ID

17407

Beschrijving

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.

Trefwoorden

Versies (2)
  1. 12-09-16 12-09-16 -
  2. 02-10-16 02-10-16 -
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12 september 2016

DOI

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Licentie

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

Engels

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

1 Formulieren  
General Information
Beschrijving

General Information

Subject Identifier
Beschrijving

Subject Identifier

Datatype

integer

Centre/Investigation Number
Beschrijving

Centre/Investigation Number

Datatype

integer

Study Procedures Chart
Beschrijving

Study Procedures Chart

Procedure: Informed Consent
Beschrijving

Procedure: Informed Consent

Datatype

text

Procedure: PGx/PGm Informed Consent
Beschrijving

Procedure: PGx/PGm Informed Consent

Datatype

text

Procedure: Telephone call to IVRS
Beschrijving

Procedure: Telephone call to IVRS

Datatype

text

Procedure: Inclusion/Exclusion Criteria Review
Beschrijving

Procedure: Inclusion/Exclusion Criteria Review

Datatype

text

Procedure: Demographics
Beschrijving

Procedure: Demographics

Datatype

text

Procedure: Medical history
Beschrijving

Procedure: Medical history

Datatype

text

Procedure: Concomitant Medication
Beschrijving

Procedure: Concomitant Medication

Datatype

text

Procedure: Physical Exam
Beschrijving

Procedure: Physical Exam

Datatype

text

Procedure: Neurological Exam
Beschrijving

Procedure: Neurological Exam

Datatype

text

Procedure: Vital signs
Beschrijving

Procedure: Vital signs

Datatype

text

Procedure: Height & Weight
Beschrijving

Procedure: Height & Weight

Datatype

text

Procedure: ECG
Beschrijving

Procedure: ECG

Datatype

text

Procedure: Echocardiogram
Beschrijving

Procedure: Echocardiogram

Datatype

text

Procedure: Chest X-ray
Beschrijving

Procedure: Chest X-ray

Datatype

text

Procedure: CT Scan
Beschrijving

Procedure: CT Scan

Datatype

text

Procedure: Fasting Laboratory Samples
Beschrijving

Procedure: Fasting Laboratory Samples

Datatype

text

Procedure: Non-Fasting Laboratory Samples
Beschrijving

Procedure: Non-Fasting Laboratory Samples

Datatype

text

Procedure: PGx Sampling
Beschrijving

Procedure: PGx Sampling

Datatype

text

Procedure: PGm Sampling
Beschrijving

Procedure: PGm Sampling

Datatype

text

Procedure: HADS
Beschrijving

Procedure: HADS

Datatype

text

Procedure: MMSE
Beschrijving

Procedure: MMSE

Datatype

text

Procedure: ADAS-cog
Beschrijving

Procedure: ADAS-cog

Datatype

text

Procedure: CIBIC+
Beschrijving

Procedure: CIBIC+

Datatype

text

Procedure: NPI
Beschrijving

Procedure: NPI

Datatype

text

Procedure: DAD
Beschrijving

Procedure: DAD

Datatype

text

Procedure: Recording of AEs
Beschrijving

Procedure: Recording of AEs

Datatype

text

Procedure: Recording of AEs
Beschrijving

Procedure: Recording of AEs

Datatype

text

Procedure: Review Medication Compliance
Beschrijving

Procedure: Review Medication Compliance

Datatype

text

Procedure: Study Conclusion Record
Beschrijving

Procedure: Study Conclusion Record

Datatype

text

Visit 2 (See Description)
Beschrijving

Visit 2 (See Description)

Subject Identifier
Beschrijving

Subject Identifier

Datatype

integer

Visit Date
Beschrijving

Visit Date

Datatype

date

Randomisation (See Description)
Beschrijving

Randomisation (See Description)

Randomisation number
Beschrijving

Randomisation number

Datatype

integer

Vital signs
Beschrijving

Vital signs

Weight
Beschrijving

Weight

Datatype

float

Maateenheden
  • kg
kg
Blood pressure: Systolic
Beschrijving

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

Datatype

integer

Blood pressure: Diastolic
Beschrijving

Blood pressure

Datatype

integer

Maateenheden
  • mmHg
mmHg
Heart rate
Beschrijving

Heart rate

Datatype

integer

Maateenheden
  • bpm
bpm
Central Laboratory (Fasting samples)
Beschrijving

Central Laboratory (Fasting samples)

Date samples taken
Beschrijving

Date

Datatype

date

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

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.

Datatype

boolean

PGm-Transcriptomic Research
Beschrijving

PGm-Transcriptomic Research

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

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

Datatype

boolean

If yes, record date and time sample taken
Beschrijving

If yes, record date and time sample taken

Datatype

datetime

PGm-Proteomic Research
Beschrijving

PGm-Proteomic Research

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

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

Datatype

boolean

If yes, record date and time sample taken
Beschrijving

If yes, record date and time sample taken

Datatype

datetime

Volume of one aliquot
Beschrijving

Volume of one aliquot

Datatype

float

Maateenheden
  • ml
ml
Length of time the centrifuge ran
Beschrijving

Length of time the centrifuge ran

Datatype

integer

Maateenheden
  • minutes
minutes
Temperature of the centrifuge
Beschrijving

Temperature of the centrifuge

Datatype

text

Centrifugation speed
Beschrijving

Centrifugation speed

Datatype

integer

Maateenheden
  • r.p.m
r.p.m
Centrifugation rotor radius
Beschrijving

Centrifugation rotor radius

Datatype

integer

Maateenheden
  • cm
cm
Time aliquotted samples were placed in the freezer
Beschrijving

Time aliquotted samples were placed in the freezer

Datatype

time

Temperature of freezer
Beschrijving

Temperature of freezer

Datatype

integer

Maateenheden
  • °C
°C
Monitor Data Validation Check (See Description)
Beschrijving

Monitor Data Validation Check (See Description)

Investigational product (See Description)
Beschrijving

Investigational product (See Description)

Investigational Product
Beschrijving

Investigational Product

Datatype

text

Start Date
Beschrijving

Start Date

Datatype

date

Stop Date
Beschrijving

Stop Date

Datatype

date

IP Container No.
Beschrijving

IP Container No.

Datatype

integer

Total Number of Tablets Dispensed
Beschrijving

Total Number of Tablets Dispensed

Datatype

float

Total Number of Tablets Returned
Beschrijving

Total Number of Tablets Returned

Datatype

float

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

Discontinuation

Datatype

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.
Beschrijving

End of visit reminder

Datatype

boolean

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Similar models

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

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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