ID

22163

Beschrijving

The present pharmacokinetic study is designed to assess the pharmacokinetics of RSG XR as monotherapy in patients with mild Alzheimer's disease (AD) as such information will not be obtained from the current phase III trials . The study aims to enroll fourteen patients (seven of each APOE genotype). Each patient will receive a single oral dose of 4mg of RSG XR in the morning under fasted conditions and PK samples will be taken up to 36h. GSK Source & Descriptions: https://clinicaltrials.gov/ct2/show/NCT00688207?term=NCT00688207&rank=1

Link

https://clinicaltrials.gov/ct2/show/NCT00688207?term=NCT00688207&rank=1

Trefwoorden

Versies (3)
  1. 08-05-17 08-05-17 -
  2. 20-05-17 20-05-17 -
  3. 22-05-17 22-05-17 -
Geüploaded op

22 mei 2017

DOI

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Licentie

Creative Commons BY-NC 3.0
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Serious Adverse Events Mild Alzheimer's Disease to Assess the of Extended Release Formulation of Rosiglitazone NCT00688207 / GSK-AVA109941

Engels

Serious Adverse Events Mild Alzheimer's Disease to Assess the of Extended Release Formulation of Rosiglitazone NCT00688207 / GSK-AVA109941

1 Formulieren  
Serious Adverse Event
Beschrijving

Serious Adverse Event

Alias
UMLS CUI-1
C1519255
Did the subject experience a serious adverse events during the study? If YES, record details below.
Beschrijving

Serious Adverse Event (SAE)

Datatype

boolean

Alias
UMLS CUI [1]
C1519255
Serious Adverse Events (SAE)
Beschrijving

Serious Adverse Events (SAE)

Alias
UMLS CUI-1
C1519255
Event Diagnosis Only (if known) Otherwise Sign/Symptoms e.g. Anaphylaxis
Beschrijving

Serious Adverse Event

Datatype

text

Alias
UMLS CUI [1]
C1519255
Start Date (Day Month Year) (e.g. 25 JAN 03)
Beschrijving

Start Date

Datatype

date

Maateenheden
  • dd/MMM/yy
Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0808070
dd/MMM/yy
Start time (e.g. 13:25)
Beschrijving

Start time

Datatype

time

Maateenheden
  • hr:min
Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1301880
hr:min
Outcome
Beschrijving

Outcome

Datatype

integer

Alias
UMLS CUI [1]
C1705586
End Date e.g. 27 Jan 03
Beschrijving

End Date

Datatype

date

Maateenheden
  • hr:min
Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0806020
hr:min
End Time e.g. 10:20
Beschrijving

End Time

Datatype

time

Maateenheden
  • hr:min
Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1522314
hr:min
Maximum Intensity
Beschrijving

Maximum Intensity

Datatype

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C0877248
Action Taken with Investigational Product(s) as a Result of the SAE
Beschrijving

Action Taken with Investigational Product

Datatype

integer

Alias
UMLS CUI [1]
C1704758
Withdrawal Did the subject withdraw from study as a result of this SAE?
Beschrijving

Withdrawal

Datatype

boolean

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C1519255
Relationship to Investigational Product(s) Is there a reasonable possibility that the SAE may have been caused by the investigational product?
Beschrijving

Relationship to Investigational Product

Datatype

boolean

Alias
UMLS CUI [1,1]
C0085978
UMLS CUI [1,2]
C0877248
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Similar models

Serious Adverse Events Mild Alzheimer's Disease to Assess the of Extended Release Formulation of Rosiglitazone NCT00688207 / GSK-AVA109941

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Serious Adverse Event
C1519255 (UMLS CUI-1)
Serious Adverse Event (SAE)
Item
Did the subject experience a serious adverse events during the study? If YES, record details below.
boolean
C1519255 (UMLS CUI [1])
Item Group
Serious Adverse Events (SAE)
C1519255 (UMLS CUI-1)
Serious Adverse Event
Item
Event Diagnosis Only (if known) Otherwise Sign/Symptoms e.g. Anaphylaxis
text
C1519255 (UMLS CUI [1])
Start Date
Item
Start Date (Day Month Year) (e.g. 25 JAN 03)
date
C1519255 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Start time
Item
Start time (e.g. 13:25)
time
C1519255 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Item
Outcome
integer
C1705586 (UMLS CUI [1])
Outcome
Code List
Outcome
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered/Resolved with sequelae (4)
CL Item
Fatal (5)
End Date
Item
End Date e.g. 27 Jan 03
date
C1519255 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
End Time
Item
End Time e.g. 10:20
time
C1519255 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Item
Maximum Intensity
integer
C0518690 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Maximum Intensity
Code List
Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (4)
Item
Action Taken with Investigational Product(s) as a Result of the SAE
integer
C1704758 (UMLS CUI [1])
Action Taken with Investigational Product
Code List
Action Taken with Investigational Product(s) as a Result of the SAE
CL Item
Investigational product(s) (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (6)
Withdrawal
Item
Withdrawal Did the subject withdraw from study as a result of this SAE?
boolean
C2349954 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Relationship to Investigational Product
Item
Relationship to Investigational Product(s) Is there a reasonable possibility that the SAE may have been caused by the investigational product?
boolean
C0085978 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
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