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    Clinical Trial Results:
    A Master Protocol to Investigate the Efficacy and Safety of Tirzepatide Once Weekly in Participants who have Obstructive Sleep Apnea and Obesity: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-OSA)

    Summary
    EudraCT number
    		 2021-004552-41
    Trial protocol
    		 CZ  
    Global end of trial date
    29 Mar 2024

    Results information
    Results version number
    		 v1
    This version publication date
    27 Mar 2025
    First version publication date
    27 Mar 2025
    Other versions
    		 v2

    Trial information

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    Trial identification
    Sponsor protocol code
    I8F-MC-GPIF
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05412004
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Eli Lilly and Company
    Sponsor organisation address
    Lilly Corporate Center, Indianapolis, IN, United States, 46285
    Public contact
    Available Mon - Fri 9 AM - 5 PM EST, Eli Lilly and Company, 1 877-CTLilly,
    Scientific contact
    Available Mon - Fri 9 AM - 5 PM EST, Eli Lilly and Company, 1 877-285-4559,
    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
    29 Mar 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Mar 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate that QW (once weekly) tirzepatide at the MTD (maximum-tolerated dose) (10 mg or 15 mg) is superior to placebo for mean percent decrease in AHI (Apnea-Hypopnea Index).
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 Jun 2022
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 149
    Country: Number of subjects enrolled
    China: 37
    Country: Number of subjects enrolled
    Japan: 20
    Country: Number of subjects enrolled
    Taiwan: 16
    Country: Number of subjects enrolled
    Brazil: 84
    Country: Number of subjects enrolled
    Mexico: 69
    Country: Number of subjects enrolled
    Australia: 25
    Country: Number of subjects enrolled
    Germany: 46
    Country: Number of subjects enrolled
    Czechia: 23
    Worldwide total number of subjects
    469
    EEA total number of subjects
    69
    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)
    418
    From 65 to 84 years
    51
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Not applicable

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Tirzepatide MTD_GPI1
    Arm description
    		 Participants not on positive airway pressure (PAP) therapy received a maximum tolerated dose (MTD) of 10 milligrams (mg) or 15 mg of Tirzepatide once weekly (QW) as a subcutaneous (SC) injection for 52 weeks, including the initial dose escalation by 2.5 mg every 4 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tirzepatide
    Investigational medicinal product code
    LY3298176
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants not on PAP therapy received 10 mg or 15 mg Tirzepatide QW after initial titration of 2.5 mg every 4 weeks as SC injection for 52 weeks.

    Arm title
    		 Placebo_GPI1
    Arm description
    		 Participants not on PAP therapy received placebo QW as an SC injection for 52 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants not on PAP therapy received placebo QW as SC injection for 52 weeks.

    Arm title
    		 TZP MTD_GPI2
    Arm description
    		 Participants who are on PAP therapy received an MTD of 10 mg or 15 mg of Tirzepatide QW as an SC injection for 52 weeks, including the initial dose escalation by 2.5 mg every 4 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tirzepatide
    Investigational medicinal product code
    LY3298176
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants who are on PAP therapy received 10 mg or 15 mg Tirzepatide QW after initial titration of 2.5 mg every 4 weeks as SC injection for 52 weeks.

    Arm title
    		 Placebo_GPI2
    Arm description
    		 Participants who are on PAP therapy received placebo QW as SC injection for 52 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants who are on PAP therapy received placebo QW as SC injection for 52 weeks.

    Number of subjects in period 1
    		Tirzepatide MTD_GPI1 Placebo_GPI1 TZP MTD_GPI2 Placebo_GPI2
    Started
    114
    120
    120
    115
    Received at Least One Dose of Study Drug
    114
    120
    119
    114
    Completed
    101
    86
    113
    89
    Not completed
    13
    34
    7
    26
         Consent withdrawn by subject
    4
    19
    4
    14
         Physician decision
    -
    1
    -
    -
         Participant quit treatment due to their schedule
    -
    -
    -
    1
         Screen Failure
    -
    -
    -
    1
         Adverse event, non-fatal
    -
    2
    1
    5
         Patient could not assist to site
    -
    1
    -
    -
         Pregnancy
    -
    1
    -
    -
         Protocol Violation
    1
    -
    -
    -
         Lost to follow-up
    3
    -
    -
    -
         Assigned Treatment by Mistake
    5
    10
    2
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Tirzepatide MTD_GPI1
    Reporting group description
    		 Participants not on positive airway pressure (PAP) therapy received a maximum tolerated dose (MTD) of 10 milligrams (mg) or 15 mg of Tirzepatide once weekly (QW) as a subcutaneous (SC) injection for 52 weeks, including the initial dose escalation by 2.5 mg every 4 weeks.

    Reporting group title
    Placebo_GPI1
    Reporting group description
    		 Participants not on PAP therapy received placebo QW as an SC injection for 52 weeks.

    Reporting group title
    TZP MTD_GPI2
    Reporting group description
    		 Participants who are on PAP therapy received an MTD of 10 mg or 15 mg of Tirzepatide QW as an SC injection for 52 weeks, including the initial dose escalation by 2.5 mg every 4 weeks.

    Reporting group title
    Placebo_GPI2
    Reporting group description
    		 Participants who are on PAP therapy received placebo QW as SC injection for 52 weeks.

    Reporting group values
    		 Tirzepatide MTD_GPI1 Placebo_GPI1 TZP MTD_GPI2 Placebo_GPI2 Total
    Number of subjects
    		 114 120 120 115 469
    Age categorical
    Units: Subjects
        <50years
    		 63 62 54 45 224
        >=50years
    		 51 58 66 70 245
    Gender categorical
    All randomized participants.
    Units: Subjects
        Female
    		 36 41 33 32 142
        Male
    		 78 79 87 83 327
    Ethnicity (NIH/OMB)
    All randomized participants.
    Units: Subjects
        Hispanic or Latino
    		 51 47 38 38 174
        Not Hispanic or Latino
    		 63 69 82 76 290
        Unknown or Not Reported
    		 0 4 0 1 5
    Race (NIH/OMB)
    All randomized participants.
    Units: Subjects
        American Indian or Alaska Native
    		 9 9 10 9 37
        Asian
    		 23 24 17 16 80
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0
        Black or African American
    		 6 7 8 3 24
        White
    		 74 80 85 86 325
        More than one race
    		 2 0 0 0 2
        Unknown or Not Reported
    		 0 0 0 1 1
    Region of Enrollment
    All randomized participants.
    Units: Subjects
        United States
    		 35 36 41 37 149
        China
    		 14 14 4 5 37
        Japan
    		 3 4 7 6 20
        Taiwan
    		 5 4 4 3 16
        Brazil
    		 24 25 18 17 84
        Mexico
    		 20 19 14 16 69
        Australia
    		 1 5 10 9 25
        Germany
    		 7 7 16 16 46
        Czechia
    		 5 6 6 6 23
    Baseline apnea-hypopnea index (AHI)
    AHI is the number of apneas or hypopneas recorded via polysomnography during the study per hour of sleep. Apnea is defined as a cessation of airflow lasting at least 10 seconds, and hypopnea as a decrease in airflow by at least 30% from baseline for at least 10 seconds occurring with a drop in oxygen saturation (SpO₂) by at least 4%. AHI values are categorized as 5-15 episodes/hr = mild; 15-<30 episodes/hr = moderate; and ≥ 30 episodes/h = severe. A significant reduction in values indicates a positive outcome.0
    Units: events per hour
        arithmetic mean (standard deviation)
    		 52.86 ( 30.50 ) 50.13 ( 31.47 ) 46.08 ( 22.35 ) 53.10 ( 30.23 ) -

    End points

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    End points reporting groups
    Reporting group title
    Tirzepatide MTD_GPI1
    Reporting group description
    		 Participants not on positive airway pressure (PAP) therapy received a maximum tolerated dose (MTD) of 10 milligrams (mg) or 15 mg of Tirzepatide once weekly (QW) as a subcutaneous (SC) injection for 52 weeks, including the initial dose escalation by 2.5 mg every 4 weeks.

