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    Clinical Trial Results:
    A Phase III, Prospective, Multicenter, Randomized, Controlled Clinical Trial to Demonstrate the Efficacy and Safety of Liposomal Cyclosporine A (LCsA) Inhalation Solution Delivered via the PARI Investigational eFlow® Device plus Standard of Care versus Standard of Care Alone in the Treatment of Chronic Lung Allograft Dysfunction / Bronchiolitis Obliterans Syndrome in Patients post Double Lung Transplantation (BOSTON 2).

    Summary
    EudraCT number
    		 2018-003205-25
    Trial protocol
    		 FR   DE   AT   BE   GB   ES   DK  
    Global end of trial date
    12 Mar 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Jul 2025
    First version publication date
    02 Jul 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BT–L-CsA–302–DLT
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03656926
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Zambon S.p.A.
    Sponsor organisation address
    Via Lillo del Duca 10, Bresso (Mi), Italy, 20091
    Public contact
    Sponsor Contact Point, Zambon SpA, Zambon SpA, +39 0266524513, clinicaltrials@zambongroup.com
    Scientific contact
    Sponsor Contact Point, Zambon SpA, Zambon SpA, +39 0266524513, clinicaltrials@zambongroup.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
    12 Mar 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Mar 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Mar 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the efficacy and safety of add-on aerosolized L-CsA to Standard of Care therapy as compared to SoC therapy alone in the treatment of BOS in double lung transplant recipients.
    Protection of trial subjects
    The clinical study was performed in accordance with the principles that have their origin in the Declaration of Helsinki, and with local regulations. The study was carried out in accordance with the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) notes for guidance on Good Clinical Practice (GCP). Investigators insured a close follow-up of safety signals, and that everything has been done to reduce the burden of study procedures (e.g. no painful procedures, etc.).
    Background therapy
    		 Standard of Care (SoC). Basic immunosuppression: Regardless of treatment allocation, all patients received SoC. Eligible patients should have been on a maintenance regimen of immunosuppressive agents including tacrolimus, a second agent such as but not limited to MMF or azathioprine, and a systemic corticosteroid such as prednisone as third agent. The regimen must have been stable within 4 weeks prior to randomization with respect to the therapeutic agents. Patients receiving azithromycin for prophylaxis or treatment of BOS must have been on a stable regimen for at least 4 weeks prior to randomization and continued to receive azithromycin during the trial as deemed appropriate by the study investigator.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Mar 2019
    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: 61
    Country: Number of subjects enrolled
    Israel: 5
    Country: Number of subjects enrolled
    Spain: 36
    Country: Number of subjects enrolled
    United Kingdom: 6
    Country: Number of subjects enrolled
    Austria: 5
    Country: Number of subjects enrolled
    Belgium: 6
    Country: Number of subjects enrolled
    Denmark: 4
    Country: Number of subjects enrolled
    France: 12
    Country: Number of subjects enrolled
    Germany: 34
    Worldwide total number of subjects
    169
    EEA total number of subjects
    97
    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)
    122
    From 65 to 84 years
    47
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 There were major recruitment issues in both BOSTON-1 and BOSTON-2 trials, in part due to COVID-19. To obtain an adequately sized safety database for inhaled L-CsA and reach the planned sample size in the 2 trials combined, it was planned to stop randomization into the 2 trials upon achievement of a combined total of around 220 patients.

    Pre-assignment
    Screening details
    		 The trial included adults who received a DLT at least 12 months prior to Screening, with clinically defined CLAD-BOS phenotype and screening FEV1 between 51% to 85% of personal best FEV1 value post-transplant or screening FEV1 >85% of personal best post-transplant with either a >=200 mL decrease in FEV1 in the previous 12 months or BOS progression.

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    This was an opel-label study hence clinical monitors, physicians, nurses, study coordinators & patients were not blinded to treatment assignment. However, pulmonary function technicians, respiratory therapists, or physiotherapists who conducted spirometry on-site were blinded to treatment assignment. Patients and other unblinded personnel were asked not to share treatment assignment infos with them. The statistician who made the blinded interim sample size re-assessment was blinded as well.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group A
    Arm description
    		 L-CsA 10 mg/2.5 mL twice daily for 48 weeks Plus Standard of Care Therapy
    Arm type
    		 Experimental

    Investigational medicinal product name
    L-CsA
    Investigational medicinal product code
    Other name
    liposomal cyclosporine A
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    L-CsA 10 mg/2.5 mL twice daily for 48 weeks Plus Standard of Care Therapy. Patients randomized to the L-CsA arm received L-CsA 10 mg twice daily in addition to SoC as prescribed by the treating physician. L-CsA was administered as 10 mg/2.5 mL inhalation via the PARI investigational eFlow device for 48 weeks

    Investigational medicinal product name
    Standard of care
    Investigational medicinal product code
    Other name
    SoC
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    SoC had L-CsA as add-on therapy in group A.

    Arm title
    		 Group B
    Arm description
    		 Standard of Care alone (as directed by treating physician)
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Standard of Care
    Investigational medicinal product code
    Other name
    SoC
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    Standard of care as directed by treating physician was administered alone

    Number of subjects in period 1
    		Group A Group B
    Started
    84
    85
    Completed
    69
    79
    Not completed
    15
    6
         Adverse event, serious fatal
    5
    4
         PI decision due to patient condition
    1
    -
         Consent withdrawn by subject
    7
    2
         Screen fail after randomization
    1
    -
         Patient unresponsiveness
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group A
    Reporting group description
    		 L-CsA 10 mg/2.5 mL twice daily for 48 weeks Plus Standard of Care Therapy

    Reporting group title
    Group B
    Reporting group description
    		 Standard of Care alone (as directed by treating physician)

    Reporting group values
    		 Group A Group B Total
    Number of subjects
    		 84 85 169
    Age categorical
    Units: Subjects
        Adults 18-64
    		 58 64 122
        Adults 65-85
    		 26 21 47
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 56.5 ( 12.69 ) 56.2 ( 10.82 ) -
    Gender categorical
    Units: Subjects
        Female
    		 34 42 76
        Male
    		 50 43 93
    Subject analysis sets

    Subject analysis set title
    Group A - Full analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The FAS was defined as all randomized patients. Patients were analyzed according to the treatment group to which they were randomized.

    Subject analysis set title
    Group A - Safety analysis set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety Analysis Set (SAF): The SAF was defined as all randomized patients receiving SoC and/or at least one dose of L-CsA, independently of the treatment allocation at randomization. Independently of the treatment allocation at randomization, patients were analyzed according to the treatment they actually received. All safety and tolerability data were summarized and analyzed using the SAF.

    Subject analysis set title
    Group A - Per protocol set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per Protocol Set (PPS): The PPS was defined as all patients included in the FAS • who completed randomized treatment as scheduled or who were withdrawn prematurely due to lack of efficacy or lack of tolerability of the clinical trial treatment, and • for whom no major PDs interfering with the assessment of treatment efficacy were observed.

    Subject analysis set title
    Group B - Full analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full Analysis Set (FAS): The FAS was defined as all randomized patients. Patients were analyzed according to the treatment group to which they were randomized. All primary, secondary and exploratory endpoints were performed using the FAS, unless otherwise specified.

    Subject analysis set title
    Group B - Safety analysis set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety Analysis Set (SAF): The SAF was defined as all randomized patients receiving SoC and/or at least one dose of L-CsA, independently of the treatment allocation at randomization. Independently of the treatment allocation at randomization, patients were analyzed according to the treatment they actually received. All safety and tolerability data were summarized and analyzed using the SAF.

    Subject analysis set title
    Group B - Per protocol set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per Protocol Set (PPS): The PPS was defined as all patients included in the FAS • who completed randomized treatment as scheduled or who were withdrawn prematurely due to lack of efficacy or lack of tolerability of the clinical trial treatment, and • for whom no major PDs interfering with the assessment of treatment efficacy were observed.

    Subject analysis sets values
    		 Group A - Full analysis set Group A - Safety analysis set Group A - Per protocol set Group B - Full analysis set Group B - Safety analysis set Group B - Per protocol set
    Number of subjects
    84
    84
    46
    85
    85
    70
    Age categorical
    Units: Subjects
        Adults 18-64
    58
    58
    64
    64
        Adults 65-85
    26
    26
    21
    21
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    56.5 ( 12.69 )
    56.5 ( 12.69 )
    54.7 ( 12.68 )
    56.2 ( 10.82 )
    56.2 ( 10.82 )
    56.4 ( 10.09 )
    Gender categorical
    Units: Subjects
        Female
    34
    34
    18
    42
    42
    35
        Male
    50
    50
    28
    43
    43
    35

    End points

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    End points reporting groups
    Reporting group title
    Group A
    Reporting group description
    		 L-CsA 10 mg/2.5 mL twice daily for 48 weeks Plus Standard of Care Therapy

    Reporting group title
    Group B
    Reporting group description
    		 Standard of Care alone (as directed by treating physician)

    Subject analysis set title
    Group A - Full analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The FAS was defined as all randomized patients. Patients were analyzed according to the treatment group to which they were randomized.

    Subject analysis set title
    Group A - Safety analysis set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety Analysis Set (SAF): The SAF was defined as all randomized patients receiving SoC and/or at least one dose of L-CsA, independently of the treatment allocation at randomization. Independently of the treatment allocation at randomization, patients were analyzed according to the treatment they actually received. All safety and tolerability data were summarized and analyzed using the SAF.

    Subject analysis set title
    Group A - Per protocol set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per Protocol Set (PPS): The PPS was defined as all patients included in the FAS • who completed randomized treatment as scheduled or who were withdrawn prematurely due to lack of efficacy or lack of tolerability of the clinical trial treatment, and • for whom no major PDs interfering with the assessment of treatment efficacy were observed.

    Subject analysis set title
    Group B - Full analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full Analysis Set (FAS): The FAS was defined as all randomized patients. Patients were analyzed according to the treatment group to which they were randomized. All primary, secondary and exploratory endpoints were performed using the FAS, unless otherwise specified.

    Subject analysis set title
    Group B - Safety analysis set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety Analysis Set (SAF): The SAF was defined as all randomized patients receiving SoC and/or at least one dose of L-CsA, independently of the treatment allocation at randomization. Independently of the treatment allocation at randomization, patients were analyzed according to the treatment they actually received. All safety and tolerability data were summarized and analyzed using the SAF.

    Subject analysis set title
    Group B - Per protocol set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per Protocol Set (PPS): The PPS was defined as all patients included in the FAS • who completed randomized treatment as scheduled or who were withdrawn prematurely due to lack of efficacy or lack of tolerability of the clinical trial treatment, and • for whom no major PDs interfering with the assessment of treatment efficacy were observed.

    Primary: Mean change in FEV1 (mL) from baseline to Week 48.

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    End point title
    		 Mean change in FEV1 (mL) from baseline to Week 48.
    End point description
    FEV1 is the Forced Expiratory Volume in One Second. The FEV1 data collected from the on-site COMPACTTM spirometer were to be considered primary, while data collected with the In2itiveTM home spirometer were to be used for supportive analyses.
    End point type
    Primary
    End point timeframe
    Week 48
    End point values
    		 Group A - Full analysis set Group B - Full analysis set
    Number of subjects analysed
    64
    80
    Units: mL
        least squares mean (standard error)
    -0.096 ( 0.1120 )
    -0.067 ( 0.1147 )
    Statistical analysis title
    		 Group A vs Group B
    Statistical analysis description
    V9 - week 48
    Comparison groups
    Group A - Full analysis set v Group B - Full analysis set
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.6639 [2]
    Method
    		 Mixed models analysis
    Parameter type
    		 least square mean difference
    Point estimate
    -0.028
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.16
         upper limit
    		 0.104
    Notes
    [1] - Estimates are from a Linear Mixed Model on the response variable change from baseline in FEV1 with factors for time splines, treatment, the interactions of time splines by treatment, baseline FEV1, the interactions of time splines with baseline FEV1, region (North America vs all other countries together), age (<55 versus >=55 years), use of azithromycin at randomization, and time as random effect.
    [2] - This is a 1-side p value.

    Secondary: Count of Participants With at Least One Adverse Event (AE)

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    End point title
    		 Count of Participants With at Least One Adverse Event (AE)
    End point description
    An untoward medical occurrence after exposure to a medicine, which is not necessarily caused by that medicine.
    End point type
    Secondary
    End point timeframe
    Baseline through study completion (52 weeks)
    End point values
    		 Group A - Safety analysis set Group B - Safety analysis set
    Number of subjects analysed
    84
    85
    Units: partecipanti
        with any TEAE
    73
    77
        with any TEAE Leading to discontinuation of study
    12
    0
        with any TEAE Leading to study discontinuation
    5
    3
        with any TEAE Leading to death
    2
    4
        with any TEAE mild
    66
    68
        with any TEAE moderate
    50
    56
        with any TEAE severe
    21
    18
        with any study treatment-related TEAE
    39
    0
        with any serious TEAE
    46
    44
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From baseline throughout the study, till week 52.
    Adverse event reporting additional description
    Serious TEAEs by System Organ Class and Preferred Term Reported by at Least 2 Patients Overall while non serious adverse events are reported with a 0% threshold.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    Group A - SAF
    Reporting group description
    		 L-CsA 10 mg/2.5 mL twice daily for 48 weeks Plus Standard of Care Therapy

    Reporting group title
    Group B - SAF
    Reporting group description
    		 Standard of Care alone (as directed by treating physician)

    Serious adverse events
    		 Group A - SAF Group B - SAF
    Total subjects affected by serious adverse events
         subjects affected / exposed
    46 / 84 (54.76%)
    44 / 85 (51.76%)
         number of deaths (all causes)
    2
    4
         number of deaths resulting from adverse events
    2
    4
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Bowen's disease
         subjects affected / exposed
    1 / 84 (1.19%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Disease progression
         subjects affected / exposed
    0 / 84 (0.00%)
    2 / 85 (2.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    2 / 84 (2.38%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Immune system disorders
    Transplant rejection
         subjects affected / exposed
    2 / 84 (2.38%)
    2 / 85 (2.35%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 84 (1.19%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 84 (1.19%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    2 / 84 (2.38%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    2 / 84 (2.38%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    2 / 84 (2.38%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 84 (0.00%)
    2 / 85 (2.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    2 / 84 (2.38%)
    3 / 85 (3.53%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 4
         deaths causally related to treatment / all
    1 / 1
    0 / 1
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    5 / 84 (5.95%)
    2 / 85 (2.35%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    23 / 84 (27.38%)
    21 / 85 (24.71%)
         occurrences causally related to treatment / all
    2 / 23
    0 / 23
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19 pneumonia
         subjects affected / exposed
    5 / 84 (5.95%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    3 / 84 (3.57%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    3 / 84 (3.57%)
    0 / 85 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prainfluenzae virus infection
         subjects affected / exposed
    1 / 84 (1.19%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    3 / 84 (3.57%)
    3 / 85 (3.53%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Urinary tract infection
         subjects affected / exposed
    0 / 84 (0.00%)
    2 / 85 (2.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 84 (1.19%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Group A - SAF Group B - SAF
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    73 / 84 (86.90%)
    77 / 85 (90.59%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    1 / 84 (1.19%)
    1 / 85 (1.18%)
         occurrences all number
    1
    1
    Bowen's disease
         subjects affected / exposed
    1 / 84 (1.19%)
    1 / 85 (1.18%)
         occurrences all number
    1
    4
    Colon adenoma
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Haemangioma of skin
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Malignant melanoma
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Melanocytic naevus
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Metastases to salivary gland
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Metastatic squamous cell carcinoma
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Prostate cancer
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Seborrhoeic keratosis
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Skin cancer
         subjects affected / exposed
    1 / 84 (1.19%)
    2 / 85 (2.35%)
         occurrences all number
    1
    2
    Skin papilloma
         subjects affected / exposed
    1 / 84 (1.19%)
    1 / 85 (1.18%)
         occurrences all number
    1
    1
    Skin squamous cell carcinoma recurrent
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    2
    0
    Squamous cell carcinoma
         subjects affected / exposed
    0 / 84 (0.00%)
    3 / 85 (3.53%)
         occurrences all number
    0
    3
    Squamous cell carcinoma of lung
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Squamous cell carcinoma of skin
         subjects affected / exposed
    2 / 84 (2.38%)
    1 / 85 (1.18%)
         occurrences all number
    2
    1
    Transitional cell carcinoma
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Vascular disorders
    Flushing
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Hot flush
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Hypertension
         subjects affected / exposed
    2 / 84 (2.38%)
    4 / 85 (4.71%)
         occurrences all number
    2
    4
    Hypotension
         subjects affected / exposed
    1 / 84 (1.19%)
    1 / 85 (1.18%)
         occurrences all number
    1
    1
    Orthostatic hypotension
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Peripheral arterial occlusive disease
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Thrombophlebitis
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Chest discomfort
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Chest pain
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Disease progression
         subjects affected / exposed
    16 / 84 (19.05%)
    15 / 85 (17.65%)
         occurrences all number
    18
    20
    Early satiety
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Fatigue
         subjects affected / exposed
    5 / 84 (5.95%)
    2 / 85 (2.35%)
         occurrences all number
    5
    2
    Impaired healing
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Influenza like illness
         subjects affected / exposed
    1 / 84 (1.19%)
    1 / 85 (1.18%)
         occurrences all number
    1
    1
    Medical device site pain
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    2 / 84 (2.38%)
    0 / 85 (0.00%)
         occurrences all number
    2
    0
    Oedema peripheral
         subjects affected / exposed
    7 / 84 (8.33%)
    7 / 85 (8.24%)
         occurrences all number
    8
    7
    Peripheral swelling
         subjects affected / exposed
    2 / 84 (2.38%)
    0 / 85 (0.00%)
         occurrences all number
    2
    0
    Pyrexia
         subjects affected / exposed
    4 / 84 (4.76%)
    0 / 85 (0.00%)
         occurrences all number
    7
    0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Hypogammaglobulinaemia
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Seasonal allergy
         subjects affected / exposed
    1 / 84 (1.19%)
    1 / 85 (1.18%)
         occurrences all number
    1
    1
    Transplant rejection
         subjects affected / exposed
    2 / 84 (2.38%)
    3 / 85 (3.53%)
         occurrences all number
    2
    3
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Erectile disfunction
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Prostatomegaly
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Vaginal haemorrage
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Increased bronchial secretion
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Acute respiratory failure
         subjects affected / exposed
    2 / 84 (2.38%)
    1 / 85 (1.18%)
         occurrences all number
    3
    1
    Aspiration
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Bronchospasm
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Bronchostenosis
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Cough
         subjects affected / exposed
    19 / 84 (22.62%)
    7 / 85 (8.24%)
         occurrences all number
    20
    8
    Dry throat
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Dyspnoea
         subjects affected / exposed
    9 / 84 (10.71%)
    5 / 85 (5.88%)
         occurrences all number
    11
    6
    Dyspnoea exertional
         subjects affected / exposed
    1 / 84 (1.19%)
    1 / 85 (1.18%)
         occurrences all number
    1
    1
    Epistaxis
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Hypoxia
         subjects affected / exposed
    2 / 84 (2.38%)
    1 / 85 (1.18%)
         occurrences all number
    2
    1
    Larynx irritation
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Nasal disorders
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Oropharyngeal pain
         subjects affected / exposed
    2 / 84 (2.38%)
    1 / 85 (1.18%)
         occurrences all number
    2
    1
    Pleural effusion
         subjects affected / exposed
    0 / 84 (0.00%)
    2 / 85 (2.35%)
         occurrences all number
    0
    3
    Pneumonia aspiration
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Pneumothorax
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Productive cough
