Englisch

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

1 Formulare  
Serious Adverse Event
Beschreibung

Serious Adverse Event

Alias
UMLS CUI-1
C1519255
Did the subject experience a serious adverse events during the study? If YES, record details below.
Beschreibung

Serious Adverse Event (SAE)

Datentyp

boolean

Alias
UMLS CUI [1]
C1519255
Serious Adverse Events (SAE)
Beschreibung

Serious Adverse Events (SAE)

Alias
UMLS CUI-1
C1519255
Event Diagnosis Only (if known) Otherwise Sign/Symptoms e.g. Headache
Beschreibung

Serious Adverse Event

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
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]
C1519255
UMLS CUI [1,2]
C0808070
dd/MMM/yy
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]
C1519255
UMLS CUI [1,2]
C0806020
Frequency
Beschreibung

Frequency

Datentyp

integer

Alias
UMLS CUI [1]
C3476109
Maximum Intensity
Beschreibung

Maximum Intensity

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
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]
C1519255
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]
C1519255
UMLS CUI [1,2]
C0085978
Fatal Outcome
Beschreibung

Fatal Outcome

Alias
UMLS CUI-1
C1705232
If fatal, was a post-mortem/autopsy performed? If yes, summaries findings in Section 11 Narrative Remarks of this SAE form.
Beschreibung

Fatal

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C0004398
Section 2 Seriousness
Beschreibung

Section 2 Seriousness

Alias
UMLS CUI-1
C1710056
Specify reson(s) for considering this a SAE, check all that apply:
Beschreibung

Specification SAE

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2348235
Specify other:
Beschreibung

Specification other

Datentyp

text

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C2348235
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Ähnliche Modelle

Serious Adverse Event (SAE) 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
Serious Adverse Event
C1519255 (UMLS CUI-1)
Serious Adverse Event (SAE)
Item
Did the subject experience a serious adverse events during the study? If YES, record details below.
boolean
C1519255 (UMLS CUI [1])
Item Group
Serious Adverse Events (SAE)
C1519255 (UMLS CUI-1)
Serious Adverse Event
Item
Event Diagnosis Only (if known) Otherwise Sign/Symptoms e.g. Headache
text
C1519255 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Start Date
Item
Start Date (Day Month Year) (e.g. 25 JAN 03)
date
C1519255 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
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
C1519255 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Frequency
integer
C3476109 (UMLS CUI [1])
Frequency
Code List
Frequency
CL Item
Single episode (1)
CL Item
Intermittent (2)
Item
Maximum Intensity
integer
C1519255 (UMLS CUI [1,1])
C0518690 (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 [1,1])
C1519255 (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
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
Item Group
Fatal Outcome
C1705232 (UMLS CUI-1)
Fatal
Item
If fatal, was a post-mortem/autopsy performed? If yes, summaries findings in Section 11 Narrative Remarks of this SAE form.
boolean
C1705586 (UMLS CUI [1,1])
C0004398 (UMLS CUI [1,2])
Item Group
Section 2 Seriousness
C1710056 (UMLS CUI-1)
Item
Specify reson(s) for considering this a SAE, check all that apply:
integer
C1519255 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Specification
Code List
Specify reson(s) for considering this a SAE, check all that apply:
CL Item
Results in death (1)
CL Item
Is life-threatening (2)
CL Item
Requires hospitalisation or prolongation of existing hospitalization (3)
CL Item
Results in disability/incapicity (4)
CL Item
Congenital abnormality/birth defect (5)
CL Item
Other (6)
Specification other
Item
Specify other:
text
C1710056 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
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