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    Clinical Trial Results:
    Phase 3, External Placebo-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Patients with Neuromyelitis Optica Spectrum Disorder (NMOSD)

    Summary
    EudraCT number
    		 2019-003352-37
    Trial protocol
    		 FR   DK   GB   DE   ES   AT   PL   IT  
    Global end of trial date
    01 Nov 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Aug 2025
    First version publication date
    30 Aug 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ALXN1210-NMO-307
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04201262
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Other Identifier: Alexion Pharmaceuticals: CHAMPION-NMO-307
    Sponsors
    Sponsor organisation name
    Alexion Pharmaceuticals, Inc.
    Sponsor organisation address
    121 Seaport Boulevard, Boston, MA, United States, 02210
    Public contact
    European Clinical Trial Information, Alexion Pharmaceuticals, Inc., +35 3874162507, clinicaltrials.eu@alexion.com
    Scientific contact
    European Clinical Trial Information, Alexion Pharmaceuticals, Inc., +35 3874162507, clinicaltrials.eu@alexion.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    01 Nov 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Nov 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the effect of ravulizumab on adjudicated On-trial Relapses in adult participants with neuromyelitis optica spectrum disorder (NMOSD).
    Protection of trial subjects
    This study was conducted in accordance with the protocol and consensus ethical principles derived from international guidelines including the Declaration of Helsinki, Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines, applicable International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Good Clinical Practice (ICH GCP) Guidelines, and other applicable laws and regulations.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Dec 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 1
    Country: Number of subjects enrolled
    Australia: 3
    Country: Number of subjects enrolled
    Canada: 1
    Country: Number of subjects enrolled
    Germany: 7
    Country: Number of subjects enrolled
    Denmark: 2
    Country: Number of subjects enrolled
    Spain: 4
    Country: Number of subjects enrolled
    United Kingdom: 4
    Country: Number of subjects enrolled
    Hong Kong: 1
    Country: Number of subjects enrolled
    Croatia: 1
    Country: Number of subjects enrolled
    Italy: 6
    Country: Number of subjects enrolled
    Japan: 14
    Country: Number of subjects enrolled
    Korea, Republic of: 13
    Country: Number of subjects enrolled
    Poland: 4
    Country: Number of subjects enrolled
    Russian Federation: 4
    Country: Number of subjects enrolled
    Türkiye: 4
    Country: Number of subjects enrolled
    Taiwan: 2
    Country: Number of subjects enrolled
    United States: 34
    Worldwide total number of subjects
    105
    EEA total number of subjects
    24
    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)
    95
    From 65 to 84 years
    10
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study utilized the placebo group from Study ECU-NMO-301 (NCT01892345) as an external placebo control.

    Pre-assignment
    Screening details
    		 Participants were screened for eligibility for up to 6 weeks during the Screening Period.

    Period 1
    Period 1 title
    Primary Treatment Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ravulizumab
    Arm description
    		 Participants received a weight-based loading dose of ravulizumab via intravenous (IV) infusion on Day 1, followed by weight-based maintenance doses on Day 15, then once every 8 weeks until the end of primary treatment period (up to 2.25 years). After the primary treatment period, participants continued to receive ravulizumab during the Long-Term Extension Period for up to approximately 3 years.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ravulizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    As specified in the arm description.

    Arm title
    		 Placebo (ECU-NMO-301)
    Arm description
    		 Participants who received eculizumab matching placebo in study ECU-NMO-301.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Ravulizumab Placebo (ECU-NMO-301)
    Started
    58
    47
    Received at Least 1 Dose of Study Drug
    58
    47
    Completed
    56
    44
    Not completed
    2
    3
         Physician decision
    1
    1
         Adverse event, non-fatal
    1
    2
    Period 2
    Period 2 title
    Long-term Extension Period
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Ravulizumab
    Arm description
    		 Participants received a weight-based loading dose of ravulizumab via intravenous (IV) infusion on Day 1, followed by weight-based maintenance doses on Day 15, then once every 8 weeks until the end of primary treatment period (up to 2.25 years). After the primary treatment period, participants continued to receive ravulizumab during the Long-Term Extension Period for up to approximately 3 years.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ravulizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    As specified in the arm description.

    Number of subjects in period 2 [1]
    		Ravulizumab
    Started
    56
    Received at Least 1 Dose of Study Drug
    56
    Completed
    55
    Not completed
    1
         Adverse event, serious fatal
    1
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Participants who entered the LTE period.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ravulizumab
    Reporting group description
    		 Participants received a weight-based loading dose of ravulizumab via intravenous (IV) infusion on Day 1, followed by weight-based maintenance doses on Day 15, then once every 8 weeks until the end of primary treatment period (up to 2.25 years). After the primary treatment period, participants continued to receive ravulizumab during the Long-Term Extension Period for up to approximately 3 years.

    Reporting group title
    Placebo (ECU-NMO-301)
    Reporting group description
    		 Participants who received eculizumab matching placebo in study ECU-NMO-301.

    Reporting group values
    		 Ravulizumab Placebo (ECU-NMO-301) Total
    Number of subjects
    		 58 47 105
    Age Categorical
    Units: participants
        <=18 years
    		 0 0 0
        Between 18 and 65 years
    		 51 44 95
        >=65 years
    		 7 3 10
    Sex: Female, Male
    Units: participants
        Female
    		 52 42 94
        Male
    		 6 5 11
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 9 3 12
        Not Hispanic or Latino
    		 45 41 86
        Unknown or Not Reported
    		 4 3 7
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 21 15 36
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 6 8 14
        White
    		 29 24 53
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 2 0 2

    End points

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    End points reporting groups
    Reporting group title
    Ravulizumab
    Reporting group description
    		 Participants received a weight-based loading dose of ravulizumab via intravenous (IV) infusion on Day 1, followed by weight-based maintenance doses on Day 15, then once every 8 weeks until the end of primary treatment period (up to 2.25 years). After the primary treatment period, participants continued to receive ravulizumab during the Long-Term Extension Period for up to approximately 3 years.

