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    Clinical Trial Results:
    A Multicenter, Double-Blind, Randomized, Phase 3 Study to Compare the Efficacy and Safety of Intravenous CXA-201 with that of Meropenem in Complicated Intraabdominal Infections

    Summary
    EudraCT number
    		 2011-002120-41
    Trial protocol
    		 HU   DE   PL   BG   LT   EE   LV  
    Global end of trial date
    15 Oct 2013

    Results information
    Results version number
    		 v2(current)
    This version publication date
    28 Sep 2018
    First version publication date
    05 Aug 2015
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Downloading results xml off record to post to sister study 2011-002119-27 ( duplicate record)

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CXA-cIAI-10-08 and CXA-cIAI-10-09
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01445678
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 2011-002119-27: EudraCT
    Sponsors
    Sponsor organisation name
    Cubist Pharmaceuticals, Inc.
    Sponsor organisation address
    65 Hayden Drive, Lexington, MA, United States,
    Public contact
    Medical Director, Cubist Pharmaceuticals, Inc., 001 781-860-8660,
    Scientific contact
    Medical Director, Cubist Pharmaceuticals, Inc., 001 781-860-8660,
    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
    18 Mar 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Oct 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Oct 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This is a Phase 3, multicenter, prospective, randomized, double-blind, double dummy study of CXA-201 intravenous (IV) infusions to demonstrate the noninferiority of ceftolozane/tazobactam (CXA-201) plus metronidazole versus meropenem in adult subjects with complicated intraabdominal infections (cIAI). Two identical Phase 3 protocol were initiated: CXA-cIAI-10-09 (2011-002120-41) and CXA-cIAI-10-08 (2011-002119-27). Based on this guidance and following scientific advice from the CHMP (Procedure No.: EMEA/H/SA/2181/2/2012/II; taking into account existing CHMP guidance) and agreement from the US FDA, Cubist revised its clinical development program for ceftolozane/tazobactam (CXA-201) leading to a single-study approval pathway for each indication.
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles of Good Clinical Practice, according to the International Conference on Harmonisation (ICH) Tripartite Guideline.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Dec 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 55
    Country: Number of subjects enrolled
    Argentina: 75
    Country: Number of subjects enrolled
    Australia: 3
    Country: Number of subjects enrolled
    Belgium: 7
    Country: Number of subjects enrolled
    Brazil: 4
    Country: Number of subjects enrolled
    Bulgaria: 24
    Country: Number of subjects enrolled
    Chile: 2
    Country: Number of subjects enrolled
    Colombia: 10
    Country: Number of subjects enrolled
    Croatia: 13
    Country: Number of subjects enrolled
    Estonia: 75
    Country: Number of subjects enrolled
    Georgia: 31
    Country: Number of subjects enrolled
    Germany: 4
    Country: Number of subjects enrolled
    Hungary: 65
    Country: Number of subjects enrolled
    Israel: 11
    Country: Number of subjects enrolled
    Latvia: 74
    Country: Number of subjects enrolled
    Lithuania: 70
    Country: Number of subjects enrolled
    Mexico: 20
    Country: Number of subjects enrolled
    Moldova, Republic of: 31
    Country: Number of subjects enrolled
    Peru: 13
    Country: Number of subjects enrolled
    Poland: 39
    Country: Number of subjects enrolled
    Romania: 109
    Country: Number of subjects enrolled
    Russian Federation: 51
    Country: Number of subjects enrolled
    Serbia: 29
    Country: Number of subjects enrolled
    Slovakia: 47
    Country: Number of subjects enrolled
    South Africa: 4
    Country: Number of subjects enrolled
    Korea, Democratic People's Republic of: 32
    Country: Number of subjects enrolled
    Spain: 23
    Country: Number of subjects enrolled
    Ukraine: 73
    Worldwide total number of subjects
    994
    EEA total number of subjects
    550
    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)
    770
    From 65 to 84 years
    215
    85 years and over
    9

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Subjects enrolled in this study were at least 18 years of age with a complicated intra-abdominal infection. Subjects were eligible to participate in the study if they met all of the inclusion criteria and none of the exclusion criteria at the Screening visit.

