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    Clinical Trial Results:
    Clinical trial for examination of efficacy and safety of ANGOCIN® Anti-Infekt N versus placebo in the continous prophylaxis of chronically recurring uncomplicated cystitis

    Summary
    EudraCT number
    		 2013-004653-25
    Trial protocol
    		 DE  
    Global end of trial date
    15 Aug 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Mar 2023
    First version publication date
    03 Mar 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    Repha_1362
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Repha GmbH
    Sponsor organisation address
    Alt-Godshorn 87, Langenhagen, Germany, 30855
    Public contact
    Clinical Research, Mediconomics GmbH, 0049 05115609980, info@mediconomics.com
    Scientific contact
    Clinical Research, Mediconomics GmbH, 0049 05115609980, info@mediconomics.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
    15 Aug 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Aug 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Aug 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Rates of first recurrences, observed during the six-month medicinal prophylaxis within the test group and the placebo group
    Protection of trial subjects
    This clinical trial was conducted according to the specifications of the protocol, in compliance with the ethical principles of the Declaration of Helsinki as amended in 1996, § 42 para. 1 sentence 1 in conjunction with Art. 1 para. 3 of Directive 2001/20/EC in conjunction with Art. 3 para. 2 of Directive 2005/28/EC, and furthermore in strict compliance with the German Medicines Act (AMG), the German GCP Regulation (GCP-V) and the German Federal Data Protection Act (BDSG). This ensured that the rights, safety and welfare of patients were protected and that the results of the clinical trial were credible.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 May 2014
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy, Scientific research
    Long term follow-up duration
    		 6 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 224
    Worldwide total number of subjects
    224
    EEA total number of subjects
    224
    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)
    161
    From 65 to 84 years
    61
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 Potential trial subjects were approached directly by the examiners at the test centres and asked about their willingness to participate.

    Pre-assignment
    Screening details
    		 After informed consent and sufficient time to think about it, patients who wanted to take part in the clinical trial signed a consent form. By giving written consent, patients were trial subjects. The examiner entered the patient in the Patient Identification Log and the Patient Enrolment Log and conducted the screening examination.

    Period 1
    Period 1 title
    Relapse prophylaxis
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    Blinding of investigator and patient was achieved by the following measures: Verum and placebo did not differ visually, There was no information on the name and strength of the study medication on the blisters and secondary packaging, The study medication of the two study arms was labelled with the same batch designation and expiry date; traceability was ensured via the randomisation number and the manufacturing documentation.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Investigational product
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Angocin Anti-Infekt N
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    3x 4 film-coated tablets daily

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    3 x 4 film-coated tablets daily

    Number of subjects in period 1
    		Investigational product Placebo
    Started
    115
    109
    Completed
    113
    108
    Not completed
    2
    1
         Consent withdrawn by subject
    -
    1
         lost sample
    2
    -
    Period 2
    Period 2 title
    Follow-up
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    Blinding of investigator and patient was achieved by the following measures: Verum and placebo did not differ visually, There was no information on the name and strength of the study medication on the blisters and secondary packaging, The study medication of the two study arms was labelled with the same batch designation and expiry date; traceability was ensured via the randomisation number and the manufacturing documentation.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Medicinal product
    Arm description
    		 Angocin Anti-Infekt N (however in this phase, no study medication was administered)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Angocin Anti-Infekt N
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    3x 4 film-coated tablets daily

    Arm title
    		 Placebo
    Arm description
    		 Placebo (however in this phase, no study medication was administered)
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    3 x 4 film-coated tablets daily

    Number of subjects in period 2 [1]
    		Medicinal product Placebo
    Started
    51
    29
    Completed
    37
    24
    Not completed
    14
    5
         Relapse
    14
    5
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Only those patients without relapse in the prophylaxis phase were continuing the follow-up phase

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Investigational product
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group values
    		 Investigational product Placebo Total
    Number of subjects
    		 115 109 224
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 78 80 158
        From 65-84 years
    		 35 26 61
        85 years and over
    		 0 2 2
        Not recorded
    		 2 1 3
    Gender categorical
    Units: Subjects
        Female
    		 112 107 219
        Male
    		 3 2 5

    End points

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    End points reporting groups
    Reporting group title
    Investigational product
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -
    Reporting group title
    Medicinal product
    Reporting group description
    		 Angocin Anti-Infekt N (however in this phase, no study medication was administered)

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo (however in this phase, no study medication was administered)

    Primary: Relapse rate

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    End point title
    		 Relapse rate
    End point description
    Rate of first relapses observed in the test group and the comparison group during the six-month drug relapse prophylaxis, determined as Kaplan-Meier estimator in the interval from 0 to 180 days. Relapses were defined as symptomatic infections (with a urophathogenic count of ≥ 10³ CFU/ml urine in pure culture confirmed by the central laboratory), as far as a urine culture was feasible. Only first relapses were recorded, i.e. for each patient only the first recurrence diagnosed after the start of prophylaxis.
    End point type
    Primary
    End point timeframe
    0-180 days
    End point values
    		 Investigational product Placebo
    Number of subjects analysed
    113
    108
    Units: number of patients
    42
    52
    Statistical analysis title
    		 Relapse rate
    Statistical analysis description
    The rates were determined as Kaplan-Meier estimators (product limit estimators) over 180 days of the Kaplan- Meier plot. Recurrence rates were compared using the logrank test.
    Comparison groups
    Investigational product v Placebo
    Number of subjects included in analysis
    221
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.0333
    Method
    		 Logrank
    Confidence interval
    Notes
    [1] - The rates were determined as Kaplan-Meier estimators (product limit estimators) over 180 days of the Kaplan- Meier plot.
    Statistical analysis title
    		 Relpase Rate Cox Regression
    Comparison groups
    Placebo v Investigational product
    Number of subjects included in analysis
    221
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.035
    Method
    		 Regression, Cox
    Confidence interval

    Secondary: Relapse rate V4-V8

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    End point title
    		 Relapse rate V4-V8
    End point description
    Relapse rate during the relapse prophylaxis period Day 30 - Day 150
    End point type
    Secondary
    End point timeframe
    Day 30 - Day 150
    End point values
    		 Investigational product Placebo
    Number of subjects analysed
    113
    108
    Units: number of patients (percentage)
        Day 30
    13
    11
        Day 60
    24
    32
        Day 90
    26
    44
        Day 120
    34
    49
        Day 150
    38
    55
        Day 180
    39
    56
    Statistical analysis title
    		 Relapse rates V4-V8
    Comparison groups
    Investigational product v Placebo
    Number of subjects included in analysis
    221
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    P-value
    		 = 0.055 [3]
    Method
    		 Chi-squared
    Confidence interval
    Notes
    [2] - cumulative results
    [3] - only day 180

    Secondary: Time without relapse

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    End point title
    		 Time without relapse
    End point description
    The relapse-free time during the relapse prophylaxis phase (day 0 to 180) was calculated in quartiles using the log-rank test. The cumulative recurrence rate were compared with the quartiles.
    End point type
    Secondary
    End point timeframe
    Day 0 - Day 180
    End point values
    		 Investigational product Placebo
    Number of subjects analysed
    113
    108
    Units: quartile (25%)
        number (confidence interval 95%)
    75 (42 to 111)
    49 (39 to 63)
    No statistical analyses for this end point

    Secondary: Relapse rate follow-up phase

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    End point title
    		 Relapse rate follow-up phase
    End point description
    Of all patients who had not yet experienced a relapse at day 180, how many had a relapse within the next 180 days?
    End point type
    Secondary
    End point timeframe
    Day 180 - Day 360
    End point values
    		 Investigational product Placebo
    Number of subjects analysed
    51
    29
    Units: number of patients
    14
    5
    Statistical analysis title
    		 Relapse rate FU
    Comparison groups
    Investigational product v Placebo
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.3563
    Method
    		 Logrank
    Confidence interval

    Secondary: Investigator´s assessment at the end of the prophylaxis phase

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    End point title
    		 Investigator´s assessment at the end of the prophylaxis phase
    End point description
    End point type
    Secondary
    End point timeframe
    At the end of the prophylaxis phase (Visit 9)
    End point values
    		 Investigational product Placebo
    Number of subjects analysed
    113
    108
    Units: number of patients
        Study medication not effective
    9
    8
        Study medication not meaningfully effective
    13
    13
        good efficacy
    41
    27
        very good efficacy
    23
    18
    Statistical analysis title
    		 Investigator´s assessment after prophylaxis phase
    Comparison groups
    Investigational product v Placebo
    Number of subjects included in analysis
    221
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.817
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Investigator´s assessment at the end of the follow-up phase

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    End point title
    		 Investigator´s assessment at the end of the follow-up phase
    End point description
    Investigator´s assessment as to how likely the study medication prevented a recurrent infection
    End point type
    Secondary
    End point timeframe
    Within the 6 months after the prophylaxis phase
    End point values
    		 Investigational product Placebo
    Number of subjects analysed
    113
    108
    Units: number of patients
        unlikely
    7
    1
        possibly
    20
    9
        likely
    21
    18
    Statistical analysis title
    		 Investigator´s assessment after follow-up phase
    Comparison groups
    Investigational product v Placebo
    Number of subjects included in analysis
    221
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.142
    Method
    		 Chi-squared
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    To evaluate safety and tolerability, 'adverse events' were recorded during the treatment period and laboratory findings and vital signs.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Angocin
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Angocin Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 113 (4.42%)
    6 / 108 (5.56%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Investigations
    Catheterisation cardiac
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Renal cell carcinoma
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Ligament rupture
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Removal of foreign body from joint
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Sciatica
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Iron deficiency anaemia
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Uterine prolapse
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholangitis
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Urosepsis
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Angocin Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    86 / 113 (76.11%)
    86 / 108 (79.63%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Colon cancer
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Adrenal neoplasm
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Adenoma thyroid
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Vascular disorders
    Angiodysplasia
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Flushing
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Flush hot
         subjects affected / exposed
    1 / 113 (0.88%)
    2 / 108 (1.85%)
         occurrences all number
    1
    2
    Hypertonia
         subjects affected / exposed
    1 / 113 (0.88%)
    1 / 108 (0.93%)
         occurrences all number
    1
    1
    Thrombophlebitis
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Varicose veins
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Surgical and medical procedures
    Wisdom teeth removal
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Peripheral nerve therapeutic procedures
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Limb operation
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Tooth extraction
         subjects affected / exposed
    1 / 113 (0.88%)
    1 / 108 (0.93%)
         occurrences all number
    1
    1
    Pregnancy, puerperium and perinatal conditions
    Pregnancy
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Morning sickness
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Chest discomfort
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Thirst
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Fatigue
         subjects affected / exposed
    6 / 113 (5.31%)
    2 / 108 (1.85%)
         occurrences all number
    6
    2
    Pyrexia
         subjects affected / exposed
    2 / 113 (1.77%)
    0 / 108 (0.00%)
         occurrences all number
    2
    0
    Sensation of foreign body
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Medical device site calcification
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Oedema peripheral
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Pain
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Chills
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Swelling
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Suprapubic pain
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Malaise
         subjects affected / exposed
    1 / 113 (0.88%)
    1 / 108 (0.93%)
         occurrences all number
    1
    1
    Drug intolerance
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Immune system disorders
    Allergy to arthropod sting
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Drug hypersensitivity
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Seasonal allergy
         subjects affected / exposed
    2 / 113 (1.77%)
    0 / 108 (0.00%)
         occurrences all number
    2
    0
    Allergy to animal
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Hypersensitivity
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Reproductive system and breast disorders
    Atrophic vulvovaginitis
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Breast disorder
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Dysmenorrhoea
         subjects affected / exposed
    1 / 113 (0.88%)
    1 / 108 (0.93%)
         occurrences all number
    1
    1
    Dyspareunia
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Menopausal symptoms
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Ovarian cyst
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Vulvovaginal pruritus
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 113 (0.88%)
    2 / 108 (1.85%)