    Reporting group title
    Placebo_GPI1
    Reporting group description
    		 Participants not on PAP therapy received placebo QW as an SC injection for 52 weeks.

    Reporting group title
    TZP MTD_GPI2
    Reporting group description
    		 Participants who are on PAP therapy received an MTD of 10 mg or 15 mg of Tirzepatide QW as an SC injection for 52 weeks, including the initial dose escalation by 2.5 mg every 4 weeks.

    Reporting group title
    Placebo_GPI2
    Reporting group description
    		 Participants who are on PAP therapy received placebo QW as SC injection for 52 weeks.

    Primary: Change From Baseline in Apnea-Hypopnea Index (AHI)

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    End point title
    		 Change From Baseline in Apnea-Hypopnea Index (AHI)
    End point description
    AHI, Apnea-Hypopnea Index, is the number of apneas or hypopneas recorded via polysomnography during the study per hour of sleep. Apnea is defined as a cessation of airflow lasting at least 10 seconds, and hypopnea as a decrease in airflow by at least 30% from baseline for at least 10 seconds occurring with a drop in oxygen saturation (SpO₂) by at least 4%. AHI values are categorized as 5-15 events/hr = mild; 15-<30 events/hr = moderate; and ≥ 30 events/hr = severe. A significant reduction in values indicates a positive outcome. Analysis Population Description (APD): Modified intent-to-treat (mITT) population consisting of all randomized participants who are exposed to at least 1 dose of study intervention and have evaluable data for this outcome.
    End point type
    Primary
    End point timeframe
    Baseline, Week 52
    End point values
    		 Tirzepatide MTD_GPI1 Placebo_GPI1 TZP MTD_GPI2 Placebo_GPI2
    Number of subjects analysed
    100
    86
    110
    87
    Units: events/hour
        least squares mean (standard error)
    -25.25 ( 2.06 )
    -5.25 ( 2.11 )
    -29.27 ( 1.99 )
    -5.51 ( 2.21 )
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Tirzepatide MTD_GPI1 v Placebo_GPI1
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [1]
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Change difference
    Point estimate
    -20.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -25.82
         upper limit
    		 -14.2
    Notes
    [1] - ANCOVA model was used with baseline, geographic region, sex, treatment (Type III sum of squares) as covariates.
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    TZP MTD_GPI2 v Placebo_GPI2
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [2]
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Change difference
    Point estimate
    -23.77
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -29.61
         upper limit
    		 -17.93
    Notes
    [2] - ANCOVA model was used with baseline, geographic region, sex, treatment (Type III sum of squares) as covariates.

    Secondary: Percent Change From Baseline in AHI

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    End point title
    		 Percent Change From Baseline in AHI
    End point description
    Percent Change From Baseline in AHI was evaluated. APD: mITT population consisting of all randomized participants who are exposed to at least 1 dose of study intervention and have evaluable data for this outcome.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 52
    End point values
    		 Tirzepatide MTD_GPI1 Placebo_GPI1 TZP MTD_GPI2 Placebo_GPI2
    Number of subjects analysed
    100
    86
    110
    87
    Units: percentage change
        least squares mean (standard error)
    -50.68 ( 5.90 )
    -3.03 ( 7.07 )
    -58.72 ( 5.28 )
    -2.50 ( 6.95 )
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Tirzepatide MTD_GPI1 v Placebo_GPI1
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [3]
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Change difference
    Point estimate
    -47.65
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -65.76
         upper limit
    		 -29.55
    Notes
    [3] - ANCOVA model was used with baseline, geographic region, sex, treatment (Type III sum of squares) as covariates.
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    TZP MTD_GPI2 v Placebo_GPI2
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [4]
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Change difference
    Point estimate
    -56.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -73.73
         upper limit
    		 -38.7
    Notes
    [4] - ANCOVA model was used with baseline, geographic region, sex, treatment (Type III sum of squares) as covariates.

    Secondary: Percentage of Participants With ≥50% AHI Reduction From Baseline

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    End point title
    		 Percentage of Participants With ≥50% AHI Reduction From Baseline
    End point description
    The percentage of participants achieving ≥50% AHI reduction from baseline to Week 52 was evaluated. APD: mITT population consisting of all randomized participants who are exposed to at least 1 dose of study intervention and have evaluable data for this outcome.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 Tirzepatide MTD_GPI1 Placebo_GPI1 TZP MTD_GPI2 Placebo_GPI2
    Number of subjects analysed
    100
    86
    110
    87
    Units: Percentage of participants
        number (not applicable)
    61.22
    18.96
    72.40
    23.25
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Tirzepatide MTD_GPI1 v Placebo_GPI1
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Regression, Logistic
    Parameter type
    		 Risk difference (RD)
    Point estimate
    42.77
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 30.76
         upper limit
    		 54.79
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    TZP MTD_GPI2 v Placebo_GPI2
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Regression, Logistic
    Parameter type
    		 Risk difference (RD)
    Point estimate
    48.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 36.55
         upper limit
    		 60.65

    Secondary: Percentage of Participants With AHI <5 or With AHI 5-14 With Epworth Sleepiness Scale (ESS) ≤10

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    End point title
    		 Percentage of Participants With AHI <5 or With AHI 5-14 With Epworth Sleepiness Scale (ESS) ≤10
    End point description
    The percentage of participants with OSA remission (AHI <5 events per hour of sleep) or with mild OSA without excessive daytime sleepiness (AHI 5-14 events per hour of sleep with ESS ≤10) at Week 52 was evaluated. The ESS is used to assess improvements in excessive daytime sleepiness from baseline to Week 52. The ESS is an 8-item, participant-completed measure that asks the participant to rate, on a scale of 0 (no chance of dozing) to 3 (high chance of dozing), their usual chances of dozing in 8 different daytime situations, with a recall period of "in recent times." The ESS total score is the sum of the 8-item scores and ranges from 0 to 24, with higher scores indicating greater daytime sleepiness.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 Tirzepatide MTD_GPI1 Placebo_GPI1 TZP MTD_GPI2 Placebo_GPI2
    Number of subjects analysed
    100
    86
    110
    87
    Units: percentage of participants
        number (not applicable)
    42.17
    15.88
    50.24
    14.33
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Tirzepatide MTD_GPI1 v Placebo_GPI1
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Regression, Logistic
    Parameter type
    		 Risk difference (RD)
    Point estimate
    28.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 18.27
         upper limit
    		 39.22
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    TZP MTD_GPI2 v Placebo_GPI2
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Regression, Logistic
    Parameter type
    		 Risk difference (RD)
    Point estimate
    33.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 22.12
         upper limit
    		 44.31

