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    Clinical Trial Results:
    A Phase II, Randomized, Multi-center, Parallel-group, Rater-blinded Study to Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mg and 20 mg Plovamer Acetate Doses Compared to Copaxone in Patients with Relapsing Remitting Multiple Sclerosis

    Due to the EudraCT – Results system being out of service between 31 July 2015 and 12 January 2016, these results have been published in compliance with revised timelines.
    Summary
    EudraCT number
    		 2013-002283-25
    Trial protocol
    		 CZ   HU   IT   GB   FI   GR   ES   BG   PL   HR  
    Global end of trial date
    03 Mar 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 Jul 2016
    First version publication date
    10 Jul 2016
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    EMR200575-001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01963611
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Merck KGaA
    Sponsor organisation address
    Frankfurter Strasse 250, Darmstadt, Germany, 64293
    Public contact
    Communication Center, Merck KGaA, +49 6151725200, service@merckgroup.com
    Scientific contact
    Communication Center, Merck KGaA, +49 6151725200, service@merckgroup.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
    03 Mar 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Mar 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    This was a Phase 2, randomized, rater-blinded, 5-arm, parallel-group trial that had 4 doses of plovamer acetate against the active comparator Copaxone in subjects with Relapsing Remitting Multiple Sclerosis (RRMS). The trial was conducted on an outpatient basis for minimum treatment duration of 40 weeks.
    Protection of trial subjects
    Subject protection was ensured by following high medical and ethical standards in accordance with the principles laid down in the Declaration of Helsinki, and that are consistent with Good Clinical Practice and applicable regulations.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Feb 2014
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 4 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    South Africa: 6
    Country: Number of subjects enrolled
    Spain: 3
    Country: Number of subjects enrolled
    Turkey: 1
    Country: Number of subjects enrolled
    Ukraine: 19
    Country: Number of subjects enrolled
    United States: 25
    Country: Number of subjects enrolled
    Bulgaria: 47
    Country: Number of subjects enrolled
    Croatia: 27
    Country: Number of subjects enrolled
    Czech Republic: 63
    Country: Number of subjects enrolled
    Hungary: 6
    Country: Number of subjects enrolled
    Italy: 8
    Country: Number of subjects enrolled
    Mexico: 1
    Country: Number of subjects enrolled
    Poland: 32
    Country: Number of subjects enrolled
    Serbia: 17
    Worldwide total number of subjects
    255
    EEA total number of subjects
    186
    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)
    255
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Of the 550 patients planned for enrollment, a total of 255 subjects were randomized and 254 were included in safety analysis set.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Plovamer acetate 0.5 milligram (mg)
    Arm description
    		 Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Plovamer acetate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Plovamer acetate was administered at a dose of 0.5 mg as subcutaneous injection.

    Arm title
    		 Plovamer acetate 3 mg
    Arm description
    		 Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Plovamer acetate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Plovamer acetate was administered at a dose of 3 mg as subcutaneous injection.

    Arm title
    		 Plovamer acetate 10 mg
    Arm description
    		 Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Plovamer acetate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Plovamer acetate was administered at a dose of 10 mg as subcutaneous injection.

    Arm title
    		 Plovamer acetate 20 mg
    Arm description
    		 Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Plovamer acetate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Plovamer acetate was administered as two subcutaneous injection of 10 mg.

    Arm title
    		 Copaxone 20 mg
    Arm description
    		 Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Copaxone 20 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Copaxone was administered at a dose of 20 mg as subcutaneous injection.

    Number of subjects in period 1 [1]
    		Plovamer acetate 0.5 milligram (mg) Plovamer acetate 3 mg Plovamer acetate 10 mg Plovamer acetate 20 mg Copaxone 20 mg
    Started
    51
    49
    52
    52
    50
    Safety Analysis Set
    51
    49
    52
    52
    50
    Completed
    0
    0
    0
    0
    0
    Not completed
    51
    49
    52
    52
    50
         Consent withdrawn by subject
    3
    2
    1
    1
    2
         Adverse event, non-fatal
    1
    1
    3
    4
    3
         Unspecified
    47
    46
    48
    45
    45
         Protocol deviation
    -
    -
    -
    1
    -
         Lack of efficacy
    -
    -
    -
    1
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: One subject in the Copaxone 20 mg arm was randomized but not treated due to withdrawal of consent.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Plovamer acetate 0.5 milligram (mg)
    Reporting group description
    		 Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.

    Reporting group title
    Plovamer acetate 3 mg
    Reporting group description
    		 Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.

    Reporting group title
    Plovamer acetate 10 mg
    Reporting group description
    		 Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.

    Reporting group title
    Plovamer acetate 20 mg
    Reporting group description
    		 Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.

    Reporting group title
    Copaxone 20 mg
    Reporting group description
    		 Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.

    Reporting group values
    		 Plovamer acetate 0.5 milligram (mg) Plovamer acetate 3 mg Plovamer acetate 10 mg Plovamer acetate 20 mg Copaxone 20 mg Total
    Number of subjects
    		 51 49 52 52 50 254
    Age categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 39.2 ( 10.73 ) 40.7 ( 9.54 ) 41.1 ( 10.83 ) 40.4 ( 9.53 ) 41.8 ( 11.61 ) -
    Gender, Male/Female
    Units: subjects
        Female
    		 38 37 39 37 26 177
        Male
    		 13 12 13 15 24 77

    End points

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    End points reporting groups
    Reporting group title
    Plovamer acetate 0.5 milligram (mg)
    Reporting group description
    		 Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.

    Reporting group title
    Plovamer acetate 3 mg
    Reporting group description
    		 Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.

    Reporting group title
    Plovamer acetate 10 mg
    Reporting group description
    		 Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.

    Reporting group title
    Plovamer acetate 20 mg
    Reporting group description
    		 Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.

    Reporting group title
    Copaxone 20 mg
    Reporting group description
    		 Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.

    Primary: Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions per Subject and Scan

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    End point title
    		 Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions per Subject and Scan [1]
    End point description
    Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions per Subject and Scan was calculated using 5 serial magnetic resonance imaging (MRI) scans. Intent to Treat (ITT) analysis set included all randomised subjects with at least 1 post-baseline efficacy (MRI) assessment. Here 'n' signifies those subjects who were evaluated for this measure at the specified time point for each arm group respectively and "99999" for standard deviation signifies data not reported as number of subject was 1 while for both arithmetic mean and standard deviation '99999' signifies data not applicable as there was no evaluable subject.
    End point type
    Primary
    End point timeframe
    Baseline , Week 12, 24, 28, 32, 36, 40
    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 the descriptive data was planned to be presented for the outcome measure.
    End point values
    		 Plovamer acetate 0.5 milligram (mg) Plovamer acetate 3 mg Plovamer acetate 10 mg Plovamer acetate 20 mg Copaxone 20 mg
    Number of subjects analysed
    45
    45
    43
    41
    44
    Units: lesions per subjects per scan
    arithmetic mean (standard deviation)
        Baseline (n=44,45,42,41,44)
    1.5 ( 2.93 )
    1.6 ( 4.12 )
    1 ( 2.43 )
    2.3 ( 5.65 )
    2.5 ( 5.12 )
        Week 12: (n=44,45,43,41,44)
    1.7 ( 3.28 )
    1.3 ( 3.55 )
    1.2 ( 2.4 )
    1.5 ( 3.7 )
    1.7 ( 4.51 )
        Week 24: (n=17,17,21,18,19)
    1.5 ( 2.53 )
    0.9 ( 2.33 )
    1.5 ( 4.14 )
    1.1 ( 1.92 )
    0.6 ( 1.46 )
        Week 28: (n=10,11,13,12,13)
    1.7 ( 2.75 )
    0.4 ( 0.92 )
    0.5 ( 1.2 )
    2 ( 4 )
    0.9 ( 1.89 )
        Week 32: (n=5,6,9,10,9)
    1 ( 1.41 )
    0.2 ( 0.41 )
    0.8 ( 1.72 )
    1.8 ( 3.33 )
    1.2 ( 3.67 )
        Week 36: (n=1,0,2,3,3)
    0 ( 99999 )
    99999 ( 99999 )
    1 ( 1.41 )
    1.3 ( 2.31 )
    7.3 ( 12.7 )
        Week 40: (n=1,0,1,1,1)
    0 ( 99999 )
    99999 ( 99999 )
    0 ( 99999 )
    0 ( 99999 )
    16 ( 99999 )
    No statistical analyses for this end point

    Secondary: Mean Annualized Relapse Rate (ARR)

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    End point title
    		 Mean Annualized Relapse Rate (ARR)
    End point description
    Relapse was defined as new, worsening or recurrent neurological symptoms attributed to multiple sclerosis that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days. These new or worsening symptoms should be noted by the patient and must be accompanied by at least one of the following: An increase of greater than or equal to (>=) 1 grade in >=2 functional scales of the Expanded Disability Status Scale (EDSS) or an increase of >=2 grades in 1 functional scale of the EDSS or an increase of >= 0.5 or an increase of >=1.0 in EDSS if the previous EDSS was 0. Annualized Relapse Rate was calculated as = 365.25 x (Number of relapses during Treatment Period) per (Number of days on treatment during Treatment Period). Safety Analysis Set (SAF) includes all randomised subjects who had received at least 1 dose of investigational medicinal product (IMP).
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 40
    End point values
    		 Plovamer acetate 0.5 milligram (mg) Plovamer acetate 3 mg Plovamer acetate 10 mg Plovamer acetate 20 mg Copaxone 20 mg
    Number of subjects analysed
    51
    49
    52
    52
    50
    Units: percent relapse
        arithmetic mean (standard deviation)
    0.3 ( 0.88 )
    0.2 ( 0.62 )
    0.2 ( 0.76 )
    0.2 ( 0.88 )
    0.2 ( 0.92 )
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Remaining Relapse-Free

