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    Clinical Trial Results:
    MyRisk: Efficacy and safety evaluation of oral Akynzeo® in patients receiving MEC at high risk of developing CINV based on a prediction tool. A multinational and multicenter study.

    Summary
    EudraCT number
    		 2019-004686-41
    Trial protocol
    		 GB   GR   CZ   DE   ES  
    Global end of trial date
    02 Jul 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Jul 2025
    First version publication date
    16 Jul 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    IBA1160
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04817189
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Helsinn Healthcare SA
    Sponsor organisation address
    Via Pian Scairolo 9, Pazzallo-Lugano, Switzerland,
    Public contact
    HelpDesk, Institut biostatistiky a analýz, s.r.o., +420 515915 100, helpdesk@biostatistika.cz
    Scientific contact
    HelpDesk, Institut biostatistiky a analýz, s.r.o., +420 515915 100, helpdesk@biostatistika.cz
    Sponsor organisation name
    Helsinn Healthcare SA
    Sponsor organisation address
    Via Pian Scairolo 9, Pazzallo-Lugano, Switzerland,
    Public contact
    Alessandro Alonzi - Medical Advisor, Helsinn Healthcare SA, Alessandro.Alonzi@helsinn.com
    Scientific contact
    Alessandro Alonzi - Medical Advisor, Helsinn Healthcare SA, Alessandro.Alonzi@helsinn.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
    24 Jun 2025
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Jul 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate if the use of NEPA (netupitant and palonosetron) in patients treated with IV moderately emetogenic chemotherapy and at high risk of CINV is more effective in preventing CINV than standard of care antiemetics over three cycles of chemotherapy
    Protection of trial subjects
    The trial subjects were treated according to a common clinical practice. The only intervention in the trail was randomization.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Feb 2021
    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
    Spain: 75
    Country: Number of subjects enrolled
    United Kingdom: 17
    Country: Number of subjects enrolled
    Czechia: 84
    Country: Number of subjects enrolled
    Germany: 97
    Country: Number of subjects enrolled
    Greece: 76
    Country: Number of subjects enrolled
    China: 53
    Country: Number of subjects enrolled
    Switzerland: 12
    Worldwide total number of subjects
    414
    EEA total number of subjects
    332
    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)
    223
    From 65 to 84 years
    190
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 Start recruitment date (FPI): 01.02.2021 Stop recruitment date (LPI): 04.04.2024 Teritories: Czech Republic, Greece, Germany, Switzerland, United Kingdom, China, Spain

    Pre-assignment
    Screening details
    		 Screened patients: 427 Screen failure: 12 Total analysis set: 415

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 NEPA
    Arm description
    		 One capsule of NEPA and Dexamethasone 8 mg (or equivalent corticosteroids) by the oral route on Day 1, approximately 1 hour before chemotherapy
    Arm type
    		 Experimental

    Investigational medicinal product name
    Akynzeo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    One capsule of NEPA by the oral route on Day 1, approximately 1 hour before chemotherapy

    Arm title
    		 Standard of care
    Arm description
    		 • One of the 5-HT3-RAs recommended by MASCC/ESMO guidelines (standard of care), i.e. either: Granisetron, 2 mg (oral) or 1 mg (IV) OR Palonosetron, 0.5 mg (oral) or 0.25mg (IV) OR Ondansetron, 16 mg (oral) or 8 mg (IV) OR Dolasetron 100 mg (oral) OR Tropisetron 5 mg (oral or IV) • Dexamethasone (or equivalent corticosteroids) 8 mg administered by the oral route (or equivalent IV dose) on Day 1, approximately 1 hour before chemotherapy
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Granisetron
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Intravesical solution, Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Granisetron, 2 mg (oral) or 1 mg (IV)

    Number of subjects in period 1
    		NEPA Standard of care
    Started
    206
    208
    Completed
    171
    177
    Not completed
    35
    31
         Adverse event, serious fatal
    2
    1
         Discontinuation of chemotherapy treatment due to C
    2
    1
         Consent withdrawn by subject
    12
    3
         Adverse event, non-fatal
    2
    5
         General or specific changes in the patient's condi
    6
    7
         Lost to follow-up
    5
    3
         Non-qualification to perform consecutive cycles (e
    3
    10
         Protocol deviation
    3
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 414 414
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 223 223
        From 65-84 years
    		 190 190
        85 years and over
    		 1 1
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 62.7 ( 11.5 ) -
    Gender categorical
    Units: Subjects
        Female
    		 187 187
        Male
    		 227 227
    Subject analysis sets

    Subject analysis set title
    Full Analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The Full Analysis Set (FAS) consists of 401 (NEPA: 196, SoC: 205) randomised patients to whom study drug was dispensed.

    Subject analysis sets values
    		 Full Analysis set
    Number of subjects
    401
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    210
        From 65-84 years
    190
        85 years and over
    1
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    62.7 ( 11.5 )
    Gender categorical
    Units: Subjects
        Female
    180
        Male
    221

    End points

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    End points reporting groups
    Reporting group title
    NEPA
    Reporting group description
    		 One capsule of NEPA and Dexamethasone 8 mg (or equivalent corticosteroids) by the oral route on Day 1, approximately 1 hour before chemotherapy

    Reporting group title
    Standard of care
    Reporting group description
    		 • One of the 5-HT3-RAs recommended by MASCC/ESMO guidelines (standard of care), i.e. either: Granisetron, 2 mg (oral) or 1 mg (IV) OR Palonosetron, 0.5 mg (oral) or 0.25mg (IV) OR Ondansetron, 16 mg (oral) or 8 mg (IV) OR Dolasetron 100 mg (oral) OR Tropisetron 5 mg (oral or IV) • Dexamethasone (or equivalent corticosteroids) 8 mg administered by the oral route (or equivalent IV dose) on Day 1, approximately 1 hour before chemotherapy

    Subject analysis set title
    Full Analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The Full Analysis Set (FAS) consists of 401 (NEPA: 196, SoC: 205) randomised patients to whom study drug was dispensed.

    Primary: The primary endpoint was complete response (defined as no emetic episode(s) and no use of rescue medication), during the overall phase (0-120h), after the start of the MEC administration over three consecutive cycles of chemotherapy.

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    End point title
    		 The primary endpoint was complete response (defined as no emetic episode(s) and no use of rescue medication), during the overall phase (0-120h), after the start of the MEC administration over three consecutive cycles of chemotherapy.
    End point description
    End point type
    Primary
    End point timeframe
    End of study
    End point values
    		 NEPA Standard of care
    Number of subjects analysed
    189
    199
    Units: Probability (%)
        number (not applicable)
    81.0
    71.8
    Statistical analysis title
    		 Probability to experience complete response
    Statistical analysis description
    Primary endpoint was defined as complete response over three cycles of chemotherapy. To estimate the probability of complete response, a generalized linear model with covariates was used to evaluate the treatment effect of the NEPA compared to the SoC arm. Estimated OR from model was used to derive the difference in the probability of responders between treatment arms. Model-based statistics were used to calculate the difference in the probability to experience a “per cycle” complete response.
    Comparison groups
    NEPA v Standard of care
    Number of subjects included in analysis
    388
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 a generalized linear model with covariat
    Confidence interval

    Secondary: Complete response during the acute (0-24h), delayed phase (>24-120h), overall (0-120h) and daily in each cycle

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    End point title
    		 Complete response during the acute (0-24h), delayed phase (>24-120h), overall (0-120h) and daily in each cycle
    End point description
    End point type
    Secondary
    End point timeframe
    acute (0-24h), delayed phase (>24-120h), overall (0-120h) and daily in each cycle
    End point values
    		 NEPA Standard of care
    Number of subjects analysed
    189
    199
    Units: Probability (%)
        number (not applicable)
    80.2
    71.1
    No statistical analyses for this end point

    Secondary: No emetic episode during the acute, delayed and overall phase and daily in each cycle

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    End point title
    		 No emetic episode during the acute, delayed and overall phase and daily in each cycle
    End point description
    End point type
    Secondary
    End point timeframe
    the acute (0-24h), delayed phase (>24-120h), overall (0-120h) and daily in each cycle
    End point values
    		 NEPA Standard of care
    Number of subjects analysed
    189
    199
    Units: Probability (%)
        number (not applicable)
    95.4
    86.7
    No statistical analyses for this end point

    Secondary: Number of vomiting episodes during the acute, delayed and overall phase and daily in each cycle

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    End point title
    		 Number of vomiting episodes during the acute, delayed and overall phase and daily in each cycle
    End point description
    End point type
    Secondary
    End point timeframe
    acute (0-24h), delayed phase (>24-120h), overall (0-120h) and daily in each cycle
    End point values
    		 NEPA Standard of care
    Number of subjects analysed
    189
    199
    Units: mean difference of episods per cycle
        number (confidence interval 95%)
    -0.37 (-0.6 to -0.14)
    0.0 (0.0 to 0.0)
    No statistical analyses for this end point

    Secondary: No rescue medication during the acute, delayed and overall phase and daily in each cycle

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    End point title
    		 No rescue medication during the acute, delayed and overall phase and daily in each cycle
    End point description
    End point type
    Secondary
    End point timeframe
    acute (0-24h), delayed phase (>24-120h), overall (0-120h) and daily in each cycle
    End point values
    		 NEPA Standard of care
    Number of subjects analysed
    189
    200
    Units: Probability (%)
        number (not applicable)
    82.4
    76.5
    No statistical analyses for this end point

    Secondary: No significant nausea (maximum MAT scale = 2) during the acute, delayed and overall phase and daily in each cycle

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    End point title
    		 No significant nausea (maximum MAT scale = 2) during the acute, delayed and overall phase and daily in each cycle
    End point description
    End point type
    Secondary
    End point timeframe
    acute (0-24h), delayed phase (>24-120h), overall (0-120h) and daily in each cycle
    End point values
    		 NEPA Standard of care
    Number of subjects analysed
    188
    197
    Units: Probability (%)
        number (not applicable)
    77.5
    72.7
    No statistical analyses for this end point

    Secondary: No nausea (MAT scale = 0) during the acute, delayed and overall phase and daily in each cycle

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    End point title
    		 No nausea (MAT scale = 0) during the acute, delayed and overall phase and daily in each cycle
    End point description
    End point type
    Secondary
    End point timeframe
    acute (0-24h), delayed phase (>24-120h), overall (0-120h) and daily in each cycle
    End point values
    		 NEPA Standard of care
    Number of subjects analysed
    189
    199
    Units: Probability (%)
        number (not applicable)
    63.7
    54.9
    No statistical analyses for this end point

    Secondary: Complete protection (no emetic episode, no rescue medication and no significant nausea) during the acute, delayed and overall phase and daily in each cycle

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    End point title
    		 Complete protection (no emetic episode, no rescue medication and no significant nausea) during the acute, delayed and overall phase and daily in each cycle
    End point description
    End point type
    Secondary
    End point timeframe
    acute (0-24h), delayed phase (>24-120h), overall (0-120h) and daily in each cycle
    End point values
    		 NEPA Standard of care
    Number of subjects analysed
    188
    198
    Units: Probability (%)
        number (not applicable)
    71.8
    62.4
    No statistical analyses for this end point

    Secondary: Nausea and Vomiting-related quality of life indicators (through the Functional Living Index Emesis scale)

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    End point title
    		 Nausea and Vomiting-related quality of life indicators (through the Functional Living Index Emesis scale)
    End point description
    End point type
    Secondary
    End point timeframe
    per cycle
    End point values
    		 NEPA Standard of care
    Number of subjects analysed
    189
    199
    Units: Mean difference between arms
        number (confidence interval 95%)
    3.5 (0.05 to 6.96)
    1.0 (1.0 to 1.0)
    No statistical analyses for this end point

    Secondary: Collection of chemotherapy delays (Delay of chemotherapy administration due to CINV were also evaluated as part of health economic endpoints)

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    End point title
    		 Collection of chemotherapy delays (Delay of chemotherapy administration due to CINV were also evaluated as part of health economic endpoints)
    End point description
    End point type
    Secondary
    End point timeframe
    per cycle
    End point values
    		 NEPA Standard of care
    Number of subjects analysed
    184
    193
    Units: mean of delay days per patient
        arithmetic mean (standard deviation)
    1.1 ( 3.49 )
    1.2 ( 3.45 )
    No statistical analyses for this end point