    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
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 CXA-201 and Metronidazole as treatment for cIAI
    Arm description
    		 CXA-201 and metronidazole: CXA-201 IV infusion (ceftolozane 1000 milligrams [mg] + tazobactam 500 mg q8h) and metronidazole IV infusion (500 mg q8h) for 4 to 14 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ceftolozane/ Tazobactam
    Investigational medicinal product code
    Other name
    CXA-201
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    CXA-201 intravenous (IV) infusion (ceftolozane 1000 milligrams [mg] and tazobactam 500 mg q8h) for 4 to 14 days

    Investigational medicinal product name
    Metronidazole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Metronidazole IV infusion (500 mg q 8h) for 4 to 14 days

    Arm title
    		 Meropenem as treatment for cIAI
    Arm description
    		 Meropenem: Meropenem IV infusion (1000 mg q8h) for 4-14 days
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Meropenem
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Meropenem: Meropenem IV infusion (1000mg q8h) for 4-14 days Of the 979 treated subjects in the integrated analysis set, 497 received meropenem.

    Number of subjects in period 1
    		CXA-201 and Metronidazole as treatment for cIAI Meropenem as treatment for cIAI
    Started
    488
    506
    Received at least 1 dose of study drug
    482
    497
    Completed
    452
    476
    Not completed
    36
    30
         Consent withdrawn by subject
    11
    7
         Physician decision
    1
    -
         Adverse event, non-fatal
    12
    8
         Lost to follow-up
    8
    5
         Reason not specified
    2
    2
         Lack of informed consent
    -
    2
         Protocol deviation
    2
    4
         Lack of efficacy
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    CXA-201 and Metronidazole as treatment for cIAI
    Reporting group description
    		 CXA-201 and metronidazole: CXA-201 IV infusion (ceftolozane 1000 milligrams [mg] + tazobactam 500 mg q8h) and metronidazole IV infusion (500 mg q8h) for 4 to 14 days.

    Reporting group title
    Meropenem as treatment for cIAI
    Reporting group description
    		 Meropenem: Meropenem IV infusion (1000 mg q8h) for 4-14 days

    Reporting group values
    		 CXA-201 and Metronidazole as treatment for cIAI Meropenem as treatment for cIAI Total
    Number of subjects
    		 488 506
    Age categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 50.6 ± 17.94 50.5 ± 16.85 -
    Gender, Male/Female
    Units: participants
        Male
    		 0
        Female
    		 0
    Subject analysis sets

    Subject analysis set title
    Ceftolozane/Tazobactam(CXA-201)+Metronidazole--MITT population
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Microbiological intention-to-treat (MITT): all randomised subjects, regardless of whether or not the subjects went on to receive study drug, who had intra-abdominal infection (IAI) as evidenced by identification of at least 1 baseline intra-abdominal pathogen, regardless of susceptibility to study drug.

    Subject analysis set title
    Meropenem--MITT population
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Microbiological intention-to-treat (MITT): all randomised subjects, regardless of whether or not the subjects went on to receive study drug, who had intra-abdominal infection (IAI) as evidenced by identification of at least 1 baseline intra-abdominal pathogen, regardless of susceptibility to study drug.

    Subject analysis set title
    Ceftolozane/Tazobactam (CXA-201) +Metronidazole--CE population
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The clinically evaluable (CE) population was a subset of the intention-to-treat (ITT) population of subjects who received an adequate amount of study drug, met the protocol-specific disease definition of cIAI, adhered to study procedures, and had a test-of-cure (TOC) visit within the specified visit window. Subjects in this population had no confounding factors that interfered with the assessment of outcome and met the key inclusion/exclusion criteria and additional protocol-defined criteria.

    Subject analysis set title
    Meropenem--CE population
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The CE population was a subset of the intention-to-treat (ITT) population of subjects who received an adequate amount of study drug, met the protocol-specific disease definition of cIAI, adhered to study procedures, and had a test-of-cure (TOC) visit within the specified visit window. Subjects in this population had no confounding factors that interfered with the assessment of outcome and met the key inclusion/exclusion criteria and additional protocol-defined criteria.