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    End point title
    		 Percentage of Subjects Remaining Relapse-Free
    End point description
    Relapse was defined as new, worsening or recurrent neurological symptoms attributed to multiple sclerosis that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days. These new or worsening symptoms should be noted by the patient and must be accompanied by at least one of the following: An increase of greater than or equal to (>=) 1 grade in >=2 functional scales of the EDSS or an increase of >=2 grades in 1 functional scale of the EDSS or an increase of >= 0.5 or an increase of >=1.0 in EDSS if the previous EDSS was 0. SAF includes all randomized subjects who had received at least 1 dose of investigational medicinal product (IMP).
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 40
    End point values
    		 Plovamer acetate 0.5 milligram (mg) Plovamer acetate 3 mg Plovamer acetate 10 mg Plovamer acetate 20 mg Copaxone 20 mg
    Number of subjects analysed
    51
    49
    52
    52
    50
    Units: percent subjects
        number (not applicable)
    86.3
    89.8
    94.2
    94.2
    90
    No statistical analyses for this end point

    Secondary: Mean number of new T1 Gadolinium (Gd)-enhancing lesions per subject and scan

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    End point title
    		 Mean number of new T1 Gadolinium (Gd)-enhancing lesions per subject and scan
    End point description
    T1 Gd-enhancing lesions per subject and scan was measured using 5 serial MRI scans. ITT analysis set included all randomized subjects with at least 1 post-baseline efficacy (MRI) assessment. Here "n" signifies those subjects who were evaluated for this measure at the specified time point for each arm group respectively and "99999" for standard deviation signifies data not reported as number of subject was 1 while for both arithmetic mean and standard deviation '99999' signifies data not applicable as there was no evaluable subject.
    End point type
    Secondary
    End point timeframe
    Weeks 12, 24, 28, 32, 36, 40
    End point values
    		 Plovamer acetate 0.5 milligram (mg) Plovamer acetate 3 mg Plovamer acetate 10 mg Plovamer acetate 20 mg Copaxone 20 mg
    Number of subjects analysed
    45
    45
    43
    41
    44
    Units: lesions/subject/scan
    arithmetic mean (standard deviation)
        Week 12: (n=44,45,43,41,44)
    1.7 ( 3.26 )
    1.2 ( 3.54 )
    1.2 ( 2.26 )
    1.3 ( 2.99 )
    1.6 ( 4.31 )
        Week 24: (n=17,17,21,18,19)
    1.5 ( 2.53 )
    0.9 ( 2.33 )
    1.4 ( 3.56 )
    1 ( 1.94 )
    0.5 ( 1.26 )
        Week 28: (n=10,11,13,12,13)
    1.2 ( 2.15 )
    0.1 ( 0.3 )
    0.5 ( 1.13 )
    1.8 ( 3.83 )
    0.5 ( 1.33 )
        Week 32: (n=5,6,9,10,9)
    0.8 ( 1.1 )
    0.2 ( 0.41 )
    0.4 ( 1.33 )
    1.5 ( 2.95 )
    0.6 ( 1.67 )
        Week 36: (n=1,0,2,3,3)
    0 ( 99999 )
    99999 ( 99999 )
    0.5 ( 0.71 )
    1 ( 1.73 )
    5.7 ( 9.81 )
        Week 40: (n=1,0,1,1,1)
    0 ( 99999 )
    99999 ( 99999 )
    0 ( 99999 )
    0 ( 99999 )
    16 ( 99999 )
    No statistical analyses for this end point

    Secondary: Mean Number of New or Enlarging Time Constant 2 (T2) Lesions per Subject and Scan