    Secondary: Change From Baseline in Sleep Apnea-Specific Hypoxic Burden (SASHB) (% Min/Hour)

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    End point title
    		 Change From Baseline in Sleep Apnea-Specific Hypoxic Burden (SASHB) (% Min/Hour)
    End point description
    SASHB is determined by measuring the respiratory event-associated area under the curve for oxygen desaturation from pre-event baseline and represents the cumulative burden of intermittent hypoxia caused by OSA-related sleep-disordered breathing at sleep. Percent change in SASHB from baseline to Week 52 was evaluated. APD: mITT population consisting of all randomized participants who are exposed to at least 1 dose of study intervention and have evaluable data for this outcome.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 52
    End point values
    		 Tirzepatide MTD_GPI1 Placebo_GPI1 TZP MTD_GPI2 Placebo_GPI2
    Number of subjects analysed
    100
    86
    110
    87
    Units: %.min/hr
        least squares mean (standard error)
    -95.19 ( 4.081 )
    -25.07 ( 9.804 )
    -102.98 ( 3.758 )
    -41.69 ( 11.313 )
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Tirzepatide MTD_GPI1 v Placebo_GPI1
    Number of subjects included in analysis
    186
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Median difference (net)
    Point estimate
    -70.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -90.94
         upper limit
    		 -49.31
    Variability estimate
    Standard error of the mean
    Dispersion value
    10.619
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    TZP MTD_GPI2 v Placebo_GPI2
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Median difference (net)
    Point estimate
    -61.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -84.66
         upper limit
    		 -37.93
    Variability estimate
    Standard error of the mean
    Dispersion value
    11.921

    Secondary: Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep-Related Impairment Short Form 8a and PROMIS Sleep Disturbance Short Form 8b

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    End point title
    		 Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep-Related Impairment Short Form 8a and PROMIS Sleep Disturbance Short Form 8b
    End point description
    PROMIS Sleep-related Impairment (SRI) assesses self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours and perceived functional impairments associated sleep problems. PROMIS SRI 8a has 8 items, each rated on a 5-point scale from "not at all" to "very much. Items recall period of "in the past 7 days. PROMIS Sleep Disturbance (SD) 8b has 8 items, each rated on a 5-point scale ranging from "not at all" to "very much," "never" to "always," or "very poor" to "very good.". Items have a recall period of "in the past 7 days." For both PROMIS SRI and PROMIS SD Individual item scores are totaled to obtain a raw score, higher scores indicates more sleep disturbance.Raw scores were converted to a T-score, which is standardized with a mean of 50 and an SD of 10. Range cannot be specified for T-score. APD: mITT population consisting of all randomized participants who are exposed to at least 1 dose of study intervention and have evaluable data for this outcome.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 52
    End point values
    		 Tirzepatide MTD_GPI1 Placebo_GPI1 TZP MTD_GPI2 Placebo_GPI2
    Number of subjects analysed
    90
    79
    93
    79
    Units: score on a scale
    least squares mean (standard error)
        Sleep Disturbance
    -4.47 ( 0.69 )
    -2.44 ( 0.70 )
    -6.98 ( 0.82 )
    -3.08 ( 0.88 )
        Sleep-Related Impairment
    -6.57 ( 0.83 )
    -3.13 ( 0.80 )
    -8.18 ( 0.95 )
    -3.91 ( 1.03 )
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Sleep Disturbance
    Comparison groups
    Tirzepatide MTD_GPI1 v Placebo_GPI1
    Number of subjects included in analysis
    169
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.037 [5]
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Change difference
    Point estimate
    -2.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.95
         upper limit
    		 -0.12
    Notes
    [5] - ANCOVA model was used with baseline, geographic region, sex, treatment (Type III sum of squares) as covariates.
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Sleep Related Impairment
    Comparison groups
    Tirzepatide MTD_GPI1 v Placebo_GPI1
    Number of subjects included in analysis
    169
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.003 [6]
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Change difference
    Point estimate
    -3.43
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.69
         upper limit
    		 -1.17
    Notes
    [6] - ANCOVA model was used with baseline, geographic region, sex, treatment (Type III sum of squares) as covariates.
    Statistical analysis title
    		 Statistical Analysis 3
    Statistical analysis description
    Sleep Disturbance
    Comparison groups
    TZP MTD_GPI2 v Placebo_GPI2
    Number of subjects included in analysis
    172
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [7]
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Change difference
    Point estimate
    -3.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.21
         upper limit
    		 -1.58
    Notes
    [7] - ANCOVA model was used with baseline, geographic region, sex, treatment (Type III sum of squares) as covariates.
    Statistical analysis title
    		 Statistical Analysis 4
    Statistical analysis description
    Sleep Related Impairment
    Comparison groups
    TZP MTD_GPI2 v Placebo_GPI2
    Number of subjects included in analysis
    172
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002 [8]
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Change difference
    Point estimate
    -4.26
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.97
         upper limit
    		 -1.56
    Notes
    [8] - ANCOVA model was used with baseline, geographic region, sex, treatment (Type III sum of squares) as covariates.

    Secondary: Percent Change From Baseline in Body Weight

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    End point title
    		 Percent Change From Baseline in Body Weight
    End point description
    Percent Change from Baseline in Body Weight is evaluated. APD: mITT population consisting of all randomized participants who are exposed to at least 1 dose of study intervention and have evaluable data for this outcome.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 52
    End point values
    		 Tirzepatide MTD_GPI1 Placebo_GPI1 TZP MTD_GPI2 Placebo_GPI2
    Number of subjects analysed
    101
    87
    113
    90
    Units: Percent change
        least squares mean (standard deviation)
    -17.65 ( 0.69 )
    -1.56 ( 0.68 )
    -19.62 ( 0.71 )
    -2.34 ( 0.74 )
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo_GPI1 v Tirzepatide MTD_GPI1
    Number of subjects included in analysis
    188
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [9]
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Change difference
    Point estimate
    -16.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -17.99
         upper limit
    		 -14.19
    Notes
    [9] - ANCOVA model was used with baseline, geographic region, sex, baseline OSA severity Group, treatment (Type III sum of squares) as covariates.
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    TZP MTD_GPI2 v Placebo_GPI2
    Number of subjects included in analysis
    203
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [10]
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Change difference
    Point estimate
    -17.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -19.29
         upper limit
    		 -15.28
    Notes
    [10] - ANCOVA model was used with baseline, geographic region, sex, baseline OSA severity Group, treatment (Type III sum of squares) as covariates.

    Secondary: Change From Baseline in High Sensitivity C Reactive Protein (hsCRP) Concentration

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    End point title
    		 Change From Baseline in High Sensitivity C Reactive Protein (hsCRP) Concentration
    End point description
    HsCRP is a marker for inflammation and was measured from blood samples to identify the presence of inflammation, to determine its severity, and to monitor response to treatment. APD: mITT population consisting of all randomized participants who are exposed to at least 1 dose of study intervention and have evaluable data for this outcome.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 52
    End point values
    		 Tirzepatide MTD_GPI1 Placebo_GPI1 TZP MTD_GPI2 Placebo_GPI2
    Number of subjects analysed
    95
    84
    102
    82
    Units: mg (milligram)/L (liter)
        least squares mean (standard error)
    -1.42 ( 0.151 )
    -0.70 ( 0.203 )
    -1.37 ( 0.130 )
    -0.33 ( 0.236 )
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Tirzepatide MTD_GPI1 v Placebo_GPI1
    Number of subjects included in analysis
    179
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.752 [11]
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Change difference
    Point estimate
    -0.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.21
         upper limit
    		 -0.22
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.253
    Notes
    [11] - ANCOVA model was used with baseline, geographic region, sex, baseline OSA severity Group, treatment (Type III sum of squares) as covariates.
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    TZP MTD_GPI2 v Placebo_GPI2
    Number of subjects included in analysis
    184
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.35 [12]
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Change difference
    Point estimate
    -1.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.57
         upper limit
    		 -0.51
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.269
    Notes
    [12] - ANCOVA model was used with baseline, geographic region, sex, baseline OSA severity Group, treatment (Type III sum of squares) as covariates.

    Secondary: Change From Baseline in Systolic Blood Pressure (SBP)

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    End point title
    		 Change From Baseline in Systolic Blood Pressure (SBP)
    End point description
    Change in systolic blood pressure from baseline to Week 48 is evaluated. APD: mITT population consisting of all randomized participants who are exposed to at least 1 dose of study intervention and have evaluable data for this outcome.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 48
    End point values
    		 Tirzepatide MTD_GPI1 Placebo_GPI1 TZP MTD_GPI2 Placebo_GPI2
    Number of subjects analysed
    100
    89
    112
    91
    Units: mmHg
        least squares mean (standard error)
    -9.46 ( 1.02 )
    -1.84 ( 1.03 )
    -7.64 ( 1.03 )
    -3.94 ( 1.18 )
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Tirzepatide MTD_GPI1 v Placebo_GPI1
    Number of subjects included in analysis
    189
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [13]
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Change difference
    Point estimate
    -7.62
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.48
         upper limit
    		 -4.77
    Notes
    [13] - ANCOVA model was used with baseline, geographic region, sex, treatment (Type III sum of squares) as covariates.
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    TZP MTD_GPI2 v Placebo_GPI2
    Number of subjects included in analysis
    203
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.017 [14]
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Change difference
    Point estimate
    -3.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.75
         upper limit
    		 -0.65
    Notes
    [14] - ANCOVA model was used with baseline, geographic region, sex, treatment (Type III sum of squares) as covariates.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All randomized participants are exposed to at least 1 dose of study intervention. Gender-specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
    Adverse event reporting additional description
    As per the prespecified statistical analysis plan, adverse events were analyzed as per the treatment regimen.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    Tirzepatide MTD_GPI1
    Reporting group description
    		 Participants not on PAP therapy received an MTD of 10 mg or 15 mg of Tirzepatide QW as an SC injection for 52 weeks, including the initial dose escalation by 2.5 mg every 4 weeks.

    Reporting group title
    Placebo_GPI2
    Reporting group description
    		 Participants who are on PAP therapy received placebo QW as an SC injection for 52 weeks.

    Reporting group title
    Placebo_GPI1
    Reporting group description
    		 Participants not on PAP therapy received placebo QW as an SC injection for 52 weeks.

    Reporting group title
    Tirzepatide MTD_GPI2
    Reporting group description
    		 Participants who are on PAP therapy received an MTD of 10 mg or 15 mg of Tirzepatide QW as an SC injection for 52 weeks, including the initial dose escalation by 2.5 mg every 4 weeks.

    Serious adverse events
    		 Tirzepatide MTD_GPI1 Placebo_GPI2 Placebo_GPI1 Tirzepatide MTD_GPI2
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 114 (7.89%)
    12 / 114 (10.53%)
    7 / 120 (5.83%)
    7 / 119 (5.88%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    clear cell renal cell carcinoma
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    gastric cancer
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    malignant melanoma
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    plasma cell myeloma
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    prostate cancer metastatic
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed [1]
    0 / 78 (0.00%)
    1 / 82 (1.22%)
    0 / 79 (0.00%)
    0 / 87 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    tonsil cancer metastatic
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    aortic stenosis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    hypotension
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    nephrectomy
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    chest pain
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    abnormal uterine bleeding
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed [2]
    0 / 36 (0.00%)
    1 / 32 (3.13%)
    0 / 41 (0.00%)
    0 / 32 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    asthmatic crisis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    depression
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    mood swings
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    suicide attempt
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    2 / 114 (1.75%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    road traffic accident
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    tendon injury
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    upper limb fracture
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    acute myocardial infarction
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    atrial fibrillation
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    2 / 120 (1.67%)
    1 / 119 (0.84%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    coronary artery disease
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    cerebral haemorrhage
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    coma
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    presyncope
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    diarrhoea
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pancreatitis acute
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    cholelithiasis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    gallbladder polyp
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    acute kidney injury
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    hydronephrosis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    nephrolithiasis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    arthritis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    intervertebral disc protrusion
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    loose body in joint
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    osteoarthritis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    spinal osteoarthritis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    appendicitis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    dengue fever
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    gastroenteritis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pneumonia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    hypokalaemia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Gender-specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Gender-specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Tirzepatide MTD_GPI1 Placebo_GPI2 Placebo_GPI1 Tirzepatide MTD_GPI2
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    91 / 114 (79.82%)
    82 / 114 (71.93%)
    91 / 120 (75.83%)
    98 / 119 (82.35%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    adrenal adenoma
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    benign neoplasm of skin
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    colorectal adenoma
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    enchondromatosis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    metastasis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    melanocytic naevus
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    neoplasm skin
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    seborrhoeic keratosis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    2
    0
    0
    squamous cell carcinoma of skin
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Vascular disorders
    aortic occlusion
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    0
    0
    1
    0
    haematoma
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    hypertension
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    2 / 114 (1.75%)
    8 / 120 (6.67%)
    2 / 119 (1.68%)
         occurrences all number
    1
    2
    9
    2
    hypotension
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    3 / 114 (2.63%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    3
    0
    0
    0
    internal haemorrhage
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Surgical and medical procedures
    cochlea implant
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    fascia release
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    intraocular lens implant
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences all number
    0
    0
    0
    1
    phlebectomy
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    1
    0
    0
    0
    tooth extraction
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    2 / 114 (1.75%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    3
    0
    1
    0
    ureteral stent insertion
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    General disorders and administration site conditions
    administration site reaction
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    4
    0
    0
    0
    application site pruritus
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    1
    0
    0
    0
    application site reaction
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    2 / 114 (1.75%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    3
    0
    0
    0
    asthenia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    1 / 119 (0.84%)
         occurrences all number
    0
    0
    1
    2
    chest discomfort
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    1
    1
    0
    0
    chest pain
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    0
    0
    1
    0
    discomfort
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    fatigue
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    2 / 114 (1.75%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    4 / 119 (3.36%)
         occurrences all number
    2
    1
    0
    22
    feeling cold
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences all number
    0
    0
    0
    2
    influenza like illness
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    1
    0
    injection site bruising
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    3 / 114 (2.63%)
    1 / 120 (0.83%)
    2 / 119 (1.68%)
         occurrences all number
    1
    3
    1
    2
    injection site erythema
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    2 / 119 (1.68%)
         occurrences all number
    0
    0
    0
    13
    injection site pain
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    0
    0
    1
    0
    injection site pruritus
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    2 / 119 (1.68%)
         occurrences all number
    1
    0
    0
    13
    injection site rash
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    1
    0
    0
    0
    injection site reaction
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    8 / 114 (7.02%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    6 / 119 (5.04%)
         occurrences all number
    70
    0
    2
    44
    injection site urticaria
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    0
    0
    1
    0
    local reaction
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences all number
    2
    0
    0
    8
    malaise
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    oedema peripheral
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    2 / 114 (1.75%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    0
    3
    1
    0
    pain
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    2 / 119 (1.68%)
         occurrences all number
    1
    0
    0
    2
    peripheral swelling
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    2 / 120 (1.67%)
    0 / 119 (0.00%)
         occurrences all number
    0
    0
    3
    0
    pyrexia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    2 / 114 (1.75%)
    1 / 114 (0.88%)
    2 / 120 (1.67%)
    0 / 119 (0.00%)
         occurrences all number
    2
    1
    2
    0
    temperature intolerance
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    2 / 119 (1.68%)
         occurrences all number
    0
    0
    0
    2
    thirst
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Immune system disorders
    anaphylactic reaction
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    1
    0
    0
    0
    drug hypersensitivity
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences all number
    0
    0
    0
    1
    seasonal allergy
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    2 / 120 (1.67%)
    1 / 119 (0.84%)
         occurrences all number
    4
    0
    2
    1
    Reproductive system and breast disorders
    benign prostatic hyperplasia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed [3]
    0 / 78 (0.00%)
    1 / 82 (1.22%)
    0 / 79 (0.00%)
    0 / 87 (0.00%)
         occurrences all number
    0
    1
    0
    0
    cervical cyst
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed [4]
    1 / 36 (2.78%)
    0 / 32 (0.00%)
    0 / 41 (0.00%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    0
    0
    cervical polyp
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed [5]
    0 / 36 (0.00%)
    0 / 32 (0.00%)
    0 / 41 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    0
    0
    1
    prostatitis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed [6]
    1 / 78 (1.28%)
    1 / 82 (1.22%)
    0 / 79 (0.00%)
    0 / 87 (0.00%)
         occurrences all number
    1
    1
    0
    0
    vaginal haemorrhage
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed [7]
    0 / 36 (0.00%)
    0 / 32 (0.00%)
    1 / 41 (2.44%)
    0 / 32 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    asthma
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    3 / 120 (2.50%)
    1 / 119 (0.84%)
         occurrences all number
    0
    1
    3
    1
    cough
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    4 / 114 (3.51%)
    2 / 114 (1.75%)
    2 / 120 (1.67%)
    3 / 119 (2.52%)
         occurrences all number
    4
    2
    3
    3
    diaphragmatic disorder
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    1
    0
    0
    0
    epistaxis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    0
    0
    1
    0
    nasal congestion
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    2 / 114 (1.75%)
    0 / 120 (0.00%)
    4 / 119 (3.36%)
         occurrences all number
    0
    2
    0
    4
    oropharyngeal pain
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    0
    0
    1
    0
    paranasal cyst
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    pleurisy
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    0
    0
    1
    0
    productive cough
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    0
    0
    1
    0
    respiratory disorder
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    0
    0
    1
    0
    pulmonary mass
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences all number
    0
    1
    0
    1
    rhinorrhoea
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    rhinitis allergic
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    sinus congestion
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    1
    0
    0
    0
    snoring
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    1
    0
    0
    0
    tonsillar inflammation
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    0
    0
    1
    0
    vasomotor rhinitis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    wheezing
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Psychiatric disorders
    anxiety disorder
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    anxiety
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    2 / 114 (1.75%)
    2 / 114 (1.75%)
    4 / 120 (3.33%)
    1 / 119 (0.84%)
         occurrences all number
    2
    2
    4
    1
    bruxism
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences all number
    0
    0
    0
    1
    confusional state
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    0
    0
    3
    0
    depression
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    3 / 114 (2.63%)
    2 / 114 (1.75%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    3
    2
    1
    0
    hallucination
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    insomnia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    3 / 114 (2.63%)
    0 / 114 (0.00%)
    2 / 120 (1.67%)
    2 / 119 (1.68%)
         occurrences all number
    4
    0
    2
    2
    libido decreased
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    1
    0
    0
    0
    mood altered
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences all number
    0
    0
    0
    1
    panic attack
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    rapid eye movement sleep behaviour disorder
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    sleep disorder
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Product issues
    device physical property issue
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Investigations
    alanine aminotransferase increased
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    0
    0
    1
    0
    albumin urine present
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    2 / 114 (1.75%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    2
    0
    0
    0
    amylase increased
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    1 / 119 (0.84%)
         occurrences all number
    0
    0
    1
    2
    blood creatine phosphokinase increased
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    4 / 114 (3.51%)
    3 / 120 (2.50%)
    1 / 119 (0.84%)
         occurrences all number
    1
    5
    3
    1
    blood bicarbonate increased
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    blood calcitonin increased
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences all number
    0
    0
    0
    1
    blood cholesterol increased
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    2 / 120 (1.67%)
    0 / 119 (0.00%)
         occurrences all number
    0
    0
    2
    0
    blood alkaline phosphatase increased
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    blood pressure decreased
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    1
    0
    0
    0
    blood osmolarity decreased
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences all number
    0
    0
    0
    1
    blood glucose increased
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    0
    2
    1
    0
    blood creatinine increased
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    1
    1
    0
    0
    blood pressure increased
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    2 / 114 (1.75%)
    1 / 120 (0.83%)
    1 / 119 (0.84%)
         occurrences all number
    0
    2
    1
    1
    blood urea increased
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    blood testosterone decreased
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    1
    0
    0
    0
    blood pressure measurement
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    cardiac murmur
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences all number
    0
    0
    0
    1
    coronavirus test positive
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    1
    0
    1
    0
    creatinine urine increased
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    1
    0
    0
    0
    electrocardiogram t wave inversion
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    0
    0
    1
    0
    gamma-glutamyltransferase increased
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    0
    0
    1
    0
    heart rate increased
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    5 / 114 (4.39%)
    0 / 114 (0.00%)
    2 / 120 (1.67%)
    1 / 119 (0.84%)
         occurrences all number
    5
    0
    2
    2
    lipids abnormal
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    0
    0
    1
    0
    lipase increased
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    3 / 114 (2.63%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    4 / 119 (3.36%)
         occurrences all number
    4
    0
    0
    5
    mean cell volume increased
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    0
    0
    1
    0
    occult blood positive
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences all number
    0
    0
    0
    1
    pancreatic enzymes increased
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    1
    0
    0
    0
    protein urine present
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    1 / 119 (0.84%)
         occurrences all number
    0
    0
    1
    1
    sars-cov-2 test positive
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    2 / 114 (1.75%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences all number
    2
    0
    0
    1
    transaminases increased
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    0
    0
    1
    0
    weight decreased
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences all number
    0
    0
    0
    1
    vitamin d decreased
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    1
    0
    0
    0
    white blood cell count decreased
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences all number
    0
    0
    0
    1
    weight increased
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    2 / 120 (1.67%)
    0 / 119 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Injury, poisoning and procedural complications
    animal bite
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    0
    0
    1
    0
    bone contusion
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences all number
    0
    0
    0
    1
    breast injury
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    0
    0
    1
    0
    contusion
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    3 / 114 (2.63%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences all number
    0
    3
    0
    1
    epicondylitis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    eye contusion
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    fall
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    3 / 114 (2.63%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    1
    5
    1
    0
    foot fracture
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    1
    0
    0
    0
    head injury
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    2 / 120 (1.67%)
    0 / 119 (0.00%)
         occurrences all number
    0
    0
    2
    0
    hand fracture
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    1
    1
    0
    0
    iatrogenic injury
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences all number
    0
    0
    0
    1
    injection related reaction
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences all number
    0
    0
    0
    1
    joint injury
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    1
    0
    lower limb fracture
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    0
    0
    1
    0
    limb injury
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    2 / 114 (1.75%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    1
    3
    1
    0
    ligament sprain
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    3 / 114 (2.63%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    3
    0
    1
    0
    meniscus injury
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    0
    0
    1
    0
    muscle strain
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    1
    0
    muscle rupture
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    nail avulsion
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    0
    0
    1
    0
    overdose
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    4 / 114 (3.51%)
    2 / 114 (1.75%)
    2 / 120 (1.67%)
    1 / 119 (0.84%)
         occurrences all number
    4
    2
    2
    2
    road traffic accident
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    0
    0
    1
    0
    skin laceration
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    2 / 119 (1.68%)
         occurrences all number
    0
    0
    0
    2
    soft tissue injury
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    1
    0
    0
    0
    spinal column injury
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    1
    0
    0
    0
    viiith nerve injury
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    wrist fracture
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    2 / 114 (1.75%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Cardiac disorders
    angina pectoris
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    2 / 114 (1.75%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    2
    0
    0
    aortic valve incompetence
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences all number
    0
    0
    0
    1
    arrhythmia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences all number
    0
    0
    0
    1
    atrioventricular block second degree
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    0
    0
    1
    0
    atrial fibrillation
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    1
    0
    bradycardia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    1 / 119 (0.84%)
         occurrences all number
    0
    0
    1
    1
    bundle branch block right
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    1
    0
    0
    0
    coronary artery disease
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    extrasystoles
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences all number
    0
    0
    0
    1
    mitral valve incompetence
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences all number
    0
    0
    0
    1
    sinus arrhythmia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    1
    0
    0
    0
    supraventricular extrasystoles
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    1 / 119 (0.84%)
         occurrences all number
    0
    0
    1
    1
    supraventricular tachycardia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    0
    0
    1
    0
    tachycardia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    2 / 114 (1.75%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    2
    0
    1
    0
    ventricular extrasystoles
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Nervous system disorders
    carotid arteriosclerosis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    1
    0
    0
    0
    carpal tunnel syndrome
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    2
    0
    0
    dizziness
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    2 / 114 (1.75%)
    3 / 114 (2.63%)
    2 / 120 (1.67%)
    1 / 119 (0.84%)
         occurrences all number
    4
    5
    2
    2
    dysgeusia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences all number
    1
    0
    0
    1
    headache
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    4 / 114 (3.51%)
    1 / 114 (0.88%)
    3 / 120 (2.50%)
    0 / 119 (0.00%)
         occurrences all number
    4
    1
    6
    0
    hypoaesthesia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    hypotonia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    1 / 119 (0.84%)
         occurrences all number
    0
    0
    1
    1
    lethargy
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    2 / 120 (1.67%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    2
    0
    memory impairment
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    0
    0
    1
    0
    migraine
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    2 / 120 (1.67%)
    0 / 119 (0.00%)
         occurrences all number
    0
    3
    2
    0
    neuralgia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences all number
    0
    0
    0
    1
    ophthalmic migraine
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    1
    0
    0
    0
    presyncope
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences all number
    0
    0
    0
    1
    sciatica
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    2 / 120 (1.67%)
    1 / 119 (0.84%)
         occurrences all number
    0
    1
    2
    1
    somnolence
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences all number
    0
    0
    0
    1
    syncope
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences all number
    0
    1
    0
    1
    taste disorder
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    0
    0
    1
    0
    tremor
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Blood and lymphatic system disorders
    anaemia macrocytic
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences all number
    0
    0
    0
    1
    anaemia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    2 / 114 (1.75%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    1
    2
    0
    0
    leukopenia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences all number
    0
    0
    0
    1
    macrocytosis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences all number
    0
    0
    0
    1
    lymphadenitis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    0
    0
    1
    0
    microcytic anaemia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    neutropenia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Ear and labyrinth disorders
    ear pain
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    sudden hearing loss
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    0
    0
    1
    0
    tinnitus
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    vertigo
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences all number
    1
    0
    0
    1
    Eye disorders
    dry eye
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    1
    0
    1
    0
    photopsia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    vitreous haemorrhage
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    1
    0
    0
    0
    vitreous degeneration
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences all number
    0
    0
    0
    1
    Gastrointestinal disorders
    abdominal distension
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    5 / 114 (4.39%)
    2 / 114 (1.75%)
    1 / 120 (0.83%)
    4 / 119 (3.36%)
         occurrences all number
    10
    2
    1
    4
    abdominal discomfort
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    2 / 114 (1.75%)
    2 / 114 (1.75%)
    1 / 120 (0.83%)
    1 / 119 (0.84%)
         occurrences all number
    3
    2
    1
    1
    abdominal pain upper
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    4 / 114 (3.51%)
    2 / 114 (1.75%)
    2 / 120 (1.67%)
    7 / 119 (5.88%)
         occurrences all number
    4
    2
    6
    8
    abdominal pain
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    7 / 114 (6.14%)
    2 / 114 (1.75%)
    4 / 120 (3.33%)
    5 / 119 (4.20%)
         occurrences all number
    7
    2
    4
    8
    aphthous ulcer
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences all number
    0
    0
    0
    1
    barrett's oesophagus
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences all number
    0
    0
    0
    1
    colon dysplasia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    constipation
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    18 / 114 (15.79%)
    5 / 114 (4.39%)
    3 / 120 (2.50%)
    18 / 119 (15.13%)
         occurrences all number
    25
    7
    4
    19
    diarrhoea
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    30 / 114 (26.32%)
    10 / 114 (8.77%)
    15 / 120 (12.50%)
    26 / 119 (21.85%)
         occurrences all number
    69
    15
    21
    56
    diverticulum intestinal
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    dyspepsia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    5 / 114 (4.39%)
    1 / 114 (0.88%)
    2 / 120 (1.67%)
    11 / 119 (9.24%)
         occurrences all number
    5
    1
    4
    11
    epigastric discomfort
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    0
    0
    1
    0
    enterocolitis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    1
    0
    0
    0
    enteritis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    1
    0
    0
    0
    eructation
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    9 / 114 (7.89%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    10 / 119 (8.40%)
         occurrences all number
    11
    1
    0
    26
    erosive oesophagitis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    flatulence
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    3 / 114 (2.63%)
    1 / 114 (0.88%)
    1 / 120 (0.83%)
    1 / 119 (0.84%)
         occurrences all number
    4
    1
    1
    1
    frequent bowel movements
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    1
    0
    gastric polyps
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    1
    1
    0
    0
    gastritis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    2 / 114 (1.75%)
    0 / 120 (0.00%)
    2 / 119 (1.68%)
         occurrences all number
    1
    2
    0
    2
    gastrointestinal hypermotility
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    0
    0
    2
    0
    gastrooesophageal reflux disease
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    9 / 114 (7.89%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    6 / 119 (5.04%)
         occurrences all number
    13
    0
    1
    8
    haemorrhoids
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    2 / 114 (1.75%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    2 / 119 (1.68%)
         occurrences all number
    2
    1
    0
    2
    hiatus hernia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    inguinal hernia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences all number
    0
    0
    0
    1
    large intestine polyp
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    malocclusion
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    3
    0
    0
    0
    mouth ulceration
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    1
    0
    0
    0
    nausea
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    29 / 114 (25.44%)
    6 / 114 (5.26%)
    12 / 120 (10.00%)
    26 / 119 (21.85%)
         occurrences all number
    59
    7
    15
    58
    oesophagitis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    1
    0
    0
    0
    pancreatitis acute
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences all number
    0
    0
    0
    1
    pelvic floor dysfunction
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    0
    0
    1
    0
    salivary gland cyst
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences all number
    0
    0
    0
    1
    toothache
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    2 / 114 (1.75%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    2
    0
    0
    0
    vomiting
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    20 / 114 (17.54%)
    1 / 114 (0.88%)
    5 / 120 (4.17%)
    11 / 119 (9.24%)
         occurrences all number
    34
    1
    6
    18
    Hepatobiliary disorders
    cholelithiasis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    2 / 119 (1.68%)
         occurrences all number
    0
    0
    0
    2
    gallbladder polyp
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    1
    0
    0
    0
    hepatic function abnormal
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    hepatic steatosis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    2 / 114 (1.75%)
    1 / 120 (0.83%)
    2 / 119 (1.68%)
         occurrences all number
    1
    2
    1
    2
    Skin and subcutaneous tissue disorders
    actinic keratosis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    acne
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences all number
    1
    0
    0
    1
    alopecia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    5 / 114 (4.39%)
    1 / 114 (0.88%)
    1 / 120 (0.83%)
    5 / 119 (4.20%)
         occurrences all number
    5
    1
    1
    5
    angioedema
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    0
    0
    1
    0
    dermatitis allergic
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    1
    0
    1
    0
    dermal cyst
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences all number
    0
    0
    0
    1
    erythema
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    2
    0
    0
    0
    hand dermatitis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    0
    0
    1
    0
    night sweats
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    pigmentation disorder
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences all number
    0
    0
    0
    1
    pruritus
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences all number
    2
    0
    0
    1
    psoriasis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    rash pruritic
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    0
    0
    1
    0
    sebaceous hyperplasia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    seborrhoeic dermatitis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences all number
    0
    0
    0
    1
    skin lesion
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    0
    0
    1
    0
    urticaria
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    2 / 114 (1.75%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences all number
    2
    0
    0
    1
    Renal and urinary disorders
    diabetic nephropathy
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    glomerulonephropathy
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    1
    1
    0
    0
    haematuria
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences all number
    0
    1
    0
    1
    hydronephrosis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    hypertonic bladder
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    microalbuminuria
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    0
    0
    1
    0
    nephrolithiasis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    3 / 114 (2.63%)
    0 / 114 (0.00%)
    2 / 120 (1.67%)
    3 / 119 (2.52%)
         occurrences all number
    3
    0
    2
    4
    nephropathy
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    0
    0
    1
    0
    pollakiuria
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    proteinuria
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    1
    0
    0
    0
    renal colic
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    1 / 119 (0.84%)
         occurrences all number
    0
    0
    1
    1
    urethral stenosis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    urinary incontinence
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    urinary retention
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences all number
    0
    0
    0
    1
    Endocrine disorders
    autoimmune thyroid disorder
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    0
    0
    1
    0
    goitre
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    0
    0
    1
    0
    hyperparathyroidism
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    thyroid mass
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    arthritis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences all number
    0
    0
    0
    1
    arthralgia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    3 / 114 (2.63%)
    5 / 114 (4.39%)
    6 / 120 (5.00%)
    4 / 119 (3.36%)
         occurrences all number
    3
    5
    6
    4
    back pain
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    5 / 114 (4.39%)
    2 / 120 (1.67%)
    1 / 119 (0.84%)
         occurrences all number
    1
    5
    2
    1
    bursitis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    extremity contracture
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    intervertebral disc protrusion
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences all number
    1
    0
    0
    1
    joint swelling
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    1
    0
    0
    0
    muscle contracture
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    muscle spasms
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences all number
    0
    0
    0
    1
    musculoskeletal stiffness
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    0