    Reporting group title
    Placebo (ECU-NMO-301)
    Reporting group description
    		 Participants who received eculizumab matching placebo in study ECU-NMO-301.
    Reporting group title
    Ravulizumab
    Reporting group description
    		 Participants received a weight-based loading dose of ravulizumab via intravenous (IV) infusion on Day 1, followed by weight-based maintenance doses on Day 15, then once every 8 weeks until the end of primary treatment period (up to 2.25 years). After the primary treatment period, participants continued to receive ravulizumab during the Long-Term Extension Period for up to approximately 3 years.

    Primary: Number of Participants With an Adjudicated On-trial Relapse in the Primary Treatment Period

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    End point title
    		 Number of Participants With an Adjudicated On-trial Relapse in the Primary Treatment Period
    End point description
    An On-trial Relapse was defined as a new onset of neurologic symptoms or worsening of existing neurologic symptoms with an objective change (clinical sign) on neurologic examination that persisted for more than 24 hours as confirmed by the treating physician. An adjudicated On-trial Relapse was defined by the protocol and positively adjudicated by the independent relapse adjudication committee. The full analysis set (FAS) included all participants who had received at least 1 dose of study drug (ravulizumab or placebo).
    End point type
    Primary
    End point timeframe
    Baseline up to 2.25 years (end of the Primary Treatment Period)
    End point values
    		 Ravulizumab Placebo (ECU-NMO-301)
    Number of subjects analysed
    58
    47
    Units: participants
    0
    20
    Statistical analysis title
    		 Ravulizumab vs placebo
    Comparison groups
    Ravulizumab v Placebo (ECU-NMO-301)
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.014
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0.103

    Secondary: Adjudicated On-trial Annualized Relapse Rate (ARR) in the Primary Treatment Period

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    End point title
    		 Adjudicated On-trial Annualized Relapse Rate (ARR) in the Primary Treatment Period
    End point description
    The adjudicated On-trial ARR was computed as the total number of relapses divided by the total number of participant years in the study period. A central independent committee was used to adjudicate all On-trial Relapses as determined by the treating physician. Results reported as adjusted adjudicated On-trial ARR based on a Poisson regression centered on the mean historical ARR in the 24 months prior to screening. 9999 = Since there were no relapses, data could not be estimated. The FAS included all participants who had received at least 1 dose of study drug (ravulizumab or placebo).
    End point type
    Secondary
    End point timeframe
    Baseline up to 2.25 years (end of the Primary Treatment Period)
    End point values
    		 Ravulizumab Placebo (ECU-NMO-301)
    Number of subjects analysed
    58
    47
    Units: relapses/year on study
        number (confidence interval 95%)
    0.000 (-9999 to 9999)
    0.350 (0.199 to 0.616)
    No statistical analyses for this end point

    Secondary: Number of Participants With Clinically Important Change From Baseline in Hauser Ambulation Index (HAI) Score at the End of Primary Treatment Period

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    End point title
    		 Number of Participants With Clinically Important Change From Baseline in Hauser Ambulation Index (HAI) Score at the End of Primary Treatment Period
    End point description
    The HAI is a rating scale developed to assess mobility by evaluating the time and degree of assistance required to walk 25 feet. The scale ranges from 0 to 9, with 0 being the best score (asymptomatic; fully ambulatory with no assistance) and 9 being the worst (restricted to wheelchair; unable to transfer self independently). Clinically important change is conditional on the baseline value: worsening if the baseline HAI is 0 and at least 2 points increase or if the baseline HAI is >0 and at least 1 point increase; improvement if the baseline value is at least 2 and at least 1 point decrease; and stable if baseline is 0 or 1 and a 0- or 1-point increase or decrease or baseline is at least 2 and not change. The FAS included all participants who had received at least 1 dose of study drug (ravulizumab or placebo).
    End point type
    Secondary
    End point timeframe
    Baseline up to 2.25 years (end of the Primary Treatment Period)
    End point values
    		 Ravulizumab Placebo (ECU-NMO-301)
    Number of subjects analysed
    58
    47
    Units: participants
        Clinical Improvement
    4
    4
        Stable
    52
    32
        Clinical Worsening
    2
    11
    Statistical analysis title
    		 Ravulizumab vs placebo
    Statistical analysis description
    The test of proportional odds was determined from a score test. The proportional odds was evaluated in univariate models.
    Comparison groups
    Ravulizumab v Placebo (ECU-NMO-301)
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0122 [1]
    Method
    		 Univariate models
    Confidence interval
    Notes
    [1] - Proportional Odds p-value

    Secondary: Change From Baseline in European Quality of Life Health 5-dimension Questionnaire (EQ-5D) Index Score at the End of Primary Treatment Period

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    End point title
    		 Change From Baseline in European Quality of Life Health 5-dimension Questionnaire (EQ-5D) Index Score at the End of Primary Treatment Period
    End point description
    The EQ-5D is a generic, standardized, self-administered instrument that provides a simple, descriptive profile and a single index value for health status. It consists of 2 parts; the EQ-5D descriptive system and the EQ-5D visual analogue scale (VAS). The EQ-5D descriptive system includes 5 dimensions; mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension measured on 3 levels: "no problem" (level 1), "some problems" (level 2), "extreme problems" (level 3). The digits for 5 dimensions can be combined in a 5-digit number describing the respondent's health state. The 5 dimensional 3-level systems was converted into single index utility score that ranges from less than 0 to 1, with higher scores representing a better health status. The FAS included all participants who had received at least 1 dose of study drug (ravulizumab or placebo).
    End point type
    Secondary
    End point timeframe
    Baseline, up to 2.25 years (end of the Primary Treatment Period)
    End point values
    		 Ravulizumab Placebo (ECU-NMO-301)
    Number of subjects analysed
    58
    47
    Units: units on a scale
        arithmetic mean (standard deviation)
    0.005 ( 0.1522 )
    -0.043 ( 0.2115 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in EQ-5D Visual Analog Scale (VAS) Score at the End of Primary Treatment Period

