ID

17744

Descrição

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 2/Visit 2.

Palavras-chave

Versões (2)
  1. 12/09/2016 12/09/2016 -
  2. 02/10/2016 02/10/2016 -
Transferido a

2 de outubro de 2016

DOI

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Licença

Creative Commons BY-NC 3.0
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NCT00334568/ GSK-AVA100193: M.Alzheimer GSK - Book 2

Inglês

NCT00334568/ GSK-AVA100193: M.Alzheimer GSK - Book 2

1 Formulários  
General Information
Descrição

General Information

Subject Identifier
Descrição

Subject Identifier

Tipo de dados

integer

Centre/Investigation Number
Descrição

Centre/Investigation Number

Tipo de dados

integer

Study Procedures Chart
Descrição

Study Procedures Chart

Procedure: Informed Consent
Descrição

Procedure: Informed Consent

Tipo de dados

text

Procedure: PGx/PGm Informed Consent
Descrição

Procedure: PGx/PGm Informed Consent

Tipo de dados

text

Procedure: Telephone call to IVRS
Descrição

Procedure: Telephone call to IVRS

Tipo de dados

text

Procedure: Inclusion/Exclusion Criteria Review
Descrição

Procedure: Inclusion/Exclusion Criteria Review

Tipo de dados

text

Procedure: Demographics
Descrição

Procedure: Demographics

Tipo de dados

text

Procedure: Medical history
Descrição

Procedure: Medical history

Tipo de dados

text

Procedure: Concomitant Medication
Descrição

Procedure: Concomitant Medication

Tipo de dados

text

Procedure: Physical Exam
Descrição

Procedure: Physical Exam

Tipo de dados

text

Procedure: Neurological Exam
Descrição

Procedure: Neurological Exam

Tipo de dados

text

Procedure: Vital signs
Descrição

Procedure: Vital signs

Tipo de dados

text

Procedure: Height & Weight
Descrição

Procedure: Height & Weight

Tipo de dados

text

Procedure: ECG
Descrição

Procedure: ECG

Tipo de dados

text

Procedure: Echocardiogram
Descrição

Procedure: Echocardiogram

Tipo de dados

text

Procedure: Chest X-ray
Descrição

Procedure: Chest X-ray

Tipo de dados

text

Procedure: CT Scan
Descrição

Procedure: CT Scan

Tipo de dados

text

Procedure: Fasting Laboratory Samples
Descrição

Procedure: Fasting Laboratory Samples

Tipo de dados

text

Procedure: Non-Fasting Laboratory Samples
Descrição

Procedure: Non-Fasting Laboratory Samples

Tipo de dados

text

Procedure: PGx Sampling
Descrição

Procedure: PGx Sampling

Tipo de dados

text

Procedure: PGm Sampling
Descrição

Procedure: PGm Sampling

Tipo de dados

text

Procedure: HADS
Descrição

Procedure: HADS

Tipo de dados

text

Procedure: MMSE
Descrição

Procedure: MMSE

Tipo de dados

text

Procedure: ADAS-cog
Descrição

Procedure: ADAS-cog

Tipo de dados

text

Procedure: CIBIC+
Descrição

Procedure: CIBIC+

Tipo de dados

text

Procedure: NPI
Descrição

Procedure: NPI

Tipo de dados

text

Procedure: DAD
Descrição

Procedure: DAD

Tipo de dados

text

Procedure: Recording of AEs
Descrição

Procedure: Recording of AEs

Tipo de dados

text

Procedure: Recording of AEs
Descrição

Procedure: Recording of AEs

Tipo de dados

text

Procedure: Review Medication Compliance
Descrição

Procedure: Review Medication Compliance

Tipo de dados

text

Procedure: Study Conclusion Record
Descrição

Procedure: Study Conclusion Record

Tipo de dados

text

Visit 2
Descrição

Visit 2

Subject Identifier
Descrição

Subject Identifier

Tipo de dados

integer

Visit Date
Descrição

Visit Date

Tipo de dados

date

Randomisation
Descrição

Randomisation

Randomisation number
Descrição

Randomisation number

Tipo de dados

integer

Vital signs
Descrição

Vital signs

Weight
Descrição

Weight

Tipo de dados

float

Unidades de medida
  • kg
kg
Blood pressure: Systolic
Descrição

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

Tipo de dados

integer

Blood pressure: Diastolic
Descrição

Blood pressure

Tipo de dados

integer

Unidades de medida
  • mmHg
mmHg
Heart rate
Descrição

Heart rate

Tipo de dados

integer

Unidades de medida
  • bpm
bpm
Central Laboratory (Fasting samples)
Descrição

Central Laboratory (Fasting samples)

