Clinical Trial Results:
Vit-D in CRC - A Randomised Double Blind Placebo-Controlled Clinical Trial Of a Single Oral Cholecalciferol Treatment Against Surrogate End Point Biomarkers (SEBs) In Colon Cancer (CRC) Patients
Summary
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EudraCT number |
2013-001664-34 |
Trial protocol |
GB |
Global end of trial date |
24 Apr 2018
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Results information
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Results version number |
v1(current) |
This version publication date |
15 Aug 2019
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First version publication date |
15 Aug 2019
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
12028-FC-SS
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Belfast Health and Social Care Trust
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Sponsor organisation address |
Grosvenor Road, Belfast, United Kingdom, BT12 6BA
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Public contact |
Alison Murphy, Belfast Health and Social Care Trust, 44 02890636366, ResearchSponsor@belfasttrust.hscni.net
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Scientific contact |
Professor Frederick Charles Campbell, Queens University Belfast, 44 02890638468, f.c.campbell@qub.ac.uk
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Sponsor organisation name |
Queens University Belfast
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Sponsor organisation address |
University Road, Belfast, United Kingdom, BT7 1NN
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Public contact |
Louise Dunlop, Queens University Belfast, 44 02890972572, l.dunlop@qub.ac.uk
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Scientific contact |
Professor Frederick Charles Campbell, Queens University Belfast, 44 02890638468, f.c.campbell@qub.ac.uk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
29 Apr 2019
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
19 Apr 2017
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Global end of trial reached? |
Yes
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Global end of trial date |
24 Apr 2018
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
Primary Objectives: Part A
To ascertain if the proposed dosing regimen of cholecalciferol achieves cancer-suppressive levels of 25(OH)D in Colorectal Cancer (CRC) patients.
To investigate the safety of the cholecalciferol dose in CRC patients.
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Protection of trial subjects |
A Data Monitoring and Ethics Committee (DMEC) was appointed. The DMEC's responsibility was to safeguard the interests of the trial participants, in particular with regarding to safety and they advised the Trial Management Group so as to protect the validity and credibility of the trial.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
20 Jan 2014
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United Kingdom: 30
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Worldwide total number of subjects |
30
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EEA total number of subjects |
30
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
16
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From 65 to 84 years |
14
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85 years and over |
0
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Recruitment
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Recruitment details |
30 patients were enrolled between 10th December 2013 and 20th March 2017. All patients were recruited from 1 site within the United Kingdom. | ||||||||||||
Pre-assignment
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Screening details |
A total of 228 patients were screened for eligibility in accordance with the study inclusion/exclusion criteria. 198 patients were found to be ineligible or declined to participate. | ||||||||||||
Period 1
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Period 1 title |
Part A Dose Confirmation (overall period)
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Is this the baseline period? |
Yes | ||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||
Roles blinded |
Investigator, Subject, Monitor, Assessor | ||||||||||||
Blinding implementation details |
Vigantol oil and the placebo oil were packaged and labeled in matching containers by Victoria Pharmaceuticals in Belfast according to the randomisation scheduled. Each bottle was labeled with a unique identifier and upon patient enrolment the medication packs were dispensed in sequential order starting with the lowest number available.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Cholecalciferol 300,000 IU | ||||||||||||
Arm description |
Single dose of 300, 000 IU cholecalciferol | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
Cholecalciferol
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Oral solution
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Routes of administration |
Oral use
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Dosage and administration details |
A single oral dose of cholecalciferol 300,000 IU on the morning of day 1. Participants were given 15 mL Vigantol oil (MERCK; cholecalciferol 20,000 IU/ml) to be taken by mouth after pre-treatment blood sampling. The study drug was taken with a glass of water and witnessed by a member of the research team.
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Arm title
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Placebo | ||||||||||||
Arm description |
Single dose of Placebo liquid oil | ||||||||||||
Arm type |
Placebo | ||||||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Oral liquid
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Routes of administration |
Oral use
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Dosage and administration details |
A single oral dose of placebo oil the morning of day 1. Participants were given 15 mL placebo oil, to be taken by mouth after pre-treatment blood sampling. The placebo oil was taken with a glass of water and witnessed by a member of the research team.
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Arm title
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Cholecalciferol 600,000 IU | ||||||||||||
Arm description |
Single dose of 600, 000 IU cholecalciferol | ||||||||||||
Arm type |
Increased Cholecalciferol Dose | ||||||||||||
Investigational medicinal product name |
Cholecalciferol
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Oral solution
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Routes of administration |
Oral use
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Dosage and administration details |
Single oral dose of cholecalciferol 600,000 IU on the morning of day 1. Participants were given 30 mL Vigantol oil (MERCK; cholecalciferol 20,000 IU/ml) to be taken by mouth after pre-treatment blood sampling. The study drug was taken with a glass of water and witnessed by a member of the research team.
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Baseline characteristics reporting groups
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Reporting group title |
Cholecalciferol 300,000 IU
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Reporting group description |
Single dose of 300, 000 IU cholecalciferol | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
Single dose of Placebo liquid oil | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Cholecalciferol 600,000 IU
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Reporting group description |
Single dose of 600, 000 IU cholecalciferol | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Cholecalciferol 300,000 IU
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Reporting group description |
Single dose of 300, 000 IU cholecalciferol | ||
Reporting group title |
Placebo
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Reporting group description |
Single dose of Placebo liquid oil | ||
Reporting group title |
Cholecalciferol 600,000 IU
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Reporting group description |
Single dose of 600, 000 IU cholecalciferol |
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End point title |
25(OH)D concentration in serum Baseline [1] | ||||||||||||||||
End point description |
25(OH)D concentration in serum
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End point type |
Primary
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End point timeframe |
Baseline
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
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No statistical analyses for this end point |
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End point title |
25(OH)D concentration in serum Week 1 [2] | ||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Week 1
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Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
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No statistical analyses for this end point |
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End point title |
25(OH)D concentration in serum Week 2 [3] | ||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Week 2
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Notes [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
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No statistical analyses for this end point |
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End point title |
25(OH)D concentration in serum Week 3 [4] | ||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Week 3
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Notes [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
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No statistical analyses for this end point |
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End point title |
25(OH)D concentration in serum Week 4 [5] | ||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Week 4
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Notes [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
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No statistical analyses for this end point |
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End point title |
Haematology_Haemoglobin Baseline [6] | ||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Baseline
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Notes [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only. |
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No statistical analyses for this end point |
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End point title |
Haematology_Haemoglobin Week 1 [7] | ||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Week 1
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Notes [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only. |
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No statistical analyses for this end point |
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End point title |
Haematology_Haemoglobin Week 2 [8] | ||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Week 2
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Notes [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only. |
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No statistical analyses for this end point |
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End point title |
Haematology_Haemoglobin Week 3 [9] | ||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Week 3
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Notes [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only. |
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No statistical analyses for this end point |
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End point title |
Haematology_Haemoglobin Week 4 [10] | ||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Week 4
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Notes [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only. |
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No statistical analyses for this end point |
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End point title |
Haematology_Haematocrit Baseline [11] | ||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Baseline
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Notes [11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only. |
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No statistical analyses for this end point |
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End point title |
Haematology_Haematocrit Week 1 [12] | ||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Week 1
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Notes [12] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only. |
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No statistical analyses for this end point |
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End point title |
Haematology_Haematocrit Week 2 [13] | ||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Week 2
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Notes [13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only. |
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No statistical analyses for this end point |
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End point title |
Haematology_Haematocrit Week 3 [14] | ||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Week 3
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Notes [14] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only. |
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No statistical analyses for this end point |
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End point title |
Haematology_Haematocrit Week 4 [15] | ||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Week 4
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Notes [15] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only. |
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No statistical analyses for this end point |
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End point title |
Haematology_Platelets Baseline [16] | ||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Baseline
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Notes [16] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only. |
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No statistical analyses for this end point |
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End point title |
Haematology_Platelets Week 1 [17] | ||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Week 1
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Notes [17] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only. |
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No statistical analyses for this end point |
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End point title |
Haematology_Platelets Week 2 [18] | ||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Week 2
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Notes [18] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only. |
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No statistical analyses for this end point |
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End point title |
Haematology_Platelets Week 3 [19] | ||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Week 3
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Notes [19] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only. |
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No statistical analyses for this end point |
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End point title |
Haematology_Platelets Week 4 [20] | ||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Week 4
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Notes [20] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only. |
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No statistical analyses for this end point |
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End point title |
Haematology_White Blood Cell Count Baseline [21] | ||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Baseline
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Notes [21] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only. |
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No statistical analyses for this end point |
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End point title |
Haematology_White Blood Cell Count Week 1 [22] | ||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Week 1
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Notes [22] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only. |
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No statistical analyses for this end point |
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End point title |
Haematology_White Blood Cell Count Week 2 [23] | ||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Week 2
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Notes [23] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only. |
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No statistical analyses for this end point |
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End point title |
Haematology_White Blood Cell Count Week 3 [24] | ||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Week 3
|
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Notes [24] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Haematology_White Blood Cell Count Week 4 [25] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 4
|
||||||||||||||||
Notes [25] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Haematology_Neutrophils Baseline [26] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Baseline
|
||||||||||||||||
Notes [26] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Haematology_Neutrophils Week 1 [27] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 1
|
||||||||||||||||
Notes [27] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Haematology_Neutrophils Week 2 [28] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 2
|
||||||||||||||||
Notes [28] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Haematology_Neutrophils Week 3 [29] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 3
|
||||||||||||||||
Notes [29] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Haematology_Neutrophils Week 4 [30] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 4
|
||||||||||||||||
Notes [30] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Haematology_Lymphocytes Baseline [31] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Baseline
|
||||||||||||||||
Notes [31] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Haematology_Lymphocytes Week 1 [32] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 1
|
||||||||||||||||
Notes [32] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Haematology_Lymphocytes Week 2 [33] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 2
|
||||||||||||||||
Notes [33] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Haematology_Lymphocytes Week 3 [34] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 3
|
||||||||||||||||
Notes [34] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Haematology_Lymphocytes Week 4 [35] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 4
|
||||||||||||||||
Notes [35] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Haematology_Monocytes Baseline [36] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Baseline
|
||||||||||||||||
Notes [36] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Haematology_Monocytes Week 1 [37] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 1
|
||||||||||||||||
Notes [37] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Haematology_Monocytes Week 2 [38] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 2
|
||||||||||||||||
Notes [38] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Haematology_Monocytes Week 3 [39] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 3
|
||||||||||||||||
Notes [39] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Haematology_Monocytes Week 4 [40] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 4
|
||||||||||||||||
Notes [40] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Haematology_Eosinophils Baseline [41] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Baseline
|
||||||||||||||||
Notes [41] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Haematology_Eosinophils Week 1 [42] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 1
|
||||||||||||||||
Notes [42] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Haematology_Eosinophils Week 2 [43] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 2
|
||||||||||||||||
Notes [43] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Haematology_Eosinophils Week 3 [44] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 3
|
||||||||||||||||
Notes [44] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Haematology_Eosinophils Week 4 [45] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 4
|
||||||||||||||||
Notes [45] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Haematology_Basophils Baseline [46] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Baseline
|
||||||||||||||||
Notes [46] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Haematology_Basophils Week 1 [47] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 1
|
||||||||||||||||
Notes [47] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Haematology_Basophils Week 2 [48] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 2
|
||||||||||||||||
Notes [48] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Haematology_Basophils Week 3 [49] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 3
|
||||||||||||||||
Notes [49] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Haematology_Basophils Week 4 [50] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 4
|
||||||||||||||||
Notes [50] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, haematology data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_Serum Calcium Baseline [51] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Baseline
|
||||||||||||||||
Notes [51] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_Serum Calcium Week 1 [52] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 1
|
||||||||||||||||
Notes [52] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_Serum Calcium Week 2 [53] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 2
|
||||||||||||||||
Notes [53] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_Serum Calcium Week 3 [54] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 3
|
||||||||||||||||
Notes [54] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_Serum Calcium Week 4 [55] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 4
|
||||||||||||||||
Notes [55] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_Corrected Serum Calcium Baseline [56] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Baseline
|
||||||||||||||||
Notes [56] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_Corrected Serum Calcium Week 1 [57] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 1
|
||||||||||||||||
Notes [57] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_Corrected Serum Calcium Week 2 [58] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 2
|
||||||||||||||||
Notes [58] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_Corrected Serum Calcium Week 3 [59] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 3
|
||||||||||||||||
Notes [59] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_Corrected Serum Calcium Week 4 [60] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 4
|
||||||||||||||||
Notes [60] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_Albumin Baseline [61] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Baseline
|
||||||||||||||||
Notes [61] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_Albumin Week 1 [62] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 1
|
||||||||||||||||
Notes [62] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_Albumin Week 2 [63] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 2
|
||||||||||||||||
Notes [63] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_Albumin Week 3 [64] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 3
|
||||||||||||||||
Notes [64] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_Albumin Week 4 [65] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 4
|
||||||||||||||||
Notes [65] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_Sodium Baseline [66] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Baseline
|
||||||||||||||||
Notes [66] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_Sodium Week 1 [67] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 1
|
||||||||||||||||
Notes [67] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_Sodium Week 2 [68] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 2
|
||||||||||||||||
Notes [68] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_Sodium Week 3 [69] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 3
|
||||||||||||||||
Notes [69] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_Sodium Week 4 [70] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 4
|
||||||||||||||||
Notes [70] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_Potassium Baseline [71] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Baseline
|
||||||||||||||||
Notes [71] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_Potassium Week 1 [72] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 1
|
||||||||||||||||
Notes [72] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_Potassium Week 2 [73] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 2
|
||||||||||||||||
Notes [73] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_Potassium Week 3 [74] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 3
|
||||||||||||||||
Notes [74] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_Potassium Week 4 [75] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 4
|
||||||||||||||||
Notes [75] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_Chloride Baseline [76] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Baseline
|
||||||||||||||||
Notes [76] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_Chloride Week 1 [77] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 1
|
||||||||||||||||
Notes [77] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_Chloride Week 2 [78] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 2
|
||||||||||||||||
Notes [78] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_Chloride Week 3 [79] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 3
|
||||||||||||||||
Notes [79] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_Chloride Week 4 [80] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 4
|
||||||||||||||||
Notes [80] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_Creatinine Baseline [81] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Baseline
|
||||||||||||||||
Notes [81] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_Creatinine Week 1 [82] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 1
|
||||||||||||||||
Notes [82] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_Creatinine Week 2 [83] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 2
|
||||||||||||||||
Notes [83] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_Creatinine Week 3 [84] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 3
|
||||||||||||||||
Notes [84] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_Creatinine Week 4 [85] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 4
|
||||||||||||||||
Notes [85] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_Glucose, Serum Baseline [86] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Baseline
|
||||||||||||||||
Notes [86] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_Glucose, Serum Week 1 [87] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 1
|
||||||||||||||||
Notes [87] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_Glucose, Serum Week 2 [88] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 2
|
||||||||||||||||
Notes [88] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_Glucose, Serum Week 3 [89] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 3
|
||||||||||||||||
Notes [89] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_Glucose, Serum Week 4 [90] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 4
|
||||||||||||||||
Notes [90] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_Alkaline Phosphatase Baseline [91] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Baseline
|
||||||||||||||||
Notes [91] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_Alkaline Phosphatase Week 1 [92] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 1
|
||||||||||||||||
Notes [92] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_Alkaline Phosphatase Week 2 [93] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 2
|
||||||||||||||||
Notes [93] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_Alkaline Phosphatase Week 3 [94] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 3
|
||||||||||||||||
Notes [94] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_Alkaline Phosphatase Week 4 [95] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 4
|
||||||||||||||||
Notes [95] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_Blood Urea Baseline [96] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Baseline
|
||||||||||||||||
Notes [96] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_Blood Urea Week 1 [97] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 1
|
||||||||||||||||
Notes [97] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_Blood Urea Week 2 [98] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 2
|
||||||||||||||||
Notes [98] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_Blood Urea Week 3 [99] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 3
|
||||||||||||||||
Notes [99] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_Blood Urea Week 4 [100] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 4
|
||||||||||||||||
Notes [100] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_SGOT/AST Baseline [101] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Baseline
|
||||||||||||||||
Notes [101] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_SGOT/AST Week 1 [102] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 1
|
||||||||||||||||
Notes [102] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_SGOT/AST Week 2 [103] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 2
|
||||||||||||||||
Notes [103] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_SGOT/AST Week 3 [104] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 3
|
||||||||||||||||
Notes [104] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_SGOT/AST Week 4 [105] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 4
|
||||||||||||||||
Notes [105] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_SGPT/ALT Baseline [106] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Baseline
|
||||||||||||||||
Notes [106] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_SGPT/ALT Week 1 [107] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 1
|
||||||||||||||||
Notes [107] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_SGPT/ALT Week 2 [108] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 2
|
||||||||||||||||
Notes [108] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_SGPT/ALT Week 3 [109] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 3
|
||||||||||||||||
Notes [109] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_SGPT/ALT Week 4 [110] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 4
|
||||||||||||||||
Notes [110] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_Bilirubin, Total Baseline [111] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Baseline
|
||||||||||||||||
Notes [111] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_Bilirubin, Total Week 1 [112] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 1
|
||||||||||||||||
Notes [112] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_Bilirubin, Total Week 2 [113] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 2
|
||||||||||||||||
Notes [113] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_Bilirubin, Total Week 3 [114] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 3
|
||||||||||||||||
Notes [114] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_Bilirubin, Total Week 4 [115] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 4
|
||||||||||||||||
Notes [115] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_Phosphorus Baseline [116] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Baseline
|
||||||||||||||||
Notes [116] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_Phosphorus Week 1 [117] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 1
|
||||||||||||||||
Notes [117] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_Phosphorus Week 2 [118] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 2
|
||||||||||||||||
Notes [118] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_Phosphorus Week 3 [119] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 3
|
||||||||||||||||
Notes [119] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_Phosphorus Week 4 [120] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 4
|
||||||||||||||||
Notes [120] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_eGFR Baseline [121] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Baseline
|
||||||||||||||||
Notes [121] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_eGFR Week 1 [122] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 1
|
||||||||||||||||
Notes [122] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_eGFR Week 2 [123] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 2
|
||||||||||||||||
Notes [123] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_eGFR Week 3 [124] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 3
|
||||||||||||||||
Notes [124] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Biochemistry_eGFR Week 4 [125] | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Week 4
|
||||||||||||||||
Notes [125] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Serum 25(OH)D >/= 33 ng/mL Baseline [126] | ||||||||||||
End point description |
Number of patients with a serum 25(OH)D concentration of greater than or equal to 33 ng/mL
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Baseline
|
||||||||||||
Notes [126] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Serum 25(OH)D >/= 33 ng/mL Week 1 [127] | ||||||||||||
End point description |
Number of patients with serum 25(OH)D concentrations greater than or equal to 33 ng/mL
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 1
|
||||||||||||
Notes [127] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Serum 25(OH)D >/= 33 ng/mL Week 2 [128] | ||||||||||||
End point description |
Number of patients with serum 25(OH)D concentration greater than or equal to 33 ng/mL
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 2
|
||||||||||||
Notes [128] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Serum 25(OH)D >/= 33 ng/mL Week 3 [129] | ||||||||||||
End point description |
Number of patients with serum 25(OH)D concentration greater than or equal to 33 ng/mL
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 3
|
||||||||||||
Notes [129] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Serum 25(OH)D >/= 33 ng/mL Week 4 [130] | ||||||||||||
End point description |
Number of patients with serum 25(OH)D concentration greater than or equal to 33 ng/mL
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 4
|
||||||||||||
Notes [130] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Serum corrected Calcium >/= 2.65mmol/I Baseline [131] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Baseline
|
||||||||||||
Notes [131] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Falls_Has fallen in the last week Baseline [132] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Baseline
|
||||||||||||
Notes [132] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Falls_Has fallen in the last week Week 2 [133] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 2
|
||||||||||||
Notes [133] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Falls_Has fallen in the last week Week 3 [134] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 3
|
||||||||||||
Notes [134] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Falls_Has fallen in the last week Week 4 [135] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 4
|
||||||||||||
Notes [135] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Serum corrected Calcium >/= 2.65mmol/I Week 1 [136] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 1
|
||||||||||||
Notes [136] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Serum corrected Calcium >/= 2.65mmol/I Week 2 [137] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 2
|
||||||||||||
Notes [137] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Serum corrected Calcium >/= 2.65mmol/I Week 3 [138] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 3
|
||||||||||||
Notes [138] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Serum corrected Calcium >/= 2.65mmol/I Week 4 [139] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 4
|
||||||||||||
Notes [139] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||
End point title |
Falls_Times fallen in the last week Baseline [140] [141] | ||||||
End point description |
|||||||
End point type |
Primary
|
||||||
End point timeframe |
Baseline
|
||||||
Notes [140] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. [141] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||
|
|||||||
No statistical analyses for this end point |
|
|||||||
End point title |
Falls_Times fallen in the last week Week 2 [142] [143] | ||||||
End point description |
|||||||
End point type |
Primary
|
||||||
End point timeframe |
Week 2
|
||||||
Notes [142] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. [143] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||
|
|||||||
No statistical analyses for this end point |
|
|||||||
End point title |
Falls_Times fallen in the last week Week 4 [144] [145] | ||||||
End point description |
|||||||
End point type |
Primary
|
||||||
End point timeframe |
Week 4
|
||||||
Notes [144] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. [145] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||
|
|||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Diet_Other Vitamins Baseline [146] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Baseline
|
||||||||||||
Notes [146] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Diet_Other Vitamins Week 1 [147] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 1
|
||||||||||||
Notes [147] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Diet_Other Vitamins Week 2 [148] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 2
|
||||||||||||
Notes [148] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Diet_Other Vitamins Week 3 [149] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 3
|
||||||||||||
Notes [149] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Diet_Other Vitamins Week 4 [150] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 4
|
||||||||||||
Notes [150] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Diet_Fish Oil Baseline [151] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Baseline
|
||||||||||||
Notes [151] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Diet_Fish Oil Week 1 [152] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 1
|
||||||||||||
Notes [152] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Diet_Fish Oil Week 2 [153] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 2
|
||||||||||||
Notes [153] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Diet_Fish Oil Week 3 [154] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 3
|
||||||||||||
Notes [154] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Diet_Fish Oil Week 4 [155] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 4
|
||||||||||||
Notes [155] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||
End point title |
Falls_Location Baseline [156] [157] | ||||||
End point description |
Inside the house
|
||||||
End point type |
Primary
|
||||||
End point timeframe |
Baseline
|
||||||
Notes [156] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. [157] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||
|
|||||||
No statistical analyses for this end point |
|
|||||||
End point title |
Falls_Location Baseline [158] [159] | ||||||
End point description |
Inside house_walking up/down stairs
|
||||||
End point type |
Primary
|
||||||
End point timeframe |
Baseline
|
||||||
Notes [158] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. [159] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||
|
|||||||
No statistical analyses for this end point |
|
|||||||
End point title |
Falls_Location Baseline [160] [161] | ||||||
End point description |
Home entrance/in garden
|
||||||
End point type |
Primary
|
||||||
End point timeframe |
Baseline
|
||||||
Notes [160] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. [161] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||
|
|||||||
No statistical analyses for this end point |
|
|||||||
End point title |
Falls_Location Baseline [162] [163] | ||||||
End point description |
Away from home
|
||||||
End point type |
Primary
|
||||||
End point timeframe |
Baseline
|
||||||
Notes [162] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. [163] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||
|
|||||||
No statistical analyses for this end point |
|
|||||||
End point title |
Falls_Location Week 2 [164] [165] | ||||||
End point description |
Inside the house
|
||||||
End point type |
Primary
|
||||||
End point timeframe |
Week 2
|
||||||
Notes [164] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. [165] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||
|
|||||||
No statistical analyses for this end point |
|
|||||||
End point title |
Falls_Location Week 2 [166] [167] | ||||||
End point description |
Home entrance/in garden
|
||||||
End point type |
Primary
|
||||||
End point timeframe |
Week 2
|
||||||
Notes [166] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. [167] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||
|
|||||||
No statistical analyses for this end point |
|
|||||||
End point title |
Falls_Location Week 2 [168] [169] | ||||||
End point description |
Home entrance/in garden_In the garden
|
||||||
End point type |
Primary
|
||||||
End point timeframe |
Week 2
|
||||||
Notes [168] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. [169] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||
|
|||||||
No statistical analyses for this end point |
|
|||||||
End point title |
Falls_Location Week 2 [170] [171] | ||||||
End point description |
Away from home
|
||||||
End point type |
Primary
|
||||||
End point timeframe |
Week 2
|
||||||
Notes [170] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. [171] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||
|
|||||||
No statistical analyses for this end point |
|
|||||||
End point title |
Falls_Location Week 4 [172] [173] | ||||||
End point description |
Inside the house
|
||||||
End point type |
Primary
|
||||||
End point timeframe |
Week 4
|
||||||
Notes [172] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. [173] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||
|
|||||||
No statistical analyses for this end point |
|
|||||||
End point title |
Falls_Location Week 4 [174] [175] | ||||||
End point description |
Home entrance/in garden
|
||||||
End point type |
Primary
|
||||||
End point timeframe |
Week 4
|
||||||
Notes [174] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. [175] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||
|
|||||||
No statistical analyses for this end point |
|
|||||||
End point title |
Falls_Location Week 4 [176] [177] | ||||||
End point description |
Away from home
|
||||||
End point type |
Primary
|
||||||
End point timeframe |
Week 4
|
||||||
Notes [176] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. [177] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||
|
|||||||
No statistical analyses for this end point |
|
|||||||
End point title |
Falls_Location Week 4 [178] [179] | ||||||
End point description |
Away from home_On a kerb/gutter
|
||||||
End point type |
Primary
|
||||||
End point timeframe |
Week 4
|
||||||
Notes [178] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. [179] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||
|
|||||||
No statistical analyses for this end point |
|
|||||||
End point title |
Falls_Injured as a result Baseline [180] [181] | ||||||
End point description |
|||||||
End point type |
Primary
|
||||||
End point timeframe |
Baseline
|
||||||
Notes [180] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. [181] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||
|
|||||||
No statistical analyses for this end point |
|
|||||||
End point title |
Falls_Injured as a result Week 2 [182] [183] | ||||||
End point description |
|||||||
End point type |
Primary
|
||||||
End point timeframe |
Week 2
|
||||||
Notes [182] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. [183] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||
|
|||||||
No statistical analyses for this end point |
|
|||||||
End point title |
Falls_Injured as a result Week 4 [184] [185] | ||||||
End point description |
|||||||
End point type |
Primary
|
||||||
End point timeframe |
Week 4
|
||||||
Notes [184] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. [185] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||
|
|||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Diet_Times per week eat oily fish Baseline [186] | ||||||||||||
End point description |
None
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Baseline
|
||||||||||||
Notes [186] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Diet_Times per week eat oily fish Baseline [187] | ||||||||||||
End point description |
Once
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Baseline
|
||||||||||||
Notes [187] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Diet_Times per week eat oily fish Baseline [188] | ||||||||||||
End point description |
Twice
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Baseline
|
||||||||||||
Notes [188] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Diet_Times per week eat oily fish Baseline [189] | ||||||||||||
End point description |
Three or More
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Baseline
|
||||||||||||
Notes [189] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Diet_Times per week eat oily fish Week 1 [190] | ||||||||||||
End point description |
None
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 1
|
||||||||||||
Notes [190] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Diet_Times per week eat oily fish Week 1 [191] | ||||||||||||
End point description |
Once
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 1
|
||||||||||||
Notes [191] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Diet_Times per week eat oily fish Week 1 [192] | ||||||||||||
End point description |
Twice
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 1
|
||||||||||||
Notes [192] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Diet_Times per week eat oily fish Week 1 [193] | ||||||||||||
End point description |
Three or more
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 1
|
||||||||||||
Notes [193] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Diet_Times per week eat oily fish Week 2 [194] | ||||||||||||
End point description |
None
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 2
|
||||||||||||
Notes [194] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Diet_Times per week eat oily fish Week 2 [195] | ||||||||||||
End point description |
Once
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 2
|
||||||||||||
Notes [195] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Diet_Times per week eat oily fish Week 2 [196] | ||||||||||||
End point description |
Twice
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 2
|
||||||||||||
Notes [196] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Diet_Times per week eat oily fish Week 2 [197] | ||||||||||||
End point description |
Three or more
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 2
|
||||||||||||
Notes [197] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Diet_Times per week eat oily fish Week 3 [198] | ||||||||||||
End point description |
None
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 3
|
||||||||||||
Notes [198] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Diet_Times per week eat oily fish Week 3 [199] | ||||||||||||
End point description |
Once
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 3
|
||||||||||||
Notes [199] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Diet_Times per week eat oily fish Week 3 [200] | ||||||||||||
End point description |
Twice
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 3
|
||||||||||||
Notes [200] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Diet_Times per week eat oily fish Week 3 [201] | ||||||||||||
End point description |
Three or more
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 3
|
||||||||||||
Notes [201] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Diet_Times per week eat oily fish Week 4 [202] | ||||||||||||
End point description |
None
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 4
|
||||||||||||
Notes [202] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Diet_Times per week eat oily fish Week 4 [203] | ||||||||||||
End point description |
Once
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 4
|
||||||||||||
Notes [203] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Diet_Times per week eat oily fish Week 4 [204] | ||||||||||||
End point description |
Twice
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 4
|
||||||||||||
Notes [204] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Diet_Times per week eat oily fish Week 4 [205] | ||||||||||||
End point description |
Three or more
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 4
|
||||||||||||
Notes [205] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Diet_Times per week eat mushrooms Baseline [206] | ||||||||||||
End point description |
None
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Baseline
|
||||||||||||
Notes [206] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Diet_Times per week eat mushrooms Baseline [207] | ||||||||||||
End point description |
Once
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Baseline
|
||||||||||||
Notes [207] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Diet_Times per week eat mushrooms Baseline [208] | ||||||||||||
End point description |
Twice
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Baseline
|
||||||||||||
Notes [208] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Diet_Times per week eat mushrooms Baseline [209] | ||||||||||||
End point description |
Three or more
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Baseline
|
||||||||||||
Notes [209] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Diet_Times per week eat mushrooms Week 1 [210] | ||||||||||||
End point description |
None
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 1
|
||||||||||||
Notes [210] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Diet_Times per week eat mushrooms Week 1 [211] | ||||||||||||
End point description |
Once
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 1
|
||||||||||||
Notes [211] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Diet_Times per week eat mushrooms Week 1 [212] | ||||||||||||
End point description |
Twice
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 1
|
||||||||||||
Notes [212] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Diet_Times per week eat mushrooms Week 1 [213] | ||||||||||||
End point description |
Three of more
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 1
|
||||||||||||
Notes [213] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Diet_Times per week eat mushrooms Week 2 [214] | ||||||||||||
End point description |
None
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 2
|
||||||||||||
Notes [214] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Diet_Times per week eat mushrooms Week 2 [215] | ||||||||||||
End point description |
Once
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 2
|
||||||||||||
Notes [215] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Diet_Times per week eat mushrooms Week 2 [216] | ||||||||||||
End point description |
Twice
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 2
|
||||||||||||
Notes [216] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Diet_Times per week eat mushrooms Week 2 [217] | ||||||||||||
End point description |
Three or more
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 2
|
||||||||||||
Notes [217] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Diet_Times per week eat mushrooms Week 3 [218] | ||||||||||||
End point description |
None
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 3
|
||||||||||||
Notes [218] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Diet_Times per week eat mushrooms Week 3 [219] | ||||||||||||
End point description |
Once
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 3
|
||||||||||||
Notes [219] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Diet_Times per week eat mushrooms Week 3 [220] | ||||||||||||
End point description |
Twice
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 3
|
||||||||||||
Notes [220] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Diet_Times per week eat mushrooms Week 3 [221] | ||||||||||||
End point description |
Three or more
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 3
|
||||||||||||
Notes [221] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Diet_Times per week eat mushrooms Week 4 [222] | ||||||||||||
End point description |
None
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 4
|
||||||||||||
Notes [222] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Diet_Times per week eat mushrooms Week 4 [223] | ||||||||||||
End point description |
Once
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 4
|
||||||||||||
Notes [223] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Diet_Times per week eat mushrooms Week 4 [224] | ||||||||||||
End point description |
Twice
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 4
|
||||||||||||
Notes [224] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Diet_Times per week eat mushrooms Week 4 [225] | ||||||||||||
End point description |
Three or more
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 4
|
||||||||||||
Notes [225] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Loss of Appetite Baseline [226] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Baseline
|
||||||||||||
Notes [226] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Loss of Appetite Week 1 [227] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 1
|
||||||||||||
Notes [227] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Loss of Appetite Week 2 [228] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 2
|
||||||||||||
Notes [228] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Loss of Appetite Week 3 [229] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 3
|
||||||||||||
Notes [229] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Loss of Appetite Week 4 [230] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 4
|
||||||||||||
Notes [230] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Nausea Baseline [231] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Baseline
|
||||||||||||
Notes [231] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Nausea Week 1 [232] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 1
|
||||||||||||
Notes [232] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Nausea Week 2 [233] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 2
|
||||||||||||
Notes [233] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Nausea Week 3 [234] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 3
|
||||||||||||
Notes [234] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Nausea Week 4 [235] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 4
|
||||||||||||
Notes [235] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Vomiting Baseline [236] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Baseline
|
||||||||||||
Notes [236] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Vomiting Week 1 [237] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 1
|
||||||||||||
Notes [237] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Vomiting Week 2 [238] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 2
|
||||||||||||
Notes [238] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Vomiting Week 3 [239] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 3
|
||||||||||||
Notes [239] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Vomiting Week 4 [240] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 4
|
||||||||||||
Notes [240] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Diarrhoea Baseline [241] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Baseline
|
||||||||||||
Notes [241] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Diarrhoea Week 1 [242] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 1
|
||||||||||||
Notes [242] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Diarrhoea Week 2 [243] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 2
|
||||||||||||
Notes [243] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Diarrhoea Week 3 [244] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 3
|
||||||||||||
Notes [244] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Diarrhoea Week 4 [245] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 4
|
||||||||||||
Notes [245] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Loss of weight Baseline [246] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Baseline
|
||||||||||||
Notes [246] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Loss of weight Week 1 [247] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 1
|
||||||||||||
Notes [247] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Loss of weight Week 2 [248] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 2
|
||||||||||||
Notes [248] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Loss of weight Week 3 [249] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 3
|
||||||||||||
Notes [249] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Loss of weight Week 4 [250] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 4
|
||||||||||||
Notes [250] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Headache Baseline [251] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Baseline
|
||||||||||||
Notes [251] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Headache Week 1 [252] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 1
|
||||||||||||
Notes [252] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Headache Week 2 [253] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 2
|
||||||||||||
Notes [253] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Headache Week 3 [254] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 3
|
||||||||||||
Notes [254] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Headache Week 4 [255] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 4
|
||||||||||||
Notes [255] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Rise at night to pass urine Baseline [256] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Baseline
|
||||||||||||
Notes [256] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Rise at night to pass urine Week 1 [257] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 1
|
||||||||||||
Notes [257] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Rise at night to pass urine Week 2 [258] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 2
|
||||||||||||
Notes [258] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Rise at night to pass urine Week 3 [259] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 3
|
||||||||||||
Notes [259] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Rise at night to pass urine Week 4 [260] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 4
|
||||||||||||
Notes [260] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Thirst Baseline [261] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Baseline
|
||||||||||||
Notes [261] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Thirst Week 1 [262] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 1
|
||||||||||||
Notes [262] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Thirst Week 2 [263] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 2
|
||||||||||||
Notes [263] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Thirst Week 2 [264] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 2
|
||||||||||||
Notes [264] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Thirst Week 3 [265] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 3
|
||||||||||||
Notes [265] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Thirst Week 4 [266] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 4
|
||||||||||||
Notes [266] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Dizziness Baseline [267] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Baseline
|
||||||||||||
Notes [267] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Dizziness Week 1 [268] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 1
|
||||||||||||
Notes [268] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Dizziness Week 2 [269] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 2
|
||||||||||||
Notes [269] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Dizziness Week 3 [270] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 3
|
||||||||||||
Notes [270] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Dizziness Week 4 [271] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 4
|
||||||||||||
Notes [271] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Constipation Baseline [272] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Baseline
|
||||||||||||
Notes [272] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Constipation Week 1 [273] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 1
|
||||||||||||
Notes [273] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Constipation Week 2 [274] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 2
|
||||||||||||
Notes [274] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Constipation Week 3 [275] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 3
|
||||||||||||
Notes [275] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Constipation Week 4 [276] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 4
|
||||||||||||
Notes [276] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Fatigue Baseline [277] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Baseline
|
||||||||||||
Notes [277] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Fatigue Week 1 [278] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 1
|
||||||||||||
Notes [278] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Fatigue Week 2 [279] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 2
|
||||||||||||
Notes [279] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Fatigue Week 3 [280] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 3
|
||||||||||||
Notes [280] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Fatigue Week 4 [281] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 4
|
||||||||||||
Notes [281] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Bone Pain Baseline [282] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Baseline
|
||||||||||||
Notes [282] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Bone Pain Week 1 [283] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 1
|
||||||||||||
Notes [283] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Bone Pain Week 2 [284] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 2
|
||||||||||||
Notes [284] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Bone Pain Week 3 [285] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 3
|
||||||||||||
Notes [285] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Bone Pain Week 4 [286] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 4
|
||||||||||||
Notes [286] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Muscle Weakness Baseline [287] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Baseline
|
||||||||||||
Notes [287] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Muscle Weakness Week 1 [288] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 1
|
||||||||||||
Notes [288] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Muscle Weakness Week 2 [289] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 2
|
||||||||||||
Notes [289] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Muscle Weakness Week 3 [290] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 3
|
||||||||||||
Notes [290] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Muscle Weakness Week 4 [291] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 4
|
||||||||||||
Notes [291] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Abdominal Pain Baseline [292] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Baseline
|
||||||||||||
Notes [292] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Abdominal Pain Week 1 [293] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 1
|
||||||||||||
Notes [293] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Abdominal Pain Week 2 [294] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 2
|
||||||||||||
Notes [294] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Abdominal Pain Week 3 [295] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 3
|
||||||||||||
Notes [295] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Toxicity_Abdominal Pain Week 4 [296] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 4
|
||||||||||||
Notes [296] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Falls_Has fallen in the last week Week 1 [297] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Week 1
|
||||||||||||
Notes [297] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As per Statistical Analysis Plan, biochemistry data analysed using descriptive statistics only. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse events information
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Timeframe for reporting adverse events |
Baseline, week 1, 2, 3 and 4
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Adverse event reporting additional description |
Patients were asked about adverse events at each study visit.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
NCI CTCAE | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
4.03
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Reporting groups
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Reporting group title |
Cholecalciferol 300,000 IU
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Reporting group description |
Participants receiving cholecalciferol 300,000 IU | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
Participants receiving placebo | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Cholecalciferol 600,000 IU
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Reporting group description |
Participants receiving 600,000 IU Cholecalciferol | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 1% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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17 Sep 2013 |
Submission to Research Ethics Committee of Protocol Version 1.1 which was created to address the comments in the Clinical Trial notice of non-acceptance of the initial clinical trial request. |
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17 Jun 2016 |
Updated documents due to additional dose of cholecalciferol being assessed in Part A dose confirmation:
Protocol V3.2 20.10.2015 (Approved version 4.1 12/02/16)
Translation of German SmPC (Address change of Copromoter) June 2014
GP Letter Part A Final 2.0 13.05.15
GP Letter Part B Final 2.0 13.05.15
Patient Card PART A 600,000 IU Final 2.0 13.05.15
Patient Card PART B Final 2.0 13.05.15
Vit D PIS_ICF Part A Final V2.0 15.05.15
Vit D PIS_ICF Part B Additional Samples Final
Vit D PIS_ICF Part B Final v2.0 15.05.2015
Victoria Pharmaceuticals Product Specification 28.04.2015
Vitamin D diet questionnaire Final 1.0 02.10.2013
Viamin D falls questionnaire Final 1.0 02.10.2013
Vitamin D toxicity questionnaire Final 1.0 02.10.2013
MIA IMP V14 22.06.15 |
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06 Sep 2016 |
Protocol updated to version 4.1 to incorporate MHRA comments from notice of non-acceptance of previous substantial amendment. |
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18 Oct 2017 |
Updated protocol to version 4.2 to allow a review of gastrointestinal adverse events and tolerability following the administration of the 600,000 IU liquid formulation. |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
Data analysis is descriptive statistics only. Results for the Part A dose confirmation only are presented. It was not possible to confirm a suitable dose of the current liquid formulation within the context of the current protocol. |