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    End point title
    		 Change From Baseline in EQ-5D Visual Analog Scale (VAS) Score at the End of Primary Treatment Period
    End point description
    The EQ-5D is a generic, standardized, self-administered instrument that provides a simple, descriptive profile and a single index value for health status. It consists of 2 parts; the EQ-5D descriptive system and the EQ-5D visual analogue scale (VAS). The EQ-5D VAS is an overall health state scale where the participant selects a number between 0 to 100 to describe the condition of their health, with 100 being ‘The best health state you can imagine’ and 0 being ‘The worst health state you can imagine’. An increase in score indicates improvement. The FAS included all participants who had received at least 1 dose of study drug (ravulizumab or placebo).
    End point type
    Secondary
    End point timeframe
    Baseline, up to 2.25 years (end of the Primary Treatment Period)
    End point values
    		 Ravulizumab Placebo (ECU-NMO-301)
    Number of subjects analysed
    58
    47
    Units: units on a scale
        arithmetic mean (standard deviation)
    2.6 ( 14.07 )
    0.6 ( 16.39 )
    No statistical analyses for this end point

    Secondary: Number of Participants With Clinically Important Worsening From Baseline in Expanded Disability Status Scale (EDSS) Score at the End of Primary Treatment Period

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    End point title
    		 Number of Participants With Clinically Important Worsening From Baseline in Expanded Disability Status Scale (EDSS) Score at the End of Primary Treatment Period
    End point description
    Disease-related disability was measured by the EDSS. The EDSS is an ordinal clinical rating scale that ranges from 0 (normal neurologic examination) to 10 (death) in half-point increments. Clinically important worsening was defined as an increase in EDSS score conditional on the baseline value: If the baseline EDSS was 0 and at least 2-point increase; if the baseline is 1 to 5, and at least 1-point increase; if the baseline is > 5 and at least 0.5 increase. The FAS included all participants who had received at least 1 dose of study drug (ravulizumab or placebo).
    End point type
    Secondary
    End point timeframe
    Baseline up to 2.25 years (end of the Primary Treatment Period)
    End point values
    		 Ravulizumab Placebo (ECU-NMO-301)
    Number of subjects analysed
    58
    47
    Units: participants
        No clinically important worsening
    52
    36
        Clinically important worsening
    6
    11
    No statistical analyses for this end point

    Secondary: Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and TEAEs Leading to Study Drug Discontinuation in the Primary Treatment Period

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    End point title
    		 Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and TEAEs Leading to Study Drug Discontinuation in the Primary Treatment Period
    End point description
    An AE was as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An SAE was an AE that met at least 1 of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization for the AE, persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug), important medical event or reaction. TEAEs were AEs with a start date on or after the date of the first dose of study drug. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the ‘Reported Adverse Events’ Section. The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo).
    End point type
    Secondary
    End point timeframe
    Baseline up to 2.25 years (end of the Primary Treatment Period)
    End point values
    		 Ravulizumab Placebo (ECU-NMO-301)
    Number of subjects analysed
    58
    47
    Units: participants
        Any TEAEs
    53
    45
        TESAEs
    8
    26
        TEAEs Leading to Study Drug Discontinuation
    1
    2
    No statistical analyses for this end point

    Secondary: Serum Ravulizumab Concentration

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    End point title
    		 Serum Ravulizumab Concentration [2]
    End point description
    Pharmacokinetics/pharmacodynamics (PK/PD) analysis set included participants who received at least 1 dose of study drug and who had at least 1 evaluable PK or PD result. Here, 'Number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed (n)' = participants evaluable at specified timepoint.
    End point type
    Secondary
    End point timeframe
    Predose and end of infusion (EOI) at Week 26
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data collected and reported for treatment arm only, as pre-specified.
    End point values
    		 Ravulizumab
    Number of subjects analysed
    56
    Units: micrograms (µg)/milliliter (mL)
    arithmetic mean (standard deviation)
        Week 26: Predose (n=55)
    760.3 ( 202.75 )
        Week 26: EOI (n=56)
    1836.4 ( 355.39 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Serum Free C5 Concentration at Week 26

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    End point title
    		 Change From Baseline in Serum Free C5 Concentration at Week 26 [3]
    End point description
    The PK/PD analysis set included participants who received at least 1 dose of study drug and who had at least 1 evaluable PK or PD result. Here, 'Number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed (n)' = participants evaluable at specified timepoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 26 (Predose and EOI)
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data collected and reported for treatment arm only, as pre-specified.
    End point values
    		 Ravulizumab
    Number of subjects analysed
    55
    Units: µg/mL
    arithmetic mean (standard deviation)
        Change at Week 26: Predose (n=54)
    -119.02 ( 42.857 )
        Change at Week 26: EOI (n=55)
    -119.32 ( 42.512 )
    No statistical analyses for this end point

    Secondary: Number of Participants With Anti-drug Antibodies (ADAs) During the Primary Treatment Period

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    End point title
    		 Number of Participants With Anti-drug Antibodies (ADAs) During the Primary Treatment Period [4]
    End point description
    The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Here, 'Number analyzed (n)' = participants evaluable at specified timepoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 26, 50, 82, and 106
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data collected and reported for treatment arm only, as pre-specified.
    End point values
    		 Ravulizumab
    Number of subjects analysed
    58
    Units: participants
        Baseline|Positive (n=58)
    5
        Week 26|Positive (n=55)
    1
        Week 50|Positive (n=52)
    0
        Week 82|Positive (n=15)
    0
        Week 106|Positive (n=1)
    0
        Baseline|Negative (n=58)
    53
        Week 26|Negative (n=55)
    54
        Week 50|Negative (n=52)
    52
        Week 82|Negative (n=15)
    15
        Week 106|Negative (n=1)
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to approximately 5.5 years
    Adverse event reporting additional description
    Safety set, all participants who received at least 1 dose of study drug (ravulizumab or placebo). Per pre-specified analysis, data for the placebo arm (study ECU-NMO-301) was reported for primary analysis results only. Data were collected/reported for the ravulizumab arm for the primary treatment period and long-term extension period separately.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.1
    Reporting groups
    Reporting group title
    Primary Treatment Period: Placebo
    Reporting group description
    		 Participants who received eculizumab matching placebo in study ECU-NMO-301.

    Reporting group title
    Long-Term Extension: Ravulizumab
    Reporting group description
    		 Participants received a weight-based loading dose of ravulizumab via intravenous (IV) infusion on Day 1, followed by weight-based maintenance doses on Day 15, then once every 8 weeks until the end of primary treatment period (up to 2.25 years). After the primary treatment period, participants continued to receive ravulizumab during the Long-Term Extension Period for up to approximately 3 years.

    Reporting group title
    Primary Treatment Period: Ravulizumab
    Reporting group description
    		 Participants received a weight-based loading dose of ravulizumab via intravenous (IV) infusion on Day 1, followed by weight-based maintenance doses on Day 15, then once every 8 weeks until the end of primary treatment period (up to 2.25 years). After the primary treatment period, participants continued to receive ravulizumab during the Long-Term Extension Period for up to approximately 3 years.

    Serious adverse events
    		 Primary Treatment Period: Placebo Long-Term Extension: Ravulizumab Primary Treatment Period: Ravulizumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    26 / 47 (55.32%)
    9 / 56 (16.07%)
    8 / 58 (13.79%)
         number of deaths (all causes)
    0
    1
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Invasive lobular breast carcinoma
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Adenocarcinoma
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Salivary gland neoplasm
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Orthostatic hypotension
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Respiratory disorder
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pleurisy
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Rib fracture
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ulna fracture
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post lumbar puncture syndrome
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ankle fracture
         subjects affected / exposed
    0 / 47 (0.00%)
    2 / 56 (3.57%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Myocardial ischaemia
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypertensive heart disease
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Cardiac failure
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Myelitis transverse
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neuromyelitis optica spectrum disorder
         subjects affected / exposed
    16 / 47 (34.04%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Paraesthesia
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Somnolence
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neuromyelitis optica pseudo relapse
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Pancytopenia
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Cataract
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Pancreatitis
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Muscular weakness
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal osteoarthritis
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Meningococcal sepsis
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intervertebral discitis
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Encephalitis meningococcal
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 56 (1.79%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumococcal infection
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Primary Treatment Period: Placebo Long-Term Extension: Ravulizumab Primary Treatment Period: Ravulizumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    43 / 47 (91.49%)
    49 / 56 (87.50%)
    53 / 58 (91.38%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Neoplasm skin
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Skin papilloma
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    1 / 58 (1.72%)
         occurrences all number
    0
    1
    1
    Uterine leiomyoma
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Anogenital warts
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Basal cell carcinoma
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Colorectal adenoma
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Benign soft tissue neoplasm
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Dysplastic naevus
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Vascular disorders
    Orthostatic hypotension
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Hypotension
         subjects affected / exposed
    2 / 47 (4.26%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    3
    0
    0
    Flushing
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Lymphoedema
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    2
    Deep vein thrombosis
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Hypertension
         subjects affected / exposed
    2 / 47 (4.26%)
    1 / 56 (1.79%)
    2 / 58 (3.45%)
         occurrences all number
    2
    2
    2
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    2 / 47 (4.26%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    12
    0
    1
    Chest discomfort
         subjects affected / exposed
    2 / 47 (4.26%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    2
    0
    1
    Axillary pain
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Asthenia
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    2 / 58 (3.45%)
         occurrences all number
    1
    0
    2
    Chills
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    3 / 58 (5.17%)
         occurrences all number
    0
    0
    5
    Swelling face
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Pyrexia
         subjects affected / exposed
    4 / 47 (8.51%)
    1 / 56 (1.79%)
    5 / 58 (8.62%)
         occurrences all number
    5
    1
    6
    Peripheral swelling
         subjects affected / exposed
    2 / 47 (4.26%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    3
    0
    1
    Pain
         subjects affected / exposed
    4 / 47 (8.51%)
    0 / 56 (0.00%)
    2 / 58 (3.45%)
         occurrences all number
    7
    0
    2
    Oedema peripheral
         subjects affected / exposed
    3 / 47 (6.38%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    3
    1
    0
    Oedema
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    2 / 58 (3.45%)
         occurrences all number
    0
    0
    2
    Malaise
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    3 / 58 (5.17%)
         occurrences all number
    0
    0
    3
    Injection site reaction
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Influenza like illness
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    3
    0
    2
    Induration
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Cyst
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Fatigue
         subjects affected / exposed
    5 / 47 (10.64%)
    1 / 56 (1.79%)
    3 / 58 (5.17%)
         occurrences all number
    5
    1
    3
    Feeling cold
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    2
    0
    0
    Gait disturbance
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Generalised oedema
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Vaccination site pruritus
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Vaccination site pain
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    3 / 58 (5.17%)
         occurrences all number
    0
    1
    3
    Immune system disorders
    Allergy to arthropod bite
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Seasonal allergy
         subjects affected / exposed
    2 / 47 (4.26%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    2
    1
    0
    Social circumstances
    Menopause
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Reproductive system and breast disorders
    Menopausal symptoms
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    1
    0
    1
    Vulvovaginal pruritus
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Dysmenorrhoea
         subjects affected / exposed
    2 / 47 (4.26%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    2
    0
    0
    Endometrial hyperplasia
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Menstruation irregular
         subjects affected / exposed
    2 / 47 (4.26%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    2
    0
    0
    Breast pain
         subjects affected / exposed
    0 / 47 (0.00%)
    2 / 56 (3.57%)
    0 / 58 (0.00%)
         occurrences all number
    0
    2
    0
    Intermenstrual bleeding
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Lactation insufficiency
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Heavy menstrual bleeding
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Respiratory disorder
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Rhinorrhoea
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    1
    1
    0
    Sinus disorder
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Cough
         subjects affected / exposed
    6 / 47 (12.77%)
    3 / 56 (5.36%)
    3 / 58 (5.17%)
         occurrences all number
    8
    4
    3
    Dyspnoea
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 56 (1.79%)
    1 / 58 (1.72%)
         occurrences all number
    1
    1
    1
    Epistaxis
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    1
    0
    2
    Hiccups
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Obstructive sleep apnoea syndrome
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Rhinitis allergic
         subjects affected / exposed
    3 / 47 (6.38%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    3
    0
    1
    Sinus congestion
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    1 / 58 (1.72%)
         occurrences all number
    0
    1
    1
    Atelectasis
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    2
    0
    0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Dysphonia
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Nasal congestion
         subjects affected / exposed
    3 / 47 (6.38%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    3
    0
    0
    Nasal discomfort
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    2 / 47 (4.26%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    2
    1
    0
    Productive cough
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Tonsillolith
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Upper-airway cough syndrome
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Catarrh
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    2
    0
    Cough variant asthma
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Interstitial lung disease
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Paranasal sinus inflammation
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Pleural thickening
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Pneumothorax
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    2 / 58 (3.45%)
         occurrences all number
    1
    0
    2
    Insomnia
         subjects affected / exposed
    4 / 47 (8.51%)
    2 / 56 (3.57%)
    2 / 58 (3.45%)
         occurrences all number
    4
    2
    2
    Depressed mood
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Depression
         subjects affected / exposed
    4 / 47 (8.51%)
    3 / 56 (5.36%)
    1 / 58 (1.72%)
         occurrences all number
    5
    3
    1
    Post-traumatic stress disorder
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Suicidal ideation
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Agitation
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Delusion
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Hallucination
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    1
    0
    1
    Obsessive-compulsive disorder
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Persistent depressive disorder
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Sleep disorder
         subjects affected / exposed
    2 / 47 (4.26%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    3
    0
    0
    Sleep talking
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Attention deficit hyperactivity disorder
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Product issues
    Medical device entrapment
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Investigations
    Gardnerella test positive
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Hepatic enzyme increased
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    2 / 58 (3.45%)
         occurrences all number
    1
    0
    2
    Lymphocyte count decreased
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    2 / 58 (3.45%)
         occurrences all number
    1
    0
    2
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    1 / 58 (1.72%)
         occurrences all number
    0
    1
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    1
    0
    1
    Haemoglobin decreased
         subjects affected / exposed
    2 / 47 (4.26%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    2
    0
    1
    SARS-CoV-2 test positive
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    1 / 58 (1.72%)
         occurrences all number
    0
    1
    1
    Urinary occult blood
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    2
    Blood potassium decreased
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Blood pressure systolic increased
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Bone density decreased
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Cortisol decreased
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Electrocardiogram abnormal
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    2
    0
    0
    Neutrophil count decreased
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Weight increased
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    White blood cell count decreased
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Weight decreased
         subjects affected / exposed
    3 / 47 (6.38%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    3
    0
    0
    Antinuclear antibody positive
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Blood creatinine increased
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    1
    0
    1
    Blood glucose increased
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Blood urea increased
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Culture cervix positive
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Protein urine present
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Red blood cell sedimentation rate increased
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Blood creatinine decreased
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Injury, poisoning and procedural complications
    Head injury
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    3
    1
    0
    Infusion related reaction
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    3 / 58 (5.17%)
         occurrences all number
    0
    0
    6
    Alcohol poisoning
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Cartilage injury
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Concussion
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Joint dislocation
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Ligament sprain
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 56 (1.79%)
    1 / 58 (1.72%)
         occurrences all number
    1
    1
    1
    Limb injury
         subjects affected / exposed
    0 / 47 (0.00%)
    2 / 56 (3.57%)
    1 / 58 (1.72%)
         occurrences all number
    0
    2
    1
    Muscle strain
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    1 / 58 (1.72%)
         occurrences all number
    0
    1
    1
    Post lumbar puncture syndrome
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 56 (1.79%)
    1 / 58 (1.72%)
         occurrences all number
    1
    1
    1
    Rib fracture
         subjects affected / exposed
    2 / 47 (4.26%)
    1 / 56 (1.79%)
    1 / 58 (1.72%)
         occurrences all number
    2
    1
    1
    Skin abrasion
         subjects affected / exposed
    2 / 47 (4.26%)
    1 / 56 (1.79%)
    1 / 58 (1.72%)
         occurrences all number
    3
    1
    1
    Tooth fracture
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    1 / 58 (1.72%)
         occurrences all number
    0
    1
    1
    Chillblains
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Contusion
         subjects affected / exposed
    2 / 47 (4.26%)
    2 / 56 (3.57%)
    0 / 58 (0.00%)
         occurrences all number
    6
    2
    0
    Fall
         subjects affected / exposed
    4 / 47 (8.51%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    8
    2
    0
    Fibula fracture
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Foot fracture
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    1
    1
    0
    Fractured sacrum
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Injury
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    1
    1
    0
    Procedural complication
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Skin laceration
         subjects affected / exposed
    2 / 47 (4.26%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    3
    0
    0
    Stress fracture
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Thermal burn
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Thoracic vertebral fracture
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Wound
         subjects affected / exposed
    2 / 47 (4.26%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    2
    0
    0
    Post procedural contusion
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Immunisation reaction
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    2 / 58 (3.45%)
         occurrences all number
    1
    0
    3
    Animal bite
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Ankle fracture
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Arthropod bite
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Arthropod sting
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Hand fracture
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Procedural headache
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Procedural pain
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Pulmonary contusion
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Wound complication
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Foreign body
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Cardiac disorders
    Extrasystoles
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Tachycardia
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Bradycardia
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Pericardial effusion
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Heart failure with preserved ejection fraction
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    6 / 47 (12.77%)
    1 / 56 (1.79%)
    4 / 58 (6.90%)
         occurrences all number
    6
    1
    4
    Headache
         subjects affected / exposed
    10 / 47 (21.28%)
    5 / 56 (8.93%)
    15 / 58 (25.86%)
         occurrences all number
    17
    6
    25
    Migraine
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    3 / 58 (5.17%)
         occurrences all number
    0
    0
    4
    Paraesthesia
         subjects affected / exposed
    3 / 47 (6.38%)
    0 / 56 (0.00%)
    2 / 58 (3.45%)
         occurrences all number
    4
    0
    3
    Hypoaesthesia
         subjects affected / exposed
    4 / 47 (8.51%)
    1 / 56 (1.79%)
    1 / 58 (1.72%)
         occurrences all number
    5
    1
    1
    Memory impairment
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    1
    0
    2
    Parosmia
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Presyncope
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Sensory disturbance
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Somnolence
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    1
    0
    1
    Syncope
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    1 / 58 (1.72%)
         occurrences all number
    0
    1
    1
    Burning sensation
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Dysgeusia
         subjects affected / exposed
    2 / 47 (4.26%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    2
    0
    0
    Head discomfort
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Mental impairment
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Muscle contractions involuntary
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Muscle spasticity
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Neuralgia
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    1
    1
    0
    Post herpetic neuralgia
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Uhthoff's phenomenon
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Neuromyelitis optica pseudo relapse
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Facial paralysis
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Carpal tunnel syndrome
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Partial seizures with secondary generalisation
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    2
    0
    Tremor
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Migraine with aura
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 56 (1.79%)
    3 / 58 (5.17%)
         occurrences all number
    2
    1
    3
    Anaemia
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    1
    0
    1
    Iron deficiency anaemia
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    1
    1
    0
    Leukopenia
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Neutropenia
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Macrocytosis
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Lymphopenia
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 47 (2.13%)
    3 / 56 (5.36%)
    3 / 58 (5.17%)
         occurrences all number
    1
    3
    3
    Ear pain
         subjects affected / exposed
    2 / 47 (4.26%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    3
    0
    1
    Paraesthesia ear
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    2
    Eustachian tube dysfunction
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Tinnitus
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    1 / 58 (1.72%)
         occurrences all number
    0
    1
    1
    Eye disorders
    Conjunctivitis allergic
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    1
    0
    1
    Blepharitis
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    2 / 58 (3.45%)
         occurrences all number
    0
    0
    2
    Eye disorder
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Eye pain
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    1
    0
    1
    Ocular discomfort
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Ocular hyperaemia
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Vision blurred
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    1
    0
    1
    Visual impairment
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    1
    0
    1
    Conjunctival haemorrhage
         subjects affected / exposed
    2 / 47 (4.26%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    2
    0
    0
    Photophobia
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Retinal degeneration
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    2
    0
    0
    Cataract
         subjects affected / exposed
    2 / 47 (4.26%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    2
    0
    0
    Photopsia
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Eyelid ptosis
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Dry eye
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    6 / 47 (12.77%)
    5 / 56 (8.93%)
    3 / 58 (5.17%)
         occurrences all number
    14
    6
    3
    Constipation
         subjects affected / exposed
    3 / 47 (6.38%)
    0 / 56 (0.00%)
    4 / 58 (6.90%)
         occurrences all number
    3
    0
    5
    Vomiting
         subjects affected / exposed
    8 / 47 (17.02%)
    1 / 56 (1.79%)
    4 / 58 (6.90%)
         occurrences all number
    10
    1
    5
    Gastrooesophageal reflux disease
         subjects affected / exposed
    3 / 47 (6.38%)
    1 / 56 (1.79%)
    3 / 58 (5.17%)
         occurrences all number
    5
    1
    4
    Nausea
         subjects affected / exposed
    12 / 47 (25.53%)
    3 / 56 (5.36%)
    2 / 58 (3.45%)
         occurrences all number
    17
    3
    2
    Abdominal distension
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Alveolar bone resorption
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Anal incontinence
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Dry mouth
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 56 (1.79%)
    2 / 58 (3.45%)
         occurrences all number
    1
    1
    2
    Abdominal tenderness
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Food poisoning
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Gastric ulcer
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Periodontal disease
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    2
    Stomatitis
         subjects affected / exposed
    2 / 47 (4.26%)
    1 / 56 (1.79%)
    1 / 58 (1.72%)
         occurrences all number
    2
    1
    3
    Abdominal pain
         subjects affected / exposed
    2 / 47 (4.26%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    3
    0
    0
    Abdominal pain upper
         subjects affected / exposed
    3 / 47 (6.38%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    3
    0
    1
    Dyspepsia
         subjects affected / exposed
    4 / 47 (8.51%)
    1 / 56 (1.79%)
    1 / 58 (1.72%)
         occurrences all number
    4
    1
    2
    Angular cheilitis
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Aphthous ulcer
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    2
    0
    0
    Colitis microscopic
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Gingival pain
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    2
    0
    0
    Intestinal obstruction
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Lip blister
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Mouth ulceration
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Presbyoesophagus
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Toothache
         subjects affected / exposed
    2 / 47 (4.26%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    2
    1
    0
    Lip pain
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    2
    0
    0
    Gastritis
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Dysphagia
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Dental caries
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Abdominal pain lower
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Abdominal fat apron
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Faeces soft
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Rectal polyp
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Pancreatic cyst
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Hiatus hernia
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Haematochezia
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Anorectal discomfort
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Hepatobiliary disorders
    Hepatic function abnormal
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Hepatic steatosis
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    1 / 58 (1.72%)
         occurrences all number
    0
    1
    1
    Cholecystitis
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Cholelithiasis
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Rash maculo-papular
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Acne
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    2 / 58 (3.45%)
         occurrences all number
    1
    0
    2
    Alopecia
         subjects affected / exposed
    2 / 47 (4.26%)
    1 / 56 (1.79%)
    2 / 58 (3.45%)
         occurrences all number
    2
    1
    2
    Rash
         subjects affected / exposed
    4 / 47 (8.51%)
    1 / 56 (1.79%)
    2 / 58 (3.45%)
         occurrences all number
    4
    1
    2
    Dermatitis
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    2 / 58 (3.45%)
         occurrences all number
    1
    0
    2
    Dry skin
         subjects affected / exposed
    2 / 47 (4.26%)
    0 / 56 (0.00%)
    2 / 58 (3.45%)
         occurrences all number
    2
    0
    2
    Eczema
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 56 (1.79%)
    1 / 58 (1.72%)
         occurrences all number
    1
    1
    1
    Erythema
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    1
    0
    1
    Hyperkeratosis
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Ingrowing nail
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Pruritus
         subjects affected / exposed
    4 / 47 (8.51%)
    2 / 56 (3.57%)
    1 / 58 (1.72%)
         occurrences all number
    8
    2
    1
    Psoriasis
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Sensitive skin
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Urticaria
         subjects affected / exposed
    2 / 47 (4.26%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    2
    0
    1
    Dermatitis allergic
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    1
    1
    0
    Dermatitis contact
         subjects affected / exposed
    2 / 47 (4.26%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    3
    0
    0
    Hyperhidrosis
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Petechiae
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Pityriasis rosea
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    2
    0
    0
    Purpura
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Skin lesion
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Androgenetic alopecia
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Dyshidrotic eczema
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Pigmentation disorder
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    2 / 58 (3.45%)
         occurrences all number
    0
    1
    2
    Acute kidney injury
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    1
    0
    1
    Haematuria
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    1
    0
    1
    Proteinuria
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Strangury
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    1 / 58 (1.72%)
         occurrences all number
    0
    1
    5
    Cystitis interstitial
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Glycosuria
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Nephrolithiasis
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Pollakiuria
         subjects affected / exposed
    2 / 47 (4.26%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    2
    0
    0
    Prerenal failure
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    2
    0
    0
    Urethral syndrome
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Urinary incontinence
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Cystitis-like symptom
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Micturition urgency
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Endocrine disorders
    Thyroid cyst
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Thyroid mass
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    1 / 58 (1.72%)
         occurrences all number
    0
    1
    1
    Musculoskeletal and connective tissue disorders
    Muscle spasms
         subjects affected / exposed
    2 / 47 (4.26%)
    1 / 56 (1.79%)
    1 / 58 (1.72%)
         occurrences all number
    2
    1
    1
    Back pain
         subjects affected / exposed
    6 / 47 (12.77%)
    2 / 56 (3.57%)
    7 / 58 (12.07%)
         occurrences all number
    9
    3
    8
    Arthralgia
         subjects affected / exposed
    4 / 47 (8.51%)
    2 / 56 (3.57%)
    6 / 58 (10.34%)
         occurrences all number
    9
    2
    6
    Myalgia
         subjects affected / exposed
    3 / 47 (6.38%)
    0 / 56 (0.00%)
    3 / 58 (5.17%)
         occurrences all number
    3
    0
    3
    Neck pain
         subjects affected / exposed
    2 / 47 (4.26%)
    0 / 56 (0.00%)
    2 / 58 (3.45%)
         occurrences all number
    2
    0
    2
    Pain in extremity
         subjects affected / exposed
    10 / 47 (21.28%)
    2 / 56 (3.57%)
    2 / 58 (3.45%)
         occurrences all number
    11
    3
    2
    Joint swelling
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Limb discomfort
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Musculoskeletal discomfort
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Periarthritis
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Rheumatoid arthritis
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Flank pain
         subjects affected / exposed
    2 / 47 (4.26%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    2
    0
    0
    Fracture pain
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Intervertebral disc protrusion
         subjects affected / exposed
    2 / 47 (4.26%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    2
    0
    0
    Muscular weakness
         subjects affected / exposed
    2 / 47 (4.26%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    2
    0
    0
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Osteonecrosis
         subjects affected / exposed
    2 / 47 (4.26%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    2
    0
    0
    Osteopenia
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    1
    1
    0
    Osteoporosis
         subjects affected / exposed
    2 / 47 (4.26%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    2
    1
    0
    Synovial disorder
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Pelvic deformity
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Muscle contracture
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    2 / 58 (3.45%)
         occurrences all number
    0
    2
    3
    Synovial cyst
         subjects affected / exposed
    0 / 47 (0.00%)
    2 / 56 (3.57%)
    0 / 58 (0.00%)
         occurrences all number
    0
    2
    0
    Systemic lupus erythematosus
         subjects affected / exposed
    0 / 47 (0.00%)
    2 / 56 (3.57%)
    0 / 58 (0.00%)
         occurrences all number
    0
    2
    0
    Temporomandibular pain and dysfunction syndrome
         subjects affected / exposed
    0 / 47 (0.00%)
    2 / 56 (3.57%)
    0 / 58 (0.00%)
         occurrences all number
    0
    2
    0
    Foot deformity
