ID

22113

Description

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

Keywords

Versions (3)
  1. 5/8/17 5/8/17 -
  2. 5/20/17 5/20/17 -
  3. 5/22/17 5/22/17 -
Uploaded on

May 20, 2017

DOI

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License

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

English

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

1 forms  
Serious Adverse Event
Description

Serious Adverse Event

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

Serious Adverse Event (SAE)

Data type

boolean

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

Serious Adverse Events (SAE)

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

Serious Adverse Event

Data type

text

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

Start Date

Data type

date

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

Start time

Data type

time

Measurement units
  • hr:min
Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C1519255
hr:min
Outcome
Description

Outcome

Data type

integer

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

End Date

Data type

date

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

End Time

Data type

time

Measurement units
  • hr:min
Alias
UMLS CUI [1,1]
C1522314
UMLS CUI [1,2]
C1519255
hr:min
Maximum Intensity
Description

Maximum Intensity

Data type

integer

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

Action Taken with Investigational Product

Data type

integer

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

Withdrawal

Data type

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?
Description

Relationship to Investigational Product

Data type

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 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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
C0808070 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Start time
Item
Start time (e.g. 13:25)
time
C1301880 (UMLS CUI [1,1])
C1519255 (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
C0806020 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
End Time
Item
End Time e.g. 10:20
time
C1522314 (UMLS CUI [1,1])
C1519255 (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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