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    Clinical Trial Results:
    A single-arm, open-label study of the palatability and tolerability of Exjade taken with meals, with different liquids or crushed and added to food Due to EudraCT system limitations, which EMA is aware of, data using 999 as data points in this record are not an accurate representation of the clinical trial results. Please use https://www.novctrd.com/CtrdWeb/home.novfor complete trial results.

    Summary
    EudraCT number
    		 2011-004217-17
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    31 Aug 2010

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Jul 2018
    First version publication date
    06 Jul 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CICL670AUS32
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00845871
    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)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001103-PIP01-10
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    31 Aug 2010
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Aug 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the study was to evaluate the palatability of deferasirox with alternative methods of administration over three months of assessment.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 May 2009
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 65
    Worldwide total number of subjects
    65
    EEA total number of subjects
    0
    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)
    15
    Adolescents (12-17 years)
    17
    Adults (18-64 years)
    23
    From 65 to 84 years
    10
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at 23 centres in United States.

    Pre-assignment
    Screening details
    		 A total of 82 subjects were screened, out of which 65 subjects were enrolled into the study.

    Period 1
    Period 1 title
    Run-in period
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    The study was open label, hence no blinding was performed.

    Arms
    Arm title
    		 Deferasirox (Run-in period)
    Arm description
    		 Subjects were administered with deferasirox starting dose of 20 milligram/kilogram/day (mg/kg/day), daily 30 minutes before meal.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Deferasirox
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects were administered with deferasirox starting dose of 20 mg/kg orally on daily basis with meal.

    Number of subjects in period 1
    		Deferasirox (Run-in period)
    Started
    65
    Completed
    65
    Period 2
    Period 2 title
    Overall period
    Is this the baseline period?
    		 Yes [1]
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    The study was open label, hence no blinding was performed.

    Arms
    Arm title
    		 Deferasirox (Assessment period)
    Arm description
    		 Subjects were administered daily with deferasirox at a minimum starting dose of 20 mg/kg/day along with different food and liquids consistently for 12 weeks of assessment period. For subjects receiving > 30 mg/kg/day, a maximum of 40 mg/kg/day was allowed.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Deferasirox
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects were administered daily with deferasirox starting dose of 20 mg/kg orally to a maximum dose of 40 mg/kg/day.

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: The study design comprised of a run-in period prior randomization of subjects into the assessment period. The assessment period was considered as baseline period.
    Number of subjects in period 2
    		Deferasirox (Assessment period)
    Started
    65
    Completed
    58
    Not completed
    7
         Abnormal laboratory value(s)
    1
         Consent withdrawn by subject
    3
         Adverse event, non-fatal
    2
         'Abnormal test procedure result(s) '
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall period
    Reporting group description
    		 All enrolled subjects were analysed regardless of any treatment received or not.

    Reporting group values
    		 Overall period Total
    Number of subjects
    		 65 65
    Age categorical
    Units: Subjects
        Children (2-11 years)
    		 15 15
        Adolescents (12-17 years)
    		 17 17
        Adults (18-64 years)
    		 23 23
        From 65-84 years
    		 10 10
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 27 ( 22.88 ) -
    Gender categorical
    Units: Subjects
        Female
    		 27 27
        Male
    		 38 38

    End points

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    End points reporting groups
    Reporting group title
    Deferasirox (Run-in period)
    Reporting group description
    		 Subjects were administered with deferasirox starting dose of 20 milligram/kilogram/day (mg/kg/day), daily 30 minutes before meal.
    Reporting group title
    Deferasirox (Assessment period)
    Reporting group description
    		 Subjects were administered daily with deferasirox at a minimum starting dose of 20 mg/kg/day along with different food and liquids consistently for 12 weeks of assessment period. For subjects receiving > 30 mg/kg/day, a maximum of 40 mg/kg/day was allowed.

    Subject analysis set title
    Breakfast (Deferasirox with soft food)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Subjects received crushed deferasirox added to soft food at breakfast

    Subject analysis set title
    Breakfast (Deferasirox with liquid)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Subjects received deferasirox dispersed in a beverage of choice (non-carbonated, non-alcoholic liquid) at breakfast.

    Subject analysis set title
    Dinner (Deferasirox with soft food)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Subjects received crushed deferasirox added to a soft food at dinner.

    Subject analysis set title
    Dinner (Deferasirox with liquid)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Subjects received deferasirox dispersed in a beverage of choice (a non-carbonated, non-alcoholic liquid) at dinner.

    Subject analysis set title
    No meal (Deferasirox with liquid)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Subjects received deferasirox dispersed in a beverage of choice (non-carbonated, non-alcoholic liquid) with no meal.

    Subject analysis set title
    No meal (Deferasirox with soft food)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Subjects received crushed deferasirox added to a soft food with no meal.

    Primary: Subjective assessment of deferasirox formulation palatability based on Facial Hedonic Scale at Week 8 and Week 12

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    End point title
    		 Subjective assessment of deferasirox formulation palatability based on Facial Hedonic Scale at Week 8 and Week 12 [1]
    End point description
    Palatability was assessed by subjects based on a five-point Facial Hedonic scale defined as: dislike extremely; somewhat dislike; neither like or dislike; somewhat like; like extremely for the meal and method of administration. For subjects under 5 years of age, the scale was completed by parent or caregiver. The primary analysis was performed in the Intent to treat (ITT) population defined as all subjects enrolled regardless of any treatment received or not.
    End point type
    Primary
    End point timeframe
    Week 8 and Week 12
    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: Only descriptive summary statistics was planned for this outcome measure.
    End point values
    		 Breakfast (Deferasirox with soft food) Breakfast (Deferasirox with liquid) Dinner (Deferasirox with soft food) Dinner (Deferasirox with liquid) No meal (Deferasirox with liquid) No meal (Deferasirox with soft food)
    Number of subjects analysed
    20
    18
    14
    17
    39
    30
    Units: Percentage of subjects
    number (not applicable)
        Week 8, Dislike extremely (n=10,7,3,7,17,7)
    10
    0
    0
    0
    0
    0
        Week 8, Somewhat dislike (n=10,7,3,7,17,7)
    0
    28.6
    0
    14.3
    5.9
    14.3
        Week 8, Neither like or dislike (n=10,7,3,7,17,7)
    20
    28.6
    33.3
    28.6
    29.4
    28.6
        Week 8, Somewhat like (n=10,7,3,7,17,7)
    30
    0
    0
    28.6
    17.6
    42.9
        Week 8, Like extremely (n=10,7,3,7,17,7)
    40
    42.9
    66.7
    28.6
    47.1
    14.3
        Week 12, Dislike extremely (n=6,4,3,3,23,10)
    0
    0
    0
    0
    4.3
    0
        Week 12, Somewhat dislike (n=6,4,3,3,23,10)
    0
    25
    0
    0
    4.3
    10
        Week 12, Neither like or dislike (n=6,4,3,3,23,10)
    16.7
    25
    0
    33.3
    56.5
    50
        Week 12, Somewhat like (n=6,4,3,3,23,10)
    33.3
    0
    66.7
    33.3
    8.7
    10
        Week 12, Like extremely (n=6,4,3,3,23,10)
    50
    50
    33.3
    33.3
    26.1
    30
    No statistical analyses for this end point

    Primary: Subjective assessment of deferasirox formulation palatability based on Facial Hedonic Scale at Week 1 to Week 4

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    End point title
    		 Subjective assessment of deferasirox formulation palatability based on Facial Hedonic Scale at Week 1 to Week 4 [2]
    End point description
    Palatability was assessed by subjects based on a five-point Facial Hedonic scale defined as: dislike extremely; somewhat dislike; neither like or dislike; somewhat like; like extremely for the meal and method of administration. For subjects under 5 years of age, the scale was completed by parent or caregiver. The primary analysis was performed in the ITT population.
    End point type
    Primary
    End point timeframe
    Week 1, Week 2, Week 3 and Week 4
    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: Only descriptive summary statistics was planned for this outcome measure.
    End point values
    		 Deferasirox (Run-in period)
    Number of subjects analysed
    65
    Units: Percentage of subjects
    number (not applicable)
        Week 1, Dislike extremely (n= 54)
    14.8
        Week 1, Somewhat dislike (n= 54)
    22.2
        Week 1, Neither like or dislike (n= 54)
    20.4
        Week 1, Somewhat like (n= 54)
    24.1
        Week 1, Like extremely (n= 54)
    18.5
        Week 2, Dislike extremely (n= 55)
    16.4
        Week 2, Somewhat dislike (n= 55)
    20
        Week 2, Neither like or dislike (n= 55)
    23.6
        Week 2, Somewhat like (n= 55)
    23.6
        Week 2, Like extremely (n= 55)
    16.4
        Week 3, Dislike extremely (n= 51)
    15.7
        Week 3, Somewhat dislike (n= 51)
    25.5
        Week 3, Neither like or dislike (n= 51)
    23.5
        Week 3, Somewhat like (n= 51)
    17.6
        Week 3, Like extremely (n= 51)
    17.6
        Week 4, Dislike extremely (n= 43)
    11.6
        Week 4, Somewhat dislike (n= 43)
    20.9
        Week 4, Neither like or dislike (n= 43)
    30.2
        Week 4, Somewhat like (n= 43)
    18.6
        Week 4, Like extremely (n= 43)
    18.6
    No statistical analyses for this end point

    Secondary: Percentage change from Week 4 in trough plasma concentration of deferasirox to Week 8, Week 12 and Week 16

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    End point title
    		 Percentage change from Week 4 in trough plasma concentration of deferasirox to Week 8, Week 12 and Week 16
    End point description
    Blood samples were drawn at every visit as close as possible to 24 hours post dose from each subject participating in the study and trough plasma concentrations were estimated. The analysis was performed in the ITT population.
    End point type
    Secondary
    End point timeframe
    Pre-dose (0), 1 hour, 2 hour, 4 hour and 6 hour (Post-dose)
    End point values
    		 Deferasirox (Assessment period)
    Number of subjects analysed
    65
    Units: Percentage change in median
    number (not applicable)
        Week 8, Deferasirox 20 mg/kg (n= 11)
    83.8
        Week 12, Deferasirox 20 mg/kg (n= 8)
    238.9
        Week 16, Deferasirox 20 mg/kg (n= 12)
    40.5
        Week 8, Deferasirox 30 mg/kg (n= 8)
    -30.4
        Week 12, Deferasirox 30 mg/kg (n= 9)
    18.5
        Week 16, Deferasirox 30 mg/kg (n= 9)
    88.3
    No statistical analyses for this end point

    Secondary: Number of subjects with adverse events (AEs), serious adverse events (SAEs), permanent discontinuation and temporary interruption

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    End point title
    		 Number of subjects with adverse events (AEs), serious adverse events (SAEs), permanent discontinuation and temporary interruption
    End point description
    Adverse events (AEs) were defined as any unfavourable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events (SAEs) were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalisation, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards. Subjects who had permanently terminated from the treatment or kept the treatment on hold/deviated from protocol due to adverse event were defined as subjects with permanent discontinuation and temporary interruption, respectively. The analysis was performed in the Safety Set (SAF) population, defined as all subjects who received at least one dose of study medication.
    End point type
    Secondary
    End point timeframe
    Day 1 up to Week 16
    End point values
    		 Deferasirox (Run-in period) Breakfast (Deferasirox with soft food) Breakfast (Deferasirox with liquid) Dinner (Deferasirox with soft food) Dinner (Deferasirox with liquid) No meal (Deferasirox with liquid) No meal (Deferasirox with soft food)
    Number of subjects analysed
    62
    20
    18
    14
    17
    39
    30
    Units: Number of subjects
        AEs
    390
    10
    6
    6
    6
    24
    11
        SAEs
    5
    5
    0
    1
    1
    6
    0
        AEs leading to permanent discontinuation
    0
    2
    0
    0
    0
    0
    1
        AEs leading to temporary interruption
    4
    2
    1
    0
    0
    2
    0
    No statistical analyses for this end point

    Secondary: Duration of gastro-intestinal side effects of deferasirox

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    End point title
    		 Duration of gastro-intestinal side effects of deferasirox
    End point description
    Gastrointestinal tolerability was assessed in subjects who experienced stomach ache, nausea, vomiting, and diarrhoea. Duration of an event was determined by taking each subject's maximum weekly duration of that event. The analysis was performed in the SAF population. Here, the value 99999.9 in the mean and standard deviation field represents not available estimable data when the subject analysed was 0 and 1, respectively.
    End point type
    Secondary
    End point timeframe
    Week 1 up to Week 16
    End point values
    		 Breakfast (Deferasirox with soft food) Breakfast (Deferasirox with liquid) Dinner (Deferasirox with soft food) Dinner (Deferasirox with liquid) No meal (Deferasirox with liquid) No meal (Deferasirox with soft food)
    Number of subjects analysed
    20
    18
    14
    17
    39
    30
    Units: Days
    arithmetic mean (standard deviation)
        Stomach ache (n= 5, 5, 7, 4, 11, 11)
    3.2 ( 2.17 )
    3.6 ( 3.13 )
    2.3 ( 1.5 )
    2.7 ( 1.38 )
    2.5 ( 1.86 )
    3.1 ( 2.21 )
        Nausea (n= 2, 2, 1, 3, 8, 5)
    1.5 ( 0.71 )
    2 ( 0 )
    1.3 ( 0.58 )
    5 ( 99999.9 )
    2.5 ( 2.07 )
    3.4 ( 1.67 )
        Vomiting (n= 1, 2, 1, 1, 5, 5,)
    2 ( 99999.9 )
    2 ( 0 )
    1 ( 99999.9 )
    5 ( 9999.9 )
    2 ( 1.73 )
    1.4 ( 0.89 )
        Diarrhoea (n= 3, 4, 3, 0, 9, 10)
    4.7 ( 2.52 )
    3.5 ( 2.38 )
    99999.9 ( 99999.9 )
    2.7 ( 0.58 )
    3.7 ( 2.45 )
    2.9 ( 1.85 )
    No statistical analyses for this end point

    Secondary: Number of subjects with gastro-intestinal side effects of deferasirox

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    End point title
    		 Number of subjects with gastro-intestinal side effects of deferasirox
    End point description
    Gastrointestinal tolerability was assessed in subjects who experienced stomach ache, nausea, vomiting, and diarrhoea. Occurence rate of stomach ache, nausea, vomiting and diarrhoea was determined. The assessment was done for the frequency and duration of the gastrointestinal side effect in subject. The analysis was performed in the SAF population.
    End point type
    Secondary
    End point timeframe
    Week 1 up to Week 16
    End point values
    		 Breakfast (Deferasirox with soft food) Breakfast (Deferasirox with liquid) Dinner (Deferasirox with soft food) Dinner (Deferasirox with liquid) No meal (Deferasirox with liquid) No meal (Deferasirox with soft food)
    Number of subjects analysed
    20
    18
    14
    17
    39
    30
    Units: Number of subjects
        Stomach ache
    6
    6
    4
    7
    13
    11
        Nausea
    2
    2
    3
    1
    9
    6
        Vomiting
    1
    2
    1
    1
    5
    5
        Diarrhoea
    3
    4
    0
    3
    9
    10
    No statistical analyses for this end point

    Secondary: Change from baseline in serum ferritin at Week 16

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    End point title
    		 Change from baseline in serum ferritin at Week 16
    End point description
    Ferritin protein stores iron and provides overall iron levels. Higher ferritin in blood showed higher iron content. Fluctuations from normal serum ferritin levels (500 ng/mL) observed at two consecutive visits led to dose adjustment of deferasirox. The analysis was performed in the ITT population. The 'n' signifies those subjects evaluable for this measure at specified time points for each group respectively.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 16 (End of study)
    End point values
    		 Deferasirox (Assessment period)
    Number of subjects analysed
    65
    Units: Nanogram/mlillilitre
    arithmetic mean (standard deviation)
        Age 2 to < 10 years (n= 10)
    -198.1 ( 653.11 )
        Age 10 to < 60 years (n= 44)
    38.3 ( 859.45 )
        Age ≥ 60 years (n= 10)
    -593 ( 1683.39 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious Adverse Events are monitored from date of First Subject First Visit (FSFV) until Last Subject Last Visit (LSLV). All other adverse events are monitored from First Subject First Treatment until Last Subject Last Visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12.0
    Reporting groups
    Reporting group title
    Deferasirox
    Reporting group description
    		 Subjects were administered daily with deferasirox at a minimum starting dose of 20 mg/kg/day along with different food and liquids consistently for 12 weeks of assessment period. For subjects receiving > 30 mg/kg/day, a maximum of 40 mg/kg/day was allowed.

    Serious adverse events
    		 Deferasirox
    Total subjects affected by serious adverse events
         subjects affected / exposed
    15 / 65 (23.08%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Congenital, familial and genetic disorders
    Sickle cell anaemia with crisis
         subjects affected / exposed
    8 / 65 (12.31%)
         occurrences causally related to treatment / all
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    Hypotension
         subjects affected / exposed
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Catheter related complication
         subjects affected / exposed
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pyrexia
         subjects affected / exposed
    3 / 65 (4.62%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Acute chest syndrome
         subjects affected / exposed
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Pancreatitis acute
         subjects affected / exposed
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Sepsis
         subjects affected / exposed
    2 / 65 (3.08%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Perirectal abscess
         subjects affected / exposed
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Viral infection
         subjects affected / exposed
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Deferasirox
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    47 / 65 (72.31%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    4 / 65 (6.15%)
         occurrences all number
    5
    Nervous system disorders
    Headache
         subjects affected / exposed
    7 / 65 (10.77%)
         occurrences all number
    11
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    8 / 65 (12.31%)
         occurrences all number
    9
    Pyrexia
         subjects affected / exposed
    15 / 65 (23.08%)
         occurrences all number
    18
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    8 / 65 (12.31%)
         occurrences all number
    14
    Abdominal pain upper
         subjects affected / exposed
    8 / 65 (12.31%)
         occurrences all number
    10
    Vomiting
         subjects affected / exposed
    10 / 65 (15.38%)
         occurrences all number
    10
    Nausea
         subjects affected / exposed
    15 / 65 (23.08%)
         occurrences all number
    16
    Diarrhoea
         subjects affected / exposed
    20 / 65 (30.77%)
         occurrences all number
    24
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    6 / 65 (9.23%)
         occurrences all number
    7
    Oropharyngeal pain
         subjects affected / exposed
    5 / 65 (7.69%)
         occurrences all number
    5
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    4 / 65 (6.15%)
         occurrences all number
    4
    Pain in extremity
         subjects affected / exposed
    5 / 65 (7.69%)
         occurrences all number
    6
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    8 / 65 (12.31%)
         occurrences all number
    11
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    4 / 65 (6.15%)
         occurrences all number
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Mar 2009
    Assessment schedule and inclusion/exclusion criteria, modified diarrhoea algorithm, and revised timing of PK assessments and pregnancy tests were updated.
    03 Sep 2009
    New safety recommendations were incorporated.

    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.
    Due to EudraCT system limitations, which EMA is aware of, data using 999 as data points in this record are not an accurate representation of the clinical trial results. Please use https://www.novctrd.com/CtrdWeb/home.novfor complete trial results.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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