         occurrences all number
    1
    2
    Dyspnoea exertional
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Oropharyngeal blistering
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Dyspnoea
         subjects affected / exposed
    0 / 113 (0.00%)
    2 / 108 (1.85%)
         occurrences all number
    0
    2
    Tonsillar hypertrophy
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Laryngeal inflammation
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Nasal dryness
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Obstructive airways disorder
         subjects affected / exposed
    2 / 113 (1.77%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Rhinorrhoea
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Oropharyngeal pain
         subjects affected / exposed
    3 / 113 (2.65%)
    0 / 108 (0.00%)
         occurrences all number
    3
    0
    Vocal cord inflammation
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Cough
         subjects affected / exposed
    4 / 113 (3.54%)
    1 / 108 (0.93%)
         occurrences all number
    5
    1
    Psychiatric disorders
    Aversion
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    2
    0
    Depression
         subjects affected / exposed
    1 / 113 (0.88%)
    1 / 108 (0.93%)
         occurrences all number
    1
    2
    Depressed mood
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Post-traumatic stress disorder
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Sleep disorder
         subjects affected / exposed
    3 / 113 (2.65%)
    2 / 108 (1.85%)
         occurrences all number
    3
    4
    Stress
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Restlessness
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Compulsive conduct disorder
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Cyclothymic disorder
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    3 / 113 (2.65%)
    0 / 108 (0.00%)
         occurrences all number
    3
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    2 / 113 (1.77%)
    0 / 108 (0.00%)
         occurrences all number
    2
    0
    Blood urine present
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Blood pressure increased
         subjects affected / exposed
    5 / 113 (4.42%)
    0 / 108 (0.00%)
         occurrences all number
    7
    0
    Blood pressure decreased
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Chlamydia test positive
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    C-reactive protein increased
         subjects affected / exposed
    2 / 113 (1.77%)
    1 / 108 (0.93%)
         occurrences all number
    4
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 113 (0.88%)
    1 / 108 (0.93%)
         occurrences all number
    1
    1
    Weight increased
         subjects affected / exposed
    1 / 113 (0.88%)
    1 / 108 (0.93%)
         occurrences all number
    1
    1
    Physical breast examination abnormal
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Liver function test increased
         subjects affected / exposed
    2 / 113 (1.77%)
    1 / 108 (0.93%)
         occurrences all number
    2
    1
    Urine output increased
         subjects affected / exposed
    0 / 113 (0.00%)
    2 / 108 (1.85%)
         occurrences all number
    0
    2
    Injury, poisoning and procedural complications
    Epicondylitis
         subjects affected / exposed
    2 / 113 (1.77%)
    0 / 108 (0.00%)
         occurrences all number
    2
    0
    Wrist fracture
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Arthropod bite
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Ligament sprain
         subjects affected / exposed
    0 / 113 (0.00%)
    2 / 108 (1.85%)
         occurrences all number
    0
    2
    Thoracic vertebral end plate fracture
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Concussion
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Joint injury
         subjects affected / exposed
    1 / 113 (0.88%)
    1 / 108 (0.93%)
         occurrences all number
    1
    1
    Meniscus injury
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Fall
         subjects affected / exposed
    0 / 113 (0.00%)
    2 / 108 (1.85%)
         occurrences all number
    0
    2
    Procedural nausea
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Spinal column injury
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Contusion
         subjects affected / exposed
    1 / 113 (0.88%)
    1 / 108 (0.93%)
         occurrences all number
    1
    1
    Cardiac disorders
    Aortic valve incompetence
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Arrhythmia
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Cardiovascular disorder
         subjects affected / exposed
    1 / 113 (0.88%)
    1 / 108 (0.93%)
         occurrences all number
    1
    1
    Palpitations
         subjects affected / exposed
    1 / 113 (0.88%)
    2 / 108 (1.85%)
         occurrences all number
    1
    2
    Nervous system disorders
    Dysgeusia
         subjects affected / exposed
    2 / 113 (1.77%)
    0 / 108 (0.00%)
         occurrences all number
    2
    0
    Hypoaesthesia
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    2
    0
    Intercostal neuralgia
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Sciatica
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Headache
         subjects affected / exposed
    13 / 113 (11.50%)
    7 / 108 (6.48%)
         occurrences all number
    16
    9
    Migraine
         subjects affected / exposed
    3 / 113 (2.65%)
    2 / 108 (1.85%)
         occurrences all number
    5
    2
    Vertigo
         subjects affected / exposed
    5 / 113 (4.42%)
    2 / 108 (1.85%)
         occurrences all number
    5
    3
    headache tension
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Tardive dyskinesia
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    2 / 113 (1.77%)
    1 / 108 (0.93%)
         occurrences all number
    3
    1
    Tinnitus
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    2
    0
    Sudden hearing loss
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Conjunctivitis allergic
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    2
    0
    Eye inflammation
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Faeces hard
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Faeces discoloured
         subjects affected / exposed
    0 / 113 (0.00%)
    2 / 108 (1.85%)
         occurrences all number
    0
    4
    Nausea
         subjects affected / exposed
    10 / 113 (8.85%)
    14 / 108 (12.96%)
         occurrences all number
    13
    18
    Gingival bleeding
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Toothache
         subjects affected / exposed
    1 / 113 (0.88%)
    2 / 108 (1.85%)
         occurrences all number
    1
    2
    Abdominal pain
         subjects affected / exposed
    2 / 113 (1.77%)
    9 / 108 (8.33%)
         occurrences all number
    4
    9
    Abdominal discomfort
         subjects affected / exposed
    6 / 113 (5.31%)
    8 / 108 (7.41%)
         occurrences all number
    6
    12
    Eructation
         subjects affected / exposed
    1 / 113 (0.88%)
    2 / 108 (1.85%)
         occurrences all number
    1
    2
    Abdominal distension
         subjects affected / exposed
    6 / 113 (5.31%)
    6 / 108 (5.56%)
         occurrences all number
    7
    8
    Retching
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Diarrhoea
         subjects affected / exposed
    13 / 113 (11.50%)
    12 / 108 (11.11%)
         occurrences all number
    14
    16
    Duodenitis
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Dysbiosis
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Dyspepsia
         subjects affected / exposed
    2 / 113 (1.77%)
    5 / 108 (4.63%)
         occurrences all number
    7
    6
    Enteritis
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Vomiting
         subjects affected / exposed
    4 / 113 (3.54%)
    0 / 108 (0.00%)
         occurrences all number
    4
    0
    Flatulence
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Gastritis
         subjects affected / exposed
    2 / 113 (1.77%)
    1 / 108 (0.93%)
         occurrences all number
    2
    1
    Gastrointestinal pain
         subjects affected / exposed
    0 / 113 (0.00%)
    2 / 108 (1.85%)
         occurrences all number
    0
    2
    Gastroesophageal reflux disease
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Haemorrhoids
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Frequent bowel movements
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Hiatus hernia
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Noninfective gingivitis
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Abdominal pain upper
         subjects affected / exposed
    10 / 113 (8.85%)
    6 / 108 (5.56%)
         occurrences all number
    15
    7
    Abdominal pain lower
         subjects affected / exposed
    1 / 113 (0.88%)
    4 / 108 (3.70%)
         occurrences all number
    1
    4
    Stomatitis
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Skin burning sensation
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Decubitus ulcer
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    hyperhidrosis
         subjects affected / exposed
    1 / 113 (0.88%)
    1 / 108 (0.93%)
         occurrences all number
    1
    1
    Pityriasis rosea
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Pruritus
         subjects affected / exposed
    0 / 113 (0.00%)
    3 / 108 (2.78%)
         occurrences all number
    0
    3
    Generalised pruritus
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Stasis dermatitis
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Dry skin
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    6 / 113 (5.31%)
    3 / 108 (2.78%)
         occurrences all number
    6
    4
    Arthritis reactive
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Muscle spasms
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Periarthritis
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Tendon pain
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Arthritis
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Joint swelling
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Limb discomfort
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Coccydynia
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Myalgia
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Osteoarthritis
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Plantar fasciitis
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Rheumatoid arthritis
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Rotator cuff syndrome
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Back pain
         subjects affected / exposed
    12 / 113 (10.62%)
    10 / 108 (9.26%)
         occurrences all number
    13
    13
    Pain in extremity
         subjects affected / exposed
    3 / 113 (2.65%)
    0 / 108 (0.00%)
         occurrences all number
    3
    0
    Musculoskeletal pain
         subjects affected / exposed
    1 / 113 (0.88%)
    1 / 108 (0.93%)
         occurrences all number
    1
    1
    Tenosynovitis
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Spinal pain
         subjects affected / exposed
    1 / 113 (0.88%)
    2 / 108 (1.85%)
