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    Clinical Trial Results:
    A Phase 2 Multi-Center, Open-Label, Follow-Up Study to Assess The Long-Term Safety and Efficacy of CDP6038 Administered Subcutaneously to Subjects With Active Rheumatoid Arthritis Who completed Study RA0056

    Summary
    EudraCT number
    2010-022224-77
    Trial protocol
    GB   BE  
    Global end of trial date
    05 Aug 2013

    Results information
    Results version number
    v1(current)
    This version publication date
    23 Mar 2022
    First version publication date
    23 Mar 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    RA0057
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    UCB Biopharma SRL
    Sponsor organisation address
    Allée de la Recherche 60, Brussels, Belgium, 1070
    Public contact
    Clin Trial Reg & Results Disclosure, UCB BIOSCIENCES GmbH, clinicaltrials@ucb.com
    Scientific contact
    Clin Trial Reg & Results Disclosure, UCB BIOSCIENCES GmbH, clinicaltrials@ucb.com
    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
    11 Oct 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 May 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Aug 2013
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To assess the long-term safety of CDP6038 dosed at 120 milligrams (mg) once every 2 weeks (q2w) while treating the signs and symptoms of active rheumatoid arthritis in participants who have previously failed TNFα blocker therapy.
    Protection of trial subjects
    During the conduct of the study all subjects were closely monitored.
    Background therapy
    Not applicable
    Evidence for comparator
    -
    Actual start date of recruitment
    07 Mar 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 3
    Country: Number of subjects enrolled
    United Kingdom: 4
    Country: Number of subjects enrolled
    United States: 183
    Worldwide total number of subjects
    190
    EEA total number of subjects
    3
    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)
    147
    From 65 to 84 years
    43
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The present study was an open-label extension to study RA0056 (NCT01242488). Subjects completing the 12-week treatment period of study RA0056 had the opportunity to participate in this study. First subject enrolled: 07 March 2011. Early termination: 05 Aug 2013.

    Pre-assignment
    Screening details
    198 subjects completed the parent study RA0056 (NCT01242488); 190 subjects were enrolled in study RA0057. The study was a single treatment study and all subjects received CDP6038 (olokizumab) 120 mg sc q2w, however, some results are also presented according to the previously assigned treatment arms of the parent study RA0056.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    RA0056 CDP6038 (Olokizumab) 120 mg q2w
    Arm description
    CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Olokizumab
    Investigational medicinal product code
    CDP6038
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 120 mg olokizumab q2w at prespecified time points.

    Arm title
    RA0056 CDP6038 (Olokizumab) 120 mg q4w
    Arm description
    CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Olokizumab
    Investigational medicinal product code
    CDP6038
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 120 mg olokizumab q4w at prespecified time points.

    Arm title
    RA0056 CDP6038 (Olokizumab) 240 mg q2w
    Arm description
    CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Olokizumab
    Investigational medicinal product code
    CDP6038
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 240 mg olokizumab q2w at prespecified time points.

    Arm title
    RA0056 CDP6038 (Olokizumab) 240 mg q4w
    Arm description
    CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Olokizumab
    Investigational medicinal product code
    CDP6038
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 240 mg olokizumab q4w at prespecified time points.

    Arm title
    RA0056 CDP6038 (Olokizumab) 60 mg q2w
    Arm description
    CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Olokizumab
    Investigational medicinal product code
    CDP6038
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 60 mg olokizumab q2w at prespecified time points.

    Arm title
    RA0056 CDP6038 (Olokizumab) 60 mg q4w
    Arm description
    CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Olokizumab
    Investigational medicinal product code
    CDP6038
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 60 mg olokizumab q4w at prespecified time points.

    Arm title
    RA0056 Placebo
    Arm description
    Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
    Arm type
    Placebo

    Investigational medicinal product name
    Olokizumab
    Investigational medicinal product code
    CDP6038
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received placebo matched to olokizumab at prespecified time points.

    Arm title
    RA0056 Tocilizumab 8 mg/kg q4w
    Arm description
    Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Tocilizumab
    Investigational medicinal product code
    CDP6038
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 8 mg tocilizumab q4w at prespecified time points.

    Number of subjects in period 1
    RA0056 CDP6038 (Olokizumab) 120 mg q2w RA0056 CDP6038 (Olokizumab) 120 mg q4w RA0056 CDP6038 (Olokizumab) 240 mg q2w RA0056 CDP6038 (Olokizumab) 240 mg q4w RA0056 CDP6038 (Olokizumab) 60 mg q2w RA0056 CDP6038 (Olokizumab) 60 mg q4w RA0056 Placebo RA0056 Tocilizumab 8 mg/kg q4w
    Started
    20
    20
    21
    20
    17
    16
    40
    36
    Completed
    4
    12
    8
    7
    7
    5
    9
    15
    Not completed
    16
    8
    13
    13
    10
    11
    31
    21
         Patient decision due to transport
    -
    -
    -
    -
    -
    -
    -
    1
         Methotrexate discontinued
    -
    -
    -
    1
    -
    -
    -
    -
         Failure to comply with visits
    -
    -
    -
    -
    -
    -
    -
    1
         Required restricted steroid injections
    -
    -
    -
    -
    -
    -
    1
    -
         Investigator discretion
    -
    -
    -
    -
    -
    -
    1
    -
         Consent withdrawn by subject
    4
    2
    2
    1
    1
    1
    2
    1
         Ongoing missed appointments
    -
    -
    -
    -
    -
    -
    1
    -
         Adverse event, non-fatal
    3
    1
    4
    3
    1
    6
    11
    3
         Study termination
    8
    1
    5
    4
    4
    4
    8
    10
         Continued elevated liver enzymes
    -
    -
    -
    1
    -
    -
    -
    -
         Unspecified
    -
    -
    -
    -
    -
    -
    1
    -
         Lost to follow-up
    -
    -
    1
    1
    2
    -
    4
    2
         Lack of efficacy
    1
    4
    1
    1
    1
    -
    2
    3
         Protocol deviation
    -
    -
    -
    1
    1
    -
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    RA0056 CDP6038 (Olokizumab) 120 mg q2w
    Reporting group description
    CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.

    Reporting group title
    RA0056 CDP6038 (Olokizumab) 120 mg q4w
    Reporting group description
    CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.

    Reporting group title
    RA0056 CDP6038 (Olokizumab) 240 mg q2w
    Reporting group description
    CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.

    Reporting group title
    RA0056 CDP6038 (Olokizumab) 240 mg q4w
    Reporting group description
    CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.

    Reporting group title
    RA0056 CDP6038 (Olokizumab) 60 mg q2w
    Reporting group description
    CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.

    Reporting group title
    RA0056 CDP6038 (Olokizumab) 60 mg q4w
    Reporting group description
    CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.

    Reporting group title
    RA0056 Placebo
    Reporting group description
    Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.

    Reporting group title
    RA0056 Tocilizumab 8 mg/kg q4w
    Reporting group description
    Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.

    Reporting group values
    RA0056 CDP6038 (Olokizumab) 120 mg q2w RA0056 CDP6038 (Olokizumab) 120 mg q4w RA0056 CDP6038 (Olokizumab) 240 mg q2w RA0056 CDP6038 (Olokizumab) 240 mg q4w RA0056 CDP6038 (Olokizumab) 60 mg q2w RA0056 CDP6038 (Olokizumab) 60 mg q4w RA0056 Placebo RA0056 Tocilizumab 8 mg/kg q4w Total
    Number of subjects
    20 20 21 20 17 16 40 36 190
    Age Categorical
    Units: participants
        <=18 years
    0 0 0 0 0 0 0 0 0
        Between 18 and 65 years
    17 16 17 14 13 14 27 29 147
        >=65 years
    3 4 4 6 4 2 13 7 43
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    53.8 ± 10.99 54.5 ± 11.9 56.1 ± 12.3 55.0 ± 12.7 57.9 ± 10.0 54.0 ± 12.1 58.9 ± 12.5 36.8 ± 10.3 -
    Gender, Male/Female
    Units: participants
        Female
    17 17 19 16 14 14 33 31 161
        Male
    3 3 2 4 3 2 7 5 29

    End points

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    End points reporting groups
    Reporting group title
    RA0056 CDP6038 (Olokizumab) 120 mg q2w
    Reporting group description
    CDP6038 (olokizumab) 120 mg administered every 2 weeks (q2w) sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of study RA0057 (Week 12 of RA0056) for 48 weeks.

    Reporting group title
    RA0056 CDP6038 (Olokizumab) 120 mg q4w
    Reporting group description
    CDP6038 (olokizumab) 120 mg administered every 4 weeks (q4w) sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.

    Reporting group title
    RA0056 CDP6038 (Olokizumab) 240 mg q2w
    Reporting group description
    CDP6038 (olokizumab) 240 mg administered q2w sc in study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.

    Reporting group title
    RA0056 CDP6038 (Olokizumab) 240 mg q4w
    Reporting group description
    CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.

    Reporting group title
    RA0056 CDP6038 (Olokizumab) 60 mg q2w
    Reporting group description
    CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.

    Reporting group title
    RA0056 CDP6038 (Olokizumab) 60 mg q4w
    Reporting group description
    CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.

    Reporting group title
    RA0056 Placebo
    Reporting group description
    Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.

    Reporting group title
    RA0056 Tocilizumab 8 mg/kg q4w
    Reporting group description
    Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.

    Subject analysis set title
    RA0056 CDP6038 (olokizumab) Combined
    Subject analysis set type
    Full analysis
    Subject analysis set description
    All doses of CDP6038 (olokizumab) (60 mg, 120 mg and 240 mg in Study RA0056) were pooled together as one combined treatment group. All subjects switched to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056).

