ID

20085

Description

An open-label extension to study AVA100193, to assess the long-term safety and efficacy of rosiglitazone (extended release tablets) in subjects with mild to moderate Alzheimer's disease Medicine: rosiglitazone, Condition: Alzheimer's Disease, Phase: 2, Clinical Study ID: AVA100468, Sponsor: GSK

Mots-clés

Versions (2)
  1. 02/02/2017 02/02/2017 -
  2. 06/02/2017 06/02/2017 -
Téléchargé le

6 février 2017

DOI

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Licence

Creative Commons BY-NC 3.0
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Running Logs Serious Adverse Events GSK-AVA100468 NCT00381238

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Running Logs Serious Adverse Events GSK-AVA100468 NCT00381238

1 Formulaires  
Serious Adverse Event
Description

Serious Adverse Event

Alias
UMLS CUI-1
C1519255
Event (diagnosis only, otherwise sign/symptom)
Description

Event

Type de données

text

Alias
UMLS CUI [1]
C1519255
Start Date
Description

Start Date

Type de données

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C1519255
Outcome
Description

Outcome

Type de données

integer

Alias
UMLS CUI [1]
C1705586
End Date
Description

End Date

Type de données

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1519255
Maximum Intensity
Description

Maximum Intensity

Type de données

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C1519255
Action Taken with Investigational Product(s) as a Result of the Serious AE
Description

Investigational product(s) withdrawn = Administration of investigational product(s) was permanently discontinued. Dose reduced = Dose is reduced for one or more investigational product(s). Dose increased = Dose increased for one or more investigational product(s). Dose not changed = Investigational product(s) continues even though an adverse event has occured. Dose interrupted = Administration of one or more investigational product(s) was stopped temporarily but then restarted. Not applicable = Subject was not receiving investigational product(s) when the event occurred (e.g., pre- or post-dosing).

Type de données

integer

Alias
UMLS CUI [1,1]
C1704758
UMLS CUI [1,2]
C1519255
Did the subject withdraw from study as a result of this SAE?
Description

Withdrawal

Type de données

boolean

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C1519255
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Description

Relationship to investigational products

Type de données

boolean

Alias
UMLS CUI [1,1]
C0085978
UMLS CUI [1,2]
C1519255
Seriousness
Description

Seriousness

Alias
UMLS CUI-1
C0871902
UMLS CUI-2
C1519255
Seriousness: Specify reason(s) for considering this a SAE, tick all that apply:
Description

Seriousness

Type de données

integer

Alias
UMLS CUI [1]
C1710056
Seriousness: If other, specify:
Description

Seriousness Other

Type de données

text

Alias
UMLS CUI [1]
C1710056
Demography Data
Description

Demography Data

Alias
UMLS CUI-1
C1704791
Date of birth
Description

Date of birth

Type de données

date

Alias
UMLS CUI [1]
C0421451
Sex
Description

Sex

Type de données

integer

Alias
UMLS CUI [1]
C0079399
Weight
Description

Weight

Type de données

float

Unités de mesure
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Investigational Product
Description

Investigational Product

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C1519255
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
Description

Investigational Product

Type de données

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1519255
Cause of SAE
Description

Cause of SAE

Alias
UMLS CUI-1
C0015127
UMLS CUI-2
C1519255
Possible Cause of SAE other than investigational Product(s), tick all that apply:
Description

Possible Cause of SAE

Type de données

integer

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C1519255
Possible Cause of SAE other than investigational Product(s), if other, specify:
Description

Possible Cause of SAE Other

Type de données

text

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C1519255
Relevant Medical Conditions
Description

Relevant Medical Conditions

Alias
UMLS CUI-1
C0262926
Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
Description

medical condition

Type de données

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C1519255
Date of Onset
Description

medical condition date

Type de données

date

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C1519255
Condition present at the time of the SAE?
Description

medical condition presence

Type de données

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C1519255
If no, Date of last occurence:
Description

medical condition occurence

Type de données

date

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C1519255
Risk Factors
Description

Risk Factors

Alias
UMLS CUI-1
C0035648
Other RELEVANT Risk Factors (e.g. smoking, alcohol, diet, drug abuse, accupational hazard) relevant to the SAE
Description

Risk Factors

Type de données

text

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C1519255
Concomitant medications
Description

Concomitant medications

Alias
UMLS CUI-1
C2347852
Drug name (Trade Name preferred)
Description

Drug name

Type de données

text

Alias
UMLS CUI [1]
C0013227
Dose
Description

Dose

Type de données

text

Alias
UMLS CUI [1]
C3174092
Unit
Description

Unit

Type de données

text

Alias
UMLS CUI [1]
C1519795
Frequency
Description

Medication frequency

Type de données

text

Alias
UMLS CUI [1]
C3476109
Route
Description

Route

Type de données

text

Alias
UMLS CUI [1]
C0013153
Taken Prior to Study?
Description

Taken Prior to Study

Type de données

boolean

Alias
UMLS CUI [1]
C2826667
Start Date
Description

Start Date

Type de données

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C2347852
Stop Date
Description

Stop Date

Type de données

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C2347852
Ongoing Medication?
Description

Ongoing Medication

Type de données

boolean

Alias
UMLS CUI [1]
C2826666
Reason for Medication (e.g. Gastric Ulcer)
Description

Reason for Medication

Type de données

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0013227
Investigational Product
Description