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    End point title
    		 Mean Number of New or Enlarging Time Constant 2 (T2) Lesions per Subject and Scan
    End point description
    New or enlarging Time Constant 2 (T2) lesions per subject and scan was calculated using 5 serial MRI scans. ITT analysis set included all randomized subjects with at least 1 post-baseline efficacy (MRI) assessment. Here 'n' signifies those subjects who were evaluated for this measure at the specified time point for each arm group respectively and "99999" for standard deviation signifies data not reported as number of subject was 1 while for both arithmetic mean and standard deviation '99999' signifies data not applicable as there was no evaluable subject.
    End point type
    Secondary
    End point timeframe
    Weeks 12, 24, 28, 32, 36,40
    End point values
    		 Plovamer acetate 0.5 milligram (mg) Plovamer acetate 3 mg Plovamer acetate 10 mg Plovamer acetate 20 mg Copaxone 20 mg
    Number of subjects analysed
    45
    45
    43
    41
    44
    Units: lesions/subject/scan
    arithmetic mean (standard deviation)
        Week 12: (n=44,45,43,41,44)
    4.5 ( 7.41 )
    2.6 ( 4.99 )
    2.7 ( 4.5 )
    4.1 ( 7.45 )
    4 ( 8.59 )
        Week 24: (n=17,17,21,18,19)
    3.1 ( 5.61 )
    1.8 ( 3.35 )
    2.3 ( 4.91 )
    3.4 ( 6.03 )
    1.7 ( 3.45 )
        Week 28: (n=10,11,13,12,13)
    1.3 ( 2.45 )
    0.2 ( 0.4 )
    0.8 ( 1.69 )
    2.5 ( 5.05 )
    0.8 ( 2.15 )
        Week 32: (n=5,6,9,10,9)
    1.4 ( 2.19 )
    0.2 ( 0.41 )
    0.3 ( 0.71 )
    2.4 ( 4.12 )
    0.9 ( 2.32 )
        Week 36: (n=1,0,2,3,3)
    0 ( 99999 )
    99999 ( 99999 )
    0.5 ( 0.71 )
    1.7 ( 2.89 )
    4.3 ( 7.51 )
        Week 40: (n=1,0,1,1,1)
    0 ( 99999 )
    99999 ( 99999 )
    0 ( 99999 )
    0 ( 99999 )
    13 ( 99999 )
    No statistical analyses for this end point

    Secondary: Mean Number of New, Unenhancing T1 Lesions (Black Holes) per Subject and Scan

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    End point title
    		 Mean Number of New, Unenhancing T1 Lesions (Black Holes) per Subject and Scan
    End point description
    New, unenhancing T1 lesions (Black Holes) per subject and scan was calculated using 5 Serial MRIs. ITT analysis set included all randomized subjects with at least 1 post-baseline efficacy (MRI) assessment. Here 'n' signifies those subjects who were evaluated for this measure at the specified time point for each arm group respectively and "99999" for standard deviation signifies data not reported as number of subject was 1 while for both arithmetic mean and standard deviation '99999' signifies data not applicable as there was no evaluable subject.
    End point type
    Secondary
    End point timeframe
    Weeks 12, 24, 28, 32, 36, 40
    End point values
    		 Plovamer acetate 0.5 milligram (mg) Plovamer acetate 3 mg Plovamer acetate 10 mg Plovamer acetate 20 mg Copaxone 20 mg
    Number of subjects analysed
    45
    45
    43
    41
    44
    Units: lesions/subject/scan
    arithmetic mean (standard deviation)
        Week 12: (n=44,45,43,41,44)
    2.8 ( 6.48 )
    1.8 ( 3.97 )
    1.4 ( 2.21 )
    2.6 ( 5.24 )
    2.6 ( 5.13 )
        Week 24: (n=17,17,21,18,19)
    2 ( 4.8 )
    0.8 ( 1.55 )
    0.8 ( 1.83 )
    1.3 ( 2.89 )
    0.8 ( 1.75 )
        Week 28: (n=10,11,13,12,13)
    0.6 ( 1.26 )
    0.2 ( 0.6 )
    0.6 ( 1.56 )
    0.5 ( 1 )
    0.4 ( 1.39 )
        Week 32: (n=5,6,9,10,9)
    2 ( 3.39 )
    0.2 ( 0.41 )
    0.8 ( 1.3 )
    0.7 ( 1.25 )
    0.3 ( 0.71 )
        Week 36: (n=1,0,2,3,3)
    0 ( 99999 )
    99999 ( 99999 )
    0 ( 0 )
    0.7 ( 1.15 )
    1.7 ( 2.89 )
        Week 40: (n=1,0,1,1,1)
    0 ( 99999 )
    99999 ( 99999 )
    0 ( 99999 )
    0 ( 99999 )
    11 ( 99999 )
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in Volume of T1 Gadolinium (Gd)-Enhancing Lesions per Subject and Scan

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    End point title
    		 Mean Change From Baseline in Volume of T1 Gadolinium (Gd)-Enhancing Lesions per Subject and Scan
    End point description
    Change from baseline in volume of T1 Gd-enhancing lesions per subject was calculated using 5 Serial MRI Scans. ITT analysis set included all randomized subjects with at least 1 post-baseline efficacy (MRI) assessment. Here 'n' signifies those subjects who were evaluated for this measure at the specified time point for each arm group respectively and "99999" for standard deviation signifies data not reported as number of subject was 1 while for both arithmetic mean and standard deviation '99999' signifies data not applicable as there was no evaluable subject.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 12, 24, 28, 32, 36, 40
    End point values
    		 Plovamer acetate 0.5 milligram (mg) Plovamer acetate 3 mg Plovamer acetate 10 mg Plovamer acetate 20 mg Copaxone 20 mg
    Number of subjects analysed
    45
    45
    43
    41
    44
    Units: cubic millimeter (mm^3)
    arithmetic mean (standard deviation)
        Baseline: (n=44,45,42,41,44)
    0.182 ( 0.4212 )
    0.209 ( 0.6325 )
    0.138 ( 0.3577 )
    0.508 ( 1.1981 )
    0.264 ( 0.5707 )
        Change at Week 12: (n=44,45,42,41,44)
    0.037 ( 0.3982 )
    -0.007 ( 0.6019 )
    0.189 ( 0.8406 )
    -0.19 ( 1.0389 )
    0.023 ( 0.5794 )
        Change at Week 24: (n=16,17,20,18,19)
    0.053 ( 0.1705 )
    0.352 ( 1.4308 )
    0.06 ( 0.4858 )
    -0.591 ( 1.491 )
    -0.25 ( 0.5393 )
        Change at Week 28: (n=9,11,12,12,13)
    0.224 ( 0.2948 )
    0.067 ( 0.464 )
    0.057 ( 0.5728 )
    -0.796 ( 1.7779 )
    -0.257 ( 0.698 )
        Change at Week 32: (n=4,6,8,10,9)
    -0.085 ( 0.2765 )
    -0.102 ( 0.2691 )
    -0.135 ( 0.6305 )
    -0.988 ( 1.98 )
    0.031 ( 0.8312 )
        Change at Week 36: (n=0,0,1,3,3)
    99999 ( 99999 )
    99999 ( 99999 )
    0.321 ( 99999 )
    -1.881 ( 3.4679 )
    0.834 ( 2.1816 )
        Change at Week 40: (n=0,0,0,1,1)
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    0 ( 99999 )
    2.18 ( 99999 )
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in Volume of T2 Gadolinium (Gd)-Enhancing Lesions per Subject and Scan

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    End point title
    		 Mean Change From Baseline in Volume of T2 Gadolinium (Gd)-Enhancing Lesions per Subject and Scan
    End point description
    Change from baseline per subjects in volume of T2 Gd-enhancing lesions was calculated using 5 series MRI scan. ITT analysis set included all randomized subjects with at least 1 post-baseline efficacy (MRI) assessment. Here 'n' signifies those subjects who were evaluated for this measure at the specified time point for each arm group respectively and "99999" for standard deviation signifies data not reported as number of subject was 1 while for both arithmetic mean and standard deviation '99999' signifies data not applicable as there was no evaluable subject.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 12, 24, 28, 32, 36, 40
    End point values
    		 Plovamer acetate 0.5 milligram (mg) Plovamer acetate 3 mg Plovamer acetate 10 mg Plovamer acetate 20 mg Copaxone 20 mg
    Number of subjects analysed
    45
    45
    43
    41
    44
    Units: cubic millimeter (mm^3)
    arithmetic mean (standard deviation)
        Baseline (n=44,45,42,41,44)
    12.24 ( 14.6956 )
    13.482 ( 19.0522 )
    11.364 ( 16.0282 )
    9.518 ( 13.2248 )
    11.616 ( 15.496 )
        Change at Week 12: (n=44,45,42,41,44)
    0.443 ( 2.2414 )
    0.397 ( 1.0399 )
    0.686 ( 2.4894 )
    -0.2 ( 4.5312 )
    0.06 ( 1.3886 )
        Change at Week 24: (n=16,17,20,18,19)
    -0.179 ( 2.2741 )
    0.871 ( 2.7803 )
    0.113 ( 1.2011 )
    -1.734 ( 6.8085 )
    -0.907 ( 2.5627 )
        Change at Week 28: (n=9,11,12,12,13)
    0.016 ( 3.2248 )
    0.858 ( 3.0417 )
    0.306 ( 1.1945 )
    -2.61 ( 8.3108 )
    -1.379 ( 3.4251 )
        Change at Week 32: (n=4,6,8,10,9)
    0.874 ( 2.4859 )
    0.163 ( 1.2524 )
    -0.106 ( 1.3423 )
    -3.246 ( 9.3533 )
    -1.867 ( 3.6432 )
        Change at Week 36: (n=0,0,1,3,3)
    99999 ( 99999 )
    99999 ( 99999 )
    1.236 ( 99999 )
    -10.324 ( 17.2227 )
    -4.433 ( 4.6895 )
        Change at Week 40: (n=0,0,0,1,1)
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    -29.965 ( 99999 )
    -10.661 ( 99999 )
    No statistical analyses for this end point

    Secondary: Time to First Relapse

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    End point title
    		 Time to First Relapse
    End point description
    Relapse was defined as new, worsening or recurrent neurological symptoms attributed to multiple sclerosis that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days. These new or worsening symptoms should be noted by the patient and must be accompanied by at least one of the following: An increase of greater than or equal to (>=) 1 grade in >=2 functional scales of the Expanded Disability Status Scale (EDSS) or an increase of >=2 grades in 1 functional scale of the EDSS or an increase of >= 0.5 or an increase of >=1.0 in EDSS if the previous EDSS was 0.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 40
    End point values
    		 Plovamer acetate 0.5 milligram (mg) Plovamer acetate 3 mg Plovamer acetate 10 mg Plovamer acetate 20 mg Copaxone 20 mg
    Number of subjects analysed
    0 [2]
    0 [3]
    0 [4]
    0 [5]
    0 [6]
    Units: rate
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    ( )
    ( )
    Notes
    [2] - The Outcome Measure was not derived due to early termination of the study.
    [3] - The Outcome Measure was not derived due to early termination of the study.
    [4] - The Outcome Measure was not derived due to early termination of the study.
    [5] - The Outcome Measure was not derived due to early termination of the study.
    [6] - The Outcome Measure was not derived due to early termination of the study.
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in Brain Volume per Subject

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    End point title
    		 Mean Change From Baseline in Brain Volume per Subject
    End point description
    Change from baseline in brain volume per subject was calculated using 5 series MRI scan.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 24, 28, 32, 36, 40
    End point values
    		 Plovamer acetate 0.5 milligram (mg) Plovamer acetate 3 mg Plovamer acetate 10 mg Plovamer acetate 20 mg Copaxone 20 mg
    Number of subjects analysed
    0 [7]
    0 [8]
    0 [9]
    0 [10]
    0 [11]
    Units: cubic millimeter (mm^3)
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    ( )
    ( )
    Notes
    [7] - The Outcome Measure was not derived due to early termination of the study.
    [8] - The Outcome Measure was not derived due to early termination of the study.
    [9] - The Outcome Measure was not derived due to early termination of the study.
    [10] - The Outcome Measure was not derived due to early termination of the study.
    [11] - The Outcome Measure was not derived due to early termination of the study.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to end of treatment (week 40)
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Plovamer acetate 0.5 milligram (mg)
    Reporting group description
    		 Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.

    Reporting group title
    Plovamer acetate 3 mg
    Reporting group description
    		 Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.

    Reporting group title
    Plovamer acetate 10 mg
    Reporting group description
    		 Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.

    Reporting group title
    Plovamer acetate 20 mg
    Reporting group description
    		 Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.

    Reporting group title
    Copaxone 20 mg
    Reporting group description
    		 Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.

