ID

17590

Descrição

NCT00428090 / GSK-AVA105640 A 24-week, double-blind, double-dummy, randomized, parallel-group study to investigate the effects of rosiglitazone (extended release tablets), donepezil, and placebo as monotherapy on cognition and overall clinical response in APOE e4-stratified subjects with mild to moderate Alzheimer’s disease. (REFLECT-1)

Palavras-chave

  1. 18/09/2016 18/09/2016 -
  2. 25/09/2016 25/09/2016 -
Transferido a

25 de setembro de 2016

DOI

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Licença

Creative Commons BY-NC-ND 3.0

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REFLECT-1 Concomitant Medication NCT00428090

REFLECT-1 Non-Serious Adverse Events NCT00428090

Patient Information
Descrição

Patient Information

Alias
UMLS CUI-1
C1955348
Subject Identifier
Descrição

Patient Study ID

Tipo de dados

text

Alias
UMLS CUI [1]
C2348585
Concomitant Medication
Descrição

Concomitant Medication

Alias
UMLS CUI-1
C2347852
Where any concomitant medications taken by the subject during the study?
Descrição

Concomitant Medications

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2347852
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.
Descrição

Drug Name

Tipo de dados

text

Alias
UMLS CUI [1]
C0013227
Total Daily Dose (e.g. 400) 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.
Descrição

Total Daily Dose

Tipo de dados

text

Alias
UMLS CUI [1]
C2348070
Units (e.g. mg) 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.
Descrição

Units

Tipo de dados

text

Alias
UMLS CUI [1]
C1519795
Route (e.g. PO) 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.
Descrição

Route

Tipo de dados

text

Alias
UMLS CUI [1]
C0013153
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.
Descrição

Reason for Medication

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0013227
Start Date (Day Month Year) (e.g. 31 MAY 02) 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.
Descrição

Start date

Tipo de dados

date

Unidades de medida
  • dd/MMM/yy
Alias
UMLS CUI [1]
C0013227
dd/MMM/yy
Stop Date (Day Month Year) (e.g. 31 MAY 02) 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.
Descrição

Stop Date

Tipo de dados

date

Alias
UMLS CUI [1]
C0806020
Ongoing Medication (Yes - No) 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.
Descrição

Ongoing Medication

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2826666

Similar models

REFLECT-1 Non-Serious Adverse Events NCT00428090

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Patient Information
C1955348 (UMLS CUI-1)
Patient Study ID
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Item Group
Concomitant Medication
C2347852 (UMLS CUI-1)
Concomitant Medications
Item
Where any concomitant medications taken by the subject during the study?
boolean
C2347852 (UMLS CUI [1])
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) 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
C2348070 (UMLS CUI [1])
Units
Item
Units (e.g. mg) 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
C1519795 (UMLS CUI [1])
Route
Item
Route (e.g. PO) 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
C0013153 (UMLS CUI [1])
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])
Start date
Item
Start Date (Day Month Year) (e.g. 31 MAY 02) 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.
date
C0013227 (UMLS CUI [1])
Stop Date
Item
Stop Date (Day Month Year) (e.g. 31 MAY 02) 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.
date
C0806020 (UMLS CUI [1])
Ongoing Medication
Item
Ongoing Medication (Yes - No) 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.
boolean
C2826666 (UMLS CUI [1])

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