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    Clinical Trial Results:
    PHASE 1/2 STUDY TO DETERMINE THE SAFETY, PHARMACOKINETICS, AND EFFICACY OF SINGLE AGENT CC-122 AND THE COMBINATIONS OF CC-122 AND IBRUTINIB AND CC-122 AND OBINUTUZUMAB IN SUBJECTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA/SMALL LYMPHOCYTIC LYMPHOMA

    Summary
    EudraCT number
    		 2014-003056-31
    Trial protocol
    		 DE   ES  
    Global end of trial date
    07 Jul 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Jul 2021
    First version publication date
    23 Jul 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CC-122-CLL-001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bristol-Myers Squibb
    Sponsor organisation address
    Chaussée de la Hulpe 185, Brussels, Belgium, 1170
    Public contact
    EU Study Start-Up Unit, Bristol-Myers Squibb International Corporation, Clinical.Trials@bms.com
    Scientific contact
    Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, Clinical.Trials@bms.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    25 Aug 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 Jul 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Jul 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objectives of the study are:  Determine the safety of single agent CC-122 in subjects with R/R CLL/SLL  Determine the safety and tolerability of the combination of CC-122 and ibrutinib and determine the RP2D of the combination in ibrutinib-naive CLL/SLL subjects  Determine the safety and tolerability of the combination of CC-122 and obinutuzumab and determine the RP2D of the combination in subjects with R/R CLL/SLL
    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 Good Clinical Practice Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 May 2015
    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
    United States: 29
    Country: Number of subjects enrolled
    Spain: 1
    Country: Number of subjects enrolled
    Italy: 8
    Country: Number of subjects enrolled
    Germany: 1
    Country: Number of subjects enrolled
    Austria: 7
    Worldwide total number of subjects
    46
    EEA total number of subjects
    17
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    23
    From 65 to 84 years
    23
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 46 participants treated

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm A
    Arm description
    		 CC-122 single agent Dose Escalation starting at the 1.0 mg dose level up to a maximum of 4.0 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    CC-122
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    1 mg escalating up to 4mg

    Arm title
    		 Arm B
    Arm description
    		 CC-122 in combination with ibrutinib Ascending fixed-dose cohorts of CC-122 starting at 0.5 mg up to a maximum of 4.0 mg or NTD, whichever occurs first, in combination with ibrutinib
    Arm type
    		 Experimental

    Investigational medicinal product name
    CC-122
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    0.5 mg escalating up to 4mg

    Investigational medicinal product name
    Ibrutinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    420mg (140mg x 3)

    Arm title
    		 Arm C
    Arm description
    		 CC-122 in combination with obinutuzumab Ascending fixed-dose cohorts of CC-122 starting at 0.5 mg up to a maximum of 4.0 mg or NTD, whichever occurs first, in combination with obinutuzumab.
    Arm type
    		 Experimental

    Investigational medicinal product name
    CC-122
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    1 mg escalating up to 4mg

    Investigational medicinal product name
    Obinutuzumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravascular use
    Dosage and administration details
    6 cycles

    Number of subjects in period 1
    		Arm A Arm B Arm C
    Started
    14
    16
    16
    Completed
    0
    0
    0
    Not completed
    14
    16
    16
         Adverse event, serious fatal
    1
    -
    -
         Physician decision
    1
    2
    1
         Progression of Disease
    5
    1
    6
         Withdrawal by Participant
    1
    2
    -
         Adverse event, non-fatal
    3
    -
    2
         Other Reasons
    1
    11
    5
         Transition to other treatment
    2
    -
    1
         Lack of efficacy
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 CC-122 single agent Dose Escalation starting at the 1.0 mg dose level up to a maximum of 4.0 mg

    Reporting group title
    Arm B
    Reporting group description
    		 CC-122 in combination with ibrutinib Ascending fixed-dose cohorts of CC-122 starting at 0.5 mg up to a maximum of 4.0 mg or NTD, whichever occurs first, in combination with ibrutinib

    Reporting group title
    Arm C
    Reporting group description
    		 CC-122 in combination with obinutuzumab Ascending fixed-dose cohorts of CC-122 starting at 0.5 mg up to a maximum of 4.0 mg or NTD, whichever occurs first, in combination with obinutuzumab.