    Serious adverse events
    		 Plovamer acetate 0.5 milligram (mg) Plovamer acetate 3 mg Plovamer acetate 10 mg Plovamer acetate 20 mg Copaxone 20 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 51 (3.92%)
    0 / 49 (0.00%)
    2 / 52 (3.85%)
    3 / 52 (5.77%)
    0 / 50 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Alcohol poisoning
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    1 / 52 (1.92%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    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
    Vascular disorders
    Venous thrombosis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    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
    General disorders and administration site conditions
    Influenza like illness
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    1 / 52 (1.92%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    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
    Immune system disorders
    Drug hypersensitivity
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    1 / 52 (1.92%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    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
    Gastrointestinal disorders
    Constipation
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    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
    Pancreatitis acute
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    1 / 52 (1.92%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    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
    Psychiatric disorders
    Major depression
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    1 / 52 (1.92%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    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
    Suicidal ideation
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    1 / 52 (1.92%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    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
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    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
    Pyelonephritis
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    1 / 52 (1.92%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    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
    Urinary tract infection
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    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
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Plovamer acetate 0.5 milligram (mg) Plovamer acetate 3 mg Plovamer acetate 10 mg Plovamer acetate 20 mg Copaxone 20 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    28 / 51 (54.90%)
    34 / 49 (69.39%)
    38 / 52 (73.08%)
    41 / 52 (78.85%)
    42 / 50 (84.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Fibroadenoma of breast
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 49 (2.04%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Skin papilloma
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Vascular disorders
    Hypertension
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 49 (2.04%)
    0 / 52 (0.00%)
    1 / 52 (1.92%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    General disorders and administration site conditions
    Injection site pain
    alternative assessment type: Systematic
         subjects affected / exposed
    8 / 51 (15.69%)
    20 / 49 (40.82%)
    26 / 52 (50.00%)
    26 / 52 (50.00%)
    28 / 50 (56.00%)
         occurrences all number
    8
    20
    26
    26
    28
    Injection site erythema
    alternative assessment type: Systematic
         subjects affected / exposed
    10 / 51 (19.61%)
    16 / 49 (32.65%)
    14 / 52 (26.92%)
    19 / 52 (36.54%)
    18 / 50 (36.00%)
         occurrences all number
    10
    16
    14
    19
    18
    Injection site pruritus
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 51 (5.88%)
    6 / 49 (12.24%)
    10 / 52 (19.23%)
    4 / 52 (7.69%)
    15 / 50 (30.00%)
         occurrences all number
    3
    6
    10
    4
    15
    Injection site induration
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 51 (1.96%)
    2 / 49 (4.08%)
    5 / 52 (9.62%)
    6 / 52 (11.54%)
    4 / 50 (8.00%)
         occurrences all number
    1
    2
    5
    6
    4
    Injection site oedema
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 51 (1.96%)
    1 / 49 (2.04%)
    2 / 52 (3.85%)
    2 / 52 (3.85%)
    2 / 50 (4.00%)
         occurrences all number
    1
    1
    2
    2
    2
    Injection site bruising
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 51 (5.88%)
    1 / 49 (2.04%)
    0 / 52 (0.00%)
    1 / 52 (1.92%)
    3 / 50 (6.00%)
         occurrences all number
    3
    1
    0
    1
    3
    Influenza like illness
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 51 (1.96%)
    1 / 49 (2.04%)
    1 / 52 (1.92%)
    0 / 52 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    1
    1
    1
    0
    1
    Injection site haematoma
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    2 / 52 (3.85%)
    4 / 50 (8.00%)
         occurrences all number
    1
    0
    0
    2
    4
    Injection site laceration
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 49 (2.04%)
    1 / 52 (1.92%)
    1 / 52 (1.92%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    1
    1
    0
    Injection site nodule
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 49 (2.04%)
    2 / 52 (3.85%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    2
    0
    0
    Injection site rash
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 49 (0.00%)
    1 / 52 (1.92%)
    1 / 52 (1.92%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    1
    1
    0
    Pyrexia
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 49 (2.04%)
    0 / 52 (0.00%)
    2 / 52 (3.85%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    2
    0
    Asthenia
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 49 (2.04%)
    1 / 52 (1.92%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Chest discomfort
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 49 (2.04%)
    0 / 52 (0.00%)
    1 / 52 (1.92%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    Chills
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 49 (2.04%)
    1 / 52 (1.92%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Fatigue
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 51 (1.96%)
    1 / 49 (2.04%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    1
    1
    0
    0
    1
    Injection site haemorrhage
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    2 / 52 (3.85%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    Injection site paraesthesia
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 49 (0.00%)
    1 / 52 (1.92%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    Injection site swelling
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    1 / 52 (1.92%)
    1 / 52 (1.92%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    1
    1
    1
    Oedema peripheral
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 49 (2.04%)
    0 / 52 (0.00%)
    1 / 52 (1.92%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    Chest pain
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 49 (2.04%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Inflammation
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    1 / 52 (1.92%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Injection site cyst
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    1 / 52 (1.92%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Injection site mass
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    1 / 52 (1.92%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Peripheral swelling
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    1 / 52 (1.92%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Cyst
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Hyperthermia
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Injection site discolouration
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Injection site granuloma
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Pain
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Reproductive system and breast disorders
    Epididymal cyst
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    1 / 52 (1.92%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Erectile dysfunction
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    1 / 52 (1.92%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Benign prostatic hyperplasia
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Bronchospasm
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    1 / 52 (1.92%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Cough
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 49 (2.04%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Dysphonia
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Dyspnoea
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 49 (2.04%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Psychiatric disorders
    Depression
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 51 (1.96%)
    1 / 49 (2.04%)
    2 / 52 (3.85%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    1
    1
    2
    0
    0
    Depressive symptom
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    2 / 49 (4.08%)
    1 / 52 (1.92%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    2
    1
    0
    0
    Anxiety
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 51 (1.96%)
    1 / 49 (2.04%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    1
    1
    0
    0
    1
    Panic attack
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    2 / 49 (4.08%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Adjustment disorder
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    1 / 52 (1.92%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Affective disorder
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    1 / 52 (1.92%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Depressed mood
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    1 / 52 (1.92%)
    0 / 52 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    1
    0
    1
    Emotional disorder
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 49 (2.04%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Insomnia
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 49 (2.04%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Mood altered
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Nightmare
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 49 (2.04%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Investigations
    Alanine aminotransferase increased
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    2 / 52 (3.85%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    Gamma-glutamyltransferase increased
