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    Clinical Trial Results:
    A phase II randomized, placebo-controlled, double-blind, dose-escalation study to evaluate safety, pharmacokinetics and pharmacodynamic dose response relationship of IFX-1 in patients undergoing complex cardiac surgery (CARDIAC)

    Summary
    EudraCT number
    		 2015-003036-12
    Trial protocol
    		 DE  
    Global end of trial date
    24 Jan 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 May 2021
    First version publication date
    14 May 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    IFX-1-P2.2
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    InflaRx GmbH
    Sponsor organisation address
    Winzerlaer Str.2, Jena, Germany, 07745
    Public contact
    InflaRx GmbH, InflaRx GmbH, +49 3641508 180, info@inflarx.de
    Scientific contact
    InflaRx GmbH, InflaRx GmbH, +49 3641508 180, info@inflarx.de
    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
    20 Oct 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 Jan 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Jan 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the effect of four different doses of IFX-1 on interleukin (IL)-6 peak levels in patients undergoing complex cardiac surgery compared to placebo.
    Protection of trial subjects
    The study was conducted in accordance with the ethical principles of the Declaration of Helsinki (Version Fortaleza 2013), as well as all pertinent laws and the International Conference on Harmonization (ICH) guidelines for Good Clinical Practice (GCP) issued in June 1996 and CPMP/ICH/135/95 from September 1997. The study only started after obtaining a positive evaluation by the leading ethics committee and approval from the respective federal authority. Only subjects that met all inclusion criteria and no exclusion criteria were to enter the study. All patients were free to discontinue their participation in the study at any time.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Jun 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 115
    Worldwide total number of subjects
    115
    EEA total number of subjects
    115
    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)
    30
    From 65 to 84 years
    84
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study included patients of 18 years or older with a planned cardiac surgical procedure with cardiopulmonary bypass. The study was conducted at 10 sites in Germany, 9 of which enrolled patients between 06 Jun 2016 and 24 Jan 2017. Due to missing age data, not the 120 patients enrolled but only the 115 patients randomized are presented above.

    Pre-assignment
    Screening details
    		 All 120 patients were screened for eligibility before participating in the active treatment phase of the study. Subjects were not to be entered to the trial treatment if any of the eligibility criteria were violated. Of the 120 patients, 115 patients were randomized and of these, 104 were treated.

    Period 1
    Period 1 title
    Overall period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer
    Blinding implementation details
    To ensure adequate blinding after reconstitution, standard measures will be taken for the investigational medicinal product (IMP, e.g., same container/closure system, storage conditions, color, and foaming property). In addition, each reconstituted IMP that is transferred to the operating room is only labeled with blinded information. In general, access to study documents containing information on IFX-1 level and treatment groups will be restricted to unblinded personnel.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Subjects in this arm were administered a single intravenous administration of placebo with doses corresponding to the IFX-1 dose cohorts. The ratio between IFX-1 and placebo within one dose cohort was 4:1. All four placebo dose cohorts of 1, 2, 4 or 8 mg/kg body weight (bw) are presented combined. Dosing started after completion of anaesthesia and was finished prior to start of surgery.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Administration of 1, 2, 4 or 8 mg/kg bw placebo as an intravenous infusion via infusomat over 30 minutes (min), and within 30 min after completion of successful anaesthesia. Placebo matching the IFX-1 was supplied in 10 mL glass vials containing the equivalent colourless phosphat buffered saline solution with polysorbate 80 without the active pharmaceutical ingredient. For patients with a body weight between 100 and 130 kg, the dose calculation was based on 100 kg body weight.

    Arm title
    		 1 mg/kg bw IFX-1
    Arm description
    		 Subjects in this arm were administered a single intravenous administration of 1 mg/kg bw IFX-1. Dosing started after completion of anaesthesia and was finished prior to start of surgery.
    Arm type
    		 Experimental

    Investigational medicinal product name
    IFX-1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intracavernous use
    Dosage and administration details
    Administration of 1 mg/kg bw IFX-1 as an intravenous infusion via infusomat over 30 min, and within 30 min after completion of successful anaesthesia. IFX-1 was formulated in a phosphate buffered saline and polysorbate 80 and was supplied in 10 mL glass vials in strength of 10 mg/mL. For patients with a body weight between 100 and 130 kg, the dose calculation was based on 100 kg body weight.

    Arm title
    		 2 mg/kg bw IFX-1
    Arm description
    		 Subjects in this arm were administered a single intravenous administration of 2 mg/kg bw IFX-1. Dosing started after completion of anaesthesia and was finished prior to start of surgery.
    Arm type
    		 Experimental

    Investigational medicinal product name
    IFX-1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intracavernous use
    Dosage and administration details
    Administration of 2 mg/kg bw IFX-1 as an intravenous infusion via infusomat over 30 min, and within 30 min after completion of successful anaesthesia. IFX-1 was formulated in a phosphate buffered saline and polysorbate 80 and was supplied in 10 mL glass vials in strength of 10 mg/mL. For patients with a body weight between 100 and 130 kg, the dose calculation was based on 100 kg body weight.

    Arm title
    		 4 mg/kg bw IFX-1
    Arm description
    		 Subjects in this arm were administered a single intravenous administration of 4 mg/kg bw IFX-1. Dosing started after completion of anaesthesia and was finished prior to start of surgery.
    Arm type
    		 Experimental

    Investigational medicinal product name
    IFX-1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intracavernous use
    Dosage and administration details
    Administration of 4 mg/kg bw IFX-1 as an intravenous infusion via infusomat over 30 min, and within 30 min after completion of successful anaesthesia. IFX-1 was formulated in a phosphate buffered saline and polysorbate 80 and was supplied in 10 mL glass vials in strength of 10 mg/mL. For patients with a body weight between 100 and 130 kg, the dose calculation was based on 100 kg body weight.

    Arm title
    		 8 mg/kg bw IFX-1
    Arm description
    		 Subjects in this arm were administered a single intravenous administration of 8 mg/kg bw IFX-1. Dosing started after completion of anaesthesia and was finished prior to start of surgery.
    Arm type
    		 Experimental

    Investigational medicinal product name
    IFX-1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intracavernous use
    Dosage and administration details
    Administration of 8 mg/kg bw IFX-1 as an intravenous infusion via infusomat over 30 min, and within 30 min after completion of successful anaesthesia. IFX-1 was formulated in a phosphate buffered saline and polysorbate 80 and was supplied in 10 mL glass vials in strength of 10 mg/mL. For patients with a body weight between 100 and 130 kg, the dose calculation was based on 100 kg body weight.

    Number of subjects in period 1 [1]
    		Placebo 1 mg/kg bw IFX-1 2 mg/kg bw IFX-1 4 mg/kg bw IFX-1 8 mg/kg bw IFX-1
    Started
    23
    21
    19
    21
    20
    Completed
    23
    19
    19
    21
    20
    Not completed
    0
    2
    0
    0
    0
         Adverse event, serious fatal
    -
    2
    -
    -
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Baseline characteristics are based on patients who were randomized after successfully completing the screening period and received study medication (Safety Population).

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall period
    Reporting group description
    		 Safety population (SAF): all subjects who received study drug, irrespective of whether the infusion was completed. Analyses on the SAF were performed according to the actual dose the subjects received.

    Reporting group values
    		 Overall period Total
    Number of subjects
    		 104 104
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 29 29
        From 65 to 84 years
    		 74 74
        85 years and over
    		 1 1
    Gender categorical
    Units: Subjects
        Female
    		 28 28
        Male
    		 76 76

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects in this arm were administered a single intravenous administration of placebo with doses corresponding to the IFX-1 dose cohorts. The ratio between IFX-1 and placebo within one dose cohort was 4:1. All four placebo dose cohorts of 1, 2, 4 or 8 mg/kg body weight (bw) are presented combined. Dosing started after completion of anaesthesia and was finished prior to start of surgery.

    Reporting group title
    1 mg/kg bw IFX-1
    Reporting group description
    		 Subjects in this arm were administered a single intravenous administration of 1 mg/kg bw IFX-1. Dosing started after completion of anaesthesia and was finished prior to start of surgery.

    Reporting group title
    2 mg/kg bw IFX-1
    Reporting group description
    		 Subjects in this arm were administered a single intravenous administration of 2 mg/kg bw IFX-1. Dosing started after completion of anaesthesia and was finished prior to start of surgery.

    Reporting group title
    4 mg/kg bw IFX-1
    Reporting group description
    		 Subjects in this arm were administered a single intravenous administration of 4 mg/kg bw IFX-1. Dosing started after completion of anaesthesia and was finished prior to start of surgery.

    Reporting group title
    8 mg/kg bw IFX-1
    Reporting group description
    		 Subjects in this arm were administered a single intravenous administration of 8 mg/kg bw IFX-1. Dosing started after completion of anaesthesia and was finished prior to start of surgery.

    Primary: IL-6 peak level

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    End point title
    		 IL-6 peak level
    End point description
    IL-6 peak level: For each subject, the highest IL-6 level measured at any time point from prior to study drug administration until 24 hours (h) after start of cardiopulmonary bypass. Values > 1500 pg/mL were set to 1500 pg/mL for the purpose of determining the IL-6 peak. Full Analysis Set (FAS): All randomized and treated subjects who had sufficient IL-6 data. IL-6 data were regarded as sufficient if the available blood samples allowed a statement about the IL-6 peak for the subject. Analyses on the FAS were performed according to the randomized dose group. Subjects who were randomized but not treated were excluded from this analysis set.
    End point type
    Primary
    End point timeframe
    From prior to study drug administration until Visit 9, 24 h after start of cardiopulmonary bypass.
    End point values
    		 Placebo 1 mg/kg bw IFX-1 2 mg/kg bw IFX-1 4 mg/kg bw IFX-1 8 mg/kg bw IFX-1
    Number of subjects analysed
    23 [1]
    21 [2]
    19 [3]
    21 [4]
    20 [5]
    Units: pg/mL
        arithmetic mean (standard deviation)
    679.21 ( 492.64 )
    718.19 ( 465.43 )
    664.31 ( 455.88 )
    550.09 ( 361.17 )
    673.92 ( 483.01 )
    Notes
    [1] - FAS
    [2] - FAS
    [3] - FAS
    [4] - FAS
    [5] - FAS
    Statistical analysis title
    		 Kruskal-Wallis test
    Statistical analysis description
    For continuous data, the standard statistics (sample size, number of missing values, mean, standard deviation [SD], minimum, Q1, median, Q3, and maximum) were presented. Continuous data at each visit / analysis day / time point were compared using the Kruskal-Wallis test, assessing an overall difference between dose groups.
    Comparison groups
    Placebo v 1 mg/kg bw IFX-1 v 2 mg/kg bw IFX-1 v 4 mg/kg bw IFX-1 v 8 mg/kg bw IFX-1
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    		 other [6]
    P-value
    		 = 0.8611
    Method
    		 Kruskal-wallis
    Confidence interval
    Notes
    [6] - Continuous data at each visit / analysis day / time point were compared using the Kruskal-Wallis test, assessing an overall difference between dose groups.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were collected from First Patient First Visit until Last Patient Last Visit. All adverse events are reported in this record from first study drug administration on Day 1 until Day 29 (last visit).
    Adverse event reporting additional description
    SAF
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    1mg/kg bw IFX-1
    Reporting group description
    		 Subjects in this arm were administered a single intravenous administration of 1 mg/kg bw IFX-1. Dosing started after completion of anaesthesia and was finished prior to start of surgery.

    Reporting group title
    2mg/kg bw IFX-1
    Reporting group description
    		 Subjects in this arm were administered a single intravenous administration of 2 mg/kg bw IFX-1. Dosing started after completion of anaesthesia and was finished prior to start of surgery.

    Reporting group title
    4mg/kg bw IFX-1
    Reporting group description
    		 Subjects in this arm were administered a single intravenous administration of 4 mg/kg bw IFX-1. Dosing started after completion of anaesthesia and was finished prior to start of surgery.

    Reporting group title
    8mg/kg bw IFX-1
    Reporting group description
    		 Subjects in this arm were administered a single intravenous administration of 8 mg/kg bw IFX-1. Dosing started after completion of anaesthesia and was finished prior to start of surgery.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects in this arm were administered a single intravenous administration of placebo with doses corresponding to the IFX-1 dose cohorts. The ratio between IFX-1 and placebo within one dose cohort was 4:1. All four placebo dose cohorts of 1, 2, 4 or 8 mg/kg body weight (bw) are presented combined. Dosing started after completion of anaesthesia and was finished prior to start of surgery.

    Serious adverse events
    		 1mg/kg bw IFX-1 2mg/kg bw IFX-1 4mg/kg bw IFX-1 8mg/kg bw IFX-1 Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 23 (39.13%)
    7 / 18 (38.89%)
    6 / 21 (28.57%)
    10 / 20 (50.00%)
    7 / 22 (31.82%)
         number of deaths (all causes)
    2
    0
    0
    0
    0
         number of deaths resulting from adverse events
    2
    0
    0
    0
    0
    Vascular disorders
    Haematoma
    Additional description: Haematoma
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemodynamic instability
    Additional description: Haemodynamic instability
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhage
    Additional description: Haemorrhage
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral artery thrombosis
    Additional description: Peripheral artery thrombosis
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    General physical health deterioration
    Additional description: General physical health deterioration
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Impaired healing
    Additional description: Impaired healing
         subjects affected / exposed
    2 / 23 (8.70%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Multiple organ dysfunction syndrome
    Additional description: Multiple organ dysfunction syndrome
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
    Additional description: Pyrexia
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Systemic inflammatory response syndrome
    Additional description: Systemic inflammatory response syndrome
         subjects affected / exposed
    2 / 23 (8.70%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Haemothorax
    Additional description: Haemothorax
         subjects affected / exposed
    1 / 23 (4.35%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mediastinal haemorrhage
    Additional description: Mediastinal haemorrhage
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pleural effusion
    Additional description: Pleural effusion
         subjects affected / exposed
    0 / 23 (0.00%)
    2 / 18 (11.11%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary oedema
    Additional description: Pulmonary oedema
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
    Additional description: Respiratory failure
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 18 (0.00%)
    2 / 21 (9.52%)
    2 / 20 (10.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Delirium
    Additional description: Delirium
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transient psychosis
    Additional description: Transient psychosis
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Blood pressure decreased
    Additional description: Blood pressure decreased
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Post procedural haemorrhage
    Additional description: Post procedural haemorrhage
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Postoperative thoracic procedure complication
    Additional description: Postoperative thoracic procedure complication
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Arteriospasm coronary
    Additional description: Arteriospasm coronary
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
    Additional description: Atrial fibrillation
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    2 / 20 (10.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrioventricular block complete
    Additional description: Atrioventricular block complete
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac arrest
    Additional description: Cardiac arrest
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac tamponade
    Additional description: Cardiac tamponade
         subjects affected / exposed
    3 / 23 (13.04%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiogenic shock
    Additional description: Cardiogenic shock
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhage coronary artery
    Additional description: Haemorrhage coronary artery
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Low cardiac output syndrome
    Additional description: Low cardiac output syndrome
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial haemorrhage
    Additional description: Myocardial haemorrhage
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pericardial effusion
    Additional description: Pericardial effusion
         subjects affected / exposed
    2 / 23 (8.70%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Right ventricular failure
    Additional description: Right ventricular failure
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ventricular fibrillation
    Additional description: Ventricular fibrillation
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Brain injury
    Additional description: Brain injury
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Brain stem stroke
    Additional description: Brain stem stroke
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral infarction
    Additional description: Cerebral infarction
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intensive care unit acquired weakness
    Additional description: Intensive care unit acquired weakness
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombotic stroke
    Additional description: Thrombotic stroke
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
    Additional description: Anaemia
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    2 / 22 (9.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coagulopathy
    Additional description: Coagulopathy
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Duodenal ulcer haemorrhage
    Additional description: Duodenal ulcer haemorrhage
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal haemorrhage
    Additional description: Intestinal haemorrhage
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal ischaemia
    Additional description: Intestinal ischaemia
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
    Additional description: Upper gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatic failure
    Additional description: Hepatic failure
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
    Additional description: Acute kidney injury
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    End stage renal disease
    Additional description: End stage renal disease
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal failure
    Additional description: Renal failure
         subjects affected / exposed
    2 / 23 (8.70%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary bladder varices
    Additional description: Urinary bladder varices
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal abscess
    Additional description: Abdominal abscess
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocarditis staphylococcal
    Additional description: Endocarditis staphylococcal
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enterococcal sepsis
    Additional description: Enterococcal sepsis
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis norovirus
    Additional description: Gastroenteritis norovirus
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Influenza
    Additional description: Influenza
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mediastinitis
    Additional description: Mediastinitis
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nosocomial infection
    Additional description: Nosocomial infection
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
    Additional description: Pneumonia
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia haemophilus
    Additional description: Pneumonia haemophilus
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
    Additional description: Sepsis
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Severe invasive streptococcal infection
    Additional description: Severe invasive streptococcal infection
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
    Additional description: Urinary tract infection
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound infection
    Additional description: Wound infection
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 1mg/kg bw IFX-1 2mg/kg bw IFX-1 4mg/kg bw IFX-1 8mg/kg bw IFX-1 Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    22 / 23 (95.65%)
    17 / 18 (94.44%)
    21 / 21 (100.00%)
    19 / 20 (95.00%)
    21 / 22 (95.45%)
    Vascular disorders
    Haematoma
    Additional description: Haematoma
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    2 / 20 (10.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    2
    1
    Haemodynamic instability
    Additional description: Haemodynamic instability
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Hypertension
    Additional description: Hypertension
         subjects affected / exposed
    3 / 23 (13.04%)
    1 / 18 (5.56%)
    3 / 21 (14.29%)
    3 / 20 (15.00%)
    4 / 22 (18.18%)
         occurrences all number
    3
    1
    3
    3
    4
    Hypertensive crisis
    Additional description: Hypertensive crisis
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    2
    0
    0
    Hypotension
    Additional description: Hypotension
         subjects affected / exposed
    1 / 23 (4.35%)
    1 / 18 (5.56%)
    3 / 21 (14.29%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    1
    3
    0
    0
    Surgical and medical procedures
    Colectomy
    Additional description: Colectomy
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Explorative laparotomy
    Additional description: Explorative laparotomy
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    General disorders and administration site conditions
    Asthenia
    Additional description: Asthenia
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Chest pain
    Additional description: Chest pain
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Drug intolerance
    Additional description: Drug intolerance
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    0
    1
    Gait disturbance
    Additional description: Gait disturbance
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Impaired healing
    Additional description: Impaired healing
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    1
    0
    0
    0
    1
    Malaise
    Additional description: Malaise
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Oedema
    Additional description: Oedema
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    1
    0
    1
    0
    2
    Oedema peripheral
    Additional description: Oedema peripheral
         subjects affected / exposed
    4 / 23 (17.39%)
    1 / 18 (5.56%)
    4 / 21 (19.05%)
    3 / 20 (15.00%)
    2 / 22 (9.09%)
         occurrences all number
    4
    1
    5
    3
    2
    Peripheral swelling
    Additional description: Peripheral swelling
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Pyrexia
    Additional description: Pyrexia
         subjects affected / exposed
    2 / 23 (8.70%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
         occurrences all number
    2
    0
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Acquired diaphragmatic eventration
    Additional description: Acquired diaphragmatic eventration
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    0
    1
    Acute respiratory failure
    Additional description: Acute respiratory failure
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Aspiration
    Additional description: Aspiration
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Atelectasis
    Additional description: Atelectasis
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    1
    0
    0
    2
    Bronchospasm
    Additional description: Bronchospasm
         subjects affected / exposed
    2 / 23 (8.70%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    2
    0
    1
    0
    0
    Cough
    Additional description: Cough
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    4 / 21 (19.05%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    4
    1
    0
    Dyspnoea
    Additional description: Dyspnoea
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Emphysema
    Additional description: Emphysema
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Epistaxis
    Additional description: Epistaxis
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    0
    0
    1
    Increased viscosity of bronchial secretion
    Additional description: Increased viscosity of bronchial secretion
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Lung disorder
    Additional description: Lung disorder
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Lung hypoinflation
    Additional description: Lung hypoinflation
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    0
    1
    Pleural effusion
    Additional description: Pleural effusion
         subjects affected / exposed
    9 / 23 (39.13%)
    6 / 18 (33.33%)
    9 / 21 (42.86%)
    4 / 20 (20.00%)
    9 / 22 (40.91%)
         occurrences all number
    13
    6
    9
    4
    9
    Pneumothorax
    Additional description: Pneumothorax
         subjects affected / exposed
    2 / 23 (8.70%)
    0 / 18 (0.00%)
    2 / 21 (9.52%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    2
    0
    2
    0
    1
    Pulmonary congestion
    Additional description: Pulmonary congestion
         subjects affected / exposed
    2 / 23 (8.70%)
    0 / 18 (0.00%)
    3 / 21 (14.29%)
    0 / 20 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    2
    0
    3
    0
    2
    Pulmonary oedema
    Additional description: Pulmonary oedema
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Respiratory failure
    Additional description: Respiratory failure
         subjects affected / exposed
    1 / 23 (4.35%)
    3 / 18 (16.67%)
    2 / 21 (9.52%)
    2 / 20 (10.00%)
    2 / 22 (9.09%)
         occurrences all number
    1
    3
    2
    2
    2
    Psychiatric disorders
    Delirium
    Additional description: Delirium
         subjects affected / exposed
    3 / 23 (13.04%)
    3 / 18 (16.67%)
    4 / 21 (19.05%)
    6 / 20 (30.00%)
    6 / 22 (27.27%)
         occurrences all number
    4
    3
    4
    6
    6
    Disorientation
    Additional description: Disorientation
         subjects affected / exposed
    3 / 23 (13.04%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
         occurrences all number
    3
    0
    1
    1
    0
    Insomnia
    Additional description: Insomnia
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Restlessness
    Additional description: Restlessness
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Sleep disorder
    Additional description: Sleep disorder
         subjects affected / exposed
    1 / 23 (4.35%)
    2 / 18 (11.11%)
    6 / 21 (28.57%)
    0 / 20 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    1
    2
    6
    0
    4
    Investigations
    Alanine aminotransferase increased
    Additional description: Alanine aminotransferase increased
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Antithrombin III decreased
    Additional description: Antithrombin III decreased
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    0
    1
    Aspartate aminotransferase increased
    Additional description: Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Blood albumin decreased
    Additional description: Blood albumin decreased
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Blood alkaline phosphatase increased
    Additional description: Blood alkaline phosphatase increased
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Blood bilirubin increased
    Additional description: Blood bilirubin increased
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Blood calcium decreased
    Additional description: Blood calcium decreased
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Blood creatine phosphokinase MB increased
    Additional description: Blood creatine phosphokinase MB increased
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    2 / 21 (9.52%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Blood creatine phosphokinase increased
    Additional description: Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    3 / 21 (14.29%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    3
    0
    0
    Blood creatinine increased
