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    Clinical Trial Results:
    Study Exploring the Supportive effect of Acarbose in weight Management - SESAM: A 26-week, double-blind, randomized trial in participants with overweight or obesity investigating the added contribution of acarbose in EMP16 on efficacy, safety and tolerability

    Summary
    EudraCT number
    		 2022-003320-40
    Trial protocol
    		 SE  
    Global end of trial date
    13 Dec 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Feb 2025
    First version publication date
    01 Feb 2025
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    EP-003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05934110
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Empros Pharma AB
    Sponsor organisation address
    Nanna Svartz väg 4, Solna, Sweden, 17165
    Public contact
    Arvid Söderhäll, Empros Pharma AB, +46 070233363, arvid.soderhall@emprospharma.com
    Scientific contact
    Arvid Söderhäll, Empros Pharma AB, +46 070233363, arvid.soderhall@emprospharma.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
    13 Dec 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Dec 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Dec 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To confirm the added effect of acarbose in EMP16-120/40 on efficacy after a 26-week period of oral treatment compared with MR-O and Conv-O
    Protection of trial subjects
    Each potential study subject was given adequate verbal and written information before any study specific assessments were performed. The information included the objectives and the procedures of the study as well as any risks or inconvenience involved. It was emphasised that participation in the study was voluntary and that the subject could withdraw from participation at any time and for any reason, without any prejudice. All subjects were given the opportunity to ask questions about the study and were given sufficient time to consider participation before signing the ICF. Before performing any studyrelated procedures, the ICF was signed and personally dated by the subject and by the Investigator. A copy of the subject information including the signed ICF was provided to the subject. The ICF included information that data were to be recorded, collected and processed and could be transferred to European Economic Area (EEA) or non-EEA countries. In accordance with the EU general data protection regulation (GDPR), Regulation (EU) 2016/679, the data will not identify any persons taking part in the study. The subject had the right to request access to their personal data and to request rectification of any data that were not correct and/or complete, in accordance with the EU GDPR Regulation (EU) 2016/679.
    Background therapy
    		 N/A
    Evidence for comparator
    		 N/A
    Actual start date of recruitment
    18 Apr 2023
    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
    Sweden: 320
    Worldwide total number of subjects
    320
    EEA total number of subjects
    320
    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)
    309
    From 65 to 84 years
    11
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were recruited from CTC’s database of volunteers, as well as from strategic marketing campaigns. Advertisements in social media and other media (newspapers, internet, radio, local distribution of flyers etc.) could be used to reach the target audience. The advertisement texts were approved by the independent ethics committee (IEC).

    Pre-assignment
    Screening details
    		 Screening (Visit 1) took place within 35 days prior to the first dose. A total of 451 potential participants were screened, 320 were randomized and 277 completed the trial.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor
    Blinding implementation details
    This was a double-blind trial, and the allocation of treatments was not disclosed until clean file had been declared and the database had been locked. EMP16-120/40, EMP16-60/20, MR-O, Conv-O (Alli® and Xenical®), and placebo capsules were identical in appearance. Alli® and Xenical® were recoated to match the EMP16, MR-O and placebo capsules.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 EMP16-120/40
    Arm description
    		 Participants were randomized to treatment with EMP16 120 mg orlistat/40 mg acarbose (referred to as EMP16-120/40).
    Arm type
    		 Experimental

    Investigational medicinal product name
    EMP16
    Investigational medicinal product code
    Other name
    Orlistat and acarbose
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    EMP16 is a modified release, fixed dose combination, of orlistat and acarbose. Week 1 to 2: 60 mg orlistat/20 mg acarbose (1 capsule per day) Week 3 to 4: 60 mg orlistat/20 mg acarbose (1 capsule TID) Week 5 to 26: 60 mg O/20 mg A (2 capsules TID)