Date samples taken
Descrição

Date

Tipo de dados

date

Pharmacogenetic (PGx) and Pharmacogenomic (PGm) Research
Descrição

Solicit written informed consent from the subject (or legally acceptable representative on behalf of the subject) for pharmacogenetic and pharmacogenomic research. Record the outcome, and details of Pharmacogenetic (PGx) sampling (only where consent is obtained) in the Pharmacogenetic and Pharmatogenomic Research section, Pharmacogenomic (PGm) sampling is recorded in the following two sections.

Tipo de dados

boolean

PGm-Transcriptomic Research
Descrição

PGm-Transcriptomic Research

Has a blood sample been collected for PGm-Transcriptomic research?
Descrição

Has a blood sample been collected for PGm-Transcriptomic research?

Tipo de dados

boolean

If yes, record date and time sample taken
Descrição

If yes, record date and time sample taken

Tipo de dados

datetime

PGm-Proteomic Research
Descrição

PGm-Proteomic Research

Has a blood sample been collected for PGm-Poteomic research?
Descrição

Has a blood sample been collected for PGm-Poteomic research?

Tipo de dados

boolean

If yes, record date and time sample taken
Descrição

If yes, record date and time sample taken

Tipo de dados

datetime

Volume of one aliquot
Descrição

Volume of one aliquot

Tipo de dados

float

Unidades de medida
  • ml
ml
Length of time the centrifuge ran
Descrição

Length of time the centrifuge ran

Tipo de dados

integer

Unidades de medida
  • minutes
minutes
Temperature of the centrifuge
Descrição

Temperature of the centrifuge

Tipo de dados

text

Centrifugation speed
Descrição

Centrifugation speed

Tipo de dados

integer

Unidades de medida
  • r.p.m
r.p.m
Centrifugation rotor radius
Descrição

Centrifugation rotor radius

Tipo de dados

integer

Unidades de medida
  • cm
cm
Time aliquotted samples were placed in the freezer
Descrição

Time aliquotted samples were placed in the freezer

Tipo de dados

time

Temperature of freezer
Descrição

Temperature of freezer

Tipo de dados

integer

Unidades de medida
  • °C
°C
Monitor Data Validation Check
Descrição

Monitor Data Validation Check

Results from Monitor Data Validation Check
Descrição

Results from Monitor Data Validation Check

Tipo de dados

text

Investigational product
Descrição

Investigational product

Investigational Product
Descrição

Investigational Product

Tipo de dados

text

Start Date
Descrição

Start Date

Tipo de dados

date

Stop Date
Descrição

Stop Date

Tipo de dados

date

IP Container No.
Descrição

IP Container No.

Tipo de dados

integer

Total Number of Tablets Dispensed
Descrição

Total Number of Tablets Dispensed

Tipo de dados

float

Total Number of Tablets Returned
Descrição

Total Number of Tablets Returned

Tipo de dados

float

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

Discontinuation

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0457454
Schedule Visit 3 for 14 days (+/- 3 days) after this visit. It is not necessary for the subject to be fasted.
Descrição

End of visit reminder

Tipo de dados

boolean

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Similar models

NCT00334568/ GSK-AVA100193: M.Alzheimer GSK - Book 2

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
General Information
Subject Identifier
Item
Subject Identifier
integer
Centre/Investigation Number
Item
Centre/Investigation Number
integer
Item Group
Study Procedures Chart
Item
Procedure: Informed Consent
text
Procedure: Informed Consent
Code List
Procedure: Informed Consent
CL Item
Visit 1, Wk -2 (1)
CL Item
Visit 2, Wk 0 (2)
CL Item
Visit 3, Wk 2 (3)
CL Item
Visit 4, Wk 4 (4)
CL Item
Visit 5, Wk 8 (5)
CL Item
Visit 6, Wk 12 (6)
CL Item
Visit 7, Wk 16 (7)
CL Item
Visit 8, Wk 24 (8)
CL Item
Study End Follow-up, Week 26 (9)
CL Item
Early Withdrawal  (10)
CL Item
Early Withdrawal Follow-up (11)
Item
Procedure: PGx/PGm Informed Consent
text
Procedure: PGx/PGm Informed Consent
Code List
Procedure: PGx/PGm Informed Consent
CL Item
Visit 1, Wk -2 (1)
CL Item
Visit 2, Wk 0 (2)
CL Item
Visit 3, Wk 2 (3)
CL Item
Visit 4, Wk 4 (4)
CL Item
Visit 5, Wk 8 (5)
CL Item
Visit 6, Wk 12 (6)
CL Item
Visit 7, Wk 16 (7)
CL Item
Visit 8, Wk 24 (8)
CL Item
Study End Follow-up, Week 26 (9)
CL Item
Early Withdrawal  (10)
CL Item
Early Withdrawal Follow-up (11)
Item
Procedure: Telephone call to IVRS
text
Procedure: Telephone call to IVRS
Code List
Procedure: Telephone call to IVRS
CL Item
Visit 1, Wk -2 (1)
CL Item
Visit 2, Wk 0 (2)
CL Item
Visit 3, Wk 2 (3)
CL Item
Visit 4, Wk 4 (4)
CL Item
Visit 5, Wk 8 (5)
CL Item
Visit 6, Wk 12 (6)
CL Item
Visit 7, Wk 16 (7)
CL Item
Visit 8, Wk 24 (8)
CL Item
Study End Follow-up, Week 26 (9)
CL Item
Early Withdrawal  (10)
CL Item
Early Withdrawal Follow-up (11)
Item
Procedure: Inclusion/Exclusion Criteria Review
text
Procedure: Inclusion/Exclusion Criteria Review
Code List
Procedure: Inclusion/Exclusion Criteria Review
CL Item
Visit 1, Wk -2 (1)
CL Item
Visit 2, Wk 0 (2)
CL Item
Visit 3, Wk 2 (3)
CL Item
Visit 4, Wk 4 (4)
CL Item
Visit 5, Wk 8 (5)
CL Item
Visit 6, Wk 12 (6)
CL Item
Visit 7, Wk 16 (7)
CL Item
Visit 8, Wk 24 (8)
CL Item
Study End Follow-up, Week 26 (9)
CL Item
Early Withdrawal  (10)
CL Item
Early Withdrawal Follow-up (11)
Item
Procedure: Demographics
text
Procedure: Demographics
Code List
Procedure: Demographics
CL Item
Visit 1, Wk -2 (1)
CL Item
Visit 2, Wk 0 (2)
CL Item
Visit 3, Wk 2 (3)
CL Item
Visit 4, Wk 4 (4)
CL Item
Visit 5, Wk 8 (5)
CL Item
Visit 6, Wk 12 (6)
CL Item
Visit 7, Wk 16 (7)
CL Item
Visit 8, Wk 24 (8)
CL Item
Study End Follow-up, Week 26 (9)
CL Item
Early Withdrawal  (10)
CL Item
Early Withdrawal Follow-up (11)
Item
Procedure: Medical history
text
Procedure: Medical history
Code List
Procedure: Medical history
CL Item
Visit 1, Wk -2 (1)
CL Item
Visit 2, Wk 0 (2)
CL Item
Visit 3, Wk 2 (3)
CL Item
Visit 4, Wk 4 (4)
CL Item
Visit 5, Wk 8 (5)
CL Item
Visit 6, Wk 12 (6)
CL Item
Visit 7, Wk 16 (7)
CL Item
Visit 8, Wk 24 (8)
CL Item
Study End Follow-up, Week 26 (9)
