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Falhas:
ID
17785
Descrição
NCT00334568/ GSK-AVA100193: M.Alzheimer GSK A 24 week double-blind, randomized, placebo-controlled, parallel-group dose-raging study to investigate the effects of rosiglitazone (extended release tablets) on cognition in subjects with mild to moderate Alzheimer´s disease. Medicine: rosiglitazone, Condition: Alzheimer´s Disease, Phase: 2, Clinical Study ID: AVA 100193, Sponsor: GSK. This ODM contains the Running Logs.
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Versões (2)
- 03/10/2016 03/10/2016 -
- 09/12/2016 09/12/2016 -
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3 de outubro de 2016
DOI
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Licença
Creative Commons BY-NC 3.0
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NCT00334568/ GSK-AVA100193: M.Alzheimer GSK - Running Logs
NCT00334568/ GSK-AVA100193: M.Alzheimer GSK - Running Logs
- StudyEvent: ODM
Similar models
NCT00334568/ GSK-AVA100193: M.Alzheimer GSK - Running Logs
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Protocol Identifier
Item
Protocol Identifier: AVA100193
boolean
Subject Identifier
Item
Subject Identifier
integer
Concomitant Medications
Item
Were any concomitant medications taken by the subject during the study?
boolean
Non-Serious Adverse Events
Item
Did the subject experience any non-serious adverse events during the study?
boolean
Drug Name
Item
Drug Name (Trade Name preferred) (e.g. Aspirin) If `YES`, record each medication on a seperate line using Trade Names where possible. If the medication is related to an Adverse Event or Serious Adverse Event, details should be expressed using the same terminology.
text
C0013227 (UMLS CUI [1])
Total Daily Dose
Item
Total Daily Dose (e.g 400)
integer
Units
Item
Units (e.g mg)
text
C1519795 (UMLS CUI [1])
Route
Item
Route (e.g PO)
text
Reason for Medication
Item
Reason for Medication (e.g. Headache) If `YES`, record each medication on a seperate line using Trade Names where possible. If the medication is related to an Adverse Event or Serious Adverse Event, details should be expressed using the same terminology.
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
Start Date
Item
Start Date
date
Stop Date
Item
Stop Date
date
Ongoing Medication
Item
Ongoing Medication?
boolean
C2826666 (UMLS CUI [1])
Event
Item
Event (Diagnosis Only - if known - Otherwise Sign/Symptom)
text
Start Date
Item
Start Date
date
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered/Resolved with sequelae (4)
End Date
Item
End Date
date
Item
Maximum Intensity
integer
C0518690 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (X)
Item
Actions Taken with Investigational Product(s) as a Result of the Non-Serious AE
text
Code List
Actions Taken with Investigational Product(s) as a Result of the Non-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 (X)
Withdrawal
Item
Did the subject withdraw from study as a result of this AE?
boolean
Relationship to Investigational Product(s)
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
Item Group
Serious Adverse Event (SAE) - General Information
Protocol Identifier
Item
Protocol Identifier: AVA100193
boolean
Subject Identifier
Item
Subject Identifier
integer
Centre/Investigation Number
Item
Centre/Investigation Number
integer
Randomization Number
Item
Randomization Number
integer
SAE
Item
Did the subject experience a serious adverse event during the study? If Yes, record details below.
boolean
Event
Item
Event (diagnosis only, otherwise sign/symptom)
text
C0877248 (UMLS CUI [1])
Start Date
Item
Start Date
date
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered/Resolved with sequelae (4)
CL Item
Fatal (5)
End Date
Item
End Date
date
Item
Maximum Intensity
integer
C0518690 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (X)
Item
Action Taken with Investigational Product as a Result of the SAE 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). Note: If this is a Serious Adverse Event (SAE), do not complete this form, go to the SAE section and complete the SAE form.
integer
Code List
Action Taken with Investigational Product as a Result of the SAE 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). Note: If this is a Serious Adverse Event (SAE), do not complete this form, go to the SAE section and complete the SAE form.
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
Relationship to Investigational Product
Item
Is there a reasonable possibility the SAE may have been caused by the investigational product?
boolean
Autopsy
Item
IF fatal, was a post-mortem/autopsy perfomed? (If `Yes`, summarise findings in Section 11 Narrative Remarks on this SAE form.)
boolean
C0004398 (UMLS CUI [1])
CL Item
Results in death (1)
CL Item
Is life-threatening (2)
CL Item
Requires hospitalization or prolongation of existing hospitalization (3)
CL Item
Results in disability/Incapacity (4)
CL Item
Congenital anomaly/birth defect (5)
CL Item
Other (specify) (6)
Specification of Other
Item
If other, please specify
text
Item Group
Serious Adverse Event (SAE) - Section III Demography Data
Date of birth
Item
Date of birth
date
CL Item
Male (1)
CL Item
Female (2)
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
text
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
Possible Causes of SAE Other Than Investigational Product(s)
text
Code List
Possible Causes of SAE Other Than Investigational Product(s)
CL Item
Disease under study (1)
CL Item
Medical condition(s) (2)
CL Item
Lack of efficacy (3)
CL Item
Withdrawal of investigational product(s) (4)
CL Item
Concomitant medication (5)
CL Item
Activity related to study participation (6)
CL Item
Other (specify) (7)
Specification of Other
Item
If Other, please specify
text
Medical Condition
Item
Specify any RELEVANT past or current medical disorder, allergies, surgeries, etc. that can help explain the SAE:
text
C0012634 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Date of onset
Item
Date of onset
date
C0574845 (UMLS CUI [1])
Current Condition while SAE
Item
Condition Present at Time of the SAE?
boolean
C3827351 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
If No, Date of Last Occurrence
Item
If No, Date of Last Occurrence
date
Other RELEVANT Risk Factors
Item
Other RELEVANT Risk Factors
text
Item Group
Serious Adverse Event (SAE) - Section VIII - Relevant Concomitant Medications
Drug Name
Item
Drug Name (Trade Name preferred) (e.g. Zantac)
text
C2360065 (UMLS CUI [1])
Dose (e.g 150)
Item
Dose (e.g 150)
integer
Unit (e.g ml)
Item
Unit (e.g ml)
text
Frequency (e.g BID)
Item
Frequency (e.g BID)
text
Route (e.g PO)
Item
Route (e.g PO)
text
Taken Prior to Study?
Item
Taken Prior to Study?
boolean
Start Date
Item
Start Date
date
Stop Date
Item
Stop Date
date
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])
C0013227 (UMLS CUI [1,2])
Details of Investigational Product(s)
Item
Details of Investigational Product(s)
text
Item
Was randomisation code broken at investigational site?
text
Code List
Was randomisation code broken at investigational site?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not applicable (3)
Details of RELEVANT Assessments
Item
Details of RELEVANT Assessments
text
Narrative Remarks
Item
Narrative Remarks (provide a brief narrative description of the SAE and details of treatment given)
text
Investigator´s signature
Item
Investigator´s signature
text
Investigator´s name (print)
Item
Investigator´s name (print)
text
Date
Item
Date
date