    Subject analysis set title
    Ceftolozane/Tazobactam(CXA-201)+Metronidazole--ITT population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT population consisted of all randomised subjects regardless of whether or not the subjects went on to receive study drug. Subjects in the ITT population were categorised based on the treatment that the subjects were randomised to, irrespective of what they actually received.

    Subject analysis set title
    Meropenem--ITT population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT population consisted of all randomised subjects regardless of whether or not the subjects went on to receive study drug. Subjects in the ITT population were categorised based on the treatment that the subjects were randomised to, irrespective of what they actually received.

    Subject analysis set title
    Ceftolozane/ Tazobactam(CA-201)+Met-expanded ME population
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The expanded microbiologically evaluable (ME) population consisted of all subjects in the MITT population who met all CE population criteria.

    Subject analysis set title
    Meropenem--expanded ME population
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The expanded ME population consisted of all subjects in the MITT population who met all CE population criteria.

    Subject analysis set title
    Ceftolozane/ Tazobactam(CXA-201)+ Metronidazole--ME population
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The ME population was the subset of CE subjects who had at least 1 baseline infecting pathogen identified that was susceptible to study drug. For subjects receiving nonstudy antibiotics with only Gram-positive activity, the per-pathogen outcome for Gram-positive organisms was indeterminate.

    Subject analysis set title
    Meropenem--ME population
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The ME population was the subset of CE subjects who had at least 1 baseline infecting pathogen identified that was susceptible to study drug. For subjects receiving nonstudy antibiotics with only Gram-positive activity, the per-pathogen outcome for Gram-positive organisms was indeterminate.

    Subject analysis sets values
    		 Ceftolozane/Tazobactam(CXA-201)+Metronidazole--MITT population Meropenem--MITT population Ceftolozane/Tazobactam (CXA-201) +Metronidazole--CE population Meropenem--CE population Ceftolozane/Tazobactam(CXA-201)+Metronidazole--ITT population Meropenem--ITT population Ceftolozane/ Tazobactam(CA-201)+Met-expanded ME population Meropenem--expanded ME population Ceftolozane/ Tazobactam(CXA-201)+ Metronidazole--ME population Meropenem--ME population
    Number of subjects
    389
    417
    375
    399
    476
    494
    307
    345
    275
    321
    Age categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    50.8 ± 18.25
    50.4 ± 16.87
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    Gender, Male/Female
    Units: participants
        Male
    218
    248
        Female
    171
    169

    End points

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    End points reporting groups
    Reporting group title
    CXA-201 and Metronidazole as treatment for cIAI
    Reporting group description
    		 CXA-201 and metronidazole: CXA-201 IV infusion (ceftolozane 1000 milligrams [mg] + tazobactam 500 mg q8h) and metronidazole IV infusion (500 mg q8h) for 4 to 14 days.

    Reporting group title
    Meropenem as treatment for cIAI
    Reporting group description
    		 Meropenem: Meropenem IV infusion (1000 mg q8h) for 4-14 days

    Subject analysis set title
    Ceftolozane/Tazobactam(CXA-201)+Metronidazole--MITT population
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Microbiological intention-to-treat (MITT): all randomised subjects, regardless of whether or not the subjects went on to receive study drug, who had intra-abdominal infection (IAI) as evidenced by identification of at least 1 baseline intra-abdominal pathogen, regardless of susceptibility to study drug.

    Subject analysis set title
    Meropenem--MITT population
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Microbiological intention-to-treat (MITT): all randomised subjects, regardless of whether or not the subjects went on to receive study drug, who had intra-abdominal infection (IAI) as evidenced by identification of at least 1 baseline intra-abdominal pathogen, regardless of susceptibility to study drug.

    Subject analysis set title
    Ceftolozane/Tazobactam (CXA-201) +Metronidazole--CE population
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The clinically evaluable (CE) population was a subset of the intention-to-treat (ITT) population of subjects who received an adequate amount of study drug, met the protocol-specific disease definition of cIAI, adhered to study procedures, and had a test-of-cure (TOC) visit within the specified visit window. Subjects in this population had no confounding factors that interfered with the assessment of outcome and met the key inclusion/exclusion criteria and additional protocol-defined criteria.

