ID

17464

Descrizione

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 Book 4/Visit 4.

Keywords

versioni (3)
  1. 16/09/16 16/09/16 -
  2. 02/10/16 02/10/16 -
  3. 14/12/16 14/12/16 -
Caricato su

16 settembre 2016

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY-NC 3.0
Commenti del modello :

Puoi commentare il modello dati qui. Tramite i fumetti nei gruppi di articoli e articoli è possibile aggiungere commenti a quelli in modo specifico.

Torna ai commenti del modello
Commenti del gruppo di articoli per :

Commenti dell'articolo per :

Per scaricare i modelli di dati devi essere registrato. Per favore accesso o registrati GRATIS.

NCT00334568/ GSK-AVA100193: M.Alzheimer GSK - Book 4

Inglese

NCT00334568/ GSK-AVA100193: M.Alzheimer GSK - Book 4

1 moduli  
General information
Descrizione

General information

Protocol Identifier: AVA100193
Descrizione

Protocol Identifier

Tipo di dati

boolean

Subject Identifier
Descrizione

Subject Identifier

Tipo di dati

integer

Visit Date
Descrizione

Visit Date

Tipo di dati

date

Visit Description: Visit 4
Descrizione

Visit Description

Tipo di dati

boolean

Subject Continuation (See Description)
Descrizione

If the subject is not continuing the study, complete all assessments for this visit, and also the Early Withdrawal ADAS-cog and CIBIC+ assessments in the Assessment Scale and CIBIC+ folders. The ADAS-cog and CIBIC+ results should then be recorded on the pages at the end of this visit. Ensure that all sections of the CRF (including the Study Conclusion page) are completed appropriately. Schedule an early withdrawal follow-up visit for 14 +/- 7 days after this visit. Make a Withdrawal call to the IVRS system.

Tipo di dati

boolean

Vital signs
Descrizione

Vital signs

Weight
Descrizione

Weight

Tipo di dati

integer

Unità di misura
  • kg
kg
Blood pressure (See Description): Systolic
Descrizione

Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.

Tipo di dati

integer

Blood pressure: Diastolic
Descrizione

Blood pressure

Tipo di dati

integer

Unità di misura
  • mmHg
mmHg
Heart rate
Descrizione

Heart rate

Tipo di dati

integer

Unità di misura
  • bpm
bpm
Central Laboratory (Non Fasting Samples)
Descrizione

Central Laboratory (Non Fasting Samples)

Date samples taken
Descrizione

Date samples taken

Tipo di dati

date

Concomitant Medications (See Description)
Descrizione

Concomitant Medications (See Description)

Adverse Events (See Description)
Descrizione

Adverse Events (See Description)

Physical Examination (See Description)
Descrizione

Physical Examination (See Description)

Pedal Oedema (See Description)
Descrizione

Pedal Oedema (See Description)

Depth of Indentation
Descrizione

Depth of Indentation

Tipo di dati

text

Indication which ankle was assessed at this visit
Descrizione

Indication which ankle was assessed at this visit

Tipo di dati

text

Monitor Data Validation Checks (See Description)
Descrizione

Monitor Data Validation Checks (See Description)

Investigational Product (See Description)
Descrizione

Investigational Product (See Description)

Investigational Product
Descrizione

Investigational Product

Tipo di dati

text

Start Date
Descrizione

Start Date

Tipo di dati

date

Stop Date
Descrizione

Stop Date

Tipo di dati

date

IP Container No.
Descrizione

IP Container No.

Tipo di dati

integer

Total Number of Tablets Dispensed
Descrizione

Total Number of Tablets Dispensed

Tipo di dati

float

Total Number of Tablets Returned
Descrizione

Total Number of Tablets Returned

Tipo di dati

float

Has the subject missed investigational product for > 7 consecutive days?
Descrizione

Discontinuation

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0457454
End of visit reminder
Descrizione

End of visit reminder

Ritorna all'inizio della pagina

Similar models

NCT00334568/ GSK-AVA100193: M.Alzheimer GSK - Book 4

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
General information
Protocol Identifier
Item
Protocol Identifier: AVA100193
boolean
Subject Identifier
Item
Subject Identifier
integer
Visit Date
Item
Visit Date
date
Visit Description
Item
Visit Description: Visit 4
boolean
Subject Continuation
Item
Subject Continuation (See Description)
boolean
Item Group
Vital signs
Weight
Item
Weight
integer
Blood pressure (See Description)
Item
Blood pressure (See Description): Systolic
integer
Blood pressure
Item
Blood pressure: Diastolic
integer
Heart rate
Item
Heart rate
integer
Item Group
Central Laboratory (Non Fasting Samples)
Date samples taken
Item
Date samples taken
date
Item Group
Concomitant Medications (See Description)
Item Group
Adverse Events (See Description)
Item Group
Physical Examination (See Description)
Item Group
Pedal Oedema (See Description)
Item
Depth of Indentation
text
Depth of Indentation
Code List
Depth of Indentation
CL Item
< 1 mm (1)
CL Item
1-2 mm (2)
CL Item
3-5 mm (3)
CL Item
6-10 mm (4)
CL Item
> 10 mm (5)
Item
Indication which ankle was assessed at this visit
text
Indication which ankle was assessed at this visit
Code List
Indication which ankle was assessed at this visit
CL Item
Right ankle (1)
CL Item
Left ankle (2)
Item Group
Monitor Data Validation Checks (See Description)
Item Group
Investigational Product (See Description)
Investigational Product
Item
Investigational Product
text
Start Date
Item
Start Date
date
Stop Date
Item
Stop Date
date
IP Container No.
Item
IP Container No.
integer
Total Number of Tablets Dispensed
Item
Total Number of Tablets Dispensed
float
Total Number of Tablets Returned
Item
Total Number of Tablets Returned
float
Discontinuation
Item
Has the subject missed investigational product for > 7 consecutive days?
boolean
C0457454 (UMLS CUI [1])
Item Group
End of visit reminder
Ritorna all'inizio della pagina 

Contatto

Si prega di utilizzare questo modulo per feedback, domande e suggerimenti per miglioramenti.

I campi contrassegnati da * sono obbligatori.

Aiuto

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial