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    Clinical Trial Results:
    A 1-week, open-label, multi-center study to explore conduction abnormalities during first dose administration of fingolimod in patients with relapsing-remitting multiple sclerosis (START)

    Summary
    EudraCT number
    		 2012-000653-32
    Trial protocol
    		 DE  
    Global end of trial date
    12 Dec 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Dec 2017
    First version publication date
    23 Dec 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CFTY720DDE17
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01585298
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111,
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111,
    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 Dec 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Dec 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the incidence of patients with bradycardia (heart rate < 45 beats per min) and bradyarrhythmic ECG events during 6-hour monitoring period as measured by heart rate and second and third-degree AV blocks after treatment initiation of fingolimod 0.5 mg.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    29 Jun 2012
    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
    Germany: 6998
    Worldwide total number of subjects
    6998
    EEA total number of subjects
    6998
    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)
    6957
    From 65 to 84 years
    41
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 All participants received open-label fingolimod.

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

    Arms
    Arm title
    		 Fingolimod
    Arm description
    		 Fingolimod 0.5 mg by mouth once daily for 7 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fingolimod
    Investigational medicinal product code
    FTY720
    Other name
    Gilenya
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Fingolimod 0.5 mg by mouth once daily for 7 days.

    Number of subjects in period 1
    		Fingolimod
    Started
    6998
    Completed
    6961
    Not completed
    37
         Consent withdrawn by subject
    4
         Abnormal test procedure results
    1
         Study completion was not documented.
    1
         Adverse event, non-fatal
    24
         Protocol deviation
    1
         Administrative problems
    4
         Lost to follow-up
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Fingolimod
    Reporting group description
    		 Fingolimod 0.5 mg by mouth once daily for 7 days.

    Reporting group values
    		 Fingolimod Total
    Number of subjects
    		 6998 6998
    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)
    		 6957 6957
        From 65-84 years
    		 41 41
        85 years and over
    		 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 39.2 ( 10.52 ) -
    Gender, Male/Female
    Units: Subjects
        Female
    		 4924 4924
        Male
    		 2074 2074

    End points

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    End points reporting groups
    Reporting group title
    Fingolimod
    Reporting group description
    		 Fingolimod 0.5 mg by mouth once daily for 7 days.

    Primary: Number of participants with 2nd or 3rd degree AV block

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    End point title
    		 Number of participants with 2nd or 3rd degree AV block [1]
    End point description
    Number of participants with 2nd or 3rd degree AV block in ECG during first dose observation. Participants can simultaneously experience both types of AV blocks. Two patients of the safety analysis set discontinued the study without having received treatment, but safety information was collected on these two patients.
    End point type
    Primary
    End point timeframe
    baseline during 6 hour monitoring post dose
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analysis does not apply to this end point.
    End point values
    		 Fingolimod
    Number of subjects analysed
    6998
    Units: Participants
        Any AV block ll degree or higher
    120
        AV block ll degree: Mobitz type I degree
    117
        AV block II degree: Mobitz type II degree
    0
        AV block II degree: 2:1
    43
        AV block III degree
    1
    No statistical analyses for this end point

    Primary: Number of patients with heart rate below 45 beats per minute (BPM)

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    End point title
    		 Number of patients with heart rate below 45 beats per minute (BPM) [2]
    End point description
    Number of patients with heart rate below 45 beats bpm in ECG during first dose observation. Two patients of the safety analysis set discontinued the study without having received treatment, but safety information was collected on these two patients.
    End point type
    Primary
    End point timeframe
    baseline during 6 hour monitoring post dose
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analysis does not apply to this end point.
    End point values
    		 Fingolimod
    Number of subjects analysed
    6998
    Units: Participants
    63
    No statistical analyses for this end point

    Secondary: Number of participants with prolonged QTc interval (Friderica)

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    End point title
    		 Number of participants with prolonged QTc interval (Friderica)
    End point description
    Number of patients with conduction abnormalities such as QT prolongation, first degree AV block during treatment initiation. Two patients of the safety analysis set discontinued the study without having received treatment, but safety information was collected on these two patients.
    End point type
    Secondary
    End point timeframe
    baseline post-dose
    End point values
    		 Fingolimod
    Number of subjects analysed
    6844
    Units: Participants
        Female, QTcFridericia Interval > 470 ms (n=4808)
    7
        Male, QTcF Interval > 450 ms (n= 2036)
    6
    No statistical analyses for this end point

    Secondary: Number of participants with bradyarrhythmic electrocardiogram (ECG) events

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    End point title
    		 Number of participants with bradyarrhythmic electrocardiogram (ECG) events
    End point description
    The number of participants with bradyarrhythmic electrocardiogram (ECG) events was assessed. Bradyarrhythmic ECG events are defined as QTc Fridericia time > 450 ms for males and > 470 ms for females. Two patients of the safety analysis set discontinued the study without having received treatment, but safety information was collected on these two patients.
    End point type
    Secondary
    End point timeframe
    up to day 7
    End point values
    		 Fingolimod
    Number of subjects analysed
    6998
    Units: Participants
    26
    No statistical analyses for this end point