    Primary: Number of subjects with treatment-emergent adverse events (TEAEs)

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    End point title
    Number of subjects with treatment-emergent adverse events (TEAEs) [1]
    End point description
    Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose. Safety Population included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) in Study RA0057.
    End point type
    Primary
    End point timeframe
    From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive analyses was planned to be reported for this endpoint.
    End point values
    RA0056 CDP6038 (Olokizumab) 120 mg q2w RA0056 CDP6038 (Olokizumab) 120 mg q4w RA0056 CDP6038 (Olokizumab) 240 mg q2w RA0056 CDP6038 (Olokizumab) 240 mg q4w RA0056 CDP6038 (Olokizumab) 60 mg q2w RA0056 CDP6038 (Olokizumab) 60 mg q4w RA0056 Placebo RA0056 Tocilizumab 8 mg/kg q4w
    Number of subjects analysed
    20
    20
    21
    20
    17
    16
    40
    36
    Units: participants
    17
    20
    19
    18
    15
    15
    39
    35
    No statistical analyses for this end point

    Secondary: Change from Baseline (Week 0 of Study RA0056) in the Disease Activity Score-28-joint count (C-reactive protein) (DAS28[CRP]) to Week 12 of Study RA0057

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    End point title
    Change from Baseline (Week 0 of Study RA0056) in the Disease Activity Score-28-joint count (C-reactive protein) (DAS28[CRP]) to Week 12 of Study RA0057
    End point description
    DAS28(CRP) was calculated using tender/painful joint count (TJC) and swollen joint count (SJC) from 28 joints, Patient’s Global Assessment of Disease Activity (PtGADA)-Visual Analog Scale (VAS) and CRP using formula:DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP calculated in mg/L. The 28 joints: shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), proximal interphalangeal (PIP) joints of hands; and knees. Scores on DAS28(CRP): 0 to 10 (higher scores = more disease activity). A negative change in score= an improvement in disease activity. Full analysis set: all enrolled subjects who received at least 1 dose of CDP6038 and had at least 1 efficacy assessment in RA0057. Number of Participants Analyzed =participants evaluable for this assessment.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0 of Study RA0056) and Week 12 (Study RA0057)
    End point values
    RA0056 CDP6038 (Olokizumab) 120 mg q2w RA0056 CDP6038 (Olokizumab) 120 mg q4w RA0056 CDP6038 (Olokizumab) 240 mg q2w RA0056 CDP6038 (Olokizumab) 240 mg q4w RA0056 CDP6038 (Olokizumab) 60 mg q2w RA0056 CDP6038 (Olokizumab) 60 mg q4w RA0056 Placebo RA0056 Tocilizumab 8 mg/kg q4w RA0056 CDP6038 (olokizumab) Combined
    Number of subjects analysed
    13
    17
    19
    15
    15
    15
    32
    29
    94
    Units: units on a scale
        arithmetic mean (standard deviation)
    -2.2809 ± 1.45737
    -2.2485 ± 1.39384
    -2.5123 ± 1.39667
    -2.2230 ± 1.17572
    -1.6957 ± 0.67335
    -2.1735 ± 1.56606
    -2.3727 ± 1.41421
    -2.4710 ± 1.43947
    -2.2020 ± 1.30149
    No statistical analyses for this end point

    Secondary: Change from Baseline (Week 0 of Study RA0056) in DAS28(CRP) to Week 24 of Study RA0057

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    End point title
    Change from Baseline (Week 0 of Study RA0056) in DAS28(CRP) to Week 24 of Study RA0057
    End point description
    DAS28(CRP) was calculated using the TJC and SJC from 28 joints, PtGADA-VAS and CRP according to formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where higher scores =more disease activity. A negative change in DAS28(CRP) score indicates an improvement in disease activity. FAS included all enrolled subjects who received at least 1 injection of CDP6038 and had at least 1 efficacy measurement in RA0057. When baseline and actual mean scores were not available, change from baseline was not calculated. Number of Participants analyzed (N)=participants who were evaluable for assessment.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0 of Study RA0056) and Week 24 (Study RA0057)
    End point values
    RA0056 CDP6038 (Olokizumab) 120 mg q2w RA0056 CDP6038 (Olokizumab) 120 mg q4w RA0056 CDP6038 (Olokizumab) 240 mg q2w RA0056 CDP6038 (Olokizumab) 240 mg q4w RA0056 CDP6038 (Olokizumab) 60 mg q2w RA0056 CDP6038 (Olokizumab) 60 mg q4w RA0056 Placebo RA0056 Tocilizumab 8 mg/kg q4w RA0056 CDP6038 (olokizumab) Combined
    Number of subjects analysed
    13
    14
    19
    10
    13
    14
    31
    29
    83
    Units: units on a scale
        arithmetic mean (standard deviation)
    -2.6441 ± 1.46566
    1.46566 ± 1.17637
    -2.5811 ± 1.40191
    -2.5999 ± 1.16812
    -1.7189 ± 0.87218
    -2.4221 ± 1.37341
    -2.1484 ± 1.34676
    -2.7624 ± 1.47841
    -2.4624 ± 1.28049
    No statistical analyses for this end point

    Secondary: Change from Baseline (Week 0 of Study RA0056) in DAS28(CRP) to Week 48 of Study RA0057

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    End point title
    Change from Baseline (Week 0 of Study RA0056) in DAS28(CRP) to Week 48 of Study RA0057
    End point description
    DAS28(CRP) was calculated using the TJC and SJC from 28 joints, PtGADA-VAS and CRP according to formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change in DAS28(CRP) score indicates an improvement in disease activity. FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057. When baseline and actual mean scores were not available, change from baseline was not calculated. N =participants who were evaluable for assessment.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0 of Study RA0056) and Week 48 (Study RA0057)
    End point values
    RA0056 CDP6038 (Olokizumab) 120 mg q2w RA0056 CDP6038 (Olokizumab) 120 mg q4w RA0056 CDP6038 (Olokizumab) 240 mg q2w RA0056 CDP6038 (Olokizumab) 240 mg q4w RA0056 CDP6038 (Olokizumab) 60 mg q2w RA0056 CDP6038 (Olokizumab) 60 mg q4w RA0056 Placebo RA0056 Tocilizumab 8 mg/kg q4w RA0056 CDP6038 (olokizumab) Combined
    Number of subjects analysed
    10
    12
    13
    10
    12
    10
    20
    22
    67
    Units: units on a scale
        arithmetic mean (standard deviation)
    -2.3257 ± 1.07427
    -2.2498 ± 1.66580
    -2.5277 ± 1.56763
    -2.7050 ± 0.96160
    -2.3824 ± 0.79065
    -2.1501 ± 0.64141
    -2.2403 ± 1.47765
    -2.7611 ± 1.31329
    -2.3919 ± 1.17675
    No statistical analyses for this end point

    Secondary: Change from Baseline (Week 0 of Study RA0056) in DAS28(CRP) to Week 96 of Study RA0057

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    End point title
    Change from Baseline (Week 0 of Study RA0056) in DAS28(CRP) to Week 96 of Study RA0057
    End point description
    DAS28(CRP) was calculated using the TJC and SJC from 28 joints, PtGADA-VAS and CRP according to formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change in DAS28(CRP) score indicates an improvement in disease activity. Analysis population was FAS. When baseline and actual mean scores were not available, change from baseline was not calculated. Here, N signifies participants who were evaluable for assessment. 99999 signifies that standard deviation (S.D.) could not be calculated as there was only 1 evaluable participant.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0 of Study RA0056) and Week 96 (Study RA0057)
    End point values
    RA0056 CDP6038 (Olokizumab) 120 mg q2w RA0056 CDP6038 (Olokizumab) 120 mg q4w RA0056 CDP6038 (Olokizumab) 240 mg q2w RA0056 CDP6038 (Olokizumab) 240 mg q4w RA0056 CDP6038 (Olokizumab) 60 mg q2w RA0056 CDP6038 (Olokizumab) 60 mg q4w RA0056 Placebo RA0056 Tocilizumab 8 mg/kg q4w RA0056 CDP6038 (olokizumab) Combined
    Number of subjects analysed
    3
    1
    3
    2
    3
    2
    2
    5
    14
    Units: units on a scale
        arithmetic mean (standard deviation)
    -3.2427 ± 1.74642
    -3.5767 ± 99999
    -2.5985 ± 2.16200
    -3.0999 ± 0.02877
    -1.7516 ± 2.03992
    -2.6451 ± 0.96108
    -3.3173 ± 3.23508
    -3.7982 ± 1.23889
    -2.7032 ± 1.50391
    No statistical analyses for this end point

    Secondary: The American College of Rheumatology (ACR) 20% (ACR20) improvement criteria response rate from Baseline (Week 0 of Study RA0056) to Week 12 of Study RA0057

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    End point title
    The American College of Rheumatology (ACR) 20% (ACR20) improvement criteria response rate from Baseline (Week 0 of Study RA0056) to Week 12 of Study RA0057
    End point description
    ACR20 =at least 20% improvement from Baseline for each of TJC (68 joints)+ SJC (66 joints)+ at least 3 components of 5 for:PtGADA-VAS, Physician’s Global Assessment of Disease Activity (PhGADA)-VAS, Patient’s Assessment of Arthritis Pain (PAAP)-VAS, Health Assessment Questionnaire-Disability Index (HAQ-DI) and CRP. Assessments: •TJC and SJC: same 2-point scale (0=absent;1=present).•PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms).•PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). •PAAP: 100 mm VAS (0=no pain;100=most severe pain). •HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, with lower scores indicates less disability. •CRP in mg/L. Missing values were considered as non-responding status. Analysis population was FAS.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0 of Study RA0056) up to Week 12 (Study RA0057)
    End point values
    RA0056 CDP6038 (Olokizumab) 120 mg q2w RA0056 CDP6038 (Olokizumab) 120 mg q4w RA0056 CDP6038 (Olokizumab) 240 mg q2w RA0056 CDP6038 (Olokizumab) 240 mg q4w RA0056 CDP6038 (Olokizumab) 60 mg q2w RA0056 CDP6038 (Olokizumab) 60 mg q4w RA0056 Placebo RA0056 Tocilizumab 8 mg/kg q4w RA0056 CDP6038 (olokizumab) Combined
    Number of subjects analysed
    20
    20
    21
    20
    17
    16
    40
    36
    114
    Units: Percentage of responders
        number (not applicable)
    40.0
    50.0
    76.2
    35.0
    58.8
    50.0
    47.5
    52.8
    51.8
    No statistical analyses for this end point

    Secondary: The ACR20 improvement criteria response rate from Baseline (Week 0 of Study RA0056) to Week 24 of Study RA0057

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    End point title
    The ACR20 improvement criteria response rate from Baseline (Week 0 of Study RA0056) to Week 24 of Study RA0057
    End point description
    ACR20 represents at least 20% improvement from Baseline for each of TJC (68 joints)+ SJC (66 joints)+ at least 3 components of 5 for:PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: •TJC and SJC: same 2-point scale (0=absent;1=present). •PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). •PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). •PAAP: 100 mm VAS (0=no pain;100=most severe pain). •HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, with lower scores indicates less disability. •CRP in mg/L. Missing values were considered as non-responding status. FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0 of Study RA0056) up to Week 24 (Study RA0057)
    End point values
    RA0056 CDP6038 (Olokizumab) 120 mg q2w RA0056 CDP6038 (Olokizumab) 120 mg q4w RA0056 CDP6038 (Olokizumab) 240 mg q2w RA0056 CDP6038 (Olokizumab) 240 mg q4w RA0056 CDP6038 (Olokizumab) 60 mg q2w RA0056 CDP6038 (Olokizumab) 60 mg q4w RA0056 Placebo RA0056 Tocilizumab 8 mg/kg q4w RA0056 CDP6038 (olokizumab) Combined
    Number of subjects analysed
    20
    20
    21
    20
    17
    16
    40
    36
    114
    Units: Percentage of responders
        number (not applicable)
    40.0
    50.0
    66.7
    30.0
    47.1
    62.5
    42.5
    63.9
    49.1
    No statistical analyses for this end point

    Secondary: The ACR20 improvement criteria response rate from Baseline (Week 0 of Study RA0056) to Week 48 of Study RA0057

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    End point title
    The ACR20 improvement criteria response rate from Baseline (Week 0 of Study RA0056) to Week 48 of Study RA0057
    End point description
    ACR20 represents at least 20% improvement from Baseline for each of TJC (68 joints)+ SJC (66 joints)+ at least 3 components of 5 for:PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: •TJC and SJC: same 2-point scale (0=absent;1=present). •PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). •PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). •PAAP: 100 mm VAS (0=no pain;100=most severe pain). •HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, with lower scores indicates less disability. •CRP in mg/L. Missing values were considered as non-responding status. FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0 of Study RA0056) up to Week 48 (Study RA0057)
    End point values
    RA0056 CDP6038 (Olokizumab) 120 mg q2w RA0056 CDP6038 (Olokizumab) 120 mg q4w RA0056 CDP6038 (Olokizumab) 240 mg q2w RA0056 CDP6038 (Olokizumab) 240 mg q4w RA0056 CDP6038 (Olokizumab) 60 mg q2w RA0056 CDP6038 (Olokizumab) 60 mg q4w RA0056 Placebo RA0056 Tocilizumab 8 mg/kg q4w RA0056 CDP6038 (olokizumab) Combined
    Number of subjects analysed
    20
    20
    21
    20
    17
    16
    40
    36
    114
    Units: Percentage of responders
        number (not applicable)
    40.0
    30.0
    42.9
    35.0
    47.1
    43.8
    25.0
    50.0
    39.5
    No statistical analyses for this end point

    Secondary: The ACR20 improvement criteria response rate from Baseline (Week 0 of Study RA0056) to Week 96 of Study RA0057

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    End point title
    The ACR20 improvement criteria response rate from Baseline (Week 0 of Study RA0056) to Week 96 of Study RA0057
    End point description
    ACR20 represents at least 20% improvement from Baseline for each of TJC (68 joints)+ SJC (66 joints)+ at least 3 components of 5 for:PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: •TJC and SJC: same 2-point scale (0=absent;1=present). •PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). •PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). •PAAP: 100 mm VAS (0=no pain;100=most severe pain). •HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, with lower scores indicates less disability. •CRP in mg/L. Missing values were considered as non-responding status. FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0 of Study RA0056) up to Week 96 (Study RA0057)
    End point values
    RA0056 CDP6038 (Olokizumab) 120 mg q2w RA0056 CDP6038 (Olokizumab) 120 mg q4w RA0056 CDP6038 (Olokizumab) 240 mg q2w RA0056 CDP6038 (Olokizumab) 240 mg q4w RA0056 CDP6038 (Olokizumab) 60 mg q2w RA0056 CDP6038 (Olokizumab) 60 mg q4w RA0056 Placebo RA0056 Tocilizumab 8 mg/kg q4w RA0056 CDP6038 (olokizumab) Combined
    Number of subjects analysed
    20
    20
    21
    20
    17
    16
    40
    36
    114
    Units: Percentage of responders
        number (not applicable)
    15.0
    5.0
    9.5
    5.0
    11.8
    12.5
    2.5
    13.9
    9.6
    No statistical analyses for this end point

    Secondary: The ACR 50% (ACR50) improvement criteria response rate from Baseline (Week 0 of Study RA0056) to Week 12 of Study RA0057

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    End point title
    The ACR 50% (ACR50) improvement criteria response rate from Baseline (Week 0 of Study RA0056) to Week 12 of Study RA0057
    End point description
    ACR50 represents at least 50% improvement from Baseline for each of TJC (68 joints)+ SJC (66 joints)+ at least 3 components of 5 for:PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: •TJC and SJC: same 2-point scale (0=absent;1=present). •PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). •PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). •PAAP: 100 mm VAS (0=no pain;100=most severe pain). •HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, with lower scores indicates less disability. •CRP in mg/L. Missing values were considered as non-responding status. FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0 of Study RA0056) up to Week 12 (Study RA0057)
    End point values
    RA0056 CDP6038 (Olokizumab) 120 mg q2w RA0056 CDP6038 (Olokizumab) 120 mg q4w RA0056 CDP6038 (Olokizumab) 240 mg q2w RA0056 CDP6038 (Olokizumab) 240 mg q4w RA0056 CDP6038 (Olokizumab) 60 mg q2w RA0056 CDP6038 (Olokizumab) 60 mg q4w RA0056 Placebo RA0056 Tocilizumab 8 mg/kg q4w RA0056 CDP6038 (olokizumab) Combined
    Number of subjects analysed
    20
    20
    21
    20
    17
    16
    40
    36
    114
    Units: Percentage of responders
        number (not applicable)
    25.0
    15.0
    33.3
    15.0
    17.6
    18.8
    27.5
    38.9
    21.1
    No statistical analyses for this end point

    Secondary: The ACR50 improvement criteria response rate from Baseline (Week 0 of Study RA0056) to Week 24 of Study RA0057

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    End point title
    The ACR50 improvement criteria response rate from Baseline (Week 0 of Study RA0056) to Week 24 of Study RA0057
    End point description
    ACR50 represents at least 50% improvement from Baseline for each of TJC (68 joints)+ SJC (66 joints)+ at least 3 components of 5 for:PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: •TJC and SJC: same 2-point scale (0=absent;1=present). •PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). •PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). •PAAP: 100 mm VAS (0=no pain;100=most severe pain). •HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, with lower scores indicates less disability. •CRP in mg/L. Missing values were considered as non-responding status. FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0 of Study RA0056) up to Week 24 (Study RA0057)
    End point values
    RA0056 CDP6038 (Olokizumab) 120 mg q2w RA0056 CDP6038 (Olokizumab) 120 mg q4w RA0056 CDP6038 (Olokizumab) 240 mg q2w RA0056 CDP6038 (Olokizumab) 240 mg q4w RA0056 CDP6038 (Olokizumab) 60 mg q2w RA0056 CDP6038 (Olokizumab) 60 mg q4w RA0056 Placebo RA0056 Tocilizumab 8 mg/kg q4w RA0056 CDP6038 (olokizumab) Combined
    Number of subjects analysed
    20
    20
    21
    20
    17
    16
    40
    36
    114
    Units: Percentage of responders
        number (not applicable)
    20.0
    20.0
    33.3
    15.0
    11.8
    43.8
    25.0
    41.7
    23.7
    No statistical analyses for this end point

    Secondary: The ACR50 improvement criteria response rate from Baseline (Week 0 of Study RA0056) to Week 48 of Study RA0057

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    End point title
    The ACR50 improvement criteria response rate from Baseline (Week 0 of Study RA0056) to Week 48 of Study RA0057
    End point description
    ACR50 represents at least 50% improvement from Baseline for each of TJC (68 joints)+ SJC (66 joints)+ at least 3 components of 5 for:PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: •TJC and SJC: same 2-point scale (0=absent;1=present). •PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). •PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). •PAAP: 100 mm VAS (0=no pain;100=most severe pain). •HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, with lower scores indicates less disability. •CRP in mg/L. Missing values were considered as non-responding status. FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0 of Study RA0056) up to Week 48 (Study RA0057)
    End point values
    RA0056 CDP6038 (Olokizumab) 120 mg q2w RA0056 CDP6038 (Olokizumab) 120 mg q4w RA0056 CDP6038 (Olokizumab) 240 mg q2w RA0056 CDP6038 (Olokizumab) 240 mg q4w RA0056 CDP6038 (Olokizumab) 60 mg q2w RA0056 CDP6038 (Olokizumab) 60 mg q4w RA0056 Placebo RA0056 Tocilizumab 8 mg/kg q4w RA0056 CDP6038 (olokizumab) Combined
    Number of subjects analysed
    20
    20
    21
    20
    17
    16
    40
    36
    114
    Units: Percentage of responders
        number (not applicable)
    10.0
    15.0
    28.6
    20.0
    35.3
    31.3
    15.0
    33.3
    22.8
    No statistical analyses for this end point

    Secondary: The ACR50 improvement criteria response rate from Baseline (Week 0 of Study RA0056) to Week 96 of Study RA0057

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    End point title
    The ACR50 improvement criteria response rate from Baseline (Week 0 of Study RA0056) to Week 96 of Study RA0057
    End point description
    ACR50 represents at least 50% improvement from Baseline for each of TJC (68 joints)+ SJC (66 joints)+ at least 3 components of 5 for:PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: •TJC and SJC: same 2-point scale (0=absent;1=present). •PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). •PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). •PAAP: 100 mm VAS (0=no pain;100=most severe pain). •HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, with lower scores indicates less disability. •CRP in mg/L. Missing values were considered as non-responding status. FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0 of Study RA0056) up to Week 96 (Study RA0057)
    End point values
    RA0056 CDP6038 (Olokizumab) 120 mg q2w RA0056 CDP6038 (Olokizumab) 120 mg q4w RA0056 CDP6038 (Olokizumab) 240 mg q2w RA0056 CDP6038 (Olokizumab) 240 mg q4w RA0056 CDP6038 (Olokizumab) 60 mg q2w RA0056 CDP6038 (Olokizumab) 60 mg q4w RA0056 Placebo RA0056 Tocilizumab 8 mg/kg q4w RA0056 CDP6038 (olokizumab) Combined
    Number of subjects analysed
    20
    20
    21
    20
    17
    16
    40
    36
    114
    Units: Percentage of responders
        number (not applicable)
    10.0
    5.0
    4.8
    0.0
    11.8
    6.3
    2.5
    8.3
    6.1
    No statistical analyses for this end point

    Secondary: The ACR 70% (ACR70) improvement criteria response rate from Baseline (Week 0 of Study RA0056) to Week 12 of Study RA0057

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    End point title
    The ACR 70% (ACR70) improvement criteria response rate from Baseline (Week 0 of Study RA0056) to Week 12 of Study RA0057
    End point description
    ACR70 represents at least 70% improvement from Baseline for each of TJC (68 joints)+ SJC (66 joints)+ at least 3 components of 5 for:PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: •TJC and SJC: same 2-point scale (0=absent;1=present). •PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). •PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). •PAAP: 100 mm VAS (0=no pain;100=most severe pain). •HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, with lower scores indicates less disability. •CRP in mg/L. Missing values were considered as non-responding status. FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0 of Study RA0056) up to Week 12 (Study RA0057)
    End point values
    RA0056 CDP6038 (Olokizumab) 120 mg q2w RA0056 CDP6038 (Olokizumab) 120 mg q4w RA0056 CDP6038 (Olokizumab) 240 mg q2w RA0056 CDP6038 (Olokizumab) 240 mg q4w RA0056 CDP6038 (Olokizumab) 60 mg q2w RA0056 CDP6038 (Olokizumab) 60 mg q4w RA0056 Placebo RA0056 Tocilizumab 8 mg/kg q4w RA0056 CDP6038 (olokizumab) Combined
    Number of subjects analysed
    20
    20
    21
    20
    17
    16
    40
    36
    114
    Units: Percentage of responders
        number (not applicable)
    10.0
    5.0
    19.0
    5.0
    0.0
    18.8
    15.0
    13.9
    9.6
    No statistical analyses for this end point

    Secondary: The ACR70 improvement criteria response rate from Baseline (Week 0 of Study RA0056) to Week 24 of Study RA0057

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    End point title
    The ACR70 improvement criteria response rate from Baseline (Week 0 of Study RA0056) to Week 24 of Study RA0057
    End point description
    ACR70 represents at least 70% improvement from Baseline for each of TJC (68 joints)+ SJC (66 joints)+ at least 3 components of 5 for:PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: •TJC and SJC: same 2-point scale (0=absent;1=present). •PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). •PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). •PAAP: 100 mm VAS (0=no pain;100=most severe pain). •HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, with lower scores indicates less disability. •CRP in mg/L. Missing values were considered as non-responding status. FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0 of Study RA0056) up to Week 24 (Study RA0057)
    End point values
    RA0056 CDP6038 (Olokizumab) 120 mg q2w RA0056 CDP6038 (Olokizumab) 120 mg q4w RA0056 CDP6038 (Olokizumab) 240 mg q2w RA0056 CDP6038 (Olokizumab) 240 mg q4w RA0056 CDP6038 (Olokizumab) 60 mg q2w RA0056 CDP6038 (Olokizumab) 60 mg q4w RA0056 Placebo RA0056 Tocilizumab 8 mg/kg q4w RA0056 CDP6038 (olokizumab) Combined
    Number of subjects analysed
    20
    20
    21
    20
    17
    16
    40
    36
    114
    Units: Percentage of responders
        number (not applicable)
    10.0
    15.0
    19.0
    5.0
    0.0
    12.5
    10.0
    25.0
    10.5
    No statistical analyses for this end point

    Secondary: The ACR70 improvement criteria response rate from Baseline (Week 0 of Study RA0056) to Week 48 of Study RA0057

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    End point title
    The ACR70 improvement criteria response rate from Baseline (Week 0 of Study RA0056) to Week 48 of Study RA0057
    End point description
    ACR70 represents at least 70% improvement from Baseline for each of TJC (68 joints)+ SJC (66 joints)+ at least 3 components of 5 for:PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: •TJC and SJC: same 2-point scale (0=absent;1=present). •PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). •PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). •PAAP: 100 mm VAS (0=no pain;100=most severe pain). •HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, with lower scores indicates less disability. •CRP in mg/L. Missing values were considered as non-responding status. FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0 of Study RA0056) up to Week 48 (Study RA0057)
    End point values
    RA0056 CDP6038 (Olokizumab) 120 mg q2w RA0056 CDP6038 (Olokizumab) 120 mg q4w RA0056 CDP6038 (Olokizumab) 240 mg q2w RA0056 CDP6038 (Olokizumab) 240 mg q4w RA0056 CDP6038 (Olokizumab) 60 mg q2w RA0056 CDP6038 (Olokizumab) 60 mg q4w RA0056 Placebo RA0056 Tocilizumab 8 mg/kg q4w RA0056 CDP6038 (olokizumab) Combined
    Number of subjects analysed
    20
    20
    21
    20
    17
    16
    40
    36
    114
    Units: Percentage of responders
        number (not applicable)
    5.0
    5.0
    23.8
    10.0
    11.8
    6.3
    10.0
    13.9
    10.5
    No statistical analyses for this end point

    Secondary: The ACR70 improvement criteria response rate from Baseline (Week 0 of Study RA0056) to Week 96 of Study RA0057

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    End point title
    The ACR70 improvement criteria response rate from Baseline (Week 0 of Study RA0056) to Week 96 of Study RA0057
    End point description
    ACR70 represents at least 70% improvement from Baseline for each of TJC (68 joints)+ SJC (66 joints)+ at least 3 components of 5 for:PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: •TJC and SJC: same 2-point scale (0=absent;1=present). •PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). •PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). •PAAP: 100 mm VAS (0=no pain;100=most severe pain). •HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), its score (0-3) computed from item scores, with lower scores indicates less disability. •CRP in mg/L. Missing values were considered as non-responding status. FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0 of Study RA0056) up to Week 96 (Study RA0057)
    End point values
    RA0056 CDP6038 (Olokizumab) 120 mg q2w RA0056 CDP6038 (Olokizumab) 120 mg q4w RA0056 CDP6038 (Olokizumab) 240 mg q2w RA0056 CDP6038 (Olokizumab) 240 mg q4w RA0056 CDP6038 (Olokizumab) 60 mg q2w RA0056 CDP6038 (Olokizumab) 60 mg q4w RA0056 Placebo RA0056 Tocilizumab 8 mg/kg q4w RA0056 CDP6038 (olokizumab) Combined
    Number of subjects analysed
    20
    20
    21
    20
    17
    16
    40
    36
    114
    Units: Percentage of responders
        number (not applicable)
    5.0
    0.0
    4.8
    0.0
    5.9
    0.0
    2.5
    5.6
    2.6
    No statistical analyses for this end point

    Secondary: Percentage of subjects with DAS28(CRP) <2.6 at Week 12 of Study RA0057

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    End point title
    Percentage of subjects with DAS28(CRP) <2.6 at Week 12 of Study RA0057
    End point description
    DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, and CRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. Scores on the DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. A DAS28(CRP) score less than 2.6 implies remission. FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057.
    End point type
    Secondary
    End point timeframe
    Week 12 (Study RA0057)
    End point values
    RA0056 CDP6038 (Olokizumab) 120 mg q2w RA0056 CDP6038 (Olokizumab) 120 mg q4w RA0056 CDP6038 (Olokizumab) 240 mg q2w RA0056 CDP6038 (Olokizumab) 240 mg q4w RA0056 CDP6038 (Olokizumab) 60 mg q2w RA0056 CDP6038 (Olokizumab) 60 mg q4w RA0056 Placebo RA0056 Tocilizumab 8 mg/kg q4w
    Number of subjects analysed
    20
    20
    21
    20
    17
    16
    40
    36
    Units: Percentage of subjects
        number (not applicable)
    25.0
    30.0
    38.1
    25.0
    0
    18.8
    25.0
    25.0
    No statistical analyses for this end point

    Secondary: Percentage of subjects with DAS28(CRP) <2.6 at Week 24 of Study RA0057

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    End point title
    Percentage of subjects with DAS28(CRP) <2.6 at Week 24 of Study RA0057
    End point description
    DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, and CRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. Scores on the DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. A DAS28(CRP) score less than 2.6 implies remission. FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057.
    End point type
    Secondary
    End point timeframe
    Week 24 (Study RA0057)
    End point values
    RA0056 CDP6038 (Olokizumab) 120 mg q2w RA0056 CDP6038 (Olokizumab) 120 mg q4w RA0056 CDP6038 (Olokizumab) 240 mg q2w RA0056 CDP6038 (Olokizumab) 240 mg q4w RA0056 CDP6038 (Olokizumab) 60 mg q2w RA0056 CDP6038 (Olokizumab) 60 mg q4w RA0056 Placebo RA0056 Tocilizumab 8 mg/kg q4w
    Number of subjects analysed
    20
    20
    21
    20
    17
    16
    40
    36
    Units: Percentage of subjects
        number (not applicable)
    25.0
    35.0
    33.3
    25.0
    17.6
    12.5
    20.0
    33.3
    No statistical analyses for this end point

    Secondary: Percentage of subjects with DAS28(CRP) <2.6 at Week 48 of Study RA0057

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    End point title
    Percentage of subjects with DAS28(CRP) <2.6 at Week 48 of Study RA0057
    End point description
    DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, and CRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. Scores on the DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. A DAS28(CRP) score less than 2.6 implies remission. FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057.
    End point type
    Secondary
    End point timeframe
    Week 48 (Study RA0057)
    End point values
    RA0056 CDP6038 (Olokizumab) 120 mg q2w RA0056 CDP6038 (Olokizumab) 120 mg q4w RA0056 CDP6038 (Olokizumab) 240 mg q2w RA0056 CDP6038 (Olokizumab) 240 mg q4w RA0056 CDP6038 (Olokizumab) 60 mg q2w RA0056 CDP6038 (Olokizumab) 60 mg q4w RA0056 Placebo RA0056 Tocilizumab 8 mg/kg q4w
    Number of subjects analysed
    20
    20
    21
    20
    17
    16
    40
    36
    Units: Percentage of subjects
        number (not applicable)
    20.0
    30.0
    23.8
    20.0
    29.4
    12.5
    15.0
    22.2
    No statistical analyses for this end point

    Secondary: Percentage of subjects with DAS28(CRP) <2.6 at Week 96 of Study RA0057

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    End point title
    Percentage of subjects with DAS28(CRP) <2.6 at Week 96 of Study RA0057
    End point description
    DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, and CRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. Scores on the DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. A DAS28(CRP) score less than 2.6 implies remission. FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057.
    End point type
    Secondary
    End point timeframe
    Week 96 (Study RA0057)
    End point values
    RA0056 CDP6038 (Olokizumab) 120 mg q2w RA0056 CDP6038 (Olokizumab) 120 mg q4w RA0056 CDP6038 (Olokizumab) 240 mg q2w RA0056 CDP6038 (Olokizumab) 240 mg q4w RA0056 CDP6038 (Olokizumab) 60 mg q2w RA0056 CDP6038 (Olokizumab) 60 mg q4w RA0056 Placebo RA0056 Tocilizumab 8 mg/kg q4w
    Number of subjects analysed
    20
    20
    21
    20
    17
    16
    40
    36
    Units: Percentage of subjects
        number (not applicable)
    10.0
    5.0
    9.5
    5.0
    11.8
    0
    2.5
    8.3
    No statistical analyses for this end point

    Secondary: Percentage of subjects with DAS28(CRP) ≤3.2 at Week 12 of Study RA0057

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    End point title
    Percentage of subjects with DAS28(CRP) ≤3.2 at Week 12 of Study RA0057
    End point description
    DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, and CRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. Scores on the DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. A DAS28(CRP) score less than or equal to (<=) 3.2 implies low disease activity. FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057.
    End point type
    Secondary
    End point timeframe
    Week 12 (Study RA0057)
    End point values
    RA0056 CDP6038 (Olokizumab) 120 mg q2w RA0056 CDP6038 (Olokizumab) 120 mg q4w RA0056 CDP6038 (Olokizumab) 240 mg q2w RA0056 CDP6038 (Olokizumab) 240 mg q4w RA0056 CDP6038 (Olokizumab) 60 mg q2w RA0056 CDP6038 (Olokizumab) 60 mg q4w RA0056 Placebo RA0056 Tocilizumab 8 mg/kg q4w
    Number of subjects analysed
    20
    20
    21
    20
    17
    16
    40
    36
    Units: Percentage of subjects
        number (not applicable)
    35.6
    40.0
    52.4
    30.0
    17.6
    25.0
    35.0
    44.4
    No statistical analyses for this end point

    Secondary: Percentage of subjects with DAS28(CRP) ≤3.2 at Week 24 of Study RA0057

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    End point title
    Percentage of subjects with DAS28(CRP) ≤3.2 at Week 24 of Study RA0057
    End point description
    DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, and CRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. Scores on the DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. A DAS28(CRP) score <=3.2 implies low disease activity. FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057.
    End point type
    Secondary
    End point timeframe
    Week 24 (Study RA0057)
    End point values
    RA0056 CDP6038 (Olokizumab) 120 mg q2w RA0056 CDP6038 (Olokizumab) 120 mg q4w RA0056 CDP6038 (Olokizumab) 240 mg q2w RA0056 CDP6038 (Olokizumab) 240 mg q4w RA0056 CDP6038 (Olokizumab) 60 mg q2w RA0056 CDP6038 (Olokizumab) 60 mg q4w RA0056 Placebo RA0056 Tocilizumab 8 mg/kg q4w
    Number of subjects analysed
    20
    20
    21
    20
    17
    16
    40
    36
    Units: Percentage of subjects
        number (not applicable)
    35.0
    40.0
    38.1
    30.0
    23.5
    37.5
    35.0
    50.0
    No statistical analyses for this end point

    Secondary: Percentage of subjects with DAS28(CRP) ≤3.2 at Week 48 of Study RA0057

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    End point title
    Percentage of subjects with DAS28(CRP) ≤3.2 at Week 48 of Study RA0057
    End point description
    DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, and CRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. Scores on the DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. A DAS28(CRP) score <=3.2 implies low disease activity. FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057.
    End point type
    Secondary
    End point timeframe
    Week 48 (Study RA0057)
    End point values
    RA0056 CDP6038 (Olokizumab) 120 mg q2w RA0056 CDP6038 (Olokizumab) 120 mg q4w RA0056 CDP6038 (Olokizumab) 240 mg q2w RA0056 CDP6038 (Olokizumab) 240 mg q4w RA0056 CDP6038 (Olokizumab) 60 mg q2w RA0056 CDP6038 (Olokizumab) 60 mg q4w RA0056 Placebo RA0056 Tocilizumab 8 mg/kg q4w
    Number of subjects analysed
    20
    20
    21
    20
    17
    16
    40
    36
    Units: Percentage of subjects
        number (not applicable)
    25.0
    45.0
    23.8
    25.0
    29.4
    18.8
    22.5
    47.2
    No statistical analyses for this end point

    Secondary: Percentage of subjects with DAS28(CRP) ≤3.2 at Week 96 of Study RA0057

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    End point title
    Percentage of subjects with DAS28(CRP) ≤3.2 at Week 96 of Study RA0057
    End point description
    DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, and CRP according to the formula: DAS28(CRP)=0.56 * (TJC)^1/2 + 0.28 * (SJC)^1/2 + 0.36 * ln(CRP[mg/L]+1) + 0.014 * PtGADA + 0.96 Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included the shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of the hands; and the knees. Scores on the DAS28(CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. A DAS28(CRP) score <=3.2 implies low disease activity. FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0057.
    End point type
    Secondary
    End point timeframe
    Week 96 (Study RA0057)
    End point values
    RA0056 CDP6038 (Olokizumab) 120 mg q2w RA0056 CDP6038 (Olokizumab) 120 mg q4w RA0056 CDP6038 (Olokizumab) 240 mg q2w RA0056 CDP6038 (Olokizumab) 240 mg q4w RA0056 CDP6038 (Olokizumab) 60 mg q2w RA0056 CDP6038 (Olokizumab) 60 mg q4w RA0056 Placebo RA0056 Tocilizumab 8 mg/kg q4w
    Number of subjects analysed
    20
    20
    21
    20
    17
    16
    40
    36
    Units: Percentage of subjects
        number (not applicable)
    15.0
    5.0
    9.5
    5.0
    11.8
    0
    2.5
    11.1
    No statistical analyses for this end point

    Secondary: Change from Baseline (Week 0 of Study RA0056) in the Clinical Disease Activity Index (CDAI) to Week 48 of Study RA0057

