ID

17464

Description

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.

Mots-clés

Versions (3)
  1. 16/09/2016 16/09/2016 -
  2. 02/10/2016 02/10/2016 -
  3. 14/12/2016 14/12/2016 -
Téléchargé le

16 septembre 2016

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0
Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Retour au modèle Commentaires
Groupe Item commentaires pour :

Item commentaires pour :

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

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

Anglais

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

1 Formulaires  
General information
Description

General information

Protocol Identifier: AVA100193
Description

Protocol Identifier

Type de données

boolean

Subject Identifier
Description

Subject Identifier

Type de données

integer

Visit Date
Description

Visit Date

Type de données

date

Visit Description: Visit 4
Description

Visit Description

Type de données

boolean

Subject Continuation (See Description)
Description

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.

Type de données

boolean

Vital signs
Description

Vital signs

Weight
Description

Weight

Type de données

integer

Unités de mesure
  • kg
kg
Blood pressure (See Description): Systolic
Description

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

Type de données

integer

Blood pressure: Diastolic
Description

Blood pressure

Type de données

integer

Unités de mesure
  • mmHg
mmHg
Heart rate
Description

Heart rate

Type de données

integer

Unités de mesure
  • bpm
bpm
Central Laboratory (Non Fasting Samples)
Description

Central Laboratory (Non Fasting Samples)

Date samples taken
Description

Date samples taken

Type de données

date

Concomitant Medications (See Description)
Description

Concomitant Medications (See Description)

Adverse Events (See Description)
Description

Adverse Events (See Description)

Physical Examination (See Description)
Description

Physical Examination (See Description)

Pedal Oedema (See Description)
Description

Pedal Oedema (See Description)

Depth of Indentation
Description

Depth of Indentation

Type de données

text

Indication which ankle was assessed at this visit
Description

Indication which ankle was assessed at this visit

Type de données

text

Monitor Data Validation Checks (See Description)
Description

Monitor Data Validation Checks (See Description)

Investigational Product (See Description)
Description

Investigational Product (See Description)

Investigational Product
Description

Investigational Product

Type de données

text

Start Date
Description

Start Date

Type de données

date

Stop Date
Description

Stop Date

Type de données

date

IP Container No.
Description

IP Container No.

Type de données

integer

Total Number of Tablets Dispensed
Description

Total Number of Tablets Dispensed

Type de données

float

Total Number of Tablets Returned
Description

Total Number of Tablets Returned

Type de données

float

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

Discontinuation

Type de données

boolean

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

End of visit reminder

Retour au début de la page

Similar models

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

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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
Retour au début de la page 

Contact

Utilisez ce formulaire pour les retours, les questions et les améliorations suggérées.

Les champs marqués d’un * sont obligatoires.

Aide

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