    0
    1
    0
    musculoskeletal pain
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences all number
    0
    0
    0
    1
    musculoskeletal chest pain
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    1 / 119 (0.84%)
         occurrences all number
    0
    0
    1
    1
    muscle tightness
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    1
    0
    myalgia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    2 / 114 (1.75%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    2
    1
    0
    0
    myositis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    0
    0
    1
    0
    neck pain
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    1
    0
    1
    0
    osteoarthritis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    2 / 114 (1.75%)
    1 / 120 (0.83%)
    1 / 119 (0.84%)
         occurrences all number
    0
    3
    1
    1
    pain in extremity
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    2 / 114 (1.75%)
    1 / 114 (0.88%)
    1 / 120 (0.83%)
    1 / 119 (0.84%)
         occurrences all number
    2
    1
    1
    1
    plantar fasciitis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    3 / 120 (2.50%)
    0 / 119 (0.00%)
         occurrences all number
    0
    0
    6
    0
    sacroiliac joint dysfunction
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    rotator cuff syndrome
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences all number
    0
    0
    0
    1
    spinal osteoarthritis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    2 / 114 (1.75%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    2
    0
    0
    0
    spinal pain
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    0
    0
    1
    0
    tendon disorder
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    tendonitis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    1 / 114 (0.88%)
    1 / 120 (0.83%)
    1 / 119 (0.84%)
         occurrences all number
    1
    1
    2
    1
    trigger finger
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    torticollis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    vertebral foraminal stenosis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Infections and infestations
    acute sinusitis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    2 / 114 (1.75%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    1
    3
    0
    0
    bronchitis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    7 / 114 (6.14%)
    0 / 120 (0.00%)
    3 / 119 (2.52%)
         occurrences all number
    0
    7
    0
    3
    covid-19
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    6 / 114 (5.26%)
    11 / 114 (9.65%)
    10 / 120 (8.33%)
    8 / 119 (6.72%)
         occurrences all number
    6
    12
    11
    8
    conjunctivitis viral
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences all number
    0
    0
    0
    1
    conjunctivitis bacterial
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences all number
    0
    0
    0
    1
    conjunctivitis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    1 / 120 (0.83%)
    2 / 119 (1.68%)
         occurrences all number
    0
    1
    1
    2
    cystitis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    2 / 120 (1.67%)
    0 / 119 (0.00%)
         occurrences all number
    0
    0
    2
    0
    dengue fever
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences all number
    0
    0
    0
    1
    diverticulitis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences all number
    0
    0
    0
    1
    ear infection
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    erysipelas
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    1
    0
    0
    0
    epstein-barr virus infection
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    0
    0
    1
    0
    fungal infection
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    0
    0
    1
    0
    fungal foot infection
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    fungal skin infection
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    gastroenteritis viral
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences all number
    0
    0
    0
    1
    gastroenteritis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    3 / 114 (2.63%)
    1 / 114 (0.88%)
    4 / 120 (3.33%)
    7 / 119 (5.88%)
         occurrences all number
    3
    1
    4
    8
    gastrointestinal infection
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    2 / 114 (1.75%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    2
    0
    0
    helicobacter infection
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    1
    0
    0
    0
    herpes zoster
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    1
    1
    0
    0
    hordeolum
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    2 / 120 (1.67%)
    0 / 119 (0.00%)
         occurrences all number
    0
    0
    2
    0
    herpes virus infection
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    influenza
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    4 / 114 (3.51%)
    3 / 114 (2.63%)
    8 / 120 (6.67%)
    3 / 119 (2.52%)
         occurrences all number
    5
    3
    8
    3
    lower respiratory tract infection
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    1 / 119 (0.84%)
         occurrences all number
    1
    0
    1
    1
    nasopharyngitis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    3 / 114 (2.63%)
    12 / 114 (10.53%)
    8 / 120 (6.67%)
    15 / 119 (12.61%)
         occurrences all number
    3
    17
    8
    24
    onychomycosis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    1
    0
    0
    0
    oral candidiasis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    0
    0
    1
    0
    otitis externa
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences all number
    0
    1
    0
    1
    otitis media acute
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    1
    0
    0
    0
    parasitic gastroenteritis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    1
    0
    0
    0
    paronychia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences all number
    0
    1
    0
    1
    pharyngitis streptococcal
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    0
    0
    1
    0
    pneumonia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    2 / 114 (1.75%)
    1 / 114 (0.88%)
    2 / 120 (1.67%)
    1 / 119 (0.84%)
         occurrences all number
    2
    1
    2
    1
    post procedural infection
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    postoperative wound infection
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    0
    0
    1
    0
    pseudomembranous colitis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    1
    0
    0
    0
    respiratory tract infection
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    3 / 114 (2.63%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    1 / 119 (0.84%)
         occurrences all number
    3
    0
    1
    1
    pyelonephritis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    respiratory tract infection viral
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    1
    0
    0
    0
    rhinitis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    2 / 114 (1.75%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    2
    0
    0
    sinusitis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    2 / 114 (1.75%)
    5 / 114 (4.39%)
    2 / 120 (1.67%)
    2 / 119 (1.68%)
         occurrences all number
    2
    5
    2
    2
    tonsillitis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    2 / 114 (1.75%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    2
    2
    0
    0
    tinea pedis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences all number
    0
    0
    0
    1
    tooth abscess
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences all number
    1
    1
    0
    1
    tooth infection
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    2 / 119 (1.68%)
         occurrences all number
    0
    0
    0
    2
    upper respiratory tract infection
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    7 / 114 (6.14%)
    8 / 114 (7.02%)
    10 / 120 (8.33%)
    5 / 119 (4.20%)
         occurrences all number
    10
    9
    11
    7
    urinary tract infection
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    2 / 114 (1.75%)
    1 / 114 (0.88%)
    2 / 120 (1.67%)
    0 / 119 (0.00%)
         occurrences all number
    2
    1
    2
    0
    viral infection
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    viral upper respiratory tract infection
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    1 / 120 (0.83%)
    1 / 119 (0.84%)
         occurrences all number
    0
    0
    1
    1
    Metabolism and nutrition disorders
    dehydration
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences all number
    0
    0
    0
    1
    decreased appetite
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    4 / 114 (3.51%)
    3 / 114 (2.63%)
    0 / 120 (0.00%)
    3 / 119 (2.52%)
         occurrences all number
    4
    3
    0
    3
    diabetes mellitus
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    dyslipidaemia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    2 / 114 (1.75%)
    3 / 120 (2.50%)
    0 / 119 (0.00%)
         occurrences all number
    1
    2
    3
    0
    gout
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    2 / 114 (1.75%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    6
    0
    0
    0
    glucose tolerance impaired
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    2 / 120 (1.67%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    2
    0
    hypertriglyceridaemia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    2 / 120 (1.67%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    2
    0
    hyperuricaemia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    2 / 114 (1.75%)
    4 / 114 (3.51%)
    4 / 120 (3.33%)
    0 / 119 (0.00%)
         occurrences all number
    3
    5
    4
    0
    hyperglycaemia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    1 / 120 (0.83%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    1
    0
    hyperkalaemia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    2 / 114 (1.75%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    1
    2
    0
    0
    hyperlipidaemia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    2 / 120 (1.67%)
    1 / 119 (0.84%)
         occurrences all number
    1
    0
    2
    1
    hypoglycaemia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    1
    0
    0
    0
    hyponatraemia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    1 / 119 (0.84%)
         occurrences all number
    1
    0
    0
    1
    increased appetite
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 114 (0.00%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    1
    0
    0
    0
    iron deficiency
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    0
    1
    0
    0
    type 2 diabetes mellitus
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 114 (0.00%)
    3 / 114 (2.63%)
    2 / 120 (1.67%)
    0 / 119 (0.00%)
         occurrences all number
    0
    3
    2
    0
    vitamin d deficiency
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 114 (0.88%)
    1 / 114 (0.88%)
    0 / 120 (0.00%)
    0 / 119 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Notes
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Gender-specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Gender-specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Gender-specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Gender-specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Gender-specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Sep 2022
    Protocol Amendment (b): 1) The secondary objective “Change in AHI." was added. 2) The endpoint for key secondary objective “Change in SBP” has been updated to Week 48 from Week 52. 3) The endpoint for the other secondary objective, “Change in Diastolic Blood Pressure (DBP),” has been updated to Week 48 from Week 52. 4) Changes have been made to the Schedule of Activities to reflect the synchronization of timing of the Columbia-Suicide Severity Rating Scale (C-SSRS) to the Patient Health Questionnaire-9 (PHQ-9).

    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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