ID

22112

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. NOTE: If this is a SERIOUS ADVERSE EVENT (AE), DO NOT COMPLETE THIS FORM, got to the SAE section and complete the SAE form. 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 (2)
  1. 08-05-17 08-05-17 -
  2. 20-05-17 20-05-17 -
Geüploaded op

20 mei 2017

DOI

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Licentie

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

Engels

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

1 Formulieren  
Non-Serious Adverse Event
Beschrijving

Non-Serious Adverse Event

Alias
UMLS CUI-1
C1518404
Did the subject experience any non-serious adverse events during the study? If YES, record details below.
Beschrijving

Non serious adverse event

Datatype

boolean

Alias
UMLS CUI [1]
C1518404
Non-Serious Adverse Events (AE)
Beschrijving

Non-Serious Adverse Events (AE)

Alias
UMLS CUI-1
C1518404
Event Diagnosis Only (if known) Otherwise Sign/Symptoms e.g. Headache
Beschrijving

Non-Serious Adverse Event

Datatype

text

Alias
UMLS CUI [1]
C1518404
Start Date (Day Month Year) (e.g. 25 JAN 03)
Beschrijving

Start Date

Datatype

date

Maateenheden
  • dd/MMM/yy
Alias
UMLS CUI [1,1]
C1518404
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]
C1518404
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]
C1518404
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]
C1518404
UMLS CUI [1,2]
C1522314
hr:min
Frequency
Beschrijving

Frequency

Datatype

integer

Alias
UMLS CUI [1]
C3476109
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 Non-Serious AE
Beschrijving

Action Taken with Investigational Product

Datatype

integer

Alias
UMLS CUI [1]
C1704758
Withdrawal
Beschrijving

Withdrawal

Datatype

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C2349954
Relationship to Investigational Product(s) Is there a reasonable possibility that the AE may have been caused by the investigational product?
Beschrijving

Relationship to Investigational Product

Datatype

boolean

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

Non-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
Non-Serious Adverse Event
C1518404 (UMLS CUI-1)
Non serious adverse event
Item
Did the subject experience any non-serious adverse events during the study? If YES, record details below.
boolean
C1518404 (UMLS CUI [1])
Item Group
Non-Serious Adverse Events (AE)
C1518404 (UMLS CUI-1)
Non-Serious Adverse Event
Item
Event Diagnosis Only (if known) Otherwise Sign/Symptoms e.g. Headache
text
C1518404 (UMLS CUI [1])
Start Date
Item
Start Date (Day Month Year) (e.g. 25 JAN 03)
date
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Start time
Item
Start time (e.g. 13:25)
time
C1518404 (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)
End Date
Item
End Date e.g. 27 Jan 03
date
C1518404 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
End Time
Item
End Time e.g. 10:20
time
C1518404 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Item
Frequency
integer
C3476109 (UMLS CUI [1])
Frequency
Code List
Frequency
CL Item
Single episode (1)
CL Item
Intermittent (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 Non-Serious AE
integer
C1704758 (UMLS CUI [1])
Action Taken with Investigational Product
Code List
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
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
boolean
C1518404 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
Relationship to Investigational Product
Item
Relationship to Investigational Product(s) Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C0877248 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
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