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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.

Keywords

Versions (2)
  1. 9/12/16 9/12/16 -
  2. 10/2/16 10/2/16 -
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September 12, 2016

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

    English

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

    1 forms  
    General Information
    Description

    General Information

    Subject Identifier
    Description

    Subject Identifier

    Data type

    integer

    Centre/Investigation Number
    Description

    Centre/Investigation Number

    Data type

    integer

    Study Procedures Chart
    Description

    Study Procedures Chart

    Procedure: Informed Consent
    Description

    Procedure: Informed Consent

    Data type

    text

    Procedure: PGx/PGm Informed Consent
    Description

    Procedure: PGx/PGm Informed Consent

    Data type

    text

    Procedure: Telephone call to IVRS
    Description

    Procedure: Telephone call to IVRS

    Data type

    text

    Procedure: Inclusion/Exclusion Criteria Review
    Description

    Procedure: Inclusion/Exclusion Criteria Review

    Data type

    text

    Procedure: Demographics
    Description

    Procedure: Demographics

    Data type

    text

    Procedure: Medical history
    Description

    Procedure: Medical history

    Data type

    text

    Procedure: Concomitant Medication
    Description

    Procedure: Concomitant Medication

    Data type

    text

    Procedure: Physical Exam
    Description

    Procedure: Physical Exam

    Data type

    text

    Procedure: Neurological Exam
    Description

    Procedure: Neurological Exam

    Data type

    text

    Procedure: Vital signs
    Description

    Procedure: Vital signs

    Data type

    text

    Procedure: Height & Weight
    Description

    Procedure: Height & Weight

    Data type

    text

    Procedure: ECG
    Description

    Procedure: ECG

    Data type

    text

    Procedure: Echocardiogram
    Description

    Procedure: Echocardiogram

    Data type

    text

    Procedure: Chest X-ray
    Description

    Procedure: Chest X-ray

    Data type

    text

    Procedure: CT Scan
    Description

    Procedure: CT Scan

    Data type

    text

    Procedure: Fasting Laboratory Samples
    Description

    Procedure: Fasting Laboratory Samples

    Data type

    text

    Procedure: Non-Fasting Laboratory Samples
    Description

    Procedure: Non-Fasting Laboratory Samples

    Data type

    text

    Procedure: PGx Sampling
    Description

    Procedure: PGx Sampling

    Data type

    text

    Procedure: PGm Sampling
    Description

    Procedure: PGm Sampling

    Data type

    text

    Procedure: HADS
    Description

    Procedure: HADS

    Data type

    text

    Procedure: MMSE
    Description

    Procedure: MMSE

    Data type

    text

    Procedure: ADAS-cog
    Description

    Procedure: ADAS-cog

    Data type

    text

    Procedure: CIBIC+
    Description

    Procedure: CIBIC+

    Data type

    text

    Procedure: NPI
    Description

    Procedure: NPI

    Data type

    text

    Procedure: DAD
    Description

    Procedure: DAD

    Data type

    text

    Procedure: Recording of AEs
    Description

    Procedure: Recording of AEs

    Data type

    text

    Procedure: Recording of AEs
    Description

    Procedure: Recording of AEs

    Data type

    text

    Procedure: Review Medication Compliance
    Description

    Procedure: Review Medication Compliance

    Data type

    text

    Procedure: Study Conclusion Record
    Description

    Procedure: Study Conclusion Record

    Data type

    text

    Visit 2 (See Description)
    Description

    Visit 2 (See Description)

    Subject Identifier
    Description

    Subject Identifier

    Data type

    integer

    Visit Date
    Description

    Visit Date

    Data type

    date

    Randomisation (See Description)
    Description

    Randomisation (See Description)

    Randomisation number
    Description

    Randomisation number

    Data type

    integer

    Vital signs
    Description

    Vital signs

    Weight
    Description

    Weight

    Data type

    float

    Measurement units
    • kg
    kg
    Blood pressure: Systolic
    Description

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

    Data type

    integer

    Blood pressure: Diastolic
    Description

    Blood pressure

    Data type

    integer

    Measurement units
    • mmHg
    mmHg
    Heart rate
    Description

    Heart rate

    Data type

    integer

    Measurement units
    • bpm
    bpm
    Central Laboratory (Fasting samples)
    Description

    Central Laboratory (Fasting samples)

    Date samples taken
    Description

    Date

    Data type

    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.

    Data type

    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?

    Data type

    boolean

    If yes, record date and time sample taken
    Description

    If yes, record date and time sample taken

    Data type

    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?

    Data type

    boolean

    If yes, record date and time sample taken
    Description

    If yes, record date and time sample taken

    Data type

    datetime

    Volume of one aliquot
    Description

    Volume of one aliquot

    Data type

    float

    Measurement units
    • ml
    ml
    Length of time the centrifuge ran
    Description

    Length of time the centrifuge ran

    Data type

    integer

    Measurement units
    • minutes
    minutes
    Temperature of the centrifuge
    Description

    Temperature of the centrifuge

    Data type

    text

    Centrifugation speed
    Description

    Centrifugation speed

    Data type

    integer

    Measurement units
    • r.p.m
    r.p.m
    Centrifugation rotor radius
    Description

    Centrifugation rotor radius

    Data type

    integer

    Measurement units
    • cm
    cm
    Time aliquotted samples were placed in the freezer
    Description

    Time aliquotted samples were placed in the freezer

    Data type

    time

    Temperature of freezer
    Description

    Temperature of freezer

    Data type

    integer

    Measurement units
    • °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

    Data type

    text

    Start Date
    Description

    Start Date

    Data type

    date

    Stop Date
    Description

    Stop Date

    Data type

    date

    IP Container No.
    Description

    IP Container No.

    Data type

    integer

    Total Number of Tablets Dispensed
    Description

    Total Number of Tablets Dispensed

    Data type

    float

    Total Number of Tablets Returned
    Description

    Total Number of Tablets Returned

    Data type

    float

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

    Discontinuation

    Data type

    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

    Data type

    boolean

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    Similar models

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

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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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