ID

17585

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.