ID

17744

Beschreibung

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.

Stichworte

Versionen (2)
  1. 12.09.16 12.09.16 -
  2. 02.10.16 02.10.16 -
Hochgeladen am

2. Oktober 2016

DOI

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Lizenz

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

Englisch

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

1 Formulare  
General Information
Beschreibung

General Information

Subject Identifier
Beschreibung

Subject Identifier

Datentyp

integer

Centre/Investigation Number
Beschreibung

Centre/Investigation Number

Datentyp

integer

Study Procedures Chart
Beschreibung

Study Procedures Chart

Procedure: Informed Consent
Beschreibung

Procedure: Informed Consent

Datentyp

text

Procedure: PGx/PGm Informed Consent
Beschreibung

Procedure: PGx/PGm Informed Consent

Datentyp

text

Procedure: Telephone call to IVRS
Beschreibung

Procedure: Telephone call to IVRS

Datentyp

text

Procedure: Inclusion/Exclusion Criteria Review
Beschreibung

Procedure: Inclusion/Exclusion Criteria Review

Datentyp

text

Procedure: Demographics
Beschreibung

Procedure: Demographics

Datentyp

text

Procedure: Medical history
Beschreibung

Procedure: Medical history

Datentyp

text

Procedure: Concomitant Medication
Beschreibung

Procedure: Concomitant Medication

Datentyp

text

Procedure: Physical Exam
Beschreibung

Procedure: Physical Exam

Datentyp

text

Procedure: Neurological Exam
Beschreibung

Procedure: Neurological Exam

Datentyp

text

Procedure: Vital signs
Beschreibung

Procedure: Vital signs

Datentyp

text

Procedure: Height & Weight
Beschreibung

Procedure: Height & Weight

Datentyp

text

Procedure: ECG
Beschreibung

Procedure: ECG

Datentyp

text

Procedure: Echocardiogram
Beschreibung

Procedure: Echocardiogram

Datentyp

text

Procedure: Chest X-ray
Beschreibung

Procedure: Chest X-ray

Datentyp

text

Procedure: CT Scan
Beschreibung

Procedure: CT Scan

Datentyp

text

Procedure: Fasting Laboratory Samples
Beschreibung

Procedure: Fasting Laboratory Samples

Datentyp

text

Procedure: Non-Fasting Laboratory Samples
Beschreibung

Procedure: Non-Fasting Laboratory Samples

Datentyp

text

Procedure: PGx Sampling
Beschreibung

Procedure: PGx Sampling

Datentyp

text

Procedure: PGm Sampling
Beschreibung

Procedure: PGm Sampling

Datentyp

text

Procedure: HADS
Beschreibung

Procedure: HADS

Datentyp

text

Procedure: MMSE
Beschreibung

Procedure: MMSE

Datentyp

text

Procedure: ADAS-cog
Beschreibung

Procedure: ADAS-cog

Datentyp

text

Procedure: CIBIC+
Beschreibung

Procedure: CIBIC+

Datentyp

text

Procedure: NPI
Beschreibung

Procedure: NPI

Datentyp

text

Procedure: DAD
Beschreibung

Procedure: DAD

Datentyp

text

Procedure: Recording of AEs
Beschreibung

Procedure: Recording of AEs

Datentyp

text

Procedure: Recording of AEs
Beschreibung

Procedure: Recording of AEs

Datentyp

text

Procedure: Review Medication Compliance
Beschreibung

Procedure: Review Medication Compliance

Datentyp

text

Procedure: Study Conclusion Record
Beschreibung

Procedure: Study Conclusion Record

Datentyp

text

Visit 2
Beschreibung

Visit 2

Subject Identifier
Beschreibung

Subject Identifier

Datentyp

integer

Visit Date
Beschreibung

Visit Date

Datentyp

date

Randomisation
Beschreibung

Randomisation

Randomisation number
Beschreibung

Randomisation number

Datentyp

integer

Vital signs
Beschreibung

Vital signs

Weight
Beschreibung

Weight

Datentyp

float

Maßeinheiten
  • kg
kg
Blood pressure: Systolic
Beschreibung

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

Datentyp

integer

Blood pressure: Diastolic
Beschreibung

Blood pressure

Datentyp

integer

Maßeinheiten
  • mmHg
mmHg
Heart rate
Beschreibung

Heart rate

Datentyp

integer

Maßeinheiten
  • bpm
bpm
Central Laboratory (Fasting samples)
Beschreibung

Central Laboratory (Fasting samples)

Date samples taken
Beschreibung

Date

Datentyp

date

Pharmacogenetic (PGx) and Pharmacogenomic (PGm) Research
Beschreibung

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.

Datentyp

boolean

PGm-Transcriptomic Research
Beschreibung

PGm-Transcriptomic Research

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

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

Datentyp

boolean

If yes, record date and time sample taken
Beschreibung

If yes, record date and time sample taken

Datentyp

datetime

PGm-Proteomic Research
Beschreibung

PGm-Proteomic Research

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

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

Datentyp

boolean

If yes, record date and time sample taken
Beschreibung

If yes, record date and time sample taken

Datentyp

datetime

Volume of one aliquot
Beschreibung

Volume of one aliquot

Datentyp

float

Maßeinheiten
  • ml
ml
Length of time the centrifuge ran
Beschreibung

Length of time the centrifuge ran

Datentyp

integer

Maßeinheiten
  • minutes
minutes
Temperature of the centrifuge
Beschreibung

Temperature of the centrifuge

Datentyp

text

Centrifugation speed
Beschreibung

Centrifugation speed

Datentyp

integer

Maßeinheiten
  • r.p.m
r.p.m
Centrifugation rotor radius
Beschreibung

Centrifugation rotor radius

Datentyp

integer

Maßeinheiten
  • cm
cm
Time aliquotted samples were placed in the freezer
Beschreibung

Time aliquotted samples were placed in the freezer

Datentyp

time

Temperature of freezer
Beschreibung

Temperature of freezer

Datentyp

integer

Maßeinheiten
  • °C
°C
Monitor Data Validation Check
Beschreibung

Monitor Data Validation Check

Results from Monitor Data Validation Check
Beschreibung

Results from Monitor Data Validation Check

Datentyp

text

Investigational product
Beschreibung

Investigational product

Investigational Product
Beschreibung

Investigational Product

Datentyp

text

Start Date
Beschreibung

Start Date

Datentyp

date

Stop Date
Beschreibung

Stop Date

Datentyp

date

IP Container No.
Beschreibung

IP Container No.

Datentyp

integer

Total Number of Tablets Dispensed
Beschreibung

Total Number of Tablets Dispensed

Datentyp

float

Total Number of Tablets Returned
Beschreibung

Total Number of Tablets Returned

Datentyp

float

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

Discontinuation

Datentyp

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.
Beschreibung

End of visit reminder

Datentyp

boolean

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Ähnliche Modelle

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

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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