    Additional description: Blood creatinine increased
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Blood fibrinogen decreased
    Additional description: Blood fibrinogen decreased
         subjects affected / exposed
    1 / 23 (4.35%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    Blood glucose increased
    Additional description: Blood glucose increased
         subjects affected / exposed
    1 / 23 (4.35%)
    2 / 18 (11.11%)
    2 / 21 (9.52%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    1
    2
    2
    0
    1
    Blood lactate dehydrogenase increased
    Additional description: Blood lactate dehydrogenase increased
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    0
    1
    Blood pressure decreased
    Additional description: Blood pressure decreased
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Blood pressure increased
    Additional description: Blood pressure increased
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Blood urea increased
    Additional description: Blood urea increased
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Body temperature increased
    Additional description: Body temperature increased
         subjects affected / exposed
    1 / 23 (4.35%)
    2 / 18 (11.11%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    3
    2
    1
    0
    1
    Breath sounds abnormal
    Additional description: Breath sounds abnormal
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    C-reactive protein increased
    Additional description: C-reactive protein increased
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    0
    0
    0
    2
    Cardiac index decreased
    Additional description: Cardiac index decreased
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Enterococcus test positive
    Additional description: Enterococcus test positive
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    2 / 21 (9.52%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Escherichia test positive
    Additional description: Escherichia test positive
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    2
    0
    0
    Gamma-glutamyltransferase increased
    Additional description: Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    Glutamate dehydrogenase increased
    Additional description: Glutamate dehydrogenase increased
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    0
    1
    Haematocrit decreased
    Additional description: Haematocrit decreased
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Haemoglobin decreased
    Additional description: Haemoglobin decreased
         subjects affected / exposed
    2 / 23 (8.70%)
    3 / 18 (16.67%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    2
    3
    1
    0
    2
    Heart rate decreased
    Additional description: Heart rate decreased
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Hepatic enzyme increased
    Additional description: Hepatic enzyme increased
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    2 / 22 (9.09%)
         occurrences all number
    1
    0
    0
    1
    2
    International normalised ratio increased
    Additional description: International normalised ratio increased
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Myocardial necrosis marker increased
    Additional description: Myocardial necrosis marker increased
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Oxygen saturation decreased
    Additional description: Oxygen saturation decreased
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Red blood cell count decreased
    Additional description: Red blood cell count decreased
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    3 / 21 (14.29%)
    3 / 20 (15.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    0
    3
    3
    2
    Staphylococcus test positive
    Additional description: Staphylococcus test positive
         subjects affected / exposed
    1 / 23 (4.35%)
    1 / 18 (5.56%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    Venous oxygen saturation decreased
    Additional description: Venous oxygen saturation decreased
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    White blood cell count increased
    Additional description: White blood cell count increased
         subjects affected / exposed
    0 / 23 (0.00%)
    2 / 18 (11.11%)
    1 / 21 (4.76%)
    2 / 20 (10.00%)
    4 / 22 (18.18%)
         occurrences all number
    0
    2
    2
    2
    4
    Injury, poisoning and procedural complications
    Anaemia postoperative
    Additional description: Anaemia postoperative
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    0
    0
    1
    2
    Fall
    Additional description: Fall
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    Injury
    Additional description: Injury
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Laceration
    Additional description: Laceration
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Periorbital haemorrhage
    Additional description: Periorbital haemorrhage
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Post procedural haematoma
    Additional description: Post procedural haematoma
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Post procedural haemorrhage
    Additional description: Post procedural haemorrhage
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    2 / 21 (9.52%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    2
    1
    0
    Postoperative renal failure
    Additional description: Postoperative renal failure
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Postoperative respiratory distress
    Additional description: Postoperative respiratory distress
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    0
    1
    Postoperative wound complication
    Additional description: Postoperative wound complication
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Procedural haemorrhage
    Additional description: Procedural haemorrhage
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Procedural nausea
    Additional description: Procedural nausea
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Procedural vomiting
    Additional description: Procedural vomiting
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    Rib fracture
    Additional description: Rib fracture
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Wound haemorrhage
    Additional description: Wound haemorrhage
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    0
    1
    Wound secretion
    Additional description: Wound secretion
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    0
    1
    Cardiac disorders
    Acute myocardial infarction
    Additional description: Acute myocardial infarction
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    0
    1
    Arrhythmia
    Additional description: Arrhythmia
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    0
    0
    1
    Atrial fibrillation
    Additional description: Atrial fibrillation
         subjects affected / exposed
    9 / 23 (39.13%)
    4 / 18 (22.22%)
    9 / 21 (42.86%)
    9 / 20 (45.00%)
    8 / 22 (36.36%)
         occurrences all number
    9
    4
    9
    11
    10
    Atrial flutter
    Additional description: Atrial flutter
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    Atrioventricular block
    Additional description: Atrioventricular block
         subjects affected / exposed
    2 / 23 (8.70%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    Atrioventricular block complete
    Additional description: Atrioventricular block complete
         subjects affected / exposed
    0 / 23 (0.00%)
    3 / 18 (16.67%)
    1 / 21 (4.76%)
    1 / 20 (5.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    3
    1
    1
    2
    Atrioventricular block second degree
    Additional description: Atrioventricular block second degree
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Bradyarrhythmia
    Additional description: Bradyarrhythmia
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    Bradycardia
    Additional description: Bradycardia
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    1 / 21 (4.76%)
