ID

22344

Description

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

Keywords

Versions (2)
  1. 5/30/17 5/30/17 -
  2. 5/30/17 5/30/17 -
Uploaded on

May 30, 2017

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

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

English

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

1 forms  
Serious Adverse Events (SAE)
Description

Serious Adverse Events (SAE)

Alias
UMLS CUI-1
C1519255
Person Reporting SAE
Description

Name

Data type

text

Alias
UMLS CUI [1]
C0008961
Serious Adverse Event (Please print clearly) GSK Use
Description

Diagnosis

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0011900
Specify reason(s) for considering this a serious AE. Mark all that apply.
Description

Reason

Data type

integer

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C1519255
Specify other reason
Description

Specify other reason

Data type

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C1519255
Onset Date/Time
Description

Onset Date/Time

Data type

datetime

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

End Date/Time

Data type

datetime

Alias
UMLS CUI [1]
C3899266
Outcome *If subject died, please inform GSK within 24 hours and complete Form D.
Description

Outcome

Data type

integer

Alias
UMLS CUI [1]
C1705586
Event Course
Description

Course

Data type

integer

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

Intensity

Data type

integer

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

Action taken

Data type

integer

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

Relationship to Investigational Drug

Data type

integer

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

Corrective Therapy

Data type

boolean

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

Withdrawal

Data type

boolean

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0877248
Serious Adverse Event
Description

Serious Adverse Event

Alias
UMLS CUI-1
C1519255
Did the SAE abate?
Description

SAE Abation

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C3853704
If study medication was interrupted, stopped or dose reduced: Was study medication reintroduced (or dose increased)?
Description

Trial medication

Data type

boolean

Alias
UMLS CUI [1]
C0013227
If yes, did SAE recur?
Description

SAE

Data type

boolean

Alias
UMLS CUI [1]
C1519255
Assessment
Description

Assessment

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C1516048
The SAE is probably associated with:
Description

sae

Data type

integer

Alias
UMLS CUI [1]
C1706737
Please specify
Description

Specify SAE

Data type

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C1519255
Back to the top of the page

Similar models

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

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Serious Adverse Events (SAE)
C1519255 (UMLS CUI-1)
Name
Item
Person Reporting SAE
text
C0008961 (UMLS CUI [1])
Diagnosis
Item
Serious Adverse Event (Please print clearly) GSK Use
text
C1519255 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Specify reason(s) for considering this a serious AE. Mark all that apply.
integer
C0392360 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Reason
Code List
Specify reason(s) for considering this a serious AE. Mark all that apply.
CL Item
results in Death (1)
CL Item
life threatening (2)
CL Item
requires hospitalization or prolongation of existing hospitalization (3)
CL Item
results in disability/incapacity (4)
CL Item
congenital anomaly/birth defect (5)
CL Item
other (see definition) (6)
Specify other reason
Item
Specify other reason
text
C0392360 (UMLS CUI [1,1])
C1519255 (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 *If subject died, please inform GSK within 24 hours and complete Form D.
integer
C1705586 (UMLS CUI [1])
Outcome
Code List
Outcome *If subject died, please inform GSK within 24 hours and complete Form D.
CL Item
Resolved (1)
CL Item
Ongoing (2)
CL Item
Died (3)
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])
Item Group
Serious Adverse Event
C1519255 (UMLS CUI-1)
SAE Abation
Item
Did the SAE abate?
boolean
C1519255 (UMLS CUI [1,1])
C3853704 (UMLS CUI [1,2])
Trial medication
Item
If study medication was interrupted, stopped or dose reduced: Was study medication reintroduced (or dose increased)?
boolean
C0013227 (UMLS CUI [1])
SAE
Item
If yes, did SAE recur?
boolean
C1519255 (UMLS CUI [1])
Item Group
Assessment
C1519255 (UMLS CUI-1)
C1516048 (UMLS CUI-2)
Item
The SAE is probably associated with:
integer
C1706737 (UMLS CUI [1])
sae
Code List
The SAE is probably associated with:
CL Item
Protocol design or procedures (but not to study drug) (1)
CL Item
Another condition (eg, condition under study, intercurrent illness) (2)
CL Item
Another drug (3)
Specify SAE
Item
Please specify
text
C0392360 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial