ID

22344

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 (2)
  1. 30.05.17 30.05.17 -
  2. 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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Serious Adverse Event Effects of Rosiglitazone on Cerebral Glucose Utilization and Cognition in Subjects With Alzheimer's Disease NCT00265148

Englisch

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

1 Formulare  
Serious Adverse Events (SAE)
Beschreibung

Serious Adverse Events (SAE)

Alias
UMLS CUI-1
C1519255
Person Reporting SAE
Beschreibung

Name

Datentyp

text

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

Diagnosis

Datentyp

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.
Beschreibung

Reason

Datentyp

integer

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

Specify other reason

Datentyp

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C1519255
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 *If subject died, please inform GSK within 24 hours and complete Form D.
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
Serious Adverse Event
Beschreibung

Serious Adverse Event

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

SAE Abation

Datentyp

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)?
Beschreibung

Trial medication

Datentyp

boolean

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

SAE

Datentyp

boolean

Alias
UMLS CUI [1]
C1519255
Assessment
Beschreibung

Assessment

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

sae

Datentyp

integer

Alias
UMLS CUI [1]
C1706737
Please specify
Beschreibung

Specify SAE

Datentyp

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C1519255
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Ähnliche Modelle

Serious 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
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])
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