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    Clinical Trial Results:
    A phase II, randomised, double-blind, parallel-group, placebo-controlled trial to assess the ongoing pregnancy rate with OXO-001 (200 mg, 300 mg) or placebo at 10 weeks following fresh single blastocyst transfer resulting from donor oocyte IVF/ICSI

    Summary
    EudraCT number
    		 2021-000001-25
    Trial protocol
    		 PL   ES   CZ  
    Global end of trial date
    31 Oct 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Nov 2024
    First version publication date
    28 Nov 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    OXO-001-201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05076032
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    OXOLIFE
    Sponsor organisation address
    C/ Riu de l’Or 12, Baixos 2a, Barcelona, Spain, 08034
    Public contact
    CEO, Oxolife S.L., +34 609771937, info@oxolife.com
    Scientific contact
    CEO, Oxolife S.L., +34 609771937, info@oxolife.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
    15 Nov 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Oct 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Assess the efficacy of oral OXO-001 (200 mg and 300 mg) versus placebo taken once-daily to increase the ongoing pregnancy rate (defined as the rate of intrauterine pregnancy with foetal heartbeat) at 10 weeks post embryo transfer (ET)
    Protection of trial subjects
    This study was conducted in full compliance with the protocol, adhering to the ethical principles outlined in the Declaration of Helsinki, the International Council for Harmonization (ICH) Harmonized Tripartite Guideline for Good Clinical Practice (GCP), the European Union Clinical Trial Directive, and all relevant local laws and regulations. Prior to the initiation of the study at any site, written approval of the protocol, Informed Consent Form (ICF), and all materials provided to potential participants were obtained ffrom Ethics Committee (IEC) and Competent Authorities (CA).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Sep 2021
    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
    Poland: 24
    Country: Number of subjects enrolled
    Spain: 241
    Country: Number of subjects enrolled
    Czechia: 114
    Worldwide total number of subjects
    379
    EEA total number of subjects
    379
    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)
    379
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 408 subjects were screened over a 9-month competitive recruitment period at 28 sites across three European countries: 15 sites in Spain, 9 in the Czech Republic, and 4 in Poland.

    Pre-assignment
    Screening details
    		 408 subjects were screened of which 379 were randomized. Out of this 379 randomized, 368 subjects received treatment and 307 underwent ET as ET eligibilty criteria. 305 subjects complete the trial as intended. One subject in OXO-001-200mg group underwent ET although ET eligibility criteria were not fulfilled and was excluded from the full analysis

    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, Data analyst
    Blinding implementation details
    All tablets (OXO-001 100 mg, OXO-001 150 mg and placebo) were identical in size, colour, taste and appearance. The packaging and labelling did not allow for any distinction between test and reference drug. No person involved in conducting the trial had access to the randomisation code before the blind was officially broken.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 OXO-001 200 mg
    Arm description
    		 Subjects randomised exposed to OXO-001-200 mg were included in this group.
    Arm type
    		 Experimental

    Investigational medicinal product name
    OXO-001
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Two tablets once daily early in the morning, Treatment started 26 to 62 days prior to ET and was continued for 5 weeks after ET

    Arm title
    		 OXO-001 300 mg
    Arm description
    		 Subjects randomised and exposed to OXO-001-300 mg were included in this group
    Arm type
    		 Experimental

    Investigational medicinal product name
    OXO-001
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Two tablets once daily early in the morning, Treatment started 26 to 62 days prior to ET and was continued for 5 weeks after ET

    Arm title
    		 Placebo
    Arm description
    		 Subjects randomised and exposed to placebo were included in this group
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Two tablets once daily early in the morning, Treatment started 26 to 62 days prior to ET and was continued for 5 weeks after ET

    Number of subjects in period 1
    		OXO-001 200 mg OXO-001 300 mg Placebo
    Started
    126
    126
    127
    Completed
    97
    106
    102
    Not completed
    29
    20
    25
         Consent withdrawn by subject
    6
    5
    3
         at sponsor request
    1
    -
    -
         Ineligibility/not fulfilling ET criteria
    8
    7
    6
         Adverse event, non-fatal
    4
    2
    5
         At the discretion of the investigator
    -
    -
    2
         Pregnancy
    3
    1
    1
         lost of follow up
    -
    -
    1
         other
    5
    5
    5
         Protocol deviation
    2
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    OXO-001 200 mg
    Reporting group description
    		 Subjects randomised exposed to OXO-001-200 mg were included in this group.

    Reporting group title
    OXO-001 300 mg
    Reporting group description
    		 Subjects randomised and exposed to OXO-001-300 mg were included in this group

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects randomised and exposed to placebo were included in this group

    Reporting group values
    		 OXO-001 200 mg OXO-001 300 mg Placebo Total
    Number of subjects
    		 126 126 127 379
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 126 126 127 379
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 39.5 ( 4.36 ) 39.7 ( 4.42 ) 40.7 ( 3.46 ) -
    Gender categorical
    Units: Subjects
        Female
    		 126 126 127 379
        Male
    		 0 0 0 0
    Subject analysis sets

    Subject analysis set title
    Modified Full Analysis set (m-FAS) analysis set
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The m-FAS analysis set was defined as all randomised and exposed subjects that fulfil elegibility ET criteria .

