ID
36223
Beschrijving
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.
Trefwoorden
Versies (3)
- 27-09-17 27-09-17 -
- 27-09-17 27-09-17 -
- 23-04-19 23-04-19 - Sarah Riepenhausen
Houder van rechten
GlaxoSmithKline
Geüploaded op
23 april 2019
DOI
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Licentie
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
Beschrijving
Serious Adverse Event: Seriousness - Section 2
Alias
- UMLS CUI-1
- C1710056
Beschrijving
Serious Adverse Event: Ongoing Event - Section 4
Alias
- UMLS CUI-1
- C0580798
Beschrijving
Ongoing event
Datatype
text
Alias
- UMLS CUI [1]
- C0580798
Beschrijving
Serious Adverse Event: Relevant Medical Condition - Section 6
Alias
- UMLS CUI-1
- C0012634
Beschrijving
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
Beschrijving
Drug Name
Datatype
text
Alias
- UMLS CUI [1]
- C2360065
Beschrijving
Unit
Datatype
text
Alias
- UMLS CUI [1]
- C1519795
Beschrijving
Route
Datatype
text
Alias
- UMLS CUI [1]
- C0013153
Beschrijving
Start Date
Datatype
date
Maateenheden
- dd/MMM/yy
Alias
- UMLS CUI [1]
- C0808070
Beschrijving
Ongoing Medication
Datatype
boolean
Alias
- UMLS CUI [1]
- C2826666
Beschrijving
Serious Adverse Event: Assessment - Section 10
Alias
- UMLS CUI-1
- C1516048
Beschrijving
Identification and Signature
Alias
- UMLS CUI-1
- C0205396
- UMLS CUI-2
- C1519316
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)