ID
31492
Beschrijving
Study ID: 104574 Clinical Study ID: AR1104574 Study Title: A randomized blinded pilot trial of fondaparinux sodium (Arixtra®) versus unfractionated heparin in addition to standard therapy in a broad range of patients undergoing percutaneous coronary intervention (ASPIRE) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: fondaparinux sodium Trade Name: Arixtra Study Indication: Thromboembolism
Trefwoorden
Versies (2)
- 28-08-18 28-08-18 -
- 28-08-18 28-08-18 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
28 augustus 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.
Itemgroep Commentaren voor :
Item Commentaren voor :
U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.
Fondaparinux sodium (Arixtra) versus unfractionated heparin with patients undergoing PCI; NCT
Baseline Form
- StudyEvent: ODM
Beschrijving
Patient Information
Alias
- UMLS CUI-1
- C1955348
Beschrijving
Sex
Datatype
text
Alias
- UMLS CUI [1]
- C0079399
Beschrijving
Patient date of birth
Datatype
date
Alias
- UMLS CUI [1]
- C0421451
Beschrijving
Ethnic Group
Datatype
text
Alias
- UMLS CUI [1]
- C0015031
Beschrijving
Body Height
Datatype
integer
Maateenheden
- cm
Alias
- UMLS CUI [1]
- C0005890
Beschrijving
Clinical Assessment Pre-Randomization
Alias
- UMLS CUI-1
- C4534461
- UMLS CUI-2
- C0332152
- UMLS CUI-3
- C0034656
Beschrijving
Symptoms/procedure inducing PCI; date of onset
Datatype
date
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205263
- UMLS CUI [1,3]
- C1532338
- UMLS CUI [1,4]
- C0574845
- UMLS CUI [2,1]
- C0199171
- UMLS CUI [2,2]
- C0205263
- UMLS CUI [2,3]
- C1532338
- UMLS CUI [2,4]
- C0574845
Beschrijving
Symptoms/procedure inducing PCI; time of onset
Datatype
time
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205263
- UMLS CUI [1,3]
- C1532338
- UMLS CUI [1,4]
- C0449244
- UMLS CUI [2,1]
- C0199171
- UMLS CUI [2,2]
- C0205263
- UMLS CUI [2,3]
- C1532338
- UMLS CUI [2,4]
- C0449244
Beschrijving
Baseline ECG; date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0013798
- UMLS CUI [1,2]
- C1442488
- UMLS CUI [1,3]
- C0011008
Beschrijving
Baseline ECG; time
Datatype
time
Alias
- UMLS CUI [1,1]
- C0013798
- UMLS CUI [1,2]
- C1442488
- UMLS CUI [1,3]
- C0040223
Beschrijving
Baseline ECG; result
Datatype
text
Alias
- UMLS CUI [1,1]
- C0013798
- UMLS CUI [1,2]
- C1442488
- UMLS CUI [1,3]
- C1274040
Beschrijving
ECG rhythm
Datatype
text
Alias
- UMLS CUI [1]
- C0232187
Beschrijving
Left ventricular hypertrophy
Datatype
text
Alias
- UMLS CUI [1]
- C0149721
Beschrijving
Intraventricular conduction delay (QRS > 120 msec)
Datatype
text
Alias
- UMLS CUI [1,1]
- C3697597
- UMLS CUI [1,2]
- C0429025
Beschrijving
Heart Rate
Datatype
integer
Maateenheden
- bpm
Alias
- UMLS CUI [1]
- C0018810
Beschrijving
Supine blood pressure
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1,1]
- C0005823
- UMLS CUI [1,2]
- C0038846
Beschrijving
Pre-Randomization Laboratory Tests
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0332152
- UMLS CUI-3
- C0034656
Beschrijving
Laboratory Procedures; Specimen collection date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C1302413
Beschrijving
Laboratory Procedures; Specimen collection time
Datatype
time
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C0040223
Beschrijving
Hemoglobin
Datatype
float
Maateenheden
- g/dl
Alias
- UMLS CUI [1]
- C0019046
Beschrijving
Hematocrit level
Datatype
integer
Maateenheden
- %
Alias
- UMLS CUI [1]
- C0518014
Beschrijving
Total WBC
Datatype
float
Maateenheden
- x 10⁹/L
Alias
- UMLS CUI [1]
- C0023508
Beschrijving
Platelet Count
Datatype
integer
Maateenheden
- x 10⁹/L
Alias
- UMLS CUI [1]
- C0005821
Beschrijving
aPTT
Datatype
integer
Maateenheden
- sec
Alias
- UMLS CUI [1]
- C0030605
Beschrijving
INR
Datatype
float