    Subject analysis set title
    Modified Full analysis set up to 40 years
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The m-FAS analysis up to 40 years set was defined as subjects up to 40 years randomised,exposed and that fulfil elegibility ET criteria .

    Subject analysis set title
    Safety analysis set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety analysis set was defined as all randomised and exposed subjects

    Subject analysis sets values
    		 Modified Full Analysis set (m-FAS) analysis set Modified Full analysis set up to 40 years Safety analysis set
    Number of subjects
    307
    145
    368
    Age categorical
    Units: Subjects
        In utero
    0
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
    0
        Newborns (0-27 days)
    0
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
    0
        Children (2-11 years)
    0
    0
    0
        Adolescents (12-17 years)
    0
    0
    0
        Adults (18-64 years)
    307
    145
    368
        From 65-84 years
    0
    0
    0
        85 years and over
    0
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    40 ( 4.10 )
    36.7 ( 3.72 )
    40.0 ( 4.13 )
    Gender categorical
    Units: Subjects
        Female
    307
    145
    368
        Male
    0
    0
    0

    End points

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    End points reporting groups
    Reporting group title
    OXO-001 200 mg
    Reporting group description
    		 Subjects randomised exposed to OXO-001-200 mg were included in this group.

    Reporting group title
    OXO-001 300 mg
    Reporting group description
    		 Subjects randomised and exposed to OXO-001-300 mg were included in this group

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects randomised and exposed to placebo were included in this group

    Subject analysis set title
    Modified Full Analysis set (m-FAS) analysis set
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The m-FAS analysis set was defined as all randomised and exposed subjects that fulfil elegibility ET criteria .

    Subject analysis set title
    Modified Full analysis set up to 40 years
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The m-FAS analysis up to 40 years set was defined as subjects up to 40 years randomised,exposed and that fulfil elegibility ET criteria .

    Subject analysis set title
    Safety analysis set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety analysis set was defined as all randomised and exposed subjects

    Primary: Ongoing pregnancy rate (OPR)

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    End point title
    		 Ongoing pregnancy rate (OPR)
    End point description
    Ongoing pregnancy rate was defined as confirmed intrauterine pregnancy with confirmed heartbeat 10 weeks post ET. Data are presented for the modified full analysis (m-FAS) set.
    End point type
    Primary
    End point timeframe
    10 weeks post Embrio Transfer (ET)
    End point values
    		 OXO-001 200 mg OXO-001 300 mg Placebo
    Number of subjects analysed
    97
    106
    104
    Units: percent
        number (not applicable)
    44.33
    47.17
    46.15
    Statistical analysis title
    		 Percentage OPR 10 weeks post -ET
    Statistical analysis description
    The analysis of the primary endpoint was performed using a logistic regression model with treatment group, age group (< 35, 35-37, 38-40, 41-42, ≥ 43), pooled site (Site 1 subgroup) and blastocyst quality (3, 4, 5-6) as factors, with a two-sided type I error of 0.05. The treatment effect was characterised by (adjusted) odds ratio of each dose group relative to placebo with associated two-sided 95% confidence intervals (CIs).
    Comparison groups
    OXO-001 200 mg v Placebo
    Number of subjects included in analysis
    201
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.54
         upper limit
    		 1.81
    Statistical analysis title
    		 Percentage OPR 10 weeks post -ET
    Statistical analysis description
    The analysis of the primary endpoint was performed using a logistic regression model with treatment group, age group (< 35, 35-37, 38-40, 41-42, ≥ 43), pooled site (Site 1 subgroup) and blastocyst quality (3, 4, 5-6) as factors, with a two-sided type I error of 0.05. The treatment effect was characterised by (adjusted) odds ratio of each dose group relative to placebo with associated two-sided 95% confidence intervals (CIs).
    Comparison groups
    OXO-001 300 mg v Placebo
    Number of subjects included in analysis
    210
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.54
         upper limit
    		 1.74

    Primary: OPR women up to 40 years

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    End point title
    		 OPR women up to 40 years
    End point description
    Confirmed intrauterine pregnancy with confirmed heartbeat 10 weeks post ET for women up to 4o years
    End point type
    Primary
    End point timeframe
    10 weeks post Embrio Transfer (ET)
    End point values
    		 OXO-001 200 mg OXO-001 300 mg Placebo
    Number of subjects analysed
    49
    54
    42
    Units: percent
        number (not applicable)
    44.90
    46.30
    35.71
    Statistical analysis title
    		 Percentage OPR 10 weeks post -ET
    Statistical analysis description
    Ongoing Pregnancy Rate (OPR) 10 weeks post ET (m-FAS )
    Comparison groups
    Placebo v OXO-001 200 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.44
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 3.5
    Statistical analysis title
    		 Percentage OPR 10 weeks post -ET
    Statistical analysis description
    Ongoing Pregnancy Rate (OPR) 10 weeks post ET (m-FAS )
    Comparison groups
    Placebo v OXO-001 300 mg
    Number of subjects included in analysis
    96
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.38
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.58
         upper limit
    		 3.32

