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    Clinical Trial Results:
    A Phase 2 Proof-of-concept Study to Evaluate the Efficacy and Safety of MEDI3902 in Mechanically Ventilated Patients for the Prevention of Nosocomial Pneumonia Caused by Pseudomonas aeruginosa

    Summary
    EudraCT number
    		 2015-001706-34
    Trial protocol
    		 ES   CZ   HU   DE   BE   GR   PT   HR   AT   SK  
    Global end of trial date
    04 Dec 2019

    Results information
    Results version number
    		 v2(current)
    This version publication date
    05 Feb 2021
    First version publication date
    20 Nov 2020
    Other versions
    		 v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    D5470C00004
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02696902
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    MedImmune, LLC
    Sponsor organisation address
    One MedImmune Way, Gaithersburg, Maryland, United States, 20878
    Public contact
    Mark Esser, MedImmune, LLC, +1 301 3986849, information.center@astrazeneca.com
    Scientific contact
    Mark Esser, MedImmune, LLC, +1 301 3986849, information.center@astrazeneca.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    26 May 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Dec 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Dec 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to evaluate the effect of MEDI3902 in reducing the incidence of nosocomial pneumonia caused by Pseudomonas aeruginosa and to evaluate the safety of a single intravenous (IV) dose of MEDI3902 in mechanically-ventilated participants.
    Protection of trial subjects
    The conduct of this clinical study met all local and regulatory requirements. The study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and are consistent with International Conference on Harmonization guideline: Good Clinical Practice, and applicable regulatory requirements. Participants signed an informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. Only investigators qualified by training and experience were selected as appropriate experts to investigate the study drug.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Apr 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
    Austria: 2
    Country: Number of subjects enrolled
    Belgium: 28
    Country: Number of subjects enrolled
    Croatia: 4
    Country: Number of subjects enrolled
    Czechia: 3
    Country: Number of subjects enrolled
    France: 74
    Country: Number of subjects enrolled
    Greece: 19
    Country: Number of subjects enrolled
    Hungary: 6
    Country: Number of subjects enrolled
    Israel: 8
    Country: Number of subjects enrolled
    Portugal: 2
    Country: Number of subjects enrolled
    Spain: 25
    Country: Number of subjects enrolled
    Turkey: 9
    Country: Number of subjects enrolled
    United Kingdom: 5
    Country: Number of subjects enrolled
    United States: 3
    Worldwide total number of subjects
    188
    EEA total number of subjects
    163
    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)
    89
    From 65 to 84 years
    97
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted between 13Apr2016 and 04Dec2019.

    Pre-assignment
    Screening details
    		 A total of 188 participants were assigned to the study treatment groups. Out of 188 participants, 4 participants did not receive the study treatment.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Participants received single intravenous (IV) dose of placebo matched to MEDI3902.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Single intravenous (IV) dose of placebo matched to MEDI3902.

    Arm title
    		 MEDI3902 500 mg
    Arm description
    		 Participants received single IV dose of 500 mg MEDI3902.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MEDI3902
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Single IV dose of 500 mg of MEDI3902.

    Arm title
    		 MEDI3902 1500 mg
    Arm description
    		 Participants received single IV dose of 1500 mg MEDI3902.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MEDI3902
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Single IV dose of 1500 mg of MEDI3902.

    Number of subjects in period 1
    		Placebo MEDI3902 500 mg MEDI3902 1500 mg
    Started
    85
    16
    87
    Treated
    83
    16
    85
    Intent-to-treat population
    85
    16
    87
    As-treated population
    83
    16
    85
    Modified intent-to-treat population
    83
    16
    85
    Completed
    63
    12
    59
    Not completed
    22
    4
    28
         Adverse event, serious fatal
    19
    3
    24
         Sponsor's decision
    1
    -
    -
         Consent withdrawn by subject
    -
    -
    1
         Participant not fit post-randomization
    -
    -
    1
         Principal investigator's decision
    1
    -
    -
         Transferred to other hospital
    1
    -
    -
         Participant not eligible (negative PCR)
    -
    -
    1
         Lost to follow-up
    -
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received single intravenous (IV) dose of placebo matched to MEDI3902.

    Reporting group title
    MEDI3902 500 mg
    Reporting group description
    		 Participants received single IV dose of 500 mg MEDI3902.

    Reporting group title
    MEDI3902 1500 mg
    Reporting group description
    		 Participants received single IV dose of 1500 mg MEDI3902.

    Reporting group values
    		 Placebo MEDI3902 500 mg MEDI3902 1500 mg Total
    Number of subjects
    		 85 16 87 188
    Age categorical
    Units: Participants
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 39 7 43 89
        From 65-84 years
    		 44 9 44 97
        85 years and over
    		 2 0 0 2
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 64.4 ( 13.0 ) 62.7 ( 9.3 ) 60.6 ( 15.1 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 22 6 32 60
        Male
    		 63 10 55 128
    Race/Ethnicity, Customized
    Units: Subjects
        Asian
    		 1 0 0 1
        Black or African American
    		 4 0 2 6
        Native Hawaiian or Other Pacific Islander
    		 1 0 0 1
        White
    		 77 16 83 176
        Other
    		 2 0 2 4

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received single intravenous (IV) dose of placebo matched to MEDI3902.

    Reporting group title
    MEDI3902 500 mg
    Reporting group description
    		 Participants received single IV dose of 500 mg MEDI3902.

    Reporting group title
    MEDI3902 1500 mg
    Reporting group description
    		 Participants received single IV dose of 1500 mg MEDI3902.

    Primary: Percentage of Participants With Nosocomial Pneumonia Caused by Pseudomonas aeruginosa

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    End point title
    		 Percentage of Participants With Nosocomial Pneumonia Caused by Pseudomonas aeruginosa
    End point description
    Percentage of participants with nosocomial pneumonia caused by Pseudomonas aeruginosa is reported. The modified intent to treat (mITT) population was analysed which included all randomized and treated participants, grouped according to assigned treatment.
    End point type
    Primary
    End point timeframe
    Day 1 through Day 22
    End point values
    		 Placebo MEDI3902 500 mg MEDI3902 1500 mg
    Number of subjects analysed
    83
    16
    85
    Units: Percentage of participants
        number (not applicable)
    18.1
    12.5
    22.4
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Placebo v MEDI3902 1500 mg
    Number of subjects included in analysis
    168
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.491
    Method
    		 Poisson regression with robust variance
    Parameter type
    		 Relative risk reduction
    Point estimate
    -23.7
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -83.8
         upper limit
    		 16.8

    Primary: Number of Participants With Treatment-emergent Adverse Events (TEAEs)

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    End point title
    		 Number of Participants With Treatment-emergent Adverse Events (TEAEs) [1]
    End point description
    An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug. The As-treated population was analysed which included all treated participants, grouped according to actual treatment received.
    End point type
    Primary
    End point timeframe
    Day 1 through Day 50
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analysis was not applicable since there were no inferential statistics, only descriptive statistics were performed for this end point.
    End point values
    		 Placebo MEDI3902 500 mg MEDI3902 1500 mg
    Number of subjects analysed
    83
    16
    85
    Units: Participants
    81
    15
    84
    No statistical analyses for this end point

    Primary: Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)

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    End point title
    		 Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs) [2]
    End point description
    An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The As-treated population was analysed which included all treated participants, grouped according to actual treatment received.
    End point type
    Primary
    End point timeframe
    Day 1 through Day 50
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analysis was not applicable since there were no inferential statistics, only descriptive statistics were performed for this end point.
    End point values
    		 Placebo MEDI3902 500 mg MEDI3902 1500 mg
    Number of subjects analysed
    83
    16
    85
    Units: Participants
    35
    4
    38
    No statistical analyses for this end point

    Primary: Number of Participants With Treatment-emergent Adverse Events of Special Interest (TEAESI)

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    End point title
    		 Number of Participants With Treatment-emergent Adverse Events of Special Interest (TEAESI) [3]
    End point description
    An AESI is one of scientific and medical interest specific event for understanding of the study drug and may require close monitoring and rapid communication by the investigator to the sponsor. An AESI may be serious or non-serious. The As-treated population was analysed which included all treated participants, grouped according to actual treatment received.
    End point type
    Primary
    End point timeframe
    Day 1 through Day 50
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analysis was not applicable since there were no inferential statistics, only descriptive statistics were performed for this end point.
    End point values
    		 Placebo MEDI3902 500 mg MEDI3902 1500 mg
    Number of subjects analysed
    83
    16
    85
    Units: Participants
    1
    0
    2
    No statistical analyses for this end point

    Secondary: Maximum Observed Concentration (Cmax) of MEDI3902

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    End point title
    		 Maximum Observed Concentration (Cmax) of MEDI3902 [4]
    End point description
    The Cmax of MEDI3902 is reported. The As-treated population was analysed which included all treated participants, grouped according to actual treatment received. Number of Subjects Analyzed denotes the number of participants evaluated for this end point.
    End point type
    Secondary
    End point timeframe
    Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, Day 22, Day 29, and Day 50
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only those baseline period arms for which analysis was planned were reported in the end point.
    End point values
    		 MEDI3902 500 mg MEDI3902 1500 mg
    Number of subjects analysed
    16
    84
    Units: mcg/mL
        arithmetic mean (standard deviation)
    87.6 ( 23.9 )
    299 ( 94.1 )
    No statistical analyses for this end point

    Secondary: Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3902

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    End point title
    		 Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3902 [5]
    End point description
    The AUC0-inf of MEDI3902 is reported. The As-treated population was analysed which included all treated participants, grouped according to actual treatment received. Number of Subjects Analyzed denotes the number of participants evaluated for this end point.
    End point type
    Secondary
    End point timeframe
    Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, Day 22, Day 29, and Day 50
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only those baseline period arms for which analysis was planned were reported in the end point.
    End point values
    		 MEDI3902 500 mg MEDI3902 1500 mg
    Number of subjects analysed
    16
    81
    Units: day*mcg/mL
        arithmetic mean (standard deviation)
    440 ( 135 )
    1510 ( 675 )
    No statistical analyses for this end point

    Secondary: Clearance (CL) of MEDI3902

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    End point title
    		 Clearance (CL) of MEDI3902 [6]
    End point description
    The CL of MEDI3902 from body after intrevanous administration of single dose is reported. The As-treated population was analysed which included all treated participants, grouped according to actual treatment received. Number of Subjects Analyzed denotes the number of participants evaluated for this end point.
    End point type
    Secondary
    End point timeframe
    Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, Day 22, Day 29, and Day 50
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only those baseline period arms for which analysis was planned were reported in the end point.
    End point values
    		 MEDI3902 500 mg MEDI3902 1500 mg
    Number of subjects analysed
    16
    81
    Units: L/day
        arithmetic mean (standard deviation)
    1.31 ( 0.638 )
    1.27 ( 0.86 )
    No statistical analyses for this end point

    Secondary: Percentage of Participants Maintaining MEDI3902 Serum Levels Above the Target Level (1.7 µg/mL) Through 21 Days Post Dose

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    End point title
    		 Percentage of Participants Maintaining MEDI3902 Serum Levels Above the Target Level (1.7 µg/mL) Through 21 Days Post Dose [7]
    End point description
    Percentage of participants maintaining MEDI3902 serum levels above the target level (1.7 µg/mL) through 21 days post dose is reported. The As-treated population was analysed which included all treated participants, grouped according to actual treatment received. Number of Subjects Analyzed denotes the number of participants evaluated for this end point.
    End point type
    Secondary
    End point timeframe
    Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, and Day 22
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only those baseline period arms for which analysis was planned were reported in the end point.
    End point values
    		 MEDI3902 500 mg MEDI3902 1500 mg
    Number of subjects analysed
    16
    84
    Units: Percentage of participants
        number (not applicable)
    50
    80.6
    No statistical analyses for this end point

    Secondary: Terminal Elimination Half-life (t1/2) of MEDI3902

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    End point title
    		 Terminal Elimination Half-life (t1/2) of MEDI3902 [8]
    End point description
    The t1/2 of MEDI3902 is reported. The As-treated population was analysed which included all treated participants, grouped according to actual treatment received. Number of Subjects Analyzed denotes the number of participants evaluated for this end point.
    End point type
    Secondary
    End point timeframe
    Day 1 (predose; 0 and 8 hours post dose), Day 2, Day 4, Day 8, Day 15, Day 22, Day 29, and Day 50
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only those baseline period arms for which analysis was planned were reported in the end point.
    End point values
    		 MEDI3902 500 mg MEDI3902 1500 mg
    Number of subjects analysed
    16
    81
    Units: day
        arithmetic mean (standard deviation)
    6.56 ( 4.03 )
    5.65 ( 2.69 )
    No statistical analyses for this end point

    Secondary: Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI3902 treatment

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    End point title
    		 Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI3902 treatment
    End point description
    Number of participants with positive ADA to MEDI3902 treatment is reported. Persistent positive is defined as positive at >= 2 post-baseline assessments or positive at last post-baseline assessment. Transient positive is defined as negative at last post-baseline assessment and positive at only one post-baseline assessment or at >= 2 post-baseline assessments. The As-treated population was analysed which included all treated participants, grouped according to actual treatment received.
    End point type
    Secondary
    End point timeframe
    Day 1 (predose), Day 15, Day 29, Day 50
    End point values
    		 Placebo MEDI3902 500 mg MEDI3902 1500 mg
    Number of subjects analysed
    83
    16
    85
    Units: Participants
        Positive at baseline and post-baseline
    3
    2
    1
        Persistent positive
    4
    2
    4
        Transient positive
    2
    2
    8
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 1 through Day 50
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    MEDI3902 500 mg
    Reporting group description
    		 -

    Reporting group title
    MEDI3902 1500 mg
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo MEDI3902 500 mg MEDI3902 1500 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    35 / 83 (42.17%)
    4 / 16 (25.00%)
    38 / 85 (44.71%)
         number of deaths (all causes)
    19
    3
    24
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Squamous cell carcinoma
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Shock
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 16 (6.25%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    General physical health deterioration
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    3 / 83 (3.61%)
    0 / 16 (0.00%)
    2 / 85 (2.35%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    Pyrexia
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    4 / 85 (4.71%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    Asphyxia
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Aspiration
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atelectasis
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    2 / 85 (2.35%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    Lower respiratory tract congestion
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mediastinal haemorrhage
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Respiratory arrest
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    Respiratory failure
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    4 / 85 (4.71%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    Product issues
    Device occlusion
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Oxygen saturation decreased
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Post procedural haemorrhage
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Weaning failure
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    5 / 83 (6.02%)
    1 / 16 (6.25%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 3
    0 / 1
    0 / 1
    Cardiac failure
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    2 / 85 (2.35%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Cardiogenic shock
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Myocarditis
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulseless electrical activity
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sinus node dysfunction
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Brain injury
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Cerebral infarction
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Coma
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    Haemorrhagic stroke
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Ischaemic stroke
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Deafness
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Duodenal ulcer
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intestinal haemorrhage
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Pancreatitis
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 16 (6.25%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    3 / 83 (3.61%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chronic kidney disease
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Polyuria
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Spinal pain
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Acinetobacter bacteraemia
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Bacterial sepsis
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Biliary tract infection
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Brain abscess
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchitis bacterial
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Burkholderia cepacia complex infection
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Candida sepsis
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Endocarditis enterococcal
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 16 (6.25%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Escherichia sepsis
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Klebsiella bacteraemia
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Klebsiella sepsis
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Peritonitis
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia pseudomonal
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pseudomonal bacteraemia
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pseudomonal sepsis
         subjects affected / exposed
    4 / 83 (4.82%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 4
    0 / 0
    0 / 1
    Septic shock
         subjects affected / exposed
    3 / 83 (3.61%)
    0 / 16 (0.00%)
    3 / 85 (3.53%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    Staphylococcal sepsis
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Placebo MEDI3902 500 mg MEDI3902 1500 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    79 / 83 (95.18%)
    15 / 16 (93.75%)
    82 / 85 (96.47%)
    Vascular disorders
    Artery dissection
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Deep vein thrombosis
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Extremity necrosis
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Haemodynamic instability
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Hypertension
         subjects affected / exposed
    7 / 83 (8.43%)
    3 / 16 (18.75%)
    3 / 85 (3.53%)
         occurrences all number
    9
    5
    6
    Hypoperfusion
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Hypotension
         subjects affected / exposed
    16 / 83 (19.28%)
    1 / 16 (6.25%)
    23 / 85 (27.06%)
         occurrences all number
    21
    1
    29
    Jugular vein thrombosis
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Orthostatic hypotension
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Peripheral coldness
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Phlebitis
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    1
    0
    1
    Subclavian vein thrombosis
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Thrombosis
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Vein disorder
         subjects affected / exposed
    1 / 83 (1.20%)
    1 / 16 (6.25%)
    0 / 85 (0.00%)
         occurrences all number
    1
    1
    0
    Vena cava thrombosis
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Venous thrombosis
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    2 / 83 (2.41%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    2
    0
    1
    Catheter site inflammation
         subjects affected / exposed
    2 / 83 (2.41%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    3
    0
    0
    Catheter site pain
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Chills
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Complication associated with device
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    2 / 85 (2.35%)
         occurrences all number
    0
    0
    2
    Generalised oedema
         subjects affected / exposed
    2 / 83 (2.41%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    2
    0
    0
    Granuloma
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Hyperthermia
         subjects affected / exposed
    2 / 83 (2.41%)
    1 / 16 (6.25%)
    2 / 85 (2.35%)
         occurrences all number
    4
    1
    2
    Hypothermia
         subjects affected / exposed
    2 / 83 (2.41%)
    0 / 16 (0.00%)
    2 / 85 (2.35%)
         occurrences all number
    3
    0
    3
    Localised oedema
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Medical device pain
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 16 (6.25%)
    0 / 85 (0.00%)
         occurrences all number
    0
    1
    0
    Medical device site dermatitis
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Medical device site haemorrhage
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    2
    0
    0
    Mucosal ulceration
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Oedema peripheral
         subjects affected / exposed
    4 / 83 (4.82%)
    1 / 16 (6.25%)
    3 / 85 (3.53%)
         occurrences all number
    4
    1
    4
    Pain
         subjects affected / exposed
    8 / 83 (9.64%)
    0 / 16 (0.00%)
    7 / 85 (8.24%)
         occurrences all number
    15
    0
    7
    Peripheral swelling
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    2 / 85 (2.35%)
         occurrences all number
    0
    0
    2
    Pyrexia
         subjects affected / exposed
    13 / 83 (15.66%)
    1 / 16 (6.25%)
