ID

22173

Beschreibung

This is an open-label extension to study 49653/461, to assess the long-term safety of rosiglitazone (extended release tablets) in subjects with mild to moderate Alzheimer's Disease. GSK Source & Descriptions: https://clinicaltrials.gov/ct2/show/NCT00381238?term=NCT00381238&rank=1

Link

https://clinicaltrials.gov/ct2/show/NCT00381238?term=NCT00381238&rank=1

Stichworte

  1. 09.05.17 09.05.17 -
  2. 22.05.17 22.05.17 -
Hochgeladen am

22. Mai 2017

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY-NC 3.0

Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Non-Serious Adverse Events (AE) Open-Label Extension Assessing Long-Term Safety Of Rosiglitazone In Subjects With Mild To Moderate Alzheimer's Disease NCT00381238

Non-Serious Adverse Events (AE) Open-Label Extension Assessing Long-Term Safety Of Rosiglitazone In Subjects With Mild To Moderate Alzheimer's Disease NCT00381238

Non-Serious Adverse Event
Beschreibung

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.
Beschreibung

Non serious adverse event

Datentyp

boolean

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

Non-Serious Adverse Events (AE)

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

Non-Serious Adverse Event

Datentyp

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0011900
Start Date (Day Month Year) (e.g. 25 JAN 03)
Beschreibung

Start Date

Datentyp

date

Maßeinheiten
  • dd/MMM/yy
Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0808070
dd/MMM/yy
Start time (e.g. 13:25)
Beschreibung

Start time

Datentyp

time

Maßeinheiten
  • hr:min
Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1301880
hr:min
Outcome
Beschreibung

Outcome

Datentyp

integer

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

End Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0806020
End Time e.g. 10:20
Beschreibung

End Time

Datentyp

time

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1522314
Frequency
Beschreibung

Frequency

Datentyp

integer

Alias
UMLS CUI [1]
C3476109
Maximum Intensity
Beschreibung

Maximum Intensity

Datentyp

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0518690
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
Beschreibung

Action Taken with Investigational Product

Datentyp

integer

Alias
UMLS CUI [1]
C1704758
Withdrawal
Beschreibung

Withdrawal

Datentyp

boolean

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

Relationship to Investigational Product

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0085978

Ähnliche Modelle

Non-Serious Adverse Events (AE) Open-Label Extension Assessing Long-Term Safety Of Rosiglitazone In Subjects With Mild To Moderate Alzheimer's Disease NCT00381238

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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 [1,1])
C0011900 (UMLS CUI [1,2])
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])
Code List
Outcome
CL Item
Single episode (1)
CL Item
Intermittent (2)
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])
Code List
Frequency
CL Item
Single episode (1)
CL Item
Intermittent (2)
Item
Maximum Intensity
integer
C1518404 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Code List
Maximum Intensity
CL Item
Single episode (1)
CL Item
Intermittent (2)
Item
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
integer
C1704758 (UMLS CUI [1])
Code List
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
CL Item
Single episode (1)
CL Item
Intermittent (2)
Withdrawal
Item
Withdrawal
boolean
C2349954 (UMLS CUI [1,1])
C1518404 (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
C1518404 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video