ID

22330

Beschreibung

A Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Investigate the Effects of Rosiglitazone (Extended Release Tablets) on Cerebral Glucose Utilization and Cognition in Subjects With Mild to Moderate Alzheimer's Disease (AD) Medicine: rosiglitazone, Condition: Alzheimer's Disease, Phase: 2, Clinical Study ID: 49653/461, This form is to be performed in Treatment Phase. Sponsor: GSK Source & Descriptions: https://clinicaltrials.gov/ct2/show/NCT00265148?term=NCT00265148&rank=1

Link

https://clinicaltrials.gov/ct2/show/NCT00265148?term=NCT00265148&rank=1

Stichworte

Versionen (1)
  1. 30.05.17 30.05.17 -
Hochgeladen am

30. Mai 2017

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Adverse Event Effects of Rosiglitazone on Cerebral Glucose Utilization and Cognition in Subjects With Alzheimer's Disease NCT00265148

Englisch

Adverse Event Effects of Rosiglitazone on Cerebral Glucose Utilization and Cognition in Subjects With Alzheimer's Disease NCT00265148

1 Formulare  
Adverse Event
Beschreibung

Adverse Event

Alias
UMLS CUI-1
C0877248
Adverse Event GSK Use
Beschreibung

Diagnosis

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0011900
Onset Date/Time
Beschreibung

Onset Date/Time

Datentyp

datetime

Alias
UMLS CUI [1]
C2985916
End Date/Time (if ongoing, please leave blank)
Beschreibung

End Date/Time

Datentyp

datetime

Alias
UMLS CUI [1]
C3899266
Outcome
Beschreibung

Outcome

Datentyp

integer

Alias
UMLS CUI [1]
C1705586
Event Course
Beschreibung

Course

Datentyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0750729
Intensity (maximum)
Beschreibung

Intensity

Datentyp

integer

Alias
UMLS CUI [1,1]
C0522510
UMLS CUI [1,2]
C0877248
Action taken with Respect to Investigational Drug
Beschreibung

Action taken

Datentyp

integer

Alias
UMLS CUI [1,1]
C0441472
UMLS CUI [1,2]
C0013230
Relationship to Investigational Drug
Beschreibung

Relationship to Investigational Drug

Datentyp

integer

Alias
UMLS CUI [1]
C0013230
Corrective Therapy If ´Yes`, Please record on Concomitant Medication form.
Beschreibung

Corrective Therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0087111
Was subject withdrawn due to this AE?
Beschreibung

Withdrawal

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0877248
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Ähnliche Modelle

Adverse Event Effects of Rosiglitazone on Cerebral Glucose Utilization and Cognition in Subjects With Alzheimer's Disease NCT00265148

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Adverse Event
C0877248 (UMLS CUI-1)
Diagnosis
Item
Adverse Event GSK Use
text
C0877248 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Onset Date/Time
Item
Onset Date/Time
datetime
C2985916 (UMLS CUI [1])
End Date/Time
Item
End Date/Time (if ongoing, please leave blank)
datetime
C3899266 (UMLS CUI [1])
Item
Outcome
integer
C1705586 (UMLS CUI [1])
Outcome
Code List
Outcome
CL Item
Resolved (1)
CL Item
Ongoing (2)
Item
Event Course
integer
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Course
Code List
Event Course
CL Item
Intermittent  (1)
CL Item
Constant (2)
Item
Intensity (maximum)
integer
C0522510 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Intensity
Code List
Intensity (maximum)
CL Item
Mild (1)
CL Item
Moderate (3)
CL Item
Severe (3)
Item
Action taken with Respect to Investigational Drug
integer
C0441472 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Action taken
Code List
Action taken with Respect to Investigational Drug
CL Item
None (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Drug interrupted/restarted (4)
CL Item
Drug stopped (5)
Item
Relationship to Investigational Drug
integer
C0013230 (UMLS CUI [1])
trial procedures
Code List
Relationship to Investigational Drug
CL Item
Not related (1)
CL Item
Unlikely (2)
CL Item
Suspected (reasonable possibility) (3)
CL Item
Probable (4)
Corrective Therapy
Item
Corrective Therapy If ´Yes`, Please record on Concomitant Medication form.
boolean
C0087111 (UMLS CUI [1])
Withdrawal
Item
Was subject withdrawn due to this AE?
boolean
C2349954 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
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