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    Clinical Trial Results:
    A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease

    Summary
    EudraCT number
    2010-022383-12
    Trial protocol
    NL   DE   NO   BE   SE   GB   DK   CZ   HU   GR   AT   ES   PL   PT   EE   IT   SK   BG  
    Global end of trial date
    23 Oct 2013

    Results information
    Results version number
    v2(current)
    This version publication date
    10 Mar 2016
    First version publication date
    18 Mar 2015
    Other versions
    v1
    Version creation reason
    • Correction of full data set
    Correction of full data set

    Trial information

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    Trial identification
    Sponsor protocol code
    CCX114157
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01316939
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    980 Great West Road, Brentford, Middlesex, United Kingdom,
    Public contact
    GSK Response Center, GlaxoSmithKline, 1 8664357343,
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 1 8664357343,
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    980 Great West Road, Brentford, Middlesex, United Kingdom,
    Public contact
    GSK Response Center, GlaxoSmithKline, 1 8664357343,
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 1 8664357343,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    05 Feb 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Oct 2013
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    • To assess the efficacy of GSK1605786A compared with placebo in maintaining clinical remission in subjects with Crohn’s disease over 52 weeks.
    Protection of trial subjects
    Subjects were allowed to continue use of certain background medications to manage their Crohn’s disease.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    09 May 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 13
    Country: Number of subjects enrolled
    Austria: 6
    Country: Number of subjects enrolled
    Belgium: 9
    Country: Number of subjects enrolled
    Canada: 15
    Country: Number of subjects enrolled
    Czech Republic: 16
    Country: Number of subjects enrolled
    Denmark: 9
    Country: Number of subjects enrolled
    Estonia: 4
    Country: Number of subjects enrolled
    France: 6
    Country: Number of subjects enrolled
    Germany: 17
    Country: Number of subjects enrolled
    Hong Kong: 4
    Country: Number of subjects enrolled
    Hungary: 1
    Country: Number of subjects enrolled
    Israel: 5
    Country: Number of subjects enrolled
    Italy: 4
    Country: Number of subjects enrolled
    Japan: 7
    Country: Number of subjects enrolled
    Korea, Republic of: 6
    Country: Number of subjects enrolled
    Netherlands: 7
    Country: Number of subjects enrolled
    New Zealand: 5
    Country: Number of subjects enrolled
    Norway: 2
    Country: Number of subjects enrolled
    Poland: 5
    Country: Number of subjects enrolled
    Russian Federation: 8
    Country: Number of subjects enrolled
    Slovakia: 13
    Country: Number of subjects enrolled
    South Africa: 1
    Country: Number of subjects enrolled
    Spain: 4
    Country: Number of subjects enrolled
    Sweden: 2
    Country: Number of subjects enrolled
    Switzerland: 4
    Country: Number of subjects enrolled
    Ukraine: 7
    Country: Number of subjects enrolled
    United Kingdom: 8
    Country: Number of subjects enrolled
    United States: 41
    Worldwide total number of subjects
    229
    EEA total number of subjects
    113
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    222
    From 65 to 84 years
    7
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Participants were eligible to enter the study if they had achieved clinical response (Crohn’s Disease Activity Index [CDAI] decrease >=100 points) and/or clinical remission (CDAI <150) for their moderately-to-severely active disease at the end of 12 weeks of treatment in the induction studies CCX114151 or CCX114643.

    Pre-assignment
    Screening details
    Participants were randomized at Baseline (Week 0) to receive placebo or one of two possible dosage regimens of GSK1605786A: 500 milligrams (mg) once daily (QD) or 500 mg twice daily (BID) for 52-weeks.

    Period 1
    Period 1 title
    Overall Study (52 Week Treatment Period) (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Participants received matching placebo via 2 oral capsules for 52 weeks
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received 2 capsules of matching placebo via oral capsules for 52 weeks

    Arm title
    GSK1605786A 500 mg QD
    Arm description
    Participants received GSK1605786A a total of 500 milligrams (mg), administered as 2 250 mg oral capsules once daily (QD) for 52 weeks
    Arm type
    Active comparator

    Investigational medicinal product name
    GSK1605786A
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    500 mg once daily oral administration

    Arm title
    GSK1605786A 500 mg BID
    Arm description
    Participants received GSK1605786A a total of 500 mg, administered as 2 250 mg oral capsules, twice daily (BID) for 52 weeks
    Arm type
    Active comparator

    Investigational medicinal product name
    GSK1605786A
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    500 mg twice daily, oral administration

    Number of subjects in period 1
    Placebo GSK1605786A 500 mg QD GSK1605786A 500 mg BID
    Started
    76
    77
    76
    Completed
    13
    9
    7
    Not completed
    63
    68
    69
         Protocol deviation
    -
    1
    -
         Protocol Defined Stopping Criteria
    1
    -
    1
         Physician decision
    2
    2
    1
         Study Closed/Terminated
    26
    25
    23
         Lack of efficacy
    24
    25
    25
         Withdrawal by subject
    1
    3
    6
         Adverse event, non-fatal
    9
    12
    11
         Lost to follow-up
    -
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Participants received matching placebo via 2 oral capsules for 52 weeks

    Reporting group title
    GSK1605786A 500 mg QD
    Reporting group description
    Participants received GSK1605786A a total of 500 milligrams (mg), administered as 2 250 mg oral capsules once daily (QD) for 52 weeks

    Reporting group title
    GSK1605786A 500 mg BID
    Reporting group description
    Participants received GSK1605786A a total of 500 mg, administered as 2 250 mg oral capsules, twice daily (BID) for 52 weeks

    Reporting group values
    Placebo GSK1605786A 500 mg QD GSK1605786A 500 mg BID Total
    Number of subjects
    76 77 76 229
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
        Newborns (0-27 days)
    0
        Infants and toddlers (28 days-23 months)
    0
        Children (2-11 years)
    0
        Adolescents (12-17 years)
    0
        Adults (18-64 years)
    0
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    38.2 ± 13.2 36.7 ± 13 38.8 ± 12.75 -
    Gender categorical
    Units: Subjects
        Female
    46 35 42 123
        Male
    30 42 34 106
    Race, Customized
    Units: Subjects
        White-Caucasian/European
    69 64 68 201
        White-Arabic/North African
    1 3 1 5
        Black
    2 1 0 3
        Asian-East
    1 4 5 10
        Asian-Japanese
    3 3 1 7
        Am. Indian/native Alaskan
    0 0 1 1
        Missing
    0 2 0 2

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Participants received matching placebo via 2 oral capsules for 52 weeks

    Reporting group title
    GSK1605786A 500 mg QD
    Reporting group description
    Participants received GSK1605786A a total of 500 milligrams (mg), administered as 2 250 mg oral capsules once daily (QD) for 52 weeks

    Reporting group title
    GSK1605786A 500 mg BID
    Reporting group description
    Participants received GSK1605786A a total of 500 mg, administered as 2 250 mg oral capsules, twice daily (BID) for 52 weeks

    Subject analysis set title
    Intent to Treat population
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    The Intent-to-Treat (ITT) population consisted of all participants randomised to treatment who had achieved a clinical response (CDAI decrease from baseline of >=100 points) or achieved clinical remission (CDAI <150 points) in Study CCX114151 or Study CCX114643.

    Subject analysis set title
    Saftey population
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    The Safety Population comprised of all participants who were randomised and took at least one dose of treatment during the study; i.e., those participants with no treatment start date are excluded from this population.

    Primary: Percentage of participants that achieved clinical remission at both Weeks 28 and 52 of the 52-Week Treatment Period

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    End point title
    Percentage of participants that achieved clinical remission at both Weeks 28 and 52 of the 52-Week Treatment Period
    End point description
    Clinical remission is defined as a Crohn’s Disease Activity Index (CDAI) score of <150 points. The CDAI is a scoring system to measure disease severity with scores of >=220 to <=450 describing the moderately-to-severely active population, a score of >450 is considered severe. The score is algorithmically derived from the sum of participants'-reported Crohn’s disease symptoms recorded over 7 days and investigator recorded assessments of the participants’ condition, laboratory parameters and use of anti-diarrhoeal medication. Missing efficacy data (premature discontinuation or otherwise) were imputed using a “no effect” imputation where missing equals no response or no change in response. The Intent-to-Treat (ITT) population consisted of all participants randomised to treatment who had achieved a clinical response (CDAI decrease from baseline of >=100 points) or achieved clinical remission (CDAI <150 points) in Study CCX114151 or Study CCX114643.
    End point type
    Primary
    End point timeframe
    Weeks 28 and 52
    End point values
    Placebo GSK1605786A 500 mg QD GSK1605786A 500 mg BID
    Number of subjects analysed
    76 [1]
    77 [2]
    76 [3]
    Units: Percentage of participants
        number (not applicable)
    10.5
    6.5
    3.9
    Notes
    [1] - ITT population
    [2] - ITT population
    [3] - ITT population
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    -4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -12.9
         upper limit
    4.8
    Statistical analysis title
    Statistical Analysis 2
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    -6.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -14.8
         upper limit
    1.6

    Secondary: Percentage of participants in clinical remission and not taking corticosteroids at both Weeks 28 and 52 of the 52-Week Treatment Period

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    End point title
    Percentage of participants in clinical remission and not taking corticosteroids at both Weeks 28 and 52 of the 52-Week Treatment Period
    End point description
    Clinical remission is defined as a CDAI score of <150 points. The CDAI is a scoring system to measure disease severity with scores of >=220 to <=450 describing the moderately-to-severely active population. The score is algorithmically derived from the sum of participants'-reported Crohn’s disease symptoms recorded over 7 days and investigator recorded assessments of the participants’ condition, laboratory parameters and use of anti-diarrhoeal medication. Missing efficacy data (premature discontinuation or otherwise) were imputed using a “no effect” imputation where missing equals no response or no change in response. Percentage of participants in clinical remission and not taking corticosteroids at both Weeks 28 and 52 of the 52-week Treatment Period were presented. A participant was considered to be not taking corticosteroids at Weeks 28 and 52 if the participant has not taken a corticosteroid for the 8 days prior to and the day of the CDAI assessment for each of Weeks 28 and 52.
    End point type
    Secondary
    End point timeframe
    Weeks 28 and 52
    End point values
    Placebo GSK1605786A 500 mg QD GSK1605786A 500 mg BID
    Number of subjects analysed
    76 [4]
    77 [5]
    76 [6]
    Units: Percentage of participants
        number (not applicable)
    9.2
    5.2
    3.9
    Notes
    [4] - ITT population
    [5] - ITT population
    [6] - ITT population
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    -4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -12.2
         upper limit
    4.2
    Statistical analysis title
    Statistical Analysis 2
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    -5.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -13.1
         upper limit
    2.6

    Secondary: Percentage of participants in clinical remission at both Weeks 28 and 52 of the 52-Week Treatment Period among those participants who were in clinical remission at Baseline

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    End point title
    Percentage of participants in clinical remission at both Weeks 28 and 52 of the 52-Week Treatment Period among those participants who were in clinical remission at Baseline
    End point description
    Clinical remission is defined as a CDAI score of <150 points. The CDAI is a scoring system to measure disease severity with scores of >=220 to <=450 describing the moderately-to-severely active population. The score is algorithmically derived from the sum of participants'-reported Crohn’s disease symptoms recorded over 7 days and investigator recorded assessments of the participants’ condition, laboratory parameters and use of anti-diarrhoeal medication. Missing efficacy data (premature discontinuation or otherwise) were imputed using a “no effect” imputation where missing equals no response or no change in response. The percentage of participants who were in clinical remission at Baseline and at both Weeks 28 and 52 of the 52-week treatment period were presented. Baseline (Week 0) is defined as the results taken at the End of Study Visit of the Induction Study. Because the Induction Study was terminated prematurely, summary statistics were not compiled.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 28 and 52
    End point values
    Placebo GSK1605786A 500 mg QD GSK1605786A 500 mg BID
    Number of subjects analysed
    0 [7]
    0 [8]
    0 [9]
    Units: Percentage of participants
        number (not applicable)
    Notes
    [7] - ITT Population, because the study was terminated prematurely, summary statistics were not compiled.
    [8] - ITT Population, because the study was terminated prematurely, summary statistics were not compiled.
    [9] - ITT Population, because the study was terminated prematurely, summary statistics were not compiled.
    No statistical analyses for this end point

    Secondary: Percentage of participants in clinical remission at all visits (continuous clinical remission) during the 52-Week Treatment Period among participants in clinical remission at Baseline (BL)

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    End point title
    Percentage of participants in clinical remission at all visits (continuous clinical remission) during the 52-Week Treatment Period among participants in clinical remission at Baseline (BL)
    End point description
    Clinical remission is defined as a CDAI score of <150 points. The CDAI is a scoring system to measure disease severity with scores of >=220 to <=450 describing the moderately-to-severely active population. The score is algorithmically derived from the sum of participants'-reported Crohn’s disease symptoms recorded over 7 days and investigator recorded assessments of the participants’ condition, laboratory parameters and use of anti-diarrhoeal medication. Missing efficacy data (premature discontinuation or otherwise) were imputed using a “no effect” imputation where missing equals no response or no change in response. The percentage of participants who were in clinical remission at BL and at all visits during 52-eek Treatment Period were presented. BL (Week 0) is the results taken at the End of Study Visit of Induction Study. CDAI score was measured at Weeks 0, 4, 8, 12, 28, 36, 44 and 52. Because the Induction study was terminated prematurely, summary statistics were not compiled.
    End point type
    Secondary
    End point timeframe
    BL (Week 0) and Weeks 4, 8, 12, 28, 36, 44 and 52.
    End point values
    Placebo GSK1605786A 500 mg QD GSK1605786A 500 mg BID
    Number of subjects analysed
    0 [10]
    0 [11]
    0 [12]
    Units: Percentage of participants
        number (not applicable)
    Notes
    [10] - ITT Population, because the study was terminated prematurely, summary statistics were not compiled.
    [11] - ITT Population, because the study was terminated prematurely, summary statistics were not compiled.
    [12] - ITT Population, because the study was terminated prematurely, summary statistics were not compiled.
    No statistical analyses for this end point

    Secondary: Percentage of participants in clinical remission at Week 52

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    End point title
    Percentage of participants in clinical remission at Week 52
    End point description
    Clinical remission is defined as a CDAI score of <150 points. The CDAI is a scoring system to measure disease severity with scores of >=220 to <=450 describing the moderately-to-severely active population. The score is algorithmically derived from the sum of participants'-reported Crohn’s disease symptoms recorded over 7 days and investigator recorded assessments of the participants’ condition, laboratory parameters and use of anti-diarrhoeal medication. Missing efficacy data (premature discontinuation or otherwise) were imputed using a “no effect” imputation where missing equals no response or no change in response.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    Placebo GSK1605786A 500 mg QD GSK1605786A 500 mg BID
    Number of subjects analysed
    76 [13]
    77 [14]
    76 [15]
    Units: Percentage of participants
        number (not applicable)
    11.8
    7.8
    6.6
    Notes
    [13] - ITT Population
    [14] - ITT Population
    [15] - ITT Population
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    GSK1605786A 500 mg QD v Placebo
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    -4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -13.5
         upper limit
    5.4
    Statistical analysis title
    Statistical analysis 2
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Mean difference (final values)
    Point estimate
    -5.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -14.4
         upper limit
    3.9

    Secondary: Percentage of participants with a clinical response at both Weeks 28 and 52 of the 52-Week Treatment Period

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    End point title
    Percentage of participants with a clinical response at both Weeks 28 and 52 of the 52-Week Treatment Period
    End point description
    Clinical response is defined as a CDAI score decrease from a Baseline value of >=100 points. The CDAI is a scoring system to measure disease severity with scores of >=220 to <=450 describing the moderately-to-severely active population. The score is algorithmically derived from the sum of participants'-reported Crohn’s disease symptoms recorded over 7 days and investigator recorded assessments of the participants’ condition, laboratory parameters and use of anti-diarrhoeal medication. Missing efficacy data (premature discontinuation or otherwise) were imputed using a “no effect” imputation where missing equals no response or no change in response. Because the study was terminated prematurely, summary statistics were not compiled.
    End point type
    Secondary
    End point timeframe
    Weeks 28 and 52
    End point values
    Placebo GSK1605786A 500 mg QD GSK1605786A 500 mg BID
    Number of subjects analysed
    0 [16]
    0 [17]
    0 [18]
    Units: Percentage of participants
        number (not applicable)
    Notes
    [16] - ITT Population, because the study was terminated prematurely, summary statistics were not compiled.
    [17] - ITT Population, because the study was terminated prematurely, summary statistics were not compiled.
    [18] - ITT Population, because the study was terminated prematurely, summary statistics were not compiled.
    No statistical analyses for this end point

    Secondary: Time to induction of clinical response at both Weeks 28 and 52 of the 52-Week Treatment Period

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    End point title
    Time to induction of clinical response at both Weeks 28 and 52 of the 52-Week Treatment Period
    End point description
    Clinical response is defined as a CDAI score decrease from a Baseline value of >=100 points. The CDAI is a scoring system to measure disease severity with scores of >=220 to <=450 describing the moderately-to-severely active population. The score is algorithmically derived from the sum of participants'-reported Crohn’s disease symptoms recorded over 7 days and investigator recorded assessments of the participants’ condition, laboratory parameters and use of anti-diarrhoeal medication. Missing efficacy data (premature discontinuation or otherwise) were imputed using a “no effect” imputation where missing equals no response or no change in response. Because the study was terminated prematurely, summary statistics were not compiled.
    End point type
    Secondary
    End point timeframe
    Weeks 28 and 52
    End point values
    Placebo GSK1605786A 500 mg QD GSK1605786A 500 mg BID
    Number of subjects analysed
    0 [19]
    0 [20]
    0 [21]
    Units: Percentage of participants
        number (not applicable)
    Notes
    [19] - ITT Population, because the study was terminated prematurely, summary statistics were not compiled.
    [20] - ITT Population, because the study was terminated prematurely, summary statistics were not compiled.
    [21] - ITT Population, because the study was terminated prematurely, summary statistics were not compiled.
    No statistical analyses for this end point

    Secondary: Change from Baseline in CDAI score at Weeks 4, 8, 12, 20, 28, 36, 44, and 52

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    End point title
    Change from Baseline in CDAI score at Weeks 4, 8, 12, 20, 28, 36, 44, and 52
    End point description
    The CDAI is a scoring system to measure disease severity with scores of >=220 to <=450 describing the moderately-to-severely active population. The score is algorithmically derived from the sum of participants-reported Crohn’s disease symptoms recorded over 7 days and investigator recorded assessments of the participant’s condition, laboratory parameters and use of anti-diarrhoeal medication. Because the study was terminated prematurely, summary statistics were not compiled.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 8, 12, 20, 28, 36, 44, and 52
    End point values
    Placebo GSK1605786A 500 mg QD GSK1605786A 500 mg BID
    Number of subjects analysed
    0 [22]
    0 [23]
    0 [24]
    Units: Score on scale
        number (not applicable)
    Notes
    [22] - ITT Population, because the study was terminated prematurely, summary statistics were not compiled.
    [23] - ITT Population, because the study was terminated prematurely, summary statistics were not compiled.
    [24] - ITT Population, because the study was terminated prematurely, summary statistics were not compiled.
    No statistical analyses for this end point

    Secondary: Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) total score at Week 52

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    End point title
    Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) total score at Week 52
    End point description
    The IBDQ is a 32-item IBD-specific health related quality of life instrument evaluating general activities of daily living, intestinal function, social performance, personal interactions, and emotional status. The IBDQ questionnaire was completed by each participant at Baseline and at Weeks 28, and 52 (or final visit if the participant withdrew prematurely). Item responses are summed for a total score and also averaged among four dimensions: 1) bowel function (10 items), 2) systemic symptoms (5 items), social function (5 items), and 4) emotional status (12 items). Change from Baseline was calculated as the Week 52 IBDQ score minus the score at Baseline. Baseline (Week 0) is defined as the results taken at the End of Study Visit of the Induction Study. Because the Induction Study was terminated prematurely, summary statistics were not compiled.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) and Week 52
    End point values
    Placebo GSK1605786A 500 mg QD GSK1605786A 500 mg BID
    Number of subjects analysed
    0 [25]
    0 [26]
    0 [27]
    Units: Score on scale
        number (not applicable)
    Notes
    [25] - ITT Population, because the study was terminated prematurely, summary statistics were not compiled.
    [26] - ITT Population, because the study was terminated prematurely, summary statistics were not compiled.
    [27] - ITT Population, because the study was terminated prematurely, summary statistics were not compiled.
    No statistical analyses for this end point

    Secondary: Number of participants with any adverse event (AE) and any serious adverse event (SAE)

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    End point title
    Number of participants with any adverse event (AE) and any serious adverse event (SAE)
    End point description
    An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect. The Safety Population comprised of all participants who were randomised and took at least one dose of treatment during the study; i.e., those participants with no treatment start date are excluded from this population.
    End point type
    Secondary
    End point timeframe
    From the start of study medication until and 4 weeks post treatment (up to Week 56)
    End point values
    Placebo GSK1605786A 500 mg QD GSK1605786A 500 mg BID
    Number of subjects analysed
    76 [28]
    77 [29]
    76 [30]
    Units: Participants
    number (not applicable)
        Any AE
    55
    50
    54
        Any SAE
    1
    3
    2
    Notes
    [28] - Safety Population
    [29] - Safety Population
    [30] - Safety Population
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    Statistical analysis provided for Any AE
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.384
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 2
    Statistical analysis description
    Statistical analysis provided for Any AE
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    > 0.999
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 3
    Statistical analysis description
    Statistical analysis provided for Any SAE
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.62
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 4
    Statistical analysis description
    Statistical analysis provided for Any SAE
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    > 0.999
    Method
    Fisher exact
    Confidence interval

    Secondary: Change from Baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP)

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    End point title
    Change from Baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP)
    End point description
    Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) values were obtained as part of vital sign monitoring and measured after the participant was at rest in the supine position for at least 5 minutes. Change from Baseline measurements in SBP and DBP were assessed at Weeks 4, 8, 12, 20, 28, 36, 44, 52 and 4 weeks post-treatment. Baseline (Week 0) is defined as the results taken at the End of Study Visit of the Induction Study. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, 52 and 4 weeks post-treatment (assessed up to Week 56)
    End point values
    Placebo GSK1605786A 500 mg QD GSK1605786A 500 mg BID
    Number of subjects analysed
    76 [31]
    77 [32]
    76 [33]
    Units: millimeters of mercury (mmHg)
    arithmetic mean (standard deviation)
        SBP, Week 4, n=74, 75, 74
    -1.6 ± 13.08
    -0.9 ± 10.15
    1.2 ± 11.06
        SBP, Week 8, n=61, 61, 61
    -2.7 ± 13.75
    0.7 ± 12.17
    0.5 ± 12.91
        SBP, Week 12, n=55, 48, 48
    -0.9 ± 11.93
    0.9 ± 11.31
    1.1 ± 13.53
        SBP, Week 20, n=44, 39, 37
    -3 ± 12.7
    -0.7 ± 10.52
    2 ± 9.64
        SBP, Week 28, n=33, 25, 24
    2.2 ± 10.62
    1.2 ± 10.47
    4.6 ± 11.63
        SBP, Week 36, n=24, 21, 13
    0.7 ± 13.5
    2.1 ± 9.49
    1.8 ± 15.76
        SBP, Week 44, n=19, 14, 10
    -0.1 ± 12.59
    -1.6 ± 13.35
    0 ± 13.18
        SBP, Week 52, n=15, 9, 7
    -1.6 ± 13.8
    1 ± 9.29
    2.3 ± 13.25
        SBP, 4 weeks post treatment, n=33, 29, 27
    -0.5 ± 13.19
    -1.3 ± 11.21
    2 ± 11.09
        DBP, Week 4, n=74, 75, 74
    -2 ± 9.9
    -2 ± 9.54
    -0.1 ± 9.05
        DBP, Week 8, n=61, 61, 61
    -0.1 ± 10.39
    -0.6 ± 8.78
    -1.3 ± 8.03
        DBP, Week 12, n=55, 48, 48
    -0.4 ± 10.22
    -1.5 ± 6.68
    -0.8 ± 10.12
        DBP, Week 20, n=44, 39, 37
    -1.1 ± 9.33
    -2 ± 8.31
    0.1 ± 8.17
        DBP, Week 28, n=33, 25, 24
    2.4 ± 8
    -1.2 ± 10.05
    2 ± 6.13
        DBP, Week 36, n=24, 21, 13
    -0.2 ± 9.94
    -0.5 ± 10.01
    0.8 ± 9.04
        DBP, Week 44, n=19, 14, 10
    0.1 ± 12.09
    -3 ± 7.91
    -0.1 ± 10.29
        DBP, Week 52, n=15, 9, 7
    -0.7 ± 8.99
    -1.4 ± 8.4
    2.4 ± 8
        DBP, 4 weeks post treatment, n=33, 29, 27
    0.2 ± 9.05
    0.1 ± 7.12
    1.3 ± 9.53
    Notes
    [31] - Safety Population. Only participants available at the specified time points were analyzed (n=X,X,X).
    [32] - Safety Population. Only participants available at the specified time points were analyzed (n=X,X,X).
    [33] - Safety Population. Only participants available at the specified time points were analyzed (n=X,X,X).
    No statistical analyses for this end point

    Secondary: Change from Baseline in heart rate (HR)

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    End point title
    Change from Baseline in heart rate (HR)
    End point description
    Heart Rate (HR) values were obtained as part of vital sign monitoring and measured after the participant was at rest in the supine position for at least 5 minutes. Change from Baseline in HR was assessed at Weeks 4, 8, 12, 20, 28, 36, 44, 52 and 4 weeks post-treatment. Baseline (Week 0) is defined as the results taken at the End of Study Visit of the Induction Study. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 4, 8, 12, 20, 28, 36, 44, 52 and 4 weeks post-treatment (assessed up to Week 56)
    End point values
    Placebo GSK1605786A 500 mg QD GSK1605786A 500 mg BID
    Number of subjects analysed
    76 [34]
    77 [35]
    76 [36]
    Units: beats per minute
    arithmetic mean (standard deviation)
        HR, Week 4, n=73, 74, 74
    1.8 ± 11.06
    -2.2 ± 11.96
    0 ± 10.17
        HR, Week 8, n=61, 61, 61
    0.9 ± 10.85
    -0.4 ± 12.23
    -0.2 ± 12.93
        HR, Week 12, n=54, 48, 48
    0.9 ± 10.27
    -2.4 ± 11.25
    -0.5 ± 11.24
        HR, Week 20, n=44, 39, 37
    -1 ± 9.59
    -0.8 ± 14.49
    -0.4 ± 13.83
        HR, Week 28, n=33, 25, 24
    1.3 ± 11.65
    0.5 ± 15.07
    -0.7 ± 11.56
        HR, Week 36, n=24, 21, 13
    -2.8 ± 9.92
    2.4 ± 9.45
    2.5 ± 8.11
        HR, Week 44, n=19, 14, 10
    2 ± 10.96
    2.6 ± 5.85
    1.4 ± 11.22
        HR, Week 52, n=15, 9, 7
    1.6 ± 8.87
    -0.1 ± 7.77
    4.1 ± 8.55
        HR, 4 week post treatment, n=33, 29, 27
    -1.1 ± 8.79
    1.5 ± 12.04
    -3.1 ± 8.43
    Notes
    [34] - Safety Population. Only participants available at the specified time points were analyzed (n=X,X,X).
    [35] - Safety Population. Only participants available at the specified time points were analyzed (n=X,X,X).
    [36] - Safety Population. Only participants available at the specified time points were analyzed (n=X,X,X).
    No statistical analyses for this end point

    Secondary: Number of participants with shifts from Baseline for the indicated hematology parameters

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    End point title
    Number of participants with shifts from Baseline for the indicated hematology parameters
    End point description
    Hematology parameters measured included platelets (PLS), neutrophils (NL), lymphocytes (LMP), monocytes (MONO), eosinophils (EOS), basophils(BASO), hematocrit (HCT), band cells (BC), red blood cell (RBC) count, hemoglobin (HGB), white blood cell (WBC) count, and segmented (seg) NL. The Baseline value is defined as the value obtained at Week 0. The number of participants with the indicated hematology parameters data reference range shifts from Baseline (defined as shift to low, shift to normal or no change, shift to high) until 4 weeks post treatment are presented.
    End point type
    Secondary
    End point timeframe
    From Baseline until 4 weeks post-treatment (assessed up to Week 56)
    End point values
    Placebo GSK1605786A 500 mg QD GSK1605786A 500 mg BID
    Number of subjects analysed
    76 [37]
    77 [38]
    76 [39]
    Units: Participants
    number (not applicable)
        PLS, shift to low, n=76, 76, 75
    1
    1
    0
        PLS, shift to normal or no change, n=76, 76, 75
    69
    63
    61
        PLS, shift to high, n=64, 61, 68
    6
    12
    14
        NL, shift to low, n=76, 76, 74
    3
    2
    1
        NL, shift to normal or no change, n=76, 76, 75
    51
    55
    54
        NL, shift to high, n=49, 47, 51
    22
    20
    20
        LMP, shift to low, n=51, 49, 50
    19
    19
    14
        LMP, shift to normal or no change, n=76, 76, 75
    54
    55
    60
        LMP, shift to high, n=75, 76, 74
    3
    2
    2
        MONO, shift to low, n=76, 76, 75
    0
    0
    0
        MONO, shift to normal or no change, n=76, 76, 75
    69
    72
    68
        MONO, shift to high, n=73, 75, 73
    7
    4
    7
        EOS, shift to low, n=0, 0, 0
    0
    0
    0
        EOS, shift to normal or no change, n=76, 76, 75
    73
    69
    73
        EOS, shift to high, n=74, 76, 75
    3
    7
    2
        BASO, shift to low, n=0, 0, 0
    0
    0
    0
        BASO, shift to normal or no change, n=76, 76, 75
    76
    76
    74
        BASO, shift to high, n=76, 76, 75
    0
    0
    1
        HCT, shift to low, n=49, 43, 51
    13
    10
    11
        HCT, shift to normal or no change, n=76, 76, 75
    63
    65
    62
        HCT, shift to high, n=75, 76, 73
    1
    1
    2
        BC, shift to low, n=0, 0, 0
    0
    0
    0
        BC, shift to normal or no change, n=1, 0, 0
    1
    0
    0
        BC, shift to high, n=0, 0, 0
    0
    0
    0
        RBC, shift to low, n=37, 40, 42
    8
    6
    9
        RBC, shift to normal or no change, n=54, 56, 53
    45
    50
    42
        RBC, shift to high, n=54, 55, 53
    1
    0
    2
        HGB, shift to low, n=37, 35, 47
    15
    13
    11
        HGB, shift to normal or no change, n=76, 76, 75
    60
    63
    64
        HGB, shift to high, n=75, 76, 75
    1
    0
    0
        WBC, shift to low, n=71, 75, 71
    4
    5
    7
        WBC, shift to normal or no change, n=76, 76, 75
    63
    59
    62
        WBC, shift to high, n=63, 62, 65
    9
    12
    6
        Seg NL, shift to low, n=76, 76, 74
    3
    2
    1
        Seg NL, shift to normal or no change, n=76, 76, 75
    51
    55
    54
        Seg NL, shift to high, n=49, 47, 51
    22
    20
    20
    Notes
    [37] - Safety Population. Only participants available at the specified time points were analyzed(n=X, X ,X)
    [38] - Safety Population. Only participants available at the specified time points were analyzed(n=X, X ,X)
    [39] - Safety Population. Only participants available at the specified time points were analyzed(n=X, X ,X)
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    Statistical analysis provided for PLS, shift to low
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    > 0.999
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 2
    Statistical analysis description
    Statistical analysis provided for PLS, shift to low
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    > 0.999
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 3
    Statistical analysis description
    Statistical analysis provided for PLS, shift to normal or no change
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.23
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 4
    Statistical analysis description
    Statistical analysis provided for PLS, shift to normal or no change
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.105
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 5
    Statistical analysis description
    Statistical analysis provided for PLS, shift to high
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.129
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 6
    Statistical analysis description
    Statistical analysis provided for PLS, shift to high
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.091
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 7
    Statistical analysis description
    Statistical analysis provided for NL, shift to low
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    > 0.999
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 8
    Statistical analysis description
    Statistical analysis provided for NL, shift to low
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.62
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 9
    Statistical analysis description
    Statistical analysis provided for NL, shift to normal or no change
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.597
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 10
    Statistical analysis description
    Statistical analysis provided for NL, shift to normal or no change
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.597
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 11
    Statistical analysis description
    Statistical analysis provided for NL, shift to high
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.84
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 12
    Statistical analysis description
    Statistical analysis provided for NL, shift to high
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.686
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 13
    Statistical analysis description
    Statistical analysis provided for LMP, shift to low
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    > 0.999
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 14
    Statistical analysis description
    Statistical analysis provided for LMP, shift to low
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.397
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 15
    Statistical analysis description
    Statistical analysis provided for LMP, shift to normal or no change
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    > 0.999
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 16
    Statistical analysis description
    Statistical analysis provided for LMP, shift to normal or no change
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.257
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 17
    Statistical analysis description
    Statistical analysis provided for LMP, shift to high
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.681
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 18
    Statistical analysis description
    Statistical analysis provided for LMP, shift to high
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    > 0.999
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 19
    Statistical analysis description
    Statistical analysis provided for MONO, shift to low. None of the participants had MONO, shift to low.
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 9999 [40]
    Method
    Fisher exact
    Confidence interval
    Notes
    [40] - A P-value of 9999 indicates a value of N/A or that it could not be calculated.
    Statistical analysis title
    Statistical analysis 20
    Statistical analysis description
    Statistical analysis provided for MONO, shift to low. None of the participants had MONO, shift to low
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 9999 [41]
    Method
    Fisher exact
    Confidence interval
    Notes
    [41] - A P-value of 9999 indicates a value of N/A or that it could not be calculated.
    Statistical analysis title
    Statistical analysis 21
    Statistical analysis description
    Statistical analysis provided for MONO, shift to normal or no change
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.533
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 22
    Statistical analysis description
    Statistical analysis provided for MONO, shift to normal or no change
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    > 0.999
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 23
    Statistical analysis description
    Statistical analysis provided for MONO, shift to high
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.364
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 24
    Statistical analysis description
    Statistical analysis provided for MONO, shift to high
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    > 0.999
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 25
    Statistical analysis description
    Statistical analysis provided for EOS, shift to low. None of the participants had EOS, shift to low
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 9999 [42]
    Method
    Fisher exact
    Confidence interval
    Notes
    [42] - A P-value of 9999 indicates a value of N/A or that it could not be calculated.
    Statistical analysis title
    Statistical analysis 26
    Statistical analysis description
    Statistical analysis provided for EOS, shift to low. None of the participants had EOS, shift to low
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 9999 [43]
    Method
    Fisher exact
    Confidence interval
    Notes
    [43] - A P-value of 9999 indicates a value of N/A or that it could not be calculated.
    Statistical analysis title
    Statistical analysis 27
    Statistical analysis description
    Statistical analysis provided for EOS, shift to normal or no change
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.327
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 28
    Statistical analysis description
    Statistical analysis provided for EOS, shift to normal or no change
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    > 0.999
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 29
    Statistical analysis description
    Statistical analysis provided for EOS, shift to high
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.327
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 30
    Statistical analysis description
    Statistical analysis provided for EOS, shift to high
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.681
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 31
    Statistical analysis description
    Statistical analysis provided for BASO, shift to low. None of the participants had BASO, shift to low
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 9999 [44]
    Method
    Fisher exact
    Confidence interval
    Notes
    [44] - A P-value of 9999 indicates a value of N/A or that it could not be calculated.
    Statistical analysis title
    Statistical analysis 32
    Statistical analysis description
    Statistical analysis provided for BASO, shift to low. None of the participants had BASO, shift to low
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 9999 [45]
    Method
    Fisher exact
    Confidence interval
    Notes
    [45] - A P-value of 9999 indicates a value of N/A or that it could not be calculated.
    Statistical analysis title
    Statistical analysis 33
    Statistical analysis description
    Statistical analysis provided for BASO, shift to normal or no change. None of the participants had BASO, shift to normal or no change
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 9999 [46]
    Method
    Fisher exact
    Confidence interval
    Notes
    [46] - A P-value of 9999 indicates a value of N/A or that it could not be calculated.
    Statistical analysis title
    Statistical analysis 34
    Statistical analysis description
    Statistical analysis provided for BASO, shift to normal or no change
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.497
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 35
    Statistical analysis description
    Statistical analysis provided for BASO, shift to high. None of the participants had BASO, shift to high
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 9999 [47]
    Method
    Fisher exact
    Confidence interval
    Notes
    [47] - A P-value of 9999 indicates a value of N/A or that it could not be calculated.
    Statistical analysis title
    Statistical analysis 36
    Statistical analysis description
    Statistical analysis provided for BASO, shift to high
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.497
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 37
    Statistical analysis description
    Statistical analysis provided for HCT, shift to low
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.811
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 38
    Statistical analysis description
    Statistical analysis provided for HCT, shift to low
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.642
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 39
    Statistical analysis description
    Statistical analysis provided for HCT, shift to normal or no change
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.824
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 40
    Statistical analysis description
    Statistical analysis provided for HCT, shift to normal or no change
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    > 0.999
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 41
    Statistical analysis description
    Statistical analysis provided for HCT, shift to high
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    > 0.999
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 42
    Statistical analysis description
    Statistical analysis provided for HCT, shift to high
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.617
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 43
    Statistical analysis description
    Statistical analysis provided for BC, shift to low. None of the participants had BC, shift to low
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 9999 [48]
    Method
    Fisher exact
    Confidence interval
    Notes
    [48] - A P-value of 9999 indicates a value of N/A or that it could not be calculated.
    Statistical analysis title
    Statistical analysis 44
    Statistical analysis description
    Statistical analysis provided for BC, shift to low. None of the participants had BC, shift to low
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 9999 [49]
    Method
    Fisher exact
    Confidence interval
    Notes
    [49] - A P-value of 9999 indicates a value of N/A or that it could not be calculated.
    Statistical analysis title
    Statistical analysis 45
    Statistical analysis description
    Statistical analysis provided for BC, shift to normal or no change
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 9999 [50]
    Method
    Fisher exact
    Confidence interval
    Notes
    [50] - A P-value of 9999 indicates a value of N/A or that it could not be calculated.
    Statistical analysis title
    Statistical analysis 46
    Statistical analysis description
    Statistical analysis provided for BC, shift to normal or no change
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 9999 [51]
    Method
    Fisher exact
    Confidence interval
    Notes
    [51] - A P-value of 9999 indicates a value of N/A or that it could not be calculated.
    Statistical analysis title
    Statistical analysis 47
    Statistical analysis description
    Statistical analysis provided for BC, shift to high. None of the participants had BC, shift to high
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 9999 [52]
    Method
    Fisher exact
    Confidence interval
    Notes
    [52] - A P-value of 9999 indicates a value of N/A or that it could not be calculated.
    Statistical analysis title
    Statistical analysis 48
    Statistical analysis description
    Statistical analysis provided for BC, shift to high. None of the participants had BC, shift to high
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 9999 [53]
    Method
    Fisher exact
    Confidence interval
    Notes
    [53] - A P-value of 9999 indicates a value of N/A or that it could not be calculated.
    Statistical analysis title
    Statistical analysis 49
    Statistical analysis description
    Statistical analysis provided for RBC, shift to low
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.559
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 50
    Statistical analysis description
    Statistical analysis provided for RBC, shift to low
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    > 0.999
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 51
    Statistical analysis description
    Statistical analysis provided for RBC, shift to normal or no change
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.414
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 52
    Statistical analysis description
    Statistical analysis provided for RBC, shift to normal or no change
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.628
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 53
    Statistical analysis description
    Statistical analysis provided for RBC, shift to high
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.495
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 54
    Statistical analysis description
    Statistical analysis provided for RBC, shift to high
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.618
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 55
    Statistical analysis description
    Statistical analysis provided for HGB, shift to low
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.812
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 56
    Statistical analysis description
    Statistical analysis provided for HGB, shift to low
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.103
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 57
    Statistical analysis description
    Statistical analysis provided for HGB, shift to normal or no change
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.68
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 58
    Statistical analysis description
    Statistical analysis provided for HGB, shift to normal or no change
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.396
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 59
    Statistical analysis description
    Statistical analysis provided for HGB, shift to high
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.497
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 60
    Statistical analysis description
    Statistical analysis provided for HGB, shift to high
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    > 0.999
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 61
    Statistical analysis description
    Statistical analysis provided for WBC, shift to low
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    > 0.999
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 62
    Statistical analysis description
    Statistical analysis provided for WBC, shift to low
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.532
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 63
    Statistical analysis description
    Statistical analysis provided for WBC, shift to normal or no change
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.541
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 64
    Statistical analysis description
    Statistical analysis provided for WBC, shift to normal or no change
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    > 0.999
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 65
    Statistical analysis description
    Statistical analysis provided for WBC, shift to high
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.482
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 66
    Statistical analysis description
    Statistical analysis provided for WBC, shift to high
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.42
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 67
    Statistical analysis description
    Statistical analysis provided for Seg NL, shift to low
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    > 0.999
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 68
    Statistical analysis description
    Statistical analysis provided for Seg NL, shift to low
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.62
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 69
    Statistical analysis description
    Statistical analysis provided for Seg NL, shift to normal or no change
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.597
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 70
    Statistical analysis description
    Statistical analysis provided for Seg NL, shift to normal or no change
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.597
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 71
    Statistical analysis description
    Statistical analysis provided for Seg NL, shift to high
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.84
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 72
    Statistical analysis description
    Statistical analysis provided for Seg NL, shift to high
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.686
    Method
    Fisher exact
    Confidence interval

    Secondary: Number of participants with shifts from Baseline for the indicated clinical chemistry parameters

    Close Top of page
    End point title
    Number of participants with shifts from Baseline for the indicated clinical chemistry parameters
    End point description
    Clinical chemistry parameters included total protein (TP), phosphorous (PPR), albumin (ALB), sodium (Na), potassium (K), chloride (Cl), calcium (Ca), glucose (GL), gamma-glutamyl transferase (GGT), total bilirubin (TB), direct bilirubin (DB), alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen (BUN)/urea (U), creatinine (CRE), uric acid (UA), bicarbonate (BIC), lactate dehydrogenase (LD), cholesterol (CHO), and creatine kinase (CK). The Baseline value is defined as the value obtained at Week 0. The number of participants with the indicated clinical chemistry parameters' data reference range shifts from Baseline (defined as shift to low, shift to normal or no change, or shift to high) until 4 weeks post-treatment are presented.
    End point type
    Secondary
    End point timeframe
    From Baseline until 4 week post-treatment (assessed up to Week 56)
    End point values
    Placebo GSK1605786A 500 mg QD GSK1605786A 500 mg BID
    Number of subjects analysed
    76 [54]
    77 [55]
    76 [56]
    Units: Participants
    number (not applicable)
        TP, shift to low, n=73, 71, 68
    3
    7
    5
        TP, shift to normal or no change, n=76, 75, 75
    73
    67
    70
        TP, shift to high, n=76, 75, 75
    0
    1
    0
        PPR, shift to low, n=69, 74, 73
    2
    9
    13
        PPR, shift to normal or no change, n=76, 75, 75
    66
    63
    59
        PPR, shift to high, n=76, 72, 73
    8
    3
    3
        ALB, shift to low, n=75, 71, 74
    1
    2
    3
        ALB, shift to normal or no change, n=76, 75, 75
    71
    69
    71
        ALB, shift to high, n=75, 75, 73
    4
    4
    1
        Na, shift to low, n=74, 75, 73
    1
    1
    3
        Na, shift to normal or no change, n=76, 75, 75
    75
    73
    72
        Na, shift to high, n=76, 75, 74
    0
    1
    0
        K, shift to low, n=76, 73, 75
    4
    1
    4
        K, shift to normal or no change, n=76, 75, 75
    68
    74
    67
        K, shift to high, n=76, 75, 73
    4
    0
    4
        Cl, shift to low, n=76, 75, 75
    0
    0
    1
        Cl, shift to normal or no change, n=76, 75, 75
    67
    67
    63
        Cl, shift to high, n=74, 71, 70
    9
    8
    11
        Ca, shift to low, n=72, 72, 71
    3
    5
    7
        Ca, shift to normal or no change, n=76, 75, 75
    71
    68
    65
        Ca, shift to high, n=75, 75, 75
    2
    2
    3
        GL, shift to low, n=74, 73, 71
    6
    8
    12
        GL, shift to normal or no change, n=76, 75, 75
    58
    52
    56
        GL, shift to high, n=70, 69, 73
    13
    16
    10
        GGT, shift to low, n=0, 0, 0
    0
    0
    0
        GGT, shift to normal or no change, n=76, 77, 76
    71
    71
    66
        GGT, shift to high, n=68, 68, 71
    5
    6
    10
        TB, shift to low, n=0, 0, 0
    0
    0
    0
        TB, shift to normal or no change, n=76, 77, 76
    72
    74
    74
        TB, shift to high, n=75, 77, 74
    4
    3
    2
        DB, shift to low, n=0, 0, 0
    0
    0
    0
        DB, shift to normal or no change, n=76, 77, 76
    75
    76
    75
        DB, shift to high, n=76, 77, 75
    1
    1
    1
        ALP, shift to low, n=76, 76, 76
    0
    0
    0
        ALP, shift to normal or no change, n=76, 77, 76
    68
    73
    69
        ALP, shift to high, n=75, 76, 74
    8
    4
    7
        ALT, shift to low, n=0, 0, 0
    0
    0
    0
        ALT, shift to normal or no change, n=76, 77, 76
    71
    74
    68
        ALT, shift to high, n=74, 77, 74
    5
    3
    8
        AST, shift to low, n=0, 0, 0
    0
    0
    0
        AST, shift to normal or no change, n=76, 77, 76
    67
    75
    71
        AST, shift to high, n=74, 76, 76
    9
    2
    5
        BUN/U, shift to low, n=71, 71, 68
    4
    6
    5
        BUN/U, shift to normal or no change, n=76, 75, 75
    71
    69
    69
        BUN/U, shift to high, n=76, 75, 75
    1
    0
    2
        CRE, shift to low, n=65, 63, 59
    6
    8
    12
        CRE, shift to normal or no change, n=76, 75, 75
    69
    67
    63
        CRE, shift to high, n=76, 75, 74
    1
    0
    0
        UA, shift to low, n=74, 72, 69
    3
    3
    3
        UA, shift to normal or no change, n=76,75,75
    73
    71
    68
        UA, shift to high, n=72, 75, 74
    0
    1
    4
        BIC, shift to low, n=70, 70, 67
    21
    16
    18
        BIC, shift to normal or no change, n=76,75,75
    55
    59
    57
        BIC, shift to high, n=76, 74, 75
    0
    0
    0
        LD, shift to low, n=0, 0, 0
    0
    0
    0
        LD, shift to normal or no change, n=76,75,75
    75
    74
    74
        LD, shift to high, n=75,73,75
    1
    1
    1
        CHO, shift to low, n=0, 0, 0
    0
    0
    0
        CHO, shift to normal or no change, n=76,75,75
    69
    71
    64
        CHO, shift to high, n=57, 61, 68
    7
    4
    11
        CK, shift to low, n=0, 0, 0
    0
    0
    0
        CK, shift to normal or no change, n=76,75,75
    69
    71
    67
        CK, shift to high, n=74, 73, 74
    7
    4
    8
    Notes
    [54] - Safety Population. Only participants available at the specified time points were analyzed(n=X, X, X)
    [55] - Safety Population. Only participants available at the specified time points were analyzed(n=X, X, X)
    [56] - Safety Population. Only participants available at the specified time points were analyzed(n=X, X, X)
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    Statistical analysis provided for TP, shift to low
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.205
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 2
    Statistical analysis description
    Statistical analysis provided for TP, shift to low
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.482
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 3
    Statistical analysis description
    Statistical analysis provided for TP, shift to normal or no change
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.13
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 4
    Statistical analysis description
    Statistical analysis provided for TP, shift to normal or no change
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.494
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 5
    Statistical analysis description
    Statistical analysis provided for TP, shift to high
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.497
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 6
    Statistical analysis description
    Statistical analysis provided for TP, shift to high. None of the participants had TP, shift to high
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 9999 [57]
    Method
    Fisher exact
    Confidence interval
    Notes
    [57] - A P-value of 9999 indicates a value of N/A or that it could not be calculated.
    Statistical analysis title
    Statistical analysis 7
    Statistical analysis description
    Statistical analysis provided for PPR, shift to low
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.057
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 8
    Statistical analysis description
    Statistical analysis provided for PPR, shift to low
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.005
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 9
    Statistical analysis description
    Statistical analysis provided for PPR, shift to normal or no change
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.652
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 10
    Statistical analysis description
    Statistical analysis provided for PPR, shift to normal or no change
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.202
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 11
    Statistical analysis description
    Statistical analysis provided for PPR, shift to high
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.211
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 12
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.21
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 13
    Statistical analysis description
    Statistical analysis provided for ALB, shift to low
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.612
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 14
    Statistical analysis description
    Statistical analysis provided for ALB, shift to low
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.367
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 15
    Statistical analysis description
    Statistical analysis provided for ALB, shift to normal or no change
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.765
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 16
    Statistical analysis description
    Statistical analysis provided for ALB, shift to normal or no change
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    > 0.999
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 17
    Statistical analysis description
    Statistical analysis provided for ALB, shift to high
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    > 0.999
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 18
    Statistical analysis description
    Statistical analysis provided for ALB, shift to high
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.367
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 19
    Statistical analysis description
    Statistical analysis provided for Na, shift to low
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    > 0.999
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 20
    Statistical analysis description
    Statistical analysis provided for Na, shift to low
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.366
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 21
    Statistical analysis description
    Statistical analysis provided for Na, shift to normal or no change
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.62
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 22
    Statistical analysis description
    Statistical analysis provided for Na, shift to normal or no change
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.367
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 23
    Statistical analysis description
    Statistical analysis provided for Na, shift to high
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.497
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 24
    Statistical analysis description
    Statistical analysis provided for Na, shift to high. None of the participants had Na, shift to high
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 9999 [58]
    Method
    Fisher exact
    Confidence interval
    Notes
    [58] - A P-value of 9999 indicates a value of N/A or that it could not be calculated.
    Statistical analysis title
    Statistical analysis 25
    Statistical analysis description
    Statistical analysis provided for K, shift to low
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.367
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 26
    Statistical analysis description
    Statistical analysis provided for K, shift to low
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    > 0.999
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 27
    Statistical analysis description
    Statistical analysis provided for K, shift to normal or no change
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.034
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 28
    Statistical analysis description
    Statistical analysis provided for K, shift to normal or no change
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    > 0.999
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 29
    Statistical analysis description
    Statistical analysis provided for K, shift to high
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.12
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 30
    Statistical analysis description
    Statistical analysis provided for K, shift to high
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    > 0.999
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 31
    Statistical analysis description
    Statistical analysis provided for Cl, shift to low. None of the participants had Cl, shift to low
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 9999 [59]
    Method
    Fisher exact
    Confidence interval
    Notes
    [59] - A P-value of 9999 indicates a value of N/A or that it could not be calculated.
    Statistical analysis title
    Statistical analysis 32
    Statistical analysis description
    Statistical analysis provided for Cl, shift to low
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.497
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 33
    Statistical analysis description
    Statistical analysis provided for Cl, shift to normal or no change
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    > 0.999
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 34
    Statistical analysis description
    Statistical analysis provided for Cl, shift to normal or no change
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.49
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 35
    Statistical analysis description
    Statistical analysis provided for Cl, shift to high
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    > 0.999
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 36
    Statistical analysis description
    Statistical analysis provided for Cl, shift to high
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.632
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 37
    Statistical analysis description
    Statistical analysis provided for Ca, shift to low
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.719
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 38
    Statistical analysis description
    Statistical analysis provided for Ca, shift to low
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.208
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 39
    Statistical analysis description
    Statistical analysis provided for Ca, shift to normal or no change
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.564
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 40
    Statistical analysis description
    Statistical analysis provided for Ca, shift to normal or no change
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.185
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 41
    Statistical analysis description
    Statistical analysis provided for Ca, shift to high
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    > 0.999
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 42
    Statistical analysis description
    Statistical analysis provided for Ca, shift to high
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    > 0.999
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 43
    Statistical analysis description
    Statistical analysis provided for GL, shift to low
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.587
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 44
    Statistical analysis description
    Statistical analysis provided for GL, shift to low
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.134
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 45
    Statistical analysis description
    Statistical analysis provided for GL, shift to normal or no change
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.365
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 46
    Statistical analysis description
    Statistical analysis provided for GL, shift to normal or no change
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.852
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 47
    Statistical analysis description
    Statistical analysis provided for GL, shift to high
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.537
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 48
    Statistical analysis description
    Statistical analysis provided for GL, shift to high
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.498
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 49
    Statistical analysis description
    Statistical analysis provided for GGT, shift to low. None of the participants had GGT, shift to low
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 9999 [60]
    Method
    Fisher exact
    Confidence interval
    Notes
    [60] - A P-value of 9999 indicates a value of N/A or that it could not be calculated.
    Statistical analysis title
    Statistical analysis 50
    Statistical analysis description
    Statistical analysis provided for GGT, shift to low. None of the participants had GGT, shift to low
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 9999 [61]
    Method
    Fisher exact
    Confidence interval
    Notes
    [61] - A P-value of 9999 indicates a value of N/A or that it could not be calculated.
    Statistical analysis title
    Statistical analysis 51
    Statistical analysis description
    Statistical analysis provided for GGT, shift to normal or no change
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    > 0.999
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 52
    Statistical analysis description
    Statistical analysis provided for GGT, shift to normal or no change
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.276
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 53
    Statistical analysis description
    Statistical analysis provided for GGT, shift to high
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    > 0.999
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 54
    Statistical analysis description
    Statistical analysis provided for GGT, shift to high
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.276
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 55
    Statistical analysis description
    Statistical analysis provided for TB, shift to low. None of the participants had TB, shift to low
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 9999 [62]
    Method
    Fisher exact
    Confidence interval
    Notes
    [62] - A P-value of 9999 indicates a value of N/A or that it could not be calculated.
    Statistical analysis title
    Statistical analysis 56
    Statistical analysis description
    Statistical analysis provided for TB, shift to low. None of the participants had TB, shift to low
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 9999 [63]
    Method
    Fisher exact
    Confidence interval
    Notes
    [63] - A P-value of 9999 indicates a value of N/A or that it could not be calculated.
    Statistical analysis title
    Statistical analysis 57
    Statistical analysis description
    Statistical analysis provided for TB, shift to normal or no change
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.719
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 58
    Statistical analysis description
    Statistical analysis provided for TB, shift to normal or no change
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.681
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 59
    Statistical analysis description
    Statistical analysis provided for TB, shift to high
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.717
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 60
    Statistical analysis description
    Statistical analysis provided for TB, shift to high
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.681
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 61
    Statistical analysis description
    Statistical analysis provided for DB, shift to low. None of the participants had DB, shift to low
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 9999 [64]
    Method
    Fisher exact
    Confidence interval
    Notes
    [64] - A P-value of 9999 indicates a value of N/A or that it could not be calculated.
    Statistical analysis title
    Statistical analysis 62
    Statistical analysis description
    Statistical analysis provided for DB, shift to low. None of the participants had DB, shift to low
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 9999 [65]
    Method
    Fisher exact
    Confidence interval
    Notes
    [65] - A P-value of 9999 indicates a value of N/A or that it could not be calculated.
    Statistical analysis title
    Statistical analysis 63
    Statistical analysis description
    Statistical analysis provided for DB, shift to normal or no change
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    > 0.999
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 64
    Statistical analysis description
    Statistical analysis provided for DB, shift to normal or no change
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    > 0.999
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 65
    Statistical analysis description
    Statistical analysis provided for DB, shift to high
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    > 0.999
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 66
    Statistical analysis description
    Statistical analysis provided for DB, shift to high
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    > 0.999
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 67
    Statistical analysis description
    Statistical analysis provided for ALP, shift to low. None of the participants had ALP, shift to low
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 9999 [66]
    Method
    Fisher exact
    Confidence interval
    Notes
    [66] - A P-value of 9999 indicates a value of N/A or that it could not be calculated.
    Statistical analysis title
    Statistical analysis 68
    Statistical analysis description
    Statistical analysis provided for ALP, shift to low. None of the participants had ALP, shift to low
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 9999 [67]
    Method
    Fisher exact
    Confidence interval
    Notes
    [67] - A P-value of 9999 indicates a value of N/A or that it could not be calculated.
    Statistical analysis title
    Statistical analysis 69
    Statistical analysis description
    Statistical analysis provided for ALP, shift to normal or no change
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.246
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 70
    Statistical analysis description
    Statistical analysis provided for ALP, shift to normal or no change
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    > 0.999
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 71
    Statistical analysis description
    Statistical analysis provided for ALP, shift to high
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.245
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 72
    Statistical analysis description
    Statistical analysis provided for ALP, shift to high
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    > 0.999
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 73
    Statistical analysis description
    Statistical analysis provided for ALT, shift to low. None of the participants had ALT, shift to low
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 9999 [68]
    Method
    Fisher exact
    Confidence interval
    Notes
    [68] - A P-value of 9999 indicates a value of N/A or that it could not be calculated.
    Statistical analysis title
    Statistical analysis 74
    Statistical analysis description
    Statistical analysis provided for ALT, shift to low. None of the participants had ALT, shift to low
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 9999 [69]
    Method
    Fisher exact
    Confidence interval
    Notes
    [69] - A P-value of 9999 indicates a value of N/A or that it could not be calculated.
    Statistical analysis title
    Statistical analysis 75
    Statistical analysis description
    Statistical analysis provided for ALT, shift to normal or no change
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.495
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 76
    Statistical analysis description
    Statistical analysis provided for ALT, shift to normal or no change
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.564
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 77
    Statistical analysis description
    Statistical analysis provided for ALT, shift to high
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.489
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 78
    Statistical analysis description
    Statistical analysis provided for ALT, shift to high
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.563
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 79
    Statistical analysis description
    Statistical analysis provided for AST, shift to low. None of the participants had AST, shift to low.
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 9999 [70]
    Method
    Fisher exact
    Confidence interval
    Notes
    [70] - A P-value of 9999 indicates a value of N/A or that it could not be calculated.
    Statistical analysis title
    Statistical analysis 80
    Statistical analysis description
    Statistical analysis provided for AST, shift to low. None of the participants had AST, shift to low.
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 9999 [71]
    Method
    Fisher exact
    Confidence interval
    Notes
    [71] - A P-value of 9999 indicates a value of N/A or that it could not be calculated.
    Statistical analysis title
    Statistical analysis 81
    Statistical analysis description
    Statistical analysis provided for AST, shift to normal or no change
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.031
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 82
    Statistical analysis description
    Statistical analysis provided for AST, shift to normal or no change
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.401
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 83
    Statistical analysis description
    Statistical analysis provided for AST, shift to high
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.03
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 84
    Statistical analysis description
    Statistical analysis provided for AST, shift to high
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.273
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 85
    Statistical analysis description
    Statistical analysis provided for BUN/U, shift to low
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.745
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 86
    Statistical analysis description
    Statistical analysis provided for BUN/U, shift to low
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.741
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 87
    Statistical analysis description
    Statistical analysis provided for BUN/U, shift to normal or no change
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.765
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 88
    Statistical analysis description
    Statistical analysis provided for BUN/U, shift to normal or no change
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.765
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 89
    Statistical analysis description
    Statistical analysis provided for BUN/U, shift to high
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    > 0.999
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 90
    Statistical analysis description
    Statistical analysis provided for BUN/U, shift to high
    Comparison groups
    GSK1605786A 500 mg BID v Placebo
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.62
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 91
    Statistical analysis description
    Statistical analysis provided for CRE, shift to low
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.581
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 92
    Statistical analysis description
    Statistical analysis provided for CRE, shift to low
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.124
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 93
    Statistical analysis description
    Statistical analysis provided for CRE, shift to normal or no change
    Comparison groups
    GSK1605786A 500 mg QD v Placebo
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.792
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 94
    Statistical analysis description
    Statistical analysis provided for CRE, shift to normal or no change
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.23
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 95
    Statistical analysis description
    Statistical analysis provided for CRE, shift to high
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    > 0.999
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 96
    Statistical analysis description
    Statistical analysis provided for CRE, shift to high
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    > 0.999
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 97
    Statistical analysis description
    Statistical analysis provided for UA, shift to low
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    > 0.999
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 98
    Statistical analysis description
    Statistical analysis provided for UA, shift to low
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    > 0.999
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 99
    Statistical analysis description
    Statistical analysis provided for UA, shift to normal or no change
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.719
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 100
    Statistical analysis description
    Statistical analysis provided for UA, shift to normal or no change
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.209
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 101
    Statistical analysis description
    Statistical analysis provided for UA, shift to high
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    > 0.999
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 102
    Statistical analysis description
    Statistical analysis provided for UA, shift to high
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.12
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 103
    Statistical analysis description
    Statistical analysis provided for BIC, shift to low
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.444
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 104
    Statistical analysis description
    Statistical analysis provided for BIC, shift to low
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.709
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 105
    Statistical analysis description
    Statistical analysis provided for BIC, shift to normal or no change
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.45
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 106
    Statistical analysis description
    Statistical analysis provided for BIC, shift to normal or no change
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.711
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 107
    Statistical analysis description
    Statistical analysis provided for BIC, shift to high. None of the participants had BIC, shift to high
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 9999 [72]
    Method
    Fisher exact
    Confidence interval
    Notes
    [72] - A P-value of 9999 indicates a value of N/A or that it could not be calculated.
    Statistical analysis title
    Statistical analysis 108
    Statistical analysis description
    Statistical analysis provided for BIC, shift to high. None of the participants had BIC, shift to high
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 9999 [73]
    Method
    Fisher exact
    Confidence interval
    Notes
    [73] - A P-value of 9999 indicates a value of N/A or that it could not be calculated.
    Statistical analysis title
    Statistical analysis 109
    Statistical analysis description
    Statistical analysis provided for LD, shift to low. None of the participants had LD, shift to low
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 9999 [74]
    Method
    Fisher exact
    Confidence interval
    Notes
    [74] - A P-value of 9999 indicates a value of N/A or that it could not be calculated.
    Statistical analysis title
    Statistical analysis 110
    Statistical analysis description
    Statistical analysis provided for LD, shift to low. None of the participants had LD, shift to low
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 9999 [75]
    Method
    Fisher exact
    Confidence interval
    Notes
    [75] - A P-value of 9999 indicates a value of N/A or that it could not be calculated.
    Statistical analysis title
    Statistical analysis 111
    Statistical analysis description
    Statistical analysis provided for LD, shift to normal or no change
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    > 0.999
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 112
    Statistical analysis description
    Statistical analysis provided for LD, shift to normal or no change
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    > 0.999
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 113
    Statistical analysis description
    Statistical analysis provided for LD, shift to high
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    > 0.999
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 114
    Statistical analysis description
    Statistical analysis provided for LD, shift to high
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    > 0.999
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 115
    Statistical analysis description
    Statistical analysis provided for CHO, shift to low. None of the participants had CHO, shift to low
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 9999 [76]
    Method
    Fisher exact
    Confidence interval
    Notes
    [76] - A P-value of 9999 indicates a value of N/A or that it could not be calculated.
    Statistical analysis title
    Statistical analysis 116
    Statistical analysis description
    Statistical analysis provided for CHO, shift to low. None of the participants had CHO, shift to low
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 9999 [77]
    Method
    Fisher exact
    Confidence interval
    Notes
    [77] - A P-value of 9999 indicates a value of N/A or that it could not be calculated.
    Statistical analysis title
    Statistical analysis 117
    Statistical analysis description
    Statistical analysis provided for CHO, shift to normal or no change
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.533
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 118
    Statistical analysis description
    Statistical analysis provided for CHO, shift to normal or no change
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.327
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 119
    Statistical analysis description
    Statistical analysis provided for CHO, shift to high
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.351
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 120
    Statistical analysis description
    Statistical analysis provided for CHO, shift to high
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.615
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 121
    Statistical analysis description
    Statistical analysis provided for CK, shift to low. None of the participants had CK, shift to low
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 9999 [78]
    Method
    Fisher exact
    Confidence interval
    Notes
    [78] - A P-value of 9999 indicates a value of N/A or that it could not be calculated.
    Statistical analysis title
    Statistical analysis 122
    Statistical analysis description
    Statistical analysis provided for CK, shift to low. None of the participants had CK, shift to low
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 9999 [79]
    Method
    Fisher exact
    Confidence interval
    Notes
    [79] - A P-value of 9999 indicates a value of N/A or that it could not be calculated.
    Statistical analysis title
    Statistical analysis 123
    Statistical analysis description
    Statistical analysis provided for CK, shift to normal or no change
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.533
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 124
    Statistical analysis description
    Statistical analysis provided for CK, shift to normal or no change
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.792
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 125
    Statistical analysis description
    Statistical analysis provided for CK, shift to high
    Comparison groups
    Placebo v GSK1605786A 500 mg QD
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.533
    Method
    Fisher exact
    Confidence interval
    Statistical analysis title
    Statistical analysis 126
    Statistical analysis description
    Statistical analysis provided for CK, shift to high
    Comparison groups
    Placebo v GSK1605786A 500 mg BID
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    > 0.999
    Method
    Fisher exact
    Confidence interval

    Secondary: Change from Baseline in ALT, AST, ALP, and GGT

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    End point title
    Change from Baseline in ALT, AST, ALP, and GGT
    End point description
    Changes in Baseline in ALP, ALT, AST and GGT were assessed to monitor liver function. Blood samples were taken at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 4 Weeks post-treatment. Baseline (Week 0) is defined as the results taken at End of Study Visit of Induction Study. Change from Baseline was calculated as the post-Baseline value at the timepoint indicated minus the value at Baseline.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 4 Weeks post-treatment (assessed up to Week 56)
    End point values
    Placebo GSK1605786A 500 mg QD GSK1605786A 500 mg BID
    Number of subjects analysed
    76 [80]
    77 [81]
    76 [82]
    Units: International Unit per Liter (IU/L)
    arithmetic mean (standard deviation)
        ALT, Week 2, n=74, 75, 74
    -1 ± 14.7
    0.3 ± 5.88
    0.2 ± 6.27
        ALT, Week 4, n=71, 67, 71
    0.2 ± 8.93
    -0.6 ± 4.83
    -0.1 ± 6.94
        ALT, Week 6, n=64, 61, 63
    0.4 ± 11.92
    1.1 ± 6.66
    0.3 ± 7.35
        ALT, Week 8, n=61, 56, 57
    0 ± 9.46
    -0.2 ± 6.2
    1 ± 6.43
        ALT, Week 10, n=56, 49, 51
    -2.1 ± 8.15
    -0.5 ± 5.24
    0.9 ± 7.33
        ALT, Week 12, n=51, 45, 48
    -2.7 ± 8.6
    -0.6 ± 5.13
    0.6 ± 7.4
        ALT, Week 16, n=48, 41, 42
    -1.4 ± 9
    0.5 ± 7.69
    0.4 ± 4.98
        ALT, Week 20, n=43, 36, 36
    -2.7 ± 8.85
    -0.4 ± 7.07
    1.4 ± 4.59
        ALT, Week 24, n=37, 32, 29
    -1.3 ± 9.94
    -0.2 ± 6.25
    2.3 ± 6.19
        ALT, Week 28, n=31, 26, 23
    -1.6 ± 10.08
    -0.2 ± 5.91
    0.3 ± 5.12
        ALT, Week 32, n=26, 23, 19
    -2.3 ± 9.48
    -0.8 ± 6.81
    11.1 ± 35.32
        ALT, Week 36, n=23, 19, 13
    -2.3 ± 8.17
    -0.6 ± 7.46
    5.4 ± 10.74
        ALT, Week 40, n=23, 15, 10
    -3.4 ± 10.74
    0.1 ± 10.24
    6 ± 10.13
        ALT, Week 44, n=18, 14, 9
    -3.2 ± 13.37
    -1.5 ± 7.72
    0.3 ± 4.82
        ALT, Week 48, n=14, 11, 8
    -3.8 ± 13.98
    -2 ± 12.21
    -0.6 ± 6.52
        ALT, Week 52, n=14, 9, 7
    -5.1 ± 11.47
    -1.2 ± 11.41
    -1.3 ± 5.22
        ALT, 4 week post treatment, n=33, 31, 28
    -5.8 ± 28.79
    0.4 ± 8.11
    10.3 ± 41.19
        AST, Week 2, n=74, 75, 74
    0.4 ± 12.18
    0.3 ± 3.76
    0.6 ± 5.41
        AST, Week 4, n=71, 67, 71
    0.5 ± 7.19
    0.1 ± 4.24
    -0.2 ± 5.45
        AST, Week 6, n=64, 61, 63
    1.2 ± 9.18
    0.8 ± 3.99
    -0.1 ± 3.94
        AST, Week 8, n=61, 56, 57
    0.1 ± 6.39
    0 ± 4.07
    1 ± 4.58
        AST, Week 10, n=56, 49, 50
    -0.7 ± 5.17
    0.6 ± 3.94
    0.8 ± 4.18
        AST, Week 12, n=51, 45, 48
    0.4 ± 8.38
    0.5 ± 5.97
    1.1 ± 6.11
        AST, Week 16, n=48, 41, 42
    0 ± 7.57
    1.5 ± 5.29
    0.4 ± 4.24
        AST, Week 20, n=43, 36, 36
    -0.2 ± 7.18
    0.8 ± 4.74
    0.2 ± 5.02
        AST, Week 24, n=37, 32, 29
    0 ± 8.35
    0.2 ± 4.52
    1.7 ± 6.21
        AST, Week 28, n=31, 26, 23
    1.3 ± 10.01
    0.5 ± 4.52
    -0.9 ± 4.42
        AST, Week 32, n=26, 23, 19
    -0.2 ± 7.06
    -0.6 ± 6.67
    4.9 ± 17.5
        AST, Week 36, n=22, 19, 13
    0 ± 8.17
    0.3 ± 4.36
    3.3 ± 7
        AST, Week 40, n=23, 15, 10
    -0.7 ± 9.95
    -0.5 ± 3.66
    3.8 ± 8.43
        AST, Week 44, n=18, 14, 9
    -1.3 ± 7.14
    -0.8 ± 5.03
    -0.8 ± 4.09
        AST, Week 48, n=14, 11, 8
    -0.1 ± 11.65
    -3.4 ± 8.87
    -0.4 ± 6.32
        AST, Week 52, n=14, 9, 7
    -1.4 ± 10.05
    -0.9 ± 3.98
    -1 ± 2.83
        AST, 4 week post treatment, n=33, 31, 28
    -2.5 ± 17.99
    -0.3 ± 4.13
    5.4 ± 20.7
        ALP, Week 2, n=74, 75, 74
    -0.2 ± 7.42
    1.3 ± 9.54
    0.4 ± 9.96
        ALP, Week 4, n=71, 67, 71
    0.1 ± 9.3
    2 ± 10.63
    0.4 ± 11
        ALP, Week 6, n=64, 61, 63
    1 ± 11.21
    3.6 ± 11.28
    1 ± 11.16
        ALP, Week 8, n=61, 56, 57
    1.7 ± 12.04
    3.9 ± 12.61
    0.2 ± 11.21
        ALP, Week 10, n=56, 49, 51
    -1.4 ± 10.54
    5.6 ± 12.55
    2.8 ± 12.93
        ALP, Week 12, n=51, 45, 48
    1.2 ± 10.99
    5.6 ± 14.85
    2.4 ± 11.38
        ALP, Week 16, n=48, 41, 42
    1.5 ± 13.71
    7.2 ± 13.16
    3.4 ± 13.23
        ALP, Week 20, n=43, 36, 36
    3.7 ± 13.7
    9.3 ± 16.74
    2 ± 12.8
        ALP, Week 24, n=37, 32, 29
    1.9 ± 13.77
    9.2 ± 17.74
    3.4 ± 11
        ALP, Week 28, n=31, 26, 23
    1.9 ± 16.62
    12.2 ± 16.71
    -0.6 ± 12.53
        ALP, Week 32, n=26, 23, 19
    -1 ± 16.55
    10.5 ± 19.52
    4.3 ± 9.63
        ALP, Week 36, n=23, 19, 13
    2.3 ± 18.43
    9.4 ± 16.98
    6.3 ± 13.11
        ALP, Week 40, n=23, 15, 10
    1.5 ± 18.6
    6.5 ± 6.71
    -0.2 ± 9.14
        ALP, Week 44, n=18, 14, 9
    2.6 ± 17.32
    6 ± 9.88
    -3.6 ± 8.31
        ALP, Week 48, n=14, 11, 8
    10.6 ± 23.54
    1.1 ± 19.93
    -5.5 ± 11.25
        ALP, Week 52, n=14, 9, 7
    2.1 ± 13.76
    3.9 ± 10.28
    3.9 ± 9.58
        ALP, 4 week post treatment, n=33, 31, 28
    3.5 ± 12.84
    3.8 ± 14.98
    4.9 ± 8.29
        GGT, Week 2, n=74, 75, 74
    -3 ± 8.06
    1.8 ± 13.22
    0.4 ± 8.89
        GGT, Week 4, n=71, 67, 71
    -4.2 ± 9.86
    -0.4 ± 12.58
    2.1 ± 11.32
        GGT, Week 6, n=64, 61, 63
    -5 ± 15.47
    1.7 ± 13.1
    1.9 ± 10.5
        GGT, Week 8, n=61, 56, 57
    -1.2 ± 24.86
    1.1 ± 16.05
    2 ± 7.55
        GGT, Week 10, n=56, 49, 51
    -6.2 ± 11.03
    0.7 ± 14.38
    2.2 ± 6.71
        GGT, Week 12, n=51, 45, 48
    -8.2 ± 15
    0.5 ± 14.94
    2.3 ± 8.21
        GGT, Week 16, n=48, 41, 42
    -3.4 ± 19.57
    -0.9 ± 12.17
    3.7 ± 8.72
        GGT, Week 20, n=43, 36, 36
    -6.5 ± 17.94
    -1.9 ± 11.95
    2.9 ± 8.57
        GGT, Week 24, n=37, 32, 29
    -6.4 ± 15.11
    -3 ± 19.17
    2.6 ± 7.95
        GGT, Week 28, n=31, 26, 23
    -7.8 ± 25.33
    -4.3 ± 17.17
    1.3 ± 6.56
        GGT, Week 32, n=26, 23, 19
    -13.2 ± 31.99
    -9 ± 31.31
    6.5 ± 13.53
        GGT, Week 36, n=23, 19, 13
    -9 ± 27.65
    -6.7 ± 18.39
    11 ± 13.38
        GGT, Week 40, n=23, 15, 10
    -11.7 ± 21.56
    -6.1 ± 18.98
    8.9 ± 10.49
        GGT, Week 44, n=18, 14, 9
    -7.4 ± 15.82
    -8.6 ± 20.03
    4.4 ± 9.15
        GGT, Week 48, n=14, 11, 8
    -4.4 ± 9.8
    -13.5 ± 40.87
    4.1 ± 9.3
        GGT, Week 52, n=14, 9, 7
    -10.4 ± 19.75
    0 ± 11.64
    8.3 ± 10.4
        GGT, 4 week post treatment, n=33, 31, 26
    -4.2 ± 12.03
    -3.4 ± 13.5
    0.8 ± 21.68
    Notes
    [80] - Safety Population. Only participants available at the specified time points were analyzed(n=X, X, X)
    [81] - Safety Population. Only participants available at the specified time points were analyzed(n=X, X, X)
    [82] - Safety Population. Only participants available at the specified time points were analyzed(n=X, X, X)
    No statistical analyses for this end point