    Reporting group values
    		 Arm A Arm B Arm C Total
    Number of subjects
    		 14 16 16 46
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 5 8 10 23
        From 65-84 years
    		 9 8 6 23
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 67.4 ± 9.41 63.4 ± 9.98 61.5 ± 6.11 -
    Sex: Female, Male
    Units: Participants
        Female
    		 4 8 2 14
        Male
    		 10 8 14 32
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0
        Asian
    		 1 0 0 1
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0
        Black or African American
    		 1 0 1 2
        White
    		 12 16 14 42
        More than one race
    		 0 0 0 0
        Unknown or Not Reported
    		 0 0 1 1
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 0 1 0 1
        Not Hispanic or Latino
    		 14 15 16 45
        Unknown or Not Reported
    		 0 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 CC-122 single agent Dose Escalation starting at the 1.0 mg dose level up to a maximum of 4.0 mg

    Reporting group title
    Arm B
    Reporting group description
    		 CC-122 in combination with ibrutinib Ascending fixed-dose cohorts of CC-122 starting at 0.5 mg up to a maximum of 4.0 mg or NTD, whichever occurs first, in combination with ibrutinib

    Reporting group title
    Arm C
    Reporting group description
    		 CC-122 in combination with obinutuzumab Ascending fixed-dose cohorts of CC-122 starting at 0.5 mg up to a maximum of 4.0 mg or NTD, whichever occurs first, in combination with obinutuzumab.

    Primary: Number of participants and severity of AEs

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    End point title
    		 Number of participants and severity of AEs [1]
    End point description
    Number and severity of adverse events using the NCI CTCAE criteria (version 4.03), including DLTs
    End point type
    Primary
    End point timeframe
    Approximately 60 Months
    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: No Statistical Analysis done for this endpoint
    End point values
    		 Arm A Arm B Arm C
    Number of subjects analysed
    14
    16
    16
    Units: Number
        Grade 3 AE
    8
    8
    9
        Grade 4 AE
    3
    5
    7
        DLTs
    0
    0
    0
    No statistical analyses for this end point

    Primary: Determination of Non tolerated dose (NTD) and Maximum tolerated dose (MTD)

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    End point title
    		 Determination of Non tolerated dose (NTD) and Maximum tolerated dose (MTD) [2]
    End point description
    Determination of the NTD and MTD in CC-122 in combination with ibrutinib and CC-122 in combination with obinutuzumab 9999 here represents the values as Not available (NA)
    End point type
    Primary
    End point timeframe
    Approximately 60 Months
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No Statistical Analysis done for this endpoint
    End point values
    		 Arm A Arm B Arm C
    Number of subjects analysed
    0 [3]
    16
    16
    Units: mg
    arithmetic mean (full range (min-max))
        NTD
    ( to )
    9999 (-9999 to 9999)
    9999 (-9999 to 9999)
        MTD
    ( to )
    9999 (-9999 to 9999)
    9999 (-9999 to 9999)
    Notes
    [3] - This arm was not analyzed in this endpoint
    No statistical analyses for this end point

    Secondary: CC-122 plasma concentrations when administered alone or in combination with ibrutinib or obinutuzumab

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    End point title
    		 CC-122 plasma concentrations when administered alone or in combination with ibrutinib or obinutuzumab
    End point description
    CC-122 plasma concentrations when administered alone or in combination with ibrutinib or obinutuzumab 9999 here represents the values as Not available (NA)
    End point type
    Secondary
    End point timeframe
    Approximately 60 Months
    End point values
    		 Arm A Arm B Arm C
    Number of subjects analysed
    14
    7
    5
    Units: Percentage
        geometric mean (geometric coefficient of variation)
    9999 ± 9999
    9999 ± 9999
    9999 ± 9999
    No statistical analyses for this end point

    Secondary: CC-122 pharmacokinetic parameters when administered in combination with ibrutinib

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    End point title
    		 CC-122 pharmacokinetic parameters when administered in combination with ibrutinib
    End point description
    CC-122 pharmacokinetic parameters when administered in combination with ibrutinib 9999 here represents the values as Not available (NA)
    End point type
    Secondary
    End point timeframe
    Approximately 60 Months
    End point values
    		 Arm A Arm B Arm C
    Number of subjects analysed
    5
    0 [4]
    0 [5]
    Units: Percentage
        arithmetic mean (confidence interval 95%)
    9999 (-9999 to 9999)
    ( to )
    ( to )
    Notes
    [4] - No subjects analyzed
    [5] - No subjects analyzed
    No statistical analyses for this end point

    Secondary: Ibrutinib plasma concentrations and/or pharmacokinetic parameters when administered in combination with CC-122

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    End point title
    		 Ibrutinib plasma concentrations and/or pharmacokinetic parameters when administered in combination with CC-122
    End point description
    Ibrutinib plasma concentrations and /or pharmacokinetic parameters when administered in combination with CC-122 9999 here represents the values as Not available (NA)
    End point type
    Secondary
    End point timeframe
    Approximately 60 Months
    End point values
    		 Arm A Arm B Arm C
    Number of subjects analysed
    14
    7
    5
    Units: Percentage
        geometric mean (geometric coefficient of variation)
    9999 ± 9999
    9999 ± 9999
    9999 ± 9999
    No statistical analyses for this end point

    Secondary: Best overall Response (BOR)

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    End point title
    		 Best overall Response (BOR)
    End point description
    Best overall response [CR, CRi, nPR, PR, PRL (applicable to Arm B only)] CR = Complete Response CRi = Complete response with incomplete marrow recovery nPR = nodular Partial Response PR = Partial response PRL= Partial response with lymphocytosis
    End point type
    Secondary
    End point timeframe
    Approximately 60 Months
    End point values
    		 Arm A Arm B Arm C
    Number of subjects analysed
    14
    16
    16
    Units: Percentage
        number (confidence interval 95%)
    7.1 (0.2 to 33.9)
    87.5 (61.7 to 98.4)
    62.5 (35.4 to 84.8)
    No statistical analyses for this end point

    Secondary: Minimal Residual Disease Response Rate

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    End point title
    		 Minimal Residual Disease Response Rate
    End point description
    Minimal Residual Disease Response Rate in bone marrow and peripheral blood
    End point type
    Secondary
    End point timeframe
    Approximately 60 Months
    End point values
    		 Arm A Arm B Arm C
    Number of subjects analysed
    14
    16
    16
    Units: Percentage
    number (confidence interval 95%)
        Bone Marrow
    0 (0.0 to 23.2)
    0 (0.0 to 20.6)
    0 (0.0 to 20.6)
        Peripheral Blood
    0 (0.0 to 23.2)
    0 (0.0 to 20.6)
    18.8 (4.0 to 45.6)
    No statistical analyses for this end point

    Secondary: Duration of Response

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    End point title
    		 Duration of Response
    End point description
    measured from the time the response is first met until the first date that progressive disease or death is documented. Participants who neither progress nor die or who withdrew consent or are lost to follow-up prior to documentation of progression will be censored at the date of their last adequate response assessment. 9999 here represents the values as Not available (NA)
    End point type
    Secondary
    End point timeframe
    Approximately 60 Months
    End point values
    		 Arm A Arm B Arm C
    Number of subjects analysed
    1
    14
    10
    Units: Days
        median (confidence interval 95%)
    113 (-9999 to 9999)
    9999 (-9999 to 9999)
    602.0 (-9999 to 9999)
    No statistical analyses for this end point

    Secondary: Progression Free Survival (PFS)

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    End point title
    		 Progression Free Survival (PFS)
    End point description
    will be calculated as the time from irst IP (i.e. any study drug) dose date to the first documented progression or death due to any cause during or after the treatment period, whichever occurs first. 9999 here represents the values as Not available (NA)
    End point type
    Secondary
    End point timeframe
    Approximately 60 Months
    End point values
    		 Arm A Arm B Arm C
    Number of subjects analysed
    14
    16
    16
    Units: Months
        median (confidence interval 95%)
    6.47 (0.43 to 12.29)
    9999 (-9999 to 9999)
    22.57 (5.55 to 9999)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Approximately 60 Months
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    A (CC-122)
    Reporting group description
    		 -

    Reporting group title
    B (CC-122+Ibrutinib)
    Reporting group description
    		 -

    Reporting group title
    C (CC-122+Obinutuzumab)
    Reporting group description
    		 -

    Serious adverse events
    		 A (CC-122) B (CC-122+Ibrutinib) C (CC-122+Obinutuzumab)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 14 (50.00%)
    7 / 16 (43.75%)
    4 / 16 (25.00%)
         number of deaths (all causes)
    2
    0
    1
         number of deaths resulting from adverse events
    0
    0
    0
    Investigations
    Troponin increased
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lung adenocarcinoma
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Comminuted fracture
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral artery occlusion
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemolytic anaemia
         subjects affected / exposed
    2 / 14 (14.29%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Stomatitis
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis contact
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bacteraemia
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Candida sepsis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Enterococcal sepsis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    3 / 14 (21.43%)
    2 / 16 (12.50%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    1 / 4
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Tumour lysis syndrome
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 A (CC-122) B (CC-122+Ibrutinib) C (CC-122+Obinutuzumab)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 14 (100.00%)
    16 / 16 (100.00%)
    16 / 16 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    0 / 14 (0.00%)
    2 / 16 (12.50%)
    1 / 16 (6.25%)
         occurrences all number
    0
    3
    1
    Benign neoplasm of skin
         subjects affected / exposed
    0 / 14 (0.00%)
    2 / 16 (12.50%)
    0 / 16 (0.00%)
         occurrences all number
    0
    3
    0
    Lipoma
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Lung adenocarcinoma
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Squamous cell carcinoma of skin
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Tumour flare
         subjects affected / exposed
    2 / 14 (14.29%)
    1 / 16 (6.25%)
    1 / 16 (6.25%)
         occurrences all number
    3
    3
    1
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Flushing
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Haematoma
         subjects affected / exposed
    0 / 14 (0.00%)
    2 / 16 (12.50%)
    0 / 16 (0.00%)
         occurrences all number
    0
    3
    0
    Hot flush
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    1 / 16 (6.25%)
         occurrences all number
    0
    2
    1
    Hypertension
         subjects affected / exposed
    2 / 14 (14.29%)
    6 / 16 (37.50%)
    3 / 16 (18.75%)
         occurrences all number
    3
    30
    9
    Systolic hypertension
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    Thrombophlebitis superficial
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    3 / 14 (21.43%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    12
    3
    0
    Catheter site bruise
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Chest pain
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Chills
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    1 / 16 (6.25%)
         occurrences all number
    0
    2
    1
    Fatigue
         subjects affected / exposed
    3 / 14 (21.43%)
    1 / 16 (6.25%)
    5 / 16 (31.25%)
         occurrences all number
    3
    1
    9
    Feeling hot
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    Influenza like illness
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Injection site pain
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Malaise
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 14 (7.14%)
    3 / 16 (18.75%)
    1 / 16 (6.25%)
         occurrences all number
    1
    3
    1
    Oedema peripheral
         subjects affected / exposed
    3 / 14 (21.43%)
    7 / 16 (43.75%)
    3 / 16 (18.75%)
         occurrences all number
    3
    11
    4
    Pain
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Peripheral swelling
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Pyrexia
         subjects affected / exposed
    5 / 14 (35.71%)
    4 / 16 (25.00%)
    3 / 16 (18.75%)
         occurrences all number
    14
    6
    3
    Immune system disorders
    Cytokine release syndrome
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Seasonal allergy
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Erectile dysfunction
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Gynaecomastia
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Nipple pain
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Vaginal haemorrhage
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    3 / 14 (21.43%)
    5 / 16 (31.25%)
    3 / 16 (18.75%)
         occurrences all number
    3
    6
    4
    Dyspnoea
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 16 (6.25%)
    3 / 16 (18.75%)
         occurrences all number
    1
    1
    5
    Dyspnoea exertional
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    0
    2
    Epistaxis
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    2
    0
    Haemoptysis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    Nasal congestion
         subjects affected / exposed
    0 / 14 (0.00%)
    2 / 16 (12.50%)
    0 / 16 (0.00%)
         occurrences all number
    0
    2
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 14 (0.00%)
    8 / 16 (50.00%)
    4 / 16 (25.00%)
         occurrences all number
    0
    9
    4
    Pleural effusion
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    Productive cough
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    2 / 16 (12.50%)
         occurrences all number
    0
    1
    2
    Pulmonary hypertension
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    Pulmonary mass
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Pulmonary oedema
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    Respiratory tract congestion
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    Rhinalgia
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Rhinitis allergic
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Sinus congestion
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 16 (6.25%)
    1 / 16 (6.25%)
         occurrences all number
    1
    1
    1
    Confusional state
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Depression
         subjects affected / exposed
    0 / 14 (0.00%)
    2 / 16 (12.50%)
    0 / 16 (0.00%)
         occurrences all number
    0
    2
    0
    Insomnia
         subjects affected / exposed
    0 / 14 (0.00%)
    2 / 16 (12.50%)
    0 / 16 (0.00%)
         occurrences all number
    0
    2
    0
    Irritability
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Libido decreased
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Mood altered
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Product issues
    Device occlusion
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    1
    3
    0
    Amylase increased
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    2
    0
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    1
    1
    0
    Blood bilirubin increased
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Blood creatine phosphokinase increased
         subjects affected / exposed
    2 / 14 (14.29%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    3
    0
    0
    Blood creatinine increased
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    Brain natriuretic peptide increased
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    2
    Electrocardiogram QT prolonged
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Hepatic enzyme increased
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    Lipase increased
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    Occult blood positive
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Weight decreased
         subjects affected / exposed
    0 / 14 (0.00%)
    2 / 16 (12.50%)
    4 / 16 (25.00%)
         occurrences all number
    0
    4
    4
    Weight increased
         subjects affected / exposed
    0 / 14 (0.00%)
    6 / 16 (37.50%)
    1 / 16 (6.25%)
         occurrences all number
    0
    12
    1
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    0 / 14 (0.00%)
    2 / 16 (12.50%)
    1 / 16 (6.25%)
         occurrences all number
    0
    2
    1
    Arthropod sting
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Buttock injury
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Comminuted fracture
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Contusion
         subjects affected / exposed
    0 / 14 (0.00%)
    4 / 16 (25.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    7
    0
    Dental restoration failure
         subjects affected / exposed
    0 / 14 (0.00%)
    2 / 16 (12.50%)
    0 / 16 (0.00%)
         occurrences all number
    0
    2
    0
    Fall
         subjects affected / exposed
    0 / 14 (0.00%)
    6 / 16 (37.50%)
    2 / 16 (12.50%)
         occurrences all number
    0
    14
    6
    Infusion related reaction
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    7 / 16 (43.75%)
         occurrences all number
    0
    0
    7
    Ligament sprain
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Limb injury
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Meniscus injury
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Muscle strain
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Post-traumatic neck syndrome
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Procedural nausea
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Procedural pain
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    1
    0
    1
    Rib fracture
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Skin abrasion
         subjects affected / exposed
    0 / 14 (0.00%)
    2 / 16 (12.50%)
    0 / 16 (0.00%)
         occurrences all number
    0
    2
    0
    Skin laceration
         subjects affected / exposed
    0 / 14 (0.00%)
    2 / 16 (12.50%)
    0 / 16 (0.00%)
         occurrences all number
    0
    2
    0
    Spinal fracture
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Subcutaneous haematoma
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Thermal burn
         subjects affected / exposed
    0 / 14 (0.00%)
    2 / 16 (12.50%)
    0 / 16 (0.00%)
         occurrences all number
    0
    2
    0
    Tooth fracture
         subjects affected / exposed
    0 / 14 (0.00%)
    2 / 16 (12.50%)
    1 / 16 (6.25%)
         occurrences all number
    0
    2
    1
    Urinary retention postoperative
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    Bradycardia
         subjects affected / exposed
    0 / 14 (0.00%)
    2 / 16 (12.50%)
    0 / 16 (0.00%)
         occurrences all number
    0
    2
    0
    Bundle branch block right
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Cardiac valve disease
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Palpitations
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Sinus bradycardia
         subjects affected / exposed
    1 / 14 (7.14%)
    4 / 16 (25.00%)
    1 / 16 (6.25%)
         occurrences all number
    1
    8
    1
    Sinus tachycardia
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Tachycardia
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Tricuspid valve incompetence
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    Ventricular hypertrophy
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Nervous system disorders