    16 / 85 (18.82%)
         occurrences all number
    20
    1
    20
    Swelling
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Thirst
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Reproductive system and breast disorders
    Cervical cyst
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Genital pain
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Oedema genital
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Penile discharge
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 16 (6.25%)
    0 / 85 (0.00%)
         occurrences all number
    0
    1
    0
    Penile oedema
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Prostatitis
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Pruritus genital
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Vulval disorder
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory distress syndrome
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    2 / 85 (2.35%)
         occurrences all number
    1
    0
    2
    Acute respiratory failure
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Apnoea
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    2
    0
    0
    Aspiration
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Atelectasis
         subjects affected / exposed
    4 / 83 (4.82%)
    1 / 16 (6.25%)
    4 / 85 (4.71%)
         occurrences all number
    5
    1
    4
    Bronchial haemorrhage
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Bronchial obstruction
         subjects affected / exposed
    2 / 83 (2.41%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    3
    0
    0
    Bronchial secretion retention
         subjects affected / exposed
    2 / 83 (2.41%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    2
    0
    1
    Bronchiectasis
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Bronchospasm
         subjects affected / exposed
    2 / 83 (2.41%)
    1 / 16 (6.25%)
    2 / 85 (2.35%)
         occurrences all number
    2
    1
    2
    Chronic respiratory failure
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 16 (6.25%)
    0 / 85 (0.00%)
         occurrences all number
    0
    1
    0
    Chylothorax
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Cough
         subjects affected / exposed
    2 / 83 (2.41%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    2
    0
    2
    Dyspnoea
         subjects affected / exposed
    2 / 83 (2.41%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    2
    0
    0
    Haemoptysis
         subjects affected / exposed
    2 / 83 (2.41%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    2
    0
    0
    Haemothorax
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Hiccups
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Hypercapnia
         subjects affected / exposed
    2 / 83 (2.41%)
    0 / 16 (0.00%)
    5 / 85 (5.88%)
         occurrences all number
    2
    0
    8
    Hyperventilation
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    1
    0
    1
    Hypopnoea
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Hypoventilation
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Hypoxia
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    2 / 85 (2.35%)
         occurrences all number
    2
    0
    2
    Increased bronchial secretion
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Increased viscosity of bronchial secretion
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    1
    0
    1
    Interstitial lung disease
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Laryngeal oedema
         subjects affected / exposed
    3 / 83 (3.61%)
    0 / 16 (0.00%)
    2 / 85 (2.35%)
         occurrences all number
    3
    0
    2
    Lung infiltration
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Nasal congestion
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 16 (6.25%)
    0 / 85 (0.00%)
         occurrences all number
    0
    1
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 83 (0.00%)
    2 / 16 (12.50%)
    1 / 85 (1.18%)
         occurrences all number
    0
    2
    1
    Pleural disorder
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Pleural effusion
         subjects affected / exposed
    2 / 83 (2.41%)
    3 / 16 (18.75%)
    3 / 85 (3.53%)
         occurrences all number
    2
    3
    4
    Pneumonitis
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Pneumothorax
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Pulmonary congestion
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Pulmonary embolism
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    2 / 85 (2.35%)
         occurrences all number
    1
    0
    2
    Pulmonary fistula
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Pulmonary oedema
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    2 / 85 (2.35%)
         occurrences all number
    0
    0
    5
    Respiratory acidosis
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Respiratory distress
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Respiratory failure
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Respiratory fatigue
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Rhinorrhoea
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Rhonchi
         subjects affected / exposed
    2 / 83 (2.41%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    2
    0
    1
    Sleep apnoea syndrome
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Sputum retention
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    1
    0
    1
    Tachypnoea
         subjects affected / exposed
    2 / 83 (2.41%)
    1 / 16 (6.25%)
    3 / 85 (3.53%)
         occurrences all number
    3
    1
    3
    Throat irritation
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 16 (6.25%)
    0 / 85 (0.00%)
         occurrences all number
    0
    1
    0
    Wheezing
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Psychiatric disorders
    Adjustment disorder with depressed mood
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Agitation
         subjects affected / exposed
    3 / 83 (3.61%)
    1 / 16 (6.25%)
    3 / 85 (3.53%)
         occurrences all number
    3
    1
    3
    Anxiety
         subjects affected / exposed
    4 / 83 (4.82%)
    3 / 16 (18.75%)
    2 / 85 (2.35%)
         occurrences all number
    5
    3
    2
    Apathy
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    1
    0
    1
    Compulsive lip biting
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Delirium
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    5 / 85 (5.88%)
         occurrences all number
    1
    0
    5
    Depression
         subjects affected / exposed
    2 / 83 (2.41%)
    0 / 16 (0.00%)
    3 / 85 (3.53%)
         occurrences all number
    2
    0
    3
    Depressive symptom
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Disinhibition
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 16 (6.25%)
    0 / 85 (0.00%)
         occurrences all number
    0
    1
    0
    Disorientation
         subjects affected / exposed
    1 / 83 (1.20%)
    1 / 16 (6.25%)
    1 / 85 (1.18%)
         occurrences all number
    1
    1
    1
    Initial insomnia
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Insomnia
         subjects affected / exposed
    9 / 83 (10.84%)
    0 / 16 (0.00%)
    7 / 85 (8.24%)
         occurrences all number
    10
    0
    7
    Intensive care unit delirium
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Nervousness
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Restlessness
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Product issues
    Stent malfunction
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Thrombosis in device
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    4 / 83 (4.82%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    4
    0
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    3 / 83 (3.61%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    3
    0
    0
    Blood albumin decreased
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    1
    0
    1
    Blood glucose increased
         subjects affected / exposed
    2 / 83 (2.41%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    2
    0
    0
    Blood magnesium decreased
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 16 (6.25%)
    0 / 85 (0.00%)
         occurrences all number
    0
    1
    0
    Blood potassium decreased
         subjects affected / exposed
    2 / 83 (2.41%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    2
    0
    0
    Blood sodium decreased
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Blood urea increased
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    3 / 85 (3.53%)
         occurrences all number
    0
    0
    3
    C-reactive protein increased
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    2 / 85 (2.35%)
         occurrences all number
    0
    0
    2
    Inflammatory marker increased
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Oxygen saturation abnormal
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Oxygen saturation decreased
         subjects affected / exposed
    3 / 83 (3.61%)
    0 / 16 (0.00%)
    3 / 85 (3.53%)
         occurrences all number
    9
    0
    10
    Transaminases increased
         subjects affected / exposed
    1 / 83 (1.20%)
    1 / 16 (6.25%)
    1 / 85 (1.18%)
         occurrences all number
    1
    1
    1
    Urine output decreased
         subjects affected / exposed
    2 / 83 (2.41%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    2
    0
    0
    White blood cell count increased
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Electrocardiogram QT prolonged
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 16 (6.25%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    1
    PCO2 increased
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    PO2 decreased
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    3
    0
    5
    Injury, poisoning and procedural complications
    Dialysis related complication
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Endotracheal intubation complication
         subjects affected / exposed
    2 / 83 (2.41%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    2
    0
    0
    Eschar
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Fall
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 16 (6.25%)
    0 / 85 (0.00%)
         occurrences all number
    0
    2
    0
    Flail chest
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    2
    0
    0
    Gastrostomy tube site complication
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Haemodilution
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    1
    0
    1
    Inflammation of wound
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Infusion related reaction
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    2 / 85 (2.35%)
         occurrences all number
    1
    0
    2
    Joint dislocation
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Overdose
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Palate injury
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Post procedural haematuria
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Post procedural inflammation
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Postoperative hypotension
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Postoperative wound complication
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Procedural haemorrhage
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Procedural hypotension
         subjects affected / exposed
    3 / 83 (3.61%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    3
    0
    1
    Procedural pain
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 16 (6.25%)
    3 / 85 (3.53%)
         occurrences all number
    0
    1
    3
    Scar
         subjects affected / exposed
    2 / 83 (2.41%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    2
    0
    1
    Scratch
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Seroma
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Skin laceration
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Stoma site erythema
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Tracheal haemorrhage
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Vascular pseudoaneurysm
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    2
    Weaning failure
         subjects affected / exposed
    2 / 83 (2.41%)
    0 / 16 (0.00%)
    2 / 85 (2.35%)
         occurrences all number
    2
    0
    2
    Wound necrosis
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    1
    0
    1
    Wound secretion
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    3 / 83 (3.61%)
    2 / 16 (12.50%)
    4 / 85 (4.71%)
         occurrences all number
    3
    2
    7
    Atrial tachycardia
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Bradycardia
         subjects affected / exposed
    2 / 83 (2.41%)
    0 / 16 (0.00%)
    3 / 85 (3.53%)
         occurrences all number
    2
    0
    5
    Cardiac arrest
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Cardiac failure
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 16 (6.25%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    1
    Cardiac failure congestive
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Cardiogenic shock
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Coronary artery occlusion
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 16 (6.25%)
    0 / 85 (0.00%)
         occurrences all number
    0
    1
    0
    Cyanosis
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Mitral valve stenosis
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Sinus bradycardia
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    1
    0
    1
    Sinus tachycardia
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Supraventricular tachycardia
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    2
    0
    0
    Tachycardia
         subjects affected / exposed
    7 / 83 (8.43%)
    0 / 16 (0.00%)
    3 / 85 (3.53%)
         occurrences all number
    11
    0
    3
    Ventricular dysfunction
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Ventricular tachycardia
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    2 / 85 (2.35%)
         occurrences all number
    1
    0
    2
    Nervous system disorders
    Aphasia
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    1
    0
    1
    Complex regional pain syndrome
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Epilepsy
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Extrapyramidal disorder
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Frontotemporal dementia
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Headache
         subjects affected / exposed
    2 / 83 (2.41%)
    0 / 16 (0.00%)
    4 / 85 (4.71%)
         occurrences all number
    3
    0
    7
    Hydrocephalus
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Hypoxic-ischaemic encephalopathy
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 16 (6.25%)
    0 / 85 (0.00%)
         occurrences all number
    0
    1
    0
    Loss of consciousness
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    1
    0
    1
    Metabolic encephalopathy
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Motor dysfunction
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Myoclonus
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Neuropathy peripheral
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Paresis
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Parkinsonism
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Peripheral motor neuropathy
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    1
    0
    1
    Peripheral sensorimotor neuropathy
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Peroneal nerve palsy
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Post cardiac arrest syndrome
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Psychomotor hyperactivity
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Seizure
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 16 (6.25%)
    0 / 85 (0.00%)
         occurrences all number
    0
    1
    0
    Somnolence
         subjects affected / exposed
    2 / 83 (2.41%)
    0 / 16 (0.00%)
    2 / 85 (2.35%)
         occurrences all number
    2
    0
    2
    Syncope
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Tremor
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    1
    0
    1
    Anaemia of chronic disease
         subjects affected / exposed
    4 / 83 (4.82%)
    0 / 16 (0.00%)
    4 / 85 (4.71%)
         occurrences all number
    5
    0
    4
    Blood loss anaemia
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Haemolytic anaemia
         subjects affected / exposed
    5 / 83 (6.02%)
    0 / 16 (0.00%)
    8 / 85 (9.41%)
         occurrences all number
    9
    0
    13
    Iron deficiency anaemia
         subjects affected / exposed
    7 / 83 (8.43%)
    1 / 16 (6.25%)
    2 / 85 (2.35%)
         occurrences all number
    10
    1
    2
    Leukocytosis
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    2 / 85 (2.35%)
         occurrences all number
    1
    0
    2
    Microcytic anaemia
         subjects affected / exposed
    2 / 83 (2.41%)
    1 / 16 (6.25%)
    0 / 85 (0.00%)
         occurrences all number
    2
    1
    0
    Normocytic anaemia
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 16 (6.25%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    1
    Splenomegaly
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Thrombocytopenia
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    4 / 85 (4.71%)
         occurrences all number
    2
    0
    4
    Thrombocytosis
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 16 (6.25%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    1
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 16 (6.25%)
    0 / 85 (0.00%)
         occurrences all number
    0
    1
    0
    Excessive cerumen production
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Eye disorders
    Blindness unilateral
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Dry eye
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Noninfective conjunctivitis
         subjects affected / exposed
    2 / 83 (2.41%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    2
    0
    0
    Ocular hyperaemia
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Pupils unequal
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 16 (6.25%)
    0 / 85 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Abdominal pain
         subjects affected / exposed
    6 / 83 (7.23%)
    2 / 16 (12.50%)
    3 / 85 (3.53%)
         occurrences all number
    6
    3
    6
    Abdominal pain upper
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Aerophagia
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 16 (6.25%)
    0 / 85 (0.00%)
         occurrences all number
    0
    1
    0
    Anal incontinence
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    1
    0
    1
    Colitis
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Constipation
         subjects affected / exposed
    11 / 83 (13.25%)
    4 / 16 (25.00%)
    11 / 85 (12.94%)
         occurrences all number
    13
    5
    11
    Diarrhoea
         subjects affected / exposed
    11 / 83 (13.25%)
    4 / 16 (25.00%)
    12 / 85 (14.12%)
         occurrences all number
    16
    5
    14
    Dysphagia
         subjects affected / exposed
    2 / 83 (2.41%)
    0 / 16 (0.00%)
    6 / 85 (7.06%)
         occurrences all number
    2
    0
    6
    Faecaloma