    Secondary: Biochemical Pergnancy Rate (BPR)

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    End point title
    		 Biochemical Pergnancy Rate (BPR)
    End point description
    Positive blood pregnancy test 10 to 15 days post ET (m-FAS)
    End point type
    Secondary
    End point timeframe
    10 to 15 days post ET
    End point values
    		 OXO-001 200 mg OXO-001 300 mg Placebo
    Number of subjects analysed
    97
    106
    104
    Units: percent
        number (not applicable)
    65.98
    72.64
    61.54
    Statistical analysis title
    		 Percentage BPR 10 to 15 days post ET
    Statistical analysis description
    Percentage of women with positive blood pregnancy test 10 to 15 days post ET (m-FAS)
    Comparison groups
    OXO-001 200 mg v Placebo
    Number of subjects included in analysis
    201
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.42
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.76
         upper limit
    		 2.65
    Statistical analysis title
    		 Percentage BPR 10 to 15 days post ET
    Statistical analysis description
    Percentage of women with positive blood pregnancy test 10 to 15 days post ET (m-FAS)
    Comparison groups
    Placebo v OXO-001 300 mg
    Number of subjects included in analysis
    210
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.63
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.87
         upper limit
    		 3.04

    Secondary: CLinical Pregnancy rate (CPR)

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    End point title
    		 CLinical Pregnancy rate (CPR)
    End point description
    Percentage of women with clinical pregnancy (defined as pregnancy withfoetal heartbeat) at 6 weeks post ET (m-FAS)
    End point type
    Secondary
    End point timeframe
    6 weeks post ET
    End point values
    		 OXO-001 200 mg OXO-001 300 mg Placebo
    Number of subjects analysed
    97
    106
    104
    Units: percent
        number (not applicable)
    49.48
    50.94
    46.15
    Statistical analysis title
    		 Percentage CPR 6 weeks post -ET
    Statistical analysis description
    Percentage of women with clinical pregnancy (defined as pregnancy withfoetal heartbeat) at 6 weeks post ET (m-FAS)
    Comparison groups
    OXO-001 200 mg v Placebo
    Number of subjects included in analysis
    201
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7
         upper limit
    		 2.38
    Statistical analysis title
    		 Percentage CPR 6 weeks post -ET
    Statistical analysis description
    Percentage of women with clinical pregnancy (defined as pregnancy withfoetal heartbeat) at 6 weeks post ET (m-FAS)
    Comparison groups
    Placebo v OXO-001 300 mg
    Number of subjects included in analysis
    210
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.63
         upper limit
    		 2.07

    Secondary: BIochemical pregnancy rate women up to 40 years .

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    End point title
    		 BIochemical pregnancy rate women up to 40 years .
    End point description
    Positive blood pregnancy test 10 to 15 days post ET women up to 40 years
    End point type
    Secondary
    End point timeframe
    10 to 15 days post ET
    End point values
    		 OXO-001 200 mg OXO-001 300 mg Placebo
    Number of subjects analysed
    49
    54
    42
    Units: percent
        number (not applicable)
    67.35
    75.93
    52.38
    Statistical analysis title
    		 Percentage BQR 10 to 15 days post ET
    Statistical analysis description
    Percentage of women with positive blood pregnancy test 10 to 15 days post ET
    Comparison groups
    OXO-001 200 mg v Placebo
    Number of subjects included in analysis
    91
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.83
         upper limit
    		 5.2
    Statistical analysis title
    		 Percentage BQR 10 to 15 days post ET
    Statistical analysis description
    Percentage of women with positive blood pregnancy test 10 to 15 days post ET
    Comparison groups
    Placebo v OXO-001 300 mg
    Number of subjects included in analysis
    96
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 = 0.022
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.17
         upper limit
    		 7.85

    Secondary: CPR women up to 40 years

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    End point title
    		 CPR women up to 40 years
    End point description
    Percentage of women with clinical pregnancy (defined as pregnancy withfoetal heartbeat) at 6 weeks post ET.
    End point type
    Secondary
    End point timeframe
    6 weeks post Embrio Transfer (ET)
    End point values
    		 OXO-001 200 mg OXO-001 300 mg Placebo
    Number of subjects analysed
    49
    54
    42
    Units: percent
        number (not applicable)
    46.94
    50.00
    35.71
    Statistical analysis title
    		 Percentage CPR 6 weeks post -ET
    Statistical analysis description
    Percentage of women with clinical pregnancy (defined as pregnancy withfoetal heartbeat) at 6 weeks post ET.
    Comparison groups
    Placebo v OXO-001 200 mg
    Number of subjects included in analysis
    91
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.56
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.64
         upper limit
    		 3.79
    Statistical analysis title
    		 Percentage CPR 6 weeks post -ET
    Statistical analysis description
    Percentage of women with clinical pregnancy (defined as pregnancy withfoetal heartbeat) at 6 weeks post ET.
    Comparison groups
    Placebo v OXO-001 300 mg
    Number of subjects included in analysis
    96
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.62
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.68
         upper limit
    		 3.88

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The period of observation for the collection of AEs extends from the time when the subject gives informed consent until 10 weeks post ET
    Adverse event reporting additional description
    In addition, the following AEs and SAEs should be reported after completion of Visit 8: - AEs which could affect foetal outcome or AEs suspected related to IP, - SAEs related to pregnancy, - Any congenital anomalies or SAEs experienced by the foetus (until birth), neonate (from birth up to 28 days) or infant (until 6 months after birth)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24
    Reporting groups
    Reporting group title
    OXO-001 200 mg
    Reporting group description
    		 Subjects randomised exposed to OXO-001-200 mg were included in this group.

    Reporting group title
    OXO-001 300 mg
    Reporting group description
    		 Subjects randomised and exposed to OXO-001-300 mg were included in this group

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects randomised and exposed to placebo were included in this group

    Serious adverse events
    		 OXO-001 200 mg OXO-001 300 mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 121 (7.44%)
    9 / 125 (7.20%)
    8 / 122 (6.56%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Brain neoplasm benign
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 125 (0.80%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    0 / 121 (0.00%)
    0 / 125 (0.00%)
    1 / 122 (0.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Atrial septal defect
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 125 (0.80%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Beckwith-Wiedemann syndrome
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 125 (0.80%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Congenital hydrocephalus
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 125 (0.00%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Congenital inguinal hernia
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 125 (0.80%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Congenital naevus
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 125 (0.00%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Congenital torticollis
         subjects affected / exposed
    0 / 121 (0.00%)
    0 / 125 (0.00%)
    1 / 122 (0.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Craniofacial deformity
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 125 (0.80%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Developmental hip dysplasia
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 125 (0.00%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Duodenal atresia
         subjects affected / exposed
    0 / 121 (0.00%)
    0 / 125 (0.00%)
    1 / 122 (0.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dysmorphism
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 125 (0.80%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infantile genetic agranulocytosis
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 125 (0.00%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Klinefelter's syndrome
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 125 (0.80%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Patent ductus arteriosus
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 125 (0.80%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Syndactyly
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 125 (0.80%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Abortion induced
         subjects affected / exposed
    0 / 121 (0.00%)
    2 / 125 (1.60%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Pre-eclampsia
         subjects affected / exposed
    3 / 121 (2.48%)
    2 / 125 (1.60%)
    3 / 122 (2.46%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abortion spontaneous
         subjects affected / exposed
    0 / 121 (0.00%)
    0 / 125 (0.00%)
    2 / 122 (1.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Premature baby
         subjects affected / exposed
    2 / 121 (1.65%)
    0 / 125 (0.00%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    abnormal cord insertion
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 125 (0.80%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ectopic pregnancy
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 125 (0.00%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Foetal growth restriction
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 125 (0.80%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pregnancy of unknown location
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 125 (0.00%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Placental transfusion syndrome
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 125 (0.80%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Hypoacusis
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 125 (0.00%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Intestinal obstruction
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 125 (0.00%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Neonatal respiratory depression
         subjects affected / exposed
    0 / 121 (0.00%)
    0 / 125 (0.00%)
    1 / 122 (0.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Adrenal haemorrhage
         subjects affected / exposed
    0 / 121 (0.00%)
    0 / 125 (0.00%)
    1 / 122 (0.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchiolitis
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 125 (0.80%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 125 (0.00%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal sepsis
         subjects affected / exposed
    0 / 121 (0.00%)
    0 / 125 (0.00%)
    1 / 122 (0.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 OXO-001 200 mg OXO-001 300 mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    71 / 121 (58.68%)
    78 / 125 (62.40%)
    62 / 122 (50.82%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Benign breast neoplasm
         subjects affected / exposed
    0 / 121 (0.00%)
    0 / 125 (0.00%)
    1 / 122 (0.82%)
         occurrences all number
    0
    0
    1
    Vascular disorders
    Hot flush
         subjects affected / exposed
    0 / 121 (0.00%)
    0 / 125 (0.00%)
    1 / 122 (0.82%)
         occurrences all number
    0
    0
    1
    Hypertension
         subjects affected / exposed
    0 / 121 (0.00%)
    0 / 125 (0.00%)
    1 / 122 (0.82%)
         occurrences all number
    0
    0
    1
    Phlebitis
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 125 (0.80%)
    0 / 122 (0.00%)
         occurrences all number
    0
    1
    0
    Thrombosis
         subjects affected / exposed
    0 / 121 (0.00%)
    0 / 125 (0.00%)
    1 / 122 (0.82%)
         occurrences all number
    0
    0
    1
    Surgical and medical procedures
    Abortion induced
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 125 (0.80%)
    0 / 122 (0.00%)
         occurrences all number
    0
    1
    0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    9 / 121 (7.44%)
    14 / 125 (11.20%)
    12 / 122 (9.84%)
         occurrences all number
    9
    14
    12
    Abortion missed
         subjects affected / exposed
    4 / 121 (3.31%)
    3 / 125 (2.40%)
    4 / 122 (3.28%)
         occurrences all number
    4
    3
    4
    Subchorionic haematoma
         subjects affected / exposed
    2 / 121 (1.65%)
    2 / 125 (1.60%)
    3 / 122 (2.46%)
         occurrences all number
    2
    2
    3
    Biochemical pregnancy
         subjects affected / exposed
    3 / 121 (2.48%)
    1 / 125 (0.80%)
    1 / 122 (0.82%)
         occurrences all number
    3
    1
    1
    Gestational diabetes
         subjects affected / exposed
    1 / 121 (0.83%)
    3 / 125 (2.40%)
    1 / 122 (0.82%)
         occurrences all number
    1
    3
    1
    Haemorrage in pregnancy
         subjects affected / exposed
    2 / 121 (1.65%)
    2 / 125 (1.60%)
    0 / 122 (0.00%)
         occurrences all number
    4
    2
    0
    Abortion threatened
         subjects affected / exposed
    1 / 121 (0.83%)
    2 / 125 (1.60%)
    0 / 122 (0.00%)
         occurrences all number
    2
    2
    0
    Gestational hypertension
         subjects affected / exposed
    0 / 121 (0.00%)
    0 / 125 (0.00%)
    3 / 122 (2.46%)
         occurrences all number
    0
    0
    3
    Anembryonic gestation
         subjects affected / exposed
    1 / 121 (0.83%)
    1 / 125 (0.80%)
    0 / 122 (0.00%)
         occurrences all number
    1
    1
    0
    Morning sickness
         subjects affected / exposed
    2 / 121 (1.65%)
    0 / 125 (0.00%)
    0 / 122 (0.00%)
         occurrences all number
    2
    0
    0
    Abortion spontaneous incomplete
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 125 (0.00%)
    0 / 122 (0.00%)
         occurrences all number
    1
    0
    0
    Foetal hypokinesia
         subjects affected / exposed
    0 / 121 (0.00%)
    0 / 125 (0.00%)
    1 / 122 (0.82%)
         occurrences all number
    0
    0
    1
    Jaundice neonatal
         subjects affected / exposed
    0 / 121 (0.00%)
    0 / 125 (0.00%)
    1 / 122 (0.82%)
         occurrences all number
    0
    0
    1
    Placenta accreta
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 125 (0.80%)
    0 / 122 (0.00%)
         occurrences all number
    0
    1
    0
    Uterine atony
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 125 (0.80%)
    0 / 122 (0.00%)
         occurrences all number
    0
    1
    0
    Vanishing twin syndrome
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 125 (0.80%)
    0 / 122 (0.00%)
         occurrences all number
    0
    1
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    2 / 121 (1.65%)
    0 / 125 (0.00%)
    1 / 122 (0.82%)
         occurrences all number
    2
    0
    1
    Fatigue
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 125 (0.00%)
    1 / 122 (0.82%)
         occurrences all number
    1
    0
    1
    Illness
         subjects affected / exposed
    2 / 121 (1.65%)
    0 / 125 (0.00%)
    0 / 122 (0.00%)
         occurrences all number
    2
    0
    0
    Chest discomfort
         subjects affected / exposed
    0 / 121 (0.00%)
    0 / 125 (0.00%)
    1 / 122 (0.82%)
         occurrences all number
    0
    0
    1
    Chest pain
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 125 (0.80%)
    0 / 122 (0.00%)
         occurrences all number
    0
    1
    0
    Chills
         subjects affected / exposed
    0 / 121 (0.00%)
    0 / 125 (0.00%)
    1 / 122 (0.82%)
         occurrences all number
    0
    0
    1
    Pain
         subjects affected / exposed
    0 / 121 (0.00%)
    0 / 125 (0.00%)
    1 / 122 (0.82%)
         occurrences all number
    0
    0
    1
    Pyrexia
         subjects affected / exposed
    0 / 121 (0.00%)
    0 / 125 (0.00%)
    1 / 122 (0.82%)
         occurrences all number
    0
    0
    1
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 125 (0.00%)
    1 / 122 (0.82%)
         occurrences all number
    1
    0
    1
    Drug hypersensitivity
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 125 (0.80%)
    0 / 122 (0.00%)
         occurrences all number
    0
    1
    0
    Reproductive system and breast disorders
    Vaginal haemorrhage
         subjects affected / exposed
    12 / 121 (9.92%)
    11 / 125 (8.80%)
    13 / 122 (10.66%)
         occurrences all number
    15
    16
    16
    Dysmenorrhoea
         subjects affected / exposed
    2 / 121 (1.65%)
    4 / 125 (3.20%)
    1 / 122 (0.82%)
         occurrences all number
    2
    4
    1
    Ovarian cyst
         subjects affected / exposed
    0 / 121 (0.00%)
    3 / 125 (2.40%)
    1 / 122 (0.82%)
         occurrences all number
    0
    3
    1
    Pelvic pain
         subjects affected / exposed
    1 / 121 (0.83%)
    2 / 125 (1.60%)
    1 / 122 (0.82%)
         occurrences all number
    1
    2
    1
    Intermenstrual bleeding
         subjects affected / exposed
    1 / 121 (0.83%)
    1 / 125 (0.80%)
    0 / 122 (0.00%)
         occurrences all number
    1
    2
    0
    Uterine haemorrhage
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 125 (0.00%)
    1 / 122 (0.82%)
         occurrences all number
    1
    0
    1
    Uterine polyp
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 125 (0.00%)
    1 / 122 (0.82%)
         occurrences all number
    1
    0
    1
    Vulvovaginal pruritus
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 125 (0.80%)
    1 / 122 (0.82%)
         occurrences all number
    0
    1
    1
    Adenomyosis
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 125 (0.00%)
    0 / 122 (0.00%)
         occurrences all number
    1
    0
    0
    Adnexa uteri pain
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 125 (0.00%)
    0 / 122 (0.00%)
         occurrences all number
    1
    0
    0
    Breast discomfort
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 125 (0.80%)
    0 / 122 (0.00%)
         occurrences all number
    0
    1
    0
    Breast pain
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 125 (0.00%)
    0 / 122 (0.00%)
         occurrences all number
    1
    0
    0
    Cervical dysplasia
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 125 (0.00%)
    0 / 122 (0.00%)
         occurrences all number
    1
    0
    0
    Endometrial disorder
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 125 (0.80%)
    0 / 122 (0.00%)
         occurrences all number
    0
    1
    0
    Hydrometra
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 125 (0.00%)
    0 / 122 (0.00%)
         occurrences all number
    1
    0
    0
    Ovarian oedema
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 125 (0.80%)
    0 / 122 (0.00%)
         occurrences all number
    0
    1
    0
    Pruritus genital
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 125 (0.80%)
    0 / 122 (0.00%)
         occurrences all number
    0
    1
    0
    Uterine haematoma
         subjects affected / exposed
    0 / 121 (0.00%)
    0 / 125 (0.00%)
    1 / 122 (0.82%)
         occurrences all number
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 121 (0.83%)
    1 / 125 (0.80%)
    0 / 122 (0.00%)
         occurrences all number
    2
    1
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 121 (0.00%)
    0 / 125 (0.00%)
    2 / 122 (1.64%)
         occurrences all number
    0
    0
    2
    Dyspnoea
         subjects affected / exposed
    0 / 121 (0.00%)
    0 / 125 (0.00%)
    1 / 122 (0.82%)
         occurrences all number
    0
    0
    1
    Nasal congestion
         subjects affected / exposed
    0 / 121 (0.00%)
    0 / 125 (0.00%)
    1 / 122 (0.82%)
         occurrences all number
    0
    0
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 125 (0.00%)
    0 / 122 (0.00%)
         occurrences all number
    1
    0
    0
    Insomnia
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 125 (0.80%)
    0 / 122 (0.00%)
         occurrences all number
    0
    1
    0
    Nervousness
         subjects affected / exposed
    0 / 121 (0.00%)
    0 / 125 (0.00%)
    1 / 122 (0.82%)
         occurrences all number
    0
    0
    1
    Stress
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 125 (0.80%)
    0 / 122 (0.00%)
         occurrences all number
    0
    1
    0
    Investigations
    SARS-CoV-2 test positive
         subjects affected / exposed
    5 / 121 (4.13%)
    2 / 125 (1.60%)
    1 / 122 (0.82%)
         occurrences all number
    5
    2
    1
    Blood triglycerides increased
         subjects affected / exposed
    1 / 121 (0.83%)
    3 / 125 (2.40%)
    2 / 122 (1.64%)
         occurrences all number
    1
    3
    2
    Vitamin D decreased
         subjects affected / exposed
    0 / 121 (0.00%)
    2 / 125 (1.60%)
    0 / 122 (0.00%)
         occurrences all number
    0
    2
    0
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 121 (0.00%)
    0 / 125 (0.00%)
    1 / 122 (0.82%)
         occurrences all number
    0
    0
    1
    Amniotic fluid volume increased
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 125 (0.80%)
    0 / 122 (0.00%)
         occurrences all number
    0
    1
    0
    Blood pressure systolic increased
         subjects affected / exposed
    0 / 121 (0.00%)
    0 / 125 (0.00%)
    1 / 122 (0.82%)
         occurrences all number
    0
    0
    1
    Liver function test increased
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 125 (0.00%)
    0 / 122 (0.00%)
         occurrences all number
    1
    0
    0
    lymphocyte morpholgy abnormal
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 125 (0.00%)
    0 / 122 (0.00%)
         occurrences all number
    1
    0
    0
    Injury, poisoning and procedural complications
    Post vaccination syndrome
         subjects affected / exposed
    2 / 121 (1.65%)
    0 / 125 (0.00%)
    0 / 122 (0.00%)
         occurrences all number
    2
    0
    0
    Ear injury
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 125 (0.00%)
    0 / 122 (0.00%)
         occurrences all number
    1
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    17 / 121 (14.05%)
    19 / 125 (15.20%)
    12 / 122 (9.84%)
         occurrences all number
    27
    25
    16
    Dizziness
         subjects affected / exposed
    1 / 121 (0.83%)
    3 / 125 (2.40%)
    4 / 122 (3.28%)
         occurrences all number
    1
    3
    7
    Somnolence
         subjects affected / exposed
    1 / 121 (0.83%)
    1 / 125 (0.80%)
    1 / 122 (0.82%)
         occurrences all number
    2
    1
    1
    Migraine
         subjects affected / exposed
    2 / 121 (1.65%)
    0 / 125 (0.00%)
    0 / 122 (0.00%)
         occurrences all number
    2
    0
    0
    Sciatica
         subjects affected / exposed
    0 / 121 (0.00%)
    0 / 125 (0.00%)
    1 / 122 (0.82%)
         occurrences all number
    0
    0
    1
    Syncope
         subjects affected / exposed
    0 / 121 (0.00%)
    0 / 125 (0.00%)
    1 / 122 (0.82%)
         occurrences all number
    0
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 121 (0.00%)
    0 / 125 (0.00%)
    1 / 122 (0.82%)
         occurrences all number
    0
    0
    1
    Eye disorders
    Eye inflammation
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 125 (0.00%)
    0 / 122 (0.00%)
         occurrences all number
    1
    0
    0
    Strabismus
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 125 (0.00%)
    0 / 122 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    9 / 121 (7.44%)
    11 / 125 (8.80%)
    11 / 122 (9.02%)
         occurrences all number
    9
    11
    11
    Vomiting
         subjects affected / exposed
    4 / 121 (3.31%)
    5 / 125 (4.00%)
    4 / 122 (3.28%)
         occurrences all number
    5
    6
    4
    Diarrhoea
         subjects affected / exposed
    1 / 121 (0.83%)
    6 / 125 (4.80%)
    1 / 122 (0.82%)
         occurrences all number
    1
    7
    1
    Dyspepsia
         subjects affected / exposed
    0 / 121 (0.00%)
    2 / 125 (1.60%)
    1 / 122 (0.82%)
         occurrences all number
    0
    2
    1
    Abdominal pain
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 125 (0.80%)
    1 / 122 (0.82%)
         occurrences all number
    0
    1
    1
    Abdominal pain lower
         subjects affected / exposed
    1 / 121 (0.83%)
    1 / 125 (0.80%)
    0 / 122 (0.00%)
         occurrences all number
    1
    1
    0
    Constipation
         subjects affected / exposed
    1 / 121 (0.83%)
    1 / 125 (0.80%)
    0 / 122 (0.00%)
         occurrences all number
    1
    1
    0
    Flatulence
         subjects affected / exposed
    1 / 121 (0.83%)
    1 / 125 (0.80%)
    0 / 122 (0.00%)
         occurrences all number
    1
    1
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 121 (0.83%)
    1 / 125 (0.80%)
    0 / 122 (0.00%)
         occurrences all number
    1
    1
    0
    Abdominal discomfort
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 125 (0.00%)
    0 / 122 (0.00%)
         occurrences all number
    1
    0
    0
    Abdominal distension
         subjects affected / exposed
    0 / 121 (0.00%)
    0 / 125 (0.00%)
    1 / 122 (0.82%)
         occurrences all number
    0
    0
    1
    Abdominal pain upper
         subjects affected / exposed
    0 / 121 (0.00%)
    0 / 125 (0.00%)
    1 / 122 (0.82%)
         occurrences all number
    0
    0
    1
    Epigastric discomfort
         subjects affected / exposed
    0 / 121 (0.00%)
    0 / 125 (0.00%)
    1 / 122 (0.82%)
         occurrences all number
    0
    0
    1
    Gastritis
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 125 (0.80%)
    0 / 122 (0.00%)
         occurrences all number
    0
    1
    0
    Haemorrhoids
         subjects affected / exposed
    0 / 121 (0.00%)
    0 / 125 (0.00%)
    1 / 122 (0.82%)
         occurrences all number
    0
    0
    1
    Rectal haemorrhage
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 125 (0.00%)
    0 / 122 (0.00%)
         occurrences all number
    1
    0
    0
    toothache
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 125 (0.00%)
    0 / 122 (0.00%)
         occurrences all number
    1
    0
    0
    Hepatobiliary disorders
    Cholestasis
         subjects affected / exposed
    0 / 121 (0.00%)
    0 / 125 (0.00%)
    1 / 122 (0.82%)
         occurrences all number
    0
    0
    1
    Hepatic mass
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 125 (0.80%)
    0 / 122 (0.00%)
         occurrences all number
    0
    1
    0
    Hyperbilirubinaemia
         subjects affected / exposed
    0 / 121 (0.00%)
    0 / 125 (0.00%)
    1 / 122 (0.82%)
         occurrences all number
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    2 / 121 (1.65%)
    0 / 125 (0.00%)
    0 / 122 (0.00%)
         occurrences all number
    2
    0
    0
    Rash erythematous
         subjects affected / exposed
    0 / 121 (0.00%)
    2 / 125 (1.60%)
    0 / 122 (0.00%)
         occurrences all number
    0
    2
    0
    Chloasma
         subjects affected / exposed
    0 / 121 (0.00%)
    0 / 125 (0.00%)
    1 / 122 (0.82%)
         occurrences all number
    0
    0
    1
    Dry skin
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 125 (0.00%)
    0 / 122 (0.00%)
         occurrences all number
    1
    0
    0
    Eczema
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 125 (0.00%)
    0 / 122 (0.00%)
         occurrences all number
    1
    0
    0
    Pruritus
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 125 (0.00%)
