ID

17700

Beskrivning

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 6/Visit 6.

Nyckelord

Versioner (3)
  1. 2016-09-18 2016-09-18 -
  2. 2016-09-28 2016-09-28 -
  3. 2016-12-05 2016-12-05 -
Uppladdad den

28 september 2016

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 3.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

NCT00334568/ GSK-AVA100193: M.Alzheimer GSK - Book 6

Engelsk

NCT00334568/ GSK-AVA100193: M.Alzheimer GSK - Book 6

1 Formulär  
General Information
Beskrivning

General Information

Protocol Identifier: AVA100193
Beskrivning

Protocol Identifier

Datatyp

boolean

Subject Identifier
Beskrivning

Subject Identifier

Datatyp

integer

Visit Date
Beskrivning

Visit Date

Datatyp

date

Visit Description: Visit 6
Beskrivning

Visit Description

Datatyp

boolean

Subject Continuation (See Description)
Beskrivning

If the subject is not continuing in 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.

Datatyp

boolean

Vital Signs
Beskrivning

Vital Signs

Weight
Beskrivning

Weight

Datatyp

float

Måttenheter
  • kg
kg
Blood pressure (See Description): Systolic
Beskrivning

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

Datatyp

integer

Blood pressure: Diastolic
Beskrivning

Blood pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0005823
mmHg
Heart rate
Beskrivning

Heart rate

Datatyp

integer

Måttenheter
  • bpm
bpm
Central Laboratory (Non fasting samples)
Beskrivning

Central Laboratory (Non fasting samples)

Date samples taken
Beskrivning

Date samples taken

Datatyp

date

Concomitant Medications
Beskrivning

Concomitant Medications

Concomitant Medications
Beskrivning

Concomitant Medications

Datatyp

text

Adverse Events
Beskrivning

Adverse Events

Adverse Events
Beskrivning

Adverse Events

Datatyp

text

Physical Examination
Beskrivning

Physical Examination

Results from Physical Examination
Beskrivning

Results from Physical Examination

Datatyp

text

Pedal Oedema
Beskrivning

Pedal Oedema

Estimated Depth of Indentation
Beskrivning

Estimated Depth of Indentation

Datatyp

text

Indicate which ankle was assessed at this visit
Beskrivning

Ankle

Datatyp

text

Monitor Data Validation Checks
Beskrivning

Monitor Data Validation Checks

Monitor Data Validation Check completed
Beskrivning

Monitor Data Validation Check

Datatyp

boolean

Investigational Product
Beskrivning

Investigational Product

Investigational Product
Beskrivning

Investigational Product

Datatyp

text

Start Date
Beskrivning

Start Date

Datatyp

date

Alias
UMLS CUI [1]
C0808070
Stop Date
Beskrivning

Stop Date

Datatyp

date

IP Container No.
Beskrivning

IP Container No.

Datatyp

integer

Total Number of Tablets Dispensed
Beskrivning

Total Number of Tablets Dispensed

Datatyp

float

Total Number of Tablets Returned
Beskrivning

Total Number of Tablets Returned

Datatyp

float

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

Discontinuation

Datatyp

boolean

Alias
UMLS CUI [1]
C0457454
End of Visit Reminder
Beskrivning

End of Visit Reminder

Visit 7 scheduled
Beskrivning

Visit 7 scheduled

Datatyp

boolean

Tillbaka till toppen

Similar models

NCT00334568/ GSK-AVA100193: M.Alzheimer GSK - Book 6

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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 6
boolean
Subject Continuation (See Description)
Item
Subject Continuation (See Description)
boolean
Item Group
Vital Signs
Weight
Item
Weight
float
Blood pressure (See Description)
Item
Blood pressure (See Description): Systolic
integer
Blood pressure
Item
Blood pressure: Diastolic
integer
C0005823 (UMLS CUI [1])
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
Concomitant Medications
Item
Concomitant Medications
text
Item Group
Adverse Events
Adverse Events
Item
Adverse Events
text
Item Group
Physical Examination
Results from Physical Examination
Item
Results from Physical Examination
text
Item Group
Pedal Oedema
Item
Estimated Depth of Indentation
text
Estimated Depth of Indentation
Code List
Estimated Depth of Indentation
CL Item
< 1mm (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
Indicate which ankle was assessed at this visit
text
Ankle
Code List
Indicate which ankle was assessed at this visit
CL Item
Right Ankle (1)
CL Item
Left Ankle (2)
Item Group
Monitor Data Validation Checks
Monitor Data Validation Check
Item
Monitor Data Validation Check completed
boolean
Item Group
Investigational Product
Investigational Product
Item
Investigational Product
text
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
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
Visit 7 scheduled
Item
Visit 7 scheduled
boolean
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

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