Engels

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

1 Formulieren  
Serious Adverse Event
Beschrijving

Serious Adverse Event

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

Serious Adverse Event (SAE)

Datatype

boolean

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

Serious Adverse Events (SAE)

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

Serious Adverse Event

Datatype

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0011900
Start Date (Day Month Year) (e.g. 25 JAN 03)
Beschrijving

Start Date

Datatype

date

Maateenheden
  • dd/MMM/yy
Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0808070
dd/MMM/yy
Outcome
Beschrijving

Outcome

Datatype

integer

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

End Date

Datatype

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0806020
Frequency
Beschrijving

Frequency

Datatype

integer

Alias
UMLS CUI [1]
C3476109
Maximum Intensity
Beschrijving

Maximum Intensity

Datatype

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
Beschrijving

Action Taken with Investigational Product

Datatype

integer

Alias
UMLS CUI [1]
C1704758
Withdrawal
Beschrijving

Withdrawal

Datatype

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?
Beschrijving

Relationship to Investigational Product

Datatype

boolean

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

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.
Beschrijving

Fatal

Datatype

boolean

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

Section 2 Seriousness

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

Specification SAE

Datatype

integer

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

Specification other

Datatype

text

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C2348235
Terug naar het begin van de pagina

Similar models

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

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Terug naar het begin van de pagina