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    Clinical Trial Results:
    A Multicenter, Multinational, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Ceftaroline fosamil Versus Ceftriaxone Plus Vancomycin in Adult Subjects with Community-acquired Bacterial Pneumonia at Risk for Infection Due to Methicillin-resistant Staphylococcus aureus

    Summary
    EudraCT number
    		 2012-002182-35
    Trial protocol
    		 ES   HU   PL  
    Global end of trial date
    03 Dec 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Aug 2018
    First version publication date
    09 Aug 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    P903-25
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Cerexa, Inc (a subsidiary of Allergan, plc)
    Sponsor organisation address
    185 Hudson Street, Plaza 5, Jersey City, New Jersey, United States, NJ 07302-3908
    Public contact
    Clinical Trial Registry Team, Cerexa, Inc (a subsidiary of Allergan, plc), +1 877-277-8566, IR-CTRegistration@allergan.com
    Scientific contact
    Clinical Trial Registry Team, Cerexa, Inc (a subsidiary of Allergan, plc), +1 877-277-8566, IR-CTRegistration@allergan.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
    03 Sep 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Dec 2013
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    • Evaluate the efficacy of ceftaroline and azithromycin versus ceftriaxone and azithromycin plus vancomycin in adult subjects with Community-acquired Bacterial Pneumonia (CABP) at risk for infection due to methicillin-resistant Staphylococcus aureus (MRSA) • Evaluate the safety of ceftaroline and azithromycin versus ceftriaxone and azithromycin plus vancomycin in adult subjects with CABP at risk for infection due to MRSA • Evaluate the pharmacokinetics of ceftaroline in adult subjects with CABP at risk for infection due to MRSA
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with good clinical practices and applicable regulatory requirements. Written informed consent from subject or legally acceptable representative was obtained before initiating study-related assessments or procedures.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Oct 2012
    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
    Georgia: 18
    Country: Number of subjects enrolled
    Poland: 8
    Country: Number of subjects enrolled
    Romania: 1
    Country: Number of subjects enrolled
    Russian Federation: 2
    Country: Number of subjects enrolled
    Ukraine: 12
    Country: Number of subjects enrolled
    United States: 8
    Worldwide total number of subjects
    49
    EEA total number of subjects
    9
    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)
    29
    From 65 to 84 years
    18
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 49 subjects (male and female) ≥ 18 years of age with Community-acquired Bacterial Pneumonia (CABP) that warranted 3 days of initial hospitalization, a minimum of 3 days of IV antibacterial therapy, and a minimum of 5 days but no more than 14 days total of study therapy (IV and oral combined) were enrolled in the study.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ceftaroline fosamil
    Arm description
    		 32 subjects aged ≥ 18 years were randomized to receive IV ceftaroline fosamil infusion every 8 hours (q8h). IV saline placebo q12h was infused to maintain blinding of vancomycin dosing. For coverage of atypical pathogens, all subjects were to receive a minimum of 3 and up to 5 days of open-label azithromycin (oral, IV, or combination), administered as a single 500-mg dose on Study Day 1, followed by a 250 mg once daily dose up through Study Day 5.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ceftaroline fosamil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    IV ceftaroline fosamil was infused every 8 hours (q8h) as follows: - First daily dose: two 300-mg doses infused consecutively, each over 30 (± 5) minutes - Second and third daily doses: 600 mg infused over 60 (± 10) minutes

    Investigational medicinal product name
    Azithromycin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection, Tablet
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    Azithromycin (open-label adjunctive macrolide) was given q24h as a single 500-mg dose on Study Day 1, followed by 250 mg daily up to Study Day 5 (3 days minimum); azithromycin dosed oral then IV (over 60 [± 10] min), or IV then oral.

    Arm title
    		 Comparator
    Arm description
    		 17 subjects aged ≥ 18 years were randomized to receive comparator (ceftriaxone plus vancomycin) in the Intent-to-Treat (ITT) Population. IV saline placebo was infused approximately q8h to match the second and third ceftaroline fosamil infusions. For coverage of atypical pathogens, all subjects were to receive a minimum of 3 and up to 5 days of open-label azithromycin (oral, IV, or combination), administered as a single 500-mg dose on Study Day 1, followed by a 250 mg once daily dose up through Study Day 5.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Vancomycin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    IV vancomycin was infused every 12 hours (q12h) at an initial dose of 15 mg/kg; subsequent dosing should be infused at 10 mg/min to maintain serum trough concentrations of 15 – 20 mg/L. Vancomycin was only to be discontinued if a non-MRSA respiratory pathogen was identified.

    Investigational medicinal product name
    Cetriaxone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    IV ceftriaxone 2 g was infused over 30 (± 5) minutes q24h immediately followed by IV saline placebo infused over 30 (± 5) minutes.

