Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44313   clinical trials with a EudraCT protocol, of which   7357   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    An Open-Label Study to Evaluate the Efficacy and Safety of APX001 in Non-Neutropenic Patients with Candidemia, with or without Invasive Candidiasis, Inclusive of Patients with Suspected Resistance to Standard of Care Antifungal Treatment.

    Summary
    EudraCT number
    		 2017-003571-56
    Trial protocol
    		 DE   BE   ES  
    Global end of trial date
    02 Jul 2020

    Results information
    Results version number
    		 v2(current)
    This version publication date
    06 Jun 2024
    First version publication date
    27 Feb 2021
    Other versions
    		 v1
    Version creation reason
    • New data added to full data set
    Sponsor details must be updated

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    C4791009
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03604705
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 APX001-201: Study id
    Sponsors
    Sponsor organisation name
    Basilea Pharmaceutica International Ltd, Allschwil
    Sponsor organisation address
    Hegenheimermattweg 167b, Allschwil, Switzerland, 4123
    Public contact
    Marc Engelhardt, Basilea Pharmaceutica International Ltd, Allschwil, +41 +41 79 701 0551, marc.engelhardt@basilea.com
    Scientific contact
    Marc Engelhardt, Basilea Pharmaceutica International Ltd, Allschwil, +41 +41 79 701 0551, marc.engelhardt@basilea.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
    31 Mar 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Jul 2020
    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 and safety of APX001 for the treatment of adult non-neutropenic subjects greater than or equal to (>=) 18 years of age with candidemia that had included subjects with suspected or confirmed resistance to standard of care (SOC) antifungal treatment.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trials subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Oct 2018
    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
    United States: 21
    Worldwide total number of subjects
    21
    EEA total number of subjects
    0
    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)
    11
    From 65 to 84 years
    10
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 21 subjects were enrolled in this study.

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 APX001 IV
    Arm description
    		 Subjects were administered 1000 milligram (mg) APX001 loading dose BID (Twice daily) followed by a 600 mg APX001 maintenance dose QD (once daily) on Study Day 2 and Day 3. From Study Day 4 onwards, the APX001 maintenance dose was administered as either 600 mg APX001 IV infusion over 3 hours QD or may be switched to 700 mg PO (Orally) QD when the criteria for PO dosing were met.
    Arm type
    		 Experimental

    Investigational medicinal product name
    APX001
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Dispersion for injection, Dispersion for infusion, Powder for concentrate for dispersion for infusion, Dispersible tablet
    Routes of administration
    Intravenous use, Intraventricular use , Oral use
    Dosage and administration details
    1000 mg APX001 loading dose was given by IV. Followed by 600 mg maintenance dose by IV route or 700 mg PO.

    Number of subjects in period 1
    		APX001 IV
    Started
    21
    Completed
    16
    Not completed
    5
         Physician decision
    2
         Adverse event, non-fatal
    3

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    APX001 IV
    Reporting group description
    		 Subjects were administered 1000 milligram (mg) APX001 loading dose BID (Twice daily) followed by a 600 mg APX001 maintenance dose QD (once daily) on Study Day 2 and Day 3. From Study Day 4 onwards, the APX001 maintenance dose was administered as either 600 mg APX001 IV infusion over 3 hours QD or may be switched to 700 mg PO (Orally) QD when the criteria for PO dosing were met.

    Reporting group values
    		 APX001 IV Total
    Number of subjects
    		 21 21
    Age Categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 11 11
        From 65-84 years
    		 10 10
        85 years and over
    		 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 62.9 ( 10.59 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 7 7
        Male
    		 14 14
    Race
    Units: Subjects
        Black or African American
    		 1 1
        White
    		 20 20
    Ethnicity
    Units: Subjects
        Not Hispanic or Latino
    		 18 18
        Not reported
    		 3 3

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    APX001 IV
    Reporting group description
    		 Subjects were administered 1000 milligram (mg) APX001 loading dose BID (Twice daily) followed by a 600 mg APX001 maintenance dose QD (once daily) on Study Day 2 and Day 3. From Study Day 4 onwards, the APX001 maintenance dose was administered as either 600 mg APX001 IV infusion over 3 hours QD or may be switched to 700 mg PO (Orally) QD when the criteria for PO dosing were met.

    Primary: Percentage of Subjects With Treatment Success at End of Study Treatment (EOST)

    		 Close Top of page
    End point title
    		 Percentage of Subjects With Treatment Success at End of Study Treatment (EOST) [1]
    End point description
    Treatment success as determined by data review committee (DRC) was defined as meeting all of the following criteria: two consecutive blood cultures negative for Candida species; alive at EOST; no concomitant use of any other systemic antifungal therapies through EOST. 95% confidence intervals (CIs) were 2-sided exact binomial CIs. Modified intent-to treat (mITT) population included all subjects who received at least 1 dose of study drug; and had a confirmed diagnosis of candidemia (blood culture positive for Candida spp.) within 96 hours of the start of treatment with APX001.
    End point type
    Primary
    End point timeframe
    Day 1 up to a maximum of Day 14
    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: Only a descriptive analysis is possible for this single-arm study.
    End point values
    		 APX001 IV
    Number of subjects analysed
    20
    Units: Percentage of subjects
        number (confidence interval 95%)
    80 (56.3 to 94.3)
    No statistical analyses for this end point

    Secondary: Time to First Negative Blood Culture - Modified intent-to treat (MITT) Population

    		 Close Top of page
    End point title
    		 Time to First Negative Blood Culture - Modified intent-to treat (MITT) Population
    End point description
    Time to first negative blood culture was defined as the number of days from first dose date of study drug to the date of first post-baseline negative blood culture + 1. Subjects without a negative blood culture at post-baseline visits were censored at the last assessment date. MITT population included all subjects who received at least 1 dose of study drug and had a confirmed diagnosis of candidemia within 96 hours of the start of treatment with APX001.
    End point type
    Secondary
    End point timeframe
    Day 1 up to end of the study (up to 7 weeks)
    End point values
    		 APX001 IV
    Number of subjects analysed
    20
    Units: Days
        median (confidence interval 95%)
    2.0 (1.0 to 4.0)
    No statistical analyses for this end point

    Secondary: Time to First Negative Blood Culture - Per-Protocol (PP) Population

    		 Close Top of page
    End point title
    		 Time to First Negative Blood Culture - Per-Protocol (PP) Population
    End point description
    Time to first negative blood culture was defined as the number of days from first dose date of study drug to the date of first post-baseline negative blood culture + 1. Subjects without a negative blood culture at post-baseline visits were censored at the last assessment date. PP population included all subjects who received at least 1 dose of study drug, had a confirmed diagnosis of candidemia within 96 hours of the start of treatment with APX001; did not exceed prior antifungal treatment (per eligibility assessed by DRC); met the protocol’s key inclusion and exclusion criteria, and had no major protocol violations.
    End point type
    Secondary
    End point timeframe
    Day 1 up to end of the study (up to 7 weeks)
    End point values
    		 APX001 IV
    Number of subjects analysed
    20
    Units: Days
        median (confidence interval 95%)
    2.0 (1.0 to 4.0)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Eradication at End of Study Treatment and End of Antifungal Treatment- MITT Population

    		 Close Top of page
    End point title
    		 Percentage of Subjects With Eradication at End of Study Treatment and End of Antifungal Treatment- MITT Population
    End point description
    Eradication was defined as a negative blood culture(s) for Candida species in the absence of concomitant antifungal therapy through EOST and EOT respectively. 95% confidence intervals (CIs) were 2-sided exact binomial CIs. MITT Population included all subjects who received at least 1 dose of study drug; had a confirmed diagnosis of candidemia within 96 hours of the start of treatment with APX001.
    End point type
    Secondary
    End point timeframe
    EOST: Day 1 up to Day 14, EOT: Day 1 up to maximum of Day 21
    End point values
    		 APX001 IV
    Number of subjects analysed
    20
    Units: Percentage of subjects
    number (confidence interval 95%)
        EOST
    80.0 (56.3 to 94.3)
        EOT
    75.0 (50.9 to 91.3)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Eradication at End of Study Treatment and End of Treatment - PP Population

    		 Close Top of page
    End point title
    		 Percentage of Subjects With Eradication at End of Study Treatment and End of Treatment - PP Population
    End point description
    Eradication was defined as a negative blood culture(s) for Candida species in the absence of additional antifungal therapy through EOST and EOT respectively. 95% CIs were 2-sided exact binomial CIs. PP population included all subjects who received at least 1 dose of study drug, had a confirmed diagnosis of candidemia within 96 hours of the start of treatment with APX001; did not exceed prior antifungal treatment (per eligibility assessed by DRC); met the protocol’s key inclusion and exclusion criteria, and had no major protocol violations.
    End point type
    Secondary
    End point timeframe
    EOST: Day 1 up to Day 14, EOT: Day 1 up to maximum of Day 21
    End point values
    		 APX001 IV
    Number of subjects analysed
    20
    Units: Percentage of subjects
    number (confidence interval 95%)
        EOST
    80.0 (56.3 to 94.3)
        EOT
    75.0 (50.9 to 91.3)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Recurrence at 2 and 4 Weeks After End of Treatment -MITT Population

    		 Close Top of page
    End point title
    		 Percentage of Subjects With Recurrence at 2 and 4 Weeks After End of Treatment -MITT Population
    End point description
    Recurrence (mycological) was defined as mycologically confirmed infection based on blood culture with the same baseline Candida species, during the 4 weeks after EOT. 95% CIs were 2-sided exact binomial CIs. 99999 indicates 95% CI could not estimate because of less number of subjects with this event. MITT population included all participants who received at least 1 dose of study drug; had a confirmed diagnosis of candidemia within 96 hours of the start of treatment with APX001.
    End point type
    Secondary
    End point timeframe
    2 weeks and 4 weeks after EOT
    End point values
    		 APX001 IV
    Number of subjects analysed
    20
    Units: Percentage of subjects
    number (confidence interval 95%)
        2 Weeks
    5.0 (0.1 to 24.9)
        4 Weeks
    0.0 (-99999 to 99999)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Treatment Success at End of Treatment and 2 and 4 Weeks After End of Treatment - MITT Population

    		 Close Top of page
    End point title
    		 Percentage of Subjects With Treatment Success at End of Treatment and 2 and 4 Weeks After End of Treatment - MITT Population
    End point description
    Treatment success as determined by DRC was defined as meeting all of the following criteria: two consecutive blood cultures negative for Candida species; alive at EOST; no concomitant use of any other systemic antifungal therapies through EOST. 95% CIs were 2-sided exact binomial CIs. MITT population included all subjects who received at least 1 dose of study drug; had a confirmed diagnosis of candidemia within 96 hours of the start of treatment with APX001.
    End point type
    Secondary
    End point timeframe
    EOT (Day 21), 2 weeks and 4 weeks after EOT
    End point values
    		 APX001 IV
    Number of subjects analysed
    20
    Units: Percentage of subjects
    number (confidence interval 95%)
        2 Weeks after EOT
    60.0 (36.1 to 80.9)
        4 Weeks after EOT
    55.0 (31.5 to 76.9)
        EOT
    75.0 (50.9 to 91.3)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Recurrence at 2 and 4 Weeks After End of Treatment - PP Population

    		 Close Top of page
    End point title
    		 Percentage of Subjects With Recurrence at 2 and 4 Weeks After End of Treatment - PP Population
    End point description
    Recurrence (mycological) was defined as a mycologically confirmed infection based on blood culture with the same baseline Candida species. during the 4 weeks after EOT. 95% CIs were 2-sided exact binomial. 99999 indicates 95% CI could not estimate because of less number of subjects with this event. PP population included all participants who received at least 1 dose of study drug, had a confirmed diagnosis of candidemia within 96 hours of the start of treatment with APX001; did not exceed prior antifungal treatment (per eligibility assessed by DRC) met the protocol’s key inclusion and exclusion criteria, and had no major protocol violations.
    End point type
    Secondary
    End point timeframe
    2 weeks and 4 weeks after EOT
    End point values
    		 APX001 IV
    Number of subjects analysed
    20
    Units: Percentage of Subjects
    number (confidence interval 95%)
        2 Weeks after EOT
    5.0 (0.1 to 24.9)
        4 Weeks after EOT
    0.0 (-99999 to 99999)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Treatment Success at End of Treatment and 2 and 4 Weeks After End of Treatment- PP Population

    		 Close Top of page
    End point title
    		 Percentage of Subjects With Treatment Success at End of Treatment and 2 and 4 Weeks After End of Treatment- PP Population
    End point description
    Treatment success as determined by DRC was defined as meeting all of the following criteria: two consecutive blood cultures negative for Candida species; alive at EOST; no concomitant use of any other systemic antifungal therapies through EOST. 95% CIs were 2-sided exact binomial CIs. The PP population included all subjects who satisfied the following criteria: received at least 1 dose of study drug; had a confirmed diagnosis of candidemia within 96 hours of the start of treatment with APX001; did not exceed prior antifungal treatment (per eligibility assessed by DRC); met the protocol’s key inclusion and exclusion criteria; had no major protocol violations.
    End point type
    Secondary
    End point timeframe
    EOT (Day 21), 2 weeks and 4 weeks after EOT
    End point values
    		 APX001 IV
    Number of subjects analysed
    20
    Units: Percentage of Subjects
    number (confidence interval 95%)
        2 Weeks after EOT
    60.0 (36.1 to 80.9)
        4 Weeks after EOT
    55.0 (31.5 to 76.9)
        EOT
    75.0 (50.9 to 91.3)
    No statistical analyses for this end point

    Secondary: Number of Subjects Alive or Dead at Study Day 30 - PP Population

    		 Close Top of page
    End point title
    		 Number of Subjects Alive or Dead at Study Day 30 - PP Population
    End point description
    PP Population included all subjects who satisfied the following criteria: received at least 1 dose of study drug; had a confirmed diagnosis of candidemia within 96 hours of the start of treatment with APX001; did not exceed prior antifungal treatment (per eligibility assessed by DRC); met the protocol’s key inclusion and exclusion criteria; had no major protocol violations.
    End point type
    Secondary
    End point timeframe
    At Day 30
    End point values
    		 APX001 IV
    Number of subjects analysed
    20
    Units: Count of Subjects
        Alive
    17
        Dead
    3
    No statistical analyses for this end point

    Secondary: Number of Subjects Alive or Dead at Study Day 30 - MITT Population

    		 Close Top of page
    End point title
    		 Number of Subjects Alive or Dead at Study Day 30 - MITT Population
    End point description
    MITT population included all subjects who received at least 1 dose of study drug; had a confirmed diagnosis of candidemia within 96 hours of the start of treatment with APX001.
    End point type
    Secondary
    End point timeframe
    At day 30
    End point values
    		 APX001 IV
    Number of subjects analysed
    20
    Units: Count of Subjects
        Alive
    17
        Dead
    3
    No statistical analyses for this end point

    Secondary: Number of Subjects With Treatment Emergent Adverse Events (TEAEs)

    		 Close Top of page
    End point title
    		 Number of Subjects With Treatment Emergent Adverse Events (TEAEs)
    End point description
    An adverse event (AE) was any untoward medical occurrence in administered medicinal product, event need not necessarily have a causal relationship with product treatment or usage. TEAEs were defined as adverse events that started on or after the administration of study drug. Safety population included all subjects who had received at least 1 dose of APX001.
    End point type
    Secondary
    End point timeframe
    Day 1 up to a maximum of 7 weeks
    End point values
    		 APX001 IV
    Number of subjects analysed
    21
    Units: Count of subjects
    20
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    From start of study treatment on Day 1 up to 7 weeks
    Adverse event reporting additional description
    Same event may appear as both non-SAE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and non-serious in another subjects, or one subject may have experienced both serious and non-serious event during the study.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    APX001
    Reporting group description
    		 -

    Serious adverse events
    		 APX001
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 21 (42.86%)
         number of deaths (all causes)
    5
         number of deaths resulting from adverse events
    0
    Cardiac disorders
    Cardiac failure congestive
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 5
    Cardio-respiratory arrest
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 5
    Blood and lymphatic system disorders
    Leukopenia
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 5
    General disorders and administration site conditions
    Euthanasia
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 5
    General physical health deterioration
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 5
    Gastrointestinal disorders
    Gastrointestinal fistula
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 5
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 5
    Interstitial lung disease
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 5
    Infections and infestations
    Urinary tract infection bacterial
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 5
    Bacteraemia
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 5
    Bacterial sepsis
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 5
    Enterobacter sepsis
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 5
    Necrotising fasciitis
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 5
    Sepsis
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 5
    Septic shock
         subjects affected / exposed
    2 / 21 (9.52%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 5
    Stenotrophomonas sepsis
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 5
    Systemic candida
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 5
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 APX001
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    20 / 21 (95.24%)
    Vascular disorders
    Hypotension
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    General disorders and administration site conditions
    Catheter site extravasation
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Fatigue
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Oedema peripheral
         subjects affected / exposed
    3 / 21 (14.29%)
         occurrences all number
    3
    Pain
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Pyrexia
         subjects affected / exposed
    2 / 21 (9.52%)
         occurrences all number
    5
    Asthenia
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Dyspnoea
         subjects affected / exposed
    2 / 21 (9.52%)
         occurrences all number
    2
    Hypercapnia
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Increased bronchial secretion
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Lung infiltration
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    2
    Pleural effusion
         subjects affected / exposed
    3 / 21 (14.29%)
         occurrences all number
    4
    Rales
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Rhonchi
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Pneumonia aspiration
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Psychiatric disorders
    Agitation
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Delirium
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Depression
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Investigations
    Activated partial thromboplastin time prolonged
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Blood uric acid increased
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Electrocardiogram QT prolonged
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Electrocardiogram ST-T segment abnormal
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Haemoglobin decreased
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Platelet count decreased
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Stenotrophomonas test positive
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Transfusion reaction
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Dysgeusia
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Headache
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Neuropathy peripheral
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Peroneal nerve palsy
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Sciatica
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Disseminated intravascular coagulation
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Eosinophilia
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Thrombocytosis
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Thrombocytopenia
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Leukocytosis
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Ear and labyrinth disorders
    Hypoacusis
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Eye disorders
    Diplopia
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Gastrointestinal disorders
    Colitis
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Abdominal pain upper
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Abdominal pain lower
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Vomiting
         subjects affected / exposed
    3 / 21 (14.29%)
         occurrences all number
    5
    Stress ulcer
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    2
    Small intestinal obstruction
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Fistula of small intestine
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Dyspepsia
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Diarrhoea
         subjects affected / exposed
    3 / 21 (14.29%)
         occurrences all number
    3
    Constipation
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Colitis ischaemic
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    2 / 21 (9.52%)
         occurrences all number
    2
    Hepatobiliary disorders
    Portal vein thrombosis
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Hyperkeratosis
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Pruritus
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    2
    Skin lesion
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Skin mass
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    2 / 21 (9.52%)
         occurrences all number
    2
    Hydronephrosis
         subjects affected / exposed
    2 / 21 (9.52%)
         occurrences all number
    2
    Renal failure
         subjects affected / exposed
    2 / 21 (9.52%)
         occurrences all number
    2
    Musculoskeletal and connective tissue disorders
    Musculoskeletal pain
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Synovitis
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Infections and infestations
    Bacteraemia
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    2
    Cellulitis
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Device related infection
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Empyema
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Enterococcal bacteraemia
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Escherichia bacteraemia
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Klebsiella bacteraemia
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Pneumonia moraxella
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Postoperative wound infection
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Staphylococcal sepsis
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Urinary tract infection enterococcal
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Hyperkalaemia
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Hypernatraemia
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Hyperproteinaemia
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1
    Metabolic alkalosis
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1

    More information

    		 Close Top of page

    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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA