right Leg
Beschreibung

Venography, Structure of right lower leg

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0031545
UMLS CUI [1,2]
C0230442
Right Leg, Date performed
Beschreibung

Venography, Structure of right lower leg, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C0031545
UMLS CUI [1,2]
C0230442
UMLS CUI [1,3]
C0011008
If NOT BILATERAL or NOT DONE, tick the primary reason.
Beschreibung

Venography; Indication

Datentyp

text

Alias
UMLS CUI [1,1]
C0031545
UMLS CUI [1,2]
C3146298
As a result of this venography, was medication given to treat DVT?
Beschreibung

Venography; Result; Pharmaceutical Preparations

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0031545
UMLS CUI [1,2]
C1274040
UMLS CUI [1,3]
C0013227
Mechanical Prophylaxis and Physical Therapy
Beschreibung

Mechanical Prophylaxis and Physical Therapy

Alias
UMLS CUI-1
C0199176
UMLS CUI-2
C0443254
UMLS CUI-3
C0949766
Intermittent Pneumatic Compression, knee-high
Beschreibung

Intermittent Pneumatic Compression Therapy, Knee, High

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1998430
UMLS CUI [1,2]
C0022742
UMLS CUI [1,3]
C0205250
Intermittent Pneumatic Compression, thigh-high
Beschreibung

Intermittent Pneumatic Compression Therapy, Thigh, High

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1998430
UMLS CUI [1,2]
C0039866
UMLS CUI [1,3]
C0205250
Compression Therapy; Date of start
Beschreibung

Intermittent Pneumatic Compression Therapy; Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1998430
UMLS CUI [1,2]
C0808070
Compression Therapy; Date of removal
Beschreibung

Intermittent Pneumatic Compression Therapy; Removing; Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C1998430
UMLS CUI [1,2]
C1883720
UMLS CUI [1,3]
C0011008
Did the subject wear elastic stockings (TED HOSE) for thrombosis prevention during the treatment period?
Beschreibung

Compression stockings

Datentyp

boolean

Alias
UMLS CUI [1]
C0038348
Date of start
Beschreibung

Compression stockings; Start date

Datentyp

date

Alias
UMLS CUI [1,1]
C0038348
UMLS CUI [1,2]
C0808070
Date of removal
Beschreibung

Compression stockings; Removing, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C0038348
UMLS CUI [1,2]
C1883720
UMLS CUI [1,3]
C0011008
Did the subject receive physical therapy during the treatment period?
Beschreibung

Physical therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0949766
What day did the subject first ambulate?
Beschreibung

Ambulate, Start date

Datentyp

date

Alias
UMLS CUI [1,1]
C4036205
UMLS CUI [1,2]
C0808070
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Ähnliche Modelle

Visit 02

1 Formulare
  1. StudyEvent: ODM
    1. Visit 02
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Study Drug Dosing
C0178602 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
Experimental drug, Medication administered
Item
Was study drug given?
boolean
C0304229 (UMLS CUI [1,1])
C0806914 (UMLS CUI [1,2])
Pharmaceutical Preparation; Dosage; Date in time; Time
Item
Date and Time of Dosing
datetime
C0013227 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Clinical Trial Subject Unique Identifier
Item
Treatment Number
integer
C2348585 (UMLS CUI [1])
Administration procedure, Not Done, Indication; Administration procedure, Late, Indication
Item
Indicate reason if not done or outside time window
text
C1533734 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C1533734 (UMLS CUI [2,1])
C0205087 (UMLS CUI [2,2])
C0392360 (UMLS CUI [2,3])
Item Group
Haematology
C0474523 (UMLS CUI-1)
Item
Day 3
text
C0474523 (UMLS CUI [1])
Hematology finding
Code List
Day 3
CL Item
Not done (Not done)
CL Item
Same laboratory as recorded before (Same laboratory as recorded before)
Hematology finding, Performing Laboratory
Item
Laboratory Name/City
text
C0474523 (UMLS CUI [1,1])
C1882331 (UMLS CUI [1,2])
Hematology finding; Sampling; Date in time; Time
Item
Date and Time of Sampling
datetime
C0474523 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
Test
text
C0474523 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
Hematology finding; Hematologic Tests
Code List
Test
CL Item
Platelet (Platelet)
CL Item
Hemoglobin (Hemoglobin)
Hematology finding; Numerical Value
Item
Value
float
C0474523 (UMLS CUI [1,1])
C1522609 (UMLS CUI [1,2])
Item
Unit
text
C0474523 (UMLS CUI [1,1])
C0439148 (UMLS CUI [1,2])
Hematology finding; Unit
Code List
Unit
CL Item
10^9/L (10^9/L)
CL Item
g/dL (g/dL)
Hematology finding; Unit, other
Item
If other unit, specify
text
C0474523 (UMLS CUI [1,1])
C0439148 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Item Group
Biochemistry
C0005477 (UMLS CUI-1)
Biochemistry; Performing Laboratory
Item
Laboratory Name/City
text
C0005477 (UMLS CUI [1,1])
C1882331 (UMLS CUI [1,2])
Biochemistry; Sampling; Date in time; Time
Item
Date and Time of Sampling
datetime
C0005477 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
Test
text
C1655775 (UMLS CUI [1])
Biochemistry test
Code List
Test
CL Item
Creatinine (Creatinine)
CL Item
AST (AST)
CL Item
ALT (ALT)
CL Item
Total Bilirubin (Total Bilirubin)
Biochemistry; Numerical Value
Item
Value
float
C0005477 (UMLS CUI [1,1])
C1522609 (UMLS CUI [1,2])
Item
Unit
text
C0005477 (UMLS CUI [1,1])
C0439148 (UMLS CUI [1,2])
Biochemistry; Unit
Code List
Unit
CL Item
mg/dL (mg/dL)
CL Item
UL (UL)
CL Item
UL (UL)
CL Item
mg/dL (mgdL)
Item
If other unit, specify
text
C0005477 (UMLS CUI [1,1])
C0439148 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Biochemistry; Unit
Code List
If other unit, specify
Item Group
Mandatory Venography to Assess Asymptomatic DVT
C0031545 (UMLS CUI-1)
Venography
Item
Not done
boolean
C0031545 (UMLS CUI [1])
Venography, Bilateral
Item
Bilateral
boolean
C0031545 (UMLS CUI [1,1])
C0238767 (UMLS CUI [1,2])
Venography, Bilateral, Date in time
Item
Bilateral, Date performed
date
C0031545 (UMLS CUI [1,1])
C0238767 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Venography, Structure of left lower leg
Item
Left Leg
boolean
C0031545 (UMLS CUI [1,1])
C0230443 (UMLS CUI [1,2])
Venography, Structure of left lower leg, Date in time
Item
Left Leg, Date performed
date
C0031545 (UMLS CUI [1,1])
C0230443 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Venography, Structure of right lower leg
Item
Right Leg
boolean
C0031545 (UMLS CUI [1,1])
C0230442 (UMLS CUI [1,2])
Venography, Structure of right lower leg, Date in time
Item
Right Leg, Date performed
date
C0031545 (UMLS CUI [1,1])
C0230442 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
If NOT BILATERAL or NOT DONE, tick the primary reason.
text
C0031545 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
Venography; Indication
Code List
If NOT BILATERAL or NOT DONE, tick the primary reason.
CL Item
Failed venous access (Failed venous access)
CL Item
Subject refused/withdrew consent (Subject refused/withdrew consent)
CL Item
Subject amputee (Subject amputee)
CL Item
Other, specify (Other, specify)
Venography; Result; Pharmaceutical Preparations
Item
As a result of this venography, was medication given to treat DVT?
boolean
C0031545 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
Item Group
Mechanical Prophylaxis and Physical Therapy
C0199176 (UMLS CUI-1)
C0443254 (UMLS CUI-2)
C0949766 (UMLS CUI-3)
Intermittent Pneumatic Compression Therapy, Knee, High
Item
Intermittent Pneumatic Compression, knee-high
boolean
C1998430 (UMLS CUI [1,1])
C0022742 (UMLS CUI [1,2])
C0205250 (UMLS CUI [1,3])
Intermittent Pneumatic Compression Therapy, Thigh, High
Item
Intermittent Pneumatic Compression, thigh-high
boolean
C1998430 (UMLS CUI [1,1])
C0039866 (UMLS CUI [1,2])
C0205250 (UMLS CUI [1,3])
Intermittent Pneumatic Compression Therapy; Start Date
Item
Compression Therapy; Date of start
date
C1998430 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Intermittent Pneumatic Compression Therapy; Removing; Date in time
Item
Compression Therapy; Date of removal
date
C1998430 (UMLS CUI [1,1])
C1883720 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Compression stockings
Item
Did the subject wear elastic stockings (TED HOSE) for thrombosis prevention during the treatment period?
boolean
C0038348 (UMLS CUI [1])
Compression stockings; Start date
Item
Date of start
date
C0038348 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Compression stockings; Removing, Date in time
Item
Date of removal
date
C0038348 (UMLS CUI [1,1])
C1883720 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Physical therapy
Item
Did the subject receive physical therapy during the treatment period?
boolean
C0949766 (UMLS CUI [1])
Ambulate, Start date
Item
What day did the subject first ambulate?
date
C4036205 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
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