         occurrences all number
    1
    3
    Infections and infestations
    Asymptomatic bacteriuria
         subjects affected / exposed
    21 / 113 (18.58%)
    17 / 108 (15.74%)
         occurrences all number
    21
    18
    respiratory tract infection
         subjects affected / exposed
    4 / 113 (3.54%)
    2 / 108 (1.85%)
         occurrences all number
    4
    2
    Rash pustular
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Bacterial vaginosis
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Bronchitis
         subjects affected / exposed
    4 / 113 (3.54%)
    0 / 108 (0.00%)
         occurrences all number
    4
    0
    Candida infection
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Clostridial infection
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Diverticulitis
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    fungal skin infection
         subjects affected / exposed
    2 / 113 (1.77%)
    0 / 108 (0.00%)
         occurrences all number
    2
    0
    Gastroenteritis
         subjects affected / exposed
    6 / 113 (5.31%)
    5 / 108 (4.63%)
         occurrences all number
    6
    5
    Gastrointestinal viral infection
         subjects affected / exposed
    0 / 113 (0.00%)
    2 / 108 (1.85%)
         occurrences all number
    0
    2
    Influenza
         subjects affected / exposed
    1 / 113 (0.88%)
    1 / 108 (0.93%)
         occurrences all number
    1
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 113 (2.65%)
    1 / 108 (0.93%)
         occurrences all number
    3
    1
    Localised infection
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Conjunctivitis
         subjects affected / exposed
    2 / 113 (1.77%)
    0 / 108 (0.00%)
         occurrences all number
    3
    0
    Laryngitis
         subjects affected / exposed
    1 / 113 (0.88%)
    1 / 108 (0.93%)
         occurrences all number
    1
    1
    Nasopharyngitis
         subjects affected / exposed
    30 / 113 (26.55%)
    25 / 108 (23.15%)
         occurrences all number
    53
    30
    Ear infection
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Onychomycosis
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Oral herpes
         subjects affected / exposed
    0 / 113 (0.00%)
    2 / 108 (1.85%)
         occurrences all number
    0
    2
    Periodontitis
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Paronychia
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Pharyngitis
         subjects affected / exposed
    1 / 113 (0.88%)
    1 / 108 (0.93%)
         occurrences all number
    1
    1
    Genital infection fungal
         subjects affected / exposed
    0 / 113 (0.00%)
    2 / 108 (1.85%)
         occurrences all number
    0
    2
    Gastrointestinal fungal infection
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Pneumonia
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Pulpitis dental
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Sinobronchitis
         subjects affected / exposed
    3 / 113 (2.65%)
    1 / 108 (0.93%)
         occurrences all number
    3
    1
    Sinusitis
         subjects affected / exposed
    4 / 113 (3.54%)
    2 / 108 (1.85%)
         occurrences all number
    5
    2
    Tinea pedis
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Tinea versicolour
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Tonsillitis
         subjects affected / exposed
    2 / 113 (1.77%)
    3 / 108 (2.78%)
         occurrences all number
    3
    3
    Vaginal infection
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    viral infection
         subjects affected / exposed
    1 / 113 (0.88%)
    1 / 108 (0.93%)
         occurrences all number
    1
    1
    Respiratory tract infection viral
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Vulvovaginal mycotic infection
         subjects affected / exposed
    5 / 113 (4.42%)
    5 / 108 (4.63%)
         occurrences all number
    5
    5
    Root canal infection
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Decreased appetite
    alternative dictionary used: MedDRA 21.1
         subjects affected / exposed
    1 / 113 (0.88%)
    2 / 108 (1.85%)
         occurrences all number
    1
    2
    Gout
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Hyperkalaemia
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Hypokalaemia
         subjects affected / exposed
    0 / 113 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    Lipoedema
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    Vitamin D deficiency
         subjects affected / exposed
    1 / 113 (0.88%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Nov 2014
    Inclusion of study centers
    21 Jan 2015
    Inlcusion of study centers
    13 Apr 2015
    Inclusion of study centers
    17 Sep 2015
    Inclusion of study centers. Unsubscription of other study centers. Change of adress of a study center. Change of exclusion criteria. Change of time between Visit 2 and Visit 3.
    28 Feb 2016
    Change of centers involved.
    06 May 2016
    Prolongation of study duration
    05 Oct 2016
    Inclusion of study centers
    04 Jan 2017
    Inclusion of study centers
    19 Sep 2017
    Inclusion of study centers
    22 Aug 2018
    Inclusion of study centers, Prolongation of study duration, Change of QPPV, outsourcing of the investigator list, Erratum Batch formula Placebo
    30 Nov 2018
    Shortening of follow-up phase duration

    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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    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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