    3 / 20 (15.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    1
    3
    1
    Bundle branch block left
    Additional description: Bundle branch block left
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    1
    0
    0
    0
    2
    Bundle branch block right
    Additional description: Bundle branch block right
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    Cardiac arrest
    Additional description: Cardiac arrest
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Cardiac failure
    Additional description: Cardiac failure
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Cardiovascular disorder
    Additional description: Cardiovascular disorder
         subjects affected / exposed
    2 / 23 (8.70%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
    3 / 20 (15.00%)
    4 / 22 (18.18%)
         occurrences all number
    2
    1
    0
    3
    4
    Extrasystoles
    Additional description: Extrasystoles
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    1
    0
    1
    0
    1
    Left ventricular dysfunction
    Additional description: Left ventricular dysfunction
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Pericardial effusion
    Additional description: Pericardial effusion
         subjects affected / exposed
    1 / 23 (4.35%)
    1 / 18 (5.56%)
    1 / 21 (4.76%)
    1 / 20 (5.00%)
    1 / 22 (4.55%)
         occurrences all number
    1
    1
    1
    1
    1
    Pericardial haemorrhage
    Additional description: Pericardial haemorrhage
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Pulmonary valve incompetence
    Additional description: Pulmonary valve incompetence
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Sinus arrest
    Additional description: Sinus arrest
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Supraventricular tachycardia
    Additional description: Supraventricular tachycardia
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Tachyarrhythmia
    Additional description: Tachyarrhythmia
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Tachycardia
    Additional description: Tachycardia
         subjects affected / exposed
    1 / 23 (4.35%)
    2 / 18 (11.11%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    Tricuspid valve incompetence
    Additional description: Tricuspid valve incompetence
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Ventricular extrasystoles
    Additional description: Ventricular extrasystoles
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    2 / 20 (10.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    0
    0
    2
    2
    Ventricular fibrillation
    Additional description: Ventricular fibrillation
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Ventricular hypokinesia
    Additional description: Ventricular hypokinesia
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Ventricular tachycardia
    Additional description: Ventricular tachycardia
         subjects affected / exposed
    2 / 23 (8.70%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
    2 / 20 (10.00%)
    1 / 22 (4.55%)
         occurrences all number
    2
    1
    0
    2
    1
    Nervous system disorders
    Anticholinergic syndrome
    Additional description: Anticholinergic syndrome
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Balance disorder
    Additional description: Balance disorder
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Brain oedema
    Additional description: Brain oedema
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Carotid artery stenosis
    Additional description: Carotid artery stenosis
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Cerebral infarction
    Additional description: Cerebral infarction
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Disturbance in attention
    Additional description: Disturbance in attention
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Headache
    Additional description: Headache
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Hemiparesis
    Additional description: Hemiparesis
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    IIIrd nerve paralysis
    Additional description: IIIrd nerve paralysis
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Peripheral nerve lesion
    Additional description: Peripheral nerve lesion
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Peripheral nerve paresis
    Additional description: Peripheral nerve paresis
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Psychomotor hyperactivity
    Additional description: Psychomotor hyperactivity
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Seizure
    Additional description: Seizure
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    0
    1
    Syncope
    Additional description: Syncope
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    2
    1
    0
    0
    Tremor
    Additional description: Tremor
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Blood and lymphatic system disorders
    Anaemia
    Additional description: Anaemia
         subjects affected / exposed
    5 / 23 (21.74%)
    1 / 18 (5.56%)
    6 / 21 (28.57%)
    3 / 20 (15.00%)
    6 / 22 (27.27%)
         occurrences all number
    6
    1
    6
    3
    6
    Coagulation factor deficiency
    Additional description: Coagulation factor deficiency
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Coagulopathy
    Additional description: Coagulopathy
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
    1 / 20 (5.00%)
    2 / 22 (9.09%)
         occurrences all number
    1
    0
    1
    1
    2
    Disseminated intravascular coagulation
    Additional description: Disseminated intravascular coagulation
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    2 / 21 (9.52%)
    2 / 20 (10.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    2
    2
    1
    Erythropenia
    Additional description: Erythropenia
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    0
    1
    Haemorrhagic anaemia
    Additional description: Haemorrhagic anaemia
         subjects affected / exposed
    0 / 23 (0.00%)
    2 / 18 (11.11%)
    1 / 21 (4.76%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    2
    1
    1
    0
    Heparin-induced thrombocytopenia
    Additional description: Heparin-induced thrombocytopenia
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    0
    1
    Leukocytosis
    Additional description: Leukocytosis
         subjects affected / exposed
    3 / 23 (13.04%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    3
    0
    0
    0
    0
    Thrombocytopenia
    Additional description: Thrombocytopenia
         subjects affected / exposed
    4 / 23 (17.39%)
    3 / 18 (16.67%)
    3 / 21 (14.29%)
    0 / 20 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    4
    3
    3
    0
    2
    Ear and labyrinth disorders
    Hypoacusis
    Additional description: Hypoacusis
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Eye disorders
    Gaze palsy
    Additional description: Gaze palsy
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Pupils unequal
    Additional description: Pupils unequal
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Visual impairment
    Additional description: Visual impairment
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Gastrointestinal disorders
    Abdominal pain
    Additional description: Abdominal pain
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    0
    1
    Abdominal pain upper
    Additional description: Abdominal pain upper
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    2 / 21 (9.52%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Anal incontinence
    Additional description: Anal incontinence
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    0
    1
    Constipation
    Additional description: Constipation
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 18 (0.00%)
    3 / 21 (14.29%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    3
    0
    0
    Diarrhoea
    Additional description: Diarrhoea
         subjects affected / exposed
    1 / 23 (4.35%)