CL Item
Early Withdrawal  (10)
CL Item
Early Withdrawal Follow-up (11)
Item
Procedure: Concomitant Medication
text
Procedure: Concomitant Medication
Code List
Procedure: Concomitant Medication
CL Item
Visit 1, Wk -2 (1)
CL Item
Visit 2, Wk 0 (2)
CL Item
Visit 3, Wk 2 (3)
CL Item
Visit 4, Wk 4 (4)
CL Item
Visit 5, Wk 8 (5)
CL Item
Visit 6, Wk 12 (6)
CL Item
Visit 7, Wk 16 (7)
CL Item
Visit 8, Wk 24 (8)
CL Item
Study End Follow-up, Week 26 (9)
CL Item
Early Withdrawal  (10)
CL Item
Early Withdrawal Follow-up (11)
Item
Procedure: Physical Exam
text
Procedure: Physical Exam
Code List
Procedure: Physical Exam
CL Item
Visit 1, Wk -2 (1)
CL Item
Visit 2, Wk 0 (2)
CL Item
Visit 3, Wk 2 (3)
CL Item
Visit 4, Wk 4 (4)
CL Item
Visit 5, Wk 8 (5)
CL Item
Visit 6, Wk 12 (6)
CL Item
Visit 7, Wk 16 (7)
CL Item
Visit 8, Wk 24 (8)
CL Item
Study End Follow-up, Week 26 (9)
CL Item
Early Withdrawal  (10)
CL Item
Early Withdrawal Follow-up (11)
Item
Procedure: Neurological Exam
text
Procedure: Neurological Exam
Code List
Procedure: Neurological Exam
CL Item
Visit 1, Wk -2 (1)
CL Item
Visit 2, Wk 0 (2)
CL Item
Visit 3, Wk 2 (3)
CL Item
Visit 4, Wk 4 (4)
CL Item
Visit 5, Wk 8 (5)
CL Item
Visit 6, Wk 12 (6)
CL Item
Visit 7, Wk 16 (7)
CL Item
Visit 8, Wk 24 (8)
CL Item
Study End Follow-up, Week 26 (9)
CL Item
Early Withdrawal  (10)
CL Item
Early Withdrawal Follow-up (11)
Item
Procedure: Vital signs
text
Procedure: Vital signs
Code List
Procedure: Vital signs
CL Item
Visit 1, Wk -2 (1)
CL Item
Visit 2, Wk 0 (2)
CL Item
Visit 3, Wk 2 (3)
CL Item
Visit 4, Wk 4 (4)
CL Item
Visit 5, Wk 8 (5)
CL Item
Visit 6, Wk 12 (6)
CL Item
Visit 7, Wk 16 (7)
CL Item
Visit 8, Wk 24 (8)
CL Item
Study End Follow-up, Week 26 (9)
CL Item
Early Withdrawal  (10)
CL Item
Early Withdrawal Follow-up (11)
Item
Procedure: Height & Weight
text
Procedure: Height & Weight
Code List
Procedure: Height & Weight
CL Item
Visit 1, Wk -2 (1)
CL Item
Visit 2, Wk 0 (2)
CL Item
Visit 3, Wk 2 (3)
CL Item
Visit 4, Wk 4 (4)
CL Item
Visit 5, Wk 8 (5)
CL Item
Visit 6, Wk 12 (6)
CL Item
Visit 7, Wk 16 (7)
CL Item
Visit 8, Wk 24 (8)
CL Item
Study End Follow-up, Week 26 (9)
CL Item
Early Withdrawal  (10)
CL Item
Early Withdrawal Follow-up (11)
Item
Procedure: ECG
text
Procedure: ECG
Code List
Procedure: ECG
CL Item
Visit 1, Wk -2 (1)
CL Item
Visit 2, Wk 0 (2)
CL Item
Visit 3, Wk 2 (3)
CL Item
Visit 4, Wk 4 (4)
CL Item
Visit 5, Wk 8 (5)
CL Item
Visit 6, Wk 12 (6)
CL Item
Visit 7, Wk 16 (7)
CL Item
Visit 8, Wk 24 (8)
CL Item
Study End Follow-up, Week 26 (9)
CL Item
Early Withdrawal  (10)
CL Item
Early Withdrawal Follow-up (11)
Item
Procedure: Echocardiogram
text
Procedure: Echocardiogram
Code List
Procedure: Echocardiogram
CL Item
Visit 1, Wk -2 (1)
CL Item
Visit 2, Wk 0 (2)
CL Item
Visit 3, Wk 2 (3)
CL Item
Visit 4, Wk 4 (4)
CL Item
Visit 5, Wk 8 (5)
CL Item
Visit 6, Wk 12 (6)
CL Item
Visit 7, Wk 16 (7)
CL Item
Visit 8, Wk 24 (8)
CL Item
Study End Follow-up, Week 26 (9)
CL Item
Early Withdrawal  (10)