    0 / 122 (0.00%)
         occurrences all number
    1
    0
    0
    Rash pruritic
         subjects affected / exposed
    0 / 121 (0.00%)
    0 / 125 (0.00%)
    1 / 122 (0.82%)
         occurrences all number
    0
    0
    1
    Urticaria
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 125 (0.80%)
    0 / 122 (0.00%)
         occurrences all number
    0
    1
    0
    Renal and urinary disorders
    Renal colic
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 125 (0.00%)
    1 / 122 (0.82%)
         occurrences all number
    1
    0
    1
    Oliguria
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 125 (0.00%)
    0 / 122 (0.00%)
         occurrences all number
    1
    0
    0
    Polyuria
         subjects affected / exposed
    0 / 121 (0.00%)
    0 / 125 (0.00%)
    1 / 122 (0.82%)
         occurrences all number
    0
    0
    1
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 125 (0.80%)
    0 / 122 (0.00%)
         occurrences all number
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 125 (0.80%)
    0 / 122 (0.00%)
         occurrences all number
    0
    1
    0
    Back pain
         subjects affected / exposed
    0 / 121 (0.00%)
    0 / 125 (0.00%)
    1 / 122 (0.82%)
         occurrences all number
    0
    0
    1
    Flank pain
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 125 (0.00%)
    0 / 122 (0.00%)
         occurrences all number
    1
    0
    0
    Myalgia
         subjects affected / exposed
    0 / 121 (0.00%)
    0 / 125 (0.00%)
    1 / 122 (0.82%)
         occurrences all number
    0
    0
    1
    Neck pain
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 125 (0.00%)
    0 / 122 (0.00%)
         occurrences all number
    3
    0
    0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    11 / 121 (9.09%)
    8 / 125 (6.40%)
    8 / 122 (6.56%)
         occurrences all number
    11
    8
    8
    Nasopharyngitis
         subjects affected / exposed
    2 / 121 (1.65%)
    2 / 125 (1.60%)
    2 / 122 (1.64%)
         occurrences all number
    2
    2
    2
    Furuncle
         subjects affected / exposed
    1 / 121 (0.83%)
    1 / 125 (0.80%)
    0 / 122 (0.00%)
         occurrences all number
    1
    1
    0
    Influenza
         subjects affected / exposed
    1 / 121 (0.83%)
    2 / 125 (1.60%)
    0 / 122 (0.00%)
         occurrences all number
    1
    2
    0
    Gastroenteritis
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 125 (0.80%)
    1 / 122 (0.82%)
         occurrences all number
    0
    1
    1
    Pharyngitis
         subjects affected / exposed
    1 / 121 (0.83%)
    1 / 125 (0.80%)
    0 / 122 (0.00%)
         occurrences all number
    1
    1
    0
    Cystitis
         subjects affected / exposed
    0 / 121 (0.00%)
    0 / 125 (0.00%)
    1 / 122 (0.82%)
         occurrences all number
    0
    0
    1
    eyelid infection
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 125 (0.00%)
    0 / 122 (0.00%)
         occurrences all number
    1
    0
    0
    Fungal infection
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 125 (0.80%)
    0 / 122 (0.00%)
         occurrences all number
    0
    1
    0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 121 (0.00%)
    0 / 125 (0.00%)
    1 / 122 (0.82%)
         occurrences all number
    0
    0
    1
    gastrointestinal bacterial overgrowth
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 125 (0.00%)
    0 / 122 (0.00%)
         occurrences all number
    1
    0
    0
    Herpes virus infection
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 125 (0.80%)
    0 / 122 (0.00%)
         occurrences all number
    0
    1
    0
    Herpes zoster
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 125 (0.00%)
    0 / 122 (0.00%)
         occurrences all number
    1
    0
    0
    Pulpitis dental
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 125 (0.00%)
    0 / 122 (0.00%)
         occurrences all number
    1
    0
    0
    Sinusitis
         subjects affected / exposed
    0 / 121 (0.00%)
    0 / 125 (0.00%)
    1 / 122 (0.82%)
         occurrences all number
    0
    0
    1
    Tonsillitis
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 125 (0.00%)
    0 / 122 (0.00%)
         occurrences all number
    1
    0
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 121 (0.00%)
    0 / 125 (0.00%)
    1 / 122 (0.82%)
         occurrences all number
    0
    0
    1
    Vaginal infection
         subjects affected / exposed
    0 / 121 (0.00%)
    0 / 125 (0.00%)
    1 / 122 (0.82%)
         occurrences all number
    0
    0
    1
    Vulvovaginal candidiasis
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 125 (0.80%)
    0 / 122 (0.00%)
         occurrences all number
    0
    1
    0
    Vulvovaginal mycotic infection
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 125 (0.80%)
    0 / 122 (0.00%)
         occurrences all number
    0
    1
    0
    Metabolism and nutrition disorders
    Fluid retention
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 125 (0.00%)
    0 / 122 (0.00%)
         occurrences all number
    1
    0
    0

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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.
    None reported
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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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