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    End point title
    Change from Baseline (Week 0 of Study RA0056) in the Clinical Disease Activity Index (CDAI) to Week 48 of Study RA0057
    End point description
    CDAI was calculated using the TJC (28 joints), SJC (28 joints), PtGADA-VAS and PhGADA-VAS, according to following formula: SJC + TJC + PtGADA + PhGADA Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 10 cm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • PhGADA: 10 cm VAS (0=very good, asymptomatic and no limitation of normal activities; 100=very poor, very severe symptoms which were intolerable and inability to carry out all normal activities). The 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and proximal PIP joints of hands; and knees. Total score range is from 0-100, with the high scores representing high disease activity. A negative change in CDAI score indicates an improvement in disease activity. Analysis population was FAS. When baseline and actual mean scores were not available, change from baseline was not calculated. Number of participants analyzed =participants who were evaluable for assessment.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0 of Study RA0056) and Week 48 (Study RA0057)
    End point values
    RA0056 CDP6038 (Olokizumab) 120 mg q2w RA0056 CDP6038 (Olokizumab) 120 mg q4w RA0056 CDP6038 (Olokizumab) 240 mg q2w RA0056 CDP6038 (Olokizumab) 240 mg q4w RA0056 CDP6038 (Olokizumab) 60 mg q2w RA0056 CDP6038 (Olokizumab) 60 mg q4w RA0056 Placebo RA0056 Tocilizumab 8 mg/kg q4w RA0056 CDP6038 (olokizumab) Combined
    Number of subjects analysed
    10
    13
    14
    10
    12
    10
    20
    23
    69
    Units: units on a scale
        arithmetic mean (standard deviation)
    -80.1000 ± 53.28425
    -65.3373 ± 63.72098
    -94.3335 ± 61.48562
    -80.8077 ± 57.91606
    -79.9231 ± 30.09849
    -84.8378 ± 33.77586
    -74.3315 ± 53.99274
    -83.4950 ± 42.48396
    -80.9650 ± 51.40554
    No statistical analyses for this end point

    Secondary: Change from Baseline (Week 0 of Study RA0056) in the CDAI to Week 96 of Study RA0057

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    End point title
    Change from Baseline (Week 0 of Study RA0056) in the CDAI to Week 96 of Study RA0057
    End point description
    CDAI was calculated using TJC (28 joints), SJC (28 joints), PtGADA-VAS and PhGADA-VAS, as per formula: SJC + TJC + PtGADA + PhGADA Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 10 cm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • PhGADA: 10 cm VAS (0=very good, asymptomatic and no limitation of normal activities; 100=very poor, very severe symptoms which were intolerable and inability to carry out all normal activities). 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and proximal PIP joints of hands; and knees. Total score range is from 0-100, high scores=high disease activity. A negative change in CDAI score indicates an improvement in disease activity. Analysis population was FAS. When baseline and actual mean scores were not available, change from baseline was not calculated. N=participants who were evaluable for assessment. 99999=S.D. could not be calculated as there was only 1 evaluable participant.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0 of Study RA0056) and Week 96 (Study RA0057)
    End point values
    RA0056 CDP6038 (Olokizumab) 120 mg q2w RA0056 CDP6038 (Olokizumab) 120 mg q4w RA0056 CDP6038 (Olokizumab) 240 mg q2w RA0056 CDP6038 (Olokizumab) 240 mg q4w RA0056 CDP6038 (Olokizumab) 60 mg q2w RA0056 CDP6038 (Olokizumab) 60 mg q4w RA0056 Placebo RA0056 Tocilizumab 8 mg/kg q4w RA0056 CDP6038 (olokizumab) Combined
    Number of subjects analysed
    3
    1
    3
    2
    3
    2
    2
    5
    14
    Units: units on a scale
        arithmetic mean (standard deviation)
    -108.0000 ± 66.77574
    -118.0000 ± 99999
    -89.0000 ± 55.97321
    -74.3846 ± 4.78657
    -74.0000 ± 55.74944
    -90.5000 ± 13.43503
    -104.5000 ± 126.57211
    -107.4000 ± 51.52960
    -90.0550 ± 3.51706
    No statistical analyses for this end point

    Secondary: Change from Baseline (Week 0 of Study RA0056) in the Simplified Disease Activity Index (SDAI) to Week 48 of Study RA0057

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    End point title
    Change from Baseline (Week 0 of Study RA0056) in the Simplified Disease Activity Index (SDAI) to Week 48 of Study RA0057
    End point description
    SDAI =TJC (28 joints), SJC (28 joints), PtGADA-VAS, PhGADA-VAS and CRP (in milligrams per decilitre [mg/dL]), as per the formula: SJC + TJC + PtGADA + PhGADA + CRP (mg/dL) Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 10 cm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • PhGADA: 10 cm VAS (0=very good, asymptomatic and no limitation of normal activities; 100=very poor, very severe symptoms which were intolerable and inability to carry out all normal activities). • CRP range was from 0 to 10 mg/dL. 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and proximal PIP joints of hands; and knees. SDAI score ranges from 0 to 86, higher scores=worse disease. A negative change in SDAI score indicates an improvement in disease activity. Analysis population was FAS. When baseline and actual mean scores were not available, change from baseline was not calculated. N=participants who were evaluable for the assessment.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0 of Study RA0056) and Week 48 (Study RA0057)
    End point values
    RA0056 CDP6038 (Olokizumab) 120 mg q2w RA0056 CDP6038 (Olokizumab) 120 mg q4w RA0056 CDP6038 (Olokizumab) 240 mg q2w RA0056 CDP6038 (Olokizumab) 240 mg q4w RA0056 CDP6038 (Olokizumab) 60 mg q2w RA0056 CDP6038 (Olokizumab) 60 mg q4w RA0056 Placebo RA0056 Tocilizumab 8 mg/kg q4w RA0056 CDP6038 (olokizumab) Combined
    Number of subjects analysed
    10
    13
    13
    10
    12
    10
    20
    23
    68
    Units: units on a scale
        arithmetic mean (standard deviation)
    -92.1000 ± 62.22799
    -75.8757 ± 74.37825
    -104.6668 ± 80.47988
    -92.4077 ± 55.42723
    -87.7564 ± 28.41084
    -112.5378 ± 52.99896
    -87.5815 ± 59.26016
    -107.4080 ± 60.17362
    -93.6851 ± 61.14304
    No statistical analyses for this end point

    Secondary: Change from Baseline (Week 0 of Study RA0056) in the SDAI to Week 96 of Study RA0057

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    End point title
    Change from Baseline (Week 0 of Study RA0056) in the SDAI to Week 96 of Study RA0057
    End point description
    SDAI was calculated using TJC (28 joints),SJC (28 joints), PtGADA-VAS, PhGADA-VAS and CRP (mg/dL), as per formula: SJC + TJC + PtGADA + PhGADA + CRP (mg/dL) Assessments:• TJC and SJC: assessed on same 2-point scale (0=absent; 1=present).• PtGADA: 10 cm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • PhGADA: 10 cm VAS (0=very good, asymptomatic and no limitation of normal activities; 100=very poor, very severe symptoms which were intolerable and inability to carry out all normal activities).• CRP range=0 to 10 mg/dL. 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and proximal PIP joints of hands; and knees. SDAI score range=0 to 86, higher scores=worse disease. A negative change in SDAI score=improvement in disease activity. Analysis population was FAS. When baseline and actual mean scores were not available, change from baseline was not calculated. N=participants evaluable for assessment. 99999=S.D. was not calculated due to 1 evaluable participant.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0 of Study RA0056) and Week 96 (Study RA0057)
    End point values
    RA0056 CDP6038 (Olokizumab) 120 mg q2w RA0056 CDP6038 (Olokizumab) 120 mg q4w RA0056 CDP6038 (Olokizumab) 240 mg q2w RA0056 CDP6038 (Olokizumab) 240 mg q4w RA0056 CDP6038 (Olokizumab) 60 mg q2w RA0056 CDP6038 (Olokizumab) 60 mg q4w RA0056 Placebo RA0056 Tocilizumab 8 mg/kg q4w RA0056 CDP6038 (olokizumab) Combined
    Number of subjects analysed
    3
    1
    3
    2
    3
    2
    2
    5
    14
    Units: units on a scale
        arithmetic mean (standard deviation)
    -111.0000 ± 68.78953
    -125.0000 ± 99999
    -90.3333 ± 56.04760
    -91.8846 ± 29.53531
    -75.3333 ± 56.09219
    -147.5000 ± 77.07464
    -128.0000 ± 147.07821
    -143.4000 ± 80.28574
    -102.4121 ± 52.99390
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Baseline (Week 0 of Study RA0057) until 30 days after the last dose (maximum up to 780 days)
    Adverse event reporting additional description
    Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0057 and within 30 days after the last dose.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    RA0056 CDP6038 (Olokizumab) 60 mg q2w
    Reporting group description
    CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.

    Reporting group title
    RA0056 CDP6038 (olokizumab) 60 mg q4w
    Reporting group description
    CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.

    Reporting group title
    RA0056 CDP6038 (olokizumab) 120 mg q2w
    Reporting group description
    CDP6038 (olokizumab) 120 mg administered q2w sc in Study RA0056, and maintained at same dose (i.e. 120 mg q2w sc) at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.

    Reporting group title
    RA0056 CDP6038 (olokizumab) 120 mg q4w
    Reporting group description
    CDP6038 (olokizumab) 120 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.

    Reporting group title
    RA0056 CDP6038 (olokizumab) 240 mg q2w
    Reporting group description
    CDP6038 (olokizumab) 240 mg administered q2w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056).