CL Item
Early Withdrawal Follow-up (11)
Item
Procedure: Chest X-ray
text
Procedure: Chest X-ray
Code List
Procedure: Chest X-ray
CL Item
Visit 1, Wk -2 (1)
CL Item
Visit 2, Wk 0 (2)
CL Item
Visit 3, Wk 2 (3)
CL Item
Visit 4, Wk 4 (4)
CL Item
Visit 5, Wk 8 (5)
CL Item
Visit 6, Wk 12 (6)
CL Item
Visit 7, Wk 16 (7)
CL Item
Visit 8, Wk 24 (8)
CL Item
Study End Follow-up, Week 26 (9)
CL Item
Early Withdrawal  (10)
CL Item
Early Withdrawal Follow-up (11)
Item
Procedure: CT Scan
text
Procedure: CT Scan
Code List
Procedure: CT Scan
CL Item
Visit 1, Wk -2 (1)
CL Item
Visit 2, Wk 0 (2)
CL Item
Visit 3, Wk 2 (3)
CL Item
Visit 4, Wk 4 (4)
CL Item
Visit 5, Wk 8 (5)
CL Item
Visit 6, Wk 12 (6)
CL Item
Visit 7, Wk 16 (7)
CL Item
Visit 8, Wk 24 (8)
CL Item
Study End Follow-up, Week 26 (9)
CL Item
Early Withdrawal  (10)
CL Item
Early Withdrawal Follow-up (11)
Item
Procedure: Fasting Laboratory Samples
text
Procedure: Fasting Laboratory Samples
Code List
Procedure: Fasting Laboratory Samples
CL Item
Visit 1, Wk -2 (1)
CL Item
Visit 2, Wk 0 (2)
CL Item
Visit 3, Wk 2 (3)
CL Item
Visit 4, Wk 4 (4)
CL Item
Visit 5, Wk 8 (5)
CL Item
Visit 6, Wk 12 (6)
CL Item
Visit 7, Wk 16 (7)
CL Item
Visit 8, Wk 24 (8)
CL Item
Study End Follow-up, Week 26 (9)
CL Item
Early Withdrawal  (10)
CL Item
Early Withdrawal Follow-up (11)
Item
Procedure: Non-Fasting Laboratory Samples
text
Procedure: Non-Fasting Laboratory Samples
Code List
Procedure: Non-Fasting Laboratory Samples
CL Item
Visit 1, Wk -2 (1)
CL Item
Visit 2, Wk 0 (2)
CL Item
Visit 3, Wk 2 (3)
CL Item
Visit 4, Wk 4 (4)
CL Item
Visit 5, Wk 8 (5)
CL Item
Visit 6, Wk 12 (6)
CL Item
Visit 7, Wk 16 (7)
CL Item
Visit 8, Wk 24 (8)
CL Item
Study End Follow-up, Week 26 (9)
CL Item
Early Withdrawal  (10)
CL Item
Early Withdrawal Follow-up (11)
Item
Procedure: PGx Sampling
text
Procedure: PGx Sampling
Code List
Procedure: PGx Sampling
CL Item
Visit 1, Wk -2 (1)
CL Item
Visit 2, Wk 0 (2)
CL Item
Visit 3, Wk 2 (3)
CL Item
Visit 4, Wk 4 (4)
CL Item
Visit 5, Wk 8 (5)
CL Item
Visit 6, Wk 12 (6)
CL Item
Visit 7, Wk 16 (7)
CL Item
Visit 8, Wk 24 (8)
CL Item
Study End Follow-up, Week 26 (9)
CL Item
Early Withdrawal  (10)
CL Item
Early Withdrawal Follow-up (11)
Item
Procedure: PGm Sampling
text
Procedure: PGm Sampling
Code List
Procedure: PGm Sampling
CL Item
Visit 1, Wk -2 (1)
CL Item
Visit 2, Wk 0 (2)
CL Item
Visit 3, Wk 2 (3)
CL Item
Visit 4, Wk 4 (4)
CL Item
Visit 5, Wk 8 (5)
CL Item
Visit 6, Wk 12 (6)
CL Item
Visit 7, Wk 16 (7)
CL Item
Visit 8, Wk 24 (8)
CL Item
Study End Follow-up, Week 26 (9)
CL Item
Early Withdrawal  (10)
CL Item
Early Withdrawal Follow-up (11)
Item
Procedure: HADS
text
Procedure: HADS
Code List
Procedure: HADS
CL Item
Visit 1, Wk -2 (1)
CL Item
Visit 2, Wk 0 (2)
CL Item
Visit 3, Wk 2 (3)
CL Item
Visit 4, Wk 4 (4)
CL Item
Visit 5, Wk 8 (5)
CL Item
Visit 6, Wk 12 (6)
CL Item
Visit 7, Wk 16 (7)
CL Item
Visit 8, Wk 24 (8)
CL Item
Study End Follow-up, Week 26 (9)
CL Item
Early Withdrawal  (10)
CL Item
Early Withdrawal Follow-up (11)
Item
Procedure: MMSE
text
Procedure: MMSE
Code List
Procedure: MMSE
CL Item
Visit 1, Wk -2 (1)
CL Item
Visit 2, Wk 0 (2)
CL Item
Visit 3, Wk 2 (3)
CL Item
Visit 4, Wk 4 (4)
CL Item
Visit 5, Wk 8 (5)
CL Item
Visit 6, Wk 12 (6)
CL Item
Visit 7, Wk 16 (7)
CL Item
Visit 8, Wk 24 (8)
CL Item
Study End Follow-up, Week 26 (9)
CL Item
Early Withdrawal  (10)
CL Item
Early Withdrawal Follow-up (11)
Item
Procedure: ADAS-cog
text
Procedure: ADAS-cog
Code List
Procedure: ADAS-cog
CL Item
Visit 1, Wk -2 (1)
CL Item
Visit 2, Wk 0 (2)
CL Item
Visit 3, Wk 2 (3)
CL Item
Visit 4, Wk 4 (4)
CL Item
Visit 5, Wk 8 (5)
CL Item
Visit 6, Wk 12 (6)
CL Item
Visit 7, Wk 16 (7)
CL Item
Visit 8, Wk 24 (8)
CL Item
Study End Follow-up, Week 26 (9)
CL Item
Early Withdrawal  (10)
CL Item
Early Withdrawal Follow-up (11)
Item
Procedure: CIBIC+
text
Procedure: CIBIC+
Code List
Procedure: CIBIC+
CL Item
Visit 1, Wk -2 (1)
CL Item
Visit 2, Wk 0 (2)
CL Item
Visit 3, Wk 2 (3)
CL Item
Visit 4, Wk 4 (4)
CL Item
Visit 5, Wk 8 (5)
CL Item
Visit 6, Wk 12 (6)
CL Item
Visit 7, Wk 16 (7)
CL Item
Visit 8, Wk 24 (8)
CL Item
Study End Follow-up, Week 26 (9)
CL Item
Early Withdrawal  (10)
CL Item
Early Withdrawal Follow-up (11)
Item
Procedure: NPI
text
Procedure: NPI
Code List
Procedure: NPI
CL Item
Visit 1, Wk -2 (1)
CL Item
Visit 2, Wk 0 (2)
CL Item
Visit 3, Wk 2 (3)
CL Item
Visit 4, Wk 4 (4)
CL Item
Visit 5, Wk 8 (5)
CL Item
Visit 6, Wk 12 (6)
CL Item
Visit 7, Wk 16 (7)
CL Item
Visit 8, Wk 24 (8)
CL Item
Study End Follow-up, Week 26 (9)
CL Item
Early Withdrawal  (10)
CL Item
Early Withdrawal Follow-up (11)
Item
Procedure: DAD
text
Procedure: DAD
Code List
Procedure: DAD
CL Item
Visit 1, Wk -2 (1)
CL Item
Visit 2, Wk 0 (2)
CL Item
Visit 3, Wk 2 (3)
CL Item
Visit 4, Wk 4 (4)
CL Item
Visit 5, Wk 8 (5)
CL Item
Visit 6, Wk 12 (6)
CL Item
Visit 7, Wk 16 (7)
CL Item
Visit 8, Wk 24 (8)
CL Item
Study End Follow-up, Week 26 (9)
CL Item
Early Withdrawal  (10)
CL Item
Early Withdrawal Follow-up (11)
Item
Procedure: Recording of AEs
text
Procedure: Recording of AEs
Code List
Procedure: Recording of AEs
CL Item
Visit 1, Wk -2 (1)
CL Item
Visit 2, Wk 0 (2)
CL Item
Visit 3, Wk 2 (3)
CL Item
Visit 4, Wk 4 (4)
CL Item
Visit 5, Wk 8 (5)
CL Item
Visit 6, Wk 12 (6)
CL Item
Visit 7, Wk 16 (7)
CL Item
Visit 8, Wk 24 (8)
CL Item
Study End Follow-up, Week 26 (9)
CL Item
Early Withdrawal  (10)
CL Item
Early Withdrawal Follow-up (11)
Item
Procedure: Recording of AEs
text
Procedure: Recording of AEs
Code List
Procedure: Recording of AEs
CL Item
Visit 1, Wk -2 (1)
CL Item
Visit 2, Wk 0 (2)
CL Item
Visit 3, Wk 2 (3)
CL Item
Visit 4, Wk 4 (4)
CL Item
Visit 5, Wk 8 (5)
CL Item
Visit 6, Wk 12 (6)
CL Item
Visit 7, Wk 16 (7)
CL Item
Visit 8, Wk 24 (8)
CL Item
Study End Follow-up, Week 26 (9)
CL Item
Early Withdrawal  (10)
CL Item
Early Withdrawal Follow-up (11)
Item
Procedure: Review Medication Compliance
text
Procedure: Review Medication Compliance
Code List
