ID

31325

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

  1. 13-08-18 13-08-18 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

13 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; Clinical Study ID: AR1104574

SAE Complementary Report

Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Patient ID, Centre No.
Beschrijving

Patient ID; Centre Number

Datatype

text

Alias
UMLS CUI [1,1]
C1269815
UMLS CUI [1,2]
C2825181
UMLS CUI [1,3]
C1300638
Patient ID, Envelope No.
Beschrijving

Patient ID; Envelope Number

Datatype

text

Alias
UMLS CUI [1,1]
C1269815
UMLS CUI [1,2]
C2348585
Patient Initials
Beschrijving

Patient Initials

Datatype

text

Alias
UMLS CUI [1]
C2986440
Serious advert event
Beschrijving

Serious advert event

Alias
UMLS CUI-1
C1519255
Date of Onset of SAE
Beschrijving

Serious advert event; date of onset

Datatype

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0574845
Time of Onset of SAE
Beschrijving

Serious advert event; time of onset

Datatype

time

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1301880
Detailed description of the serious adverse event
Beschrijving

Serious advert event; description

Datatype

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0678257
List relevant concomitant medications (report name only) taken within 30 days of this SAE: (exclude treatment for SAE)
Beschrijving

Serious advert event; concomitant medications

Datatype

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
List relevant medical history
Beschrijving

Medical History; Serious advert events

Datatype

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C1519255
List relevant concomitant diseases
Beschrijving

Concomitant diseases; Serious advert events

Datatype

text

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C1519255

Similar models

SAE Complementary Report

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Patient ID; Centre Number
Item
Patient ID, Centre No.
text
C1269815 (UMLS CUI [1,1])
C2825181 (UMLS CUI [1,2])
C1300638 (UMLS CUI [1,3])
Patient ID; Envelope Number
Item
Patient ID, Envelope No.
text
C1269815 (UMLS CUI [1,1])
C2348585 (UMLS CUI [1,2])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Item Group
Serious advert event
C1519255 (UMLS CUI-1)
Serious advert event; date of onset
Item
Date of Onset of SAE
date
C1519255 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
Serious advert event; time of onset
Item
Time of Onset of SAE
time
C1519255 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Serious advert event; description
Item
Detailed description of the serious adverse event
text
C1519255 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Serious advert event; concomitant medications
Item
List relevant concomitant medications (report name only) taken within 30 days of this SAE: (exclude treatment for SAE)
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Medical History; Serious advert events
Item
List relevant medical history
text
C0262926 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Concomitant diseases; Serious advert events
Item
List relevant concomitant diseases
text
C0009488 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

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