    2 / 18 (11.11%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    2 / 22 (9.09%)
         occurrences all number
    1
    2
    0
    1
    2
    Duodenal ulcer
    Additional description: Duodenal ulcer
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    0
    1
    Dysphagia
    Additional description: Dysphagia
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Flatulence
    Additional description: Flatulence
         subjects affected / exposed
    1 / 23 (4.35%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    Gastritis
    Additional description: Gastritis
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Gastrointestinal haemorrhage
    Additional description: Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Large intestinal ulcer
    Additional description: Large intestinal ulcer
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    0
    1
    Nausea
    Additional description: Nausea
         subjects affected / exposed
    6 / 23 (26.09%)
    0 / 18 (0.00%)
    4 / 21 (19.05%)
    2 / 20 (10.00%)
    2 / 22 (9.09%)
         occurrences all number
    6
    0
    5
    2
    2
    Pancreatitis
    Additional description: Pancreatitis
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Subileus
    Additional description: Subileus
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    0
    0
    1
    Vomiting
    Additional description: Vomiting
         subjects affected / exposed
    1 / 23 (4.35%)
    4 / 18 (22.22%)
    2 / 21 (9.52%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    4
    2
    1
    0
    Skin and subcutaneous tissue disorders
    Decubitus ulcer
    Additional description: Decubitus ulcer
         subjects affected / exposed
    1 / 23 (4.35%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    Erythema
    Additional description: Erythema
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    Rash generalised
    Additional description: Rash generalised
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    0
    1
    Subcutaneous emphysema
    Additional description: Subcutaneous emphysema
         subjects affected / exposed
    1 / 23 (4.35%)
    2 / 18 (11.11%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    Renal and urinary disorders
    Acute kidney injury
    Additional description: Acute kidney injury
         subjects affected / exposed
    3 / 23 (13.04%)
    2 / 18 (11.11%)
    2 / 21 (9.52%)
    5 / 20 (25.00%)
    6 / 22 (27.27%)
         occurrences all number
    3
    2
    2
    5
    6
    Acute prerenal failure
    Additional description: Acute prerenal failure
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Dysuria
    Additional description: Dysuria
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Haematuria
    Additional description: Haematuria
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    Oliguria
    Additional description: Oliguria
         subjects affected / exposed
    2 / 23 (8.70%)
    3 / 18 (16.67%)
    2 / 21 (9.52%)
    0 / 20 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    2
    3
    2
    0
    2
    Renal failure
    Additional description: Renal failure
         subjects affected / exposed
    2 / 23 (8.70%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0
    Urinary incontinence
    Additional description: Urinary incontinence
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    2 / 21 (9.52%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    2
    0
    0
    Urinary retention
    Additional description: Urinary retention
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    1
    1
    Musculoskeletal and connective tissue disorders
    Back pain
    Additional description: Back pain
         subjects affected / exposed
    2 / 23 (8.70%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    2
    1
    0
    0
    1
    Muscle spasms
    Additional description: Muscle spasms
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    Muscular weakness
    Additional description: Muscular weakness
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Musculoskeletal chest pain
    Additional description: Musculoskeletal chest pain
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    1
    0
    2
    Musculoskeletal pain
    Additional description: Musculoskeletal pain
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Infections and infestations
    Bacterial disease carrier
    Additional description: Bacterial disease carrier
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Bronchitis
    Additional description: Bronchitis
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    1
    1
    Clostridial infection
    Additional description: Clostridial infection
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Cystitis
    Additional description: Cystitis
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    1
    0
    1
    0
    1
    Device related infection
    Additional description: Device related infection
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Enterococcal infection
    Additional description: Enterococcal infection
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Infection
    Additional description: Infection
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    0
    1
    Infectious disease carrier
    Additional description: Infectious disease carrier
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    Nasopharyngitis
    Additional description: Nasopharyngitis
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Nosocomial infection
    Additional description: Nosocomial infection
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Pneumonia
    Additional description: Pneumonia
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    2 / 21 (9.52%)
    1 / 20 (5.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    1
    2
    1
    2
    Pneumonia escherichia
    Additional description: Pneumonia escherichia
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Pneumonia klebsiella
    Additional description: Pneumonia klebsiella
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    Tracheobronchitis
    Additional description: Tracheobronchitis
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Urinary tract infection
    Additional description: Urinary tract infection
         subjects affected / exposed
    2 / 23 (8.70%)
    1 / 18 (5.56%)
    3 / 21 (14.29%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    2
    1
    3
    0
    1
    Metabolism and nutrition disorders
    Fluid retention
    Additional description: Fluid retention
         subjects affected / exposed
    0 / 23 (0.00%)
    2 / 18 (11.11%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Gout
    Additional description: Gout
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Hyperkalaemia
    Additional description: Hyperkalaemia
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Hypernatraemia
    Additional description: Hypernatraemia
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Hypoalbuminaemia
    Additional description: Hypoalbuminaemia
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    0
    0
    1
    Hyponatraemia
    Additional description: Hyponatraemia
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 21 (0.00%)
    1 / 20 (5.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    1
    1
    Hypovolaemia
    Additional description: Hypovolaemia
         subjects affected / exposed
    2 / 23 (8.70%)
    0 / 18 (0.00%)
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    2
    0
    1
    0
    1
    Metabolic acidosis
    Additional description: Metabolic acidosis
         subjects affected / exposed
    1 / 23 (4.35%)
    2 / 18 (11.11%)
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    2
    2
    0
    0
    2
    Protein deficiency
    Additional description: Protein deficiency
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    2 / 21 (9.52%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    2
    0
    0

    More information

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

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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