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    Clinical Trial Results:
    A Phase IIIb/IV Randomized, Controlled, Open-Label, Parallel Group Study to Compare the Efficacy of Vancomycin Therapy to Extended Duration Fidaxomicin Therapy in the Sustained Clinical Cure of Clostridium difficile Infection in an Older Population

    Summary
    EudraCT number
    2013-004619-31
    Trial protocol
    SE   FI   GB   CZ   DK   DE   IT   GR   SI   HU   IE   AT   BE   PT   HR  
    Global end of trial date
    05 May 2016

    Results information
    Results version number
    v2(current)
    This version publication date
    15 Dec 2017
    First version publication date
    14 May 2017
    Other versions
    v1
    Version creation reason

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    2819-MA-1002
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02254967
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Astellas Pharma Europe Ltd.
    Sponsor organisation address
    2000 Hillswood Drive, Chertsey Surey, United Kingdom, KT16 0RS
    Public contact
    Clinical Trial Disclosure, Astellas Pharma Europe Ltd., astellas.resultsdisclosure.@astellas.com
    Scientific contact
    Clinical Trial Disclosure, Astellas Pharma Europe Ltd., astellas.resultsdisclosure.@astellas.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
    05 May 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    05 May 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to evaluate the efficacy of fidaxomicin extended pulsed (EPFX) in the treatment of Clostridium difficile (C. difficile) infection (CDI) in male and female patients aged 60 years and older compared with standard vancomycin therapy.
    Protection of trial subjects
    International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) Guidelines, and applicable local regulations, including the European Directive 2001/20/EC, on the protection of human rights, and with the ethical principles that have their origin in the Declaration of Helsinki. Astellas ensures that the use and disclosure of protected health information (PHI) obtained during a research study complies with the fed ral, national and/or regional legislation related to the privacy and protection of personal information.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    06 Nov 2014
    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
    Belgium: 1
    Country: Number of subjects enrolled
    Austria: 4
    Country: Number of subjects enrolled
    Croatia: 9
    Country: Number of subjects enrolled
    Czech Republic: 27
    Country: Number of subjects enrolled
    Denmark: 2
    Country: Number of subjects enrolled
    Finland: 4
    Country: Number of subjects enrolled
    France: 27
    Country: Number of subjects enrolled
    Germany: 17
    Country: Number of subjects enrolled
    Greece: 45
    Country: Number of subjects enrolled
    Hungary: 28
    Country: Number of subjects enrolled
    Italy: 35
    Country: Number of subjects enrolled
    Poland: 37
    Country: Number of subjects enrolled
    Portugal: 3
    Country: Number of subjects enrolled
    Romania: 45
    Country: Number of subjects enrolled
    Russian Federation: 14
    Country: Number of subjects enrolled
    Slovenia: 10
    Country: Number of subjects enrolled
    Spain: 14
    Country: Number of subjects enrolled
    Sweden: 11
    Country: Number of subjects enrolled
    Switzerland: 5
    Country: Number of subjects enrolled
    Turkey: 7
    Country: Number of subjects enrolled
    United Kingdom: 19
    Worldwide total number of subjects
    364
    EEA total number of subjects
    338
    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)
    55
    From 65 to 84 years
    245
    85 years and over
    64

    Subject disposition

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    Recruitment
    Recruitment details
    Participants were enrolled at 86 clinical sites in 21 countries in Europe and Asia. Randomization was stratified by CDI severity (severe or non-severe), presence or absence of cancer, age (≥ 75 years or < 75 years) and number of previous recurrences (0, 1, 2) in the 3 months prior to the study.

    Pre-assignment
    Screening details
    Females and males of ≥ 60 years of age with CDI confirmed by clinical symptoms (either > 3 UBMs or ≥ 200 mL of unformed stool [for patients having rectal collection devices] in the 24 hours prior to randomization and CDI test confirmed positive for presence of C. difficile toxin A/B in stool (within 48 hours prior to randomization) were enrolled.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Fidaxomicin Extended Pulsed Regimen (EPFX)
    Arm description
    Participants received 200 mg fidaxomicin from day 1 to day 5 twice daily, followed by a 1-day gap (day 6) before starting alternate day dosing of 1 tablet of fidaxomicin 200 mg once daily from day 7 to day 25.
    Arm type
    Experimental

    Investigational medicinal product name
    Fidaxomicin
    Investigational medicinal product code
    ASP2819, OPT-80
    Other name
    DIFICLIR™, DIFICID
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received 200 mg of immediate-release fidaxomicin tablets orally in the morning and evening from day 1-5 twice daily and alternate day dosing from day 7-25 once daily.

    Arm title
    Vancomycin
    Arm description
    Participants received 125 mg vancomycin from day 1 to day 10, 4 times daily.
    Arm type
    Active comparator

    Investigational medicinal product name
    Vancomycin
    Investigational medicinal product code
    Other name
    Vancocin
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received 125 mg of vancomycin 4 times daily (with a time interval of 6 hours) at the same time each day from day 1 to day 10.

    Number of subjects in period 1
    Fidaxomicin Extended Pulsed Regimen (EPFX) Vancomycin
    Started
    183
    181
    Treated
    181
    181
    Completed
    132
    125
    Not completed
    51
    56
         Death
    29
    36
         Withdrawal by Patient
    6
    7
         Miscellaneous
    1
    2
         Randomized but Never Received/Dispensed Study Drug
    2
    -
         Physician Decision
    7
    2
         Lost to Follow-up
    6
    9

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Fidaxomicin Extended Pulsed Regimen (EPFX)
    Reporting group description
    Participants received 200 mg fidaxomicin from day 1 to day 5 twice daily, followed by a 1-day gap (day 6) before starting alternate day dosing of 1 tablet of fidaxomicin 200 mg once daily from day 7 to day 25.

    Reporting group title
    Vancomycin
    Reporting group description
    Participants received 125 mg vancomycin from day 1 to day 10, 4 times daily.

    Reporting group values
    Fidaxomicin Extended Pulsed Regimen (EPFX) Vancomycin Total
    Number of subjects
    183 181 364
    Age categorical
    Units: Subjects
        < 75 years
    85 82 167
        ≥ 75 years
    98 99 197
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    75.2 ± 8.4 74.9 ± 8.9 -
    Gender categorical
    Units:
        Male
    72 79 151
        Female
    111 102 213
    CDI Severity at Baseline
    Units: Subjects
        Severe
    66 67 133
        Non-severe
    117 114 231
    Number of Previous Recurrences in the 3 Months prior to Randomization
    Units: Subjects
        0 recurrences
    146 142 288
        1 recurrence
    27 29 56
        2 recurrences
    10 10 20
    Cancer Status
    Units: Subjects
        Presence
    40 37 77
        Absence
    143 144 287

    End points

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    End points reporting groups
    Reporting group title
    Fidaxomicin Extended Pulsed Regimen (EPFX)
    Reporting group description
    Participants received 200 mg fidaxomicin from day 1 to day 5 twice daily, followed by a 1-day gap (day 6) before starting alternate day dosing of 1 tablet of fidaxomicin 200 mg once daily from day 7 to day 25.

    Reporting group title
    Vancomycin
    Reporting group description
    Participants received 125 mg vancomycin from day 1 to day 10, 4 times daily.

    Primary: Percentage of Participants with a Sustained Clinical Cure of CDI at 30 Days after End of Treatment

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    End point title
    Percentage of Participants with a Sustained Clinical Cure of CDI at 30 Days after End of Treatment
    End point description
    Sustained clinical cure was defined as an assessment of clinical response at test of cure (TOC; day 12 for vancomycin and day 27 or 12 for EPFX arm) and no recurrence of CDI from TOC until time of assessment. Clinical response was determined by the investigator based on the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) criteria at TOC. Treatment response was present when either stool frequency decreases or stool consistency improved and parameters of disease severity (clinical, laboratory, radiological) improved and no new signs of severe disease developed. The analysis population was the modified Full Analysis Set (mFAS), which consisted of randomized participants who received at least 1 dose of study drug and had confirmed CDI in the 24 hours prior to randomization and CDI test confirmed positive for presence of C. difficile toxin A or B in stool 48 hours prior to randomization.
    End point type
    Primary
    End point timeframe
    Day 40 (for vancomycin) and day 55 (for EPFX)
    End point values
    Fidaxomicin Extended Pulsed Regimen (EPFX) Vancomycin
    Number of subjects analysed
    177
    179
    Units: percentage of participants
        number (confidence interval 95%)
    70.1 (63.3 to 76.8)
    59.2 (52.0 to 66.4)
    Statistical analysis title
    Treatment Difference
    Statistical analysis description
    This analysis was the difference between the rates (EPFX – vancomycin) and the associated 95% CI around the difference.
    Comparison groups
    Fidaxomicin Extended Pulsed Regimen (EPFX) v Vancomycin
    Number of subjects included in analysis
    356
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.03 [1]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Treatment difference
    Point estimate
    10.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1
         upper limit
    20.7
    Notes
    [1] - P-value was adjusted for the randomization factors (CDI severity [severe or non-severe], presence or absence of cancer, age [≥ 75 years or < 75 years] and number of previous recurrences [0, 1, and 2]).