    Reporting group title
    RA0056 CDP6038 (olokizumab) 240 mg q4w
    Reporting group description
    CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.

    Reporting group title
    RA0056 Placebo
    Reporting group description
    Placebo (sodium chloride, 0.9%) was administered q2w or q4w sc in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.

    Reporting group title
    RA0056 Tocilizumab 8 mg/kg q4w
    Reporting group description
    Tocilizumab 8 mg/kg administered q4w iv in Study RA0056, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0057 (Week 12 of RA0056) for 48 weeks.

    Serious adverse events
    RA0056 CDP6038 (Olokizumab) 60 mg q2w RA0056 CDP6038 (olokizumab) 60 mg q4w RA0056 CDP6038 (olokizumab) 120 mg q2w RA0056 CDP6038 (olokizumab) 120 mg q4w RA0056 CDP6038 (olokizumab) 240 mg q2w RA0056 CDP6038 (olokizumab) 240 mg q4w RA0056 Placebo RA0056 Tocilizumab 8 mg/kg q4w
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 17 (29.41%)
    3 / 16 (18.75%)
    3 / 20 (15.00%)
    6 / 20 (30.00%)
    6 / 21 (28.57%)
    7 / 20 (35.00%)
    14 / 40 (35.00%)
    4 / 36 (11.11%)
         number of deaths (all causes)
    0
    1
    0
    0
    0
    0
    1
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    1
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Bladder cancer
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Basal cell carcinoma
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    B-cell lymphoma
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal cell carcinoma
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Basosquamous carcinoma
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Haematoma
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Femoral artery occlusion
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Cholecystectomy
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal fusion surgery
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    2 / 20 (10.00%)
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chest discomfort
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Unevaluable event
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Multi-organ failure
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary infarction
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Asthma
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
    1 / 20 (5.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Emphysema
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary fibrosis
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Laryngospasm
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression suicidal
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anxiety disorder
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Rib fracture
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Transient ischaemic attack
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastric perforation
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash maculo-papular
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal failure acute
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Endocrine disorders
    Goitre
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Cervical spinal stenosis
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthralgia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal pain
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal infection
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Localised infection
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gangrene
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
    1 / 20 (5.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetic foot infection
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Incision site cellulitis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Furuncle
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Necrotising fasciitis
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    RA0056 CDP6038 (Olokizumab) 60 mg q2w RA0056 CDP6038 (olokizumab) 60 mg q4w RA0056 CDP6038 (olokizumab) 120 mg q2w RA0056 CDP6038 (olokizumab) 120 mg q4w RA0056 CDP6038 (olokizumab) 240 mg q2w RA0056 CDP6038 (olokizumab) 240 mg q4w RA0056 Placebo RA0056 Tocilizumab 8 mg/kg q4w
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 17 (88.24%)
    15 / 16 (93.75%)
    16 / 20 (80.00%)
    20 / 20 (100.00%)
    18 / 21 (85.71%)
    17 / 20 (85.00%)
    36 / 40 (90.00%)
    35 / 36 (97.22%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Skin papilloma
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 16 (12.50%)
    3 / 20 (15.00%)
    1 / 20 (5.00%)
    3 / 21 (14.29%)
    0 / 20 (0.00%)
    2 / 40 (5.00%)
    5 / 36 (13.89%)
         occurrences all number
    0
    2
    4
    1
    3
    0
    2
    5
    Deep vein thrombosis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 16 (12.50%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    4 / 40 (10.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    2
    1
    0
    0
    1
    4
    2
    Injection site reaction
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 16 (0.00%)
    2 / 20 (10.00%)
    2 / 20 (10.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    6 / 40 (15.00%)
    8 / 36 (22.22%)
         occurrences all number
    2
    0
    2
    3
    0
    1
    8
    14
    Oedema peripheral
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    2 / 21 (9.52%)
    1 / 20 (5.00%)
    3 / 40 (7.50%)
    2 / 36 (5.56%)
         occurrences all number
    1
    0
    2
    0
    3
    1
    3
    3
    Injection site erythema
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 16 (6.25%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    2 / 40 (5.00%)
    2 / 36 (5.56%)
         occurrences all number
    9
    2
    0
    1
    0
    0
    4
    2
    Injection site bruising
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 16 (6.25%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    1
    1
    0
    0
    0
    1
    0
    2
    Injection site pain
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 16 (6.25%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    3 / 40 (7.50%)
    3 / 36 (8.33%)
         occurrences all number
    1
    16
    0
    0
    0
    11
    18
    21
    Injection site induration
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Injection site rash
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    1
    Vessel puncture site haematoma
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Injection site swelling
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    1
    Pyrexia
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 40 (2.50%)
    2 / 36 (5.56%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    2
    Pain
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    2
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    0 / 20 (0.00%)
    2 / 20 (10.00%)
    2 / 21 (9.52%)
    2 / 20 (10.00%)
    2 / 40 (5.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    0
    2
    2
    2
    2
    1
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    2 / 20 (10.00%)
    0 / 21 (0.00%)
    2 / 20 (10.00%)
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    0
    3
    0
    2
    2
    0
    Nasal congestion
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    2 / 20 (10.00%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    2 / 40 (5.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    2
    1
    0
    1
    2
    1
    Respiratory tract congestion
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
    1 / 20 (5.00%)
    1 / 40 (2.50%)
    2 / 36 (5.56%)
         occurrences all number
    0
    0
    3
    0
    1
    1
    1
    3
    Wheezing
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    0
    Cough
         subjects affected / exposed
    1 / 17 (5.88%)
    4 / 16 (25.00%)
    0 / 20 (0.00%)
    4 / 20 (20.00%)
    3 / 21 (14.29%)
    2 / 20 (10.00%)
    6 / 40 (15.00%)
    5 / 36 (13.89%)
         occurrences all number
    1
    6
    0
    6
    3
    2
    7
    8
    Rhinorrhoea
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 16 (6.25%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    1
    0
    1
    0
    0
    0
    0
    Dyspnoea
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    0
    0
    Haemoptysis
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    1
    0
    0
    2
    0
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    1 / 17 (5.88%)
    3 / 16 (18.75%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    1 / 40 (2.50%)
    1 / 36 (2.78%)
         occurrences all number
    1
    3
    0
    0
    0
    2
    1
    1
    Sinus congestion
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 40 (0.00%)
    3 / 36 (8.33%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    3
    Laryngeal mass
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Upper-airway cough syndrome
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    4 / 40 (10.00%)
    1 / 36 (2.78%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    4
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    2 / 40 (5.00%)
    1 / 36 (2.78%)
         occurrences all number
    1
    0
    0
    1
    1
    0
    5
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    2 / 40 (5.00%)
    1 / 36 (2.78%)
         occurrences all number
    2
    0
    0
    1
    1
    0
    5
    1
    Blood pressure increased
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    1 / 40 (2.50%)
    2 / 36 (5.56%)
         occurrences all number
    0
    3
    1
    0
    2
    0
    1
    8
    Lipids increased
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Blood cholesterol increased
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 16 (6.25%)
    0 / 20 (0.00%)
    2 / 20 (10.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    1
    1
    0
    2
    0
    1
    1
    0
    Liver function test abnormal
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    1 / 21 (4.76%)
    1 / 20 (5.00%)
    3 / 40 (7.50%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    0
    1
    1
    1
    3
    1
    Platelet count decreased
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    2 / 40 (5.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    4
    2
    Low density lipoprotein increased
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Blood pressure diastolic increased
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Blood pressure systolic increased
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    3 / 40 (7.50%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    5
    0
    Blood triglycerides increased
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 40 (2.50%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    1
    Haematocrit decreased
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 16 (12.50%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    2
    0
    Haemoglobin decreased
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    2 / 40 (5.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    3
    0
    Mammogram abnormal
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Red cell distribution width increased
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    3 / 20 (15.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    2 / 40 (5.00%)
    1 / 36 (2.78%)
         occurrences all number
    1
    0
    0
    3
    0
    0
    2
    2
    Contusion
         subjects affected / exposed
    2 / 17 (11.76%)
    1 / 16 (6.25%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    2 / 40 (5.00%)
    0 / 36 (0.00%)
         occurrences all number
    4
    1
    0
    1
    0
    1
    3
    0
    Limb injury
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 16 (6.25%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    1
    0
    1
    1
    0
    0
    0
    Muscle strain
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 40 (2.50%)
    2 / 36 (5.56%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    1
    3
    Excoriation
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    2 / 40 (5.00%)
    2 / 36 (5.56%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    2
    4
    Fall
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
    2 / 20 (10.00%)
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    2
    0
    0
    0
    1
    5
    0
    1
    Wound
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    2 / 21 (9.52%)
    0 / 20 (0.00%)
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    1
    0
    Cartilage injury
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Ligament sprain
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    Upper limb fracture
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Meniscus injury
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    1 / 20 (5.00%)
    6 / 20 (30.00%)
    1 / 21 (4.76%)
    1 / 20 (5.00%)
    1 / 40 (2.50%)
    4 / 36 (11.11%)