Investigational Product

Alias
UMLS CUI-1
C0304229
Details of Investigational Product(s)
Description

Investigational Product

Type de données

text

Alias
UMLS CUI [1]
C0304229
Was randomisation code broken at investigational site?
Description

Investigational Product randomisation

Type de données

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0034656
Assessments
Description

Assessments

Alias
UMLS CUI-1
C0220825
Details of RELEVANT assessments.
Description

Assessment

Type de données

text

Alias
UMLS CUI [1,1]
C1516048
UMLS CUI [1,2]
C1519255
Narrative Remarks
Description

Narrative Remarks

Alias
UMLS CUI-1
C0947611
Narrative Remarks (provide a brief narrative description of the SAE and details of tretment given).
Description

Narrative Remarks

Type de données

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C1519255
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Similar models

Running Logs Serious Adverse Events GSK-AVA100468 NCT00381238

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Serious Adverse Event
C1519255 (UMLS CUI-1)
Event
Item
Event (diagnosis only, otherwise sign/symptom)
text
C1519255 (UMLS CUI [1])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Outcome
integer
C1705586 (UMLS CUI [1])
Outcome
Code List
Outcome
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not Recovered/Not Resolved (3)
End Date
Item
End Date
date
C0806020 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Maximum Intensity
integer
C0518690 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Maximum Intensity
Code List
Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (4)
Item
Action Taken with Investigational Product(s) as a Result of the Serious AE
integer
C1704758 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Action Taken with Investigational Product
Code List
Action Taken with Investigational Product(s) as a Result of the Serious AE
CL Item
Investigational product(s) withdrawn  (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (6)
Withdrawal
Item
Did the subject withdraw from study as a result of this SAE?
boolean
C2349954 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Relationship to investigational products
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C0085978 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
Seriousness
C0871902 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
Item
Seriousness: Specify reason(s) for considering this a SAE, tick all that apply:
integer
C1710056 (UMLS CUI [1])
Seriousness
Code List
Seriousness: Specify reason(s) for considering this a SAE, tick all that apply:
CL Item
Results in death (1)
CL Item
Is life-threatening (2)
CL Item
Requires hospitalisation or prolongation of existing hospitalisation (3)
CL Item
Results in disability/incapacity (4)
CL Item
Congenital anomaly/birth defect (5)
CL Item
Other (6)
Seriousness Other
Item
Seriousness: If other, specify:
text
C1710056 (UMLS CUI [1])
Item Group
Demography Data
C1704791 (UMLS CUI-1)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
integer
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Male (1)
CL Item
Female (2)
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item Group
Investigational Product
C0304229 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
Item
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
integer
C0304229 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Investigational Product
Code List
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown at this time (3)
CL Item
Not applicable (4)
Item Group
Cause of SAE
C0015127 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
Item
Possible Cause of SAE other than investigational Product(s), tick all that apply:
integer
C0015127 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Possible Cause of SAE
Code List
Possible Cause of SAE other than investigational Product(s), tick all that apply:
CL Item
Disease under study (1)
CL Item
Medical Condition(s) (record in nect section) (2)
CL Item
Lack of efficacy (3)
CL Item
Withdrawal of Investigational Product(s) (4)
CL Item
Concomitant medication (record) (5)
CL Item
Activity related to study participation (e.g. procedures) (6)
CL Item
Other (7)
Possible Cause of SAE Other
Item
Possible Cause of SAE other than investigational Product(s), if other, specify:
text
C0015127 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
Relevant Medical Conditions
C0262926 (UMLS CUI-1)
medical condition
Item
Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
text
C0262926 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
medical condition date
Item
Date of Onset
date
C0012634 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
medical condition presence
Item
Condition present at the time of the SAE?
boolean
C0012634 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
medical condition occurence
Item
If no, Date of last occurence:
date
C0012634 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Item Group
Risk Factors
C0035648 (UMLS CUI-1)
Risk Factors
Item
Other RELEVANT Risk Factors (e.g. smoking, alcohol, diet, drug abuse, accupational hazard) relevant to the SAE
text
C0035648 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
Concomitant medications
C2347852 (UMLS CUI-1)
Drug name
Item
Drug name (Trade Name preferred)
text
C0013227 (UMLS CUI [1])
Dose
Item
Dose
text
C3174092 (UMLS CUI [1])
Unit
Item
Unit
text
C1519795 (UMLS CUI [1])
Medication frequency
Item
Frequency
text
C3476109 (UMLS CUI [1])
Route
Item
Route
text
C0013153 (UMLS CUI [1])
Taken Prior to Study
Item
Taken Prior to Study?
boolean
C2826667 (UMLS CUI [1])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Ongoing Medication
Item
Ongoing Medication?
boolean
C2826666 (UMLS CUI [1])
Reason for Medication
Item
Reason for Medication (e.g. Gastric Ulcer)
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Item Group
Investigational Product
C0304229 (UMLS CUI-1)
Investigational Product
Item
Details of Investigational Product(s)
text
C0304229 (UMLS CUI [1])
Item
Was randomisation code broken at investigational site?
integer
C0304229 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
Investigational Product randomisation
Code List
Was randomisation code broken at investigational site?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not applicable (3)
Item Group
Assessments
C0220825 (UMLS CUI-1)
Assessment
Item
Details of RELEVANT assessments.
text
C1516048 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
Narrative Remarks
C0947611 (UMLS CUI-1)
Narrative Remarks
Item
Narrative Remarks (provide a brief narrative description of the SAE and details of tretment given).
text
C0947611 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
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