ID
36223
Description
NCT00428090 / GSK-AVA105640 A 24-week, double-blind, double-dummy, randomized, parallel-group study to investigate the effects of rosiglitazone (extended release tablets), donepezil, and placebo as monotherapy on cognition and overall clinical response in APOE e4-stratified subjects with mild to moderate Alzheimer’s disease. (REFLECT-1) A serious adverse event is any untoward medical occurence taht, at any dose: a) results in death. b) is life-threatening. Note: The term "life-threatening" in the definition of "serious" refers to an event in which the subject was at risk of death at the time of the event. It dies not refer to an event, which hypothetically might have caused death, if it were more severe. c) requires hospitalisation or prolongation of existing hospitalisation. Note: In general, hospitalisation signifies that the subject has been detained (usually involving at least an overnight stay9 at the hospital or emergency ward fro observation and/or treatment that would not have been appropriate in the physicican's office or out-patient setting. Complications that occur during hospitalisation are AEs. If a complication prolongs hopsialisation or fulfills any other serious criteria, the event is "serious". When in doubt as to whether "hospitalisation" occured or was necessary, the AE should be considered "serious". Hospitalisation for elective treatment of pre-existing condition that did not worsen from baseline is not considered an AE. d) results in disability/incapacity, or Note: the term disability means a sbustantial disruption of a person's ability to conduct normal life functions. This definition is not intended to include experiences of relatively minor medical significance such as uncomplicated headache, nausea, vomiting, diarrhoea, influenza, and accidental trauma (e.g., sprained ankle) which may interfere or prevent everyday life functions but do not consitute a substantial disruption. e) is a congenital anomaly/birht defect. f) other. Medical or scientific judgement should be exercised in deiding whether reporting is appropriate in other situations, such as important medical events that may not be immedaitely life-threatening or result in death or hospitalisation but may jeopardise the subejct or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition. These should also be considered serious. Examples of such events are invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convusions that do not result in hospitalisation, or development of drug dependency or drug abuse.
Mots-clés
Versions (3)
- 27/09/2017 27/09/2017 -
- 27/09/2017 27/09/2017 -
- 23/04/2019 23/04/2019 - Sarah Riepenhausen
Détendeur de droits
GlaxoSmithKline
Téléchargé le
23 avril 2019
DOI
Pour une demande vous connecter.
Licence
Creative Commons BY-NC-ND 3.0
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REFLECT-1 Serious Adverse Events NCT00428090
REFLECT-1 Serious Adverse Events NCT00428090
- StudyEvent: ODM
Description
Serious Adverse Event: Seriousness - Section 2
Alias
- UMLS CUI-1
- C1710056
Description
Serious Adverse Event: Ongoing Event - Section 4
Alias
- UMLS CUI-1
- C0580798
Description
Ongoing event
Type de données
text
Alias
- UMLS CUI [1]
- C0580798
Description
Serious Adverse Event: Relevant Medical Condition - Section 6
Alias
- UMLS CUI-1
- C0012634
Description
Date of Onset
Type de données
date
Unités de mesure
- dd/MMM/yy
Alias
- UMLS CUI [1]
- C0574845
Description
Date of Last Occurrence
Type de données
date
Unités de mesure
- dd/MMM/yy
Alias
- UMLS CUI [1,1]
- C2745955
- UMLS CUI [1,2]
- C0011008
Description
Serious Adverse Event: RELEVANT Concomitant Medication (include details of any concomitant medication(s) which may have contributed to the event) - Section 8
Alias
- UMLS CUI-1
- C2347852
Description
Drug Name
Type de données
text
Alias
- UMLS CUI [1]
- C2360065
Description
Unit
Type de données
text
Alias
- UMLS CUI [1]
- C1519795
Description
Route
Type de données
text
Alias
- UMLS CUI [1]
- C0013153
Description
Start Date
Type de données
date
Unités de mesure
- dd/MMM/yy
Alias
- UMLS CUI [1]
- C0808070
Description
Ongoing Medication
Type de données
boolean
Alias
- UMLS CUI [1]
- C2826666
Description
Serious Adverse Event: Assessment - Section 10
Alias
- UMLS CUI-1
- C1516048
Description
Identification and Signature
Alias
- UMLS CUI-1
- C0205396
- UMLS CUI-2
- C1519316
Description
Date of report
Type de données
date
Unités de mesure
- dd/MMM/yy
Alias
- UMLS CUI [1]
- C1302584
Description
Investigator's Signature
Type de données
text
Alias
- UMLS CUI [1]
- C2346576
Similar models
REFLECT-1 Serious Adverse Events NCT00428090
- StudyEvent: ODM
C2348235 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C1519316 (UMLS CUI-2)