ID
17493
Descrição
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) Any untoward medical occurence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, wether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of effiacy), abuse or misuse. Examples of an AE includes: - Significant or unexpected worsening or exacerbation of the condition/ indication under study. - Exacerbation of a chronic or intermittent pre-existing condition including either an increase in frequency and/or intensity of the condition. - New condition(s) detected or diagnosed after investigational product administration even though it may have been present prior to the start of the study. - Signs, symptoms, or the clinical sequelae of a suspected interaction. - Signs, symptoms, or the clinical sequelae of a suspected overdose of either investigational product or a concomitant medication (overdose per se should not be reported as an AE/SAE). Examples of an AE does NOT include a/an: - Medical or surgical procedure (e.g. endescopy, appendectomy); the condition that leads to the procedure is an AE. -Situations where an untoward medical occurence did not occur (social and/or convenience admission to a hospital). - Anticipated day-to-day fluctuations of pre-existing disease(s) or condition(s) present or detected at the start of the study that do not worsen. -The disease/disorder being studied, or expected progression, signs, or symptoms of the diseae/disorder being studied, unless more severe than expected for the subject's condition. For GSK clinical studies, AEs may include pre- or post-treatment events that occur as a result of protocol-mandated procedures (i.e., invasive procedures, modification of subject's previous therapeutic regimen). See protocol for clarification. If this event meets the definition of serious, complete the Serious Adverse Event Section.
Palavras-chave
Versões (2)
- 18/09/2016 18/09/2016 -
- 25/09/2016 25/09/2016 -
Transferido a
18 de setembro de 2016
DOI
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Licença
Creative Commons BY-NC-ND 3.0
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GSK Non-Serious Adverse Events NCT00428090
GSK Non-Serious Adverse Events NCT00428090
- StudyEvent: ODM
Descrição
Non-Serious Adverse Events (AE)
Alias
- UMLS CUI-1
- C1518404
Descrição
Non-Serious Adverse Event
Tipo de dados
text
Alias
- UMLS CUI [1]
- C1518404
Descrição
Non-Serious Adverse Event Specification
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C2348235
Descrição
Start Date
Tipo de dados
date
Unidades de medida
- dd/MMM/yy
Alias
- UMLS CUI [1]
- C0808070
Descrição
Outcome
Tipo de dados
integer
Alias
- UMLS CUI [1]
- C1705586
Descrição
End Date
Tipo de dados
date
Unidades de medida
- dd/MMM/yy
Alias
- UMLS CUI [1]
- C0806020
Descrição
Maximum Intensity
Tipo de dados
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C0877248
Descrição
Action Taken with Investigational Product
Tipo de dados
integer
Alias
- UMLS CUI [1]
- C1704758
Descrição
Withdrawal
Tipo de dados
boolean
Alias
- UMLS CUI [1]
- C2349954
Descrição
Relationship to Investigational Product
Tipo de dados
boolean
Alias
- UMLS CUI [1,1]
- C0085978
- UMLS CUI [1,2]
- C0877248
Similar models
GSK Non-Serious Adverse Events NCT00428090
- StudyEvent: ODM
C2348235 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])