    Secondary: Percentage of Participants with a Sustained Clinical Cure of CDI at Day 40, Day 55 and Day 90

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    End point title
    Percentage of Participants with a Sustained Clinical Cure of CDI at Day 40, Day 55 and Day 90
    End point description
    Sustained clinical cure was defined as an assessment of clinical response at test of cure (TOC; day 12 for vancomycin and day 27 or 12 for EPFX arm) and no recurrence of CDI from TOC until time of assessment. Clinical response was determined by the investigator based on the ESCMID criteria at TOC. Treatment response was present when either stool frequency decreases or stool consistency improved and parameters of disease severity (clinical, laboratory, radiological) improved and no new signs of severe disease developed. The analysis population was the mFAS.
    End point type
    Secondary
    End point timeframe
    Day 40, 55, 90
    End point values
    Fidaxomicin Extended Pulsed Regimen (EPFX) Vancomycin
    Number of subjects analysed
    177
    179
    Units: percentage of participants
    number (confidence interval 95%)
        Day 40
    75.1 (68.8 to 81.5)
    59.2 (52.0 to 66.4)
        Day 55
    70.1 (63.3 to 76.8)
    55.3 (48.0 to 62.6)
        Day 90
    65.5 (58.5 to 72.5)
    51.4 (44.1 to 58.7)
    Statistical analysis title
    Treatment Difference (Day 40)
    Statistical analysis description
    This analysis was the difference between the rates (EPFX – vancomycin) and the associated 95% CI around the difference.
    Comparison groups
    Fidaxomicin Extended Pulsed Regimen (EPFX) v Vancomycin
    Number of subjects included in analysis
    356
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.001 [2]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Treatment difference
    Point estimate
    15.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    6.3
         upper limit
    25.5
    Notes
    [2] - P-value was adjusted for the randomization factors (CDI severity [severe or non-severe], presence or absence of cancer, age [≥ 75 years or < 75 years] and number of previous recurrences [0, 1, and 2]).
    Statistical analysis title
    Treatment Difference (Day 90)
    Statistical analysis description
    This analysis was the difference between the rates (EPFX – vancomycin) and the associated 95% CI around the difference.
    Comparison groups
    Fidaxomicin Extended Pulsed Regimen (EPFX) v Vancomycin
    Number of subjects included in analysis
    356
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.007 [3]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Treatment difference
    Point estimate
    14.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    4
         upper limit
    24.3
    Notes
    [3] - P-value was adjusted for the randomization factors (CDI severity [severe or non-severe], presence or absence of cancer, age [≥ 75 years or < 75 years] and number of previous recurrences [0, 1, and 2]).
    Statistical analysis title
    Treatment Difference (Day 55)
    Statistical analysis description
    This analysis was the difference between the rates (EPFX – vancomycin) and the associated 95% CI around the difference.
    Comparison groups
    Fidaxomicin Extended Pulsed Regimen (EPFX) v Vancomycin
    Number of subjects included in analysis
    356
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.004 [4]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Treatment difference
    Point estimate
    14.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    4.8
         upper limit
    24.7
    Notes
    [4] - P-value was adjusted for the randomization factors (CDI severity [severe or non-severe], presence or absence of cancer, age [≥ 75 years or < 75 years] and number of previous recurrences [0, 1, and 2]).

    Secondary: Percentage of Participants with a Clinical Response of CDI at Day 12

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    End point title
    Percentage of Participants with a Clinical Response of CDI at Day 12
    End point description
    Clinical response was determined by the investigator based on the ESCMID criteria (i.e., Treatment response was present when either stool frequency decreases or stool consistency improved and parameters of disease severity [clinical, laboratory, radiological] improved and no new signs of severe disease developed. Treatment response should have been daily observed and evaluated after at least three days, assuming that the participant was not worsening on treatment) at TOC. The analysis population was the mFAS.
    End point type
    Secondary
    End point timeframe
    Day 12
    End point values
    Fidaxomicin Extended Pulsed Regimen (EPFX) Vancomycin
    Number of subjects analysed
    177
    179
    Units: percentage of participants
        number (confidence interval 95%)
    80.2 (74.4 to 86.1)
    82.1 (76.5 to 87.7)
    Statistical analysis title
    Treatment Difference
    Statistical analysis description
    This analysis was the difference between the rates (EPFX – vancomycin) and the associated 95% CI around the difference.
    Comparison groups
    Fidaxomicin Extended Pulsed Regimen (EPFX) v Vancomycin
    Number of subjects included in analysis
    356
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.721 [5]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Treatment difference
    Point estimate
    -1.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -10
         upper limit
    6.2
    Notes
    [5] - P-value was adjusted for the randomization factors (CDI severity [severe or non-severe], presence or absence of cancer, age [≥ 75 years or < 75 years] and number of previous recurrences [0, 1, and 2]).

    Secondary: Number of Participants with a Relapse on Day 90 as Determined by Whole Genome Sequencing of C. Difficile Isolates

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    End point title
    Number of Participants with a Relapse on Day 90 as Determined by Whole Genome Sequencing of C. Difficile Isolates
    End point description
    For participants with a recurrence after TOC, whole genome sequencing of isolates was performed on paired samples from day 1 and the day of the confirmed recurrence. Relapse was defined as paired isolates from a single recurrent participant with ≤ 2 single nucleotide variations (SNVs). Only participants who had a recurrence (45) and had paired samples available for whole sequencing from baseline and at time of recurrence are included in the analysis. The analysis population was the mFAS.
    End point type
    Secondary
    End point timeframe
    Baseline through day 90
    End point values
    Fidaxomicin Extended Pulsed Regimen (EPFX) Vancomycin
    Number of subjects analysed
    2
    9
    Units: participants
        number (not applicable)
    1
    3
    No statistical analyses for this end point

    Secondary: Percentage of Participants with a Clinical Response of CDI at 2 Days after End of Treatment

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    End point title
    Percentage of Participants with a Clinical Response of CDI at 2 Days after End of Treatment
    End point description
    Clinical response was determined by the investigator based on the ESCMID criteria (i.e., Treatment response was present when either stool frequency decreases or stool consistency improved and parameters of disease severity [clinical, laboratory, radiological] improved and no new signs of severe disease developed. Treatment response should have been daily observed and evaluated after at least three days, assuming that the patient was not worsening on treatment) at TOC. The analysis population was the mFAS.
    End point type
    Secondary
    End point timeframe
    Day 12, 27
    End point values
    Fidaxomicin Extended Pulsed Regimen (EPFX) Vancomycin
    Number of subjects analysed
    177
    179
    Units: percentage of participants
        number (confidence interval 95%)
    78.0 (71.9 to 84.1)
    82.1 (76.5 to 87.7)
    Statistical analysis title
    Treatment Difference
    Statistical analysis description
    This analysis was the difference between the rates (EPFX – vancomycin) and the associated 95% CI around the difference.
    Comparison groups
    Fidaxomicin Extended Pulsed Regimen (EPFX) v Vancomycin
    Number of subjects included in analysis
    356
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.399 [6]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Treatment difference
    Point estimate
    -4.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -12.5
         upper limit
    4.1
    Notes
    [6] - P-value was adjusted for the randomization factors (CDI severity [severe or non-severe], presence or absence of cancer, age [≥ 75 years or < 75 years] and number of previous recurrences [0, 1, and 2]).