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Pulmonary congestion
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Pulmonary embolism
         subjects affected / exposed
    0 / 84 (0.00%)
    2 / 85 (2.35%)
         occurrences all number
    0
    2
    Pulmonary mass
         subjects affected / exposed
    1 / 84 (1.19%)
    1 / 85 (1.18%)
         occurrences all number
    1
    1
    Pulmonary oedema
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Respiratory failure
         subjects affected / exposed
    2 / 84 (2.38%)
    3 / 85 (3.53%)
         occurrences all number
    2
    4
    Respiratory tract congestion
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Respiratory tract irritation
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Rhinitis allergic
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Rhinorrhoea
         subjects affected / exposed
    3 / 84 (3.57%)
    4 / 85 (4.71%)
         occurrences all number
    3
    4
    Sinus congestion
         subjects affected / exposed
    1 / 84 (1.19%)
    1 / 85 (1.18%)
         occurrences all number
    1
    1
    Sleep apnoea syndrome
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Sneezing
         subjects affected / exposed
    1 / 84 (1.19%)
    2 / 85 (2.35%)
         occurrences all number
    1
    2
    Sputum discoloured
         subjects affected / exposed
    1 / 84 (1.19%)
    1 / 85 (1.18%)
         occurrences all number
    1
    1
    Throat clearing
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Throat irritation
         subjects affected / exposed
    9 / 84 (10.71%)
    0 / 85 (0.00%)
         occurrences all number
    9
    0
    Upper respiratory tract irritation
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Wheezing
         subjects affected / exposed
    3 / 84 (3.57%)
    1 / 85 (1.18%)
         occurrences all number
    3
    1
    Oropharyngeal discomfort
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 84 (0.00%)
    2 / 85 (2.35%)
         occurrences all number
    0
    2
    Depressed mood
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Insomnia
         subjects affected / exposed
    1 / 84 (1.19%)
    2 / 85 (2.35%)
         occurrences all number
    1
    2
    Panic attack
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Sleep disorder
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Suicidal ideation
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Actinomyces test positive
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Blood bilirubin increased
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Blood glucose increased
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Blood phosphorus decreased
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Blood potassium decreased
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Blood pressure increased
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Breath sounds abnormal
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Bronchoscopy
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    C-reactive protein increased
         subjects affected / exposed
    1 / 84 (1.19%)
    1 / 85 (1.18%)
         occurrences all number
    1
    1
    Cardiac murmur
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Drug level increased
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Eosinophil count decreased
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Forced expiratory volume abnormal
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Forced expiratory volume decreased
         subjects affected / exposed
    0 / 84 (0.00%)
    2 / 85 (2.35%)
         occurrences all number
    0
    2
    Fungal test positive
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Haematocrit decreased
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Haemoglobin decereased
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Haptoglobin increased
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    2
    0
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Liver function test increased
         subjects affected / exposed
    1 / 84 (1.19%)
    1 / 85 (1.18%)
         occurrences all number
    1
    1
    Lymphocyte count decreased
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Monocyte count increased
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    2
    0
    Neutrophil count increased
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    2
    0
    Platelet count decreased
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    SARS-CoV-2 test positive
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Transaminases increased
         subjects affected / exposed
    0 / 84 (0.00%)
    2 / 85 (2.35%)
         occurrences all number
    0
    2
    Troponin increased
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Vitamin D increased
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Weight decreased
         subjects affected / exposed
    3 / 84 (3.57%)
    2 / 85 (2.35%)
         occurrences all number
    3
    2
    White blood cell count increased
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    2
    0
    Injury, poisoning and procedural complications
    Ankle fracture
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Breast injury
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Contusion
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Fall
         subjects affected / exposed
    2 / 84 (2.38%)
    1 / 85 (1.18%)
         occurrences all number
    2
    1
    Femur fracture
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Gastrointestinal procedural complication
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Heat exhaustion
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Humerus fracture
         subjects affected / exposed
    1 / 84 (1.19%)
    1 / 85 (1.18%)
         occurrences all number
    1
    1
    Injury
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Ligament sprain
         subjects affected / exposed
    1 / 84 (1.19%)
    2 / 85 (2.35%)
         occurrences all number
    1
    2
    Limb injury
         subjects affected / exposed
    0 / 84 (0.00%)
    2 / 85 (2.35%)
         occurrences all number
    0
    2
    Muscle injury
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Pelvic fracture
         subjects affected / exposed
    1 / 84 (1.19%)
    1 / 85 (1.18%)
         occurrences all number
    1
    1
    Periorbital haematoma
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Post procedural diarrhoea
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Post procedural haematoma
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Post procedural haemorrage
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Post-traumatic pain
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Procedural pain
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    2
    0
    Seroma
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Skin abrasion
         subjects affected / exposed
    2 / 84 (2.38%)
    0 / 85 (0.00%)
         occurrences all number
    2
    0
    Skin laceration
         subjects affected / exposed
    1 / 84 (1.19%)
    1 / 85 (1.18%)
         occurrences all number
    1
    1
    Spinal compression fracture
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Toxicity to various agents
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Traumatic haematoma
         subjects affected / exposed
    0 / 84 (0.00%)
    2 / 85 (2.35%)
         occurrences all number
    0
    2
    Ulna fracture
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Upper limb fracture
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Wound
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Wrist fracture
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Muscle strain
         subjects affected / exposed
    1 / 84 (1.19%)
    1 / 85 (1.18%)
         occurrences all number
    1
    1
    Post procedural complications
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Congenital, familial and genetic disorders
    Alpha-1 antitrypsin deficiency
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Angina pectoris
         subjects affected / exposed
    0 / 84 (0.00%)
    2 / 85 (2.35%)
         occurrences all number
    0
    2
    Atrial fibrillation
         subjects affected / exposed
    0 / 84 (0.00%)
    2 / 85 (2.35%)
         occurrences all number
    0
    2
    Atrial flutter
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Cardiac arrest
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Cardiac failure
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    2
    0
    Cardiac failure congestive
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Extrasystoles
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Myocarditis
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Palpitations
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Pericarditis constrictive
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Sinus tachycardia
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Tachycardia
         subjects affected / exposed
    0 / 84 (0.00%)
    2 / 85 (2.35%)
         occurrences all number
    0
    2
    Tricuspid valve incompetence
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Ageusia
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Dizziness
         subjects affected / exposed
    3 / 84 (3.57%)
    0 / 85 (0.00%)
         occurrences all number
    4
    0
    Headache
         subjects affected / exposed
    8 / 84 (9.52%)
    0 / 85 (0.00%)
         occurrences all number
    8
    0
    Hypoaesthesia
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Hyposmia
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Lethargy
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Loss of consciousness
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Neuropathy perypheral
         subjects affected / exposed
    1 / 84 (1.19%)
    1 / 85 (1.18%)
         occurrences all number
    1
    1
    Orthostatic intolerance
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    2
    Paraesthesia
         subjects affected / exposed
    2 / 84 (2.38%)
    0 / 85 (0.00%)
         occurrences all number
    2
    0
    Sciatica
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Seizure
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Sensory loss
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Tremor
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Trigeminal neuralgia
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Visual field defect
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 84 (1.19%)
    2 / 85 (2.35%)
         occurrences all number
    1
    3
    Anaemia macrocytic
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Hypocromic anaemia
         subjects affected / exposed
    0 / 84 (0.00%)
    3 / 85 (3.53%)
         occurrences all number
    0
    3
    Iron deficiency anaemia
         subjects affected / exposed
    2 / 84 (2.38%)
    1 / 85 (1.18%)
         occurrences all number
    2
    1
    Leukocytosis
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Leukopenia
         subjects affected / exposed
    2 / 84 (2.38%)
    1 / 85 (1.18%)
         occurrences all number
    2
    1
    Lymphadenopathy
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Lymphopenia
         subjects affected / exposed
    1 / 84 (1.19%)
    1 / 85 (1.18%)
         occurrences all number
    1
    1
    Microangiopathic haemolytic anaemia
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Neutropenia
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Neutrophilia
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Thrombocytopenia
         subjects affected / exposed
    1 / 84 (1.19%)
    2 / 85 (2.35%)
         occurrences all number
    1
    2
    Thrombotic microangiopathy
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Cataract
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    2
    Dry eye
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Ocular hyperaemia
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Vision blurred
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Visual impairment
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Abdominal distension
         subjects affected / exposed
    0 / 84 (0.00%)
    2 / 85 (2.35%)
         occurrences all number
    0
    2
    Abdominal pain
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Abdominal pain upper
         subjects affected / exposed
    1 / 84 (1.19%)
    2 / 85 (2.35%)
         occurrences all number
    1
    2
    Abdominal strangulated hernia
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Barret's oesophagus
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Colitis
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Constipation
         subjects affected / exposed
    1 / 84 (1.19%)
    1 / 85 (1.18%)
         occurrences all number
    1
    1
    Diarrhoea
         subjects affected / exposed
    8 / 84 (9.52%)
    6 / 85 (7.06%)
         occurrences all number
    11
    6
    Diverticular perforation
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Dyspepsia
         subjects affected / exposed
    2 / 84 (2.38%)
    1 / 85 (1.18%)
         occurrences all number
    2
    1
    Gastritis
         subjects affected / exposed
    1 / 84 (1.19%)
    1 / 85 (1.18%)
         occurrences all number
    1
    1
    Gastroesophageal reflux disease
         subjects affected / exposed
    1 / 84 (1.19%)
    4 / 85 (4.71%)
         occurrences all number
    1
    4
    Haematochezia
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Hiatus hernia
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Leukoplakia oral
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Nausea
         subjects affected / exposed
    3 / 84 (3.57%)
    3 / 85 (3.53%)
         occurrences all number
    3
    3
    Pancreatitis acute
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Rectal haemorrage
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Retching
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Tongue discomfort
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Vomiting
         subjects affected / exposed
    3 / 84 (3.57%)
    1 / 85 (1.18%)
         occurrences all number
    3
    1
    Hepatobiliary disorders
    Hepatic steatosis
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Actinic keratosis
         subjects affected / exposed
    1 / 84 (1.19%)
    2 / 85 (2.35%)
         occurrences all number
    1
    5
    Decubitus ulcer
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Erythema
         subjects affected / exposed
    1 / 84 (1.19%)
    1 / 85 (1.18%)
         occurrences all number
    1
    1
    Hand dermatitis
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Onychoclasis
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Pain of skin
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Precancerous skin lesion
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Pruritus
         subjects affected / exposed
    1 / 84 (1.19%)
    1 / 85 (1.18%)
         occurrences all number
    1
    1
    Rash
         subjects affected / exposed
    2 / 84 (2.38%)
    0 / 85 (0.00%)
         occurrences all number
    2
    0
    Scab
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Skin lesion
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    6 / 84 (7.14%)
    4 / 85 (4.71%)
         occurrences all number
    6
    4
    Azotaemia
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Chronic kidney disease
         subjects affected / exposed
    3 / 84 (3.57%)
    0 / 85 (0.00%)
         occurrences all number
    3
    0
    Hypertonic bladder
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Proteinuria
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Renal disorder
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Renal failure
         subjects affected / exposed
    1 / 84 (1.19%)
    3 / 85 (3.53%)
         occurrences all number
    1
    4
    Renal impairment
         subjects affected / exposed
    4 / 84 (4.76%)
    1 / 85 (1.18%)
         occurrences all number
    4
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Back pain
         subjects affected / exposed
    3 / 84 (3.57%)
    4 / 85 (4.71%)
         occurrences all number
    3
    5
    Foot deformity
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Intervertebral disc protusion
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Joint swelling
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Muscle contracture
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Muscle spasms
         subjects affected / exposed
    2 / 84 (2.38%)
    1 / 85 (1.18%)
         occurrences all number
    2
    1
    Muscular weakness
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Osteoarthritis
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Osteoporotic fracture
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Pain in extremity
         subjects affected / exposed
    3 / 84 (3.57%)
    0 / 85 (0.00%)
         occurrences all number
    3
    0
    Rhabdomyolysis
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Rheumatoid arthritis
         subjects affected / exposed
    2 / 84 (2.38%)
    0 / 85 (0.00%)
         occurrences all number
    2
    0
    Tendonitis
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Aspergillus infection
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Bacterial disease carrier
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Bacteriuria
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Bordetella infection
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    2
    Bronchitis
         subjects affected / exposed
    8 / 84 (9.52%)
    5 / 85 (5.88%)
         occurrences all number
    9
    6
    Bronchitis bacterial
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    2
    COVID-19
         subjects affected / exposed
    23 / 84 (27.38%)
    21 / 85 (24.71%)
         occurrences all number
    23
    23
    COVID-19 pneumonia
         subjects affected / exposed
    5 / 84 (5.95%)
    1 / 85 (1.18%)
         occurrences all number
    5
    1
    Candida infection
         subjects affected / exposed
    1 / 84 (1.19%)
    2 / 85 (2.35%)
         occurrences all number
    1
    2
    Cellulitis
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Chronic sinusitis
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Clostridium colitis
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Clostridium difficile infection
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Cystitis
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Cytomegalovirus infection
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Diverticulitis
         subjects affected / exposed
    1 / 84 (1.19%)
    1 / 85 (1.18%)
         occurrences all number
    1
    1
    Enterovirus infection
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Fungal infection
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Gastroenteritis
         subjects affected / exposed
    5 / 84 (5.95%)
    1 / 85 (1.18%)
         occurrences all number
    5
    1
    Gastroenteritis infection
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Gastroenteritis norovirus
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Gastroenteritis viral
         subjects affected / exposed
    1 / 84 (1.19%)
    1 / 85 (1.18%)
         occurrences all number
    1
    1
    Gastroenteritis viral infection
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Genital herpes
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    H1N1 influenza
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Hepatitis E
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Herpes zoster
         subjects affected / exposed
    3 / 84 (3.57%)
    4 / 85 (4.71%)
         occurrences all number
    3
    4
    Herpes simplex
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Influenza
         subjects affected / exposed
    3 / 84 (3.57%)
    1 / 85 (1.18%)
         occurrences all number
    3
    1
    Large intestine infection
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Localised infection
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 84 (0.00%)
    2 / 85 (2.35%)
         occurrences all number
    0
    2
    Lower respiratory tract infection fungal
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Metapneumovirus infection
         subjects affected / exposed
    1 / 84 (1.19%)
    1 / 85 (1.18%)
         occurrences all number
    1
    1
    Nasopharyngitis
         subjects affected / exposed
    6 / 84 (7.14%)
    8 / 85 (9.41%)
         occurrences all number
    7
    9
    Oral candidiasis
         subjects affected / exposed
    0 / 84 (0.00%)
    2 / 85 (2.35%)
         occurrences all number
    0
    2
    Oral herpes
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Parainfluenzae virus infection
         subjects affected / exposed
    1 / 84 (1.19%)
    3 / 85 (3.53%)
         occurrences all number
    1
    4
    Pharyngitis
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    2
    Pneumonia
         subjects affected / exposed
    4 / 84 (4.76%)
    4 / 85 (4.71%)
         occurrences all number
    4
    7
    Pneumonia bacterial
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Pneumonia pseudomonal
         subjects affected / exposed
    2 / 84 (2.38%)
    0 / 85 (0.00%)
         occurrences all number
    2
    0
    Pseudomonas bronchitis
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Pseudomonas infection
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Pustule
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    2
    0
    Respiratory syncytial virus infection
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Respiratory tract infection
         subjects affected / exposed
    2 / 84 (2.38%)
    3 / 85 (3.53%)
         occurrences all number
    2
    3
    Respiratory tract infection bacterial
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Respiratory tract infection viral
         subjects affected / exposed
    2 / 84 (2.38%)
    1 / 85 (1.18%)
         occurrences all number
    2
    1
    Rhinitis
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Rhinovirus infection
         subjects affected / exposed
    1 / 84 (1.19%)
    4 / 85 (4.71%)
         occurrences all number
    1
    5
    Septic shock
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Sinusitis
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Superinfection bacterial
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Tinea pedis
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Tooth infection
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 84 (4.76%)
    5 / 85 (5.88%)
         occurrences all number
    6
    5
    Urinary tract infection
         subjects affected / exposed
    4 / 84 (4.76%)
    4 / 85 (4.71%)
         occurrences all number
    4
    5
    Urinary tract infection bacterial
         subjects affected / exposed
    1 / 84 (1.19%)
    1 / 85 (1.18%)
         occurrences all number
    1
    1
    Viral infection
         subjects affected / exposed
    2 / 84 (2.38%)
    0 / 85 (0.00%)
         occurrences all number
    2
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 84 (1.19%)
    1 / 85 (1.18%)
         occurrences all number
    1
    1
    Clostridium difficile colitis
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Cytomegalovirus colitis
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    2 / 84 (2.38%)
    1 / 85 (1.18%)
         occurrences all number
    2
    1
    Dehydration
         subjects affected / exposed
    2 / 84 (2.38%)
    2 / 85 (2.35%)
         occurrences all number
    2
    2
    Diabetes mellitus
         subjects affected / exposed
    0 / 84 (0.00%)
    2 / 85 (2.35%)
         occurrences all number
    0
    2
    Dyslipidaemia
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Electrolyte imbalance
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Fluid overload
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Gout
         subjects affected / exposed
    1 / 84 (1.19%)
    2 / 85 (2.35%)
         occurrences all number
    1
    2
    Hypercholesterolaemia
         subjects affected / exposed
    2 / 84 (2.38%)
    2 / 85 (2.35%)
         occurrences all number
    2
    2
    Hyperglycaemia
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Hyperkalaemia
         subjects affected / exposed
    4 / 84 (4.76%)
    1 / 85 (1.18%)
         occurrences all number
    4
    2
    Hypoproteinaemia
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Hyperuricaemia
         subjects affected / exposed
    1 / 84 (1.19%)
    0 / 85 (0.00%)
         occurrences all number
    1
    0
    Hypervoleamia
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Hypokalaemia
         subjects affected / exposed
    4 / 84 (4.76%)
    2 / 85 (2.35%)
         occurrences all number
    5
    2
    Hypomagnesaemia
         subjects affected / exposed
    1 / 84 (1.19%)
    2 / 85 (2.35%)
         occurrences all number
    1
    2
    Iron deficiency
         subjects affected / exposed
    0 / 84 (0.00%)
    3 / 85 (3.53%)
         occurrences all number
    0
    4
    Steroid diabetes
         subjects affected / exposed
    0 / 84 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    0
    1
    Type 2 diabetes mellitus
         subjects affected / exposed
    1 / 84 (1.19%)
    1 / 85 (1.18%)
         occurrences all number
    1
    1

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Apr 2019
    Amendment 1 has been issued to review the Eligibility Criteria, Treatment of Patients, Assessment of Efficacy and Safety, Visits Schedule and Statistical considerations. This amendment had considered to be substantial based on the criteria set forth in Article 10(a) of Directive 2001/20/EC of the European Parliament and the Council of the European Union.
    09 Jun 2020
    Amendment 2 has been issued to add the COVID-19 related measures in order to ensure patient safety and efficacy data collection in case a given on-site visits cannot take place due to COVID-19 outbreak, including the possibility to perform remote visits, to carry out spirometry examination at patient home and the IMP re-supply at patient home. Furthermore the Eligibility Criteria have been reviewed. The amendment had considered to be substantial based on the criteria set forth in Article 10(a) of Directive 2001/20/EC of the European Parliament and the Council of the European Union
    19 Jan 2021
    Amendment 3 has been issued to include the Sponsorship change and to revise the Eligibility Criteria to ensure that the study population is aligned with the most recent criteria for CLAD-BOS (Chronic Lung Allograft Dysfunction - Bronchiolitis Obliterans Syndrome) stages. Furthermore Statistical sections have been modified according to the FDA Written Response Only discussions (type C meeting) and the EMA guidelines on clinical trial conducted during the COVID-19 contingency was added. This amendment had considered to be substantial based on the criteria set forth in Article 10(a) of Directive 2001/20/EC of the European Parliament and the Council of the European Union.
    28 Oct 2022
    Amendment 4 has been issued to accomplish with FDA recommendations received during last interactions (WRO) to continue BOSTON-1 and BOSTON-2 enrolment to achieve the originally planned total number of 220 patients for both clinical trials combined, to ensure the adequacy of the safety database and to implement the efforts to minimize missing data in both studies. This amendment is considered to be substantial based on the criteria set forth in Article 10(a) of Directive 2001/20/EC of the European Parliament and the Council of the European Union. The main changes are related to the Sample Size re-estimation to accomplish with the FDA recommendation.

    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.
    No limitations or caveats are applicable to this summary of results.
    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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