ID

17407

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 2/Visit 2.

Mots-clés

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

12 septembre 2016

DOI

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Licence

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

Anglais

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

1 Formulaires  
General Information
Description

General Information

Subject Identifier
Description

Subject Identifier

Type de données

integer

Centre/Investigation Number
Description

Centre/Investigation Number

Type de données

integer

Study Procedures Chart
Description

Study Procedures Chart

Procedure: Informed Consent
Description

Procedure: Informed Consent

Type de données

text

Procedure: PGx/PGm Informed Consent
Description

Procedure: PGx/PGm Informed Consent

Type de données

text

Procedure: Telephone call to IVRS
Description

Procedure: Telephone call to IVRS

Type de données

text

Procedure: Inclusion/Exclusion Criteria Review
Description

Procedure: Inclusion/Exclusion Criteria Review

Type de données

text

Procedure: Demographics
Description

Procedure: Demographics

Type de données

text

Procedure: Medical history
Description

Procedure: Medical history

Type de données

text

Procedure: Concomitant Medication
Description

Procedure: Concomitant Medication

Type de données

text

Procedure: Physical Exam
Description

Procedure: Physical Exam

Type de données

text

Procedure: Neurological Exam
Description

Procedure: Neurological Exam

Type de données

text

Procedure: Vital signs
Description

Procedure: Vital signs

Type de données

text

Procedure: Height & Weight
Description

Procedure: Height & Weight

Type de données

text

Procedure: ECG
Description

Procedure: ECG

Type de données

text

Procedure: Echocardiogram
Description

Procedure: Echocardiogram

Type de données

text

Procedure: Chest X-ray
Description

Procedure: Chest X-ray

Type de données

text

Procedure: CT Scan
Description

Procedure: CT Scan

Type de données

text

Procedure: Fasting Laboratory Samples
Description

Procedure: Fasting Laboratory Samples

Type de données

text

Procedure: Non-Fasting Laboratory Samples
Description

Procedure: Non-Fasting Laboratory Samples

Type de données

text

Procedure: PGx Sampling
Description

Procedure: PGx Sampling

Type de données

text

Procedure: PGm Sampling
Description

Procedure: PGm Sampling

Type de données

text

Procedure: HADS
Description

Procedure: HADS

Type de données

text

Procedure: MMSE
Description

Procedure: MMSE

Type de données

text

Procedure: ADAS-cog
Description

Procedure: ADAS-cog

Type de données

text

Procedure: CIBIC+
Description

Procedure: CIBIC+

Type de données

text

Procedure: NPI
Description

Procedure: NPI

Type de données

text

Procedure: DAD
Description

Procedure: DAD

Type de données

text

Procedure: Recording of AEs
Description

Procedure: Recording of AEs

Type de données

text

Procedure: Recording of AEs
Description

Procedure: Recording of AEs

Type de données

text

Procedure: Review Medication Compliance
Description

Procedure: Review Medication Compliance

Type de données

text

Procedure: Study Conclusion Record
Description

Procedure: Study Conclusion Record

Type de données

text

Visit 2 (See Description)
Description

Visit 2 (See Description)

Subject Identifier
Description

Subject Identifier

Type de données

integer

Visit Date
Description

Visit Date

Type de données

date

Randomisation (See Description)
Description

Randomisation (See Description)

Randomisation number
Description

Randomisation number

Type de données

integer

Vital signs
Description

Vital signs

Weight
Description

Weight

Type de données

float

Unités de mesure
  • kg
kg
Blood pressure: Systolic
Description

Blood pressure 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 (Fasting samples)
Description

Central Laboratory (Fasting samples)

Date samples taken
Description

Date

Type de données

date

Pharmacogenetic (PGx) and Pharmacogenomic (PGm) Research (See Description)
Description

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.

Type de données

boolean

PGm-Transcriptomic Research
Description

PGm-Transcriptomic Research

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

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

Type de données

boolean

If yes, record date and time sample taken
Description

If yes, record date and time sample taken

Type de données

datetime

PGm-Proteomic Research
Description

PGm-Proteomic Research

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

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

Type de données

boolean

If yes, record date and time sample taken
Description

If yes, record date and time sample taken

Type de données

datetime

Volume of one aliquot
Description

Volume of one aliquot

Type de données

float

Unités de mesure
  • ml
ml
Length of time the centrifuge ran
Description

Length of time the centrifuge ran

Type de données

integer

Unités de mesure
  • minutes
minutes
Temperature of the centrifuge
Description

Temperature of the centrifuge

Type de données

text

Centrifugation speed
Description

Centrifugation speed

Type de données

integer

Unités de mesure
  • r.p.m
r.p.m
Centrifugation rotor radius
Description

Centrifugation rotor radius

Type de données

integer

Unités de mesure
  • cm
cm
Time aliquotted samples were placed in the freezer
Description

Time aliquotted samples were placed in the freezer

Type de données

time

Temperature of freezer
Description

Temperature of freezer

Type de données

integer

Unités de mesure
  • °C
°C
Monitor Data Validation Check (See Description)
Description

Monitor Data Validation Check (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
Schedule Visit 3 for 14 days (+/- 3 days) after this visit. It is not necessary for the subject to be fasted.
Description

End of visit reminder

Type de données

boolean

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Similar models

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

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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 (See Description)
Subject Identifier
Item
Subject Identifier
integer
Visit Date
Item
Visit Date
date
Item Group
Randomisation (See Description)
Randomisation number
Item
Randomisation number
integer
Item Group
Vital signs
Weight
Item
Weight
float
Blood pressure (See Description)
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 (See Description)
Item
Pharmacogenetic (PGx) and Pharmacogenomic (PGm) Research (See Description)
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 (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])
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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