    Secondary: Time to Resolution of Diarrhea

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    End point title
    Time to Resolution of Diarrhea
    End point description
    Time to resolution of diarrhea was defined as the time elapsing (in hours rounded up from minutes > 30) from the start of treatment (time of first dose of study drug) to resolution of diarrhea (time of the last unformed bowel movement [UBM] the day prior to the first of 2 consecutive days of ≤ 3 UBMs, > 50% reduction in number of stools or > 75% reduction in volume of liquid stool) that are sustained through to TOC. Participants without a resolution of diarrhea on day 25 (600 hours) for EPFX or day 10 (240 hours) for standard vancomycin were censored on day 25 or 10. Participants who discontinued early before resolution of diarrhea were also censored on the day of discontinuation. Participants with no UBM records were excluded from the analysis. The analysis population was the mFAS.
    End point type
    Secondary
    End point timeframe
    Up to day 10 (for vancomycin) or up to day 25 (for EPFX)
    End point values
    Fidaxomicin Extended Pulsed Regimen (EPFX) Vancomycin
    Number of subjects analysed
    168
    174
    Units: hours
    median (confidence interval 95%)
        Percentile 50
    34.0 (25.00 to 49.00)
    22.0 (10.00 to 30.00)
    Statistical analysis title
    Hazard Ratio
    Statistical analysis description
    From the Cox proportional hazards model with covariates for treatment, CDI severity, presence or absence of cancer, age (≥ 75 or < 75 years) and number of previous recurrences (0, 1 or 2) in the 3 months prior to the study.
    Comparison groups
    Fidaxomicin Extended Pulsed Regimen (EPFX) v Vancomycin
    Number of subjects included in analysis
    342
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.066 [7]
    Method
    Cox Proportional Hazards Model
    Parameter type
    Hazard ratio (HR)
    Point estimate
    0.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.63
         upper limit
    1.01
    Notes
    [7] - Adjusted for treatment, CDI severity, presence or absence of cancer, age (≥ 75 or < 75 years) and number of previous recurrences (0, 1 or 2) in the 3 months prior to the study.
    Statistical analysis title
    Comparison of Survival Curves
    Statistical analysis description
    The comparison of the difference of the 2 treatment groups was done using a stratified Wilcoxon-Gehan test, stratified by CDI severity, presence or absence of cancer, age (≥ 75 or < 75 years) and number of previous recurrences (0, 1 or 2) in the 3 months prior to the study.
    Comparison groups
    Fidaxomicin Extended Pulsed Regimen (EPFX) v Vancomycin
    Number of subjects included in analysis
    342
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.068 [8]
    Method
    Stratified Wilcoxon-Gehan test
    Confidence interval
    Notes
    [8] - Stratified by CDI severity, presence or absence of cancer, age group (≥ 75 or < 75 years) and number of previous recurrences (0, 1 or 2) in the 3 months prior to the study.

    Secondary: Percentage of Participants with a Recurrence of CDI at Day 40, Day 55 and Day 90

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    End point title
    Percentage of Participants with a Recurrence of CDI at Day 40, Day 55 and Day 90
    End point description
    For participants with clinical response at TOC, recurrence of CDI was defined as re-establishment of diarrhea after TOC to an extent (judged by the requency of passed UBMs) that is greater than the frequency recorded on day 10 for vancomycin arm or day 25 for EPFX arm (2 days prior to TOC), confirmed by a CDI test positive for Toxin A/B and requiring further CDI therapy. The analysis population was the mFAS.
    End point type
    Secondary
    End point timeframe
    Day 40, 55, 90
    End point values
    Fidaxomicin Extended Pulsed Regimen (EPFX) Vancomycin
    Number of subjects analysed
    177
    179
    Units: percentage of participants
    number (confidence interval 95%)
        Day 40
    1.7 (0.0 to 3.6)
    16.8 (11.3 to 22.2)
        Day 55
    4.0 (1.1 to 6.8)
    17.9 (12.3 to 23.5)
        Day 90
    6.2 (2.7 to 9.8)
    19.0 (13.2 to 24.7)
    Statistical analysis title
    Treatment Difference (Day 40)
    Statistical analysis description
    This analysis was the difference between the rates (EPFX – vancomycin) and the associated 95% CI around the difference.
    Comparison groups
    Fidaxomicin Extended Pulsed Regimen (EPFX) v Vancomycin
    Number of subjects included in analysis
    356
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [9]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Treatment difference
    Point estimate
    -15.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -20.9
         upper limit
    -9.3
    Notes
    [9] - P-value was adjusted for the randomization factors (CDI severity [severe or non-severe], presence or absence of cancer, age [≥ 75 years or < 75 years] and number of previous recurrences [0, 1, and 2]).
    Statistical analysis title
    Treatment Difference (Day 55)
    Statistical analysis description
    This analysis was the difference between the rates (EPFX – vancomycin) and the associated 95% CI around the difference.
    Comparison groups
    Fidaxomicin Extended Pulsed Regimen (EPFX) v Vancomycin
    Number of subjects included in analysis
    356
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [10]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Treatment difference
    Point estimate
    -13.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -20.2
         upper limit
    -7.6
    Notes
    [10] - P-value was adjusted for the randomization factors (CDI severity [severe or non-severe], presence or absence of cancer, age [≥ 75 years or < 75 years] and number of previous recurrences [0, 1, and 2]).
    Statistical analysis title
    Treatment Difference (Day 90)
    Statistical analysis description
    This analysis was the difference between the rates (EPFX – vancomycin) and the associated 95% CI around the difference.
    Comparison groups
    Fidaxomicin Extended Pulsed Regimen (EPFX) v Vancomycin
    Number of subjects included in analysis
    356
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [11]
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Treatment difference
    Point estimate
    -12.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -19.5
         upper limit
    -6
    Notes
    [11] - P-value was adjusted for the randomization factors (CDI severity [severe or non-severe], presence or absence of cancer, age [≥ 75 years or < 75 years] and number of previous recurrences [0, 1, and 2]).

    Secondary: Time to Recurrence of CDI after End of Active Treatment

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    End point title
    Time to Recurrence of CDI after End of Active Treatment
    End point description
    Time to recurrence of CDI was defined as the time in days from clinical response until onset of recurrence of CDI for participants who responded at TOC. Participants who completed the study but did not show recurrence of CDI were censored on day 90, and participants who discontinued early were censored on the day of discontinuation. The analysis population was the mFAS. Due to the low number of participants with a recurrence, median and 95% CI could not be estimated and are denoted as "99999."
    End point type
    Secondary
    End point timeframe
    From day 10 up to day 90
    End point values
    Fidaxomicin Extended Pulsed Regimen (EPFX) Vancomycin
    Number of subjects analysed
    137
    147
    Units: days
    median (confidence interval 95%)
        Percentile 50
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    Statistical analysis title
    Comparison of Survival Curves
    Statistical analysis description
    The comparison of the difference of the 2 treatment groups was done using a stratified Wilcoxon-Gehan test, stratified by CDI severity, presence or absence of cancer, age (≥ 75 or < 75 years) and number of previous recurrences (0, 1 or 2) in the 3 months prior to the study.
    Comparison groups
    Fidaxomicin Extended Pulsed Regimen (EPFX) v Vancomycin
    Number of subjects included in analysis
    284
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.006 [12]
    Method
    Stratified Wilcoxon-Gehan test
    Confidence interval
    Notes
    [12] - Stratified by CDI severity, presence or absence of cancer, age group (≥ 75 or < 75 years) and number of previous recurrences (0, 1 or 2) in the 3 months prior to the study.
    Statistical analysis title
    Hazard Ratio
    Statistical analysis description
    From the Cox proportional hazards model with covariates for treatment, CDI severity, presence or absence of cancer, age (≥ 75 or < 75 years) and number of previous recurrences (0, 1 or 2) in the 3 months prior to the study.
    Comparison groups
    Fidaxomicin Extended Pulsed Regimen (EPFX) v Vancomycin
    Number of subjects included in analysis
    284
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [13]
    Method
    Cox Proportional Hazards Model
    Parameter type
    Hazard ratio (HR)
    Point estimate
    0.27
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.12
         upper limit
    0.52
    Notes
    [13] - Adjusted for treatment, CDI severity, presence or absence of cancer, age (≥ 75 or < 75 years) and number of previous recurrences (0, 1 or 2) in the 3 months prior to the study.

    Secondary: Disease-free Survival After Day 10

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    End point title
    Disease-free Survival After Day 10
    End point description
    Disease-free survival was defined as the time in days a participant did not have symptoms of diarrhea from day 10 up to day 90 for participants who responded at TOC. Participants who completed the study but did not show symptoms of diarrhea were censored at day 90, and participants who discontinued early were censored at the day of discontinuation. The analysis population was mFAS. Due to the low number of participants with symptoms of diarrhea, median and 95% CI could not estimated and are denoted as "99999."
    End point type
    Secondary
    End point timeframe
    From day 10 up to day 90
    End point values
    Fidaxomicin Extended Pulsed Regimen (EPFX) Vancomycin
    Number of subjects analysed
    137
    147
    Units: days
    median (confidence interval 95%)
        Percentile 50
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    Statistical analysis title
    Hazard Ratio
    Statistical analysis description
    From the Cox proportional hazards model with covariates for treatment, CDI severity, presence or absence of cancer, age (≥ 75 or < 75 years) and number of previous recurrences (0, 1 or 2) in the 3 months prior to the study.
    Comparison groups
    Fidaxomicin Extended Pulsed Regimen (EPFX) v Vancomycin
    Number of subjects included in analysis
    284
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [14]
    Method
    Cox Proportional Hazards Model
    Parameter type
    Hazard ratio (HR)
    Point estimate
    0.26
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.12
         upper limit
    0.5
    Notes
    [14] - Adjusted for treatment, CDI severity, presence or absence of cancer, age (≥ 75 or < 75 years) and number of previous recurrences (0, 1 or 2) in the 3 months prior to the study.
    Statistical analysis title
    Comparison of Survival Curves
    Statistical analysis description
    The comparison of the difference of the 2 treatment groups was done using a stratified Wilcoxon-Gehan test, stratified by CDI severity, presence or absence of cancer, age (≥ 75 or < 75 years) and number of previous recurrences (0, 1 or 2) in the 3 months prior to the study.
    Comparison groups
    Fidaxomicin Extended Pulsed Regimen (EPFX) v Vancomycin
    Number of subjects included in analysis
    284
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.003 [15]
    Method
    Stratified Wilcoxon-Gehan test
    Confidence interval
    Notes
    [15] - Stratified by CDI severity, presence or absence of cancer, age group (≥ 75 or < 75 years) and number of previous recurrences (0, 1 or 2) in the 3 months prior to the study.

