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    Clinical Trial Results:
    A randomized, observer-blinded, active-controlled, Phase IIIb study to compare IV / Oral delafloxacin fixed-dose monotherapy with best available treatments in a microbiologically enriched population with surgical site infections

    Summary
    EudraCT number
    		 2018-001082-17
    Trial protocol
    		 CZ   GB   HU   LV   SI   ES   AT   PL   EE   BG   HR   IT   RO  
    Global end of trial date
    28 Oct 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Oct 2021
    First version publication date
    15 Oct 2021
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    DELA-01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04042077
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Menarini Ricerche S.p.A
    Sponsor organisation address
    via Sette Santi 1, Firenze, Italy, 50131
    Public contact
    Corp. Director Of Clinical Sciences, MENARINI RICERCHE S.p.A., +39 0555680 9933, ACapriati@menarini-ricerche.it
    Scientific contact
    Corp. Director Of Clinical Sciences, MENARINI RICERCHE S.p.A., +39 0555680 9933, ACapriati@menarini-ricerche.it
    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 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 Oct 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Oct 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To assess the comparability of delafloxacin and best available therapy (BAT) in terms of Clinical Success response in patients with superficial or deep incisional Surgical site infection (SSI) following a cardiothoracic / related leg or abdominal surgical procedure.
    Protection of trial subjects
    Patients underwent standard procedures, no specific measures were put in place. Procedures and examinations were done according to the local hospital standards.
    Background therapy
    		 No background therapy planned.
    Evidence for comparator
    		 DELA-01 has been designed to assess the efficacy and the effectiveness of delafloxacin compared to well-known best available treatments, that have been selected to address the microbiological flora causative of post cardiothoracic and abdominal SSI, on the basis of the current international guidances.
    Actual start date of recruitment
    25 Sep 2019
    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
    Poland: 7
    Country: Number of subjects enrolled
    Slovenia: 2
    Country: Number of subjects enrolled
    Spain: 4
    Country: Number of subjects enrolled
    Croatia: 7
    Country: Number of subjects enrolled
    Austria: 1
    Country: Number of subjects enrolled
    Bulgaria: 91
    Country: Number of subjects enrolled
    Czechia: 24
    Country: Number of subjects enrolled
    Estonia: 77
    Country: Number of subjects enrolled
    Hungary: 3
    Country: Number of subjects enrolled
    Latvia: 18
    Country: Number of subjects enrolled
    Serbia: 19
    Country: Number of subjects enrolled
    Romania: 13
    Worldwide total number of subjects
    266
    EEA total number of subjects
    247
    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)
    116
    From 65 to 84 years
    137
    85 years and over
    13

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment started in Estonia on 25 September 2019 with the FPI. It was stopped on 15 September 2020 due to COVID-19 pandemic. Overall, it lasted 13 months and was mostly conducted at Abdominal and General surgery departments.

    Pre-assignment
    Screening details
    		 In total, 274 patients were screened while 266 were randomized and treated. The Screening Visit was performed within 30 days after the surgical intervention.

    Period 1
    Period 1 title
    Screening/Visit 1 (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    The study was open-label, however an observer-blinded was selected in order to increase the objectivity in the clinical assessments and to minimize the intentional or unintentional Investigator’s bias with respect to the assigned treatment. This observer blinded role was assigned by PI to a physician who was responsible for the assessment of parameters relevant for defining the patient as eligible to IV/PO switch of therapy and dischargeable from the hospital.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Delafloxacin
    Arm description
    		 Delafloxacin arm was the Test arm. Patients started the treatment IV with the option to switch to oral formulation.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Delafloxacin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion, Tablet
    Routes of administration
    Infusion , Oral use
    Dosage and administration details
    Delafloxacin 300 mg IV given every 12 hours, with the option to switch to delafloxacin 450 mg OS every 12 hours as soon as patient met the eligibility criteria to switch to oral formulation

    Arm title
    		 Best Available Therapy
    Arm description
    		 Best Available Therapy was the Reference arm. Reference Treatments for cardiothoracic / related leg SSI ● Vancomycin OR ● Linezolid Reference Treatments for abdominal SSI ● Piperacillin / tazobactam OR ● Tigecycline In case of suspicion of Gram-negative in the cardiothoracic SSI or MRSA in patients treated with piperacillin/tazobactam, the Investigator shall indicate an additional therapy as per local SoC (with the only exclusion of quinolones).
    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
    Infusion
    Dosage and administration details
    15 mg/kg given IV every 12 hours

    Investigational medicinal product name
    Linezolid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion, Tablet
    Routes of administration
    Infusion , Oral use
    Dosage and administration details
    600 mg IV or OS every 12 hours

    Investigational medicinal product name
    Piperacillin/tazobactam
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    4/0,5g every 8 hours

    Investigational medicinal product name
    Tigecycline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Infusion
    Dosage and administration details
    100 mg loading, then 50 mg every 12 hours

    Number of subjects in period 1
    		Delafloxacin Best Available Therapy
    Started
    134
    132
    Completed
    125
    123
    Not completed
    9
    9
         Consent withdrawn by subject
    4
    2
         Physician decision
    -
    2
         Adverse event, non-fatal
    2
    2
         Lack of efficacy
    2
    3
         Protocol deviation
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Delafloxacin
    Reporting group description
    		 Delafloxacin arm was the Test arm. Patients started the treatment IV with the option to switch to oral formulation.

    Reporting group title
    Best Available Therapy
    Reporting group description
    		 Best Available Therapy was the Reference arm. Reference Treatments for cardiothoracic / related leg SSI ● Vancomycin OR ● Linezolid Reference Treatments for abdominal SSI ● Piperacillin / tazobactam OR ● Tigecycline In case of suspicion of Gram-negative in the cardiothoracic SSI or MRSA in patients treated with piperacillin/tazobactam, the Investigator shall indicate an additional therapy as per local SoC (with the only exclusion of quinolones).

    Reporting group values
    		 Delafloxacin Best Available Therapy Total
    Number of subjects
    		 134 132 266
    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)
    		 61 55 116
        From 65-84 years
    		 60 77 137
        85 years and over
    		 13 0 13
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 66 ( 13.65 ) 63.7 ( 13.71 ) -
    Gender categorical
    Gender was collected at Screening within the demographic data.
    Units: Subjects
        Female
    		 61 53 114
        Male
    		 73 79 152
    Site of infection
    The category distinguishes among abdominal and cardiothoracic/related leg site.
    Units: Subjects
        Abdominal SSI
    		 124 122 246
        Cardiothoracic SSI
    		 10 10 20
    Depth of infection
    The category distinguishes between the superfical and deep SSI.
    Units: Subjects
        Superficial SSI
    		 82 79 161
        Deep SSI
    		 52 53 105
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 3 1 4
        Not Hispanic or Latino
    		 131 131 262
        Unknown or Not reported
    		 0 0
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 0 0 0
        Natve Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 1 0 1
        White
    		 133 132 265
        More than one race
    		 0 0 0
        Unknown or not reported
    		 0 0 0
    Subject analysis sets

    Subject analysis set title
    ITT analysis set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All randomized and treated subjects analyzed according to the randomized treatment arm (Test or Reference).

    Subject analysis sets values
    		 ITT analysis set
    Number of subjects
    266
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    116
        From 65-84 years
    137
        85 years and over
    13
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    ( )
    Gender categorical
    Gender was collected at Screening within the demographic data.
    Units: Subjects
        Female
        Male
    Site of infection
    The category distinguishes among abdominal and cardiothoracic/related leg site.
    Units: Subjects
        Abdominal SSI
        Cardiothoracic SSI
    Depth of infection
    The category distinguishes between the superfical and deep SSI.
    Units: Subjects
        Superficial SSI
        Deep SSI
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    4
        Not Hispanic or Latino
    262
        Unknown or Not reported
    0
    Race
    Units: Subjects
        American Indian or Alaska Native
    0
        Asian
    0
        Natve Hawaiian or Other Pacific Islander
    0
        Black or African American
    1
        White
    265
        More than one race
    0
        Unknown or not reported
    0

    End points

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    End points reporting groups
    Reporting group title
    Delafloxacin
    Reporting group description
    		 Delafloxacin arm was the Test arm. Patients started the treatment IV with the option to switch to oral formulation.

    Reporting group title
    Best Available Therapy
    Reporting group description
    		 Best Available Therapy was the Reference arm. Reference Treatments for cardiothoracic / related leg SSI ● Vancomycin OR ● Linezolid Reference Treatments for abdominal SSI ● Piperacillin / tazobactam OR ● Tigecycline In case of suspicion of Gram-negative in the cardiothoracic SSI or MRSA in patients treated with piperacillin/tazobactam, the Investigator shall indicate an additional therapy as per local SoC (with the only exclusion of quinolones).

    Subject analysis set title
    ITT analysis set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All randomized and treated subjects analyzed according to the randomized treatment arm (Test or Reference).

    Primary: Clinical Success at TOC in the Intent-to-Treat (ITT) and the Clinical Evaluable (CE) populations.

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    End point title
    		 Clinical Success at TOC in the Intent-to-Treat (ITT) and the Clinical Evaluable (CE) populations.
    End point description
    Clinical success is defined as the clinical response of “Cure” or “Improved”
    End point type
    Primary
    End point timeframe
    Test of Cure Visit, i.e. 7 - 14 days after last dose
    End point values
    		 Delafloxacin Best Available Therapy
    Number of subjects analysed
    134
    132
    Units: N. of pts achieving the clinical success
        Success at TOC Visit
    123
    119
    Statistical analysis title
    		 Primary efficacy analysis
    Statistical analysis description
    The clinical success response at TOC is defined as cure or improved response within 7 - 14 days after last dose. The rate of the efficacy variable is the sample responder rate defined in the following equation: responder rate=(number of responder)/(number of responder+number of nonresponder) All the statistical comparisons will be a test for non-inferiority of delafloxacin versus the Reference arm at a 10% non-inferiority margin, with the possibility of switching to the superiority.
    Comparison groups
    Delafloxacin v Best Available Therapy
    Number of subjects included in analysis
    266
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.6 [1]
    Method
    		 Chi-squared corrected
    Parameter type
    		 Risk difference (RD)
    Point estimate
    0.0171
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.0568
         upper limit
    		 0.091
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.0377
    Notes
    [1] - P-value is referred to superiority testing (not achieved); non-inferiority achieved (95% CI[-0.05; 0.09])

    Secondary: Hospital Infection Related Length of Stay (IRLOS)

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    End point title
    		 Hospital Infection Related Length of Stay (IRLOS)
    End point description
    The endpoint measures the lenght of stay since beginning of therapy till patient stabilization and eligibility to discharge based on blinded oberver assessment.
    End point type
    Secondary
    End point timeframe
    Starting from Day 2 up to end of treatment (ie. 14 days maximum)
    End point values
    		 Delafloxacin Best Available Therapy
    Number of subjects analysed
    134
    132
    Units: N. of patients
        IRLOS
    119
    115
    No statistical analyses for this end point

    Secondary: Hospital Length of Stay (LOS)

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    End point title
    		 Hospital Length of Stay (LOS)
    End point description
    Lenght of Stay since Screening till actual hospital discharge
    End point type
    Secondary
    End point timeframe
    up to 45 days (i.e. Late Follow Up visit)
    End point values
    		 Delafloxacin Best Available Therapy
    Number of subjects analysed
    134
    132
    Units: hours
    arithmetic mean (standard deviation)
        Lenght of Stay
    178.8 ( 95.44 )
    193.5 ( 119.72 )
    No statistical analyses for this end point

    Secondary: Eligibility to switch to oral formulation

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    End point title
    		 Eligibility to switch to oral formulation
    End point description
    Blinded observer assessment based on patient stabilization and ability to tolerate OS diet
    End point type
    Secondary
    End point timeframe
    Starting from Day 2 up to the end of treatment (i.e. 14 days maximum)
    End point values
    		 Delafloxacin Best Available Therapy
    Number of subjects analysed
    134
    132
    Units: N. of patients
        Eligibility to switch to oral formulation
    129
    129
    No statistical analyses for this end point

    Secondary: Microbiological response

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    End point title
    		 Microbiological response
    End point description
    Documented or presumed pathogen eradication or persistence
    End point type
    Secondary
    End point timeframe
    up to 14 days (End of Treatment Visit) and 7-14 days after last dose (Test of Cure Visit)
    End point values
    		 Delafloxacin Best Available Therapy
    Number of subjects analysed
    105
    102
    Units: N.of patients
        Eradicated
    94
    81
        Persisted
    11
    21
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were collected starting from the FPFV up to LPLV.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    Delafloxacin
    Reporting group description
    		 Delafloxacin arm was the Test arm. Patients started the treatment IV with the option to switch to oral formulation.

    Reporting group title
    Best Available Therapy
    Reporting group description
    		 Best Available Therapy was the Reference arm. Reference Treatments for cardiothoracic / related leg SSI ● Vancomycin OR ● Linezolid Reference Treatments for abdominal SSI ● Piperacillin / tazobactam OR ● Tigecycline In case of suspicion of Gram-negative in the cardiothoracic SSI or MRSA in patients treated with piperacillin/tazobactam, the Investigator shall indicate an additional therapy as per local SoC (with the only exclusion of quinolones).

    Serious adverse events
    		 Delafloxacin Best Available Therapy
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 134 (6.72%)
    14 / 132 (10.61%)
         number of deaths (all causes)
    2
    1
         number of deaths resulting from adverse events
    2
    1
    Injury, poisoning and procedural complications
    Abdominal wound dehiscence
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    postoperative wound dehiscence
         subjects affected / exposed
    0 / 134 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound dehiscence
         subjects affected / exposed
    0 / 134 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 134 (0.75%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac arrest
         subjects affected / exposed
    1 / 134 (0.75%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Angina pectoris
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Surgery
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    0 / 134 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    0 / 134 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Malaise
         subjects affected / exposed
    0 / 134 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Enterocutaneous fistula
         subjects affected / exposed
    0 / 134 (0.00%)
    1 / 132 (0.76%)
         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 / 134 (0.75%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal perforation
         subjects affected / exposed
    0 / 134 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    0 / 134 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pleural effusion
         subjects affected / exposed
    0 / 134 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary artery thrombosis
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 134 (0.75%)
    2 / 132 (1.52%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal wall abscess
         subjects affected / exposed
    0 / 134 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gas gangrene
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 134 (0.75%)
    0 / 132 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    0 / 134 (0.00%)
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Delafloxacin Best Available Therapy
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    19 / 134 (14.18%)
    13 / 132 (9.85%)
    Investigations
    Hypokalaemia
         subjects affected / exposed
    3 / 134 (2.24%)
    2 / 132 (1.52%)
         occurrences all number
    3
    3
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 134 (0.00%)
    2 / 132 (1.52%)
         occurrences all number
    0
    2
    Phlebitis
         subjects affected / exposed
    2 / 134 (1.49%)
    0 / 132 (0.00%)
         occurrences all number
    2
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 134 (1.49%)
    3 / 132 (2.27%)
         occurrences all number
    2
    3
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    2 / 134 (1.49%)
    1 / 132 (0.76%)
         occurrences all number
    2
    5
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    3 / 134 (2.24%)
    3 / 132 (2.27%)
         occurrences all number
    3
    3
    Nausea
         subjects affected / exposed
    2 / 134 (1.49%)
    0 / 132 (0.00%)
         occurrences all number
    2
    0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    1 / 134 (0.75%)
    2 / 132 (1.52%)
         occurrences all number
    1
    2
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    2 / 134 (1.49%)
    0 / 132 (0.00%)
         occurrences all number
    2
    0
    Metabolism and nutrition disorders
    Hypophosphataemia
         subjects affected / exposed
    2 / 134 (1.49%)
    0 / 132 (0.00%)
         occurrences all number
    2
    0

    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.
    The study was prematurely closed due to COVID-19 pandemic affecting both the recruitment and the patient distribution. 266 patients were treated instead of the planned 600.
    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.

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