    Subject analysis set title
    Meropenem--CE population
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The CE population was a subset of the intention-to-treat (ITT) population of subjects who received an adequate amount of study drug, met the protocol-specific disease definition of cIAI, adhered to study procedures, and had a test-of-cure (TOC) visit within the specified visit window. Subjects in this population had no confounding factors that interfered with the assessment of outcome and met the key inclusion/exclusion criteria and additional protocol-defined criteria.

    Subject analysis set title
    Ceftolozane/Tazobactam(CXA-201)+Metronidazole--ITT population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT population consisted of all randomised subjects regardless of whether or not the subjects went on to receive study drug. Subjects in the ITT population were categorised based on the treatment that the subjects were randomised to, irrespective of what they actually received.

    Subject analysis set title
    Meropenem--ITT population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT population consisted of all randomised subjects regardless of whether or not the subjects went on to receive study drug. Subjects in the ITT population were categorised based on the treatment that the subjects were randomised to, irrespective of what they actually received.

    Subject analysis set title
    Ceftolozane/ Tazobactam(CA-201)+Met-expanded ME population
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The expanded microbiologically evaluable (ME) population consisted of all subjects in the MITT population who met all CE population criteria.

    Subject analysis set title
    Meropenem--expanded ME population
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The expanded ME population consisted of all subjects in the MITT population who met all CE population criteria.

    Subject analysis set title
    Ceftolozane/ Tazobactam(CXA-201)+ Metronidazole--ME population
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The ME population was the subset of CE subjects who had at least 1 baseline infecting pathogen identified that was susceptible to study drug. For subjects receiving nonstudy antibiotics with only Gram-positive activity, the per-pathogen outcome for Gram-positive organisms was indeterminate.

    Subject analysis set title
    Meropenem--ME population
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The ME population was the subset of CE subjects who had at least 1 baseline infecting pathogen identified that was susceptible to study drug. For subjects receiving nonstudy antibiotics with only Gram-positive activity, the per-pathogen outcome for Gram-positive organisms was indeterminate.

    Primary: The percentage of subjects with clinical outcome of cure at the test of cure (TOC) visit in the clinically evaluable (CE) population

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    End point title
    		 The percentage of subjects with clinical outcome of cure at the test of cure (TOC) visit in the clinically evaluable (CE) population
    End point description
    Clinical cure is complete resolution or significant improvement in signs and symptoms of the index infection, such that no additional antibacterial therapy or surgical or drainage procedure was required for the index infection.
    End point type
    Primary
    End point timeframe
    TOC; 26-30 days after start of study drug administration
    End point values
    		 Ceftolozane/Tazobactam (CXA-201) +Metronidazole--CE population Meropenem--CE population
    Number of subjects analysed
    375 [1]
    399 [2]
    Units: percentage of subjects
    number (not applicable)
        Cure
    94.1
    94
        Failure
    5.9
    6
    Notes
    [1] - CE population
    [2] - CE population
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Meropenem--CE population v Ceftolozane/Tazobactam (CXA-201) +Metronidazole--CE population
    Number of subjects included in analysis
    774
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    Method
    Parameter type
    		 Percentage difference
    Point estimate
    0
    Confidence interval
         level
    		 99%
         sides
    2-sided
         lower limit
    		 -4.16
         upper limit
    		 4.3
    Notes
    [3] - The hypotheses were tested at the 1-sided 0.005 significance level, through a 2-sided 99% confidence interval (CI) approach. The 2-sided 99% CI on the difference of proportions for ceftolozane/tazobactam plus metronidazole minus comparator (meropenem) was constructed using stratified Newcombe CI with Minimum Risk weights. Noninferiority was concluded if the lower bound of the 2-sided 99% CI was greater than minus 12.5%, in the CE population.