    Secondary: Number of Participants with Adverse Events

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    End point title
    Number of Participants with Adverse Events
    End point description
    Safety was assessed by adverse events (AEs), which included abnormalities identified during a medical test (e.g. laboratory tests, vital signs, electrocardiogram, etc.) if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. A serious AE (SAE) was an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. The analysis population was the Safety Analysis Set (SAF), which consisted of all randomized participants who took at least 1 dose of study medication.
    End point type
    Secondary
    End point timeframe
    From first dose of study drug to end of study (up to 90 days)
    End point values
    Fidaxomicin Extended Pulsed Regimen (EPFX) Vancomycin
    Number of subjects analysed
    181
    181
    Units: participants
        AEs
    121
    128
        Drug-related AEs
    14
    9
        Deaths
    28
    36
        SAEs
    68
    78
        Drug-related SAEs
    3
    6
        AEs Leading to Discontinuation of Study Drug
    14
    5
        Drug-related AEs Leading to Discont. of Study Drug
    2
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose of study drug to end of study (up to 90 days)
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    Vancomycin
    Reporting group description
    Participants received 125 mg vancomycin from day 1 to day 10, 4 times daily.

    Reporting group title
    Fidaxomicin Extended Pulsed Regimen (EPFX)
    Reporting group description
    Participants received 200 mg fidaxomicin from day 1 to day 5 twice daily, followed by a 1-day gap (day 6) before starting alternate day dosing of 1 tablet of fidaxomicin 200 mg once daily from day 7 to day 25.