Procedure: Review Medication Compliance
CL Item
Visit 1, Wk -2 (1)
CL Item
Visit 2, Wk 0 (2)
CL Item
Visit 3, Wk 2 (3)
CL Item
Visit 4, Wk 4 (4)
CL Item
Visit 5, Wk 8 (5)
CL Item
Visit 6, Wk 12 (6)
CL Item
Visit 7, Wk 16 (7)
CL Item
Visit 8, Wk 24 (8)
CL Item
Study End Follow-up, Week 26 (9)
CL Item
Early Withdrawal  (10)
CL Item
Early Withdrawal Follow-up (11)
Item
Procedure: Study Conclusion Record
text
Procedure: Study Conclusion Record
Code List
Procedure: Study Conclusion Record
CL Item
Visit 1, Wk -2 (1)
CL Item
Visit 2, Wk 0 (2)
CL Item
Visit 3, Wk 2 (3)
CL Item
Visit 4, Wk 4 (4)
CL Item
Visit 5, Wk 8 (5)
CL Item
Visit 6, Wk 12 (6)
CL Item
Visit 7, Wk 16 (7)
CL Item
Visit 8, Wk 24 (8)
CL Item
Study End Follow-up, Week 26 (9)
CL Item
Early Withdrawal  (10)
CL Item
Early Withdrawal Follow-up (11)
Item Group
Visit 2
Subject Identifier
Item
Subject Identifier
integer
Visit Date
Item
Visit Date
date
Item Group
Randomisation
Randomisation number
Item
Randomisation number
integer
Item Group
Vital signs
Weight
Item
Weight
float
Blood pressure
Item
Blood pressure: Systolic
integer
Blood pressure
Item
Blood pressure: Diastolic
integer
Heart rate
Item
Heart rate
integer
Item Group
Central Laboratory (Fasting samples)
Date
Item
Date samples taken
date
Pharmacogenetic (PGx) and Pharmacogenomic (PGm) Research
Item
Pharmacogenetic (PGx) and Pharmacogenomic (PGm) Research
boolean
Item Group
PGm-Transcriptomic Research
Has a blood sample been collected for PGm-Transcriptomic research?
Item
Has a blood sample been collected for PGm-Transcriptomic research?
boolean
If yes, record date and time sample taken
Item
If yes, record date and time sample taken
datetime
Item Group
PGm-Proteomic Research
Has a blood sample been collected for PGm-Poteomic research?
Item
Has a blood sample been collected for PGm-Poteomic research?
boolean
If yes, record date and time sample taken
Item
If yes, record date and time sample taken
datetime
Volume of one aliquot
Item
Volume of one aliquot
float
Length of time the centrifuge ran
Item
Length of time the centrifuge ran
integer
Item
Temperature of the centrifuge
text
Temperature of the centrifuge
Code List
Temperature of the centrifuge
CL Item
Room temperature (1)
CL Item
Refrigerated centrifuge (2)
Centrifugation speed
Item
Centrifugation speed
integer
Centrifugation rotor radius
Item
Centrifugation rotor radius
integer
Time aliquotted samples were placed in the freezer
Item
Time aliquotted samples were placed in the freezer
time
Temperature of freezer
Item
Temperature of freezer
integer
Item Group
Monitor Data Validation Check
Results from Monitor Data Validation Check
Item
Results from Monitor Data Validation Check
text
Item Group
Investigational product
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])
End of visit reminder
Item
Schedule Visit 3 for 14 days (+/- 3 days) after this visit. It is not necessary for the subject to be fasted.
boolean
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