    Carotid arteriosclerosis
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Carpal tunnel syndrome
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Cerebral artery occlusion
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Dizziness
         subjects affected / exposed
    1 / 14 (7.14%)
    5 / 16 (31.25%)
    1 / 16 (6.25%)
         occurrences all number
    1
    7
    1
    Dizziness postural
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    Headache
         subjects affected / exposed
    3 / 14 (21.43%)
    2 / 16 (12.50%)
    2 / 16 (12.50%)
         occurrences all number
    3
    3
    2
    Memory impairment
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Paraesthesia
         subjects affected / exposed
    0 / 14 (0.00%)
    4 / 16 (25.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    4
    2
    Peripheral sensory neuropathy
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Presyncope
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    Speech disorder
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Syncope
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Tremor
         subjects affected / exposed
    1 / 14 (7.14%)
    2 / 16 (12.50%)
    1 / 16 (6.25%)
         occurrences all number
    1
    2
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    8 / 14 (57.14%)
    0 / 16 (0.00%)
    4 / 16 (25.00%)
         occurrences all number
    11
    0
    6
    Autoimmune haemolytic anaemia
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Haemorrhagic disorder
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    2
    0
    Leukocytosis
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Leukopenia
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    5 / 16 (31.25%)
         occurrences all number
    0
    0
    18
    Lymph node pain
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    Lymphadenopathy
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Lymphocytosis
         subjects affected / exposed
    0 / 14 (0.00%)
    3 / 16 (18.75%)
    4 / 16 (25.00%)
         occurrences all number
    0
    3
    7
    Lymphopenia
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    7 / 16 (43.75%)
         occurrences all number
    0
    1
    18
    Neutropenia
         subjects affected / exposed
    5 / 14 (35.71%)
    6 / 16 (37.50%)
    13 / 16 (81.25%)
         occurrences all number
    16
    27
    66
    Splenomegaly
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Thrombocytopenia
         subjects affected / exposed
    2 / 14 (14.29%)
    2 / 16 (12.50%)
    6 / 16 (37.50%)
         occurrences all number
    2
    8
    12
    Ear and labyrinth disorders
    Autophony
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Ear discomfort
         subjects affected / exposed
    0 / 14 (0.00%)
    2 / 16 (12.50%)
    1 / 16 (6.25%)
         occurrences all number
    0
    2
    1
    Ear disorder
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Ear pain
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Hypoacusis
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Tinnitus
         subjects affected / exposed
    0 / 14 (0.00%)
    2 / 16 (12.50%)
    0 / 16 (0.00%)
         occurrences all number
    0
    2
    0
    Vertigo
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    Eye disorders
    Cataract
         subjects affected / exposed
    1 / 14 (7.14%)
    2 / 16 (12.50%)
    0 / 16 (0.00%)
         occurrences all number
    1
    3
    0
    Chalazion
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Conjunctival haemorrhage
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    Conjunctivitis allergic
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Diplopia
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Dry eye
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Dyschromatopsia
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Eye haemorrhage
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Eye irritation
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Eye pain
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Foreign body sensation in eyes
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Macular degeneration
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Maculopathy
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Meibomian gland dysfunction
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Photophobia
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Photopsia
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Vision blurred
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Visual impairment
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 14 (7.14%)
    4 / 16 (25.00%)
    1 / 16 (6.25%)
         occurrences all number
    1
    4
    1
    Abdominal pain lower
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Abdominal pain upper
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    Angular cheilitis
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Constipation
         subjects affected / exposed
    2 / 14 (14.29%)
    4 / 16 (25.00%)
    2 / 16 (12.50%)
         occurrences all number
    2
    5
    2
    Dental caries
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Diarrhoea
         subjects affected / exposed
    3 / 14 (21.43%)
    7 / 16 (43.75%)
    4 / 16 (25.00%)
         occurrences all number
    4
    9
    7
    Dry mouth
         subjects affected / exposed
    0 / 14 (0.00%)
    2 / 16 (12.50%)
    2 / 16 (12.50%)
         occurrences all number
    0
    2
    2
    Dyspepsia
         subjects affected / exposed
    0 / 14 (0.00%)
    2 / 16 (12.50%)
    0 / 16 (0.00%)
         occurrences all number
    0
    2
    0
    Dysphagia
         subjects affected / exposed
    0 / 14 (0.00%)
    2 / 16 (12.50%)