         occurrences all number
    2
    0
    5
    7
    2
    1
    1
    8
    Carpal tunnel syndrome
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    2 / 21 (9.52%)
    0 / 20 (0.00%)
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    2
    0
    Sciatica
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    1 / 40 (2.50%)
    1 / 36 (2.78%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    1
    1
    Hypoaesthesia
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    Tremor
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    1
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 16 (12.50%)
    1 / 20 (5.00%)
    1 / 20 (5.00%)
    2 / 21 (9.52%)
    0 / 20 (0.00%)
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    0
    6
    1
    2
    2
    0
    1
    0
    Leukopenia
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 16 (12.50%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    6
    0
    1
    1
    0
    0
    0
    Anaemia
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 16 (6.25%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    1
    Macrocytosis
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Monocytopenia
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    Vertigo
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    2 / 21 (9.52%)
    1 / 20 (5.00%)
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    0
    1
    0
    0
    3
    1
    1
    0
    Ear pain
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Eye disorders
    Eye pain
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Vision blurred
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    1
    0
    Conjunctivitis
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    2 / 20 (10.00%)
    1 / 20 (5.00%)
    3 / 21 (14.29%)
    1 / 20 (5.00%)
    7 / 40 (17.50%)
    4 / 36 (11.11%)
         occurrences all number
    1
    0
    2
    1
    4
    1
    8
    4
    Flatulence
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    2 / 20 (10.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    0
    Vomiting
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    1 / 20 (5.00%)
    3 / 20 (15.00%)
    3 / 21 (14.29%)
    1 / 20 (5.00%)
    3 / 40 (7.50%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    1
    3
    3
    1
    3
    4
    Constipation
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    2 / 20 (10.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    1 / 40 (2.50%)
    2 / 36 (5.56%)
         occurrences all number
    0
    0
    0
    2
    1
    0
    1
    2
    Haemorrhoids
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    2 / 20 (10.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    0
    Nausea
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    3 / 21 (14.29%)
    1 / 20 (5.00%)
    5 / 40 (12.50%)
    2 / 36 (5.56%)
         occurrences all number
    0
    1
    0
    2
    4
    5
    5
    2
    Abdominal pain
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    2 / 40 (5.00%)
    3 / 36 (8.33%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    2
    3
    Periodontal disease
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Hiatus hernia
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    2 / 20 (10.00%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    2
    0
    1
    0
    0
    0
    Rash
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 16 (6.25%)
    5 / 20 (25.00%)
    1 / 20 (5.00%)
    2 / 21 (9.52%)
    0 / 20 (0.00%)
    1 / 40 (2.50%)
    3 / 36 (8.33%)
         occurrences all number
    1
    1
    5
    1
    2
    0
    1
    5
    Ecchymosis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    2 / 20 (10.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    2
    0
    0
    0
    0
    Erythema
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    2
    Blister
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 16 (6.25%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    1
    1
    0
    0
    0
    1
    0
    1
    Skin ulcer
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    1
    0
    0
    0
    0
    2
    0
    1
    Onychomadesis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Rash erythematous
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    Dermatitis allergic
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Ingrowing nail
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    3 / 40 (7.50%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    3
    0
    Renal and urinary disorders
    Pyuria
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Nephrolithiasis
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 17 (17.65%)
    1 / 16 (6.25%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    2 / 21 (9.52%)
    3 / 20 (15.00%)
    5 / 40 (12.50%)
    6 / 36 (16.67%)
         occurrences all number
    3
    2
    6
    0
    2
    5
    5
    10
    Muscle spasms
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 16 (6.25%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    2 / 40 (5.00%)
    2 / 36 (5.56%)
         occurrences all number
    1
    1
    2
    0
    1
    0
    3
    3
    Musculoskeletal pain
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    1 / 20 (5.00%)
    1 / 20 (5.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    2 / 40 (5.00%)
    2 / 36 (5.56%)
         occurrences all number
    1
    0
    2
    2
    1
    0
    3
    3
    Pain in extremity
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    3 / 20 (15.00%)
    2 / 20 (10.00%)
    1 / 21 (4.76%)
    1 / 20 (5.00%)
    4 / 40 (10.00%)
    3 / 36 (8.33%)
         occurrences all number
    0
    0
    4
    2
    1
    1
    4
    5
    Rheumatoid arthritis
         subjects affected / exposed
    1 / 17 (5.88%)
    3 / 16 (18.75%)
    3 / 20 (15.00%)
    2 / 20 (10.00%)
    1 / 21 (4.76%)
    3 / 20 (15.00%)
    3 / 40 (7.50%)
    4 / 36 (11.11%)
         occurrences all number
    1
    3
    3
    3
    2
    3
    3
    5
    Back pain
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    5 / 20 (25.00%)
    2 / 21 (9.52%)
    2 / 20 (10.00%)
    7 / 40 (17.50%)
    4 / 36 (11.11%)
         occurrences all number
    0
    0
    0
    5
    2
    2
    7
    4
    Bursitis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    2 / 20 (10.00%)
    1 / 21 (4.76%)
    1 / 20 (5.00%)
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    1
    0
    0
    2
    1
    1
    0
    1
    Joint swelling
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    2 / 21 (9.52%)
    0 / 20 (0.00%)
    2 / 40 (5.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    0
    1
    2
    0
    2
    1
    Osteoarthritis
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 16 (6.25%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    2 / 40 (5.00%)
    1 / 36 (2.78%)
         occurrences all number
    1
    1
    0
    1
    0
    0
    2
    1
    Fibromyalgia
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    Neck pain
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 16 (12.50%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    2
    Sacroiliitis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Tendon calcification
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    Rheumatoid nodule
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 40 (2.50%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    1
    Spinal osteoarthritis
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    2
    Myalgia
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 40 (2.50%)
    2 / 36 (5.56%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    3
    Bone pain
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    2
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    2
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 17 (5.88%)
    3 / 16 (18.75%)
    1 / 20 (5.00%)
    2 / 20 (10.00%)
    3 / 21 (14.29%)
    3 / 20 (15.00%)
    5 / 40 (12.50%)
    3 / 36 (8.33%)
         occurrences all number
    1
    3
    1
    2
    3
    4
    7
    4
    Cellulitis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    1 / 20 (5.00%)
    2 / 20 (10.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    1 / 40 (2.50%)
    2 / 36 (5.56%)
         occurrences all number
    1
    0
    1
    4
    1
    0
    1
    3
    Ear infection
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    1 / 20 (5.00%)
    2 / 20 (10.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    2 / 40 (5.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    1
    2
    1
    0
    2
    1
    Herpes zoster
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
    1 / 20 (5.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    1
    0
    1
    1
    0
    0
    Influenza
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    3 / 40 (7.50%)
    2 / 36 (5.56%)
         occurrences all number
    1
    0
    1
    0
    1
    0
    3
    2
    Nasopharyngitis
         subjects affected / exposed
    2 / 17 (11.76%)
    2 / 16 (12.50%)
    1 / 20 (5.00%)
    6 / 20 (30.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    3 / 40 (7.50%)
    3 / 36 (8.33%)
         occurrences all number
    2
    2
    3
    10
    0
    1
    3
    5
    Oral herpes
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    1 / 20 (5.00%)
    1 / 20 (5.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    1 / 40 (2.50%)
    2 / 36 (5.56%)
         occurrences all number
    0
    0
    2
    3
    1
    0
    1
    2
    Otitis media
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 16 (12.50%)
    1 / 20 (5.00%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    0
    2
    1
    1
    0
    0
    1
    0
    Sinusitis
         subjects affected / exposed
    1 / 17 (5.88%)
    2 / 16 (12.50%)
    1 / 20 (5.00%)
    3 / 20 (15.00%)
    0 / 21 (0.00%)
    2 / 20 (10.00%)
    4 / 40 (10.00%)
    6 / 36 (16.67%)
         occurrences all number
    1
    3
    1
    3
    0
    2
    4
    7
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 17 (23.53%)
    3 / 16 (18.75%)
    3 / 20 (15.00%)
    3 / 20 (15.00%)
    9 / 21 (42.86%)
    2 / 20 (10.00%)
    7 / 40 (17.50%)
    5 / 36 (13.89%)
         occurrences all number
    6
    3
    3
    3
    12
    2
    10
    9
    Urinary tract infection
         subjects affected / exposed
    2 / 17 (11.76%)
    3 / 16 (18.75%)
    2 / 20 (10.00%)
    1 / 20 (5.00%)
    6 / 21 (28.57%)
    2 / 20 (10.00%)
    5 / 40 (12.50%)
    5 / 36 (13.89%)
         occurrences all number
    3
    5
    2
    3
    24
    2
    12
    11
    Gastroenteritis viral
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    2 / 21 (9.52%)
    0 / 20 (0.00%)
    2 / 40 (5.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    0
    1
    2
    0
    2
    3
    Pharyngitis
         subjects affected / exposed
    2 / 17 (11.76%)
    1 / 16 (6.25%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    2 / 40 (5.00%)
    1 / 36 (2.78%)
         occurrences all number
    2
    1
    0
    1
    0
    0
    2
    1
    Pneumonia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    2 / 20 (10.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    2 / 40 (5.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    2
    0
    0
    2
    0
    Fungal infection
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
    1 / 20 (5.00%)
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    0
    2
    1
    1
    0
    Skin infection
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    0
    Staphylococcal infection
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    1 / 40 (2.50%)
    2 / 36 (5.56%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    1
    3
    Respiratory tract infection
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    1
    Vaginitis bacterial
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    1
    0
    Staphylococcal abscess
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    Viral infection
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 40 (2.50%)
    2 / 36 (5.56%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    2
    Metabolism and nutrition disorders
    Hypercholesterolaemia
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 16 (12.50%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    3 / 40 (7.50%)
    1 / 36 (2.78%)
         occurrences all number
    0
    2
    1
    0
    0
    0
    3
    1
    Hyperlipidaemia
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    1 / 20 (5.00%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    3 / 40 (7.50%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    1
    3
    0
    Hypokalaemia
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    1
    0
    1
    0
    0
    1
    Hypoglycaemia
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
    2 / 20 (10.00%)
    0 / 40 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    2
    0
    0