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    Clinical Trial Results:
    A phase II multicenter clinical study evaluating long-term safety, tolerability and efficacy of 5-year treatment with deferasirox in pediatric patients with beta-thalassemia major An extension of: An open label, phase IIa study to evaluate the safety, tolerability, pharmacokinetics and the effects on liver iron concentration of repeated doses of 10 mg/kg/day of ICL670 administered to pediatric patients with transfusion-dependent beta-thalassemia major

    Summary
    EudraCT number
    		 2015-003535-35
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    12 Feb 2008

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Jul 2016
    First version publication date
    27 Jul 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CICL670A0106E1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00390858
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    12 Feb 2008
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Feb 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the trial was to evaluate the long-term safety and tolerability profile of deferasirox (ICL670) after administration of multiple doses.
    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
    24 Sep 2003
    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
    Italy: 38
    Country: Number of subjects enrolled
    France: 2
    Worldwide total number of subjects
    40
    EEA total number of subjects
    40
    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)
    20
    Adolescents (12-17 years)
    20
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was performed at 4 centres in Italy and France.

    Pre-assignment
    Screening details
    		 A total of 40 subjects (20 children and 20 adolescents) were enrolled, out of which 39 completed the 1-year treatment (core study) and entered the 4-year extension study. One subject withdrew consent from extension phase of the study.

    Period 1
    Period 1 title
    Core Study 1 year
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Deferasirox in Children (< 12 years)
    Arm description
    		 Children of age below 12 years were orally administered with initial once daily dose of 10 milligram (mg)/kilogram (kg) of deferasirox 30 minutes prior to breakfast. Dose adjustments were performed (± 5 or 10 mg/kg) depending on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Deferasirox
    Investigational medicinal product code
    ICL670
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects were administered with once daily dose of 10 mg/kg of deferasirox 30 minutes prior to breakfast.

    Arm title
    		 Deferasirox in Adolescents (≥ 12 years)
    Arm description
    		 Adolescents of age equal to or above 12 years up to 17 years were orally administered with initial once daily dose of 10 mg/kg of deferasirox 30 minutes prior to breakfast. Dose adjustments were performed (± 5 or 10 mg/kg) depending on safety parameters (e.g. renal and hematology) and whether LIC and serum ferritin were increasing or decreasing.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Deferasirox
    Investigational medicinal product code
    ICL670
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects were administered with once daily dose of 10 mg/kg of deferasirox 30 minutes prior to breakfast.

    Number of subjects in period 1
    		Deferasirox in Children (< 12 years) Deferasirox in Adolescents (≥ 12 years)
    Started
    20
    20
    Completed
    19
    20
    Not completed
    1
    0
         Consent withdrawn by subject
    1
    -
    Period 2
    Period 2 title
    Extension 4 years
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Extension Defersirox in children(<12years)
    Arm description
    		 Children of age below 12 years were orally administered with initial once daily dose of 10 milligram (mg)/kilogram (kg) of deferasirox 30 minutes prior to breakfast. Dose adjustments were performed (± 5 or 10 mg/kg) depending on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Deferasirox
    Investigational medicinal product code
    ICL670
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects were administered with once daily dose of 10 mg/kg of deferasirox 30 minutes prior to breakfast.

    Arm title
    		 Extension Defersirox in children(≥12years)
    Arm description
    		 Adolescents of age equal to or above 12 years up to 17 years were orally administered with initial once daily dose of 10 mg/kg of deferasirox 30 minutes prior to breakfast. Dose adjustments were performed (± 5 or 10 mg/kg) depending on safety parameters (e.g. renal and hematology) and whether LIC and serum ferritin were increasing or decreasing
    Arm type
    		 Experimental

    Investigational medicinal product name
    Deferasirox
    Investigational medicinal product code
    ICL670
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects were administered with once daily dose of 10 mg/kg of deferasirox 30 minutes prior to breakfast.

    Number of subjects in period 2
    		Extension Defersirox in children(<12years) Extension Defersirox in children(≥12years)
    Started
    19
    20
    Completed
    11
    13
    Not completed
    8
    7
         Consent withdrawn by subject
    2
    4
         Adverse event, non-fatal
    6
    2
         Unsatisfactory therapeutic effect
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Deferasirox in Children (< 12 years)
    Reporting group description
    		 Children of age below 12 years were orally administered with initial once daily dose of 10 milligram (mg)/kilogram (kg) of deferasirox 30 minutes prior to breakfast. Dose adjustments were performed (± 5 or 10 mg/kg) depending on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing.

    Reporting group title
    Deferasirox in Adolescents (≥ 12 years)
    Reporting group description
    		 Adolescents of age equal to or above 12 years up to 17 years were orally administered with initial once daily dose of 10 mg/kg of deferasirox 30 minutes prior to breakfast. Dose adjustments were performed (± 5 or 10 mg/kg) depending on safety parameters (e.g. renal and hematology) and whether LIC and serum ferritin were increasing or decreasing.

    Reporting group values
    		 Deferasirox in Children (< 12 years) Deferasirox in Adolescents (≥ 12 years) Total
    Number of subjects
    		 20 20 40
    Age categorical
    Units: Subjects
        Children (2-11 years)
    		 20 0 20
        Adolescents (12-17 years)
    		 0 20 20
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 6.7 ( 2.83 ) 14.1 ( 1.64 ) -
    Gender, Male/Female
    Units: participants
        Female
    		 12 11 23
        Male
    		 8 9 17
    Race/Ethnicity, Customized
    Units: Subjects
        Caucasian
    		 20 20 40

    End points

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    End points reporting groups
    Reporting group title
    Deferasirox in Children (< 12 years)
    Reporting group description
    		 Children of age below 12 years were orally administered with initial once daily dose of 10 milligram (mg)/kilogram (kg) of deferasirox 30 minutes prior to breakfast. Dose adjustments were performed (± 5 or 10 mg/kg) depending on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing.

    Reporting group title
    Deferasirox in Adolescents (≥ 12 years)
    Reporting group description
    		 Adolescents of age equal to or above 12 years up to 17 years were orally administered with initial once daily dose of 10 mg/kg of deferasirox 30 minutes prior to breakfast. Dose adjustments were performed (± 5 or 10 mg/kg) depending on safety parameters (e.g. renal and hematology) and whether LIC and serum ferritin were increasing or decreasing.
    Reporting group title
    Extension Defersirox in children(<12years)
    Reporting group description
    		 Children of age below 12 years were orally administered with initial once daily dose of 10 milligram (mg)/kilogram (kg) of deferasirox 30 minutes prior to breakfast. Dose adjustments were performed (± 5 or 10 mg/kg) depending on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing.

    Reporting group title
    Extension Defersirox in children(≥12years)
    Reporting group description
    		 Adolescents of age equal to or above 12 years up to 17 years were orally administered with initial once daily dose of 10 mg/kg of deferasirox 30 minutes prior to breakfast. Dose adjustments were performed (± 5 or 10 mg/kg) depending on safety parameters (e.g. renal and hematology) and whether LIC and serum ferritin were increasing or decreasing

    Primary: Number of subjects with adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation and who died

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    End point title
    		 Number of subjects with adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation and who died [1]
    End point description
    AEs are defined as any unfavorable 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 are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards. The analysis was performed on safety set population defined as all subjects who received at least one dose of deferasirox during the core or extension study.
    End point type
    Primary
    End point timeframe
    Core: 1 year, Extension: 4 years
    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
    		 Deferasirox in Children (< 12 years) Deferasirox in Adolescents (≥ 12 years)
    Number of subjects analysed
    20
    20
    Units: Subjects
        AEs
    18
    11
        SAEs
    4
    8
        AEs leading to Discontinuation
    6
    2
        Deaths
    0
    0
    No statistical analyses for this end point

    Primary: Change in liver iron concentration (LIC) from baseline of core period to end of extension period

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    End point title
    		 Change in liver iron concentration (LIC) from baseline of core period to end of extension period [2]
    End point description
    Change in liver iron content (LIC) as assessed by superconducting quantum interference device (SQUID) was evaluated by comparing the LIC at the start of deferasirox treatment to the LIC at the end of the extension study. LIC was expressed in milligrams of iron per gram of liver dry weight (mgFe/g dw). The analysis was performed in safety set population.
    End point type
    Primary
    End point timeframe
    Core period: Baseline, 4, 12, 24, 36 and 48 weeks. Extension period: 6 months for 1st and 2nd year and annually for 3rd and 4th year.
    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 in Children (< 12 years) Deferasirox in Adolescents (≥ 12 years)
    Number of subjects analysed
    20
    20
    Units: mg Fe/g dw
    arithmetic mean (standard deviation)
        Core Baseline LIC (n = 20, 20)
    6.25 ( 2.507 )
    5.73 ( 2.185 )
        End of Extension LIC (n=19, 20)
    5.46 ( 3.192 )
    4.66 ( 3.533 )
        Change from Baseline LIC (n=19, 20)
    -0.9 ( 3.85 )
    -1.1 ( 3.03 )
    No statistical analyses for this end point

    Secondary: Total Body Iron Elimination (TBIE) Rate from baseline of core period to end of extension period

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    End point title
    		 Total Body Iron Elimination (TBIE) Rate from baseline of core period to end of extension period
    End point description
    Total body iron elimination rate (TBIE) was defined as TBIE = Kin + [Us(t0)-Us(t)]/(t-t0) where, Kin was the known iron influx rate from transfusions, calculated from time t0 to time t, Us(t) (mg(s) of iron) was the estimated TBI from LIC at time t, Us(t) = 10.6 × LIC× (body weight), where LIC was in mg(s) of iron/g of dry weight of liver and body weight in kilograms, and t0 was taken as last available date prior start of treatment with deferasirox, where LIC was measured. The analysis was performed in safety set population.
    End point type
    Secondary
    End point timeframe
    Baseline of Core Study to End of Extension Study (up to 5 years)
    End point values
    		 Deferasirox in Children (< 12 years) Deferasirox in Adolescents (≥ 12 years)
    Number of subjects analysed
    20
    20
    Units: mg/kg/Day
    arithmetic mean (standard deviation)
        Core Baseline TBIE (n=19, 20)
    0.4292 ( 0.06454 )
    0.4083 ( 0.07158 )
        End of Extension TBIE (n=11,14)
    0.4939 ( 0.05175 )
    0.4286 ( 0.0637 )
    No statistical analyses for this end point

    Secondary: Relative Change in serum ferritin level from baseline of core period to end of extension period

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    End point title
    		 Relative Change in serum ferritin level from baseline of core period to end of extension period
    End point description
    Serum levels were drawn at the baseline of the Core Study up to 18 months of the Extension Study. Relative change (%) in serum ferritin level was assessed. Relative Change was defined as 1 - (Change in ferritin level from Baseline/Baseline level) x 100. The analysis was performed in safety set population.
    End point type
    Secondary
    End point timeframe
    Baseline of Core Study to End of Extension Study (up to 5 years)
    End point values
    		 Deferasirox in Children (< 12 years) Deferasirox in Adolescents (≥ 12 years)
    Number of subjects analysed
    20
    20
    Units: percent change
    arithmetic mean (standard deviation)
        Core Baseline
    2146.3 ( 1422.53 )
    1867.5 ( 711.37 )
        Last available value
    2973.7 ( 1016.39 )
    2707.7 ( 1107.11 )
        Relative change
    62.4 ( 53.47 )
    54.9 ( 64.64 )
    No statistical analyses for this end point

    Secondary: Relative Change in Serum Transferrin Level from baseline of core period to end of extension period

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    End point title
    		 Relative Change in Serum Transferrin Level from baseline of core period to end of extension period
    End point description
    Transferrin saturation were calculated as a variable derived from serum iron and transferrin concentrations. Relative change (%) in serum transferrin level was assessed, relative change was defined as 1 - (Change in transferrin level from Baseline/Baseline level) x 100. The analysis was performed in safety set population.
    End point type
    Secondary
    End point timeframe
    Baseline of Core Study to End of Extension Study (up to 5 years)
    End point values
    		 Deferasirox in Children (< 12 years) Deferasirox in Adolescents (≥ 12 years)
    Number of subjects analysed
    20
    20
    Units: percent change
    arithmetic mean (standard deviation)
        Core Baseline
    1.246 ( 0.1891 )
    1.449 ( 0.2613 )
        End of study
    1.212 ( 0.198 )
    1.37 ( 0.2101 )
        Relative change
    -1.86 ( 13.5137 )
    -4.177 ( 11.6573 )
    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 LSLV.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    11.0
    Reporting groups
    Reporting group title
    Deferasirox in Adolescents (≥ 12 years)
    Reporting group description
    		 Adolescents of age equal to or above 12 years up to 17 years were orally administered with initial once daily dose of 10 mg/kg of deferasirox 30 minutes prior to breakfast. Dose adjustments were performed (± 5 or 10 mg/kg) depending on safety parameters (e.g. renal and hematology) and whether LIC and serum ferritin were increasing or decreasing.

    Reporting group title
    Deferasirox in Children (< 12 years)
    Reporting group description
    		 Children of age below 12 years were orally administered with initial once daily dose of 10 mg/kg of deferasirox 30 minutes prior to breakfast. Dose adjustments were performed (± 5 or 10 mg/kg) depending on safety parameters (e.g. renal and hematology) and whether LIC and serum ferritin were increasing or decreasing.

    Serious adverse events
    		 Deferasirox in Adolescents (≥ 12 years) Deferasirox in Children (< 12 years)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 20 (40.00%)
    4 / 20 (20.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Investigations
    Transaminases increased
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Head injury
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Allergic transfusion reaction
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Splenectomy
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystectomy
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillectomy
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Splenomegaly
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Local swelling
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatolithiasis
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Ovarian cyst
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic fluid collection
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Biliary colic
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infectious mononucleosis
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Deferasirox in Adolescents (≥ 12 years) Deferasirox in Children (< 12 years)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    20 / 20 (100.00%)
    20 / 20 (100.00%)
    Vascular disorders
    Haematoma
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Hypotension
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    8 / 20 (40.00%)
    7 / 20 (35.00%)
         occurrences all number
    16
    7
    Chest pain
         subjects affected / exposed
    3 / 20 (15.00%)
    1 / 20 (5.00%)
         occurrences all number
    3
    1
    Influenza like illness
         subjects affected / exposed
    1 / 20 (5.00%)
    3 / 20 (15.00%)
         occurrences all number
    1
    3
    Hyperpyrexia
         subjects affected / exposed
    3 / 20 (15.00%)
    1 / 20 (5.00%)
         occurrences all number
    3
    2
    Cyst
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Pyrexia
         subjects affected / exposed
    16 / 20 (80.00%)
    18 / 20 (90.00%)
         occurrences all number
    40
    59
    Suprapubic pain
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Immune system disorders
    Allergy to plants
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Food allergy
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Drug hypersensitivity
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Hypersensitivity
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Reproductive system and breast disorders
    Amenorrhoea
         subjects affected / exposed
    3 / 20 (15.00%)
    0 / 20 (0.00%)
         occurrences all number
    6
    0
    Menorrhagia
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Dysmenorrhoea
         subjects affected / exposed
    4 / 20 (20.00%)
    0 / 20 (0.00%)
         occurrences all number
    9
    0
    Breast discomfort
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Menstrual disorder
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Polymenorrhoea
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Pelvic pain
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Ovarian cyst
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Dysphonia
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Cough
         subjects affected / exposed
    16 / 20 (80.00%)
    18 / 20 (90.00%)
         occurrences all number
    40
    70
    Asthma
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    3
    Dyspnoea
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Epistaxis
         subjects affected / exposed
    3 / 20 (15.00%)
    4 / 20 (20.00%)
         occurrences all number
    4
    6
    Nasal congestion
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Pharyngolaryngeal pain
         subjects affected / exposed
    9 / 20 (45.00%)
    7 / 20 (35.00%)
         occurrences all number
    11
    13
    Productive cough
         subjects affected / exposed
    0 / 20 (0.00%)
    3 / 20 (15.00%)
         occurrences all number
    0
    3
    Throat irritation
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 20 (0.00%)
         occurrences all number
    3
    0
    Depression
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Anxiety
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 20 (0.00%)
         occurrences all number
    5
    0
    Nervousness
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    2
    Beta 2 microglobulin urine increased
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Blood bilirubin increased
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Blood creatinine increased
         subjects affected / exposed
    2 / 20 (10.00%)
    1 / 20 (5.00%)
         occurrences all number
    4
    1
    Blood folate decreased
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Blood homocysteine increased
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Creatinine renal clearance decreased
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Electrocardiogram QT prolonged
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Glomerular filtration rate abnormal
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Transaminases increased
         subjects affected / exposed
    2 / 20 (10.00%)
    8 / 20 (40.00%)
         occurrences all number
    4
    10
    Protein C decreased
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Glucose urine present
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Urinary casts
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    2
    Urine protein/creatinine ratio increased
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    White blood cell count increased
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Vitamin E decreased
         subjects affected / exposed
    4 / 20 (20.00%)
    2 / 20 (10.00%)
         occurrences all number
    4
    2
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    1
    Chest injury
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Eye injury
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Head injury
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    1
    Hand fracture
         subjects affected / exposed
    1 / 20 (5.00%)
    2 / 20 (10.00%)
         occurrences all number
    2
    2
    Foreign body trauma
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Injury
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Joint injury
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Joint sprain
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 20 (0.00%)
         occurrences all number
    2
    0
    Limb injury
         subjects affected / exposed
    0 / 20 (0.00%)
    3 / 20 (15.00%)
         occurrences all number
    0
    3
    Transfusion reaction
         subjects affected / exposed
    1 / 20 (5.00%)
    2 / 20 (10.00%)
         occurrences all number
    1
    3
    Thermal burn
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 20 (0.00%)
         occurrences all number
    2
    0
    Sunburn
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Vertebral injury
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Wound
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    1
    Congenital, familial and genetic disorders
    Talipes
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Cardiac disorders
    Extrasystoles
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Palpitations
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 20 (0.00%)
         occurrences all number
    2
    0
    Cardiomyopathy
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Tachycardia
         subjects affected / exposed
    2 / 20 (10.00%)
    1 / 20 (5.00%)
         occurrences all number
    4
    1
    Nervous system disorders
    Aphonia
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Disturbance in attention
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Headache
         subjects affected / exposed
    12 / 20 (60.00%)
    9 / 20 (45.00%)
         occurrences all number
    36
    27
    Migraine
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Presyncope
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    2
    Somnolence
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Splenomegaly
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Lymphadenopathy
         subjects affected / exposed
    4 / 20 (20.00%)
    0 / 20 (0.00%)
         occurrences all number
    4
    0
    Ear and labyrinth disorders
    Auricular pseudocyst
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Ear pain
         subjects affected / exposed
    4 / 20 (20.00%)
    8 / 20 (40.00%)
         occurrences all number
    4
    13
    Vertigo
         subjects affected / exposed
    3 / 20 (15.00%)
    1 / 20 (5.00%)
         occurrences all number
    6
    1
    Hypoacusis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Eye disorders
    Conjunctival haemorrhage
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Conjunctivitis
         subjects affected / exposed
    4 / 20 (20.00%)
    3 / 20 (15.00%)
         occurrences all number
    4
    3
    Conjunctivitis allergic
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Eye irritation
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Eyelid oedema
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Ocular icterus
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Lacrimation increased
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Hypermetropia
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Retinal degeneration
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Retinopathy
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Vision blurred
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    10 / 20 (50.00%)
    15 / 20 (75.00%)
         occurrences all number
    24
    28
    Abdominal pain upper
         subjects affected / exposed
    8 / 20 (40.00%)
    1 / 20 (5.00%)
         occurrences all number
    14
    1
    Cheilitis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Aphthous stomatitis
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Dental caries
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    2
    Constipation
         subjects affected / exposed
    3 / 20 (15.00%)
    1 / 20 (5.00%)
         occurrences all number
    4
    1
    Diarrhoea
         subjects affected / exposed
    9 / 20 (45.00%)
    8 / 20 (40.00%)
         occurrences all number
    24
    12
    Dry mouth
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Dyspepsia
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 20 (0.00%)
         occurrences all number
    2
    0
    Dysphagia
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Gastritis
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    1
    Flatulence
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Enteritis
         subjects affected / exposed
    4 / 20 (20.00%)
    3 / 20 (15.00%)
         occurrences all number
    6
    3
    Gingivitis
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 20 (0.00%)
         occurrences all number
    2
    0
    Gingival bleeding
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Intestinal congestion
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    10 / 20 (50.00%)
    2 / 20 (10.00%)
         occurrences all number
    23
    2
    Odynophagia
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Stomatitis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Toothache
         subjects affected / exposed
    4 / 20 (20.00%)
    2 / 20 (10.00%)
         occurrences all number
    4
    2
    Vomiting
         subjects affected / exposed
    9 / 20 (45.00%)
    12 / 20 (60.00%)
         occurrences all number
    24
    33
    Hepatobiliary disorders
    Biliary colic
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    2
    0
    Cholecystitis
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Cholelithiasis
         subjects affected / exposed
    4 / 20 (20.00%)
    1 / 20 (5.00%)
         occurrences all number
    4
    1
    Jaundice
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    1
    Dermatitis
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    1
    Eczema
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 20 (0.00%)
         occurrences all number
    2
    0
    Erythema
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    2
    Hyperkeratosis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Ingrowing nail
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Pityriasis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Pityriasis alba
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Psoriasis
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Rash
         subjects affected / exposed
    1 / 20 (5.00%)
    2 / 20 (10.00%)
         occurrences all number
    1
    2
    Rash pruritic
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    2
    Rash papular
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    2
    Skin discolouration
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    1
    Skin exfoliation
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Urticaria
         subjects affected / exposed
    2 / 20 (10.00%)
    2 / 20 (10.00%)
         occurrences all number
    2
    2
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Pollakiuria
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Nephropathy toxic
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Renal colic
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 20 (0.00%)
         occurrences all number
    11
    0
    Proteinuria
         subjects affected / exposed
    2 / 20 (10.00%)
    2 / 20 (10.00%)
         occurrences all number
    2
    6
    Endocrine disorders
    Growth hormone deficiency
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Hypogonadism
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Hypothyroidism
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 20 (15.00%)
    5 / 20 (25.00%)
         occurrences all number
    4
    5
    Groin pain
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Bone swelling
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Back pain
         subjects affected / exposed
    9 / 20 (45.00%)
    3 / 20 (15.00%)
         occurrences all number
    20
    6
    Musculoskeletal pain
         subjects affected / exposed
    3 / 20 (15.00%)
    0 / 20 (0.00%)
         occurrences all number
    4
    0
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 20 (0.00%)
    3 / 20 (15.00%)
         occurrences all number
    0
    4
    Muscle spasms
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Myalgia
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Neck mass
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Neck pain
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Pain in extremity
         subjects affected / exposed
    2 / 20 (10.00%)
    1 / 20 (5.00%)
         occurrences all number
    2
    1
    Torticollis
         subjects affected / exposed
    3 / 20 (15.00%)
    1 / 20 (5.00%)
         occurrences all number
    3
    1
    Infections and infestations
    Acute tonsillitis
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Bacterial infection
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Bronchitis
         subjects affected / exposed
    5 / 20 (25.00%)
    5 / 20 (25.00%)
         occurrences all number
    5
    7
    Bronchopneumonia
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Ear infection
         subjects affected / exposed
    2 / 20 (10.00%)
    9 / 20 (45.00%)
         occurrences all number
    2
    17
    Catheter related infection
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Fungal infection
         subjects affected / exposed
    2 / 20 (10.00%)
    2 / 20 (10.00%)
         occurrences all number
    2
    2
    Gastroenteritis
         subjects affected / exposed
    8 / 20 (40.00%)
    10 / 20 (50.00%)
         occurrences all number
    11
    20
    Gastroenteritis viral
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Genital infection female
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Herpes simplex
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    2
    Impetigo
         subjects affected / exposed
    1 / 20 (5.00%)
    2 / 20 (10.00%)
         occurrences all number
    1
    3
    Influenza
         subjects affected / exposed
    11 / 20 (55.00%)
    7 / 20 (35.00%)
         occurrences all number
    19
    18
    Laryngitis
         subjects affected / exposed
    1 / 20 (5.00%)
    2 / 20 (10.00%)
         occurrences all number
    1
    3
    Localised infection
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Leptospirosis
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Lymphangitis
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    2 / 20 (10.00%)
    6 / 20 (30.00%)
         occurrences all number
    2
    13
    Oral candidiasis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Oral herpes
         subjects affected / exposed
    2 / 20 (10.00%)
    2 / 20 (10.00%)
         occurrences all number
    2
    2
    Otitis media
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    2
    0
    Pharyngitis
         subjects affected / exposed
    10 / 20 (50.00%)
    12 / 20 (60.00%)
         occurrences all number
    40
    24
    Pharyngotonsillitis
         subjects affected / exposed
    4 / 20 (20.00%)
    1 / 20 (5.00%)
         occurrences all number
    5
    2
    Pyoderma
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Rhinitis
         subjects affected / exposed
    13 / 20 (65.00%)
    17 / 20 (85.00%)
         occurrences all number
    27
    70
    Sinusitis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Subcutaneous abscess
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    1
    Skin infection
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 20 (0.00%)
         occurrences all number
    2
    0
    Tinea versicolour
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Tonsillitis
         subjects affected / exposed
    5 / 20 (25.00%)
    3 / 20 (15.00%)
         occurrences all number
    6
    4
    Tooth abscess
         subjects affected / exposed
    1 / 20 (5.00%)
    2 / 20 (10.00%)
         occurrences all number
    1
    3
    Urinary tract infection
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 20 (0.00%)
         occurrences all number
    4
    0
    Tracheitis
         subjects affected / exposed
    2 / 20 (10.00%)
    2 / 20 (10.00%)
         occurrences all number
    2
    3
    Varicella
         subjects affected / exposed
    1 / 20 (5.00%)
    5 / 20 (25.00%)
         occurrences all number
    1
    5
    Vulvitis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Glucose tolerance impaired
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Decreased appetite
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Hyperinsulinism
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Zinc deficiency
         subjects affected / exposed
    5 / 20 (25.00%)
    3 / 20 (15.00%)
         occurrences all number
    5
    3
    Vitamin C deficiency
         subjects affected / exposed
    2 / 20 (10.00%)
    1 / 20 (5.00%)
         occurrences all number
    2
    1
    Hypozincaemia
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Jan 2006
    Prolonged the duration of the extension study to 4 years in order to obtain long-term data on safety and efficacy of deferasirox treatment. Together with the core study duration this resulted in a total of 5 years exposure for enrolled subjects.
    06 Nov 2006
    • Aligned the deferasirox dosing guidelines in the protocol as specified in the EU approved deferasirox label. • Specified the frequency of data safety reviews by the independent Program Safety Board (PSB) as “within approximately every 12 – 18 months” in line with the timing of regular safety updates to the European regulatory authority, EMEA. • Clarified that for efficacy, the success criteria analysis would be based on absolute and relative changes from baseline in LIC.

    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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