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    Clinical Trial Results:
    Continuos versus periodic intravenous iron supplementation in maintenance hemodialysis patients

    Summary
    EudraCT number
    		 2012-003914-15
    Trial protocol
    		 AT  
    Global end of trial date
    14 May 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Nov 2021
    First version publication date
    21 Nov 2021
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    Studienprotokoll/V5.1/01.12.2013
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02198495
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University of Vienna
    Sponsor organisation address
    Währinger Gürtel 18-20, Vienn, Austria, 1090
    Public contact
    Nephrologie und Dialyse, Medizinische Universität Wien, Klinik für Innere Medizin III, Kli Abteilung für Nephrologie und Dia, +43 14040043910, gere.sunder-plassmann@meduniwien.ac.at
    Scientific contact
    Nephrologie und Dialyse, Medizinische Universität Wien, Klinik für Innere Medizin III, Klin Abteilung für Nephrologie und , +43 14040043910, gere.sunder-plassmann@meduniwien.ac.at
    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
    06 Sep 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 May 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    14 May 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Ferric carboxymaltose (Ferinject) in comparison to iron sucrose (Venofer) is non inferior in maintaining the target hemoglobin-level (Hb 10-12 g/dl)
    Protection of trial subjects
    Patients were observed at least 30 minutes after injection in order to allow prompt treatment of rare intolerance reactions. Only one occurence, the patient was discharged well on the same day. As the partecipating patients were dialysis patients, they were under continuos surveillance during the dialysis session.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Jun 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 142
    Worldwide total number of subjects
    142
    EEA total number of subjects
    142
    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)
    94
    From 65 to 84 years
    45
    85 years and over
    3

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 All patients were screened according to the exclusion/inclusion criteria. The eligible patients were contacted and asked if they agree to partecipate to the study

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Iron sucrose administration
    Arm description
    		 The patients received iron sucrose i.v. 100mg every 2 weeks from baseline to week 40
    Arm type
    		 Experimental

    Investigational medicinal product name
    Iron sucrose
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    100 mg every 2 weeks

    Arm title
    		 Ferric Carboxymaltose
    Arm description
    		 Patients received 500 mg Ferric Carboxymaltose i.v. every 10 weeks from baseline to 40 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ferric Carboxymaltose
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    500 mg every 10 weeks

    Number of subjects in period 1
    		Iron sucrose administration Ferric Carboxymaltose
    Started
    71
    71
    Completed
    53
    55
    Not completed
    18
    16
         Adverse event, serious fatal
    6
    2
         Consent withdrawn by subject
    4
    1
         Adverse event, non-fatal
    -
    1
         Lost to follow-up
    -
    2
         Protocol deviation
    8
    10

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 142 142
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 94 94
        From 65-84 years
    		 45 45
        85 years and over
    		 3 3
    Gender categorical
    Units: Subjects
        Female
    		 41 41
        Male
    		 101 101

    End points

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    End points reporting groups
    Reporting group title
    Iron sucrose administration
    Reporting group description
    		 The patients received iron sucrose i.v. 100mg every 2 weeks from baseline to week 40

    Reporting group title
    Ferric Carboxymaltose
    Reporting group description
    		 Patients received 500 mg Ferric Carboxymaltose i.v. every 10 weeks from baseline to 40 weeks

    Primary: The primary endpoint was defined as the difference between hemoglobin level at baseline and week 40

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    End point title
    		 The primary endpoint was defined as the difference between hemoglobin level at baseline and week 40
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to 40 weeks
    End point values
    		 Iron sucrose administration Ferric Carboxymaltose
    Number of subjects analysed
    71
    71
    Units: g/dL
        least squares mean (confidence interval 95%)
    -0.27 (-0.64 to 0.09)
    -0.74 (-1.10 to -0.39)
    Attachments
    		 SAE Ferinject
    SAE Venofer
    Statistical analysis title
    		 ANCOVA
    Comparison groups
    Ferric Carboxymaltose v Iron sucrose administration
    Number of subjects included in analysis
    142
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Confidence interval

    Secondary: Cumulative ESA doses

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    End point title
    		 Cumulative ESA doses
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to week 40
    End point values
    		 Iron sucrose administration Ferric Carboxymaltose
    Number of subjects analysed
    68
    67
    Units: IU/week
        median (inter-quartile range (Q1-Q3))
    6000 (3500 to 12000)
    7000 (2300 to 12800)
    No statistical analyses for this end point

    Secondary: Ferritin serum level

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    End point title
    		 Ferritin serum level
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to week 40
    End point values
    		 Iron sucrose administration Ferric Carboxymaltose
    Number of subjects analysed
    71
    70
    Units: ng/mL
        least squares mean (confidence interval 98.3%)
    -10.1 (-32.1 to 19)
    -37.8 (-52.5 to -18.5)
    No statistical analyses for this end point

    Secondary: Hemoglobin level

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    End point title
    		 Hemoglobin level
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to 40 weeks
    End point values
    		 Iron sucrose administration Ferric Carboxymaltose
    Number of subjects analysed
    71
    70
    Units: g/dl
        least squares mean (confidence interval 95%)
    -0.27 (-0.64 to 0.09)
    -0.74 (-1.10 to -0.39)
    No statistical analyses for this end point

    Secondary: Transferin Saturation

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    End point title
    		 Transferin Saturation
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to week 40
    End point values
    		 Iron sucrose administration Ferric Carboxymaltose
    Number of subjects analysed
    71
    70
    Units: procent
        least squares mean (confidence interval 98.3%)
    7.1 (-6.8 to 22.9)
    -22.2 (-31.9 to -11.1)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From enrollment to end of study (40 weeks)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23
    Reporting groups
    Reporting group title
    Venofer
    Reporting group description
    		 -

    Reporting group title
    Ferinject
    Reporting group description
    		 -

    Serious adverse events
    		 Venofer Ferinject
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 71 (0.00%)
    0 / 71 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Venofer Ferinject
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    69 / 71 (97.18%)
    13 / 71 (18.31%)
    Vascular disorders
    Haematoma
         subjects affected / exposed
    0 / 71 (0.00%)
    2 / 71 (2.82%)
         occurrences all number
    0
    2
    Hypotension
         subjects affected / exposed
    2 / 71 (2.82%)
    0 / 71 (0.00%)
         occurrences all number
    2
    0
    Surgical and medical procedures
    Antibiotic therapy
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    Coronary angioplasty
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    1
    Coronary arterial stent insertion
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    1
    Stent placement
         subjects affected / exposed
    1 / 71 (1.41%)
    1 / 71 (1.41%)
         occurrences all number
    1
    1
    Surgery
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    Toe amputation
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    Tooth extraction
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    1
    Tumour excision
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Catheter site inflammation
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    Chest discomfort
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    1
    Chest pain
         subjects affected / exposed
    2 / 71 (2.82%)
    0 / 71 (0.00%)
         occurrences all number
    2
    0
    Chills
         subjects affected / exposed
    1 / 71 (1.41%)
    2 / 71 (2.82%)
         occurrences all number
    1
    2
    Fatigue
         subjects affected / exposed
    3 / 71 (4.23%)
    0 / 71 (0.00%)
         occurrences all number
    5
    0
    Inflammation
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    Necrosis
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    Pain
         subjects affected / exposed
    3 / 71 (4.23%)
    2 / 71 (2.82%)
         occurrences all number
    3
    2
    Peripheral swelling
         subjects affected / exposed
    0 / 71 (0.00%)
    3 / 71 (4.23%)
         occurrences all number
    0
    3
    Pyrexia
         subjects affected / exposed
    11 / 71 (15.49%)
    9 / 71 (12.68%)
         occurrences all number
    11
    13
    Swelling face
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    14 / 71 (19.72%)
    11 / 71 (15.49%)
         occurrences all number
    17
    15
    Dyspnoea
         subjects affected / exposed
    4 / 71 (5.63%)
    11 / 71 (15.49%)
         occurrences all number
    4
    14
    Nasal polyps
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    Oropharyngeal pain
         subjects affected / exposed
    3 / 71 (4.23%)
    4 / 71 (5.63%)
         occurrences all number
    3
    4
    Pulmonary hypertension
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    1
    Investigations
    Angiocardiogram
         subjects affected / exposed
    1 / 71 (1.41%)
    1 / 71 (1.41%)
         occurrences all number
    1
    1
    Blood pressure decreased
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    Catheterisation cardiac
         subjects affected / exposed
    0 / 71 (0.00%)
    2 / 71 (2.82%)
         occurrences all number
    0
    2
    C-reactive protein increased
         subjects affected / exposed
    5 / 71 (7.04%)
    0 / 71 (0.00%)
         occurrences all number
    5
    0
    Haemoglobin decreased
         subjects affected / exposed
    2 / 71 (2.82%)
    0 / 71 (0.00%)
         occurrences all number
    2
    0
    Injury, poisoning and procedural complications
    Arteriovenous fistula site complication
         subjects affected / exposed
    0 / 71 (0.00%)
    2 / 71 (2.82%)
         occurrences all number
    0
    5
    Fall
         subjects affected / exposed
    1 / 71 (1.41%)
    1 / 71 (1.41%)
         occurrences all number
    1
    1
    Joint injury
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    Postoperative wound complication
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    Procedural pain
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    Shunt thrombosis
         subjects affected / exposed
    2 / 71 (2.82%)
    0 / 71 (0.00%)
         occurrences all number
    2
    0
    Spinal compression fracture
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    Wound
         subjects affected / exposed
    2 / 71 (2.82%)
    1 / 71 (1.41%)
         occurrences all number
    2
    1
    Wound complication
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    1
    Arrhythmia
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    1
    Atrial fibrillation
         subjects affected / exposed
    2 / 71 (2.82%)
    1 / 71 (1.41%)
         occurrences all number
    2
    1
    Atrioventricular block first degree
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    Bradycardia
         subjects affected / exposed
    2 / 71 (2.82%)
    1 / 71 (1.41%)
         occurrences all number
    2
    1
    Bundle branch block right
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    Tachycardia
         subjects affected / exposed
    2 / 71 (2.82%)
    3 / 71 (4.23%)
         occurrences all number
    2
    3
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    3 / 71 (4.23%)
    5 / 71 (7.04%)
         occurrences all number
    3
    7
    Dysgeusia
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    Headache
         subjects affected / exposed
    5 / 71 (7.04%)
    5 / 71 (7.04%)
         occurrences all number
    5
    6
    Hypoaesthesia
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    Hypotonia
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    Migraine with aura
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    Phantom limb syndrome
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    Syncope
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    1
    Bone marrow oedema
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    Leukocytopenia
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    1
    Pancytopenia
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    1
    Thrombocytopenia
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    1
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Blindness
         subjects affected / exposed
    0 / 71 (0.00%)
    2 / 71 (2.82%)
         occurrences all number
    0
    2
    Conjunctival haemorrhage
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    1
    Vitreous haemorrhage
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    1
    Abdominal pain
         subjects affected / exposed
    2 / 71 (2.82%)
    2 / 71 (2.82%)
         occurrences all number
    2
    3
    Abdominal pain upper
         subjects affected / exposed
    0 / 71 (0.00%)
    2 / 71 (2.82%)
         occurrences all number
    0
    2
    Diarrhoea
         subjects affected / exposed
    10 / 71 (14.08%)
    9 / 71 (12.68%)
         occurrences all number
    13
    14
    Dyspepsia
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    6 / 71 (8.45%)
    5 / 71 (7.04%)
         occurrences all number
    7
    5
    Toothache
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    1
    Vomiting
         subjects affected / exposed
    7 / 71 (9.86%)
    7 / 71 (9.86%)
         occurrences all number
    10
    8
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    Erythema
         subjects affected / exposed
    1 / 71 (1.41%)
    1 / 71 (1.41%)
         occurrences all number
    1
    1
    Hyperhidrosis
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    1
    Pruritus
         subjects affected / exposed
    3 / 71 (4.23%)
    4 / 71 (5.63%)
         occurrences all number
    3
    4
    Rash
         subjects affected / exposed
    0 / 71 (0.00%)
    3 / 71 (4.23%)
         occurrences all number
    0
    3
    Rash macular
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    1
    Skin ulcer
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    4 / 71 (5.63%)
    3 / 71 (4.23%)
         occurrences all number
    5
    3
    Back pain
         subjects affected / exposed
    4 / 71 (5.63%)
    3 / 71 (4.23%)
         occurrences all number
    5
    3
    Foot deformity
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    Groin pain
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    Joint swelling
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    1
    Muscle spasms
         subjects affected / exposed
    5 / 71 (7.04%)
    9 / 71 (12.68%)
         occurrences all number
    9
    14
    Musculoskeletal pain
         subjects affected / exposed
    3 / 71 (4.23%)
    0 / 71 (0.00%)
         occurrences all number
    3
    0
    Myalgia
         subjects affected / exposed
    2 / 71 (2.82%)
    0 / 71 (0.00%)
         occurrences all number
    2
    0
    Neck pain
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 71 (0.00%)
         occurrences all number
    2
    0
    Osteoarthritis
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    Pain in extremity
         subjects affected / exposed
    6 / 71 (8.45%)
    8 / 71 (11.27%)
         occurrences all number
    6
    11
    Infections and infestations
    Abscess limb
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    Conjunctivitis
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    1
    Device related infection
         subjects affected / exposed
    4 / 71 (5.63%)
    2 / 71 (2.82%)
         occurrences all number
    5
    2
    Erysipelas
         subjects affected / exposed
    2 / 71 (2.82%)
    0 / 71 (0.00%)
         occurrences all number
    3
    0
    Gangrene
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    Infection
         subjects affected / exposed
    2 / 71 (2.82%)
    1 / 71 (1.41%)
         occurrences all number
    2
    1
    Influenza
         subjects affected / exposed
    5 / 71 (7.04%)
    2 / 71 (2.82%)
         occurrences all number
    6
    3
    Nasopharyngitis
         subjects affected / exposed
    4 / 71 (5.63%)
    4 / 71 (5.63%)
         occurrences all number
    5
    4
    Osteomyelitis
         subjects affected / exposed
    1 / 71 (1.41%)
    1 / 71 (1.41%)
         occurrences all number
    1
    1
    Pulpitis dental
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    Respiratory tract infection
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    1
    Rhinitis
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    Sinusitis fungal
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    Staphylococcal infection
         subjects affected / exposed
    3 / 71 (4.23%)
    1 / 71 (1.41%)
         occurrences all number
    3
    1
    Urinary tract infection
         subjects affected / exposed
    5 / 71 (7.04%)
    1 / 71 (1.41%)
         occurrences all number
    9
    1
    Wound infection
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 71 (1.41%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0
    Decreased appetite
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 71 (0.00%)
         occurrences all number
    1
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

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