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    Clinical Trial Results:
    A Phase Ib/II study of the ALK inhibitor ceritinib in combination with the CDK4/6 inhibitor LEE011 in patients with ALK-positive Non-Small Cell Lung Cancer

    Summary
    EudraCT number
    		 2014-003032-39
    Trial protocol
    		 ES   FR   IT  
    Global end of trial date
    26 Sep 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Oct 2019
    First version publication date
    11 Oct 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CLEE011X2110C
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharmaceuticals
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Study Director, Novartis Pharma AG, 41 613241111, novartis.email@novartis.com
    Scientific contact
    Study Director, Novartis Pharmaceuticals, 41 613241111, novartis.email@novartis.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
    03 Jun 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Sep 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Sep 2018
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Primary Objectives were, in the Phase Ib part, to estimate the maximum tolerated doses (MTD(s)) and/or recommended Phase 2 doses (RP2D(s)) and schedule of ribociclib in combination with ceritinib in ALKpositive NSCLC patients.  And in the Phase II part: To assess preliminary anti-tumor activity of the ribociclib and ceritinib combination
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 May 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 1
    Country: Number of subjects enrolled
    Italy: 9
    Country: Number of subjects enrolled
    Korea, Republic of: 1
    Country: Number of subjects enrolled
    Spain: 8
    Country: Number of subjects enrolled
    Taiwan: 8
    Worldwide total number of subjects
    27
    EEA total number of subjects
    18
    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)
    22
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Phase II was not initiated & enrollment in Phase Ib was terminated early based on changes in treatment landscape for ALK+ NSCLC. The RP2D was identified on 19-Apr-2017 based on additional safety data. Recruitment halt & early termination were not a result of any safety concerns. Patients that moved to a rollover protocol were considered completed

    Pre-assignment
    Screening details
    		 27 patients were enrolled between 14-May-2015 (FPFV) and 26-Sep-2018 (LPLV) in the dose escalation phase, and all discontinued study treatment. Primary reason for discontinuation was Progressive Disease (PD) (14 patients, 51.9%). Other reasons for discontinuations included moved to rollover protocol due to early termination and AEs

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ribociclib 100 mg + Ceritinib 300 mg
    Arm description
    		 LEE011 capsule for oral use (ribociclib) and Ceritinib for oral use
    Arm type
    		 Experimental

    Investigational medicinal product name
    LEE011
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    CAPSULE

    Arm title
    		 Ribociclib 100 mg + Ceritinib 450 mg
    Arm description
    		 LEE011 capsule for oral use (ribociclib) and Ceritinib for oral use
    Arm type
    		 Experimental

    Investigational medicinal product name
    LEE011
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    CAPSULE

    Arm title
    		 Ribociclib 200 mg + Ceritinib 300 mg
    Arm description
    		 LEE011 capsule for oral use (ribociclib) and Ceritinib for oral use
    Arm type
    		 Experimental

    Investigational medicinal product name
    LEE011
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    CAPSULE

    Arm title
    		 Ribociclib 200 mg + Ceritinib 450 mg
    Arm description
    		 LEE011 capsule for oral use (ribociclib) and Ceritinib for oral use
    Arm type
    		 Experimental

    Investigational medicinal product name
    LEE011
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    CAPSULE

    Arm title
    		 Ribociclib 300 mg + Ceritinib 450 mg
    Arm description
    		 LEE011 capsule for oral use (ribociclib) and Ceritinib for oral use
    Arm type
    		 Experimental

    Investigational medicinal product name
    LEE011
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    CAPSULE

    Number of subjects in period 1
    		Ribociclib 100 mg + Ceritinib 300 mg Ribociclib 100 mg + Ceritinib 450 mg Ribociclib 200 mg + Ceritinib 300 mg Ribociclib 200 mg + Ceritinib 450 mg Ribociclib 300 mg + Ceritinib 450 mg
    Started
    4
    7
    4
    7
    5
    Completed
    0
    0
    0
    0
    0
    Not completed
    4
    7
    4
    7
    5
         Adverse event, serious fatal
    -
    -
    -
    1
    -
         Physician decision
    -
    -
    -
    -
    1
         Adverse event, non-fatal
    -
    2
    -
    1
    -
         Progressive disease
    4
    2
    2
    3
    3
         Moved to rollover protocol
    -
    2
    1
    2
    1
         Protocol deviation
    -
    1
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ribociclib 100 mg + Ceritinib 300 mg
    Reporting group description
    		 LEE011 capsule for oral use (ribociclib) and Ceritinib for oral use

    Reporting group title
    Ribociclib 100 mg + Ceritinib 450 mg
    Reporting group description
    		 LEE011 capsule for oral use (ribociclib) and Ceritinib for oral use

    Reporting group title
    Ribociclib 200 mg + Ceritinib 300 mg
    Reporting group description
    		 LEE011 capsule for oral use (ribociclib) and Ceritinib for oral use

    Reporting group title
    Ribociclib 200 mg + Ceritinib 450 mg
    Reporting group description
    		 LEE011 capsule for oral use (ribociclib) and Ceritinib for oral use

    Reporting group title
    Ribociclib 300 mg + Ceritinib 450 mg
    Reporting group description
    		 LEE011 capsule for oral use (ribociclib) and Ceritinib for oral use

    Reporting group values
    		 Ribociclib 100 mg + Ceritinib 300 mg Ribociclib 100 mg + Ceritinib 450 mg Ribociclib 200 mg + Ceritinib 300 mg Ribociclib 200 mg + Ceritinib 450 mg Ribociclib 300 mg + Ceritinib 450 mg Total
    Number of subjects
    		 4 7 4 7 5 27
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0 0
        Adults (18-64 years)
    		 4 4 4 6 4 22
        From 65-84 years
    		 0 3 0 1 1 5
        85 years and over
    		 0 0 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 52.75 ± 8.655 62.43 ± 12.501 53.00 ± 14.652 47.57 ± 12.882 57.00 ± 14.000 -
    Gender categorical
    Units: Subjects
        Female
    		 1 4 4 4 3 16
        Male
    		 3 3 0 3 2 11

    End points

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    End points reporting groups
    Reporting group title
    Ribociclib 100 mg + Ceritinib 300 mg
    Reporting group description
    		 LEE011 capsule for oral use (ribociclib) and Ceritinib for oral use

    Reporting group title
    Ribociclib 100 mg + Ceritinib 450 mg
    Reporting group description
    		 LEE011 capsule for oral use (ribociclib) and Ceritinib for oral use

    Reporting group title
    Ribociclib 200 mg + Ceritinib 300 mg
    Reporting group description
    		 LEE011 capsule for oral use (ribociclib) and Ceritinib for oral use

    Reporting group title
    Ribociclib 200 mg + Ceritinib 450 mg
    Reporting group description
    		 LEE011 capsule for oral use (ribociclib) and Ceritinib for oral use

    Reporting group title
    Ribociclib 300 mg + Ceritinib 450 mg
    Reporting group description
    		 LEE011 capsule for oral use (ribociclib) and Ceritinib for oral use

    Primary: Incidence rate of dose limiting toxicities (DLTs) during the first cycle of treatment (Phase Ib )

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    End point title
    		 Incidence rate of dose limiting toxicities (DLTs) during the first cycle of treatment (Phase Ib ) [1]
    End point description
    Maximum Tolerated Dose(s) (MTD(s)) and/or recommended phase 2 dose (RP2D(s)) and schedule of LEE011 in combination with ceritinib in ALK-positive non-small cell lung cancer (NSCLC) patients. Cycle = 28 days
    End point type
    Primary
    End point timeframe
    Day 28
    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 was planned for phase Ib. This study did not move into Phase II.
    End point values
    		 Ribociclib 100 mg + Ceritinib 300 mg Ribociclib 100 mg + Ceritinib 450 mg Ribociclib 200 mg + Ceritinib 300 mg Ribociclib 200 mg + Ceritinib 450 mg Ribociclib 300 mg + Ceritinib 450 mg
    Number of subjects analysed
    4
    6
    4
    6
    5
    Units: participants
    0
    1
    0
    0
    0
    No statistical analyses for this end point

    Primary: Exposure to LEE011 and ceritinib (Phase Ib)

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    End point title
    		 Exposure to LEE011 and ceritinib (Phase Ib) [2]
    End point description
    Duration of exposure to study treatment by treatment group in Phase Ib (Safety Set)
    End point type
    Primary
    End point timeframe
    Up to 36 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 was planned for phase Ib. This study did not move into Phase II.
    End point values
    		 Ribociclib 100 mg + Ceritinib 300 mg Ribociclib 100 mg + Ceritinib 450 mg Ribociclib 200 mg + Ceritinib 300 mg Ribociclib 200 mg + Ceritinib 450 mg Ribociclib 300 mg + Ceritinib 450 mg
    Number of subjects analysed
    4
    7
    4
    7
    5
    Units: months
        arithmetic mean (standard deviation)
    30.90 ± 5.797
    13.43 ± 10.769
    14.63 ± 12.962
    8.49 ± 7.445
    7.04 ± 5.356
    No statistical analyses for this end point

    Secondary: Overall Response Rate (ORR) as per RECIST v1.1

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    End point title
    		 Overall Response Rate (ORR) as per RECIST v1.1
    End point description
    Preliminary anti-tumor activity of the LEE011 and ceritinib combination
    End point type
    Secondary
    End point timeframe
    Up to 24 months
    End point values
    		 Ribociclib 100 mg + Ceritinib 300 mg Ribociclib 100 mg + Ceritinib 450 mg Ribociclib 200 mg + Ceritinib 300 mg Ribociclib 200 mg + Ceritinib 450 mg Ribociclib 300 mg + Ceritinib 450 mg
    Number of subjects analysed
    4
    7
    4
    7
    5
    Units: participants
        Complete Response (CR)
    1
    0
    0
    0
    0
        Partial Response (PR)
    2
    2
    2
    2
    1
        Stable Disease (SD)
    1
    3
    1
    3
    3
        Progressive Disease (PD)
    0
    0
    0
    0
    1
        Unknown (UNK)
    0
    2
    1
    2
    0
        Overall Response Rate (ORR: CR+PR)
    3
    2
    2
    2
    1
        Disease Control Rate (DCR: CR+PR+SD)
    4
    5
    3
    5
    4
    No statistical analyses for this end point

    Secondary: PK parameters of LEE011 and ceritinib

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    End point title
    		 PK parameters of LEE011 and ceritinib
    End point description
    Characterization of the PK of LEE011 and ceritinib
    End point type
    Secondary
    End point timeframe
    Up to 6 months
    End point values
    		 Ribociclib 100 mg + Ceritinib 300 mg Ribociclib 100 mg + Ceritinib 450 mg Ribociclib 200 mg + Ceritinib 300 mg Ribociclib 200 mg + Ceritinib 450 mg Ribociclib 300 mg + Ceritinib 450 mg
    Number of subjects analysed
    4
    7
    4
    7
    5
    Units: participants
        number (not applicable)
    4
    7
    4
    7
    5
    No statistical analyses for this end point

    Secondary: Frequency of dose interruptions and dose reductions phase lb

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    End point title
    		 Frequency of dose interruptions and dose reductions phase lb
    End point description
    Characterization of tolerability Number of patients requiring dose reductions, interruptions of ceritinib, by treatment group in Phase Ib
    End point type
    Secondary
    End point timeframe
    Up to 24 months
    End point values
    		 Ribociclib 100 mg + Ceritinib 300 mg Ribociclib 100 mg + Ceritinib 450 mg Ribociclib 200 mg + Ceritinib 300 mg Ribociclib 200 mg + Ceritinib 450 mg Ribociclib 300 mg + Ceritinib 450 mg
    Number of subjects analysed
    4
    7
    4
    7
    5
    Units: participants
        0 dose reductions
    3
    4
    4
    5
    2
        1 dose reduction
    1
    2
    0
    1
    3
        2 dose reductions
    0
    0
    0
    1
    0
        >=3 dose reductions
    0
    1
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Progression free survival (PFS) per RECIST v1.1 - Phase Ib

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    End point title
    		 Progression free survival (PFS) per RECIST v1.1 - Phase Ib
    End point description
    Preliminary measures of anti-tumor activity of LEE011 and ceritinib combination
    End point type
    Secondary
    End point timeframe
    median number of day 28 (min-max)
    End point values
    		 Ribociclib 100 mg + Ceritinib 300 mg Ribociclib 100 mg + Ceritinib 450 mg Ribociclib 200 mg + Ceritinib 300 mg Ribociclib 200 mg + Ceritinib 450 mg Ribociclib 300 mg + Ceritinib 450 mg
    Number of subjects analysed
    4
    7
    4
    7
    5
    Units: days
        median (full range (min-max))
    845.5 (653 to 1171)
    167.0 (1 to 813)
    460.5 (1 to 765)
    113.0 (1 to 588)
    168.0 (48 to 416)
    No statistical analyses for this end point

    Secondary: Duration of response (DOR)

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    End point title
    		 Duration of response (DOR)
    End point description
    Preliminary measure of anti-tumor activity of LEE011 and ceritinib combination
    End point type
    Secondary
    End point timeframe
    Up to 24 months
    End point values
    		 Ribociclib 100 mg + Ceritinib 300 mg Ribociclib 100 mg + Ceritinib 450 mg Ribociclib 200 mg + Ceritinib 300 mg Ribociclib 200 mg + Ceritinib 450 mg Ribociclib 300 mg + Ceritinib 450 mg
    Number of subjects analysed
    4
    7
    4
    7
    5
    Units: median number of days (min-max)
        median (full range (min-max))
    706.0 (248 to 868)
    84.5 (1 to 763)
    413.5 (111 to 716)
    254.0 (58 to 460)
    113.0 (113 to 113)
    No statistical analyses for this end point

    Secondary: Time to response (TTR) - Phase Ib

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    End point title
    		 Time to response (TTR) - Phase Ib
    End point description
    Preliminary measures of anti-tumor activity of LEE011 and ceritinib combination
    End point type
    Secondary
    End point timeframe
    Up to 24 months
    End point values
    		 Ribociclib 100 mg + Ceritinib 300 mg Ribociclib 100 mg + Ceritinib 450 mg Ribociclib 200 mg + Ceritinib 300 mg Ribociclib 200 mg + Ceritinib 450 mg Ribociclib 300 mg + Ceritinib 450 mg
    Number of subjects analysed
    4
    7
    4
    7
    5
    Units: median number of days (min-max)
        median (full range (min-max))
    62.0 (57 to 924)
    53.0 (27 to 56)
    53.5 (50 to 57)
    52.0 (52 to 335)
    56.0 (56 to 56)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AE timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 24 months
    Adverse event reporting additional description
    Any sign or symptom that occurs during the study treatment plus the 28 days post treatment
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    LEE011 100mg +@CERITINIB 300mg
    Reporting group description
    		 LEE011 100mg +@CERITINIB 300mg

    Reporting group title
    LEE011 100mg +@CERITINIB 450mg
    Reporting group description
    		 LEE011 100mg +@CERITINIB 450mg

    Reporting group title
    LEE011 200mg +@CERITINIB 300mg
    Reporting group description
    		 LEE011 200mg +@CERITINIB 300mg

    Reporting group title
    LEE011 200mg +@CERITINIB 450mg
    Reporting group description
    		 LEE011 200mg +@CERITINIB 450mg

    Reporting group title
    LEE011 300mg +@CERITINIB 450mg
    Reporting group description
    		 LEE011 300mg +@CERITINIB 450mg

    Reporting group title
    All patients
    Reporting group description
    		 All patients

