ID

32164

Beschrijving

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

Trefwoorden

Versies (1)
  1. 22-10-18 22-10-18 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

22 oktober 2018

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

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

Engels

Visit 02

1 Formulieren  
  1. StudyEvent: ODM
    1. Visit 02
Study Drug Dosing
Beschrijving

Study Drug Dosing

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

Experimental drug, Medication administered

Datatype

boolean

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

Pharmaceutical Preparation; Dosage; Date in time; Time

Datatype

datetime

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

Clinical Trial Subject Unique Identifier

Datatype

integer

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

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

Datatype

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
Beschrijving

Haematology

Alias
UMLS CUI-1
C0474523
Day 3
Beschrijving

Hematology finding

Datatype

text

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

Hematology finding, Performing Laboratory

Datatype

text

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

Hematology finding; Sampling; Date in time; Time

Datatype

datetime

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

Hematology finding; Hematologic Tests

Datatype

text

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

Hematology finding; Numerical Value

Datatype

float

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

Hematology finding; Unit

Datatype

text

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

Hematology finding; Unit, other

Datatype

text

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

Biochemistry

Alias
UMLS CUI-1
C0005477
Laboratory Name/City
Beschrijving

Biochemistry; Performing Laboratory

Datatype

text

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

Biochemistry; Sampling; Date in time; Time

Datatype

datetime

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

Biochemistry test

Datatype

text

Alias
UMLS CUI [1]
C1655775
Value
Beschrijving

Biochemistry; Numerical Value

Datatype

float

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

Biochemistry; Unit

Datatype

text

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

Biochemistry; Unit; other

Datatype

text

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

Mandatory Venography to Assess Asymptomatic DVT

Alias
UMLS CUI-1
C0031545
Not done
Beschrijving

Venography

Datatype

boolean

Alias
UMLS CUI [1]
C0031545
Bilateral
Beschrijving

Venography, Bilateral

Datatype

boolean

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

Venography, Bilateral, Date in time

Datatype

date

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

Venography, Structure of left lower leg

Datatype

boolean

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

Venography, Structure of left lower leg, Date in time

Datatype

date

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

Venography, Structure of right lower leg

Datatype

boolean

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

Venography, Structure of right lower leg, Date in time

Datatype

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.
Beschrijving

Venography; Indication

Datatype

text

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

Venography; Result; Pharmaceutical Preparations

Datatype

boolean

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

Mechanical Prophylaxis and Physical Therapy

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

Intermittent Pneumatic Compression Therapy, Knee, High

Datatype

boolean

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

Intermittent Pneumatic Compression Therapy, Thigh, High

Datatype

boolean

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

Intermittent Pneumatic Compression Therapy; Start Date

Datatype

date

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

Intermittent Pneumatic Compression Therapy; Removing; Date in time

Datatype

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?
Beschrijving

Compression stockings

Datatype

boolean

Alias
UMLS CUI [1]
C0038348
Date of start
Beschrijving

Compression stockings; Start date

Datatype

date

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

Compression stockings; Removing, Date in time

Datatype

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?
Beschrijving

Physical therapy

Datatype

boolean

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

Ambulate, Start date

Datatype

date

Alias
UMLS CUI [1,1]
C4036205
UMLS CUI [1,2]
C0808070
Terug naar het begin van de pagina

Similar models

Visit 02

1 Formulieren
  1. StudyEvent: ODM
    1. Visit 02
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial