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    Clinical Trial Results:
    A one-year,open-label,single arm, multi-center trial evaluating the efficacy and safety of oral ICL670 (20 mg/kg/day) in patients diagnosed with transfusion-dependent iron overload 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
    		 2004-003953-16
    Trial protocol
    		 GB   ES   IT   DK   BE   DE   NO   AT  
    Global end of trial date
    19 Jul 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

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CICL670A2409 (core and extension)
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00171821
    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
    19 Jul 2010
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Jul 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 if fixed starting doses of deferasirox, based on transfusion history and subsequent dose titration can provide clinically acceptable chelation, as measured by serum ferritin, in the subjects with transfusional hemosiderosis and abnormal serum ferritin.
    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. Rescue medication was allowed during the course of the study as per the discretion of duty physician.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Apr 2005
    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
    Australia: 83
    Country: Number of subjects enrolled
    China: 127
    Country: Number of subjects enrolled
    Egypt: 161
    Country: Number of subjects enrolled
    France: 153
    Country: Number of subjects enrolled
    Greece: 74
    Country: Number of subjects enrolled
    Hong Kong: 54
    Country: Number of subjects enrolled
    Israel: 25
    Country: Number of subjects enrolled
    Lebanon: 34
    Country: Number of subjects enrolled
    Malaysia: 129
    Country: Number of subjects enrolled
    Netherlands: 17
    Country: Number of subjects enrolled
    South Africa: 9
    Country: Number of subjects enrolled
    Korea, Republic of: 88
    Country: Number of subjects enrolled
    Switzerland: 14
    Country: Number of subjects enrolled
    Taiwan: 79
    Country: Number of subjects enrolled
    Thailand: 156
    Country: Number of subjects enrolled
    Turkey: 52
    Country: Number of subjects enrolled
    Spain: 22
    Country: Number of subjects enrolled
    United Kingdom: 109
    Country: Number of subjects enrolled
    Austria: 15
    Country: Number of subjects enrolled
    Belgium: 24
    Country: Number of subjects enrolled
    Denmark: 21
    Country: Number of subjects enrolled
    Germany: 93
    Country: Number of subjects enrolled
    Italy: 205
    Worldwide total number of subjects
    1744
    EEA total number of subjects
    733
    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)
    384
    Adolescents (12-17 years)
    281
    Adults (18-64 years)
    822
    From 65 to 84 years
    248
    85 years and over
    9

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 The study was conducted at 136 centres in 23 countries.

    Pre-assignment
    Screening details
    		 A total of 1744 subjects were enrolled in the study.

    Period 1
    Period 1 title
    Core study
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    As the study was an open-label study, this section was not applicable.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Deferasirox (thalassemic subjects) - Core Study
    Arm description
    		 Subjects received a recommended daily dose of deferasirox of 20 mg/kg/day based on the frequency of their blood transfusions history (7-14 millilitres (mL)/kg/month). Subjects receiving less number of blood transfusions were administered with deferasirox; at an initial daily dose of 10 mg/kg/day. Subjects receiving more number of blood transfusions were administered with deferasirox 30 mg/kg/day.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Deferasirox
    Investigational medicinal product code
    ICL670
    Other name
    Pharmaceutical forms
    Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    Deferasirox 10 mg/kg/day or 20 mg/kg/day or 30 mg/kg/day was administered for 52 weeks.

    Arm title
    		 Deferasirox (myelodysplastic syndrome subjects) - Core Study
    Arm description
    		 Subjects received a recommended daily dose of deferasirox of 20 mg/kg/day based on the frequency of their blood transfusions history (7-14 mL/kg/month). Subjects receiving less number of blood transfusions were administered with deferasirox; at an initial daily dose of 10 mg/kg/day. Subjects receiving more number of blood transfusions were administered with deferasirox 30 mg/kg/day.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Deferasirox
    Investigational medicinal product code
    ICL670
    Other name
    Pharmaceutical forms
    Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    Deferasirox 10 mg/kg/day or 20 mg/kg/day or 30 mg/kg/day was administered for 52 weeks.

    Arm title
    		 Deferasirox (sickle cell disease subjects) - Core Study
    Arm description
    		 Deferasirox was administered to the subjects suffered with sickle cell disease as per the frequency of blood transfusions history. Subjects treated with the initial dose of either 20 mg/kg/day (for the subjects with frequency of blood transfusions about 2 to 4 units/month or 7 to 14 mL/kg/month of packed RBC) or 30 mg/kg/day (for the subjects with more frequency of blood transfusions) or 10 mg/kg/day (for the subjects with less frequency of blood transfusions).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Deferasirox
    Investigational medicinal product code
    ICL670
    Other name
    Pharmaceutical forms
    Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    Deferasirox 10 mg/kg/day or 20 mg/kg/day or 30 mg/kg/day was administered for 52 weeks.

    Arm title
    		 Deferasirox (rare anemia subjects) - Core Study
    Arm description
    		 Subjects received a recommended daily dose of deferasirox of 20 mg/kg/day based on the frequency of their blood transfusions history (7-14 mL/kg/month). Subjects receiving less number of blood transfusions were administered with deferasirox; at an initial daily dose of 10 mg/kg/day. Subjects receiving more number of blood transfusions were administered with deferasirox 30 mg/kg/day.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Deferasirox
    Investigational medicinal product code
    ICL670
    Other name
    Pharmaceutical forms
    Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    Deferasirox 10 mg/kg/day or 20 mg/kg/day or 30 mg/kg/day was administered for 52 weeks.

    Arm title
    		 Deferasirox (aplastic anemia subjects)- Core Study
    Arm description
    		 Subjects received a recommended daily dose of deferasirox of 20 mg/kg/day based on the frequency of their blood transfusions history (7-14 mL/kg/month). Subjects receiving less number of blood transfusions were administered with deferasirox; at an initial daily dose of 10 mg/kg/day. Subjects receiving more number of blood transfusions were administered with deferasirox 30 mg/kg/day.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Deferasirox
    Investigational medicinal product code
    ICL670
    Other name
    Pharmaceutical forms
    Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    Deferasirox 10 mg/kg/day or 20 mg/kg/day or 30 mg/kg/day was administered for 52 weeks.

    Arm title
    		 Deferasirox (malignant disease subjects) - Core Study
    Arm description
    		 Subjects received a recommended daily dose of deferasirox of 20 mg/kg/day based on the frequency of their blood transfusions history (7-14 mL/kg/month). Subjects receiving less number of blood transfusions were administered with deferasirox; at an initial daily dose of 10 mg/kg/day. Subjects receiving more number of blood transfusions were administered with deferasirox 30 mg/kg/day.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Deferasirox
    Investigational medicinal product code
    ICL670
    Other name
    Pharmaceutical forms
    Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    Deferasirox 10 mg/kg/day or 20 mg/kg/day or 30 mg/kg/day was administered for 52 weeks.

    Arm title
    		 Deferasirox (other disease subjects) - Core Study
    Arm description
    		 Subjects received a recommended daily dose of deferasirox of 20 mg/kg/day based on the frequency of their blood transfusions history (7-14 mL/kg/month). Subjects receiving less number of blood transfusions were administered with deferasirox; at an initial daily dose of 10 mg/kg/day. Subjects receiving more number of blood transfusions were administered with deferasirox 30 mg/kg/day.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Deferasirox
    Investigational medicinal product code
    ICL670
    Other name
    Pharmaceutical forms
    Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    Deferasirox 10 mg/kg/day or 20 mg/kg/day or 30 mg/kg/day was administered for 52 weeks.

    Number of subjects in period 1
    		Deferasirox (thalassemic subjects) - Core Study Deferasirox (myelodysplastic syndrome subjects) - Core Study Deferasirox (sickle cell disease subjects) - Core Study Deferasirox (rare anemia subjects) - Core Study Deferasirox (aplastic anemia subjects)- Core Study Deferasirox (malignant disease subjects) - Core Study Deferasirox (other disease subjects) - Core Study
    Started
    1115
    341
    80
    43
    116
    41
    8
    Completed
    1010
    175
    63
    30
    88
    16
    7
    Not completed
    105
    166
    17
    13
    28
    25
    1
         Others
    42
    46
    10
    1
    10
    5
    -
         Adverse event, non-fatal
    39
    78
    2
    8
    13
    12
    1
         Protocol violation
    5
    4
    3
    1
    -
    2
    -
         Death
    4
    26
    -
    2
    5
    5
    -
         Administrative reasons
    2
    6
    2
    -
    -
    1
    -
         Lack of efficacy
    13
    6
    -
    1
    -
    -
    -
    Period 2
    Period 2 title
    Extension study
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    As the study was an open-label study, this section was not applicable.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Deferasirox (thalassemic subjects) - Extension study
    Arm description
    		 Subjects received a recommended daily dose of deferasirox of 20 mg/kg/day based on the frequency of their blood transfusions history (7-14 mL/kg/month). Subjects receiving less number of blood transfusions were administered with deferasirox; at an initial daily dose of 10 mg/kg/day. Subjects receiving more number of blood transfusions were administered with deferasirox 30 mg/kg/day.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Deferasirox
    Investigational medicinal product code
    ICL670
    Other name
    Pharmaceutical forms
    Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    Deferasirox 10 mg/kg/day or 20 mg/kg/day or 30 mg/kg/day was administered for 18 months.

    Arm title
    		 Deferasirox (myelodysplastic syndrome)- Extension study
    Arm description
    		 Subjects received a recommended daily dose of deferasirox of 20 mg/kg/day based on the frequency of their blood transfusions history (7-14 mL/kg/month). Subjects receiving less number of blood transfusions were administered with deferasirox; at an initial daily dose of 10 mg/kg/day. Subjects receiving more number of blood transfusions were administered with deferasirox 30 mg/kg/day.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Deferasirox
    Investigational medicinal product code
    ICL670
    Other name
    Pharmaceutical forms
    Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    Deferasirox 10 mg/kg/day or 20 mg/kg/day or 30 mg/kg/day was administered for 18 months.

    Arm title
    		 Deferasirox (sickle cell disease subjects) - Extension study
    Arm description
    		 Deferasirox was administered to the subjects suffered with sickle cell disease as per the frequency of blood transfusions history. Subjects treated with the initial dose of either 20 mg/kg/day (for the subjects with frequency of blood transfusions about 2 to 4 units/month or 7 to 14 mL/kg/month of packed RBC) or 30 mg/kg/day (for the subjects with more frequency of blood transfusions) or 10 mg/kg/day (for the subjects with less frequency of blood transfusions).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Deferasirox
    Investigational medicinal product code
    ICL670
    Other name
    Pharmaceutical forms
    Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    Deferasirox 10 mg/kg/day or 20 mg/kg/day or 30 mg/kg/day was administered for 18 months.

    Arm title
    		 Deferasirox (rare anemia subjects)- Extension study
    Arm description
    		 Subjects received a recommended daily dose of deferasirox of 20 mg/kg/day based on the frequency of their blood transfusions history (7-14 mL/kg/month). Subjects receiving less number of blood transfusions were administered with deferasirox; at an initial daily dose of 10 mg/kg/day. Subjects receiving more number of blood transfusions were administered with deferasirox 30 mg/kg/day.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Deferasirox
    Investigational medicinal product code
    ICL670
    Other name
    Pharmaceutical forms
    Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    Deferasirox 10 mg/kg/day or 20 mg/kg/day or 30 mg/kg/day was administered for 18 months.

    Arm title
    		 Deferasirox (aplastic anemia subjects) - Extension study
    Arm description
    		 Subjects received a recommended daily dose of deferasirox of 20 mg/kg/day based on the frequency of their blood transfusions history (7-14 mL/kg/month). Subjects receiving less number of blood transfusions were administered with deferasirox; at an initial daily dose of 10 mg/kg/day. Subjects receiving more number of blood transfusions were administered with deferasirox 30 mg/kg/day.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Deferasirox
    Investigational medicinal product code
    ICL670
    Other name
    Pharmaceutical forms
    Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    Deferasirox 10 mg/kg/day or 20 mg/kg/day or 30 mg/kg/day was administered for 18 months.

    Arm title
    		 Deferasirox (malignant disease subjects) - Extension study
    Arm description
    		 Subjects received a recommended daily dose of deferasirox of 20 mg/kg/day based on the frequency of their blood transfusions history (7-14 mL/kg/month). Subjects receiving less number of blood transfusions were administered with deferasirox; at an initial daily dose of 10 mg/kg/day. Subjects receiving more number of blood transfusions were administered with deferasirox 30 mg/kg/day.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Deferasirox
    Investigational medicinal product code
    ICL670
    Other name
    Pharmaceutical forms
    Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    Deferasirox 10 mg/kg/day or 20 mg/kg/day or 30 mg/kg/day was administered for 18 months.

    Arm title
    		 Deferasirox (other disease subjects) - Extension study
    Arm description
    		 Subjects received a recommended daily dose of deferasirox of 20 mg/kg/day based on the frequency of their blood transfusions history (7-14 mL/kg/month). Subjects receiving less number of blood transfusions were administered with deferasirox; at an initial daily dose of 10 mg/kg/day. Subjects receiving more number of blood transfusions were administered with deferasirox 30 mg/kg/day.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Deferasirox
    Investigational medicinal product code
    ICL670
    Other name
    Pharmaceutical forms
    Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    Deferasirox 10 mg/kg/day or 20 mg/kg/day or 30 mg/kg/day was administered for 18 months.

    Number of subjects in period 2 [1]
    		Deferasirox (thalassemic subjects) - Extension study Deferasirox (myelodysplastic syndrome)- Extension study Deferasirox (sickle cell disease subjects) - Extension study Deferasirox (rare anemia subjects)- Extension study Deferasirox (aplastic anemia subjects) - Extension study Deferasirox (malignant disease subjects) - Extension study Deferasirox (other disease subjects) - Extension study
    Started
    495
    45
    20
    6
    8
    2
    2
    Completed
    454
    37
    17
    6
    7
    2
    2
    Not completed
    41
    8
    3
    0
    1
    0
    0
         Consent withdrawn by subject
    10
    2
    1
    -
    1
    -
    -
         Adverse event, non-fatal
    4
    1
    1
    -
    -
    -
    -
         Protocol violation
    1
    -
    -
    -
    -
    -
    -
         Death
    1
    3
    -
    -
    -
    -
    -
         Abnormal test procedure result (s)
    1
    -
    -
    -
    -
    -
    -
         Unsatisfactory therapeutic effect
    21
    1
    -
    -
    -
    -
    -
         Subject’s condition no longer requires study drug
    -
    1
    -
    -
    -
    -
    -
         Lost to follow-up
    2
    -
    1
    -
    -
    -
    -
         Abnormal laboratory values (s)
    1
    -
    -
    -
    -
    -
    -
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Not all patients entered the extension phase. This is the reason for the difference in numbers.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Deferasirox (thalassemic subjects) - Core Study
    Reporting group description
    		 Subjects received a recommended daily dose of deferasirox of 20 mg/kg/day based on the frequency of their blood transfusions history (7-14 millilitres (mL)/kg/month). Subjects receiving less number of blood transfusions were administered with deferasirox; at an initial daily dose of 10 mg/kg/day. Subjects receiving more number of blood transfusions were administered with deferasirox 30 mg/kg/day.

    Reporting group title
    Deferasirox (myelodysplastic syndrome subjects) - Core Study
    Reporting group description
    		 Subjects received a recommended daily dose of deferasirox of 20 mg/kg/day based on the frequency of their blood transfusions history (7-14 mL/kg/month). Subjects receiving less number of blood transfusions were administered with deferasirox; at an initial daily dose of 10 mg/kg/day. Subjects receiving more number of blood transfusions were administered with deferasirox 30 mg/kg/day.

    Reporting group title
    Deferasirox (sickle cell disease subjects) - Core Study
    Reporting group description
    		 Deferasirox was administered to the subjects suffered with sickle cell disease as per the frequency of blood transfusions history. Subjects treated with the initial dose of either 20 mg/kg/day (for the subjects with frequency of blood transfusions about 2 to 4 units/month or 7 to 14 mL/kg/month of packed RBC) or 30 mg/kg/day (for the subjects with more frequency of blood transfusions) or 10 mg/kg/day (for the subjects with less frequency of blood transfusions).

    Reporting group title
    Deferasirox (rare anemia subjects) - Core Study
    Reporting group description
    		 Subjects received a recommended daily dose of deferasirox of 20 mg/kg/day based on the frequency of their blood transfusions history (7-14 mL/kg/month). Subjects receiving less number of blood transfusions were administered with deferasirox; at an initial daily dose of 10 mg/kg/day. Subjects receiving more number of blood transfusions were administered with deferasirox 30 mg/kg/day.

    Reporting group title
    Deferasirox (aplastic anemia subjects)- Core Study
    Reporting group description
    		 Subjects received a recommended daily dose of deferasirox of 20 mg/kg/day based on the frequency of their blood transfusions history (7-14 mL/kg/month). Subjects receiving less number of blood transfusions were administered with deferasirox; at an initial daily dose of 10 mg/kg/day. Subjects receiving more number of blood transfusions were administered with deferasirox 30 mg/kg/day.

    Reporting group title
    Deferasirox (malignant disease subjects) - Core Study
    Reporting group description
    		 Subjects received a recommended daily dose of deferasirox of 20 mg/kg/day based on the frequency of their blood transfusions history (7-14 mL/kg/month). Subjects receiving less number of blood transfusions were administered with deferasirox; at an initial daily dose of 10 mg/kg/day. Subjects receiving more number of blood transfusions were administered with deferasirox 30 mg/kg/day.

    Reporting group title
    Deferasirox (other disease subjects) - Core Study
    Reporting group description
    		 Subjects received a recommended daily dose of deferasirox of 20 mg/kg/day based on the frequency of their blood transfusions history (7-14 mL/kg/month). Subjects receiving less number of blood transfusions were administered with deferasirox; at an initial daily dose of 10 mg/kg/day. Subjects receiving more number of blood transfusions were administered with deferasirox 30 mg/kg/day.

    Reporting group values
    		 Deferasirox (thalassemic subjects) - Core Study Deferasirox (myelodysplastic syndrome subjects) - Core Study Deferasirox (sickle cell disease subjects) - Core Study Deferasirox (rare anemia subjects) - Core Study Deferasirox (aplastic anemia subjects)- Core Study Deferasirox (malignant disease subjects) - Core Study Deferasirox (other disease subjects) - Core Study Total
    Number of subjects
    		 1115 341 80 43 116 41 8 1744
    Age categorical
    Units: Subjects
        <6 years
    		 132 0 2 4 4 1 2 145
        6- <12 years
    		 215 1 13 2 7 0 1 239
        12- <16 years
    		 172 0 13 1 5 1 1 193
        16- <50 years
    		 588 14 50 24 82 11 4 773
        50- <65 years
    		 6 104 2 3 10 12 0 137
        ≥ 65 years
    		 2 222 0 9 8 16 0 257
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 18.2 (2 to 72) 67.9 (11 to 89) 23.9 (4 to 60) 39.5 (2 to 82) 33.3 (2 to 79) 55.5 (5 to 83) 23.8 (4 to 49) -
    Gender categorical
    Units: Subjects
        Female
    		 577 137 41 23 49 13 3 843
        Male
    		 538 204 39 20 67 28 5 901

    End points

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    End points reporting groups
    Reporting group title
    Deferasirox (thalassemic subjects) - Core Study
    Reporting group description
    		 Subjects received a recommended daily dose of deferasirox of 20 mg/kg/day based on the frequency of their blood transfusions history (7-14 millilitres (mL)/kg/month). Subjects receiving less number of blood transfusions were administered with deferasirox; at an initial daily dose of 10 mg/kg/day. Subjects receiving more number of blood transfusions were administered with deferasirox 30 mg/kg/day.

    Reporting group title
    Deferasirox (myelodysplastic syndrome subjects) - Core Study
    Reporting group description
    		 Subjects received a recommended daily dose of deferasirox of 20 mg/kg/day based on the frequency of their blood transfusions history (7-14 mL/kg/month). Subjects receiving less number of blood transfusions were administered with deferasirox; at an initial daily dose of 10 mg/kg/day. Subjects receiving more number of blood transfusions were administered with deferasirox 30 mg/kg/day.

    Reporting group title
    Deferasirox (sickle cell disease subjects) - Core Study
    Reporting group description
    		 Deferasirox was administered to the subjects suffered with sickle cell disease as per the frequency of blood transfusions history. Subjects treated with the initial dose of either 20 mg/kg/day (for the subjects with frequency of blood transfusions about 2 to 4 units/month or 7 to 14 mL/kg/month of packed RBC) or 30 mg/kg/day (for the subjects with more frequency of blood transfusions) or 10 mg/kg/day (for the subjects with less frequency of blood transfusions).

    Reporting group title
    Deferasirox (rare anemia subjects) - Core Study
    Reporting group description
    		 Subjects received a recommended daily dose of deferasirox of 20 mg/kg/day based on the frequency of their blood transfusions history (7-14 mL/kg/month). Subjects receiving less number of blood transfusions were administered with deferasirox; at an initial daily dose of 10 mg/kg/day. Subjects receiving more number of blood transfusions were administered with deferasirox 30 mg/kg/day.

    Reporting group title
    Deferasirox (aplastic anemia subjects)- Core Study
    Reporting group description
    		 Subjects received a recommended daily dose of deferasirox of 20 mg/kg/day based on the frequency of their blood transfusions history (7-14 mL/kg/month). Subjects receiving less number of blood transfusions were administered with deferasirox; at an initial daily dose of 10 mg/kg/day. Subjects receiving more number of blood transfusions were administered with deferasirox 30 mg/kg/day.

    Reporting group title
    Deferasirox (malignant disease subjects) - Core Study
    Reporting group description
    		 Subjects received a recommended daily dose of deferasirox of 20 mg/kg/day based on the frequency of their blood transfusions history (7-14 mL/kg/month). Subjects receiving less number of blood transfusions were administered with deferasirox; at an initial daily dose of 10 mg/kg/day. Subjects receiving more number of blood transfusions were administered with deferasirox 30 mg/kg/day.

    Reporting group title
    Deferasirox (other disease subjects) - Core Study
    Reporting group description
    		 Subjects received a recommended daily dose of deferasirox of 20 mg/kg/day based on the frequency of their blood transfusions history (7-14 mL/kg/month). Subjects receiving less number of blood transfusions were administered with deferasirox; at an initial daily dose of 10 mg/kg/day. Subjects receiving more number of blood transfusions were administered with deferasirox 30 mg/kg/day.
    Reporting group title
    Deferasirox (thalassemic subjects) - Extension study
    Reporting group description
    		 Subjects received a recommended daily dose of deferasirox of 20 mg/kg/day based on the frequency of their blood transfusions history (7-14 mL/kg/month). Subjects receiving less number of blood transfusions were administered with deferasirox; at an initial daily dose of 10 mg/kg/day. Subjects receiving more number of blood transfusions were administered with deferasirox 30 mg/kg/day.

    Reporting group title
    Deferasirox (myelodysplastic syndrome)- Extension study
    Reporting group description
    		 Subjects received a recommended daily dose of deferasirox of 20 mg/kg/day based on the frequency of their blood transfusions history (7-14 mL/kg/month). Subjects receiving less number of blood transfusions were administered with deferasirox; at an initial daily dose of 10 mg/kg/day. Subjects receiving more number of blood transfusions were administered with deferasirox 30 mg/kg/day.

    Reporting group title
    Deferasirox (sickle cell disease subjects) - Extension study
    Reporting group description
    		 Deferasirox was administered to the subjects suffered with sickle cell disease as per the frequency of blood transfusions history. Subjects treated with the initial dose of either 20 mg/kg/day (for the subjects with frequency of blood transfusions about 2 to 4 units/month or 7 to 14 mL/kg/month of packed RBC) or 30 mg/kg/day (for the subjects with more frequency of blood transfusions) or 10 mg/kg/day (for the subjects with less frequency of blood transfusions).

    Reporting group title
    Deferasirox (rare anemia subjects)- Extension study
    Reporting group description
    		 Subjects received a recommended daily dose of deferasirox of 20 mg/kg/day based on the frequency of their blood transfusions history (7-14 mL/kg/month). Subjects receiving less number of blood transfusions were administered with deferasirox; at an initial daily dose of 10 mg/kg/day. Subjects receiving more number of blood transfusions were administered with deferasirox 30 mg/kg/day.

    Reporting group title
    Deferasirox (aplastic anemia subjects) - Extension study
    Reporting group description
    		 Subjects received a recommended daily dose of deferasirox of 20 mg/kg/day based on the frequency of their blood transfusions history (7-14 mL/kg/month). Subjects receiving less number of blood transfusions were administered with deferasirox; at an initial daily dose of 10 mg/kg/day. Subjects receiving more number of blood transfusions were administered with deferasirox 30 mg/kg/day.

    Reporting group title
    Deferasirox (malignant disease subjects) - Extension study
    Reporting group description
    		 Subjects received a recommended daily dose of deferasirox of 20 mg/kg/day based on the frequency of their blood transfusions history (7-14 mL/kg/month). Subjects receiving less number of blood transfusions were administered with deferasirox; at an initial daily dose of 10 mg/kg/day. Subjects receiving more number of blood transfusions were administered with deferasirox 30 mg/kg/day.

    Reporting group title
    Deferasirox (other disease subjects) - Extension study
    Reporting group description
    		 Subjects received a recommended daily dose of deferasirox of 20 mg/kg/day based on the frequency of their blood transfusions history (7-14 mL/kg/month). Subjects receiving less number of blood transfusions were administered with deferasirox; at an initial daily dose of 10 mg/kg/day. Subjects receiving more number of blood transfusions were administered with deferasirox 30 mg/kg/day.

    Subject analysis set title
    Baseline Liver iron concentration (LIC) < 7 mg Fe/g dry weight
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Deferasirox 10 mg/kg/day or 20 mg/kg/day or 30 mg/kg/day was administered for 52 weeks.

    Subject analysis set title
    Baseline LIC greater than or equal ( ≥ ) 7 Fe/g dw
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Deferasirox 10 mg/kg/day or 20 mg/kg/day or 30 mg/kg/day was administered for 18 months.

    Subject analysis set title
    Baseline LIC < 7 mg Fe/g dw
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Deferasirox 10 mg/kg/day or 20 mg/kg/day or 30 mg/kg/day was administered for 18 months.

    Primary: Change from baseline in serum ferritin to Week 52

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    End point title
    		 Change from baseline in serum ferritin to Week 52 [1]
    End point description
    Ferritin, an iron storage protein in the body is used to measure the iron concentration in the body. Change from baseline was calculated by using the formula = Week 52 ferritin – baseline ferritin. Negative change in serum ferritin levels indicated improvement. The analysis was performed in the full analysis set (FAS)-core phase, defined as all the subjects who successfully passed screening and started or continued to receive deferasirox in the core study. If no serum ferritin determination was available at 52 weeks for a subject, the last available value was used. The 'n' signifies those subjects evaluable for this measure at specified time points for each group, respectively. Here, 99999.9 represents not applicable data because EudraCT system is not accepting "NA" for not available/not applicable data.
    End point type
    Primary
    End point timeframe
    Baseline of core study, Week 52
    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 primary outcome measure.
    End point values
    		 Deferasirox (thalassemic subjects) - Core Study Deferasirox (myelodysplastic syndrome subjects) - Core Study Deferasirox (sickle cell disease subjects) - Core Study Deferasirox (rare anemia subjects) - Core Study Deferasirox (aplastic anemia subjects)- Core Study Deferasirox (malignant disease subjects) - Core Study Deferasirox (other disease subjects) - Core Study
    Number of subjects analysed
    1115
    341
    80 [2]
    43 [3]
    116 [4]
    41 [5]
    8 [6]
    Units: nanograms/millilitres (ng/mL)
    median (full range (min-max))
        < 20 mg/kg/day (n=231,183,39,25,75,28,5)
    -28.5 (-6010 to 9501)
    -273.5 (-6040 to 6124)
    -235 (-2315 to 2707)
    -846 (-4466 to 3939)
    -970 (-11753 to 7883)
    -660.2 (-8927 to 4285)
    -330 (-886 to 2004)
        ≥ 20 to < 30 mg/kg/day (n=732,130,39,17,40,11,3)
    -92.8 (-7837 to 7933)
    -219 (-7125 to 14145)
    -71.5 (-3728 to 2846)
    -770.5 (-4522 to 7064)
    -883.8 (-15704 to 13894)
    -1006.7 (-3509 to 2166)
    -478.5 (-2657 to 1614)
        ≥ 30 mg/kg/day (n=141, 8, 0, 0, 0, 0, 0)
    -926 (-10282 to 7680)
    -638 (-1623 to 2580)
    99999.9 (99999.9 to 99999.9)
    99999.9 (99999.9 to 99999.9)
    99999.9 (99999.9 to 99999.9)
    99999.9 (99999.9 to 99999.9)
    99999.9 (99999.9 to 99999.9)
    Notes
    [2] - 99999.9 represents not applicable data as total number of subject analysed was 0 in category (ies)
    [3] - 99999.9 represents not applicable data as total number of subject analysed was 0 in category (ies)
    [4] - 99999.9 represents not applicable data as total number of subject analysed was 0 in category (ies)
    [5] - 99999.9 represents not applicable data as total number of subject analysed was 0 in category (ies)
    [6] - 99999.9 represents not applicable data as total number of subject analysed was 0 in category (ies)
    No statistical analyses for this end point

    Primary: Change from baseline in serum ferritin to Month 18 of the extension study

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    End point title
    		 Change from baseline in serum ferritin to Month 18 of the extension study [7]
    End point description
    Ferritin, an iron storage protein in the body is used to measure the iron concentration in the body. Change from baseline in the extension study was calculated by using the formula = Month 18 ferritin – baseline ferritin. Negative change in serum ferritin levels indicated improvement. The analysis was performed in the full analysis set (FAS)-extension phase, defined as all the subjects who successfully completed the core study and continued to receive deferasirox in the extension study. If no serum ferritin determination was available at 18 months for a subject, the last available value was used. The 'n' signifies those subjects evaluable for this measure at specified time points for each group, respectively. Here, 99999.9 represents not applicable data because EudraCT system is not accepting "NA" for not available/not applicable data
    End point type
    Primary
    End point timeframe
    Baseline of extension study, Month 18 (end of extension study)
    Notes
    [7] - 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 primary outcome measure.
    End point values
    		 Deferasirox (thalassemic subjects) - Extension study Deferasirox (myelodysplastic syndrome)- Extension study Deferasirox (sickle cell disease subjects) - Extension study Deferasirox (rare anemia subjects)- Extension study Deferasirox (aplastic anemia subjects) - Extension study Deferasirox (malignant disease subjects) - Extension study Deferasirox (other disease subjects) - Extension study
    Number of subjects analysed
    495
    45 [8]
    20 [9]
    6 [10]
    8 [11]
    2 [12]
    2 [13]
    Units: ng/mL
    median (full range (min-max))
        7.5 to < 15 mg/kg/day (n=7, 11, 0, 0, 1, 1, 0)
    -407 (-8038 to 25127.2)
    -417 (-2431 to 1914)
    99999.9 (-99999.9 to 99999.9)
    99999.9 (-99999.9 to 99999.9)
    -2862.1 (-2862.1 to -2862.1)
    -4546.5 (-4546.5 to -4546.5)
    99999.9 (-99999.9 to 99999.9)
        15 to < 25 mg/kg/day (n=214, 19, 19, 5, 6, 1, 2)
    -495.25 (-1055 to 402.5)
    -192 (-8225 to 2349.5)
    -990 (-2497.5 to 2846)
    -715 (-1782 to 987.1)
    -948.25 (-3693.9 to 549.6)
    -15100.5 (-15100.5 to -15100.5)
    759 (-1720 to 3238)
        25 to < 35 mg/kg/day (n=203, 14, 1, 1, 1, 0, 0)
    -729 (-8699.9 to 4287.1)
    -736 (-6575.5 to 1899)
    -6180 (-6180 to -6180)
    1999.7 (1999.7 to 1999.7)
    -11224.2 (-11224.2 to -11224.2)
    99999.9 (-99999.9 to 99999.9)
    99999.9 (-99999.9 to 99999.9)
        ≥ 35 mg/kg/day (n=70, 0, 0, 0, 0, 0, 0)
    -2203 (-11982.1 to 6233.7)
    99999.9 (-99999.9 to 99999.9)
    99999.9 (-99999.9 to 99999.9)
    99999.9 (-99999.9 to 99999.9)
    99999.9 (-99999.9 to 99999.9)
    99999.9 (-99999.9 to 99999.9)
    99999.9 (-99999.9 to 99999.9)
    Notes
    [8] - 99999.9 represents not applicable data as total number of subject analysed was 0 in category (ies)
    [9] - 99999.9 represents not applicable data as total number of subject analysed was 0 in category (ies)
    [10] - 99999.9 represents not applicable data as total number of subject analysed was 0 in category (ies)
    [11] - 99999.9 represents not applicable data as total number of subject analysed was 0 in category (ies)
    [12] - 99999.9 represents not applicable data as total number of subject analysed was 0 in category (ies)
    [13] - 99999.9 represents not applicable data as total number of subject analysed was 0 in category (ies)
    No statistical analyses for this end point

    Secondary: Absolute change from baseline in Liver iron concentration (LIC) at Week 52

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    End point title
    		 Absolute change from baseline in Liver iron concentration (LIC) at Week 52
    End point description
    LIC was assessed by noninvasive magnetic resonance imaging of the proton transverse relaxation rate (R2MRI). The change in serum ferritin from baseline to week 52 was analysed in the subgroup population of subjects with baseline LIC less than (<) 7 mg Fe/g dry weight (dw). Absolute change from baseline in LIC was calculated as week 52 value–baseline value. The analysis was performed in FAS-core phase population.
    End point type
    Secondary
    End point timeframe
    Baseline of core study, Week 52
    End point values
    		 Baseline Liver iron concentration (LIC) < 7 mg Fe/g dry weight
    Number of subjects analysed
    71
    Units: Fe/g dw
        arithmetic mean (standard deviation)
    -0.02 ( 2.368 )
    No statistical analyses for this end point

    Secondary: Absolute change from baseline in transferrin at Week 52

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    End point title
    		 Absolute change from baseline in transferrin at Week 52
    End point description
    Change from baseline was calculated by using the formula = Week 52 transferrin – baseline transferrin. The analysis was performed in FAS-core phase population. Here, "Number of subjects analysed" signifies those subjects evaluable for absolute change from baseline in transferrin at end of the study at specified time points for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline of core study, Week 52
    End point values
    		 Deferasirox (thalassemic subjects) - Core Study Deferasirox (myelodysplastic syndrome subjects) - Core Study Deferasirox (sickle cell disease subjects) - Core Study Deferasirox (rare anemia subjects) - Core Study Deferasirox (aplastic anemia subjects)- Core Study Deferasirox (malignant disease subjects) - Core Study Deferasirox (other disease subjects) - Core Study
    Number of subjects analysed
    1004
    169
    64
    30
    88
    17
    7
    Units: grams/litres
        arithmetic mean (standard deviation)
    0.1 ( 0.21 )
    0.1 ( 0.21 )
    0.1 ( 0.2 )
    0.2 ( 0.29 )
    0.2 ( 0.33 )
    0.3 ( 0.34 )
    0.1 ( 0.31 )
    No statistical analyses for this end point

    Secondary: Absolute change from baseline in transferrin saturation at Week 52

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    End point title
    		 Absolute change from baseline in transferrin saturation at Week 52
    End point description
    Change from baseline was calculated by using the formula = Week 52 transferrin saturation – baseline transferrin saturation. The analysis was performed in FAS-core phase population. Here, "Number of subjects analysed" signifies those subjects evaluable for absolute change from baseline in transferrin saturation at end of the study at specified time points for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline of core study, Week 56
    End point values
    		 Deferasirox (thalassemic subjects) - Core Study Deferasirox (myelodysplastic syndrome subjects) - Core Study Deferasirox (sickle cell disease subjects) - Core Study Deferasirox (rare anemia subjects) - Core Study Deferasirox (aplastic anemia subjects)- Core Study Deferasirox (malignant disease subjects) - Core Study Deferasirox (other disease subjects) - Core Study
    Number of subjects analysed
    591
    37
    45
    17
    68
    10
    4
    Units: Percent saturation
        arithmetic mean (standard deviation)
    10.9 ( 34.85 )
    -0.1 ( 21.92 )
    6.4 ( 23.74 )
    -7.6 ( 17.66 )
    -5.8 ( 30.29 )
    -20.2 ( 23.4 )
    2.5 ( 43.3 )
    No statistical analyses for this end point

    Secondary: Absolute change from baseline in total iron at Week 52

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    End point title
    		 Absolute change from baseline in total iron at Week 52
    End point description
    Absolute change from baseline in total iron during study by visit and underlying disease was measured. The analysis was performed in FAS-core phase population. Here, "Number of subjects analysed" signifies those subjects evaluable for absolute change from baseline in total iron at end of the study at specified time points for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline of core study, Week 52
    End point values
    		 Deferasirox (thalassemic subjects) - Core Study Deferasirox (myelodysplastic syndrome subjects) - Core Study Deferasirox (sickle cell disease subjects) - Core Study Deferasirox (rare anemia subjects) - Core Study Deferasirox (aplastic anemia subjects)- Core Study Deferasirox (malignant disease subjects) - Core Study Deferasirox (other disease subjects) - Core Study
    Number of subjects analysed
    1004
    170
    59
    30
    88
    16
    7
    Units: micromoles/litres
        arithmetic mean (standard deviation)
    7.7 ( 17.32 )
    6.7 ( 12.66 )
    3.4 ( 10.23 )
    0.7 ( 9.62 )
    1 ( 13.82 )
    -1.5 ( 16.58 )
    3.2 ( 9.64 )
    No statistical analyses for this end point

    Secondary: Number of subjects with adverse events (AEs), serious adverse events (SAEs), treatment related AEs or SAEs and deaths during core study

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    End point title
    		 Number of subjects with adverse events (AEs), serious adverse events (SAEs), treatment related AEs or SAEs and deaths during core study
    End point description
    An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. A SAE was defined as an event which was fatal or life threatening, required or prolonged hospitalization, was significantly or permanently disabling or incapacitating, constituted a congenital anomaly or a birth defect, or encompassed any other clinically significant event that could jeopardize the subject or require medical or surgical intervention to prevent one of the aforementioned outcomes. Treatment related AEs were defined as AEs that were suspected to be related to study treatment as per investigator. The analysis was performed in the safety analysis set-core phase, defined as all the subjects who received at least one dose of deferasirox and had at least one post baseline safety assessment in the core study.
    End point type
    Secondary
    End point timeframe
    Baseline of core study, Week 52
    End point values
    		 Deferasirox (thalassemic subjects) - Core Study Deferasirox (myelodysplastic syndrome subjects) - Core Study Deferasirox (sickle cell disease subjects) - Core Study Deferasirox (rare anemia subjects) - Core Study Deferasirox (aplastic anemia subjects)- Core Study Deferasirox (malignant disease subjects) - Core Study Deferasirox (other disease subjects) - Core Study
    Number of subjects analysed
    1115
    341
    80
    43
    116
    41
    8
    Units: Subjects
        AEs
    883
    327
    66
    42
    110
    41
    8
        AEs leading to discontinuation
    51
    108
    3
    9
    18
    18
    1
        AEs suspected to be drug related
    492
    226
    32
    30
    64
    28
    5
        SAEs
    101
    143
    30
    13
    26
    21
    2
        SAEs suspected to be drug related
    11
    15
    2
    0
    0
    3
    0
        Deaths
    4
    26
    0
    2
    5
    5
    0
    No statistical analyses for this end point

    Secondary: Absolute change from baseline in Liver iron concentration (LIC) at Month 18 in the extension study

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    End point title
    		 Absolute change from baseline in Liver iron concentration (LIC) at Month 18 in the extension study
    End point description
    LIC was assessed by non-invasive R2MRI. The change in serum ferritin from baseline of extension study to month 18 was analysed in the subgroup population of subjects with baseline LIC less than < 7 mg Fe/g dw and ≥ 7 mg Fe/g dw. Absolute change from baseline in LIC was calculated as respective time point value–baseline value. The analysis was performed in FAS-extension phase.
    End point type
    Secondary
    End point timeframe
    Baseline of extension study, Month 18 (end of extension study)
    End point values
    		 Baseline LIC < 7 mg Fe/g dw Baseline LIC greater than or equal ( ≥ ) 7 Fe/g dw
    Number of subjects analysed
    9
    157
    Units: Fe/g dw
        arithmetic mean (standard deviation)
    -0.5 ( 2.88 )
    -9.8 ( 12.15 )
    No statistical analyses for this end point

    Secondary: Number of subjects with adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, treatment related AEs and deaths during extension study

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    End point title
    		 Number of subjects with adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, treatment related AEs and deaths during extension study
    End point description
    An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. A SAE was defined as an event which was fatal or life threatening, required or prolonged hospitalization, was significantly or permanently disabling or incapacitating, constituted a congenital anomaly or a birth defect, or encompassed any other clinically significant event that could jeopardize the subject or require medical or surgical intervention to prevent one of the aforementioned outcomes. Treatment related AEs were defined as AEs that were suspected to be related to study treatment as per investigator. Death was a fatal event leading to permanent cessations of all vital functions of the body. The analysis was performed in safety set, defined as all subjects from extension period who received at least one dose of study medication during the whole treatment period and had atleast one post-baseline safety assessment.
    End point type
    Secondary
    End point timeframe
    Baseline of core study, end of extension study (Week 156)
    End point values
    		 Deferasirox (thalassemic subjects) - Extension study Deferasirox (myelodysplastic syndrome)- Extension study Deferasirox (sickle cell disease subjects) - Extension study Deferasirox (rare anemia subjects)- Extension study Deferasirox (aplastic anemia subjects) - Extension study Deferasirox (malignant disease subjects) - Extension study Deferasirox (other disease subjects) - Extension study
    Number of subjects analysed
    495
    45
    20
    6
    8
    2
    2
    Units: Subjects
        AEs
    406
    43
    16
    6
    8
    2
    2
        AEs leading to discontinuation
    7
    2
    1
    0
    0
    0
    0
        AEs suspected to be drug related
    234
    25
    5
    4
    4
    2
    0
        SAEs
    51
    19
    7
    2
    1
    0
    0
        Deaths
    1
    3
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Absolute change from baseline in transferrin at end of the extension study

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    End point title
    		 Absolute change from baseline in transferrin at end of the extension study
    End point description
    Change from baseline in the extension study was calculated by using the formula = End of the study transferrin – baseline transferrin. The analysis was performed in FAS-extension phase population. Here, "Number of subjects analysed" signifies those subjects evaluable for absolute change from baseline in transferrin at end of the study at specified time points for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline of extension study, End of extension study
    End point values
    		 Deferasirox (thalassemic subjects) - Extension study Deferasirox (myelodysplastic syndrome)- Extension study Deferasirox (sickle cell disease subjects) - Extension study Deferasirox (rare anemia subjects)- Extension study Deferasirox (aplastic anemia subjects) - Extension study Deferasirox (malignant disease subjects) - Extension study Deferasirox (other disease subjects) - Extension study
    Number of subjects analysed
    493
    44
    20
    6
    8
    2
    2
    Units: grams/litres
        arithmetic mean (standard deviation)
    0.14 ( 0.253 )
    0.08 ( 0.281 )
    0.19 ( 0.266 )
    0.16 ( 0.086 )
    0.18 ( 0.42 )
    0.83 ( 0.035 )
    0 ( 0.283 )
    No statistical analyses for this end point

    Secondary: Absolute change from baseline in transferrin saturation at end of the extension study

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    End point title
    		 Absolute change from baseline in transferrin saturation at end of the extension study
    End point description
    Change from baseline in the extension study was calculated by using the formula = End of the study transferrin saturation – baseline transferrin saturation. The analysis was performed in FAS-extension phase population. Here, "Number of subjects analysed" signifies those subjects evaluable for absolute change from baseline in transferrin saturation at end of the study at specified time points for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline of extension study, End of extension study
    End point values
    		 Deferasirox (thalassemic subjects) - Extension study Deferasirox (myelodysplastic syndrome)- Extension study Deferasirox (sickle cell disease subjects) - Extension study Deferasirox (rare anemia subjects)- Extension study Deferasirox (aplastic anemia subjects) - Extension study Deferasirox (malignant disease subjects) - Extension study Deferasirox (other disease subjects) - Extension study
    Number of subjects analysed
    296
    11
    16
    5
    6
    1
    1
    Units: Percent saturation
        arithmetic mean (standard deviation)
    10.38 ( 29.14 )
    5.03 ( 20.113 )
    -3.81 ( 20.07 )
    -4.2 ( 19.614 )
    -1.83 ( 15.079 )
    -70.5 ( 0 )
    -41 ( 0 )
    No statistical analyses for this end point

    Secondary: Absolute change from baseline in total iron at end of the extension study

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    End point title
    		 Absolute change from baseline in total iron at end of the extension study
    End point description
    Absolute change from baseline in total iron during extension study by visit and underlying disease was measured. The analysis was performed in FAS-extension phase population. Here, "Number of subjects analysed" signifies those subjects evaluable for absolute change from baseline in total iron at end of the study at specified time points for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Baseline of extension study, End of the extension study
    End point values
    		 Deferasirox (thalassemic subjects) - Extension study Deferasirox (myelodysplastic syndrome)- Extension study Deferasirox (sickle cell disease subjects) - Extension study Deferasirox (rare anemia subjects)- Extension study Deferasirox (aplastic anemia subjects) - Extension study Deferasirox (malignant disease subjects) - Extension study Deferasirox (other disease subjects) - Extension study
    Number of subjects analysed
    494
    44
    20
    6
    8
    2
    2
    Units: micromoles/litres
        arithmetic mean (standard deviation)
    8.55 ( 16.711 )
    5.98 ( 13.469 )
    0.8 ( 7.885 )
    0.33 ( 9.48 )
    4.38 ( 12.34 )
    -16.5 ( 14.849 )
    42.5 ( 57.276 )
    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 are reported in this record from First Patient First Treatment until Last Patient Last Visit.
    Adverse event reporting additional description
    Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field “number of deaths resulting from adverse events” all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13
    Reporting groups
    Reporting group title
    Deferasirox (thalassemic subjects)
    Reporting group description
    		 Subjects received a recommended daily dose of deferasirox of 20 mg/kg/day based on the frequency of their blood transfusions history (7-14 millilitres (mL)/kg/month). Subjects receiving less number of blood transfusions were administered with deferasirox; at an initial daily dose of 10 mg/kg/day. Subjects receiving more number of blood transfusions were administered with deferasirox 30 mg/kg/day.

    Reporting group title
    Deferasirox (myelodysplastic syndrome subjects)
    Reporting group description
    		 Subjects received a recommended daily dose of deferasirox of 20 mg/kg/day based on the frequency of their blood transfusions history (7-14 mL/kg/month). Subjects receiving less number of blood transfusions were administered with deferasirox; at an initial daily dose of 10 mg/kg/day. Subjects receiving more number of blood transfusions were administered with deferasirox 30 mg/kg/day.

    Reporting group title
    Deferasirox (sickle cell disease subjects)
    Reporting group description
    		 Deferasirox was administered to the subjects suffered with sickle cell disease as per the frequency of blood transfusions history. Subjects treated with the initial dose of either 20 mg/kg/day (for the subjects with frequency of blood transfusions about 2 to 4 units/month or 7 to 14 mL/kg/month of packed RBC) or 30 mg/kg/day (for the subjects with more frequency of blood transfusions) or 10 mg/kg/day (for the subjects with less frequency of blood transfusions).

    Reporting group title
    Deferasirox (rare anemia subjects)
    Reporting group description
    		 Subjects received a recommended daily dose of deferasirox of 20 mg/kg/day based on the frequency of their blood transfusions history (7-14 mL/kg/month). Subjects receiving less number of blood transfusions were administered with deferasirox; at an initial daily dose of 10 mg/kg/day. Subjects receiving more number of blood transfusions were administered with deferasirox 30 mg/kg/day.

    Reporting group title
    Deferasirox (aplastic anemia subjects)
    Reporting group description
    		 Subjects received a recommended daily dose of deferasirox of 20 mg/kg/day based on the frequency of their blood transfusions history (7-14 mL/kg/month). Subjects receiving less number of blood transfusions were administered with deferasirox; at an initial daily dose of 10 mg/kg/day. Subjects receiving more number of blood transfusions were administered with deferasirox 30 mg/kg/day.

    Reporting group title
    Deferasirox (malignant disease subjects)
    Reporting group description
    		 Subjects received a recommended daily dose of deferasirox of 20 mg/kg/day based on the frequency of their blood transfusions history (7-14 mL/kg/month). Subjects receiving less number of blood transfusions were administered with deferasirox; at an initial daily dose of 10 mg/kg/day. Subjects receiving more number of blood transfusions were administered with deferasirox 30 mg/kg/day.

    Reporting group title
    Deferasirox (other disease subjects)
    Reporting group description
    		 Subjects received a recommended daily dose of deferasirox of 20 mg/kg/day based on the frequency of their blood transfusions history (7-14 mL/kg/month). Subjects receiving less number of blood transfusions were administered with deferasirox; at an initial daily dose of 10 mg/kg/day. Subjects receiving more number of blood transfusions were administered with deferasirox 30 mg/kg/day.

    Serious adverse events
    		 Deferasirox (thalassemic subjects) Deferasirox (myelodysplastic syndrome subjects) Deferasirox (sickle cell disease subjects) Deferasirox (rare anemia subjects) Deferasirox (aplastic anemia subjects) Deferasirox (malignant disease subjects) Deferasirox (other disease subjects)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    101 / 1115 (9.06%)
    143 / 341 (41.94%)
    30 / 80 (37.50%)
    13 / 43 (30.23%)
    26 / 116 (22.41%)
    21 / 41 (51.22%)
    2 / 8 (25.00%)
         number of deaths (all causes)
    4
    26
    0
    2
    5
    5
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute leukaemia
         subjects affected / exposed
    0 / 1115 (0.00%)
    2 / 341 (0.59%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute myeloid leukaemia
         subjects affected / exposed
    0 / 1115 (0.00%)
    10 / 341 (2.93%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    3 / 41 (7.32%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 10
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute myeloid leukaemia recurrent
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    1 / 41 (2.44%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Basal cell carcinoma
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    1 / 41 (2.44%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bladder cancer recurrent
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bladder neoplasm
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    1 / 43 (2.33%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Bowen's disease
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    1 / 41 (2.44%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral hygroma
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Leukaemia
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lymphoma
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myelodysplastic syndrome
         subjects affected / exposed
    0 / 1115 (0.00%)
    3 / 341 (0.88%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myelofibrosis
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myeloid leukaemia
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasm
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neuroblastoma recurrent
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    1 / 41 (2.44%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Salivary gland cancer
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin cancer
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    1 / 41 (2.44%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    1 / 41 (2.44%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Angiodysplasia
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arterial rupture
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    1 / 43 (2.33%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    1 / 1115 (0.09%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemodynamic instability
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhage
         subjects affected / exposed
    1 / 1115 (0.09%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    0 / 1115 (0.00%)
    4 / 341 (1.17%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypovolaemic shock
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pallor
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    1 / 80 (1.25%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Shock
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    1 / 116 (0.86%)
    1 / 41 (2.44%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    1 / 43 (2.33%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy
         subjects affected / exposed
    2 / 1115 (0.18%)
    0 / 341 (0.00%)
    1 / 80 (1.25%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 1115 (0.09%)
    5 / 341 (1.47%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    1 / 116 (0.86%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 5
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chills
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    1 / 43 (2.33%)
    1 / 116 (0.86%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Concomitant disease progression
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    1 / 41 (2.44%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cyst
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Disease progression
         subjects affected / exposed
    0 / 1115 (0.00%)
    3 / 341 (0.88%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    1 / 41 (2.44%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Euthanasia
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Face oedema
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    1 / 1115 (0.09%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    1 / 43 (2.33%)
    0 / 116 (0.00%)
    2 / 41 (4.88%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    0 / 1115 (0.00%)
    5 / 341 (1.47%)
    1 / 80 (1.25%)
    0 / 43 (0.00%)
    1 / 116 (0.86%)
    1 / 41 (2.44%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
    0 / 1
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Generalised oedema
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Granuloma
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperpyrexia
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    1 / 43 (2.33%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperthermia
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    2 / 41 (4.88%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Multi-organ failure
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    1 / 41 (2.44%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Necrosis
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    3 / 80 (3.75%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oedema
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    1 / 1115 (0.09%)
    3 / 341 (0.88%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    4 / 80 (5.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 8
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    12 / 1115 (1.08%)
    22 / 341 (6.45%)
    2 / 80 (2.50%)
    3 / 43 (6.98%)
    7 / 116 (6.03%)
    3 / 41 (7.32%)
    2 / 8 (25.00%)
         occurrences causally related to treatment / all
    2 / 13
    2 / 23
    0 / 3
    0 / 5
    0 / 13
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sudden death
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    2 / 1115 (0.18%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypersensitivity
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Social circumstances
    Disability
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy of partner
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    1 / 43 (2.33%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Cervical dysplasia
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    1 / 116 (0.86%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhagic ovarian cyst
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metrorrhagia
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    1 / 43 (2.33%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ovarian cyst ruptured
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    1 / 116 (0.86%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Priapism
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    1 / 80 (1.25%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostatitis
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute pulmonary oedema
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Asthma
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atelectasis
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    1 / 80 (1.25%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchial obstruction
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchospasm
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    1 / 41 (2.44%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cough
         subjects affected / exposed
    2 / 1115 (0.18%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    2 / 116 (1.72%)
    1 / 41 (2.44%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    3 / 1115 (0.27%)
    7 / 341 (2.05%)
    2 / 80 (2.50%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    2 / 41 (4.88%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 7
    0 / 3
    0 / 0
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea exertional
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    1 / 80 (1.25%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    1 / 41 (2.44%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    1 / 1115 (0.09%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Laryngeal dyspnoea
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    1 / 41 (2.44%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung disorder
         subjects affected / exposed
    0 / 1115 (0.00%)
    4 / 341 (1.17%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 4
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung infiltration
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Painful respiration
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    1 / 80 (1.25%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pharyngolaryngeal pain
         subjects affected / exposed
    2 / 1115 (0.18%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    1 / 116 (0.86%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    0 / 1115 (0.00%)
    5 / 341 (1.47%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonitis
         subjects affected / exposed
    0 / 1115 (0.00%)
    2 / 341 (0.59%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Productive cough
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    2 / 116 (1.72%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary congestion
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    2 / 1115 (0.18%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary haemorrhage
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary hypertension
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 1115 (0.00%)
    4 / 341 (1.17%)
    0 / 80 (0.00%)
    1 / 43 (2.33%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 4
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Tachypnoea
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    1 / 80 (1.25%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Alcohol abuse
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    1 / 116 (0.86%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Alcoholism
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bradyphrenia
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Confusional state
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Delirium
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Impaired self-care
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mental disorder
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    2 / 80 (2.50%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    2 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    2 / 80 (2.50%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    2 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Beta-N-acetyl-D-glucosaminidase increased
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blast cell count increased
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood creatinine increased
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Creatinine renal clearance decreased
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematocrit decreased
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Heart rate irregular
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intraocular pressure increased
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial strain
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    1 / 80 (1.25%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oxygen saturation decreased
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    1 / 80 (1.25%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urine output decreased
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urine potassium increased
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urine sodium increased
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Allergic transfusion reaction
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    1 / 41 (2.44%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anaphylactic transfusion reaction
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthropod bite
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cervical vertebral fracture
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Clavicle fracture
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Extradural haematoma
         subjects affected / exposed
    0 / 1115 (0.00%)
    2 / 341 (0.59%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Facial bones fracture
         subjects affected / exposed
    1 / 1115 (0.09%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    1 / 41 (2.44%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    0 / 1115 (0.00%)
    2 / 341 (0.59%)
    0 / 80 (0.00%)
    1 / 43 (2.33%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    0 / 1115 (0.00%)
    2 / 341 (0.59%)
    0 / 80 (0.00%)
    1 / 43 (2.33%)
    1 / 116 (0.86%)
    0 / 41 (0.00%)
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fractured coccyx
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic rupture
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    1 / 116 (0.86%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Jaw fracture
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lumbar vertebral fracture
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Multiple injuries
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Patella fracture
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    1 / 43 (2.33%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Scapula fracture
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skeletal injury
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skull fracture
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skull fractured base
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Splenic rupture
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subcutaneous haematoma
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    0 / 1115 (0.00%)
    2 / 341 (0.59%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    2 / 116 (1.72%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thoracic vertebral fracture
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transfusion reaction
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Traumatic shock
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Gastrointestinal angiodysplasia haemorrhagic
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Porphyria acute
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    1 / 43 (2.33%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sickle cell anaemia
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    1 / 80 (1.25%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sickle cell anaemia with crisis
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    20 / 80 (25.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 36
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    0 / 1115 (0.00%)
    4 / 341 (1.17%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    1 / 1115 (0.09%)
    6 / 341 (1.76%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 6
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    1 / 41 (2.44%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    3 / 1115 (0.27%)
    6 / 341 (1.76%)
    0 / 80 (0.00%)
    1 / 43 (2.33%)
    0 / 116 (0.00%)
    2 / 41 (4.88%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    1 / 6
    0 / 0
    0 / 1
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Cardiac failure acute
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    3 / 1115 (0.27%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure high output
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiomegaly
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiomyopathy
         subjects affected / exposed
    2 / 1115 (0.18%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Palpitations
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    1 / 43 (2.33%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Right ventricular failure
         subjects affected / exposed
    2 / 1115 (0.18%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tachycardia
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    1 / 80 (1.25%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ventricular arrhythmia
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ventricular failure
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ventricular tachycardia
         subjects affected / exposed
    2 / 1115 (0.18%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Aphasia
         subjects affected / exposed
    0 / 1115 (0.00%)
    2 / 341 (0.59%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral haemorrhage
         subjects affected / exposed
    0 / 1115 (0.00%)
    2 / 341 (0.59%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    2 / 80 (2.50%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Convulsion
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dementia
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    0 / 1115 (0.00%)
    2 / 341 (0.59%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    2 / 1115 (0.18%)
    2 / 341 (0.59%)
    1 / 80 (1.25%)
    1 / 43 (2.33%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 2
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intercostal neuralgia
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intraventricular haemorrhage
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    1 / 80 (1.25%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Loss of consciousness
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    1 / 80 (1.25%)
    1 / 43 (2.33%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Movement disorder
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Paresis
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral motor neuropathy
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    1 / 116 (0.86%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral sensory neuropathy
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    1 / 116 (0.86%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyramidal tract syndrome
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Somnolence
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    1 / 116 (0.86%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    1 / 116 (0.86%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Unresponsive to stimuli
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Agranulocytosis
         subjects affected / exposed
    0 / 1115 (0.00%)
    2 / 341 (0.59%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anaemia
         subjects affected / exposed
    3 / 1115 (0.27%)
    9 / 341 (2.64%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 12
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anaemia haemolytic autoimmune
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    1 / 41 (2.44%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Bone marrow failure
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coagulopathy
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    1 / 41 (2.44%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Disseminated intravascular coagulation
         subjects affected / exposed
    1 / 1115 (0.09%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    1 / 116 (0.86%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Febrile bone marrow aplasia
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    0 / 1115 (0.00%)
    3 / 341 (0.88%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    2 / 116 (1.72%)
    4 / 41 (9.76%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 0
    0 / 0
    0 / 2
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemolysis
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    1 / 80 (1.25%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemolytic anaemia
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypersplenism
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Jaundice acholuric
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Leukocytosis
         subjects affected / exposed
    2 / 1115 (0.18%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Leukopenia
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lymphadenitis
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lymphadenopathy
         subjects affected / exposed
    0 / 1115 (0.00%)
    2 / 341 (0.59%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    1 / 1115 (0.09%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    1 / 41 (2.44%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neutrophilia
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reticulocytopenia
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Splenomegaly
         subjects affected / exposed
    1 / 1115 (0.09%)
    3 / 341 (0.88%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 1115 (0.00%)
    5 / 341 (1.47%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    1 / 41 (2.44%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Otorrhoea
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    1 / 116 (0.86%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vertigo
         subjects affected / exposed
    2 / 1115 (0.18%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    1 / 41 (2.44%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye pain
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    1 / 43 (2.33%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye pruritus
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ulcerative keratitis
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vision blurred
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal mass
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    5 / 1115 (0.45%)
    13 / 341 (3.81%)
    1 / 80 (1.25%)
    0 / 43 (0.00%)
    2 / 116 (1.72%)
    1 / 41 (2.44%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    2 / 13
    0 / 1
    0 / 0
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain lower
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    3 / 116 (2.59%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    1 / 1115 (0.09%)
    2 / 341 (0.59%)
    1 / 80 (1.25%)
    2 / 43 (4.65%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 2
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal wall disorder
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    1 / 41 (2.44%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anal fissure
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    1 / 1115 (0.09%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    1 / 1115 (0.09%)
    2 / 341 (0.59%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    4 / 1115 (0.36%)
    8 / 341 (2.35%)
    0 / 80 (0.00%)
    1 / 43 (2.33%)
    1 / 116 (0.86%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    2 / 10
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticular perforation
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulum
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Duodenal ulcer
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enteritis
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enterocolitis
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Food poisoning
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric haemorrhage
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric ulcer
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric ulcer haemorrhage
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastritis haemorrhagic
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorder
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 1115 (0.00%)
    4 / 341 (1.17%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematemesis
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematochezia
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    1 / 116 (0.86%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia, obstructive
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal infarction
         subjects affected / exposed
    0 / 1115 (0.00%)
    2 / 341 (0.59%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Melaena
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    1 / 41 (2.44%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 1115 (0.09%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    1 / 116 (0.86%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neutropenic colitis
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    1 / 116 (0.86%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Odynophagia
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    1 / 41 (2.44%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophagitis
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    1 / 116 (0.86%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophagitis haemorrhagic
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oral pain
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    1 / 1115 (0.09%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Parotid gland enlargement
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peritoneal haemorrhage
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    1 / 116 (0.86%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    0 / 1115 (0.00%)
    2 / 341 (0.59%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    0 / 1115 (0.00%)
    2 / 341 (0.59%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sigmoiditis
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stomatitis
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Toothache
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 1115 (0.09%)
    5 / 341 (1.47%)
    0 / 80 (0.00%)
    1 / 43 (2.33%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 6
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    0 / 1115 (0.00%)
    2 / 341 (0.59%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    4 / 1115 (0.36%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    2 / 1115 (0.18%)
    2 / 341 (0.59%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cytolytic hepatitis
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    1 / 43 (2.33%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic calcification
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic cirrhosis
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic failure
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatitis
         subjects affected / exposed
    2 / 1115 (0.18%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatosplenomegaly
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatotoxicity
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    1 / 41 (2.44%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperbilirubinaemia
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Jaundice cholestatic
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Liver disorder
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    1 / 43 (2.33%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Angiolymphoid hyperplasia with eosinophilia
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dermatitis allergic
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dermatitis atopic
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psoriasis
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyoderma gangrenosum
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    1 / 41 (2.44%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rash
         subjects affected / exposed
    1 / 1115 (0.09%)
    2 / 341 (0.59%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    1 / 41 (2.44%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rash maculo-papular
         subjects affected / exposed
    2 / 1115 (0.18%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Swelling face
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Anuria
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Calculus ureteric
         subjects affected / exposed
    2 / 1115 (0.18%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    1 / 116 (0.86%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Calculus urinary
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    1 / 116 (0.86%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fanconi syndrome acquired
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    0 / 1115 (0.00%)
    2 / 341 (0.59%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Microalbuminuria
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nephritis
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    2 / 1115 (0.18%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    1 / 43 (2.33%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Proteinuria
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal colic
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    1 / 43 (2.33%)
    0 / 116 (0.00%)
    1 / 41 (2.44%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal failure acute
         subjects affected / exposed
    1 / 1115 (0.09%)
    3 / 341 (0.88%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    1 / 41 (2.44%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal tubular disorder
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal tubular necrosis
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 1115 (0.00%)
    2 / 341 (0.59%)
    2 / 80 (2.50%)
    1 / 43 (2.33%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 3
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    0 / 1115 (0.00%)
    3 / 341 (0.88%)
    1 / 80 (1.25%)
    0 / 43 (0.00%)
    1 / 116 (0.86%)
    1 / 41 (2.44%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 2
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bone cyst
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bone pain
         subjects affected / exposed
    1 / 1115 (0.09%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fistula
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Flank pain
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    1 / 116 (0.86%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    1 / 116 (0.86%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Joint swelling
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    1 / 116 (0.86%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Muscle spasms
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    1 / 80 (1.25%)
    0 / 43 (0.00%)
    1 / 116 (0.86%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    1 / 43 (2.33%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal pain
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myalgia
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    1 / 43 (2.33%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myositis
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neck mass
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteonecrosis
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    1 / 116 (0.86%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    2 / 80 (2.50%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Polyarthritis
         subjects affected / exposed
    0 / 1115 (0.00%)
    2 / 341 (0.59%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rheumatoid arthritis
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Synostosis
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abscess limb
         subjects affected / exposed
    0 / 1115 (0.00%)
    3 / 341 (0.88%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abscess neck
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute tonsillitis
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    2 / 1115 (0.18%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    2 / 116 (1.72%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthritis bacterial
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    1 / 80 (1.25%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aspergillosis
         subjects affected / exposed
    1 / 1115 (0.09%)
    2 / 341 (0.59%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    1 / 1115 (0.09%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bacterial infection
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bacterial sepsis
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    1 / 80 (1.25%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 1115 (0.09%)
    3 / 341 (0.88%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    1 / 116 (0.86%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    1 / 1115 (0.09%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    1 / 116 (0.86%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchopulmonary aspergillosis
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    1 / 41 (2.44%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Carbuncle
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Catheter related infection
         subjects affected / exposed
    1 / 1115 (0.09%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Catheter sepsis
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    1 / 116 (0.86%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Catheter site infection
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    2 / 1115 (0.18%)
    3 / 341 (0.88%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    1 / 116 (0.86%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Central line infection
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    1 / 43 (2.33%)
    0 / 116 (0.00%)
    1 / 41 (2.44%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis infective
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Clostridial infection
         subjects affected / exposed
    0 / 1115 (0.00%)
    2 / 341 (0.59%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cystitis
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dengue fever
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    0 / 1115 (0.00%)
    2 / 341 (0.59%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enterobacter bacteraemia
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Escherichia infection
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Febrile infection
         subjects affected / exposed
    1 / 1115 (0.09%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastritis viral
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    5 / 1115 (0.45%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    1 / 43 (2.33%)
    0 / 116 (0.00%)
    1 / 41 (2.44%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal infection
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Incision site infection
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infectious mononucleosis
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Klebsiella bacteraemia
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Klebsiella sepsis
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    1 / 80 (1.25%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Liver abscess
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    1 / 116 (0.86%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 1115 (0.09%)
    1 / 341 (0.29%)
    3 / 80 (3.75%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung infection
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    1 / 43 (2.33%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meningitis
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nasopharyngitis
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    1 / 116 (0.86%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    1 / 80 (1.25%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Otitis externa
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    1 / 41 (2.44%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Otitis media
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    1 / 116 (0.86%)
    1 / 41 (2.44%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pelvic abscess
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Perianal abscess
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    1 / 116 (0.86%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Perineal abscess
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    1 / 116 (0.86%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Periorbital cellulitis
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peritonsillar abscess
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    1 / 116 (0.86%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    2 / 1115 (0.18%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    1 / 116 (0.86%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pharyngotonsillitis
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    1 / 43 (2.33%)
    1 / 116 (0.86%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 1115 (0.18%)
    14 / 341 (4.11%)
    1 / 80 (1.25%)
    1 / 43 (2.33%)
    3 / 116 (2.59%)
    2 / 41 (4.88%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 16
    0 / 1
    0 / 1
    0 / 3
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia fungal
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia klebsiella
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Progressive multifocal leukoencephalopathy
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary sepsis
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary tuberculosis
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    1 / 80 (1.25%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retroperitoneal abscess
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    4 / 1115 (0.36%)
    7 / 341 (2.05%)
    1 / 80 (1.25%)
    1 / 43 (2.33%)
    3 / 116 (2.59%)
    4 / 41 (9.76%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 7
    0 / 2
    0 / 1
    0 / 3
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 3
    0 / 2
    0 / 0
    Septic shock
         subjects affected / exposed
    0 / 1115 (0.00%)
    5 / 341 (1.47%)
    1 / 80 (1.25%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 4
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal bacteraemia
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal infection
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    1 / 80 (1.25%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Systemic mycosis
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    1 / 116 (0.86%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tooth abscess
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    1 / 41 (2.44%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tooth infection
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    1 / 43 (2.33%)
    0 / 116 (0.00%)
    1 / 41 (2.44%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Typhoid fever
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 1115 (0.27%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 1115 (0.09%)
    6 / 341 (1.76%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 7
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    4 / 1115 (0.36%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    1 / 1115 (0.09%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    1 / 1115 (0.09%)
    2 / 341 (0.59%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    2 / 1115 (0.18%)
    3 / 341 (0.88%)
    1 / 80 (1.25%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetes mellitus
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    1 / 116 (0.86%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetic ketoacidosis
         subjects affected / exposed
    3 / 1115 (0.27%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    2 / 116 (1.72%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypervolaemia
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    1 / 116 (0.86%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoalbuminaemia
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypocalcaemia
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypovolaemia
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malnutrition
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolic disorder
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    1 / 41 (2.44%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oral intake reduced
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Deferasirox (thalassemic subjects) Deferasirox (myelodysplastic syndrome subjects) Deferasirox (sickle cell disease subjects) Deferasirox (rare anemia subjects) Deferasirox (aplastic anemia subjects) Deferasirox (malignant disease subjects) Deferasirox (other disease subjects)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    755 / 1115 (67.71%)
    302 / 341 (88.56%)
    55 / 80 (68.75%)
    42 / 43 (97.67%)
    106 / 116 (91.38%)
    37 / 41 (90.24%)
    8 / 8 (100.00%)
    Vascular disorders
    Haematoma
         subjects affected / exposed
    0 / 1115 (0.00%)
    10 / 341 (2.93%)
    0 / 80 (0.00%)
    1 / 43 (2.33%)
    1 / 116 (0.86%)
    4 / 41 (9.76%)
    0 / 8 (0.00%)
         occurrences all number
    0
    10
    0
    1
    1
    4
    0
    Hypertension
         subjects affected / exposed
    1 / 1115 (0.09%)
    14 / 341 (4.11%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    6 / 116 (5.17%)
    2 / 41 (4.88%)
    0 / 8 (0.00%)
         occurrences all number
    1
    15
    0
    0
    6
    2
    0
    Hypotension
         subjects affected / exposed
    4 / 1115 (0.36%)
    3 / 341 (0.88%)
    1 / 80 (1.25%)
    3 / 43 (6.98%)
    3 / 116 (2.59%)
    1 / 41 (2.44%)
    0 / 8 (0.00%)
         occurrences all number
    4
    3
    1
    3
    4
    1
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    16 / 1115 (1.43%)
    34 / 341 (9.97%)
    14 / 80 (17.50%)
    5 / 43 (11.63%)
    8 / 116 (6.90%)
    4 / 41 (9.76%)
    0 / 8 (0.00%)
         occurrences all number
    22
    47
    16
    6
    8
    4
    0
    Chest pain
         subjects affected / exposed
    4 / 1115 (0.36%)
    4 / 341 (1.17%)
    1 / 80 (1.25%)
    3 / 43 (6.98%)
    1 / 116 (0.86%)
    1 / 41 (2.44%)
    0 / 8 (0.00%)
         occurrences all number
    4
    6
    1
    4
    1
    1
    0
    Fatigue
         subjects affected / exposed
    25 / 1115 (2.24%)
    32 / 341 (9.38%)
    2 / 80 (2.50%)
    10 / 43 (23.26%)
    9 / 116 (7.76%)
    2 / 41 (4.88%)
    1 / 8 (12.50%)
         occurrences all number
    26
    40
    2
    10
    11
    3
    2
    General physical health deterioration
         subjects affected / exposed
    0 / 1115 (0.00%)
    4 / 341 (1.17%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    1 / 41 (2.44%)
    1 / 8 (12.50%)
         occurrences all number
    0
    4
    0
    0
    0
    1
    1
    Injection site pain
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    Oedema
         subjects affected / exposed
    3 / 1115 (0.27%)
    19 / 341 (5.57%)
    1 / 80 (1.25%)
    3 / 43 (6.98%)
    5 / 116 (4.31%)
    1 / 41 (2.44%)
    0 / 8 (0.00%)
         occurrences all number
    3
    21
    1
    3
    5
    2
    0
    Oedema peripheral
         subjects affected / exposed
    26 / 1115 (2.33%)
    45 / 341 (13.20%)
    1 / 80 (1.25%)
    3 / 43 (6.98%)
    2 / 116 (1.72%)
    4 / 41 (9.76%)
    0 / 8 (0.00%)
         occurrences all number
    32
    49
    1
    3
    2
    4
    0
    Pain
         subjects affected / exposed
    3 / 1115 (0.27%)
    6 / 341 (1.76%)
    3 / 80 (3.75%)
    1 / 43 (2.33%)
    6 / 116 (5.17%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    3
    6
    3
    1
    8
    0
    0
    Pyrexia
         subjects affected / exposed
    117 / 1115 (10.49%)
    59 / 341 (17.30%)
    7 / 80 (8.75%)
    8 / 43 (18.60%)
    27 / 116 (23.28%)
    11 / 41 (26.83%)
    0 / 8 (0.00%)
         occurrences all number
    154
    94
    11
    12
    45
    13
    0
    Secretion discharge
         subjects affected / exposed
    0 / 1115 (0.00%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    Reproductive system and breast disorders
    Erectile dysfunction
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    1 / 43 (2.33%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    86 / 1115 (7.71%)
    33 / 341 (9.68%)
    7 / 80 (8.75%)
    4 / 43 (9.30%)
    13 / 116 (11.21%)
    11 / 41 (26.83%)
    2 / 8 (25.00%)
         occurrences all number
    111
    43
    9
    6
    19
    15
    3
    Dyspnoea
         subjects affected / exposed
    11 / 1115 (0.99%)
    24 / 341 (7.04%)
    2 / 80 (2.50%)
    5 / 43 (11.63%)
    6 / 116 (5.17%)
    4 / 41 (9.76%)
    0 / 8 (0.00%)
         occurrences all number
    11
    28
    2
    5
    9
    7
    0
    Epistaxis
         subjects affected / exposed
    8 / 1115 (0.72%)
    10 / 341 (2.93%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    15 / 116 (12.93%)
    3 / 41 (7.32%)
    0 / 8 (0.00%)
         occurrences all number
    10
    12
    0
    0
    26
    4
    0
    Pharyngolaryngeal pain
         subjects affected / exposed
    45 / 1115 (4.04%)
    11 / 341 (3.23%)
    0 / 80 (0.00%)
    3 / 43 (6.98%)
    12 / 116 (10.34%)
    2 / 41 (4.88%)
    1 / 8 (12.50%)
         occurrences all number
    59
    12
    0
    4
    14
    2
    1
    Productive cough
         subjects affected / exposed
    10 / 1115 (0.90%)
    6 / 341 (1.76%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    2 / 116 (1.72%)
    3 / 41 (7.32%)
    0 / 8 (0.00%)
         occurrences all number
    10
    11
    0
    0
    2
    7
    0
    Rhinorrhoea
         subjects affected / exposed
    13 / 1115 (1.17%)
    3 / 341 (0.88%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    6 / 116 (5.17%)
    2 / 41 (4.88%)
    0 / 8 (0.00%)
         occurrences all number
    14
    4
    0
    0
    11
    3
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    4 / 1115 (0.36%)
    9 / 341 (2.64%)
    1 / 80 (1.25%)
    1 / 43 (2.33%)
    2 / 116 (1.72%)
    3 / 41 (7.32%)
    0 / 8 (0.00%)
         occurrences all number
    4
    9
    1
    1
    3
    3
    0
    Depression
         subjects affected / exposed
    4 / 1115 (0.36%)
    6 / 341 (1.76%)
    3 / 80 (3.75%)
    3 / 43 (6.98%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    4
    6
    3
    3
    0
    0
    0
    Insomnia
         subjects affected / exposed
    11 / 1115 (0.99%)
    18 / 341 (5.28%)
    2 / 80 (2.50%)
    1 / 43 (2.33%)
    6 / 116 (5.17%)
    6 / 41 (14.63%)
    0 / 8 (0.00%)
         occurrences all number
    13
    18
    2
    1
    10
    8
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    95 / 1115 (8.52%)
    5 / 341 (1.47%)
    1 / 80 (1.25%)
    6 / 43 (13.95%)
    2 / 116 (1.72%)
    1 / 41 (2.44%)
    0 / 8 (0.00%)
         occurrences all number
    119
    5
    1
    9
    4
    1
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    67 / 1115 (6.01%)
    1 / 341 (0.29%)
    1 / 80 (1.25%)
    4 / 43 (9.30%)
    1 / 116 (0.86%)
    1 / 41 (2.44%)
    0 / 8 (0.00%)
         occurrences all number
    85
    1
    1
    5
    2
    1
    0
    Blood creatinine decreased
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Blood creatinine increased
         subjects affected / exposed
    68 / 1115 (6.10%)
    36 / 341 (10.56%)
    3 / 80 (3.75%)
    6 / 43 (13.95%)
    12 / 116 (10.34%)
    5 / 41 (12.20%)
    0 / 8 (0.00%)
         occurrences all number
    115
    44
    3
    7
    15
    7
    0
    Gallbladder palpable
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    Serum ferritin increased
         subjects affected / exposed
    6 / 1115 (0.54%)
    2 / 341 (0.59%)
    0 / 80 (0.00%)
    1 / 43 (2.33%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    8
    2
    0
    1
    0
    0
    1
    Spleen palpable
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Weight decreased
         subjects affected / exposed
    4 / 1115 (0.36%)
    11 / 341 (3.23%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    1 / 116 (0.86%)
    2 / 41 (4.88%)
    1 / 8 (12.50%)
         occurrences all number
    4
    11
    0
    0
    1
    2
    1
    Injury, poisoning and procedural complications
    Animal bite
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    Excoriation
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    1 / 116 (0.86%)
    0 / 41 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    1
    Congenital, familial and genetic disorders
    Sickle cell anaemia with crisis
         subjects affected / exposed
    0 / 1115 (0.00%)
    0 / 341 (0.00%)
    14 / 80 (17.50%)
    1 / 43 (2.33%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    23
    1
    0
    0
    0
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    20 / 1115 (1.79%)
    0 / 341 (0.00%)
    2 / 80 (2.50%)
    3 / 43 (6.98%)
    3 / 116 (2.59%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    22
    0
    2
    3
    3
    0
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    16 / 1115 (1.43%)
    31 / 341 (9.09%)
    2 / 80 (2.50%)
    5 / 43 (11.63%)
    14 / 116 (12.07%)
    3 / 41 (7.32%)
    1 / 8 (12.50%)
         occurrences all number
    20
    39
    3
    9
    19
    7
    1
    Headache
         subjects affected / exposed
    89 / 1115 (7.98%)
    39 / 341 (11.44%)
    11 / 80 (13.75%)
    9 / 43 (20.93%)
    25 / 116 (21.55%)
    3 / 41 (7.32%)
    2 / 8 (25.00%)
         occurrences all number
    116
    57
    13
    9
    40
    3
    2
    Memory impairment
         subjects affected / exposed
    0 / 1115 (0.00%)
    2 / 341 (0.59%)
    1 / 80 (1.25%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    2
    1
    0
    0
    0
    1
    Muscle contractions involuntary
         subjects affected / exposed
    1 / 1115 (0.09%)
    0 / 341 (0.00%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    1
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    7 / 1115 (0.63%)
    1 / 341 (0.29%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    3 / 41 (7.32%)
    0 / 8 (0.00%)
         occurrences all number
    7
    1
    0
    0
    0
    4
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    12 / 1115 (1.08%)
    15 / 341 (4.40%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    1 / 116 (0.86%)
    3 / 41 (7.32%)
    0 / 8 (0.00%)
         occurrences all number
    15
    16
    0
    0
    1
    3
    0
    Eye disorders
    Eye pruritus
         subjects affected / exposed
    3 / 1115 (0.27%)
    2 / 341 (0.59%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    3
    2
    0
    0
    0
    0
    1
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    10 / 1115 (0.90%)
    3 / 341 (0.88%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    6 / 116 (5.17%)
    1 / 41 (2.44%)
    1 / 8 (12.50%)
         occurrences all number
    10
    3
    0
    0
    6
    1
    1
    Abdominal distension
         subjects affected / exposed
    19 / 1115 (1.70%)
    8 / 341 (2.35%)
    2 / 80 (2.50%)
    5 / 43 (11.63%)
    5 / 116 (4.31%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    21
    11
    2
    5
    6
    0
    0
    Abdominal pain
         subjects affected / exposed
    100 / 1115 (8.97%)
    48 / 341 (14.08%)
    12 / 80 (15.00%)
    8 / 43 (18.60%)
    19 / 116 (16.38%)
    7 / 41 (17.07%)
    0 / 8 (0.00%)
         occurrences all number
    130
    65
    13
    14
    28
    9
    0
    Abdominal pain upper
         subjects affected / exposed
    54 / 1115 (4.84%)
    44 / 341 (12.90%)
    9 / 80 (11.25%)
    5 / 43 (11.63%)
    21 / 116 (18.10%)
    5 / 41 (12.20%)
    1 / 8 (12.50%)
         occurrences all number
    63
    53
    13
    5
    26
    5
    1
    Constipation
         subjects affected / exposed
    34 / 1115 (3.05%)
    59 / 341 (17.30%)
    3 / 80 (3.75%)
    6 / 43 (13.95%)
    13 / 116 (11.21%)
    4 / 41 (9.76%)
    1 / 8 (12.50%)
         occurrences all number
    40
    73
    3
    7
    17
    4
    1
    Diarrhoea
         subjects affected / exposed
    140 / 1115 (12.56%)
    153 / 341 (44.87%)
    18 / 80 (22.50%)
    17 / 43 (39.53%)
    34 / 116 (29.31%)
    18 / 41 (43.90%)
    4 / 8 (50.00%)
         occurrences all number
    189
    248
    23
    26
    60
    35
    5
    Dry mouth
         subjects affected / exposed
    1 / 1115 (0.09%)
    4 / 341 (1.17%)
    1 / 80 (1.25%)
    1 / 43 (2.33%)
    0 / 116 (0.00%)
    2 / 41 (4.88%)
    1 / 8 (12.50%)
         occurrences all number
    1
    4
    1
    1
    0
    2
    1
    Dyspepsia
         subjects affected / exposed
    24 / 1115 (2.15%)
    17 / 341 (4.99%)
    0 / 80 (0.00%)
    2 / 43 (4.65%)
    19 / 116 (16.38%)
    5 / 41 (12.20%)
    1 / 8 (12.50%)
         occurrences all number
    27
    20
    0
    2
    31
    5
    1
    Gingival bleeding
         subjects affected / exposed
    1 / 1115 (0.09%)
    6 / 341 (1.76%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    6 / 116 (5.17%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    1
    6
    0
    0
    16
    0
    0
    Haemorrhoids
         subjects affected / exposed
    1 / 1115 (0.09%)
    6 / 341 (1.76%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    4 / 116 (3.45%)
    1 / 41 (2.44%)
    1 / 8 (12.50%)
         occurrences all number
    1
    6
    0
    0
    5
    1
    1
    Nausea
         subjects affected / exposed
    80 / 1115 (7.17%)
    67 / 341 (19.65%)
    13 / 80 (16.25%)
    10 / 43 (23.26%)
    38 / 116 (32.76%)
    12 / 41 (29.27%)
    1 / 8 (12.50%)
         occurrences all number
    103
    94
    17
    16
    83
    20
    2
    Toothache
         subjects affected / exposed
    6 / 1115 (0.54%)
    6 / 341 (1.76%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    7 / 116 (6.03%)
    1 / 41 (2.44%)
    0 / 8 (0.00%)
         occurrences all number
    6
    6
    0
    0
    8
    1
    0
    Vomiting
         subjects affected / exposed
    68 / 1115 (6.10%)
    42 / 341 (12.32%)
    6 / 80 (7.50%)
    6 / 43 (13.95%)
    26 / 116 (22.41%)
    6 / 41 (14.63%)
    1 / 8 (12.50%)
         occurrences all number
    80
    58
    7
    17
    36
    11
    1
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    6 / 1115 (0.54%)
    3 / 341 (0.88%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    3 / 41 (7.32%)
    0 / 8 (0.00%)
         occurrences all number
    6
    5
    0
    0
    0
    3
    0
    Petechiae
         subjects affected / exposed
    1 / 1115 (0.09%)
    9 / 341 (2.64%)
    0 / 80 (0.00%)
    3 / 43 (6.98%)
    7 / 116 (6.03%)
    1 / 41 (2.44%)
    0 / 8 (0.00%)
         occurrences all number
    1
    9
    0
    3
    13
    1
    0
    Pruritus
         subjects affected / exposed
    19 / 1115 (1.70%)
    29 / 341 (8.50%)
    1 / 80 (1.25%)
    6 / 43 (13.95%)
    15 / 116 (12.93%)
    2 / 41 (4.88%)
    0 / 8 (0.00%)
         occurrences all number
    21
    32
    3
    8
    18
    2
    0
    Rash
         subjects affected / exposed
    160 / 1115 (14.35%)
    35 / 341 (10.26%)
    4 / 80 (5.00%)
    6 / 43 (13.95%)
    22 / 116 (18.97%)
    2 / 41 (4.88%)
    1 / 8 (12.50%)
         occurrences all number
    179
    45
    9
    7
    30
    2
    1
    Urticaria
         subjects affected / exposed
    28 / 1115 (2.51%)
    8 / 341 (2.35%)
    0 / 80 (0.00%)
    2 / 43 (4.65%)
    9 / 116 (7.76%)
    1 / 41 (2.44%)
    0 / 8 (0.00%)
         occurrences all number
    37
    10
    0
    2
    10
    1
    0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    1 / 1115 (0.09%)
    3 / 341 (0.88%)
    0 / 80 (0.00%)
    1 / 43 (2.33%)
    6 / 116 (5.17%)
    2 / 41 (4.88%)
    0 / 8 (0.00%)
         occurrences all number
    1
    4
    0
    1
    7
    4
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    34 / 1115 (3.05%)
    23 / 341 (6.74%)
    11 / 80 (13.75%)
    4 / 43 (9.30%)
    9 / 116 (7.76%)
    4 / 41 (9.76%)
    1 / 8 (12.50%)
         occurrences all number
    37
    24
    14
    4
    11
    5
    2
    Back pain
         subjects affected / exposed
    44 / 1115 (3.95%)
    33 / 341 (9.68%)
    6 / 80 (7.50%)
    2 / 43 (4.65%)
    10 / 116 (8.62%)
    4 / 41 (9.76%)
    0 / 8 (0.00%)
         occurrences all number
    53
    37
    9
    2
    11
    5
    0
    Muscle spasms
         subjects affected / exposed
    10 / 1115 (0.90%)
    23 / 341 (6.74%)
    0 / 80 (0.00%)
    2 / 43 (4.65%)
    6 / 116 (5.17%)
    9 / 41 (21.95%)
    1 / 8 (12.50%)
         occurrences all number
    10
    27
    0
    2
    7
    9
    1
    Musculoskeletal chest pain
         subjects affected / exposed
    9 / 1115 (0.81%)
    6 / 341 (1.76%)
    4 / 80 (5.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    2 / 41 (4.88%)
    1 / 8 (12.50%)
         occurrences all number
    9
    6
    5
    0
    0
    2
    1
    Musculoskeletal pain
         subjects affected / exposed
    8 / 1115 (0.72%)
    5 / 341 (1.47%)
    4 / 80 (5.00%)
    0 / 43 (0.00%)
    1 / 116 (0.86%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    8
    6
    5
    0
    1
    0
    0
    Myalgia
         subjects affected / exposed
    22 / 1115 (1.97%)
    15 / 341 (4.40%)
    1 / 80 (1.25%)
    3 / 43 (6.98%)
    6 / 116 (5.17%)
    5 / 41 (12.20%)
    0 / 8 (0.00%)
         occurrences all number
    23
    22
    1
    4
    6
    5
    0
    Neck pain
         subjects affected / exposed
    7 / 1115 (0.63%)
    2 / 341 (0.59%)
    2 / 80 (2.50%)
    0 / 43 (0.00%)
    1 / 116 (0.86%)
    0 / 41 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    8
    2
    2
    0
    1
    0
    1
    Pain in extremity
         subjects affected / exposed
    22 / 1115 (1.97%)
    13 / 341 (3.81%)
    9 / 80 (11.25%)
    2 / 43 (4.65%)
    14 / 116 (12.07%)
    1 / 41 (2.44%)
    0 / 8 (0.00%)
         occurrences all number
    24
    16
    13
    2
    15
    1
    0
    Infections and infestations
    Acute tonsillitis
         subjects affected / exposed
    10 / 1115 (0.90%)
    1 / 341 (0.29%)
    1 / 80 (1.25%)
    1 / 43 (2.33%)
    0 / 116 (0.00%)
    3 / 41 (7.32%)
    2 / 8 (25.00%)
         occurrences all number
    10
    1
    1
    1
    0
    5
    2
    Bronchitis
         subjects affected / exposed
    23 / 1115 (2.06%)
    11 / 341 (3.23%)
    4 / 80 (5.00%)
    2 / 43 (4.65%)
    5 / 116 (4.31%)
    2 / 41 (4.88%)
    0 / 8 (0.00%)
         occurrences all number
    27
    15
    4
    3
    7
    3
    0
    Gastroenteritis
         subjects affected / exposed
    45 / 1115 (4.04%)
    6 / 341 (1.76%)
    1 / 80 (1.25%)
    5 / 43 (11.63%)
    4 / 116 (3.45%)
    1 / 41 (2.44%)
    0 / 8 (0.00%)
         occurrences all number
    56
    7
    1
    6
    4
    1
    0
    Influenza
         subjects affected / exposed
    33 / 1115 (2.96%)
    5 / 341 (1.47%)
    4 / 80 (5.00%)
    1 / 43 (2.33%)
    1 / 116 (0.86%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    37
    5
    5
    1
    2
    0
    0
    Lower respiratory tract infection
         subjects affected / exposed
    3 / 1115 (0.27%)
    6 / 341 (1.76%)
    1 / 80 (1.25%)
    3 / 43 (6.98%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    4
    12
    1
    4
    0
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    96 / 1115 (8.61%)
    24 / 341 (7.04%)
    6 / 80 (7.50%)
    6 / 43 (13.95%)
    7 / 116 (6.03%)
    3 / 41 (7.32%)
    1 / 8 (12.50%)
         occurrences all number
    129
    34
    6
    6
    10
    6
    2
    Pharyngitis
         subjects affected / exposed
    83 / 1115 (7.44%)
    5 / 341 (1.47%)
    3 / 80 (3.75%)
    1 / 43 (2.33%)
    3 / 116 (2.59%)
    3 / 41 (7.32%)
    0 / 8 (0.00%)
         occurrences all number
    116
    5
    4
    1
    3
    3
    0
    Upper respiratory tract infection
         subjects affected / exposed
    152 / 1115 (13.63%)
    17 / 341 (4.99%)
    3 / 80 (3.75%)
    6 / 43 (13.95%)
    48 / 116 (41.38%)
    0 / 41 (0.00%)
    4 / 8 (50.00%)
         occurrences all number
    239
    26
    5
    8
    92
    0
    6
    Urinary tract infection
         subjects affected / exposed
    17 / 1115 (1.52%)
    23 / 341 (6.74%)
    3 / 80 (3.75%)
    2 / 43 (4.65%)
    3 / 116 (2.59%)
    4 / 41 (9.76%)
    0 / 8 (0.00%)
         occurrences all number
    21
    28
    4
    2
    3
    6
    0
    Viral infection
         subjects affected / exposed
    17 / 1115 (1.52%)
    1 / 341 (0.29%)
    1 / 80 (1.25%)
    3 / 43 (6.98%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    18
    1
    1
    3
    0
    0
    0
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    11 / 1115 (0.99%)
    18 / 341 (5.28%)
    2 / 80 (2.50%)
    3 / 43 (6.98%)
    13 / 116 (11.21%)
    3 / 41 (7.32%)
    0 / 8 (0.00%)
         occurrences all number
    11
    20
    2
    4
    17
    4
    0
    Dehydration
         subjects affected / exposed
    0 / 1115 (0.00%)
    2 / 341 (0.59%)
    0 / 80 (0.00%)
    0 / 43 (0.00%)
    0 / 116 (0.00%)
    0 / 41 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Oct 2005
    Determination of LIC by R2-MRI, assessment of quality of life (QoL) and subject satisfaction were included in the secondary objective of the study.
    03 May 2007
    The duration of the extension study was extended to a maximum of 18 months to provide access to the study drug to subjects until commercially available.
    31 Jul 2007
    Updated safety assessment critera for sub-analysis of subjects with LIC < 7 mg Fe/g dw.

    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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