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Flatulence
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Gastrointestinal hypomotility
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Gastrointestinal motility disorder
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Gastrointestinal oedema
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 16 (6.25%)
    0 / 85 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    2 / 83 (2.41%)
    1 / 16 (6.25%)
    1 / 85 (1.18%)
         occurrences all number
    2
    1
    1
    Ileus
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 16 (6.25%)
    0 / 85 (0.00%)
         occurrences all number
    0
    1
    0
    Ileus paralytic
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Intestinal dilatation
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Lip haemorrhage
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Melaena
         subjects affected / exposed
    3 / 83 (3.61%)
    0 / 16 (0.00%)
    2 / 85 (2.35%)
         occurrences all number
    3
    0
    2
    Nausea
         subjects affected / exposed
    3 / 83 (3.61%)
    4 / 16 (25.00%)
    1 / 85 (1.18%)
         occurrences all number
    5
    5
    2
    Oesophagopleural fistula
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Oral mucosa haematoma
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Pancreatic failure
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 16 (6.25%)
    0 / 85 (0.00%)
         occurrences all number
    0
    1
    0
    Pancreatic necrosis
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Pancreatitis
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 16 (6.25%)
    0 / 85 (0.00%)
         occurrences all number
    0
    1
    0
    Perianal erythema
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Rectal haemorrhage
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    2
    Salivary hypersecretion
         subjects affected / exposed
    1 / 83 (1.20%)
    1 / 16 (6.25%)
    2 / 85 (2.35%)
         occurrences all number
    1
    1
    2
    Vomiting
         subjects affected / exposed
    3 / 83 (3.61%)
    2 / 16 (12.50%)
    4 / 85 (4.71%)
         occurrences all number
    5
    4
    6
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Cholelithiasis
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Cholestasis
         subjects affected / exposed
    2 / 83 (2.41%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    2
    0
    0
    Drug-induced liver injury
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Hepatocellular injury
         subjects affected / exposed
    2 / 83 (2.41%)
    0 / 16 (0.00%)
    2 / 85 (2.35%)
         occurrences all number
    2
    0
    2
    Ischaemic hepatitis
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Blister
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Decubitus ulcer
         subjects affected / exposed
    6 / 83 (7.23%)
    0 / 16 (0.00%)
    5 / 85 (5.88%)
         occurrences all number
    6
    0
    6
    Dermatitis
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Dry skin
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Erythema
         subjects affected / exposed
    3 / 83 (3.61%)
    0 / 16 (0.00%)
    2 / 85 (2.35%)
         occurrences all number
    5
    0
    2
    Generalised erythema
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Hyperhidrosis
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 16 (6.25%)
    3 / 85 (3.53%)
         occurrences all number
    0
    1
    5
    Rash
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    1
    0
    1
    Rash erythematous
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Rash maculo-papular
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Rash papular
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Rash pruritic
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Scab
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    2
    Skin irritation
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    2 / 85 (2.35%)
         occurrences all number
    0
    0
    2
    Skin ulcer
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Skin ulcer haemorrhage
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Stasis dermatitis
         subjects affected / exposed
    1 / 83 (1.20%)
    1 / 16 (6.25%)
    0 / 85 (0.00%)
         occurrences all number
    1
    1
    0
    Subcutaneous emphysema
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Swelling face
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    3 / 83 (3.61%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    3
    0
    1
    Anuria
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Chronic kidney disease
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Haematuria
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    2 / 85 (2.35%)
         occurrences all number
    1
    0
    2
    Haemorrhage urinary tract
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Nephrolithiasis
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Oliguria
         subjects affected / exposed
    5 / 83 (6.02%)
    1 / 16 (6.25%)
    5 / 85 (5.88%)
         occurrences all number
    6
    1
    5
    Polyuria
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Proteinuria
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Renal cyst
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 16 (6.25%)
    0 / 85 (0.00%)
         occurrences all number
    0
    1
    0
    Renal failure
         subjects affected / exposed
    3 / 83 (3.61%)
    0 / 16 (0.00%)
    5 / 85 (5.88%)
         occurrences all number
    3
    0
    5
    Renal impairment
         subjects affected / exposed
    1 / 83 (1.20%)
    1 / 16 (6.25%)
    2 / 85 (2.35%)
         occurrences all number
    1
    1
    2
    Tubulointerstitial nephritis
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Urinary retention
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    1
    0
    1
    Urinary tract disorder
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    1
    0
    1
    Urine abnormality
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    2 / 85 (2.35%)
         occurrences all number
    1
    0
    2
    Vesical fistula
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Endocrine disorders
    Adrenal insufficiency
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Diabetes insipidus
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Euthyroid sick syndrome
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Hyperprolactinaemia
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 16 (6.25%)
    0 / 85 (0.00%)
         occurrences all number
    0
    1
    0
    Hypothyroidism
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    1
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Back pain
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 16 (6.25%)
    2 / 85 (2.35%)
         occurrences all number
    0
    1
    2
    Bone disorder
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Coccydynia
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Exposed bone in jaw
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 16 (6.25%)
    0 / 85 (0.00%)
         occurrences all number
    0
    1
    0
    Muscle spasms
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    3
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Musculoskeletal pain
         subjects affected / exposed
    3 / 83 (3.61%)
    3 / 16 (18.75%)
    2 / 85 (2.35%)
         occurrences all number
    4
    3
    2
    Musculoskeletal stiffness
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Myopathy
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Neck pain
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Pain in extremity
         subjects affected / exposed
    3 / 83 (3.61%)
    1 / 16 (6.25%)
    3 / 85 (3.53%)
         occurrences all number
    3
    1
    3
    Infections and infestations
    Abdominal infection
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Acinetobacter infection
         subjects affected / exposed
    2 / 83 (2.41%)
    0 / 16 (0.00%)
    5 / 85 (5.88%)
         occurrences all number
    2
    0
    5
    Anal fungal infection
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Bacteraemia
         subjects affected / exposed
    4 / 83 (4.82%)
    0 / 16 (0.00%)
    4 / 85 (4.71%)
         occurrences all number
    4
    0
    5
    Bacterial abdominal infection
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Bacterial disease carrier
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    3 / 85 (3.53%)
         occurrences all number
    2
    0
    5
    Bacterial infection
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    1
    0
    1
    Bacterial sepsis
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    4 / 85 (4.71%)
         occurrences all number
    0
    0
    4
    Bacteriuria
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Bronchitis bacterial
         subjects affected / exposed
    2 / 83 (2.41%)
    0 / 16 (0.00%)
    2 / 85 (2.35%)
         occurrences all number
    2
    0
    2
    Candida infection
         subjects affected / exposed
    2 / 83 (2.41%)
    0 / 16 (0.00%)
    2 / 85 (2.35%)
         occurrences all number
    2
    0
    2
    Candiduria
         subjects affected / exposed
    2 / 83 (2.41%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    2
    0
    1
    Cellulitis
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Citrobacter bacteraemia
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Clostridium difficile colitis
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    2 / 85 (2.35%)
         occurrences all number
    0
    0
    3
    Conjunctivitis
         subjects affected / exposed
    1 / 83 (1.20%)
    1 / 16 (6.25%)
    0 / 85 (0.00%)
         occurrences all number
    3
    1
    0
    Cystitis klebsiella
