ID

17744

Beskrivning

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.

Nyckelord

Versioner (2)
  1. 2016-09-12 2016-09-12 -
  2. 2016-10-02 2016-10-02 -
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2 oktober 2016

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

Engelsk

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

1 Formulär  
General Information
Beskrivning

General Information

Subject Identifier
Beskrivning

Subject Identifier

Datatyp

integer

Centre/Investigation Number
Beskrivning

Centre/Investigation Number

Datatyp

integer

Study Procedures Chart
Beskrivning

Study Procedures Chart

Procedure: Informed Consent
Beskrivning

Procedure: Informed Consent

Datatyp

text

Procedure: PGx/PGm Informed Consent
Beskrivning

Procedure: PGx/PGm Informed Consent

Datatyp

text

Procedure: Telephone call to IVRS
Beskrivning

Procedure: Telephone call to IVRS

Datatyp

text

Procedure: Inclusion/Exclusion Criteria Review
Beskrivning

Procedure: Inclusion/Exclusion Criteria Review

Datatyp

text

Procedure: Demographics
Beskrivning

Procedure: Demographics

Datatyp

text

Procedure: Medical history
Beskrivning

Procedure: Medical history

Datatyp

text

Procedure: Concomitant Medication
Beskrivning

Procedure: Concomitant Medication

Datatyp

text

Procedure: Physical Exam
Beskrivning

Procedure: Physical Exam

Datatyp

text

Procedure: Neurological Exam
Beskrivning

Procedure: Neurological Exam

Datatyp

text

Procedure: Vital signs
Beskrivning

Procedure: Vital signs

Datatyp

text

Procedure: Height & Weight
Beskrivning

Procedure: Height & Weight

Datatyp

text

Procedure: ECG
Beskrivning

Procedure: ECG

Datatyp

text

Procedure: Echocardiogram
Beskrivning

Procedure: Echocardiogram

Datatyp

text

Procedure: Chest X-ray
Beskrivning

Procedure: Chest X-ray

Datatyp

text

Procedure: CT Scan
Beskrivning

Procedure: CT Scan

Datatyp

text

Procedure: Fasting Laboratory Samples
Beskrivning

Procedure: Fasting Laboratory Samples

Datatyp

text

Procedure: Non-Fasting Laboratory Samples
Beskrivning

Procedure: Non-Fasting Laboratory Samples

Datatyp

text

Procedure: PGx Sampling
Beskrivning

Procedure: PGx Sampling

Datatyp

text

Procedure: PGm Sampling
Beskrivning

Procedure: PGm Sampling

Datatyp

text

Procedure: HADS
Beskrivning

Procedure: HADS

Datatyp

text

Procedure: MMSE
Beskrivning

Procedure: MMSE

Datatyp

text

Procedure: ADAS-cog
Beskrivning

Procedure: ADAS-cog

Datatyp

text

Procedure: CIBIC+
Beskrivning

Procedure: CIBIC+

Datatyp

text

Procedure: NPI
Beskrivning

Procedure: NPI

Datatyp

text

Procedure: DAD
Beskrivning

Procedure: DAD

Datatyp

text

Procedure: Recording of AEs
Beskrivning

Procedure: Recording of AEs

Datatyp

text

Procedure: Recording of AEs
Beskrivning

Procedure: Recording of AEs

Datatyp

text

Procedure: Review Medication Compliance
Beskrivning

Procedure: Review Medication Compliance

Datatyp

text

Procedure: Study Conclusion Record
Beskrivning

Procedure: Study Conclusion Record

Datatyp

text

Visit 2
Beskrivning

Visit 2

Subject Identifier
Beskrivning

Subject Identifier

Datatyp

integer

Visit Date
Beskrivning

Visit Date

Datatyp

date

Randomisation
Beskrivning

Randomisation

Randomisation number
Beskrivning

Randomisation number

Datatyp

integer

Vital signs
Beskrivning

Vital signs

Weight
Beskrivning

Weight

Datatyp

float

Måttenheter
  • kg
kg
Blood pressure: Systolic
Beskrivning

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

Datatyp

integer

Blood pressure: Diastolic
Beskrivning

Blood pressure

Datatyp

integer

Måttenheter
  • mmHg
mmHg
Heart rate
Beskrivning

Heart rate

Datatyp

integer

Måttenheter
  • bpm
bpm
Central Laboratory (Fasting samples)
Beskrivning

Central Laboratory (Fasting samples)

Date samples taken
Beskrivning

Date

Datatyp

date

Pharmacogenetic (PGx) and Pharmacogenomic (PGm) Research
Beskrivning

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.

Datatyp

boolean

PGm-Transcriptomic Research
Beskrivning

PGm-Transcriptomic Research

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

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

Datatyp

boolean

If yes, record date and time sample taken
Beskrivning

If yes, record date and time sample taken

Datatyp

datetime

PGm-Proteomic Research
Beskrivning

PGm-Proteomic Research

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

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

Datatyp

boolean

If yes, record date and time sample taken
Beskrivning

If yes, record date and time sample taken

Datatyp

datetime

Volume of one aliquot
Beskrivning

Volume of one aliquot

Datatyp

float

Måttenheter
  • ml
ml
Length of time the centrifuge ran
Beskrivning

Length of time the centrifuge ran

Datatyp

integer

Måttenheter
  • minutes
minutes
Temperature of the centrifuge
Beskrivning

Temperature of the centrifuge

Datatyp

text

Centrifugation speed
Beskrivning

Centrifugation speed

Datatyp

integer

Måttenheter
  • r.p.m
r.p.m
Centrifugation rotor radius
Beskrivning

Centrifugation rotor radius

Datatyp

integer

Måttenheter
  • cm
cm
Time aliquotted samples were placed in the freezer
Beskrivning

Time aliquotted samples were placed in the freezer

Datatyp

time

Temperature of freezer
Beskrivning

Temperature of freezer

Datatyp

integer

Måttenheter
  • °C
°C
Monitor Data Validation Check
Beskrivning

Monitor Data Validation Check

Results from Monitor Data Validation Check
Beskrivning

Results from Monitor Data Validation Check

Datatyp

text

Investigational product
Beskrivning

Investigational product

Investigational Product
Beskrivning

Investigational Product

Datatyp

text

Start Date
Beskrivning

Start Date

Datatyp

date

Stop Date
Beskrivning

Stop Date

Datatyp

date

IP Container No.
Beskrivning

IP Container No.

Datatyp

integer

Total Number of Tablets Dispensed
Beskrivning

Total Number of Tablets Dispensed

Datatyp

float

Total Number of Tablets Returned
Beskrivning

Total Number of Tablets Returned

Datatyp

float

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

Discontinuation

Datatyp

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.
Beskrivning

End of visit reminder

Datatyp

boolean

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Similar models

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

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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