    Arm title
    		 MR orlistat
    Arm description
    		 Participants were randomized to treatment with 120 mg modified release orlistat.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MR-O (modified release orlistat)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    MR-O (120 mg orlistat) was the same as EMP16-120/40 but without the acarbose component in matching oral capsules. Week 1 to 2: 60 mg MR-O (1 capsule per day) Week 3 to 4: 60 mg MR-O (1 capsule TID) Week 5 to 26: 60 mg MR-O (2 capsules TID)

    Arm title
    		 Conventional orlistat
    Arm description
    		 Participants were randomized to treatment with 120 mg conventional orlistat.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Conv-O (Conventional orlistat)
    Investigational medicinal product code
    Other name
    Alli®, Xenical®
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Conv-O was Alli® 60 mg during week 1 to 4 and Xenical® 120 mg from week 5 and onwards in matching oral capsules. Week 1 to 2: 60 mg Conv-O (1 capsule per day) Week 3 to 4: 60 mg Conv-O (1 capsule TID) Week 5 to 26: 120 mg Conv-O plus placebo (1 capsule of each TID)

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo was inert material in a matching capsule. Week 5 to 26: Participants received 120 mg Conv-O plus placebo (1 capsule of each TID)

    Arm title
    		 EMP16-60/20
    Arm description
    		 Participants were randomized to treatment with EMP16 60 mg orlistat/20 mg acarbose (referred to as EMP16-60/20).
    Arm type
    		 Experimental

    Investigational medicinal product name
    EMP16-60/20
    Investigational medicinal product code
    Other name
    Orlistat and acarbose
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    EMP16 is a modified release, fixed dose combination, of orlistat and acarbose. . Week 1 to 2: 60 mg orlistat/20 mg acarbose (1 capsule per day) Week 3 to 4: 60 mg orlistat/20 mg acarbose (1 capsule TID) Week 5 to 26: 60 mg orlistat/20 mg acarbose plus placebo (1 capsule of each TID)

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo was inert material in a matching capsule. Week 5 to 26: Participants received 60 mg orlistat/20 mg acarbose plus placebo (1 capsule of each TID)

    Arm title
    		 Placebo
    Arm description
    		 Participants were randomized to treatment with placebo.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo was inert material in a matching capsule. Week 1 to 2: Placebo (1 capsule per day) Week 3 to 4: Placebo (1 capsule TID) Week 5 to 26: Placebo (2 capsules TID)

    Number of subjects in period 1
    		EMP16-120/40 MR orlistat Conventional orlistat EMP16-60/20 Placebo
    Started
    80
    80
    80
    40
    40
    Completed
    66
    69
    73
    36
    33
    Not completed
    14
    11
    7
    4
    7
         Consent withdrawn by subject
    11
    10
    5
    4
    4
         Physician decision
    -
    -
    1
    -
    1
         Pregnancy
    -
    -
    -
    -
    1
         Lost to follow-up
    3
    1
    1
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    EMP16-120/40
    Reporting group description
    		 Participants were randomized to treatment with EMP16 120 mg orlistat/40 mg acarbose (referred to as EMP16-120/40).

    Reporting group title
    MR orlistat
    Reporting group description
    		 Participants were randomized to treatment with 120 mg modified release orlistat.

    Reporting group title
    Conventional orlistat
    Reporting group description
    		 Participants were randomized to treatment with 120 mg conventional orlistat.

    Reporting group title
    EMP16-60/20
    Reporting group description
    		 Participants were randomized to treatment with EMP16 60 mg orlistat/20 mg acarbose (referred to as EMP16-60/20).

    Reporting group title
    Placebo
    Reporting group description
    		 Participants were randomized to treatment with placebo.

    Reporting group values
    		 EMP16-120/40 MR orlistat Conventional orlistat EMP16-60/20 Placebo Total
    Number of subjects
    		 80 80 80 40 40 320
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 44.9 ( 11.1 ) 46.0 ( 10.6 ) 46.1 ( 10.7 ) 46.0 ( 11.6 ) 46.9 ( 11.0 ) -
    Gender categorical
    Units: Subjects
        Female
    		 41 38 40 20 20 159
        Male
    		 39 42 40 20 20 161

    End points

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    End points reporting groups
    Reporting group title
    EMP16-120/40
    Reporting group description
    		 Participants were randomized to treatment with EMP16 120 mg orlistat/40 mg acarbose (referred to as EMP16-120/40).

    Reporting group title
    MR orlistat
    Reporting group description
    		 Participants were randomized to treatment with 120 mg modified release orlistat.

    Reporting group title
    Conventional orlistat
    Reporting group description
    		 Participants were randomized to treatment with 120 mg conventional orlistat.

    Reporting group title
    EMP16-60/20
    Reporting group description
    		 Participants were randomized to treatment with EMP16 60 mg orlistat/20 mg acarbose (referred to as EMP16-60/20).

    Reporting group title
    Placebo
    Reporting group description
    		 Participants were randomized to treatment with placebo.

    Primary: Relative (%) change from baseline in body weight at week 26

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    End point title
    		 Relative (%) change from baseline in body weight at week 26
    End point description
    Weight was measured in kg (one decimal) without shoes and without thick clothes such as jumpers. Weight at Visit 2 was compared with weight at Visit 1 prior to randomization, to ensure that the participant was not meeting exclusion criteria. The mean±SD relative change from baseline in body weight at week 26 was -7.73±6.03% for the EMP16-120/40 group as compared to -5.78±5.29% and -5.13±4.59% for the MR-O and Conv-O groups, respectively. The treatment effect of EMP16-120/40 was statistically significant compared to both MR-O (-2.37%) and Conv-O (-2.64%).
    End point type
    Primary
    End point timeframe
    Weight was measured at the screening visit and on week 0, 4, 10, 18 and 26.
    End point values
    		 EMP16-120/40 MR orlistat Conventional orlistat EMP16-60/20 Placebo
    Number of subjects analysed
    66
    69
    73
    36
    33
    Units: percent
    arithmetic mean (standard deviation)
        Relative change from baseline (%) at week 26
    7.73 ( 6.03 )
    5.78 ( 5.29 )
    5.13 ( 4.59 )
    5.12 ( 4.05 )
    3.94 ( 5.97 )
    Statistical analysis title
    		 Relative (%) change from baseline in body weight
    Statistical analysis description
    Relative (%) change from baseline in body weight at week 26, with EMP16-120/40 as compared to MR-O and Conv-O, respectively, was analyzed using mixed model repeated measures (MMRM).
    Comparison groups
    EMP16-120/40 v MR orlistat v Conventional orlistat v EMP16-60/20 v Placebo
    Number of subjects included in analysis
    277
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.0065 [1]
    Method
    		 Mixed models analysis
    Confidence interval
    Notes
    [1] - EMP16 120/40 mg compared to MR orlistat 120 mg: p-value 0.0065 EMP16 120/40 mg compared to Conventional orlistat 120 mg: 0

    Primary: Proportion of participants with ≥5% decrease in body weight at week 26

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    End point title
    		 Proportion of participants with ≥5% decrease in body weight at week 26 [2]
    End point description
    The proportion of participants with ≥5% decrease in body weight at week 26 was 61% for the EMP16-120/40 group as compared to 51% and 48% in the MR-O and Conv-O groups, respectively. The differences between the EMP16-120/40 group and the MR-O and Conv-O groups were, however, not statistically significant.
    End point type
    Primary
    End point timeframe
    Weight was measured at the screening visit and on week 0, 4, 10, 18 and 26.
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The proportion of participants with ≥5% decrease in body weight at week 26 was analyzed for the main treatment groups.
    End point values
    		 EMP16-120/40 MR orlistat Conventional orlistat
    Number of subjects analysed
    66
    69
    73
    Units: percent
    number (not applicable)
        Proportion of participants (%) at week 26
    61
    51
    48
    Statistical analysis title
    		 Proportion of participants (%)
    Statistical analysis description
    The proportion of participants with ≥5% decrease in body weight at week 26 was analyzed pairwise using chi-square tests (i.e., separate analyses per comparison) for difference in sample proportions. Descriptive statistics was used to address this endpoint.
    Comparison groups
    EMP16-120/40 v MR orlistat v Conventional orlistat
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.059 [3]
    Method
    		 Chi-squared
    Confidence interval
    Notes
    [3] - Pairwise chi-square test p-value for the proportional difference to EMP16: MR orlistat 120 mg: 0.0590 Conventional orlistat: 0.0862

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs (including serious AEs [SAEs]) were collected from the start of IMP administration until the end-of-trial visit at week 26.
    Adverse event reporting additional description
    The grading of the severity/intensity (grade 1 to grade 5) of AEs followed the common terminology criteria for AEs (CTCAE) v5.0. AEs were assessed as unlikely, possibly or probably related to the IMP. Fecal incontinence and/or oily spotting were documented as AEs of special interest (AESI) and the level of discomfort was rated by the participants.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    EMP16-120/40
    Reporting group description
    		 Participants were randomized to treatment with EMP16 120 mg orlistat/40 mg acarbose (referred to as EMP16-120/40). The participants followed a dose escalation schedule: - Week 1 to 2: 60 mg orlistat/20 mg acarbose (1 capsule per day) - Week 3 to 4: 60 mg orlistat/20 mg acarbose (1 capsule TID) - Week 5 to 26: 60 mg orlistat/20 mg acarbose (2 capsules TID)

    Reporting group title
    MR orlistat
    Reporting group description
    		 Participants were randomized to treatment with 120 mg orlistat. The participants followed a dose escalation schedule: - Week 1 to 2: 60 mg MR-O (1 capsule per day) - Week 3 to 4: 60 mg MR-O (1 capsule TID) - Week 5 to 26: 60 mg MR-O (2 capsules TID)

    Reporting group title
    Conventional orlistat
    Reporting group description
    		 Participants were randomized to treatment with 120 mg orlistat. The participants followed a dose escalation schedule: - Week 1 to 2: 60 mg Conv-O (1 capsule per day) - Week 3 to 4: 60 mg Conv-O (1 capsule TID) - Week 5 to 26: 120 mg Conv-O plus placebo (1 capsule of each TID)

    Reporting group title
    EMP16-60/20
    Reporting group description
    		 Participants were randomized to treatment with EMP16 60 mg orlistat/20 mg acarbose (referred to as EMP16-60/20). The participants followed a dose escalation schedule: - Week 1 to 2: 60 mg orlistat/20 mg acarbose (1 capsule per day) - Week 3 to 4: 60 mg orlistat/20 mg acarbose (1 capsule TID) - Week 5 to 26: 60 mg orlistat/20 mg acarbose plus placebo (1 capsule of each TID)

    Reporting group title
    Placebo
    Reporting group description
    		 Participants were randomized to treatment with placebo. The participants followed a dose escalation schedule: - Week 1 to 2: Placebo (1 capsule per day) - Week 3 to 4: Placebo (1 capsule TID) - Week 5 to 26: Placebo (2 capsules TID)

    Serious adverse events
    		 EMP16-120/40 MR orlistat Conventional orlistat EMP16-60/20 Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 EMP16-120/40 MR orlistat Conventional orlistat EMP16-60/20 Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    78 / 80 (97.50%)
    73 / 80 (91.25%)
    75 / 80 (93.75%)
    36 / 40 (90.00%)
    34 / 40 (85.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 80 (2.50%)
    0 / 80 (0.00%)
    3 / 80 (3.75%)
    2 / 40 (5.00%)
    4 / 40 (10.00%)
         occurrences all number
    3
    0
    3
    2
    4
    Hypotension
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Surgical and medical procedures
    Dental operation
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Eye operation
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Foot operation
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Hip surgery
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Knee operation
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Limb operation
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Nail operation
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Shoulder operation
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Tooth extraction
         subjects affected / exposed
    1 / 80 (1.25%)
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    1
    1
    0
    1
    0
    Wisdom teeth removal
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    General disorders and administration site conditions
    Cyst
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Exercise tolerance decreased
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Fatigue
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    3 / 80 (3.75%)
    1 / 40 (2.50%)
    3 / 40 (7.50%)
         occurrences all number
    1
    0
    3
    1
    3
    Feeling cold
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    0
    0
    0
    1
    Hunger
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Inflammation
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Malaise
         subjects affected / exposed
    0 / 80 (0.00%)
    2 / 80 (2.50%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Pyrexia
         subjects affected / exposed
    1 / 80 (1.25%)
    2 / 80 (2.50%)
    0 / 80 (0.00%)
    1 / 40 (2.50%)
    4 / 40 (10.00%)
         occurrences all number
    1
    2
    0
    1
    4
    Sensation of foreign body
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    0
    0
    0
    1
    Thirst
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Immunisation reaction
         subjects affected / exposed
    2 / 80 (2.50%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    Seasonal allergy
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Reproductive system and breast disorders
    dysmenorrhoea
         subjects affected / exposed
    1 / 80 (1.25%)
    3 / 80 (3.75%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    3
    1
    0
    0
    Heavy menstrual bleeding
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Intermenstrual bleeding
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    menstruation delayed
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Scrotal mass
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    dyspnoea
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Nasal congestion
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Oropharyngeal pain
         subjects affected / exposed
    2 / 80 (2.50%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    2
    0
    1
    0
    0
    Psychiatric disorders
    Acute stress disorder
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Anxiety
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    0
    0
    0
    1
    Depressed mood
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Depression
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    0
    1
    0
    1
    Insomnia
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Sleep disorder
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    Stress
         subjects affected / exposed
    0 / 80 (0.00%)
    2 / 80 (2.50%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    2 / 40 (5.00%)
         occurrences all number
    0
    2
    1
    0
    2
    Investigations
    alanin
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Blood glucose decreased
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    blood glucose increased
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Blood pressure increased
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Heart rate decreased
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    2 / 80 (2.50%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Injury, poisoning and procedural complications
    Animal bite
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    0
    0
    0
    1
    Ankle fracture
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    0
    0
    0
    1
    Arthropod sting
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Bite
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Carbon monoxide poisoning
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Fall
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    0
    0
    0
    1
    Fibula fracture
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Joint dislocation
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    0
    0
    0
    1
    Ligament sprain
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Limb injury
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    1 / 40 (2.50%)
    1 / 40 (2.50%)
         occurrences all number
    1
    0
    0
    1
    1
    Muscle strain
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    post-traumatic pain
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    1 / 40 (2.50%)
    1 / 40 (2.50%)
         occurrences all number
    0
    0
    0
    1
    1
    Road traffic accident
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    0
    0
    0
    1
    Cardiac disorders
    Chest discomfort
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    0
    0
    0
    1
    Palpitations
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    3 / 80 (3.75%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    3
    0
    1
    0
    0
    Headache
         subjects affected / exposed
    13 / 80 (16.25%)
    7 / 80 (8.75%)
    8 / 80 (10.00%)
    7 / 40 (17.50%)
    6 / 40 (15.00%)
         occurrences all number
    13
    8
    11
    9
    8
    Migraine
         subjects affected / exposed
    1 / 80 (1.25%)
    3 / 80 (3.75%)
    1 / 80 (1.25%)
    1 / 40 (2.50%)
    2 / 40 (5.00%)
         occurrences all number
    1
    4
    1
    1
    2
    Nerve compression
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Sciatica
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Somnolence
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Syncope
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Ear and labyrinth disorders
    Aural polyp
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    ear pain
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Motion sickness
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Vertigo
         subjects affected / exposed
    3 / 80 (3.75%)
    0 / 80 (0.00%)
    3 / 80 (3.75%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    3
    0
    3
    0
    0
    Eye disorders
    Dry eye
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    13 / 80 (16.25%)
    9 / 80 (11.25%)
    5 / 80 (6.25%)
    4 / 40 (10.00%)
    5 / 40 (12.50%)
         occurrences all number
    15
    9
    7
    4
    5
    Abdominal pain
         subjects affected / exposed
    5 / 80 (6.25%)
    6 / 80 (7.50%)
    5 / 80 (6.25%)
    5 / 40 (12.50%)
    2 / 40 (5.00%)
         occurrences all number
    7
    6
    5
    6
    3
    Abdominal pain upper
         subjects affected / exposed
    4 / 80 (5.00%)
    5 / 80 (6.25%)
    6 / 80 (7.50%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    7
    5
    6
    0
    1
    Abnormal faeces
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Anal incontinence
         subjects affected / exposed
    19 / 80 (23.75%)
    10 / 80 (12.50%)
    11 / 80 (13.75%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    22
    12
    11
    1
    0
    Breath odour
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Constipation
         subjects affected / exposed
    1 / 80 (1.25%)
    1 / 80 (1.25%)
    2 / 80 (2.50%)
    2 / 40 (5.00%)
    2 / 40 (5.00%)
         occurrences all number
    1
    1
    2
    2
    2
    defecation urgency
         subjects affected / exposed
    3 / 80 (3.75%)
    4 / 80 (5.00%)
    8 / 80 (10.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    3
    5
    11
    1
    0
    Diarrhoea
         subjects affected / exposed
    50 / 80 (62.50%)
    51 / 80 (63.75%)
    53 / 80 (66.25%)
    23 / 40 (57.50%)
    10 / 40 (25.00%)
         occurrences all number
    57
    67
    58
    24
    11
    Dry mouth
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    2 / 80 (2.50%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Dyspepsia
         subjects affected / exposed
    2 / 80 (2.50%)
    2 / 80 (2.50%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    3
    2
    1
    0
    1
    Eructation
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    feces discolored
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    feces hard
         subjects affected / exposed
    2 / 80 (2.50%)
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    2
    1
    0
    0
    1
    Flatulence
         subjects affected / exposed
    46 / 80 (57.50%)
    24 / 80 (30.00%)
    15 / 80 (18.75%)
    23 / 40 (57.50%)
    12 / 40 (30.00%)
         occurrences all number
    49
    24
    15
    24
    14
    Food poisoning
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Frequent bowel movements
         subjects affected / exposed
    1 / 80 (1.25%)
    1 / 80 (1.25%)
    1 / 80 (1.25%)
    1 / 40 (2.50%)
    1 / 40 (2.50%)
         occurrences all number
    1
    1
    1
    1
    1
    gastroesophageal reflux disease
         subjects affected / exposed
    2 / 80 (2.50%)
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0
    hematochezia
         subjects affected / exposed
    2 / 80 (2.50%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    hemorrhoids
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Nausea
         subjects affected / exposed
    4 / 80 (5.00%)
    1 / 80 (1.25%)
    5 / 80 (6.25%)
    1 / 40 (2.50%)
    1 / 40 (2.50%)
         occurrences all number
    4
    1
    5
    2
    1
    Proctalgia
         subjects affected / exposed
    0 / 80 (0.00%)
    2 / 80 (2.50%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    0
    2
    1
    0
    0
    Rectal discharge
         subjects affected / exposed
    33 / 80 (41.25%)
    22 / 80 (27.50%)
    25 / 80 (31.25%)
    10 / 40 (25.00%)
    2 / 40 (5.00%)
         occurrences all number
    38
    26
    29
    13
    2
    Steatorrhoea
         subjects affected / exposed
    15 / 80 (18.75%)
    4 / 80 (5.00%)
    10 / 80 (12.50%)
    4 / 40 (10.00%)
    0 / 40 (0.00%)
         occurrences all number
    15
    4
    10
    4
    0
    Toothache
         subjects affected / exposed
    3 / 80 (3.75%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    3
    0
    1
    1
    0
    Vomiting
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    1
    1
    0
    Hepatobiliary disorders
    biliary colic
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    0
    1
    0
    1
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    2 / 40 (5.00%)
         occurrences all number
    2
    0
    1
    0
    2
    Erythema
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Hyperhidrosis
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    Pruritus