    Secondary: The percentage of subjects with clinical outcome of cure at the TOC visit in the intention-to-treat (ITT) Population

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    End point title
    		 The percentage of subjects with clinical outcome of cure at the TOC visit in the intention-to-treat (ITT) Population
    End point description
    Clinical cure is complete resolution or significant improvement in signs and symptoms of the index infection, such that no additional antibacterial therapy or surgical or drainage procedure was required for the index infection.
    End point type
    Secondary
    End point timeframe
    TOC; 26-30 days after start of study drug administration
    End point values
    		 Ceftolozane/Tazobactam(CXA-201)+Metronidazole--ITT population Meropenem--ITT population
    Number of subjects analysed
    476 [4]
    494 [5]
    Units: percentage of subjects
    number (not applicable)
        Cure
    83.8
    85.8
        Failure
    16.2
    14.2
    Notes
    [4] - ITT population
    [5] - ITT population
    Statistical analysis title
    		 Statistial Analysis
    Statistical analysis description
    The hypotheses were tested at the 1-sided 0.005 significance level, through a 2-sided 99% confidence interval (CI) approach. The 2-sided 99% CI on the difference of proportions for ceftolozane/tazobactam plus metronidazole minus comparator (meropenem) was constructed using stratified Newcombe CI with Minimum Risk weights as described. Noninferiority was concluded if the lower bound of the 2-sided 99% CI was greater than minus 12.5%, in the the ITT population
    Comparison groups
    Ceftolozane/Tazobactam(CXA-201)+Metronidazole--ITT population v Meropenem--ITT population
    Number of subjects included in analysis
    970
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Percentage difference
    Point estimate
    -2.2
    Confidence interval
         level
    		 99%
         sides
    2-sided
         lower limit
    		 -7.95
         upper limit
    		 3.44

    Secondary: The percentage of subjects with clinical outcome of cure at the test of cure (TOC) visit in the microbiologically evaluable (ME), MITT, and expanded ME population

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    End point title
    		 The percentage of subjects with clinical outcome of cure at the test of cure (TOC) visit in the microbiologically evaluable (ME), MITT, and expanded ME population
    End point description
    Clinical cure is complete resolution or significant improvement in signs and symptoms of the index infection, such that no additional antibacterial therapy or surgical or drainage procedure was required for the index infection.
    End point type
    Secondary
    End point timeframe
    TOC; 26-30 days after start of study drug administration
    End point values
    		 Ceftolozane/Tazobactam(CXA-201)+Metronidazole--MITT population Meropenem--MITT population Ceftolozane/ Tazobactam(CA-201)+Met-expanded ME population Meropenem--expanded ME population Ceftolozane/ Tazobactam(CXA-201)+ Metronidazole--ME population Meropenem--ME population
    Number of subjects analysed
    389 [6]
    417 [7]
    307 [8]
    345 [9]
    275 [10]
    321 [11]
    Units: percentage of subjects
    number (not applicable)
        Cure
    83
    87.3
    93.8
    93.6
    94.2
    94.7
        Failure
    17
    12.7
    6.2
    6.4
    5.8
    5.3
    Notes
    [6] - MITT
    [7] - MITT
    [8] - Expanded ME
    [9] - Expanded ME
    [10] - ME population
    [11] - ME population
    No statistical analyses for this end point

    Secondary: The percentage of subjects with microbiological success at the TOC visit in the MITT, ME, and expanded ME populations

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    End point title
    		 The percentage of subjects with microbiological success at the TOC visit in the MITT, ME, and expanded ME populations
    End point description
    An overall microbiological response was determined for each subject based on individual microbiological responses for each baseline pathogen at the TOC visit. In order for the subject to have a favourable overall microbiological response (ie, success), each baseline pathogen must have had a favourable microbiological outcome. If the outcome for any pathogen was unfavourable, the subject was considered an overall microbiological failure.
    End point type
    Secondary
    End point timeframe
    TOC visit; 26-30 days after start of study drug administration
    End point values
    		 Ceftolozane/Tazobactam(CXA-201)+Metronidazole--MITT population Meropenem--MITT population Ceftolozane/ Tazobactam(CA-201)+Met-expanded ME population Meropenem--expanded ME population Ceftolozane/ Tazobactam(CXA-201)+ Metronidazole--ME population Meropenem--ME population
    Number of subjects analysed
    389 [12]
    417 [13]
    307 [14]
    345 [15]
    275 [16]
    321 [17]
    Units: percentage of subjects
    number (not applicable)
        Microbiological success
    85.3
    88.7
    95.4
    94.5
    96
    95.6
        Microbiological failure
    6.4
    6.7
    4.6
    5.5
    4
    4.4
    Notes
    [12] - MITT population
    [13] - MITT population
    [14] - Expanded ME population
    [15] - Expanded ME population
    [16] - ME population
    [17] - ME population
    No statistical analyses for this end point

