Englisch

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

1 Formulare  
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]
C1518404
Start Date (Day Month Year) (e.g. 25 JAN 03)
Beschreibung

Start Date

Datentyp

date

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

Start time

Datentyp

time

Maßeinheiten
  • hr:min
Alias
UMLS CUI [1]
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]
C0806020
End Time e.g. 10:20
Beschreibung

End Time

Datentyp

time

Alias
UMLS CUI [1]
C1522314
Frequency
Beschreibung

Frequency

Datentyp

integer

Alias
UMLS CUI [1]
C3476109
Maximum Intensity
Beschreibung

Maximum Intensity

Datentyp

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
Beschreibung

Action Taken with Investigational Product

Datentyp

integer

Alias
UMLS CUI [1]
C1704758
Withdrawal
Beschreibung

Withdrawal

Datentyp

boolean

Alias
UMLS CUI [1]
C2349954
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]
C0085978
UMLS CUI [1,2]
C0877248
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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

1 Formulare
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])
Start Date
Item
Start Date (Day Month Year) (e.g. 25 JAN 03)
date
C0808070 (UMLS CUI [1])
Start time
Item
Start time (e.g. 13:25)
time
C1301880 (UMLS CUI [1])
Item
Outcome
integer
C1705586 (UMLS CUI [1])
Frequency
Code List
Outcome
CL Item
Single episode (1)
CL Item
Intermittent (2)
End Date
Item
End Date e.g. 27 Jan 03
date
C0806020 (UMLS CUI [1])
End Time
Item
End Time e.g. 10:20
time
C1522314 (UMLS CUI [1])
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])
Frequency
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])
Frequency
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])
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
C0085978 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
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