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    2
    0
    1
    1
    0
    Rash
         subjects affected / exposed
    1 / 80 (1.25%)
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    Urticaria
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Renal and urinary disorders
    Calculus urinary
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    0
    0
    0
    1
    hematuria
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Micturition urgency
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    0
    0
    0
    2
    Pollakiuria
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    Renal colic
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    0
    0
    0
    1
    Endocrine disorders
    hyperglycemia
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    0
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 80 (2.50%)
    1 / 80 (1.25%)
    2 / 80 (2.50%)
    0 / 40 (0.00%)
    2 / 40 (5.00%)
         occurrences all number
    2
    1
    2
    0
    2
    Back pain
         subjects affected / exposed
    2 / 80 (2.50%)
    4 / 80 (5.00%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    5 / 40 (12.50%)
         occurrences all number
    2
    4
    1
    0
    5
    Bursitis
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    0
    0
    0
    1
    Coccydynia
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Muscle spasms
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    2 / 80 (2.50%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    0
    2
    0
    1
    Myalgia
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    2
    0
    1
    0
    0
    Osteoarthritis
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Pain in extremity
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    0
    1
    0
    1
    Plantar fasciitis
         subjects affected / exposed
    0 / 80 (0.00%)
    2 / 80 (2.50%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    0
    2
    1
    0
    0
    Rotator cuff syndrome
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Tendonitis
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Torticollis
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Infections and infestations
    Borrelia infection
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    2
    0
    0
    0
    1
    Bronchitis
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    COVID-19
         subjects affected / exposed
    0 / 80 (0.00%)
    4 / 80 (5.00%)
    1 / 80 (1.25%)
    2 / 40 (5.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    4
    1
    2
    1
    Conjunctivitis
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Diverticulitis
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Ear infection
         subjects affected / exposed
    0 / 80 (0.00%)
    2 / 80 (2.50%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    2
    0
    0
    1
    Gastroenteritis
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Gastroenteritis viral
         subjects affected / exposed
    2 / 80 (2.50%)
    0 / 80 (0.00%)
    3 / 80 (3.75%)
    0 / 40 (0.00%)
    2 / 40 (5.00%)
         occurrences all number
    2
    0
    3
    0
    2
    Hand-foot-and-mouth disease
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    Herpes zoster
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    1
    0
    0
    0
    1
    Influenza
         subjects affected / exposed
    3 / 80 (3.75%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    3
    0
    1
    0
    0
    Localised infection
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    0
    0
    0
    1
    Lyme disease
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    2 / 80 (2.50%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    2
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    23 / 80 (28.75%)
    32 / 80 (40.00%)
    26 / 80 (32.50%)
    16 / 40 (40.00%)
    12 / 40 (30.00%)
         occurrences all number
    25
    40
    31
    18
    18
    Oral herpes
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Otitis media
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Pneumonia
         subjects affected / exposed
    1 / 80 (1.25%)
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    Respiratory tract infection
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Respiratory tract infection viral
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Rhinitis
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Sinusitis
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Skin infection
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Tonsillitis
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    2 / 80 (2.50%)
    1 / 40 (2.50%)
    1 / 40 (2.50%)
         occurrences all number
    0
    0
    2
    1
    1
    Tooth infection
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 80 (1.25%)
    4 / 80 (5.00%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    4
    1
    0
    0
    Food craving
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Gout
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Hyperinsulinaemia
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Hyperlipidaemia
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Hypertriglyceridaemia
         subjects affected / exposed
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    2 / 80 (2.50%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    2
    0
    0
    Increased appetite
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Iron deficiency
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Type 2 diabetes mellitus
         subjects affected / exposed
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0

    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? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    N/A
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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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