    Secondary: The percentage of subjects with a gram-negative aerobes microbiological response at the TOC visit in the ME population

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    End point title
    		 The percentage of subjects with a gram-negative aerobes microbiological response at the TOC visit in the ME population
    End point description
    A microbiological response for gram-negative aerobes isolated at baseline at both the EOT and TOC visits. Microbiological response categories were eradication, presumed eradication, persistence, persistence acquiring resistance, presumed persistence, and indeterminate. Favourable microbiological responses included “eradication” or “presumed eradication.” Unfavourable responses were considered “persistence,” “persistence acquiring resistance,” and “presumed persistence.”
    End point type
    Secondary
    End point timeframe
    End of treatment (EOT) through TOC; 26-30 days after start of study drug administration
    End point values
    		 Ceftolozane/ Tazobactam(CXA-201)+ Metronidazole--ME population Meropenem--ME population
    Number of subjects analysed
    243 [18]
    282 [19]
    Units: percentage of subjects
        number (not applicable)
    96.3
    95.4
    Notes
    [18] - ME population
    [19] - ME population
    No statistical analyses for this end point

    Secondary: The percentage of subjects with sustained clinical cure at LFU Visit in the CE, ITT, and ME populations

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    End point title
    		 The percentage of subjects with sustained clinical cure at LFU Visit in the CE, ITT, and ME populations
    End point description
    Sustained clinical cure at LFU is defined as no signs and symptoms recur or worsen since the TOC visit.
    End point type
    Secondary
    End point timeframe
    Last follow up (LFU) visit; 38 to 45 days after first study drug administration
    End point values
    		 Ceftolozane/Tazobactam (CXA-201) +Metronidazole--CE population Meropenem--CE population Ceftolozane/Tazobactam(CXA-201)+Metronidazole--ITT population Meropenem--ITT population Ceftolozane/ Tazobactam(CXA-201)+ Metronidazole--ME population Meropenem--ME population
    Number of subjects analysed
    350 [20]
    374 [21]
    476 [22]
    494 [23]
    258 [24]
    304 [25]
    Units: percentage of subjects
        number (not applicable)
    100
    99.5
    83
    85
    100
    99.3
    Notes
    [20] - CE population with evaluable LFU data
    [21] - CE population with evaluable LFU data
    [22] - ITT population
    [23] - ITT population
    [24] - ME population with evaluable LFU data
    [25] - ME population with evaluable LFU data
    No statistical analyses for this end point

    Secondary: Percentage of subjects with superinfections or new infections in the MITT population

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    End point title
    		 Percentage of subjects with superinfections or new infections in the MITT population
    End point description
    Superinfection outcome was defined as isolation of a pathogen, other than the original baseline pathogen(s), from an intra-abdominal specimen taken from a subject with signs or symptoms of infection while on study drug. A new infection was defined as isolation of a pathogen, other than the original baseline pathogen(s), from an intra-abdominal specimen in a subject with signs or symptoms of infection after treatment with study drug.
    End point type
    Secondary
    End point timeframe
    Baseline through TOC visit
    End point values
    		 Ceftolozane/Tazobactam(CXA-201)+Metronidazole--MITT population Meropenem--MITT population
    Number of subjects analysed
    389 [26]
    417 [27]
    Units: Percentage
    number (not applicable)
        Superinfection
    2.6
    3.1
        New infection
    3.1
    2.2
    Notes
    [26] - MITT population
    [27] - MITT population
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were recorded for all subjects from the start of study drug administration through the last follow up visit, which occurred 38 to 45 days after the first dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    Ceftolozane/Tazobactam + Metronidazole
    Reporting group description
    		 -