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Plantar fasciitis
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Spinal retrolisthesis
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Infections and infestations
    Laryngitis
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    COVID-19
         subjects affected / exposed
    0 / 47 (0.00%)
    16 / 56 (28.57%)
    14 / 58 (24.14%)
         occurrences all number
    0
    16
    15
    Urinary tract infection
         subjects affected / exposed
    9 / 47 (19.15%)
    6 / 56 (10.71%)
    6 / 58 (10.34%)
         occurrences all number
    12
    14
    7
    Cystitis
         subjects affected / exposed
    1 / 47 (2.13%)
    2 / 56 (3.57%)
    5 / 58 (8.62%)
         occurrences all number
    1
    3
    7
    Upper respiratory tract infection
         subjects affected / exposed
    6 / 47 (12.77%)
    6 / 56 (10.71%)
    5 / 58 (8.62%)
         occurrences all number
    10
    12
    5
    Nasopharyngitis
         subjects affected / exposed
    8 / 47 (17.02%)
    4 / 56 (7.14%)
    3 / 58 (5.17%)
         occurrences all number
    12
    6
    3
    Sinusitis
         subjects affected / exposed
    0 / 47 (0.00%)
    2 / 56 (3.57%)
    3 / 58 (5.17%)
         occurrences all number
    0
    2
    3
    Conjunctivitis
         subjects affected / exposed
    4 / 47 (8.51%)
    0 / 56 (0.00%)
    2 / 58 (3.45%)
         occurrences all number
    8
    0
    2
    Oral herpes
         subjects affected / exposed
    2 / 47 (4.26%)
    4 / 56 (7.14%)
    3 / 58 (5.17%)
         occurrences all number
    2
    6
    3
    Periodontitis
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    2 / 58 (3.45%)
         occurrences all number
    0
    0
    2
    Bronchitis
         subjects affected / exposed
    1 / 47 (2.13%)
    2 / 56 (3.57%)
    1 / 58 (1.72%)
         occurrences all number
    1
    2
    1
    Cellulitis
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Gingivitis
         subjects affected / exposed
    0 / 47 (0.00%)
    2 / 56 (3.57%)
    1 / 58 (1.72%)
         occurrences all number
    0
    2
    1
    Herpes simplex
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    2
    Nasal herpes
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Paronychia
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    1 / 58 (1.72%)
         occurrences all number
    0
    1
    1
    Post-acute COVID-19 syndrome
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Rhinitis
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 56 (1.79%)
    1 / 58 (1.72%)
         occurrences all number
    1
    1
    1
    Stenotrophomonas infection
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Tinea pedis
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Chronic tonsillitis
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    3
    0
    0
    Tooth infection
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    1 / 58 (1.72%)
         occurrences all number
    0
    1
    1
    Viral pharyngitis
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Vulvovaginal candidiasis
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Bacterial vaginosis
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    1
    1
    0
    Body tinea
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    2
    0
    0
    Tinea versicolour
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    0
    0
    1
    Diarrhoea infectious
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Tooth abscess
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    1
    1
    0
    Gastroenteritis
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    1
    1
    0
    Influenza
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    1
    1
    0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Mastitis bacterial
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Nail infection
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Oesophageal candidiasis
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Onychomycosis
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Oral candidiasis
         subjects affected / exposed
    2 / 47 (4.26%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    2
    0
    0
    Otitis externa
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Pharyngitis
         subjects affected / exposed
    3 / 47 (6.38%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    3
    1
    0
    Pneumonia
         subjects affected / exposed
    3 / 47 (6.38%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    3
    1
    0
    Post procedural infection
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Ear infection
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    1
    1
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    1
    1
    0
    Vulvovaginal mycotic infection
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Subcutaneous abscess
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Respiratory tract infection viral
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Postoperative wound infection
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Pharyngitis streptococcal
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Otitis media
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    2
    0
    Hordeolum
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Fungal skin infection
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Folliculitis
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Eye infection
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Diverticulitis
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Coronavirus infection
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Conjunctivitis viral
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Bacterial vulvovaginitis
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Respiratory tract infection
         subjects affected / exposed
    0 / 47 (0.00%)
    2 / 56 (3.57%)
    0 / 58 (0.00%)
         occurrences all number
    0
    2
    0
    Localised infection
         subjects affected / exposed
    0 / 47 (0.00%)
    2 / 56 (3.57%)
    0 / 58 (0.00%)
         occurrences all number
    0
    2
    0
    Herpes zoster
         subjects affected / exposed
    0 / 47 (0.00%)
    3 / 56 (5.36%)
    0 / 58 (0.00%)
         occurrences all number
    0
    3
    0
    Otitis media chronic
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0
    Klebsiella bacteraemia
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    2
    0
    0
    Enterococcal bacteraemia
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    2 / 58 (3.45%)
         occurrences all number
    1
    0
    2
    Hypercholesterolaemia
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    1
    0
    1
    Hypokalaemia
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    1
    0
    1
    Vitamin D deficiency
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    1 / 58 (1.72%)
         occurrences all number
    1
    0
    1
    Decreased appetite
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Dehydration
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Folate deficiency
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Hypophosphataemia
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    1
    0
    0
    Hypoproteinaemia
         subjects affected / exposed
    2 / 47 (4.26%)
    0 / 56 (0.00%)
    0 / 58 (0.00%)
         occurrences all number
    2
    0
    0
    Iron deficiency
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    1
    1
    0
    Hyperlipidaemia
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 56 (1.79%)
    0 / 58 (0.00%)
         occurrences all number
    0
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Jul 2020
    The main purpose of this amendment was to provide updated criteria and an updated definition for the End of Primary Treatment (EOPT), to establish the modified Full Analysis Set as the primary analysis set for efficacy endpoints, to add biweekly phone visits, to provide guidance on regional enrollment limits, and to provide further instruction on off-site visits, infusion reactions, and minor updates on the statistical analysis. and operational aspects of the protocol.
    01 Sep 2021
    The main purpose of this amendment was to allow a change in study drug formulation of ravulizumab during the Long-Term Extension Period, add visits to reflect the Treatment Period of up to 4.5 years, update the statistical methods, and incorporate administrative changes, as appropriate.

    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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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