    Serious adverse events
    		 LEE011 100mg +@CERITINIB 300mg LEE011 100mg +@CERITINIB 450mg LEE011 200mg +@CERITINIB 300mg LEE011 200mg +@CERITINIB 450mg LEE011 300mg +@CERITINIB 450mg All patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 4 (25.00%)
    1 / 7 (14.29%)
    1 / 4 (25.00%)
    2 / 7 (28.57%)
    4 / 5 (80.00%)
    9 / 27 (33.33%)
         number of deaths (all causes)
    0
    0
    1
    1
    1
    3
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Amylase increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 5 (20.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood bilirubin increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood creatinine increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neutrophil count decreased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 5 (20.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 5 (20.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intracranial mass
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Lymphopenia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 5 (20.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholangitis
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    1 / 5 (20.00%)
    2 / 27 (7.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    Interstitial lung disease
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 5 (20.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    Infections and infestations
    Influenza
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 5 (20.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lymphangitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    Respiratory tract infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 5 (20.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    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
    		 LEE011 100mg +@CERITINIB 300mg LEE011 100mg +@CERITINIB 450mg LEE011 200mg +@CERITINIB 300mg LEE011 200mg +@CERITINIB 450mg LEE011 300mg +@CERITINIB 450mg All patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 4 (100.00%)
    7 / 7 (100.00%)
    4 / 4 (100.00%)
    7 / 7 (100.00%)
    5 / 5 (100.00%)
    27 / 27 (100.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
    2 / 27 (7.41%)
         occurrences all number
    0
    1
    1
    0
    0
    2
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    4 / 4 (100.00%)
    0 / 7 (0.00%)
    2 / 4 (50.00%)
    2 / 7 (28.57%)
    1 / 5 (20.00%)
    9 / 27 (33.33%)
         occurrences all number
    6
    0
    3
    2
    2
    13
    Chills
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    Fatigue
         subjects affected / exposed
    0 / 4 (0.00%)
    4 / 7 (57.14%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
    4 / 27 (14.81%)
         occurrences all number
    0
    4
    0
    0
    0
    4
    Feeling jittery
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    Non-cardiac chest pain
         subjects affected / exposed
    2 / 4 (50.00%)
    1 / 7 (14.29%)
    2 / 4 (50.00%)
    0 / 7 (0.00%)
    1 / 5 (20.00%)
    6 / 27 (22.22%)
         occurrences all number
    2
    1
    2
    0
    1
    6
    Oedema peripheral
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    Pyrexia
         subjects affected / exposed
    3 / 4 (75.00%)
    1 / 7 (14.29%)
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
    5 / 27 (18.52%)
         occurrences all number
    4
    1
    1
    0
    0
    6
    Immune system disorders
    Food allergy
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 5 (20.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    0
    0
    2
    2
    Reproductive system and breast disorders
    Menstruation delayed
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    Menstruation irregular
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    Penile erythema
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    2
    0
    0
    0
    0
    2
    Polymenorrhoea
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Catarrh
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    2 / 7 (28.57%)
    0 / 5 (0.00%)
    2 / 27 (7.41%)
         occurrences all number
    0
    0
    0
    3
    0
    3
    Cough
         subjects affected / exposed
    1 / 4 (25.00%)
    2 / 7 (28.57%)
    0 / 4 (0.00%)
    2 / 7 (28.57%)
    1 / 5 (20.00%)
    6 / 27 (22.22%)
         occurrences all number
    1
    3
    0
    3
    1
    8
    Dysphonia
         subjects affected / exposed
    2 / 4 (50.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
    3 / 27 (11.11%)
         occurrences all number
    4
    1
    0
    0
    0
    5
    Dyspnoea
         subjects affected / exposed
    2 / 4 (50.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 5 (20.00%)
    4 / 27 (14.81%)
         occurrences all number
    2
    1
    0
    0
    1
    4
    Haemoptysis
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
    2 / 27 (7.41%)
         occurrences all number
    1
    0
    1
    0
    0
    2
    Oropharyngeal pain
         subjects affected / exposed
    2 / 4 (50.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 5 (0.00%)
    3 / 27 (11.11%)
         occurrences all number
    2
    0
    0
    1
    0
    3
    Rhinorrhoea
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    1 / 4 (25.00%)
    1 / 7 (14.29%)
    1 / 5 (20.00%)
    4 / 27 (14.81%)
         occurrences all number
    0
    1
    1
    1
    1
    4
    Sneezing
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    Sputum increased
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    Sputum retention
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    Wheezing
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 4 (25.00%)
    1 / 7 (14.29%)
    2 / 4 (50.00%)
    1 / 7 (14.29%)
    0 / 5 (0.00%)
    5 / 27 (18.52%)
         occurrences all number
    1
    1
    2
    1
    0
    5
    Mood altered
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 4 (25.00%)
    4 / 7 (57.14%)
    1 / 4 (25.00%)
    3 / 7 (42.86%)
    3 / 5 (60.00%)
    12 / 27 (44.44%)
         occurrences all number
    3
    5
    1
    9
    4
    22
    Amylase increased
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    1 / 5 (20.00%)
    3 / 27 (11.11%)
         occurrences all number
    0
    1
    0
    2
    1
    4
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 4 (25.00%)
    4 / 7 (57.14%)
    1 / 4 (25.00%)
    3 / 7 (42.86%)
    3 / 5 (60.00%)
    12 / 27 (44.44%)
         occurrences all number
    3
    10
    1
    6
    4
    24
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
    2 / 27 (7.41%)
         occurrences all number
    0
    3
    1
    0
    0
    4
    Blood bilirubin increased
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 5 (0.00%)
    2 / 27 (7.41%)
         occurrences all number
    0
    1
    0
    1
    0
    2
    Blood creatine increased
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
    2 / 7 (28.57%)
    1 / 5 (20.00%)
    4 / 27 (14.81%)
         occurrences all number
    0
    1
    0
    2
    1
    4
    Blood creatinine increased
         subjects affected / exposed
    1 / 4 (25.00%)
    2 / 7 (28.57%)
    1 / 4 (25.00%)
    3 / 7 (42.86%)
    2 / 5 (40.00%)
    9 / 27 (33.33%)
         occurrences all number
    1
    2
    4
    6
    3
    16
    Blood thyroid stimulating hormone decreased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    Electrocardiogram QT prolonged
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 7 (28.57%)
    1 / 4 (25.00%)
    2 / 7 (28.57%)
    0 / 5 (0.00%)
    5 / 27 (18.52%)
         occurrences all number
    0
    2
    1
    2
    0
    5
    Lipase increased
         subjects affected / exposed
    1 / 4 (25.00%)
    1 / 7 (14.29%)
    1 / 4 (25.00%)
    1 / 7 (14.29%)
    0 / 5 (0.00%)
    4 / 27 (14.81%)
         occurrences all number
    2
    2
    1
    2
    0
    7
    Monocyte count decreased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 5 (20.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    Neutrophil count decreased
         subjects affected / exposed
    0 / 4 (0.00%)
    3 / 7 (42.86%)
    0 / 4 (0.00%)
    4 / 7 (57.14%)
    4 / 5 (80.00%)
    11 / 27 (40.74%)
         occurrences all number
    0
    8
    0
    5
    16
    29
    Platelet count decreased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    Weight decreased
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 7 (28.57%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 5 (0.00%)
    3 / 27 (11.11%)
         occurrences all number
    0
    2
    0
    1
    0
    3
    White blood cell count decreased
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    1 / 5 (20.00%)
    3 / 27 (11.11%)
         occurrences all number
    0
    4
    0
    2
    8
    14
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    2
    0
    0
    0
    2
    Ligament sprain
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    Tachycardia
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    Nervous system disorders
    Amnesia
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    Balance disorder
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    Dizziness
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 7 (28.57%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    1 / 5 (20.00%)
    4 / 27 (14.81%)
         occurrences all number
    0
    2
    0
    1
    1
    4
    Dysgeusia
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 7 (28.57%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
    2 / 27 (7.41%)
         occurrences all number
    0
    2
    0
    0
    0
    2
    Headache
         subjects affected / exposed
    1 / 4 (25.00%)
    1 / 7 (14.29%)
    1 / 4 (25.00%)
    2 / 7 (28.57%)
    2 / 5 (40.00%)
    7 / 27 (25.93%)
         occurrences all number