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Empyema
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Endocarditis
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Enterobacter bacteraemia
         subjects affected / exposed
    2 / 83 (2.41%)
    0 / 16 (0.00%)
    2 / 85 (2.35%)
         occurrences all number
    2
    0
    2
    Enterobacter pneumonia
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Enterococcal bacteraemia
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 16 (6.25%)
    2 / 85 (2.35%)
         occurrences all number
    0
    1
    2
    Enterococcal infection
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    1
    0
    2
    Enterococcal sepsis
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Escherichia bacteraemia
         subjects affected / exposed
    2 / 83 (2.41%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    2
    0
    0
    Escherichia urinary tract infection
         subjects affected / exposed
    5 / 83 (6.02%)
    1 / 16 (6.25%)
    3 / 85 (3.53%)
         occurrences all number
    5
    2
    4
    Eye infection
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Fungaemia
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Fungal skin infection
         subjects affected / exposed
    2 / 83 (2.41%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    2
    0
    1
    Genital infection female
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 16 (6.25%)
    0 / 85 (0.00%)
         occurrences all number
    0
    1
    0
    Haematoma infection
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Herpes virus infection
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Herpes zoster
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Infectious pleural effusion
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Influenza
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Klebsiella bacteraemia
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    3 / 85 (3.53%)
         occurrences all number
    1
    0
    3
    Klebsiella infection
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    2 / 85 (2.35%)
         occurrences all number
    0
    0
    2
    Klebsiella sepsis
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Lower respiratory tract infection bacterial
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Lung infection pseudomonal
         subjects affected / exposed
    2 / 83 (2.41%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    5
    0
    1
    Morganella infection
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Oral candidiasis
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    3 / 85 (3.53%)
         occurrences all number
    1
    0
    3
    Oral fungal infection
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Oral herpes
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Oropharyngeal candidiasis
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Pneumonia
         subjects affected / exposed
    1 / 83 (1.20%)
    1 / 16 (6.25%)
    3 / 85 (3.53%)
         occurrences all number
    1
    1
    3
    Pneumonia acinetobacter
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    1
    0
    1
    Pneumonia bacterial
         subjects affected / exposed
    12 / 83 (14.46%)
    2 / 16 (12.50%)
    4 / 85 (4.71%)
         occurrences all number
    13
    2
    5
    Pneumonia escherichia
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Pneumonia proteus
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Pneumonia pseudomonal
         subjects affected / exposed
    12 / 83 (14.46%)
    1 / 16 (6.25%)
    13 / 85 (15.29%)
         occurrences all number
    13
    1
    15
    Pneumonia staphylococcal
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    1
    0
    1
    Proteus infection
         subjects affected / exposed
    4 / 83 (4.82%)
    1 / 16 (6.25%)
    1 / 85 (1.18%)
         occurrences all number
    4
    2
    1
    Pseudomonal bacteraemia
         subjects affected / exposed
    6 / 83 (7.23%)
    0 / 16 (0.00%)
    6 / 85 (7.06%)
         occurrences all number
    6
    0
    6
    Pseudomonal sepsis
         subjects affected / exposed
    5 / 83 (6.02%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    6
    0
    0
    Pseudomonas bronchitis
         subjects affected / exposed
    5 / 83 (6.02%)
    4 / 16 (25.00%)
    4 / 85 (4.71%)
         occurrences all number
    5
    4
    4
    Pseudomonas infection
         subjects affected / exposed
    4 / 83 (4.82%)
    0 / 16 (0.00%)
    4 / 85 (4.71%)
         occurrences all number
    4
    0
    4
    Pyuria
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Septic shock
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    2 / 85 (2.35%)
         occurrences all number
    0
    0
    2
    Serratia bacteraemia
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Serratia sepsis
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Staphylococcal bacteraemia
         subjects affected / exposed
    2 / 83 (2.41%)
    1 / 16 (6.25%)
    4 / 85 (4.71%)
         occurrences all number
    2
    1
    4
    Staphylococcal infection
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    2 / 85 (2.35%)
         occurrences all number
    0
    0
    2
    Staphylococcal sepsis
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    1
    0
    1
    Stenotrophomonas infection
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Stoma site infection
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Systemic candida
         subjects affected / exposed
    3 / 83 (3.61%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    3
    0
    1
    Tracheobronchitis
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    2 / 85 (2.35%)
         occurrences all number
    0
    0
    2
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 83 (1.20%)
    1 / 16 (6.25%)
    3 / 85 (3.53%)
         occurrences all number
    1
    2
    3
    Urinary tract infection bacterial
         subjects affected / exposed
    3 / 83 (3.61%)
    0 / 16 (0.00%)
    3 / 85 (3.53%)
         occurrences all number
    3
    0
    3
    Urinary tract infection pseudomonal
         subjects affected / exposed
    5 / 83 (6.02%)
    0 / 16 (0.00%)
    4 / 85 (4.71%)
         occurrences all number
    6
    0
    4
    Urinary tract infection staphylococcal
         subjects affected / exposed
    2 / 83 (2.41%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    2
    0
    0
    Varicella zoster virus infection
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Vulvovaginal candidiasis
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Vulvovaginal mycotic infection
         subjects affected / exposed
    1 / 83 (1.20%)
    1 / 16 (6.25%)
    0 / 85 (0.00%)
         occurrences all number
    1
    1
    0
    Metabolism and nutrition disorders
    Acidosis
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    3
    Alkalosis
         subjects affected / exposed
    2 / 83 (2.41%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    2
    0
    6
    Decreased appetite
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Dehydration
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Fluid overload
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Fluid retention
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    1
    0
    1
    Hyperammonaemia
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Hypercalcaemia
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    2 / 85 (2.35%)
         occurrences all number
    0
    0
    2
    Hypercholesterolaemia
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Hyperglycaemia
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    4 / 85 (4.71%)
         occurrences all number
    1
    0
    5
    Hyperkalaemia
         subjects affected / exposed
    2 / 83 (2.41%)
    0 / 16 (0.00%)
    3 / 85 (3.53%)
         occurrences all number
    2
    0
    4
    Hypernatraemia
         subjects affected / exposed
    3 / 83 (3.61%)
    1 / 16 (6.25%)
    5 / 85 (5.88%)
         occurrences all number
    3
    1
    5
    Hyperphosphataemia
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Hypoalbuminaemia
         subjects affected / exposed
    4 / 83 (4.82%)
    0 / 16 (0.00%)
    3 / 85 (3.53%)
         occurrences all number
    4
    0
    3
    Hypocalcaemia
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    2 / 85 (2.35%)
         occurrences all number
    0
    0
    2
    Hypoglycaemia
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 16 (6.25%)
    2 / 85 (2.35%)
         occurrences all number
    0
    1
    2
    Hypokalaemia
         subjects affected / exposed
    9 / 83 (10.84%)
    1 / 16 (6.25%)
    15 / 85 (17.65%)
         occurrences all number
    12
    1
    25
    Hypomagnesaemia
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    3 / 85 (3.53%)
         occurrences all number
    1
    0
    3
    Hyponatraemia
         subjects affected / exposed
    3 / 83 (3.61%)
    0 / 16 (0.00%)
    2 / 85 (2.35%)
         occurrences all number
    3
    0
    2
    Hypophosphataemia
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    4 / 85 (4.71%)
         occurrences all number
    0
    0
    4
    Hypoproteinaemia
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    0
    1
    Hypovolaemia
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    0
    Metabolic acidosis
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    2 / 85 (2.35%)
         occurrences all number
    1
    0
    2
    Metabolic alkalosis
         subjects affected / exposed
    3 / 83 (3.61%)
    0 / 16 (0.00%)
    4 / 85 (4.71%)
         occurrences all number
    3
    0
    5
    Vitamin K deficiency
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 16 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    1
    0
    1