    1 / 16 (6.25%)
         occurrences all number
    0
    2
    1
    Flatulence
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    1
    0
    2
    Gastritis
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal polyp
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 14 (0.00%)
    2 / 16 (12.50%)
    0 / 16 (0.00%)
         occurrences all number
    0
    2
    0
    Gingival bleeding
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Inguinal hernia
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Large intestine polyp
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Nausea
         subjects affected / exposed
    1 / 14 (7.14%)
    7 / 16 (43.75%)
    5 / 16 (31.25%)
         occurrences all number
    1
    11
    5
    Noninfective gingivitis
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Oral mucosal erythema
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    1
    1
    0
    Oral pain
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Paraesthesia oral
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Stomatitis
         subjects affected / exposed
    0 / 14 (0.00%)
    7 / 16 (43.75%)
    1 / 16 (6.25%)
         occurrences all number
    0
    15
    1
    Toothache
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Umbilical hernia
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    Vomiting
         subjects affected / exposed
    1 / 14 (7.14%)
    3 / 16 (18.75%)
    2 / 16 (12.50%)
         occurrences all number
    1
    5
    2
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Actinic keratosis
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Alopecia
         subjects affected / exposed
    0 / 14 (0.00%)
    2 / 16 (12.50%)
    1 / 16 (6.25%)
         occurrences all number
    0
    2
    1
    Dermatitis
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Dermatitis contact
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    2 / 16 (12.50%)
         occurrences all number
    0
    2
    2
    Dry skin
         subjects affected / exposed
    0 / 14 (0.00%)
    2 / 16 (12.50%)
    0 / 16 (0.00%)
         occurrences all number
    0
    2
    0
    Ecchymosis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    Erythema
         subjects affected / exposed
    0 / 14 (0.00%)
    2 / 16 (12.50%)
    0 / 16 (0.00%)
         occurrences all number
    0
    2
    0
    Hair texture abnormal
         subjects affected / exposed
    0 / 14 (0.00%)
    2 / 16 (12.50%)
    0 / 16 (0.00%)
         occurrences all number
    0
    2
    0
    Hyperhidrosis
         subjects affected / exposed
    1 / 14 (7.14%)
    2 / 16 (12.50%)
    2 / 16 (12.50%)
         occurrences all number
    1
    2
    2
    Hyperkeratosis
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Nail discolouration
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Nail disorder
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Night sweats
         subjects affected / exposed
    4 / 14 (28.57%)
    3 / 16 (18.75%)
    2 / 16 (12.50%)
         occurrences all number
    4
    3
    2
    Onychoclasis
         subjects affected / exposed
    0 / 14 (0.00%)
    3 / 16 (18.75%)
    0 / 16 (0.00%)
         occurrences all number
    0
    3
    0
    Onychomadesis
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Petechiae
         subjects affected / exposed
    0 / 14 (0.00%)
    3 / 16 (18.75%)
    1 / 16 (6.25%)
         occurrences all number
    0
    3
    1
    Precancerous skin lesion
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Pruritus
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 16 (6.25%)
    3 / 16 (18.75%)
         occurrences all number
    1
    1
    4
    Rash
         subjects affected / exposed
    1 / 14 (7.14%)
    3 / 16 (18.75%)
    2 / 16 (12.50%)
         occurrences all number
    2
    3
    2
    Rash erythematous
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    1
    1
    0
    Rash macular
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Rash maculo-papular
         subjects affected / exposed
    0 / 14 (0.00%)
    3 / 16 (18.75%)
    2 / 16 (12.50%)
         occurrences all number
    0
    4
    2
    Seborrhoeic dermatitis
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Skin haemorrhage
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Skin lesion
         subjects affected / exposed
    0 / 14 (0.00%)
    3 / 16 (18.75%)
    2 / 16 (12.50%)
         occurrences all number
    0
    3
    5
    Skin mass
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Solar lentigo
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Urticaria
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Haematuria
         subjects affected / exposed
    0 / 14 (0.00%)
    2 / 16 (12.50%)
    0 / 16 (0.00%)
         occurrences all number
    0
    2
    0
    Nephrolithiasis
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    2
    Pollakiuria
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Strangury
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Urethral haemorrhage
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    Urinary retention
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Urinary tract obstruction
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 14 (14.29%)
    5 / 16 (31.25%)
    2 / 16 (12.50%)
         occurrences all number
    3
    12
    2
    Back pain
         subjects affected / exposed
    1 / 14 (7.14%)
    4 / 16 (25.00%)
    4 / 16 (25.00%)
         occurrences all number
    1
    9
    4
    Flank pain
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Joint swelling
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    1
    0
    1
    Muscle contracture
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    Muscle spasms
         subjects affected / exposed