    1
    1
    1
    2
    2
    7
    Hypoaesthesia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    Paraesthesia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 5 (20.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    Seizure
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 5 (20.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    0
    0
    2
    2
    Somnolence
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 5 (20.00%)
    2 / 27 (7.41%)
         occurrences all number
    1
    0
    0
    0
    1
    2
    Speech disorder
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 5 (0.00%)
    2 / 27 (7.41%)
         occurrences all number
    1
    0
    0
    1
    0
    2
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 4 (25.00%)
    1 / 7 (14.29%)
    1 / 5 (20.00%)
    3 / 27 (11.11%)
         occurrences all number
    0
    0
    1
    1
    1
    3
    Anaemia macrocytic
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    Febrile neutropenia
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    Lymphopenia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    1 / 5 (20.00%)
    2 / 27 (7.41%)
         occurrences all number
    0
    0
    1
    0
    2
    3
    Neutropenia
         subjects affected / exposed
    2 / 4 (50.00%)
    1 / 7 (14.29%)
    1 / 4 (25.00%)
    3 / 7 (42.86%)
    0 / 5 (0.00%)
    7 / 27 (25.93%)
         occurrences all number
    8
    1
    1
    7
    0
    17
    Pancytopenia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    Thrombocytopenia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    1 / 5 (20.00%)
    2 / 27 (7.41%)
         occurrences all number
    0
    0
    0
    1
    1
    2
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    2 / 4 (50.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
    2 / 27 (7.41%)
         occurrences all number
    2
    0
    0
    0
    0
    2
    Tinnitus
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    2
    0
    0
    0
    2
    Vertigo
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 4 (25.00%)
    1 / 7 (14.29%)
    0 / 5 (0.00%)
    2 / 27 (7.41%)
         occurrences all number
    0
    0
    1
    1
    0
    2
    Eye disorders
    Blepharitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    Macular oedema
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 5 (20.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 5 (0.00%)
    2 / 27 (7.41%)
         occurrences all number
    0
    1
    0
    1
    0
    2
    Abdominal pain
         subjects affected / exposed
    0 / 4 (0.00%)
    3 / 7 (42.86%)
    1 / 4 (25.00%)
    1 / 7 (14.29%)
    0 / 5 (0.00%)
    5 / 27 (18.52%)
         occurrences all number
    0
    3
    1
    2
    0
    6
    Abdominal pain upper
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 4 (25.00%)
    1 / 7 (14.29%)
    0 / 5 (0.00%)
    2 / 27 (7.41%)
         occurrences all number
    0
    0
    1
    2
    0
    3
    Constipation
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 5 (0.00%)
    2 / 27 (7.41%)
         occurrences all number
    1
    0
    0
    2
    0
    3
    Diarrhoea
         subjects affected / exposed
    4 / 4 (100.00%)
    5 / 7 (71.43%)
    4 / 4 (100.00%)
    6 / 7 (85.71%)
    4 / 5 (80.00%)
    23 / 27 (85.19%)
         occurrences all number
    13
    6
    7
    16
    4
    46
    Dry mouth
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    Duodenal ulcer
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    Dyspepsia
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    2 / 5 (40.00%)
    4 / 27 (14.81%)
         occurrences all number
    1
    0
    0
    2
    2
    5
    Gastritis
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 4 (25.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
    2 / 27 (7.41%)
         occurrences all number
    1
    1
    0
    0
    0
    2
    Gingival swelling
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    Haematemesis
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    Haemorrhoids
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    Nausea
         subjects affected / exposed
    0 / 4 (0.00%)
    3 / 7 (42.86%)
    3 / 4 (75.00%)
    1 / 7 (14.29%)
    2 / 5 (40.00%)
    9 / 27 (33.33%)
         occurrences all number
    0
    4
    3
    1
    4
    12
    Stomatitis
         subjects affected / exposed
    1 / 4 (25.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
    2 / 7 (28.57%)
    0 / 5 (0.00%)
    4 / 27 (14.81%)
         occurrences all number
    1
    1
    0
    2
    0
    4
    Toothache
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
    2 / 27 (7.41%)
         occurrences all number
    0
    1
    1
    0
    0
    2
    Vomiting
         subjects affected / exposed
    2 / 4 (50.00%)
    5 / 7 (71.43%)
    2 / 4 (50.00%)
    4 / 7 (57.14%)
    4 / 5 (80.00%)
    17 / 27 (62.96%)
         occurrences all number