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    1 / 52 (1.92%)
    1 / 52 (1.92%)
    2 / 50 (4.00%)
         occurrences all number
    0
    0
    1
    1
    2
    Aspartate aminotransferase increased
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    1 / 52 (1.92%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Electrocardiogram PR shortened
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 49 (2.04%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Liver function test abnormal
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    1 / 52 (1.92%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Injury, poisoning and procedural complications
    Head injury
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Ligament sprain
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    1 / 52 (1.92%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Sunburn
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 49 (2.04%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Wound
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    1 / 52 (1.92%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Arthropod sting
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Cardiac disorders
    Hypertensive heart disease
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 49 (2.04%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Palpitations
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    1 / 52 (1.92%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Supraventricular tachycardia
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Nervous system disorders
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 51 (7.84%)
    0 / 49 (0.00%)
    1 / 52 (1.92%)
    4 / 52 (7.69%)
    0 / 50 (0.00%)
         occurrences all number
    4
    0
    1
    4
    0
    Dizziness
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 49 (2.04%)
    1 / 52 (1.92%)
    2 / 52 (3.85%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    1
    2
    1
    Carpal tunnel syndrome
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    1 / 52 (1.92%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Essential tremor
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    1 / 52 (1.92%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Muscle spasticity
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    1 / 52 (1.92%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Paraesthesia
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Radicular pain
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    1 / 52 (1.92%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Restless legs syndrome
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    1 / 52 (1.92%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Loss of consciousness
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Perineurial cyst
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Peripheral sensory neuropathy
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Blood and lymphatic system disorders
    Increased tendency to bruise
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 49 (2.04%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Ear and labyrinth disorders
    Tinnitus
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    1 / 52 (1.92%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Vertigo
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Eye disorders
    Eyelid skin dryness
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    1 / 52 (1.92%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Iritis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 49 (2.04%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Vision blurred
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Gastrointestinal disorders
    Nausea
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 51 (3.92%)
    0 / 49 (0.00%)
    2 / 52 (3.85%)
    2 / 52 (3.85%)
    2 / 50 (4.00%)
         occurrences all number
    2
    0
    2
    2
    2
    Constipation
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    1 / 52 (1.92%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Diarrhoea
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    2 / 49 (4.08%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Abdominal pain lower
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    1 / 52 (1.92%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Abdominal pain upper
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    1 / 52 (1.92%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Melanosis coli
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Abdominal rigidity
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Hepatobiliary disorders
    Cholecystitis acute
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    1 / 52 (1.92%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Cholelithiasis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    1 / 52 (1.92%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Hepatomegaly
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    1 / 52 (1.92%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Alopecia
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 49 (0.00%)
    1 / 52 (1.92%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    Acne
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Ecchymosis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    1 / 52 (1.92%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Erythema
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 49 (2.04%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Renal and urinary disorders
    Urinary hesitation
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    1 / 52 (1.92%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Urinary incontinence
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Back pain
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 51 (5.88%)
    0 / 49 (0.00%)
    1 / 52 (1.92%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    3
    0
    1
    0
    0
    Pain in extremity
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 49 (0.00%)
    1 / 52 (1.92%)
    1 / 52 (1.92%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    1
    1
    0
    Muscular weakness
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 49 (0.00%)
    1 / 52 (1.92%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    Neck pain
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 51 (1.96%)
    1 / 49 (2.04%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    Joint stiffness
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    1 / 52 (1.92%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Muscle spasms
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Myalgia
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Myokymia
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 49 (2.04%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Osteoarthritis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 49 (0.00%)
    1 / 52 (1.92%)
    6 / 52 (11.54%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    1
    6
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 49 (0.00%)
    1 / 52 (1.92%)
    3 / 52 (5.77%)
    4 / 50 (8.00%)
         occurrences all number
    1
    0
    1
    3
    4
    Urinary tract infection
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 51 (3.92%)
    0 / 49 (0.00%)
    1 / 52 (1.92%)
    0 / 52 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    2
    0
    1
    0
    1
    Bronchitis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 51 (1.96%)
    1 / 49 (2.04%)
    1 / 52 (1.92%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    Cystitis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 49 (2.04%)
    2 / 52 (3.85%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    2
    0
    0
    Gastroenteritis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    2 / 49 (4.08%)
    1 / 52 (1.92%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    2
    1
    0
    0
    Tonsillitis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    2 / 52 (3.85%)
    1 / 52 (1.92%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    2
    1
    0
    Conjunctivitis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 49 (2.04%)
    1 / 52 (1.92%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Erythema migrans
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    2 / 52 (3.85%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    Herpes simplex
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 49 (2.04%)
    1 / 52 (1.92%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Chronic tonsillitis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    1 / 52 (1.92%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Ear infection
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 49 (2.04%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    0
    0
    1
    Gastroenteritis viral
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 49 (2.04%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Herpes zoster
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Influenza
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    1 / 52 (1.92%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Laryngitis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    1 / 52 (1.92%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Pneumonia
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    1 / 52 (1.92%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Tracheitis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    1 / 52 (1.92%)
    0 / 52 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Urethritis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    1 / 52 (1.92%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Sinusitis
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Metabolism and nutrition disorders
    Hypertriglyceridaemia
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 49 (0.00%)
    0 / 52 (0.00%)
    0 / 52 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    29 Oct 2014
    In late 2014, Merck KGaA made the business decision to discontinue the clinical development program of its investigational plovamer acetate therapy for multiple sclerosis. This decision was not related to any new safety or efficacy findings. The study was discontinued before all patients could be enrolled; of the 550 patients planned for enrollment, a total of 255 patients were randomized and 254 were included in the safety analysis set.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Based on Sponsor decision to discontinue the clinical development program of plovamer acetate therapy for multiple sclerosis the trial was prematurely terminated.
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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