    1 / 14 (7.14%)
    5 / 16 (31.25%)
    4 / 16 (25.00%)
         occurrences all number
    1
    6
    4
    Muscular weakness
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    0
    2
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    Musculoskeletal pain
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Myalgia
         subjects affected / exposed
    2 / 14 (14.29%)
    5 / 16 (31.25%)
    2 / 16 (12.50%)
         occurrences all number
    2
    6
    3
    Neck pain
         subjects affected / exposed
    0 / 14 (0.00%)
    2 / 16 (12.50%)
    1 / 16 (6.25%)
         occurrences all number
    0
    5
    1
    Osteoporosis
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Pain in extremity
         subjects affected / exposed
    1 / 14 (7.14%)
    2 / 16 (12.50%)
    1 / 16 (6.25%)
         occurrences all number
    1
    2
    2
    Synovial cyst
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Infections and infestations
    Arthritis infective
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Bacteraemia
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Balanitis candida
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Body tinea
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Bronchitis
         subjects affected / exposed
    0 / 14 (0.00%)
    2 / 16 (12.50%)
    0 / 16 (0.00%)
         occurrences all number
    0
    2
    0
    Cellulitis
         subjects affected / exposed
    0 / 14 (0.00%)
    2 / 16 (12.50%)
    1 / 16 (6.25%)
         occurrences all number
    0
    3
    1
    Conjunctivitis
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Cystitis
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Diverticulitis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    Fungal balanitis
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Gingivitis
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Haematoma infection
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Infection
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    Influenza
         subjects affected / exposed
    0 / 14 (0.00%)
    3 / 16 (18.75%)
    0 / 16 (0.00%)
         occurrences all number
    0
    4
    0
    Nasal herpes
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    1 / 14 (7.14%)
    4 / 16 (25.00%)
    5 / 16 (31.25%)
         occurrences all number
    1
    4
    8
    Oral candidiasis
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 16 (6.25%)
    1 / 16 (6.25%)
         occurrences all number
    1
    1
    1
    Oral herpes
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    4
    Pharyngitis
         subjects affected / exposed
    0 / 14 (0.00%)
    2 / 16 (12.50%)
    0 / 16 (0.00%)
         occurrences all number
    0
    2
    0
    Pneumonia
         subjects affected / exposed
    1 / 14 (7.14%)
    2 / 16 (12.50%)
    1 / 16 (6.25%)
         occurrences all number
    1
    3
    1
    Pseudomonal sepsis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    Respiratory tract infection
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Rhinitis
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    Sinusitis
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    3 / 16 (18.75%)
         occurrences all number
    0
    1
    6
    Skin infection
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Tinea cruris
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Tinea infection
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Tonsillitis
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Tooth abscess
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Tooth infection
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 14 (7.14%)
    6 / 16 (37.50%)
    5 / 16 (31.25%)
         occurrences all number
    2
    10
    7
    Urinary tract infection
         subjects affected / exposed
    0 / 14 (0.00%)
    3 / 16 (18.75%)
    4 / 16 (25.00%)
         occurrences all number
    0
    5
    8
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Vulvovaginal mycotic infection
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Wound infection
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    Dehydration
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Diabetes mellitus
         subjects affected / exposed
    0 / 14 (0.00%)
    3 / 16 (18.75%)
    1 / 16 (6.25%)
         occurrences all number
    0
    4
    2
    Folate deficiency
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    Gout
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    Hypercalcaemia
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    0
    2
    Hyperglycaemia
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 16 (6.25%)
    1 / 16 (6.25%)
         occurrences all number
    0
    2
    2
    Hyperkalaemia
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    Hyperphosphataemia
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    Hyperuricaemia
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 16 (6.25%)
    2 / 16 (12.50%)
         occurrences all number
    1
    1
    2
    Hypocalcaemia
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    2
    Hypokalaemia
         subjects affected / exposed
    0 / 14 (0.00%)
    2 / 16 (12.50%)
    2 / 16 (12.50%)
         occurrences all number
    0
    2
    2
    Hypomagnesaemia
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    0
    2
    Hypophosphataemia
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Iron deficiency
         subjects affected / exposed
    1 / 14 (7.14%)
    2 / 16 (12.50%)
    3 / 16 (18.75%)
         occurrences all number
    1
    3
    3
    Polydipsia
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    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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