    Investigational medicinal product name
    Azithromycin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection, Tablet
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    Azithromycin (open-label adjunctive macrolide) was given q24h as a single 500-mg dose on Study Day 1, followed by 250 mg daily up to Study Day 5 (3 days minimum); azithromycin dosed oral then IV (over 60 [± 10] min), or IV then oral.

    Number of subjects in period 1
    		Ceftaroline fosamil Comparator
    Started
    32
    17
    Completed
    27
    15
    Not completed
    5
    2
         Adverse event, serious fatal
    1
    -
         Consent withdrawn by subject
    1
    -
         Adverse event, non-fatal
    -
    1
         Lack of efficacy
    3
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ceftaroline fosamil
    Reporting group description
    		 32 subjects aged ≥ 18 years were randomized to receive IV ceftaroline fosamil infusion every 8 hours (q8h). IV saline placebo q12h was infused to maintain blinding of vancomycin dosing. For coverage of atypical pathogens, all subjects were to receive a minimum of 3 and up to 5 days of open-label azithromycin (oral, IV, or combination), administered as a single 500-mg dose on Study Day 1, followed by a 250 mg once daily dose up through Study Day 5.

    Reporting group title
    Comparator
    Reporting group description
    		 17 subjects aged ≥ 18 years were randomized to receive comparator (ceftriaxone plus vancomycin) in the Intent-to-Treat (ITT) Population. IV saline placebo was infused approximately q8h to match the second and third ceftaroline fosamil infusions. For coverage of atypical pathogens, all subjects were to receive a minimum of 3 and up to 5 days of open-label azithromycin (oral, IV, or combination), administered as a single 500-mg dose on Study Day 1, followed by a 250 mg once daily dose up through Study Day 5.

    Reporting group values
    		 Ceftaroline fosamil Comparator Total
    Number of subjects
    		 32 17 49
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 23 6 29
        From 65-84 years
    		 9 9 18
        85 years and over
    		 0 2 2
    Gender categorical
    Units: Subjects
        Female
    		 20 13 33
        Male
    		 12 4 16

    End points

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    End points reporting groups
    Reporting group title
    Ceftaroline fosamil
    Reporting group description
    		 32 subjects aged ≥ 18 years were randomized to receive IV ceftaroline fosamil infusion every 8 hours (q8h). IV saline placebo q12h was infused to maintain blinding of vancomycin dosing. For coverage of atypical pathogens, all subjects were to receive a minimum of 3 and up to 5 days of open-label azithromycin (oral, IV, or combination), administered as a single 500-mg dose on Study Day 1, followed by a 250 mg once daily dose up through Study Day 5.

    Reporting group title
    Comparator
    Reporting group description
    		 17 subjects aged ≥ 18 years were randomized to receive comparator (ceftriaxone plus vancomycin) in the Intent-to-Treat (ITT) Population. IV saline placebo was infused approximately q8h to match the second and third ceftaroline fosamil infusions. For coverage of atypical pathogens, all subjects were to receive a minimum of 3 and up to 5 days of open-label azithromycin (oral, IV, or combination), administered as a single 500-mg dose on Study Day 1, followed by a 250 mg once daily dose up through Study Day 5.

    Subject analysis set title
    Ceftaroline - MITT Set
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The Modified-Intent-to-Treat (MITT) Population consists of all randomised subjects who received any amount of IV study drug and who had a confirmed diagnosis of CABP with risk factors for MRSA (excluding those that have a sole atypical pathogen).

    Subject analysis set title
    Comparator - MITT Set
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The Modified-Intent-to-Treat (MITT) Population consists of all randomized subjects who received any amount of IV study drug and who had a confirmed diagnosis of CABP with risk factors for MRSA (excluding those that have a sole atypical pathogen).

    Subject analysis set title
    Ceftaroline - mMITT Set
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The microbiological Modified Intent-to-Treat (mMITT Population) consists of all subjects for whom at least 1 typical bacterial pathogen has been identified from an adequate microbiological specimen at baseline.

    Subject analysis set title
    Comparator - mMITT Set
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The microbiological Modified Intent-to-Treat (mMITT) Population consists of all subjects for whom at least 1 typical bacterial pathogen has been identified from an adequate microbiological specimen at baseline.

    Subject analysis set title
    Ceftaroline - Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety Population consists of all randomized subjects who received any amount of IV study drug, and will be analysed according to the treatment actually received.

    Subject analysis set title
    Comparator - Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety Population consists of all randomized subjects who received any amount of IV study drug, and will be analysed according to the treatment actually received.