    Serious adverse events
    Vancomycin Fidaxomicin Extended Pulsed Regimen (EPFX)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    78 / 181 (43.09%)
    68 / 181 (37.57%)
         number of deaths (all causes)
    36
    28
         number of deaths resulting from adverse events
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Haematoma
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    1 / 181 (0.55%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive crisis
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombosis
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Surgical and medical procedures
    Aortic valve replacement
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endotracheal intubation
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrectomy
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Bile duct cancer recurrent
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon cancer
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic neoplasm
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic neoplasm malignant
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Lung neoplasm malignant
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Lymphoma
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Metastases to central nervous system
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to gastrointestinal tract
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastasis
         subjects affected / exposed
    0 / 181 (0.00%)
    2 / 181 (1.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Metastatic carcinoma of the bladder
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Metastatic gastric cancer
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Multiple myeloma
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Neoplasm malignant
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Rectal neoplasm
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal neoplasm
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    3 / 181 (1.66%)
    3 / 181 (1.66%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 3
    0 / 3
    Fatigue
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incorrect product storage
         subjects affected / exposed
    1 / 181 (0.55%)
    2 / 181 (1.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multi-organ failure
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    3 / 181 (1.66%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Treatment failure
         subjects affected / exposed
    2 / 181 (1.10%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Abnormal behaviour
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Confusional state
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Cardiac valve rupture
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Clavicle fracture
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    3 / 181 (1.66%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar vertebral fracture
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Medication error
         subjects affected / exposed
    2 / 181 (1.10%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic fracture
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Culture positive
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    0 / 181 (0.00%)
    2 / 181 (1.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial flutter
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block complete
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    3 / 181 (1.66%)
    3 / 181 (1.66%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 3
    0 / 1
    Cardiac failure
         subjects affected / exposed
    8 / 181 (4.42%)
    3 / 181 (1.66%)
         occurrences causally related to treatment / all
    1 / 8
    0 / 3
         deaths causally related to treatment / all
    1 / 3
    0 / 2
    Cardiac failure acute
         subjects affected / exposed
    0 / 181 (0.00%)
    2 / 181 (1.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiopulmonary failure
         subjects affected / exposed
    1 / 181 (0.55%)
    2 / 181 (1.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Congestive cardiomyopathy
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Left ventricular failure
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Myocardial infarction
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Tachyarrhythmia
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 181 (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
    Acute pulmonary oedema
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    0 / 181 (0.00%)
    2 / 181 (1.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Aspiration
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    2 / 181 (1.10%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pleural effusion
         subjects affected / exposed
    1 / 181 (0.55%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleurisy
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 181 (0.55%)
    2 / 181 (1.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Pulmonary oedema
         subjects affected / exposed
    3 / 181 (1.66%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory distress
         subjects affected / exposed
    1 / 181 (0.55%)
    1 / 181 (0.55%)
         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
    4 / 181 (2.21%)
    2 / 181 (1.10%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 181 (1.10%)
    2 / 181 (1.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Disseminated intravascular coagulation
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    3 / 181 (1.66%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular disorder
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Convulsion
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic encephalopathy
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Somnolence
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VIIth nerve paralysis
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal hernia
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    1 / 181 (0.55%)
    2 / 181 (1.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute abdomen
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis microscopic
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    1 / 181 (0.55%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Crohn's disease
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    2 / 181 (1.10%)
    2 / 181 (1.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea haemorrhagic
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Disbacteriosis
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal ulcer haemorrhage
         subjects affected / exposed
    1 / 181 (0.55%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterocolitis
         subjects affected / exposed
    1 / 181 (0.55%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Faecaloma
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral hernia, obstructive
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer haemorrhage
         subjects affected / exposed
    1 / 181 (0.55%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 181 (0.55%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal ulcer
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematemesis
         subjects affected / exposed
    2 / 181 (1.10%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Haematochezia
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal perforation
         subjects affected / exposed
    1 / 181 (0.55%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophagitis
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    1 / 181 (0.55%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subileus
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal failure acute
         subjects affected / exposed
    2 / 181 (1.10%)
    3 / 181 (1.66%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Hepatobiliary disorders
    Bile duct stone
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic cirrhosis
         subjects affected / exposed
    2 / 181 (1.10%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hepatic failure
         subjects affected / exposed
    2 / 181 (1.10%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Hepatorenal syndrome
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pruritus
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myositis
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 181 (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
    Hyperkalaemia
         subjects affected / exposed
    1 / 181 (0.55%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bacterial pyelonephritis
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    1 / 181 (0.55%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiac valve abscess
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Citrobacter sepsis
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridial infection
         subjects affected / exposed
    18 / 181 (9.94%)
    5 / 181 (2.76%)
         occurrences causally related to treatment / all
    1 / 19
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocarditis enterococcal
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterococcal sepsis
         subjects affected / exposed
    1 / 181 (0.55%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Escherichia bacteraemia
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia sepsis
         subjects affected / exposed
    3 / 181 (1.66%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected skin ulcer
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infectious pleural effusion
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Klebsiella infection
         subjects affected / exposed
    1 / 181 (0.55%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mediastinitis
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nosocomial infection
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Osteomyelitis
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parotitis
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    7 / 181 (3.87%)
    2 / 181 (1.10%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 3
         deaths causally related to treatment / all
    0 / 4
    0 / 1
    Pyelonephritis
         subjects affected / exposed
    2 / 181 (1.10%)
    0 / 181 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia staphylococcal
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    9 / 181 (4.97%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    1 / 9
    0 / 1
         deaths causally related to treatment / all
    1 / 6
    0 / 1
    Septic shock
         subjects affected / exposed
    2 / 181 (1.10%)
    3 / 181 (1.66%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    Skin infection
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal bacteraemia
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 181 (0.00%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    4 / 181 (2.21%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection bacterial
         subjects affected / exposed
    11 / 181 (6.08%)
    1 / 181 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Vancomycin Fidaxomicin Extended Pulsed Regimen (EPFX)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 181 (5.52%)
    8 / 181 (4.42%)
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    10 / 181 (5.52%)
    8 / 181 (4.42%)
         occurrences all number
    11
    9

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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