Alias
- UMLS CUI [1]
- C0525032
Beschrijving
Creatinine
Datatype
float
Maateenheden
- µmol/L
Alias
- UMLS CUI [1]
- C0201976
Beschrijving
Total CK
Datatype
integer
Maateenheden
- U/L
Alias
- UMLS CUI [1]
- C0201973
Beschrijving
Total CK; ULN
Datatype
integer
Maateenheden
- U/L
Alias
- UMLS CUI [1,1]
- C0201973
- UMLS CUI [1,2]
- C1519815
Beschrijving
CK-MB
Datatype
float
Maateenheden
- U/L
Alias
- UMLS CUI [1]
- C0523584
Beschrijving
CK-MB; ULN
Datatype
float
Maateenheden
- U/L
Alias
- UMLS CUI [1,1]
- C0523584
- UMLS CUI [1,2]
- C1519815
Beschrijving
CK-MB
Datatype
integer
Maateenheden
- %
Alias
- UMLS CUI [1]
- C0523584
Beschrijving
CK-MB; ULN
Datatype
integer
Maateenheden
- %
Alias
- UMLS CUI [1,1]
- C0523584
- UMLS CUI [1,2]
- C1519815
Beschrijving
CK-MB Mass
Datatype
float
Maateenheden
- µg/L
Alias
- UMLS CUI [1,1]
- C0523584
- UMLS CUI [1,2]
- C1306372
Beschrijving
CK-MB Mass ULN
Datatype
float
Maateenheden
- µg/L
Alias
- UMLS CUI [1,1]
- C0523584
- UMLS CUI [1,2]
- C1306372
- UMLS CUI [1,3]
- C1519815
Beschrijving
Troponin T
Datatype
float
Maateenheden
- µg/L
Alias
- UMLS CUI [1]
- C1141947
Beschrijving
Troponin T; ULN
Datatype
float
Maateenheden
- µg/L
Alias
- UMLS CUI [1,1]
- C1141947
- UMLS CUI [1,2]
- C1519815
Beschrijving
Troponin I
Datatype
float
Maateenheden
- µg/L
Alias
- UMLS CUI [1]
- C0920210
Beschrijving
Troponin I; ULN
Datatype
float
Maateenheden
- µg/L
Alias
- UMLS CUI [1,1]
- C0920210
- UMLS CUI [1,2]
- C1519815
Beschrijving
Patient History
Alias
- UMLS CUI-1
- C0679831
Beschrijving
Patient History; MI
Datatype
boolean
Alias
- UMLS CUI [1]
- C1275835
Beschrijving
Patient History; MI; Date of most recent
Datatype
date
Alias
- UMLS CUI [1,1]
- C1275835
- UMLS CUI [1,2]
- C2924287
- UMLS CUI [1,3]
- C1513491
Beschrijving
Patient History; Previous PCI with stent
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0679831
- UMLS CUI [1,2]
- C1532338
- UMLS CUI [1,3]
- C0038257
Beschrijving
Patient History; Previous PCI with stent; Date of most recent
Datatype
date
Alias
- UMLS CUI [1,1]
- C0679831
- UMLS CUI [1,2]
- C1532338
- UMLS CUI [1,3]
- C0038257
- UMLS CUI [1,4]
- C0011008
- UMLS CUI [1,5]
- C1513491
Beschrijving
Patient History; Previous PCI without stent
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0679831
- UMLS CUI [1,2]
- C1532338
Beschrijving
Patient History; Previous PCI without stent; Date of most recent
Datatype
date
Alias
- UMLS CUI [1,1]
- C0679831
- UMLS CUI [1,2]
- C1532338
- UMLS CUI [1,3]
- C0011008
- UMLS CUI [1,4]
- C1513491
Beschrijving
Patient History; CABG Surgery
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0679831
- UMLS CUI [1,2]
- C0010055
Beschrijving
Patient History; CABG Surgery, Date of most recent
Datatype
date
Alias
- UMLS CUI [1,1]
- C0679831
- UMLS CUI [1,2]
- C0010055
- UMLS CUI [1,3]
- C0011008
- UMLS CUI [1,4]
- C1513491
Beschrijving
Patient History; CABG Surgery, Date of most recent
Datatype
date
Alias
- UMLS CUI [1,1]
- C0679831
- UMLS CUI [1,2]
- C0010055
- UMLS CUI [1,3]
- C0011008
- UMLS CUI [1,4]
- C1513491
Beschrijving
Patient History; Coronary Artery Disease, Evidence, Other
Datatype
text
Alias
- UMLS CUI [1,1]
- C0679831
- UMLS CUI [1,2]
- C1956346
- UMLS CUI [1,3]
- C0332120
- UMLS CUI [1,4]
- C0205394
Beschrijving
Patient History; Family history; Coronary Artery Disease, Early-onset
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0679831
- UMLS CUI [1,2]
- C0241889
- UMLS CUI [1,3]
- C1956346
- UMLS CUI [1,4]
- C1833334
Beschrijving
Patient History; Stroke
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0679831
- UMLS CUI [1,2]
- C0038454
Beschrijving
Patient History; Stroke; Date in time; most recent
Datatype
date
Alias
- UMLS CUI [1,1]
- C0679831
- UMLS CUI [1,2]
- C0038454
- UMLS CUI [1,3]
- C0011008
- UMLS CUI [1,4]
- C1513491
Beschrijving
Patient History; Peripheral arterial disease
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0679831
- UMLS CUI [1,2]
- C1704436
Beschrijving
Patient History; Hypertension
Datatype
text
Alias
- UMLS CUI [1,1]
- C0679831
- UMLS CUI [1,2]
- C0020538
Beschrijving
Patient History; Heart Failure
Datatype
text
Alias
- UMLS CUI [1,1]
- C0679831
- UMLS CUI [1,2]
- C0018801
Beschrijving
Patient History; Diabetes
Datatype
text
Alias
- UMLS CUI [1,1]
- C0679831
- UMLS CUI [1,2]
- C0011849
Beschrijving
Patient History; Diabetes; Date of diagnosis
Datatype
date
Alias
- UMLS CUI [1,1]
- C0679831
- UMLS CUI [1,2]
- C0011849
- UMLS CUI [1,3]
- C2316983
Beschrijving
Patient History; Hypercholesterolemia
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0679831
- UMLS CUI [1,2]
- C0020443
Beschrijving
Patient History; Malignant Neoplasms
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0679831
- UMLS CUI [1,2]
- C0006826
Beschrijving
Patient History; Malignant Neoplasms, date of diagnosis
Datatype
date
Alias
- UMLS CUI [1,1]
- C0679831
- UMLS CUI [1,2]
- C0006826
- UMLS CUI [1,3]
- C2316983
Beschrijving
Patient History; Malignant Neoplasms, site
Datatype
text
Alias
- UMLS CUI [1,1]
- C0679831
- UMLS CUI [1,2]
- C0006826
- UMLS CUI [1,3]
- C1515974
Beschrijving
Patient History; concomitant disease
Datatype
text
Alias
- UMLS CUI [1,1]
- C0679831
- UMLS CUI [1,2]
- C0243087
Beschrijving
Patient History; smoker
Datatype
text
Alias
- UMLS CUI [1,1]
- C0679831
- UMLS CUI [1,2]
- C0243087
Similar models
Baseline Form
- StudyEvent: ODM
C2825181 (UMLS CUI [1,2])
C1300638 (UMLS CUI [1,3])
C2348585 (UMLS CUI [1,2])
C0332152 (UMLS CUI-2)
C0034656 (UMLS CUI-3)
C0205263 (UMLS CUI [1,2])
C1532338 (UMLS CUI [1,3])
C0574845 (UMLS CUI [1,4])
C0199171 (UMLS CUI [2,1])
C0205263 (UMLS CUI [2,2])
C1532338 (UMLS CUI [2,3])
C0574845 (UMLS CUI [2,4])
C0205263 (UMLS CUI [1,2])
C1532338 (UMLS CUI [1,3])
C0449244 (UMLS CUI [1,4])
C0199171 (UMLS CUI [2,1])
C0205263 (UMLS CUI [2,2])
C1532338 (UMLS CUI [2,3])
C0449244 (UMLS CUI [2,4])
C1442488 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1442488 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C1442488 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C0429025 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,2])
C0332152 (UMLS CUI-2)
C0034656 (UMLS CUI-3)
C1302413 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C1519815 (UMLS CUI [1,2])
C1519815 (UMLS CUI [1,2])
C1519815 (UMLS CUI [1,2])
C1306372 (UMLS CUI [1,2])
C1306372 (UMLS CUI [1,2])
C1519815 (UMLS CUI [1,3])
C1519815 (UMLS CUI [1,2])
C1519815 (UMLS CUI [1,2])
C2924287 (UMLS CUI [1,2])
C1513491 (UMLS CUI [1,3])
C1532338 (UMLS CUI [1,2])
C0038257 (UMLS CUI [1,3])
C1532338 (UMLS CUI [1,2])
C0038257 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C1513491 (UMLS CUI [1,5])
C1532338 (UMLS CUI [1,2])
C1532338 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1513491 (UMLS CUI [1,4])
C0010055 (UMLS CUI [1,2])
C0010055 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1513491 (UMLS CUI [1,4])
C0010055 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1513491 (UMLS CUI [1,4])
C1956346 (UMLS CUI [1,2])
C0332120 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C0241889 (UMLS CUI [1,2])
C1956346 (UMLS CUI [1,3])
C1833334 (UMLS CUI [1,4])
C0038454 (UMLS CUI [1,2])
C0038454 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1513491 (UMLS CUI [1,4])
C1704436 (UMLS CUI [1,2])
C0020538 (UMLS CUI [1,2])
C0018801 (UMLS CUI [1,2])
C0011849 (UMLS CUI [1,2])
C2316983 (UMLS CUI [1,3])
C0020443 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,2])
C2316983 (UMLS CUI [1,3])
C0006826 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,3])
C0243087 (UMLS CUI [1,2])
C0243087 (UMLS CUI [1,2])