    Secondary: Number of patients with cardiac adverse events

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    End point title
    		 Number of patients with cardiac adverse events
    End point description
    The number of participants with the occurrence of subsequent cardiac adverse events (AEs) and serious cardiac AEs during study was assessed. Cardiac events were defined as the following Medical Dictionary for Regulatory Activities (MedDRA) preferred terms: angina pectoris, chest discomfort, dizziness, dyspnoea, dyspnoea exertional, fatigue, palpitations, syncope, vertigo, vertigo positional and vision blurred. Two patients of the safety analysis set discontinued the study without having received treatment, but safety information was collected on these two patients.
    End point type
    Secondary
    End point timeframe
    7 days
    End point values
    		 Fingolimod
    Number of subjects analysed
    6998
    Units: Participants
        Cardiac events
    489
        Serious cardiac AEs
    9
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Fingolimod 0.5 mg
    Reporting group description
    		 Fingolimod 0.5 mg

    Serious adverse events
    		 Fingolimod 0.5 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    160 / 6998 (2.29%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Brain neoplasm benign
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    Blood pressure fluctuation
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypertension
         subjects affected / exposed
    3 / 6998 (0.04%)
         occurrences causally related to treatment / all
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    Hypertensive crisis
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Unintended pregnancy
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Malaise
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Painful respiration
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory tract inflammation
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Borderline personality disorder
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Depression suicidal
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Mental fatigue
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Panic attack
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Investigations
    CD4/CD8 ratio decreased
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Electrocardiogram QT prolonged
         subjects affected / exposed
    4 / 6998 (0.06%)
         occurrences causally related to treatment / all
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Heart rate decreased
         subjects affected / exposed
    4 / 6998 (0.06%)
         occurrences causally related to treatment / all
    3 / 4
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Subdural haematoma
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Tendon rupture
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Arrhythmia
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    3 / 6998 (0.04%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    Atrioventricular block complete
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Atrioventricular block second degree
         subjects affected / exposed
    49 / 6998 (0.70%)
         occurrences causally related to treatment / all
    47 / 49
         deaths causally related to treatment / all
    0 / 0
    Bradycardia
         subjects affected / exposed
    24 / 6998 (0.34%)
         occurrences causally related to treatment / all
    24 / 24
         deaths causally related to treatment / all
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Ischaemic cardiomyopathy
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Sinus bradycardia
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Supraventricular extrasystoles
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Ataxia
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Central nervous system lesion
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Dizziness
         subjects affected / exposed
    3 / 6998 (0.04%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    Embolic cerebral infarction
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Epilepsy
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Headache
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypoaesthesia
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Intracranial aneurysm
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Multiple sclerosis relapse
         subjects affected / exposed
    26 / 6998 (0.37%)
         occurrences causally related to treatment / all
    0 / 26
         deaths causally related to treatment / all
    0 / 0
    Optic neuritis
         subjects affected / exposed
    3 / 6998 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Partial seizures
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Restless legs syndrome
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Seizure
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Subdural hygroma
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Leukocytosis
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Leukopenia
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Lymphopenia
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Eye disorders
    Macular oedema
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Visual acuity reduced
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Anal fistula
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Diarrhoea
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Dysphagia
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Mouth haemorrhage
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pancreatitis
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Skin irritation
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Calculus urethral
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Muscle spasms
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Myalgia
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Abdominal abscess
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Anal abscess
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cystitis
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Herpes zoster
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Infection
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Oral herpes
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Fingolimod 0.5 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2179 / 6998 (31.14%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Pharyngeal neoplasm benign
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Vascular disorders
    Blood pressure fluctuation
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences all number
    2
    Circulatory collapse
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Diastolic hypertension
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Flushing
         subjects affected / exposed
    4 / 6998 (0.06%)
         occurrences all number
    4
    Haematoma
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Hot flush
         subjects affected / exposed
    3 / 6998 (0.04%)
         occurrences all number
    3
    Hypertension
         subjects affected / exposed
    64 / 6998 (0.91%)
         occurrences all number
    64
    Hypotension
         subjects affected / exposed
    12 / 6998 (0.17%)
         occurrences all number
    12
    Pallor
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Peripheral coldness
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences all number
    2
    Varicose vein
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Pregnancy, puerperium and perinatal conditions
    Pregnancy
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Pregnancy of unknown location
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Unintended pregnancy
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    General disorders and administration site conditions
    Application site reaction
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Asthenia
         subjects affected / exposed
    10 / 6998 (0.14%)
         occurrences all number
    10
    Chest discomfort
         subjects affected / exposed
    24 / 6998 (0.34%)
         occurrences all number
    25
    Chest pain
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Chills
         subjects affected / exposed
    11 / 6998 (0.16%)
         occurrences all number
    11
    Chronic fatigue syndrome
         subjects affected / exposed
    3 / 6998 (0.04%)
         occurrences all number
    3
    Discomfort
         subjects affected / exposed
    5 / 6998 (0.07%)
         occurrences all number
    5
    Face oedema
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences all number
    2
    Fatigue
         subjects affected / exposed
    227 / 6998 (3.24%)
         occurrences all number
    227
    Feeling abnormal
         subjects affected / exposed
    4 / 6998 (0.06%)
         occurrences all number
    4
    Feeling cold
         subjects affected / exposed
    8 / 6998 (0.11%)
         occurrences all number
    8
    Feeling drunk
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Feeling hot
         subjects affected / exposed
    5 / 6998 (0.07%)
         occurrences all number
    5
    Gait disturbance
         subjects affected / exposed
    5 / 6998 (0.07%)
         occurrences all number
    5
    Inflammation
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Influenza like illness
         subjects affected / exposed
    19 / 6998 (0.27%)
         occurrences all number
    19
    Infusion site inflammation
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Infusion site necrosis
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Local swelling
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Malaise
         subjects affected / exposed
    11 / 6998 (0.16%)
         occurrences all number
    11
    Mucosal dryness
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Non-cardiac chest pain
         subjects affected / exposed
    31 / 6998 (0.44%)
         occurrences all number
    31
    Oedema peripheral
         subjects affected / exposed
    7 / 6998 (0.10%)
         occurrences all number
    7
    Pain
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences all number
    2
    Peripheral swelling
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Pyrexia
         subjects affected / exposed
    17 / 6998 (0.24%)
         occurrences all number
    17
    Secretion discharge
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Sensation of foreign body
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Sense of oppression
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Temperature intolerance
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences all number
    2
    Thirst
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences all number
    2
    Immune system disorders
    Food allergy
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Hypersensitivity
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences all number
    2
    Seasonal allergy
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Social circumstances
    Walking disability
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Reproductive system and breast disorders
    Breast discomfort
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences all number
    2
    Breast disorder
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Breast pain
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences all number
    3
    Breast tenderness
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Cervical dysplasia
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Dysmenorrhoea
         subjects affected / exposed
    3 / 6998 (0.04%)
         occurrences all number
    3
    Metrorrhagia
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Ovulation pain
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Priapism
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Uterine haemorrhage
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Vulvovaginal burning sensation
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences all number
    2
    Respiratory, thoracic and mediastinal disorders
    Allergic bronchitis
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Asthma
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Cough
         subjects affected / exposed
    20 / 6998 (0.29%)
         occurrences all number
    20
    Dysphonia
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Dyspnoea
         subjects affected / exposed
    18 / 6998 (0.26%)
         occurrences all number
    18
    Dyspnoea exertional
         subjects affected / exposed
    6 / 6998 (0.09%)
         occurrences all number
    6
    Epistaxis
         subjects affected / exposed
    4 / 6998 (0.06%)
         occurrences all number
    4
    Increased bronchial secretion
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences all number
    2
    Nasal congestion
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Nasal oedema
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Oropharyngeal pain
         subjects affected / exposed
    27 / 6998 (0.39%)
         occurrences all number
    27
    Painful respiration
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Pleurisy
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Respiratory distress
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences all number
    2
    Rhinitis allergic
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Rhinorrhoea
         subjects affected / exposed
    4 / 6998 (0.06%)
         occurrences all number
    4
    Sinus disorder
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Throat irritation
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Throat tightness
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Psychiatric disorders
    Adjustment disorder
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Adjustment disorder with depressed mood
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Affective disorder
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Aggression
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Agitation
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences all number
    2
    Anxiety
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Depressed mood
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Depression
         subjects affected / exposed
    19 / 6998 (0.27%)
         occurrences all number
    19
    Dyssomnia
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Emotional disorder
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Initial insomnia
         subjects affected / exposed
    3 / 6998 (0.04%)
         occurrences all number
    3
    Insomnia
         subjects affected / exposed
    12 / 6998 (0.17%)
         occurrences all number
    12
    Irritability
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences all number
    2
    Laziness
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Listless
         subjects affected / exposed
    4 / 6998 (0.06%)
         occurrences all number
    4
    Mental disorder
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Mental fatigue
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences all number
    2
    Middle insomnia
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Mood altered
         subjects affected / exposed
    3 / 6998 (0.04%)
         occurrences all number
    3
    Mood swings
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences all number
    2
    Nervousness
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Nightmare
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Panic attack
         subjects affected / exposed
    7 / 6998 (0.10%)
         occurrences all number
    7
    Persistent depressive disorder
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Restlessness
         subjects affected / exposed
    8 / 6998 (0.11%)
         occurrences all number
    8
    Sleep disorder
         subjects affected / exposed
    18 / 6998 (0.26%)
         occurrences all number
    18
    Product issues
    Device defective
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Hepatobiliary disorders
    Hepatic steatosis
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Hyperbilirubinaemia
         subjects affected / exposed
    5 / 6998 (0.07%)
         occurrences all number
    5
    Liver disorder
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    21 / 6998 (0.30%)
         occurrences all number
    21
    Aspartate aminotransferase increased
         subjects affected / exposed
    3 / 6998 (0.04%)
         occurrences all number
    3
    Basophil count increased
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Blood alkaline phosphatase increased
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Blood bilirubin increased
         subjects affected / exposed
    11 / 6998 (0.16%)
         occurrences all number
    11
    Blood chloride decreased
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Blood creatinine increased
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences all number
    2
    Blood glucose decreased
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences all number
    2
    Blood glucose increased
         subjects affected / exposed
    9 / 6998 (0.13%)
         occurrences all number
    10
    Blood pressure decreased
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Blood pressure diastolic decreased
         subjects affected / exposed
    3 / 6998 (0.04%)
         occurrences all number
    3
    Blood pressure diastolic increased
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences all number
    2
    Blood pressure increased
         subjects affected / exposed
    10 / 6998 (0.14%)
         occurrences all number
    10
    Blood pressure systolic increased
         subjects affected / exposed
    3 / 6998 (0.04%)
         occurrences all number
    3
    Blood urea increased
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Body temperature increased
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Electrocardiogram P wave abnormal
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Electrocardiogram QRS complex prolonged
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Electrocardiogram QT prolonged
         subjects affected / exposed
    9 / 6998 (0.13%)
         occurrences all number
    9
    Electrocardiogram ST segment abnormal
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Electrocardiogram ST segment depression
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences all number
    2
    Electrocardiogram T wave inversion
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Electrocardiogram abnormal
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Eosinophil count decreased
         subjects affected / exposed
    13 / 6998 (0.19%)
         occurrences all number
    13
    Eosinophil count increased
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    8 / 6998 (0.11%)
         occurrences all number
    9
    Haematocrit decreased
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Haematocrit increased
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Haemoglobin decreased
         subjects affected / exposed
    3 / 6998 (0.04%)
         occurrences all number
    3
    Haemoglobin increased
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Heart rate abnormal
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Heart rate decreased
         subjects affected / exposed
    13 / 6998 (0.19%)
         occurrences all number
    13
    Heart rate increased
         subjects affected / exposed
    7 / 6998 (0.10%)
         occurrences all number
    7
    Hepatic enzyme increased
         subjects affected / exposed
    14 / 6998 (0.20%)
         occurrences all number
    14
    Liver function test increased
         subjects affected / exposed
    3 / 6998 (0.04%)
         occurrences all number
    3
    Lymphocyte count abnormal
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences all number
    2
    Lymphocyte count decreased
         subjects affected / exposed
    36 / 6998 (0.51%)
         occurrences all number
    36
    Lymphocyte count increased
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Monocyte count decreased
         subjects affected / exposed
    3 / 6998 (0.04%)
         occurrences all number
    3
    Monocyte count increased
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences all number
    2
    Neutrophil count decreased
         subjects affected / exposed
    6 / 6998 (0.09%)
         occurrences all number
    6
    Neutrophil count increased
         subjects affected / exposed
    7 / 6998 (0.10%)
         occurrences all number
    7
    Platelet aggregation
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Platelet count decreased
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Pulse abnormal
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Red blood cell count decreased
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Transaminases increased
         subjects affected / exposed
    3 / 6998 (0.04%)
         occurrences all number
    3
    Weight decreased
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences all number
    2
    Weight increased
         subjects affected / exposed
    3 / 6998 (0.04%)
         occurrences all number
    3
    White blood cell count decreased
         subjects affected / exposed
    18 / 6998 (0.26%)
         occurrences all number
    18
    White blood cell count increased
         subjects affected / exposed
    5 / 6998 (0.07%)
         occurrences all number
    5
    White blood cells urine
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Animal bite
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Animal scratch
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Chest injury
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Fall
         subjects affected / exposed
    6 / 6998 (0.09%)
         occurrences all number
    6
    Foot fracture
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Laceration
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Ligament sprain
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences all number
    2
    Limb injury
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Meniscus injury
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Post procedural complication
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Skin abrasion
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Thermal burn
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences all number
    2
    Congenital, familial and genetic disorders
    Corneal dystrophy
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    11 / 6998 (0.16%)
         occurrences all number
    11
    Arrhythmia
         subjects affected / exposed
    7 / 6998 (0.10%)
         occurrences all number
    7
    Atrioventricular block first degree
         subjects affected / exposed
    116 / 6998 (1.66%)
         occurrences all number
    117
    Atrioventricular block second degree
         subjects affected / exposed
    74 / 6998 (1.06%)
         occurrences all number
    74
    Bradycardia
         subjects affected / exposed
    48 / 6998 (0.69%)
         occurrences all number
    48
    Bundle branch block right
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Cardiac discomfort