    Secondary: Change from Baseline in total bilirubin

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    End point title
    Change from Baseline in total bilirubin
    End point description
    Changes in Baseline in TB were assessed to monitor liver function. Blood samples were taken at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 4 Weeks post-treatment. Baseline (Week 0) is defined as the results taken at End of Study Visit of Induction Study. Change from Baseline was calculated as the post-Baseline value at the timepoint indicated minus the value at Baseline.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 4 Weeks post treatment (assessed up to Week 56)
    End point values
    Placebo GSK1605786A 500 mg QD GSK1605786A 500 mg BID
    Number of subjects analysed
    76 [83]
    77 [84]
    76 [85]
    Units: micromole/Liter (umol/L)
    arithmetic mean (standard deviation)
        TB, Week 2, n=74, 75, 74
    0.7 ± 3.21
    0 ± 2.09
    -0.7 ± 2.48
        TB, Week 4, n=71, 67, 71
    0.7 ± 3.46
    0 ± 2.33
    -0.1 ± 2.24
        TB, Week 6, n=64, 61, 63
    0.9 ± 2.29
    0.1 ± 2.6
    -0.4 ± 2.95
        TB, Week 8, n=61, 56, 57
    1 ± 3.38
    0.2 ± 2.49
    0 ± 2.31
        TB, Week 10, n=56, 49, 51
    0.9 ± 3.46
    0.5 ± 3.25
    -0.1 ± 3.27
        TB, Week 12, n=51, 45, 48
    0.8 ± 2.7
    0.2 ± 2.42
    0.6 ± 3.33
        TB, Week 16, n=48, 41, 42
    0.8 ± 3.75
    0.8 ± 2.99
    -0.2 ± 2
        TB, Week 20, n=43, 36, 36
    1.4 ± 3.07
    0.9 ± 3.25
    0.4 ± 2.89
        TB, Week 24, n=37, 32, 29
    1 ± 3.26
    0.8 ± 2.63
    0.8 ± 4.27
        TB, Week 28, n=31, 26, 23
    0.8 ± 3.37
    0.4 ± 2.08
    0.2 ± 4.3
        TB, Week 32, n=26, 23, 19
    0.5 ± 2.37
    0.2 ± 2.41
    0.8 ± 5.7
        TB, Week 36, n=23, 19, 13
    0.4 ± 2.62
    0.6 ± 3.09
    0.5 ± 2.44
        TB, Week 40, n=23, 15, 10
    0.7 ± 2.52
    -0.5 ± 2.67
    0.7 ± 3.16
        TB, Week 44, n=18, 14, 9
    1.4 ± 2.79
    0 ± 1.66
    1 ± 6.44
        TB, Week 48, n=14, 11, 8
    1 ± 4.49
    -1.4 ± 3.35
    -1.5 ± 6.97
        TB, Week 52, n=14, 9, 7
    0.7 ± 4.81
    0.6 ± 1.42
    -1.7 ± 9.53
        TB, 4 week post treatment, n=33, 31, 28
    0.2 ± 3.69
    1.4 ± 2.81
    1.8 ± 3.47
    Notes
    [83] - Safety Population. Only participants available at the specified time points were analyzed(n=X, X, X)
    [84] - Safety Population. Only participants available at the specified time points were analyzed(n=X, X, X)
    [85] - Safety Population. Only participants available at the specified time points were analyzed(n=X, X, X)
    No statistical analyses for this end point

    Secondary: Change from Baseline in albumin (ALB)

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    End point title
    Change from Baseline in albumin (ALB)
    End point description
    Changes in Baseline in ALB were assessed to monitor liver function. Blood samples were taken at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 4 Weeks post-treatment. Baseline (Week 0) is defined as the results taken at End of Study Visit of Induction Study. Change from Baseline was calculated as the post-Baseline value at the timepoint indicated minus the value at Baseline.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 4 Weeks post treatment (assessed up to Week 56)
    End point values
    Placebo GSK1605786A 500 mg QD GSK1605786A 500 mg BID
    Number of subjects analysed
    76 [86]
    77 [87]
    76 [88]
    Units: Gram/Liter (G/L)
    arithmetic mean (standard deviation)
        ALB, Week 2, n=4, 8, 7
    -0.3 ± 1.26
    0 ± 2.51
    -0.1 ± 1.35
        ALB, Week 4, n=70, 66, 69
    0.7 ± 2.2
    0.1 ± 2.39
    -0.2 ± 2.3
        ALB, Week 6, n=1, 3, 7
    -1 ± 0
    -1 ± 2
    -0.6 ± 2.3
        ALB, Week 8, n=61, 56, 57
    0.2 ± 2.44
    0.3 ± 2.37
    -0.6 ± 2.63
        ALB, Week 10, n=6, 4, 5
    -2 ± 2.97
    -1.5 ± 2.08
    -1.4 ± 1.34
        ALB, Week 12, n=50, 45, 48
    0 ± 2.48
    0 ± 2.43
    0 ± 2.7
        ALB, Week 16, n=3, 5, 4
    -3 ± 2.65
    -1 ± 3
    -1.5 ± 2.52
        ALB, Week 20, n=43, 35, 36
    0.4 ± 2.02
    0.7 ± 2.78
    0 ± 2.42
        ALB, Week 24, n=5, 4, 3
    -0.2 ± 4.55
    -2.3 ± 4.35
    -4 ± 3.61
        ALB, Week 28, n=30, 24, 23
    0.1 ± 2.06
    0.1 ± 4.47
    0.5 ± 2.89
        ALB, Week 32, n=0, 3, 0
    0 ± 0
    -4 ± 4.36
    0 ± 0
        ALB, Week 36, n=23, 19, 13
    -0.2 ± 2.78
    0.7 ± 4.01
    0.4 ± 2.79
        ALB, Week 40, n=2, 0, 0
    0.5 ± 2.12
    0 ± 0
    0 ± 0
        ALB, Week 44, n=18, 14, 8
    -0.2 ± 2.55
    0 ± 2.69
    0.4 ± 2.33
        ALB, Week 48, n=1, 1, 1
    2 ± 0
    1 ± 0
    1 ± 0
        ALB, Week 52, n=14, 9, 7
    -0.1 ± 2.14
    -1.3 ± 1.94
    1.9 ± 2.27
        ALB, 4 week post treatment, n=33, 31, 26
    -1 ± 2.48
    -0.5 ± 3.52
    -0.2 ± 3.03
    Notes
    [86] - Safety Population. Only participants available at the specified time points were analyzed(n=X, X, X)
    [87] - Safety Population. Only participants available at the specified time points were analyzed(n=X, X, X)
    [88] - Safety Population. Only participants available at the specified time points were analyzed(n=X, X, X)
    No statistical analyses for this end point

    Secondary: Number of participants with abnormal 12-lead electrocardiogram (ECG) findings at Baseline and Weeks 28 and 52

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    End point title
    Number of participants with abnormal 12-lead electrocardiogram (ECG) findings at Baseline and Weeks 28 and 52
    End point description
    A 12-lead ECG was recorded in a supine position after the participant was kept at rest in this position for at least 5 minutes. Data are presented as clinically significant (CS) or not clinically significant (NCS) abnormal findings. The study investigator determined if the abnormal ECG finding was CS or NCS. Baseline (Week 0) is defined as the results taken at End of Study Visit of Induction Study.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 28 and 52
    End point values
    Placebo GSK1605786A 500 mg QD GSK1605786A 500 mg BID
    Number of subjects analysed
    76 [89]
    77 [90]
    76 [91]
    Units: Participants
    number (not applicable)
        BL (Week 0), Normal, n=76, 77, 76
    62
    69
    54
        BL (Week 0), Abnormal NCS, n=76, 77, 76
    13
    8
    54
        BL (Week 0), Abnormal CS, n=76, 77, 76
    1
    0
    2
        Week 28, Normal, n=32, 23, 24
    27
    16
    20
        Week 28, Abnormal NCS, n=32, 23, 24
    5
    7
    4
        Week 28, Abnormal CS, n=32, 23, 24
    0
    0
    0
        Week 52, Normal, n=14, 8, 7
    12
    8
    6
        Week 52, Abnormal NCS, n=14, 8, 7
    2
    0
    1
        Week 52, Abnormal CS, n=14, 8, 7
    0
    0
    0
    Notes
    [89] - Safety Population. Only participants available at the specified time points were analyzed(n=X, X, X)
    [90] - Safety Population. Only participants available at the specified time points were analyzed(n=X, X, X)
    [91] - Safety Population. Only participants available at the specified time points were analyzed(n=X, X, X)
    No statistical analyses for this end point

    Secondary: Change from Baseline in Short Form – 36 version 2 (SF-36v2) at Weeks 28 and 52

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    End point title
    Change from Baseline in Short Form – 36 version 2 (SF-36v2) at Weeks 28 and 52
    End point description
    The SF-36v2 is a 36-item general health related quality of life instrument focusing on 7 health concept scales and one general health indicator scale. This provides information about how participants feel, and how well they have been able to perform their usual activities, over the past 4 weeks. Scores on each item are summed and averaged (range = 0-100). The higher scores represents better health state and better functioning. Change from Baseline was calculated as the value at indicated time point minus the value at Baseline.Baseline (Week 0) is defined as the results taken at End of Study Visit of Induction Study. Because the study was terminated prematurely, summary statistics were not compiled.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 28 and 52
    End point values
    Placebo GSK1605786A 500 mg QD GSK1605786A 500 mg BID
    Number of subjects analysed
    0 [92]
    0 [93]
    0 [94]
    Units: Score on scale
        number (not applicable)
    Notes
    [92] - ITT Population
    [93] - ITT Population
    [94] - ITT Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in EQ-5D at Weeks 28 and 52

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    End point title
    Change from Baseline in EQ-5D at Weeks 28 and 52
    End point description
    The EQ-5D provides a simple, self-reported descriptive profile and a single index value for health status. The EQ-5D consists of two parts comprising the EQ-5D descriptive system and the EQ visual analogue scale(VAS). The EQ-5D descriptive system comprises 5 dimensions of health (mobility, self-care, usual activities, and pain/discomfort anxiety/depression). Each dimension has three levels(no problems, some/moderate problems,extreme problems). A unique EQ-5D health state index value is calculated by subtracting from 1 the instrument’s predefined coefficients corresponding to the response level for each dimension. The EQ VAS records the respondents self-rated health status on a vertical graduated scale(0=worst imaginable-100=best imaginable). Change from BL was calculated as the value at indicated time point minus the value at BL. BL(Week 0) is defined as the results taken at the End of Induction Study visit. The study was terminated prematurely so summary statistics were not compiled.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 28 and 52
    End point values
    Placebo GSK1605786A 500 mg QD GSK1605786A 500 mg BID
    Number of subjects analysed
    0 [95]
    0 [96]
    0 [97]
    Units: Score on scale
        number (not applicable)
    Notes
    [95] - ITT Population
    [96] - ITT Population
    [97] - ITT Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in Work Productivity and Activity Impairment-CD (WPAI-CD) at Weeks 28 and 52

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    End point title
    Change from Baseline in Work Productivity and Activity Impairment-CD (WPAI-CD) at Weeks 28 and 52
    End point description
    The WPAI-CD questionnaire assesses the impact of disease on work productivity and activity and consists of 6 items: employment status, hours missed due to Crohn’s disease, hours missed for other reasons, hours worked, lost productivity, and daily activity impairment due to Crohn’s disease. The following scores are calculated and expressed as percentages (with higher scores indicating more productivity loss): absenteeism, presenteeism (impairment while at work), work productivity loss (absenteeism + presenteeism), and daily activity impairment. Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. Baseline (Week 0) is defined as the results taken at End of Study Visit of Induction Study. Because the study was terminated prematurely, summary statistics were not compiled.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 28 and 52
    End point values
    Placebo GSK1605786A 500 mg QD GSK1605786A 500 mg BID
    Number of subjects analysed
    0 [98]
    0 [99]
    0 [100]
    Units: Score on scale
        number (not applicable)
    Notes
    [98] - ITT Population
    [99] - ITT Population
    [100] - ITT Population
    No statistical analyses for this end point

    Secondary: Number of participants who received of disability benefits or health-related resources at Weeks 28 and 52