    2
    37
    5
    15
    6
    65
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    1 / 5 (20.00%)
    2 / 27 (7.41%)
         occurrences all number
    0
    0
    1
    0
    1
    2
    Dermatitis
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    2
    0
    0
    0
    2
    Dry skin
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    Night sweats
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    Pruritus
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    1 / 5 (20.00%)
    3 / 27 (11.11%)
         occurrences all number
    1
    0
    0
    1
    1
    3
    Rash
         subjects affected / exposed
    3 / 4 (75.00%)
    2 / 7 (28.57%)
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    1 / 5 (20.00%)
    7 / 27 (25.93%)
         occurrences all number
    3
    3
    2
    0
    3
    11
    Skin exfoliation
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    Urticaria
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    Renal and urinary disorders
    Nocturia
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    2
    0
    0
    0
    0
    2
    Renal failure
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    Endocrine disorders
    Hyperthyroidism
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    Hypothyroidism
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    2 / 4 (50.00%)
    1 / 7 (14.29%)
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    1 / 5 (20.00%)
    5 / 27 (18.52%)
         occurrences all number
    3
    1
    1
    0
    1
    6
    Bone pain
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    Muscle contracture
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    Muscle spasms
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    Muscular weakness
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 5 (0.00%)
    2 / 27 (7.41%)
         occurrences all number
    2
    0
    0
    1
    0
    3
    Musculoskeletal pain
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 5 (20.00%)
    2 / 27 (7.41%)
         occurrences all number
    1
    0
    0
    0
    1
    2
    Myalgia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    Neck pain
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 5 (0.00%)
    2 / 27 (7.41%)
         occurrences all number
    1
    0
    0
    1
    0
    2
    Trigger finger
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 5 (20.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    Infections and infestations
    Conjunctivitis
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
    2 / 27 (7.41%)
         occurrences all number
    1
    0
    1
    0
    0
    2
    Cystitis
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    Escherichia urinary tract infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    Gingivitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    Helicobacter infection
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    Herpes zoster
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    Influenza
         subjects affected / exposed
    2 / 4 (50.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
    2 / 27 (7.41%)
         occurrences all number
    2
    0
    0
    0
    0
    2
    Oral candidiasis
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    Respiratory tract infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    Tooth abscess
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    1 / 4 (25.00%)
    1 / 7 (14.29%)
    0 / 5 (0.00%)
    3 / 27 (11.11%)
         occurrences all number
    1
    0
    2
    1
    0
    4
    Urinary tract infection
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 4 (0.00%)
    3 / 7 (42.86%)
    1 / 4 (25.00%)
    3 / 7 (42.86%)
    2 / 5 (40.00%)
    9 / 27 (33.33%)
         occurrences all number
    0
    3
    1
    3
    3
    10
    Diabetes mellitus
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    Hyperglycaemia
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 5 (0.00%)
    2 / 27 (7.41%)
         occurrences all number
    2
    0
    0
    1
    0
    3
    Hyperkalaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    Hyperuricaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    1 / 4 (25.00%)
    0 / 7 (0.00%)
    0 / 5 (0.00%)
    2 / 27 (7.41%)
         occurrences all number
    0
    2
    1
    0
    0
    3
    Hypoalbuminaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    1 / 7 (14.29%)
    0 / 5 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    Steroid diabetes
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    0 / 7 (0.00%)
    1 / 5 (20.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    0
    0
    1
    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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    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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