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Jul 2016
    New Onset of Chronic Diseases (NOCDs) as a safety assessment was removed. Blood for culture assessments on Days 2 and 4 were removed from the Schedule of Investigational Product Administration and Follow-up Study Procedures. Clarified that only protein markers of inflammation (only while participant is intubated) in tracheal aspirate will be assessed. Added footnote to clarify that the tracheal aspirate for protein markers of inflammation (only while participant is intubated) sample collected on Day 8 would also be collected on day of extubation if it occurred on day between scheduled assessments. Added tracheal or bronchial (not just tracheal) aspirate may be collected (in intubated participants only) for Gram stain and culture. Clarified that qualitative respiratory culture results would be recorded by all study sites and that quantitative and semi-quantitative respiratory culture results would be recorded by study sites when available. Clarified that chest X-rays performed as part of routine medical care can be used when available. Clarified that respiratory specimen positive for P aeruginosa by culture also includes expectorated sputum. Clarified that a participant is not considered to be mechanically ventilated when an endotracheal or nasotracheal tube is not in place and the participant does not require positive ventilation support for at least 8 hours. Clarified the text to reflect the change in blood collection. Added additional information for the sample size re estimation method. Approximated the antibiotic usage time after randomization from hours to days. Clarified that for participants with P aeruginosa pneumonia, the microbiology culture results would be summarized descriptively for both quantitative and semi-quantitative results, when available. Clarified that no interim analyses were planned during the study.
    22 Dec 2016
    Clarified that interactive web response system (IWRS) would be used as a method for assigning participants to treatment groups. Included the rationale for discontinuing enrolment in the 500 mg MEDI3902 group. Modified text to reflect the number of participants who would be enrolled and randomised into the study. Removed the restriction of 75% in either stratum. Updated the study flow diagram. Modified text to reflect the new treatment regimen. Added results from PK study in mice. Modified the text to maintain 1:1 ratio with the placebo group, if the 3000 mg dose was used. Modified text to increase the sequential organ failure assessment (SOFA) score to ≥ 12 (instead of ≥ 9) and added that vasopressors used to improve cerebral perfusion pressure should not be used in the calculation of the cardiovascular component of the SOFA score. Modified text to state that the tracheal/bronchial aspirate (for Gram stain and culture) and expectorated sputum (Gram stain and culture) was to be collected on Day 1 of onset of illness, Day 2, Day 3 and from Day 4 as clinically indicated, instead of daily, until clinical resolution. Modified text that described the reconstitution procedure, dose preparation for MEDI3902 and duration of infusion. Added section describing the unblinding plan and personnel who will remain blinded. Added that if a dose adjustment was made from 1500 mg MEDI3902 to 3000 mg MEDI3902, the key efficacy analyses would be based on 3000 mg MEDI3902 and placebo participants and that the participants who received 500 mg or 1500 mg MEDI3902 would be summarized descriptively. Added section to describe the PK interim analysis. Modified the definition of overdose.
    06 Jun 2018
    Removed the secondary objective: To evaluate the effect of MEDI3902 in reducing the incidence of nosocomial pneumonia caused by P aeruginosa by mechanical ventilation status. Removed the secondary endpoints corresponding to the secondary objective above. Removed “white blood cell count and differential” from the list of biomarkers that were to be analysed from tracheal aspirate. Modified text to reflect change in terms of stratification by receipt of anti-P aeruginosa antibiotic treatment (no antibiotics use, duration of =< 72 hours, duration of > 72 hours) within 96 hours prior to randomisation. Modified exclusion criteria to state that only receipt of systemic colistin and aerosolized colistin anti-P aeruginosa antibiotics for > 72 hours within 96 hours prior to randomisation or anticipated ongoing receipt of the aforementioned anti-P aeruginosa antibiotics are exclusionary. Removed “blood markers of inflammation” from routine schedule of events at Day 1, pre dose and Day 8. Added tracheobronchitis as suspected outcome in Schedule of Procedures for Participants With Suspected or Confirmed Pneumonia, Tracheobronchitis or Bacteremia, prompting Day 1 onset visit assessments. Clarified the definition of tracheobronchitis. Clarified that if the duration of the infusion exceeded 8 hours for the 1500 mg MEDI3902/placebo groups and 12 hours (in case of dose adjustment) for the 3000 mg MEDI3902/placebo groups, the medical monitor should be notified immediately. Changed primary efficacy population to mITT rather than ITT. Removed secondary efficacy endpoint analyses. Added clarification to primary efficacy analysis. Added Appendix 10 with list of study-specified anti-P aeruginosa antibiotics for stratification.

    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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