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    End point title
    Number of participants who received of disability benefits or health-related resources at Weeks 28 and 52
    End point description
    The summary of the number of participants who received disability benefits, or with all cause and Crohn’s disease-related hospitalisations, surgeries, and out-patient visits was planned to compare between each GSK1605786A dose group and placebo using Fisher’s exact test. Because the Induction Study was terminated prematurely, summary statistics were not compiled.
    End point type
    Secondary
    End point timeframe
    Weeks 28 and 52
    End point values
    Placebo GSK1605786A 500 mg QD GSK1605786A 500 mg BID
    Number of subjects analysed
    0 [101]
    0 [102]
    0 [103]
    Units: Participants
        number (not applicable)
    Notes
    [101] - ITT Population
    [102] - ITT Population
    [103] - ITT Population
    No statistical analyses for this end point

    Secondary: Duration of hospital visits

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    End point title
    Duration of hospital visits
    End point description
    The duration of hospital visits was planned to summarize by treatment group using a five-number summary and compare between each GSK1605786A dose group and placebo using Wilcoxon rank sum tests. Because the study was terminated prematurely, summary statistics were not compiled.
    End point type
    Secondary
    End point timeframe
    Baseline to Weeks 52
    End point values
    Placebo GSK1605786A 500 mg QD GSK1605786A 500 mg BID
    Number of subjects analysed
    0 [104]
    0 [105]
    0 [106]
    Units: Days
        number (not applicable)
    Notes
    [104] - ITT Population
    [105] - ITT Population
    [106] - ITT Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in C-reactive protein concentration at Weeks 28 and 52

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    End point title
    Change from Baseline in C-reactive protein concentration at Weeks 28 and 52
    End point description
    Blood samples were collected for the measurement of c-reactive protein at Baseline and Weeks 28 and 52. Baseline (Week 0) is defined as the results taken at End of Study Visit of Induction Study. Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. Because the study was terminated prematurely, summary statistics were not compiled.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 28 and 52
    End point values
    Placebo GSK1605786A 500 mg QD GSK1605786A 500 mg BID
    Number of subjects analysed
    0 [107]
    0 [108]
    0 [109]
    Units: Milligrams per liter
        number (not applicable)
    Notes
    [107] - ITT Population
    [108] - ITT Population
    [109] - ITT Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in faecal calprotectin at Week 28 and 52

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    End point title
    Change from Baseline in faecal calprotectin at Week 28 and 52
    End point description
    Blood samples were collected for the measurement of faecal calprotectin at Baseline and Weeks 28 and 52. Baseline (Week 0) is defined as the results taken at End of Study Visit of Induction Study. Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. Because the study was terminated prematurely, summary statistics were not compiled.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 28 and 52
    End point values
    Placebo GSK1605786A 500 mg QD GSK1605786A 500 mg BID
    Number of subjects analysed
    0 [110]
    0 [111]
    0 [112]
    Units: microgram per gram
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    Notes
    [110] - ITT Population
    [111] - ITT Population
    [112] - ITT Population
    No statistical analyses for this end point

    Secondary: Pharmacokinetics (PK) of GSK1605786A

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    End point title
    Pharmacokinetics (PK) of GSK1605786A
    End point description
    The PK analyses was planned to perform to characterize the PK of the study drug GSK1605786A in the participant population. PK is defined as the concentration of drug in a participant’s blood at certain time points after the drug was taken by mouth. These PK analyses was not conducted following the early termination of the study. Because the study was terminated prematurely, summary statistics were not compiled.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
    End point values
    Placebo GSK1605786A 500 mg QD GSK1605786A 500 mg BID
    Number of subjects analysed
    0 [113]
    0 [114]
    0 [115]
    Units: microgram per gram
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    Notes
    [113] - ITT Population
    [114] - ITT Population
    [115] - ITT Population
    No statistical analyses for this end point

    Secondary: Pharmacogenetic analyses

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    End point title
    Pharmacogenetic analyses
    End point description
    Sample for the pharmacogenetic analyses was collected during prior induction study was planned to use. The pharmacogenetic analyses was planned to perform to investigate the relationship between the genetic markers with the safety and efficacy response to GSK1605786A. These pharmacogenetic analyses was not conducted following the early termination of the study. Because the study was terminated prematurely, summary statistics were not compiled.
    End point type
    Secondary
    End point timeframe
    Post randomization any time during early two weeks
    End point values
    Placebo GSK1605786A 500 mg QD GSK1605786A 500 mg BID
    Number of subjects analysed
    0 [116]
    0 [117]
    0 [118]
    Units: presence or absence of certain genes
        number (not applicable)
    Notes
    [116] - ITT Population
    [117] - ITT Population
    [118] - ITT Population
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the start of study medication until and 4 weeks post treatment (up to Week 56)
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Participants received matching placebo via 2 oral capsules for 52 weeks

    Reporting group title
    GSK1605786A 500 mg QD
    Reporting group description
    Participants received GSK1605786A a total of 500 milligrams (mg), administered as 2 250 mg oral capsules once daily (QD) for 52 weeks

    Reporting group title
    GSK1605786A 500 mg BID
    Reporting group description
    Participants received GSK1605786A a total of 500 mg, administered as 2 250 mg oral capsules, twice daily (BID) for 52 weeks

    Serious adverse events
    Placebo GSK1605786A 500 mg QD GSK1605786A 500 mg BID
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 76 (1.32%)
    3 / 77 (3.90%)
    2 / 76 (2.63%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Cardiac disorders
    Sinus tachycardia
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 77 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 77 (1.30%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Crohn's disease
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 77 (1.30%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthritis
         subjects affected / exposed
    0 / 76 (0.00%)
    0 / 77 (0.00%)
    1 / 76 (1.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Anal abscess
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 77 (1.30%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 76 (0.00%)
    0 / 77 (0.00%)
    1 / 76 (1.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Placebo GSK1605786A 500 mg QD GSK1605786A 500 mg BID
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    54 / 76 (71.05%)
    48 / 77 (62.34%)
    54 / 76 (71.05%)
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 76 (0.00%)
    2 / 77 (2.60%)
    4 / 76 (5.26%)
         occurrences all number
    0
    2
    4
    Nervous system disorders
    Headache
         subjects affected / exposed
    6 / 76 (7.89%)
    3 / 77 (3.90%)
    9 / 76 (11.84%)
         occurrences all number
    7
    8
    19
    General disorders and administration site conditions
    Abdominal pain
         subjects affected / exposed
    10 / 76 (13.16%)
    5 / 77 (6.49%)
    9 / 76 (11.84%)
         occurrences all number
    11
    7
    10
    Gastrointestinal disorders
    Crohn's disease
         subjects affected / exposed
    13 / 76 (17.11%)
    12 / 77 (15.58%)
    10 / 76 (13.16%)
         occurrences all number
    14
    13
    11
    Diarrhoea
         subjects affected / exposed
    8 / 76 (10.53%)
    3 / 77 (3.90%)
    3 / 76 (3.95%)
         occurrences all number
    9
    3
    5
    Nausea
         subjects affected / exposed
    6 / 76 (7.89%)
    1 / 77 (1.30%)
    6 / 76 (7.89%)
         occurrences all number
    8
    2
    12
    Vomiting
         subjects affected / exposed
    4 / 76 (5.26%)
    2 / 77 (2.60%)
    3 / 76 (3.95%)
         occurrences all number
    5
    2
    4
    Toothache
         subjects affected / exposed
    3 / 76 (3.95%)
    0 / 77 (0.00%)
    4 / 76 (5.26%)
         occurrences all number
    3
    0
    4
    Dyspepsia
         subjects affected / exposed
    1 / 76 (1.32%)
    4 / 77 (5.19%)
    1 / 76 (1.32%)
         occurrences all number
    2
    4
    2
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    7 / 76 (9.21%)
    2 / 77 (2.60%)
    1 / 76 (1.32%)
         occurrences all number
    7
    2
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    8 / 76 (10.53%)
    5 / 77 (6.49%)
    4 / 76 (5.26%)
         occurrences all number
    11
    6
    5
    Back pain
         subjects affected / exposed
    4 / 76 (5.26%)
    4 / 77 (5.19%)
    5 / 76 (6.58%)
         occurrences all number
    4
    4
    5
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    9 / 76 (11.84%)
    9 / 77 (11.69%)
    9 / 76 (11.84%)
         occurrences all number
    12
    11
    12
    Influenza
         subjects affected / exposed
    1 / 76 (1.32%)
    4 / 77 (5.19%)
    2 / 76 (2.63%)
         occurrences all number
    1
    4
    2

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Jul 2011
    To update sponsor departmental and contact information, include revised information and to correct previous errors vand minor typographical and protocol errors, update secondary objectives for health outcomes, include work productivity and activity impairment assessment, update secondary objectives to include biomarkers of inflammation, include exploratory objective of assessment of fistula closure to clarify that this will be an exploratory objective of this study, update approximation of number of subjects required for screening based on current screen failure rate, amend 50% limitation of enrolment of subjects receiving prior treatment with an anti-TNF agent, include only subjects who discontinued due to loss or lack of efficacy, clarify for other secondary efficacy endpoints that changes in IBDQ total score will be assessed at Week 8 in addition to Week 12, clarify for safety endpoints that changes in body weight and temperature will be performed only in relation to CDAI scoring and not as a separate assessment, include assessment of liver function test parameters as a safety endpoint, clarify that changes in CRP concentrations will also be assessed at Weeks 4 and 8, clarify that the investigator should conduct a Follow-up visit in addition to an Early Withdrawal visit for safety follow up, remove specification of version of Investigator Brochure as this document will be updated throughout the life of the study. Investigators should refer to most recent version of the Investigator Brochure, amend Inclusion Criteria as follows: clarify the criterion for determination of an elevated CRP laboratory value, allow subjects to qualify based on current evidence of active disease by either endoscopic assessment or inflammatory biomarkers. Subjects who do not qualify based on endoscopic assessment may be eligible if the CRP and faecal calprotectin criteria are met, updated criteria for acceptable contraceptive methods of birth control according to sponsor standards
    27 Jul 2011
    Amend Exclusion Criteria as follows: clarify criteria for fixed symptomatic stenoses and stricture, to clarify that prohibited medications should not be taken throughout the study,to specify the duration of the wash-out period for previous use of biologics based on scheduling of randomisation visit,to include criterion to prohibit use of digoxin or related cardiac glycosides(e.g digitoxin, deslanoside, lanatoside C, metildigoxin) within 7 days prior to screening, to clarify that subjects should not receive immunisation with a live vaccine, with the exception of influenza vaccine, for the duration of the study to ensure subject safety, correct typographical error in exclusion of alkaline phosphatase to > 1.5 times the upper limit of normal,to specify that Investigators should confirm that subjects continue to meet the requirements for Exclusion Criterion #20 based on Week 0 liver function test results, subjects who do not continue to meet this criterion should be withdrawn from the study, to clarify testing procedures for exclusion on basis of a positive test for Hepatitis C, clarify exclusion criterion for subject with Bundle Branch Block and to include information on procedures for QTc assessment, update withdrawal and stopping criteria and testing procedures for liver chemistry abnormalities and ECG findings to be consistent with revisions to GSK standard withdrawal criteria, clarify permitted treatment with oral antibiotics for Crohn’s disease and the allowable use of short courses of oral antibiotics for intercurrent To include use of digoxin or related cardiac glycosides(e.g digitoxin, deslanoside, lanatoside C, metildigoxin) as prohibited medications, correct errors in the Time and Events table for consistency with protocol text or to clarify study procedures, increase potential duration of Screening period to allow sufficient time for scheduling of ileocolonoscopy for subjects who do not qualify on the basis of biomarker testing.
    27 Jul 2011
    To clarify that information on obtaining haematocrit values for CDAI determination is available in the SPM, To clarify that subjects should initiate study drug administration the evening of the day of the randomisation visit, To provide clarification that adverse events should be collected at the Week 16 visit and to provide additional clarification regarding reporting of worsening of Crohn’s disease as an adverse event, To include information on reporting and analyses of Disease-related events common in Crohn’s disease for consistency with new FDA safety reporting guidance. Protocol-specified events related to worsening of Crohn’s disease will not be reported as SAEs, To clarify assessments at Early Withdrawal and Follow-up visits, To clarify process for pharmacokinetics sample collection, To provide additional clarification on data handling, To include additional information on analyses of components of SF-36v2 and disability benefit data To provide additional clarification on IDMC purpose and safety review, To amend CDAI to clarify that investigator should assess symptoms/findings for subject based on current conditions and fever should be documented if present over the past week, To include most recent version of IBDQ which is being utilised in the study

    Interruptions (globally)

    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    23 Aug 2013
    Discontinue investigational product and discontinue enrollment of new subjects. 4 September 2013 - Study Termination.
    -

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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