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences all number
    2
    Cardiovascular disorder
         subjects affected / exposed
    3 / 6998 (0.04%)
         occurrences all number
    3
    Coronary artery stenosis
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Extrasystoles
         subjects affected / exposed
    4 / 6998 (0.06%)
         occurrences all number
    4
    Palpitations
         subjects affected / exposed
    26 / 6998 (0.37%)
         occurrences all number
    26
    Pericardial effusion
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Sinus arrhythmia
         subjects affected / exposed
    3 / 6998 (0.04%)
         occurrences all number
    3
    Sinus bradycardia
         subjects affected / exposed
    8 / 6998 (0.11%)
         occurrences all number
    8
    Sinus tachycardia
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences all number
    2
    Supraventricular extrasystoles
         subjects affected / exposed
    10 / 6998 (0.14%)
         occurrences all number
    10
    Tachycardia
         subjects affected / exposed
    6 / 6998 (0.09%)
         occurrences all number
    6
    Ventricular extrasystoles
         subjects affected / exposed
    4 / 6998 (0.06%)
         occurrences all number
    4
    Ventricular pre-excitation
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Ventricular tachycardia
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Nervous system disorders
    Aphasia
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Ataxia
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Balance disorder
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences all number
    2
    Carpal tunnel syndrome
         subjects affected / exposed
    3 / 6998 (0.04%)
         occurrences all number
    3
    Disturbance in attention
         subjects affected / exposed
    4 / 6998 (0.06%)
         occurrences all number
    4
    Dizziness
         subjects affected / exposed
    126 / 6998 (1.80%)
         occurrences all number
    126
    Dizziness exertional
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Dizziness postural
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Dysaesthesia
         subjects affected / exposed
    5 / 6998 (0.07%)
         occurrences all number
    5
    Dysgeusia
         subjects affected / exposed
    21 / 6998 (0.30%)
         occurrences all number
    21
    Epilepsy
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences all number
    2
    Facial spasm
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Head discomfort
         subjects affected / exposed
    6 / 6998 (0.09%)
         occurrences all number
    6
    Headache
         subjects affected / exposed
    316 / 6998 (4.52%)
         occurrences all number
    325
    Hemiparesis
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Hyperaesthesia
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Hypertonia
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Hypoaesthesia
         subjects affected / exposed
    14 / 6998 (0.20%)
         occurrences all number
    14
    Lhermitte's sign
         subjects affected / exposed
    3 / 6998 (0.04%)
         occurrences all number
    3
    Migraine
         subjects affected / exposed
    17 / 6998 (0.24%)
         occurrences all number
    18
    Migraine with aura
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences all number
    2
    Monoparesis
         subjects affected / exposed
    3 / 6998 (0.04%)
         occurrences all number
    3
    Multiple sclerosis
         subjects affected / exposed
    3 / 6998 (0.04%)
         occurrences all number
    3
    Multiple sclerosis relapse
         subjects affected / exposed
    70 / 6998 (1.00%)
         occurrences all number
    70
    Muscle spasticity
         subjects affected / exposed
    6 / 6998 (0.09%)
         occurrences all number
    6
    Neuralgia
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Neuropathy peripheral
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Optic neuritis
         subjects affected / exposed
    4 / 6998 (0.06%)
         occurrences all number
    4
    Orthostatic intolerance
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Paraesthesia
         subjects affected / exposed
    29 / 6998 (0.41%)
         occurrences all number
    29
    Peroneal nerve palsy
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Presyncope
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Psychogenic pseudosyncope
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Radial nerve compression
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Restless legs syndrome
         subjects affected / exposed
    3 / 6998 (0.04%)
         occurrences all number
    3
    Sciatica
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Sensory disturbance
         subjects affected / exposed
    7 / 6998 (0.10%)
         occurrences all number
    7
    Somnolence
         subjects affected / exposed
    5 / 6998 (0.07%)
         occurrences all number
    5
    Syncope
         subjects affected / exposed
    5 / 6998 (0.07%)
         occurrences all number
    5
    Tension headache
         subjects affected / exposed
    3 / 6998 (0.04%)
         occurrences all number
    3
    Tremor
         subjects affected / exposed
    9 / 6998 (0.13%)
         occurrences all number
    9
    Trigeminal neuralgia
         subjects affected / exposed
    3 / 6998 (0.04%)
         occurrences all number
    3
    Visual field defect
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    4 / 6998 (0.06%)
         occurrences all number
    4
    Eosinopenia
         subjects affected / exposed
    7 / 6998 (0.10%)
         occurrences all number
    7
    Eosinophilia
         subjects affected / exposed
    12 / 6998 (0.17%)
         occurrences all number
    12
    Granulocytosis
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Haemoglobinaemia
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Leukocytosis
         subjects affected / exposed
    11 / 6998 (0.16%)
         occurrences all number
    11
    Leukopenia
         subjects affected / exposed
    68 / 6998 (0.97%)
         occurrences all number
    68
    Lymphadenopathy
         subjects affected / exposed
    5 / 6998 (0.07%)
         occurrences all number
    5
    Lymphopenia
         subjects affected / exposed
    119 / 6998 (1.70%)
         occurrences all number
    119
    Microcytic anaemia
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Monocytopenia
         subjects affected / exposed
    4 / 6998 (0.06%)
         occurrences all number
    4
    Monocytosis
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences all number
    2
    Neutropenia
         subjects affected / exposed
    9 / 6998 (0.13%)
         occurrences all number
    9
    Neutrophilia
         subjects affected / exposed
    5 / 6998 (0.07%)
         occurrences all number
    5
    Pancytopenia
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Thrombocytopenia
         subjects affected / exposed
    7 / 6998 (0.10%)
         occurrences all number
    7
    Ear and labyrinth disorders
    Deafness
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Ear discomfort
         subjects affected / exposed
    3 / 6998 (0.04%)
         occurrences all number
    3
    Ear pain
         subjects affected / exposed
    3 / 6998 (0.04%)
         occurrences all number
    3
    External ear inflammation
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Sudden hearing loss
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Tinnitus
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences all number
    2
    Vertigo
         subjects affected / exposed
    68 / 6998 (0.97%)
         occurrences all number
    69
    Vertigo positional
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Eye disorders
    Amblyopia
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences all number
    2
    Blepharospasm
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Cataract
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Diplopia
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences all number
    2
    Eye irritation
         subjects affected / exposed
    3 / 6998 (0.04%)
         occurrences all number
    3
    Eye pain
         subjects affected / exposed
    11 / 6998 (0.16%)
         occurrences all number
    12
    Eye swelling
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Eyelid oedema
         subjects affected / exposed
    3 / 6998 (0.04%)
         occurrences all number
    3
    Foreign body sensation in eyes
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Iridocyclitis
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Macular oedema
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences all number
    2
    Ocular discomfort
         subjects affected / exposed
    6 / 6998 (0.09%)
         occurrences all number
    6
    Photopsia
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Retinal vein thrombosis
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Vision blurred
         subjects affected / exposed
    20 / 6998 (0.29%)
         occurrences all number
    20
    Visual acuity reduced
         subjects affected / exposed
    3 / 6998 (0.04%)
         occurrences all number
    3
    Visual impairment
         subjects affected / exposed
    6 / 6998 (0.09%)
         occurrences all number
    6
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    9 / 6998 (0.13%)
         occurrences all number
    9
    Abdominal distension
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Abdominal pain
         subjects affected / exposed
    9 / 6998 (0.13%)
         occurrences all number
    10
    Abdominal pain lower
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences all number
    2
    Abdominal pain upper
         subjects affected / exposed
    53 / 6998 (0.76%)
         occurrences all number
    53
    Anal incontinence
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences all number
    2
    Aphthous ulcer
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Bowel movement irregularity
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Constipation
         subjects affected / exposed
    13 / 6998 (0.19%)
         occurrences all number
    13
    Diarrhoea
         subjects affected / exposed
    96 / 6998 (1.37%)
         occurrences all number
    96
    Dry mouth
         subjects affected / exposed
    7 / 6998 (0.10%)
         occurrences all number
    7
    Dyspepsia
         subjects affected / exposed
    11 / 6998 (0.16%)
         occurrences all number
    11
    Dysphagia
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences all number
    2
    Enteritis
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Eructation
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Faeces soft
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Flatulence
         subjects affected / exposed
    9 / 6998 (0.13%)
         occurrences all number
    9
    Frequent bowel movements
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Gastric disorder
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences all number
    2
    Gastritis
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences all number
    2
    Gastrointestinal disorder
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences all number
    2
    Gastrointestinal erosion
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences all number
    2
    Haemorrhoids
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    143 / 6998 (2.04%)
         occurrences all number
    143
    Odynophagia
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Oral dysaesthesia
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Oral pain
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Oral pruritus
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Paraesthesia oral
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences all number
    2
    Tongue blistering
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Tooth disorder
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Toothache
         subjects affected / exposed
    6 / 6998 (0.09%)
         occurrences all number
    6
    Vomiting
         subjects affected / exposed
    13 / 6998 (0.19%)
         occurrences all number
    13
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    8 / 6998 (0.11%)
         occurrences all number
    8
    Alopecia
         subjects affected / exposed
    15 / 6998 (0.21%)
         occurrences all number
    15
    Blister
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Dermatitis
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences all number
    2
    Dermatitis allergic
         subjects affected / exposed
    4 / 6998 (0.06%)
         occurrences all number
    4
    Dermatitis contact
         subjects affected / exposed
    3 / 6998 (0.04%)
         occurrences all number
    3
    Dermatitis exfoliative
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Dermatosis
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Drug eruption
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Dry skin
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Dyshidrotic eczema
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Eczema
         subjects affected / exposed
    3 / 6998 (0.04%)
         occurrences all number
    3
    Erythema
         subjects affected / exposed
    4 / 6998 (0.06%)
         occurrences all number
    4
    Hand dermatitis
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Hyperhidrosis
         subjects affected / exposed
    14 / 6998 (0.20%)
         occurrences all number
    15
    Night sweats
         subjects affected / exposed
    3 / 6998 (0.04%)
         occurrences all number
    3
    Photosensitivity reaction
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Pigmentation disorder
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Pityriasis rosea
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences all number
    2
    Pruritus
         subjects affected / exposed
    24 / 6998 (0.34%)
         occurrences all number
    24
    Pruritus generalised
         subjects affected / exposed
    4 / 6998 (0.06%)
         occurrences all number
    4
    Rash
         subjects affected / exposed
    15 / 6998 (0.21%)
         occurrences all number
    15
    Rash pruritic
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Rash vesicular
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Rosacea
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Seborrhoeic dermatitis
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Skin burning sensation
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Skin disorder
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences all number
    2
    Skin exfoliation
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Skin irritation
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences all number
    2
    Skin odour abnormal
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Skin reaction
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Swelling face
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences all number
    2
    Renal and urinary disorders
    Bladder dysfunction
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Dysuria
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Haematuria
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Micturition urgency
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences all number
    2
    Nephritis
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Neurogenic bladder
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Nocturia
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences all number
    2
    Pollakiuria
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Renal pain
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Urge incontinence
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    16 / 6998 (0.23%)
         occurrences all number
    17
    Arthritis
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Back pain
         subjects affected / exposed
    46 / 6998 (0.66%)
         occurrences all number
    46
    Bone pain
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences all number
    2
    Bursitis
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences all number
    2
    Coccydynia
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Flank pain
         subjects affected / exposed
    3 / 6998 (0.04%)
         occurrences all number
    3
    Groin pain
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences all number
    2
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Joint stiffness
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences all number
    2
    Limb discomfort
         subjects affected / exposed
    6 / 6998 (0.09%)
         occurrences all number
    6
    Mobility decreased
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Muscle fatigue
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences all number
    2
    Muscle rigidity
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Muscle spasms
         subjects affected / exposed
    3 / 6998 (0.04%)
         occurrences all number
    3
    Muscle tightness
         subjects affected / exposed
    3 / 6998 (0.04%)
         occurrences all number
    3
    Muscle twitching
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Muscular weakness
         subjects affected / exposed
    8 / 6998 (0.11%)
         occurrences all number
    8
    Musculoskeletal chest pain
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences all number
    2
    Musculoskeletal pain
         subjects affected / exposed
    3 / 6998 (0.04%)
         occurrences all number
    3
    Musculoskeletal stiffness
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences all number
    2
    Myalgia
         subjects affected / exposed
    16 / 6998 (0.23%)
         occurrences all number
    17
    Myofascial pain syndrome
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Neck pain
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences all number
    2
    Pain in extremity
         subjects affected / exposed
    19 / 6998 (0.27%)
         occurrences all number
    19
    Spinal disorder
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Infections and infestations
    Anal abscess
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Anorectal infection
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Bacterial infection
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Bronchitis
         subjects affected / exposed
    7 / 6998 (0.10%)
         occurrences all number
    7
    Chronic sinusitis
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Conjunctivitis
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences all number
    2
    Cystitis
         subjects affected / exposed
    6 / 6998 (0.09%)
         occurrences all number
    6
    Dysentery
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences all number
    2
    Erysipelas
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Febrile infection
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences all number
    2
    Fungal infection
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Gastroenteritis
         subjects affected / exposed
    4 / 6998 (0.06%)
         occurrences all number
    4
    Gastroenteritis viral
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Gastrointestinal infection
         subjects affected / exposed
    5 / 6998 (0.07%)
         occurrences all number
    5
    Genital herpes
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Genitourinary tract infection
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Gingivitis
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences all number
    2
    Helminthic infection
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Herpes simplex
         subjects affected / exposed
    3 / 6998 (0.04%)
         occurrences all number
    3
    Herpes virus infection
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences all number
    2
    Herpes zoster
         subjects affected / exposed
    4 / 6998 (0.06%)
         occurrences all number
    4
    Hordeolum
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences all number
    2
    Infected bite
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Infection
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Influenza
         subjects affected / exposed
    23 / 6998 (0.33%)
         occurrences all number
    23
    Laryngitis
         subjects affected / exposed
    3 / 6998 (0.04%)
         occurrences all number
    3
    Mastoiditis
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Myelitis
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Nasopharyngitis
         subjects affected / exposed
    137 / 6998 (1.96%)
         occurrences all number
    137
    Onychomycosis
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Oral herpes
         subjects affected / exposed
    27 / 6998 (0.39%)
         occurrences all number
    27
    Pharyngitis
         subjects affected / exposed
    3 / 6998 (0.04%)
         occurrences all number
    3
    Pyelonephritis
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Respiratory tract infection
         subjects affected / exposed
    7 / 6998 (0.10%)
         occurrences all number
    7
    Rhinitis
         subjects affected / exposed
    12 / 6998 (0.17%)
         occurrences all number
    12
    Sialoadenitis
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Sinusitis
         subjects affected / exposed
    6 / 6998 (0.09%)
         occurrences all number
    6
    Tinea versicolour
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Tonsillitis
         subjects affected / exposed
    5 / 6998 (0.07%)
         occurrences all number
    5
    Upper respiratory tract infection
         subjects affected / exposed
    12 / 6998 (0.17%)
         occurrences all number
    12
    Urinary tract infection
         subjects affected / exposed
    15 / 6998 (0.21%)
         occurrences all number
    15
    Vaginal abscess
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Viral infection
         subjects affected / exposed
    2 / 6998 (0.03%)
         occurrences all number
    2
    Viral rhinitis
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Vulvovaginal candidiasis
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Vulvovaginal mycotic infection
         subjects affected / exposed
    5 / 6998 (0.07%)
         occurrences all number
    5
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    9 / 6998 (0.13%)
         occurrences all number
    9
    Food craving
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Gluten sensitivity
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Hyperglycaemia
         subjects affected / exposed
    4 / 6998 (0.06%)
         occurrences all number
    4
    Hyperkalaemia
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Hypoglycaemia
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Hypokalaemia
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Increased appetite
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Type 2 diabetes mellitus
         subjects affected / exposed
    1 / 6998 (0.01%)
         occurrences all number
    1
    Vitamin D deficiency
         subjects affected / exposed
    6 / 6998 (0.09%)
         occurrences all number
    6

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Apr 2012
    change of inclusion and exclusion criteria with regards to cardiac risk patients and inclusion of further criteria for study drug discontinuation; inclusion of the most recent recommendations from EMA in terms of cardiac response monitoring following the first dose of fingolimod (April 20, 2012)
    26 Mar 2013
    implementation of an update to the Gilenya® (fingolimod) label in the EU approved by the CHMP; as the incidence of cardiac events after enrolling 1000 patients was found to be significantly lower than the incidence from recent studies which was the basis for the initial sample size calculation, the sample size needed to be increased from 2000 to a flexible sample size ranging from 3800 to 7000 patients with a fixed study termination by end of 2015
    20 Mar 2014
    implementation of a further update to the Gilenya® (fingolimod) label regarding interruption and restart of fingolimod real-life data: inter-patient regarding the incidence of bradycardia and bradyarrhythmic ECG events of patients who paused fingolimod treatment in comparison to fingolimod-naïve patients, treated for the first time in the START study, as well as within-patient comparisons for patients formerly treated with fingolimod within the START study.
    24 Apr 2014
    Correction of minor errors in version 3
    20 Jul 2014
    Clarification of the handling of safety cases for patients participating in both the interventional study START and the non-interventional study PASSAGE, thereby ensuring compliance with both the GCP regulations (START) and the modified regulations of the good pharmacovigilance practices module (specifically VI).
    11 May 2015
    Addition of the same procedure as defined in amendment 5 for the PASSAGE study for patients participating in the PANGAEA 2.0 study; Change of the definition of bradycardia from <40 bpm to <45 beats per minute to harmonize with the current Gilenya® label in the EU; Removal of the exploratory endpoints regarding a sub-population of patients receiving a 24-hour monitoring due to low recruitment in this subgroup; Extension of fixed recruitment end to June 2016 to enroll approximately 7000 patients.
    11 Nov 2015
    implementation of an update to the Gilenya® (fingolimod) label in the EU approved by the CHMP. The CHMP adopted a change to the existing indication to reflect a modification in the criteria for disease activity that needed to be fulfilled in order to enable a switch from a first line disease modifying therapy to Gilenya®. Hence, inclusion criterion #3 was adapted accordingly

    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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