    Reporting group title
    Meropenem
    Reporting group description
    		 -

    Serious adverse events
    		 Ceftolozane/Tazobactam + Metronidazole Meropenem
    Total subjects affected by serious adverse events
         subjects affected / exposed
    39 / 482 (8.09%)
    36 / 497 (7.24%)
         number of deaths (all causes)
    11
    8
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Colon cancer
         subjects affected / exposed
    1 / 482 (0.21%)
    0 / 497 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 482 (0.21%)
    0 / 497 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intra-abdominal haemorrhage
         subjects affected / exposed
    0 / 482 (0.00%)
    1 / 497 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic venous thrombosis
         subjects affected / exposed
    1 / 482 (0.21%)
    0 / 497 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Circulatory collapse
         subjects affected / exposed
    0 / 482 (0.00%)
    1 / 497 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Shock haemorrhagic
         subjects affected / exposed
    1 / 482 (0.21%)
    0 / 497 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Sudden death
         subjects affected / exposed
    2 / 482 (0.41%)
    0 / 497 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 482 (0.00%)
    1 / 497 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multi-organ failure
         subjects affected / exposed
    3 / 482 (0.62%)
    0 / 497 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 3
    0 / 0
    Reproductive system and breast disorders
    Atrophic vulvovaginitis
         subjects affected / exposed
    1 / 482 (0.21%)
    0 / 497 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pleurisy
         subjects affected / exposed
    1 / 482 (0.21%)
    0 / 497 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute respiratory distress syndrome
         subjects affected / exposed
    1 / 482 (0.21%)
    1 / 497 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    1 / 482 (0.21%)
    0 / 497 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    0 / 482 (0.00%)
    1 / 497 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 482 (0.00%)
    1 / 497 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Respiratory distress
         subjects affected / exposed
    1 / 482 (0.21%)
    1 / 497 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 482 (0.21%)
    2 / 497 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Hepatic enzyme increased
         subjects affected / exposed
    1 / 482 (0.21%)
    0 / 497 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Abdominal wound dehiscence
         subjects affected / exposed
    0 / 482 (0.00%)
    1 / 497 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anastomotic leak
         subjects affected / exposed
    1 / 482 (0.21%)
    1 / 497 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumoconiosis
         subjects affected / exposed
    0 / 482 (0.00%)
    1 / 497 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    0 / 482 (0.00%)
    1 / 497 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Anaemia postoperative
         subjects affected / exposed
    1 / 482 (0.21%)
    0 / 497 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suture rupture
         subjects affected / exposed
    1 / 482 (0.21%)
    0 / 497 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound evisceration
         subjects affected / exposed
    2 / 482 (0.41%)
    0 / 497 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound dehiscence
         subjects affected / exposed
    1 / 482 (0.21%)
    1 / 497 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiopulmonary failure
         subjects affected / exposed
    1 / 482 (0.21%)
    0 / 497 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    0 / 482 (0.00%)
    1 / 497 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiogenic shock
         subjects affected / exposed
    1 / 482 (0.21%)
    0 / 497 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiac failure
         subjects affected / exposed
    1 / 482 (0.21%)
    1 / 497 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 482 (0.21%)
    1 / 497 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Cardiovascular insufficiency
         subjects affected / exposed
    0 / 482 (0.00%)
    1 / 497 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Nervous system disorders
    Ischaemic stroke
         subjects affected / exposed
    2 / 482 (0.41%)
    0 / 497 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    0 / 482 (0.00%)
    1 / 497 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Encephalopathy
         subjects affected / exposed
    0 / 482 (0.00%)
    1 / 497 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Thrombocytosis
         subjects affected / exposed
    1 / 482 (0.21%)
    0 / 497 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Duodenal ulcer haemorrhage
         subjects affected / exposed
    1 / 482 (0.21%)
    0 / 497 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus paralytic
         subjects affected / exposed
    1 / 482 (0.21%)
    0 / 497 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    1 / 482 (0.21%)
    1 / 497 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterocutaneous fistula
         subjects affected / exposed
    1 / 482 (0.21%)
    0 / 497 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal ischaemia
         subjects affected / exposed
    1 / 482 (0.21%)
    0 / 497 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal perforation
         subjects affected / exposed
    1 / 482 (0.21%)
    0 / 497 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 482 (0.21%)
    1 / 497 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal perforation
         subjects affected / exposed
    1 / 482 (0.21%)
    0 / 497 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestine perforation
         subjects affected / exposed
    1 / 482 (0.21%)
    0 / 497 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 482 (0.21%)
    0 / 497 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 482 (0.00%)
    1 / 497 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal perforation
         subjects affected / exposed
    1 / 482 (0.21%)
    0 / 497 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    1 / 482 (0.21%)
    2 / 497 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile duct stone
         subjects affected / exposed
    0 / 482 (0.00%)
    2 / 497 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary fistula
         subjects affected / exposed
    0 / 482 (0.00%)
    1 / 497 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Portal vein thrombosis
         subjects affected / exposed
    1 / 482 (0.21%)
    0 / 497 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Perforation bile duct
         subjects affected / exposed
    0 / 482 (0.00%)
    1 / 497 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal failure acute
         subjects affected / exposed
    1 / 482 (0.21%)
    0 / 497 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Endocrine disorders
    Goitre
         subjects affected / exposed
    0 / 482 (0.00%)
    1 / 497 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Muscular weakness
         subjects affected / exposed
    0 / 482 (0.00%)
    1 / 497 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal abscess
         subjects affected / exposed
    2 / 482 (0.41%)
    2 / 497 (0.40%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal infection
         subjects affected / exposed
    1 / 482 (0.21%)
    0 / 497 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendiceal abscess
         subjects affected / exposed
    0 / 482 (0.00%)
    1 / 497 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    0 / 482 (0.00%)
    1 / 497 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    1 / 482 (0.21%)
    1 / 497 (0.20%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver abscess
         subjects affected / exposed
    0 / 482 (0.00%)
    3 / 497 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Graft infection
         subjects affected / exposed
    0 / 482 (0.00%)
    1 / 497 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Gallbladder abscess
         subjects affected / exposed
    0 / 482 (0.00%)
    1 / 497 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infectious peritonitis
         subjects affected / exposed
    1 / 482 (0.21%)
    0 / 497 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung infection pseudomonal
         subjects affected / exposed
    1 / 482 (0.21%)
    0 / 497 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pelvic abscess
         subjects affected / exposed
    1 / 482 (0.21%)
    2 / 497 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lobar pneumonia
         subjects affected / exposed
    0 / 482 (0.00%)
    1 / 497 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peridiverticular abscess
         subjects affected / exposed
    1 / 482 (0.21%)
    0 / 497 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 482 (0.00%)
    2 / 497 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 482 (0.00%)
    1 / 497 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pseudomembranous colitis
         subjects affected / exposed
    0 / 482 (0.00%)
    1 / 497 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    3 / 482 (0.62%)
    2 / 497 (0.40%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Pneumonia staphylococcal
         subjects affected / exposed
    1 / 482 (0.21%)
    0 / 497 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 482 (0.21%)
    0 / 497 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdiaphragmatic abscess
         subjects affected / exposed
    0 / 482 (0.00%)
    2 / 497 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal bacteraemia
         subjects affected / exposed
    1 / 482 (0.21%)
    0 / 497 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 482 (0.00%)
    1 / 497 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Decreased appetite
         subjects affected / exposed
    1 / 482 (0.21%)
    0 / 497 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Ceftolozane/Tazobactam + Metronidazole Meropenem
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    78 / 482 (16.18%)
    61 / 497 (12.27%)
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    25 / 482 (5.19%)
    20 / 497 (4.02%)
         occurrences all number
    27
    21
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    37 / 482 (7.68%)
    28 / 497 (5.63%)
         occurrences all number
    40
    31
    Diarrhoea
         subjects affected / exposed
    30 / 482 (6.22%)
    25 / 497 (5.03%)
         occurrences all number
    31
    26

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

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Cubist revised its clinical development program for ceftolozane/tazobactam leading to a single-study approval pathway for each indication, based guidance and following scientific advice from the CHMP and agreement from the US FDA.
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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