ID

22170

Description

This is an open-label extension to study 49653/461, to assess the long-term safety of rosiglitazone (extended release tablets) in subjects with mild to moderate Alzheimer's Disease. GSK Source & Descriptions: https://clinicaltrials.gov/ct2/show/NCT00381238?term=NCT00381238&rank=1

Link

https://clinicaltrials.gov/ct2/show/NCT00381238?term=NCT00381238&rank=1

Keywords

  1. 5/9/17 5/9/17 -
  2. 5/22/17 5/22/17 -
Uploaded on

May 22, 2017

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Investigational Product Visit 1 (Week 0) Open-Label Extension Assessing Long-Term Safety Of Rosiglitazone In Subjects With Mild To Moderate Alzheimer's Disease NCT00381238

Laboratory Data Open-Label Extension Assessing Long-Term Safety Of Rosiglitazone In Subjects With Mild To Moderate Alzheimer's Disease NCT00381238

Investigational Product
Description

Investigational Product

Alias
UMLS CUI-1
C0304229
Has the subject missed investigational product for >7 days? (e.g Bottle 1)
Description

Investigational Product

Data type

boolean

Alias
UMLS CUI [1]
C0304229
Investigational Product (e.g Bottle A)
Description

Investigational Product

Data type

integer

Alias
UMLS CUI [1]
C0304229
Start Date (e.g. 05 Jun 02)
Description

Start Date

Data type

date

Measurement units
  • dd/MMM/yy
Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0808070
dd/MMM/yy
Stop Date (e.g. 10 Jun 02)
Description

Stop Date

Data type

date

Measurement units
  • dd/MMM/yy
Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0806020
dd/MMM/yy
Dose
Description

Dose

Data type

float

Measurement units
  • mg
Alias
UMLS CUI [1]
C3174092
mg
Compliance
Description

Compliance

Alias
UMLS CUI-1
C1321605
Total number of Tablets Dispensed
Description

Total number of Tablets Dispensed

Data type

float

Alias
UMLS CUI [1,1]
C0805077
UMLS CUI [1,2]
C0039225
Total number of Tablets Returned
Description

Total number of Tablets Returned

Data type

float

Alias
UMLS CUI [1,1]
C2699071
UMLS CUI [1,2]
C0039225
Treatment Confirmation
Description

Treatment Confirmation

Alias
UMLS CUI-1
C0750484
UMLS CUI-2
C0087111
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
Description

Therapeutic Procedures

Data type

boolean

Alias
UMLS CUI [1]
C0087111
If No, record reasons
Description

If No

Data type

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2348235

Similar models

Laboratory Data Open-Label Extension Assessing Long-Term Safety Of Rosiglitazone In Subjects With Mild To Moderate Alzheimer's Disease NCT00381238

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Investigational Product
C0304229 (UMLS CUI-1)
Investigational Product
Item
Has the subject missed investigational product for >7 days? (e.g Bottle 1)
boolean
C0304229 (UMLS CUI [1])
Item
Investigational Product (e.g Bottle A)
integer
C0304229 (UMLS CUI [1])
Code List
Investigational Product (e.g Bottle A)
CL Item
Bottle A (1)
CL Item
Bottle B (2)
CL Item
Bottle C (3)
CL Item
Bottle D (4)
Start Date
Item
Start Date (e.g. 05 Jun 02)
date
C0304229 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Stop Date
Item
Stop Date (e.g. 10 Jun 02)
date
C0304229 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Dose
Item
Dose
float
C3174092 (UMLS CUI [1])
Item Group
Compliance
C1321605 (UMLS CUI-1)
Total number of Tablets Dispensed
Item
Total number of Tablets Dispensed
float
C0805077 (UMLS CUI [1,1])
C0039225 (UMLS CUI [1,2])
Total number of Tablets Returned
Item
Total number of Tablets Returned
float
C2699071 (UMLS CUI [1,1])
C0039225 (UMLS CUI [1,2])
Item Group
Treatment Confirmation
C0750484 (UMLS CUI-1)
C0087111 (UMLS CUI-2)
Therapeutic Procedures
Item
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
boolean
C0087111 (UMLS CUI [1])
If No
Item
If No, record reasons
text
C0087111 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

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