    Primary: Symptom Improvement at Study Day 4 - MITT Set

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    End point title
    		 Symptom Improvement at Study Day 4 - MITT Set [1]
    End point description
    A response for symptom improvement at Study Day 4 is defined as improvement in at least 2 and no worsening of any of the following symptoms: cough, dyspnoea, sputum production, and chest pain.
    End point type
    Primary
    End point timeframe
    Symptom Improvement at Study Day 4 was evaluated from Study Day 1 (the first day of IV study drug administration) to Study Day 4.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This study is not powered for inferential statistical analysis.
    End point values
    		 Ceftaroline - MITT Set Comparator - MITT Set
    Number of subjects analysed
    32
    17
    Units: Number of patients
        Responder
    24
    14
        Non-responder
    5
    2
        Incomplete data
    3
    1
    No statistical analyses for this end point

    Primary: Clinical Stability at Study Day 4 - MITT Set

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    End point title
    		 Clinical Stability at Study Day 4 - MITT Set [2]
    End point description
    A response for clinical stability at Study Day 4 is defined as meeting all of the following criteria: (1) Temperature ≤ 37.8°C), (2) Heart rate ≤ 100 beats/min, (3) Respiratory rate ≤ 24 breaths/min, (4) Systolic blood pressure ≥ 90 mm Hg, and (5) Oxygen saturation ≥ 90%.
    End point type
    Primary
    End point timeframe
    Clinical Stability at Study Day 4 was evaluated from Study Day 1 (the first day of IV study drug administration) to Study Day 4.
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This study is not powered for inferential statistical analysis.
    End point values
    		 Ceftaroline - MITT Set Comparator - MITT Set
    Number of subjects analysed
    32
    17
    Units: Number of patients
        Responder
    15
    9
        Non-responder
    14
    7
        Incomplete data
    3
    1
    No statistical analyses for this end point

    Primary: Clinical Success at Study day 4 - MITT Set

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    End point title
    		 Clinical Success at Study day 4 - MITT Set [3]
    End point description
    A response for clinical success is defined as a subject with a response for both symptom improvement and clinical stability.
    End point type
    Primary
    End point timeframe
    Clinical Success at Study Day 4 was evaluated from Study Day 1 (the first day of IV study drug administration) to Study Day 4.
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This study is not powered for inferential statistical analysis.
    End point values
    		 Ceftaroline - MITT Set Comparator - MITT Set
    Number of subjects analysed
    32
    17
    Units: Number of patients
        Responder
    14
    8
        Non-responder
    16
    8
        Incomplete data
    2
    1
    No statistical analyses for this end point

    Primary: Symptom Improvement at Study Day 4 - mMITT Set

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    End point title
    		 Symptom Improvement at Study Day 4 - mMITT Set [4]
    End point description
    A response for symptom improvement at Study Day 4 is defined as improvement in at least 2 and no worsening of any of the following symptoms: cough, dyspnoea, sputum production, and chest pain.
    End point type
    Primary
    End point timeframe
    Symptom Improvement at Study Day 4 was evaluated from Study Day 1 (the first day of IV study drug administration) to Study Day 4.
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This study is not powered for inferential statistical analysis.
    End point values
    		 Ceftaroline - mMITT Set Comparator - mMITT Set
    Number of subjects analysed
    25
    14
    Units: Number of patients
        Responder
    22
    11
        Non-responder
    2
    2
        Incomplete data
    1
    1
    No statistical analyses for this end point

    Primary: Clinical Stability at Study Day 4 - mMITT Set

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    End point title
    		 Clinical Stability at Study Day 4 - mMITT Set [5]
    End point description
    A response for clinical stability at Study Day 4 is defined as meeting all of the following criteria: (1) Temperature ≤ 37.8°C), (2) Heart rate ≤ 100 beats/min, (3) Respiratory rate ≤ 24 breaths/min, (4) Systolic blood pressure ≥ 90 mm Hg, and (5) Oxygen saturation ≥ 90%.
    End point type
    Primary
    End point timeframe
    Clinical Stability at Study Day 4 was evaluated from Study Day 1 (the first day of IV study drug administration) to Study Day 4.
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This study is not powered for inferential statistical analysis.
    End point values
    		 Ceftaroline - mMITT Set Comparator - mMITT Set
    Number of subjects analysed
    25
    14
    Units: Number of patients
        Responder
    13
    6
        Non-responder
    9
    7
        Incomplete data
    3
    1
    No statistical analyses for this end point

    Primary: Clinical Success at Study Day 4 - mMITT Set

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    End point title
    		 Clinical Success at Study Day 4 - mMITT Set [6]
    End point description
    A response for clinical success is defined as a subject with a response for both symptom improvement and clinical stability.
    End point type
    Primary
    End point timeframe
    Clinical Success at Study Day 4 was evaluated from Study Day 1 (the first day of IV study drug administration) to Study Day 4.
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This study is not powered for inferential statistical analysis.
    End point values
    		 Ceftaroline - mMITT Set Comparator - mMITT Set
    Number of subjects analysed
    25
    14
    Units: Number of patients
        Responder
    12
    5
        Non-responder
    11
    8
        Incomplete data
    2
    1
    No statistical analyses for this end point

    Primary: Clinical Outcome at TOC - MITT Set

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    End point title
    		 Clinical Outcome at TOC - MITT Set [7]
    End point description
    Clinical Outcome at TOC is defined as assessment of clinical cure, clinical failure and indeterminate for the MITT population at Test-Of-Cure.
    End point type
    Primary
    End point timeframe
    Clinical Outcome at Test-of-Cure (TOC) was evaluated 8 to 15 days after administration of the last dose of any study drug [IV or PO].
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This study is not powered for inferential statistical analysis.
    End point values
    		 Ceftaroline - MITT Set Comparator - MITT Set
    Number of subjects analysed
    32
    17
    Units: Number of patients
        Clinical cure
    27
    15
        Clinical failure
    3
    2
        Indeterminate
    2
    0
    No statistical analyses for this end point

    Primary: Clinical Outcome at TOC - mMITT Set

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    End point title
    		 Clinical Outcome at TOC - mMITT Set [8]
    End point description
    Clinical Outcome at TOC is defined as assessment of clinical cure, clinical failure and indeterminate for the mMITT population at Test-Of-Cure.
    End point type
    Primary
    End point timeframe
    Clinical Outcome at Test-of-Cure (TOC) was evaluated 8 to 15 days after the last dose of any study drug [IV or PO].
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This study is not powered for inferential statistical analysis.
    End point values
    		 Ceftaroline - mMITT Set Comparator - mMITT Set
    Number of subjects analysed
    25
    14
    Units: Number of patients
        Clinical cure
    23
    12
        Clinical failure
    0
    2
        Indeterminate
    2
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From signing of the ICF to 21 to 35 days after last dose of any study drug [IV or PO]).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Ceftaroline fosamil
    Reporting group description
    		 32 subjects aged ≥ 18 years of age were randomized to receive IV ceftaroline fosamil infusion every 8 hours (q8h). IV saline placebo q12h was infused to maintain blinding of vancomycin dosing. For coverage of atypical pathogens, all subjects were to receive a minimum of 3 and up to 5 days of open-label azithromycin (oral, IV, or combination), administered as a single 500-mg dose on Study Day 1, followed by a 250 mg once daily dose up through Study Day 5.

    Reporting group title
    Comparator
    Reporting group description
    		 17 subjects ≥ 18 years of age were randomized to comparator (ceftriaxone plus vancomycin) in the Intent-to-Treat (ITT) Population. IV saline placebo was infused approximately q8h to match the second and third ceftaroline fosamil infusions. For coverage of atypical pathogens, all subjects were to receive a minimum of 3 and up to 5 days of open-label azithromycin (oral, IV, or combination), administered as a single 500-mg dose on Study Day 1, followed by a 250 mg once daily dose up through Study Day 5.

    Serious adverse events
    		 Ceftaroline fosamil Comparator
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 32 (9.38%)
    2 / 17 (11.76%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    0
    0
    Investigations
    Computerised tomogram abnormal
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 17 (5.88%)
         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
    1 / 32 (3.13%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 17 (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
    Renal failure
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Clostridium difficile colitis
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 17 (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
    		 Ceftaroline fosamil Comparator
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 32 (53.13%)
    9 / 17 (52.94%)
    Investigations
    Blood pressure increased
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Body temperature increased
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Computerised tomogram thorax abnormal
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Neutrophil count increased
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Hypophosphataemia
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Procedural pain
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 17 (0.00%)
         occurrences all number
    2
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 32 (0.00%)
    2 / 17 (11.76%)
         occurrences all number
    0
    2
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 32 (9.38%)
    1 / 17 (5.88%)
         occurrences all number
    3
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Leukopenia
         subjects affected / exposed
    0 / 32 (0.00%)
    2 / 17 (11.76%)
         occurrences all number
    0
    2
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 32 (3.13%)
    1 / 17 (5.88%)
         occurrences all number
    1
    1
    Oedema peripheral
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Diarrhoea
         subjects affected / exposed
    2 / 32 (6.25%)
    1 / 17 (5.88%)
         occurrences all number
    2
    1
    Nausea
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Disorientation
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Renal failure acute
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 17 (0.00%)
         occurrences all number
    2
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Hypocalcaemia
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Hypokalaemia
         subjects affected / exposed
    0 / 32 (0.00%)
    3 / 17 (17.65%)
         occurrences all number
    0
    3

    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? Yes
    Date
    Interruption
    Restart date
    29 Oct 2013
    Study early termination
    -

    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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    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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