    Secondary: Collection of chemotherapy dose reductions

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    End point title
    		 Collection of chemotherapy dose reductions
    End point description
    End point type
    Secondary
    End point timeframe
    per cycle
    End point values
    		 NEPA Standard of care
    Number of subjects analysed
    184
    193
    Units: Probability (%)
        number (not applicable)
    3.0
    4.1
    No statistical analyses for this end point

    Secondary: Number of daily doses of rescue medication administered for the treatment of CINV

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    End point title
    		 Number of daily doses of rescue medication administered for the treatment of CINV
    End point description
    End point type
    Secondary
    End point timeframe
    per cycle
    End point values
    		 NEPA Standard of care
    Number of subjects analysed
    187
    200
    Units: mean dose
        arithmetic mean (standard deviation)
    16.3 ( 68.53 )
    46.3 ( 343.13 )
    No statistical analyses for this end point

    Other pre-specified: Number of days of rescue medication administered for the treatment of CINV

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    End point title
    		 Number of days of rescue medication administered for the treatment of CINV
    End point description
    End point type
    Other pre-specified
    End point timeframe
    per cycle
    End point values
    		 NEPA Standard of care
    Number of subjects analysed
    187
    200
    Units: mean of days and doses
        arithmetic mean (standard deviation)
    0.5 ( 1.20 )
    0.5 ( 1.13 )
    No statistical analyses for this end point

    Other pre-specified: Number of re-hydration bags given for at least grade 2 vomiting (more details below)

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    End point title
    		 Number of re-hydration bags given for at least grade 2 vomiting (more details below)
    End point description
    End point type
    Other pre-specified
    End point timeframe
    per cycle
    End point values
    		 NEPA Standard of care
    Number of subjects analysed
    187
    198
    Units: mean number of re-hydration bags per pat
        arithmetic mean (standard deviation)
    0.0 ( 0 )
    0.0 ( 0.2 )
    No statistical analyses for this end point

    Other pre-specified: The number of days of unplanned hospitalisations related to CINV and department of hospitalization (type of ward)

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    End point title
    		 The number of days of unplanned hospitalisations related to CINV and department of hospitalization (type of ward)
    End point description
    End point type
    Other pre-specified
    End point timeframe
    per cycle
    End point values
    		 NEPA Standard of care
    Number of subjects analysed
    187
    198
    Units: Mean number of days per patient
        arithmetic mean (standard deviation)
    0.0 ( 0.07 )
    0.1 ( 0.75 )
    No statistical analyses for this end point

    Other pre-specified: The number of outpatient physician visits and health care consultations due to CINV (e.g., general practitioner)

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    End point title
    		 The number of outpatient physician visits and health care consultations due to CINV (e.g., general practitioner)
    End point description
    End point type
    Other pre-specified
    End point timeframe
    per cycle
    End point values
    		 NEPA Standard of care
    Number of subjects analysed
    196
    205
    Units: mean of visits per patient
        arithmetic mean (standard deviation)
    0.0 ( 0.07 )
    0.0 ( 0.16 )
    No statistical analyses for this end point

    Other pre-specified: The number of unplanned laboratory tests including those at unplanned hospitalisations due to CINV

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    End point title
    		 The number of unplanned laboratory tests including those at unplanned hospitalisations due to CINV
    End point description
    End point type
    Other pre-specified
    End point timeframe
    per cycle
    End point values
    		 NEPA Standard of care
    Number of subjects analysed
    187
    198
    Units: mean number of tests
        arithmetic mean (standard deviation)
    0.0 ( 0.07 )
    0.1 ( 0.46 )
    No statistical analyses for this end point

    Other pre-specified: Discontinuation of chemotherapy treatment due to CINV

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    End point title
    		 Discontinuation of chemotherapy treatment due to CINV
    End point description
    End point type
    Other pre-specified
    End point timeframe
    per cycle
    End point values
    		 NEPA Standard of care
    Number of subjects analysed
    196
    205
    Units: patients
    1
    0
    No statistical analyses for this end point

    Other pre-specified: Delay of chemotherapy administration due to CINV

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    End point title
    		 Delay of chemotherapy administration due to CINV
    End point description
    End point type
    Other pre-specified
    End point timeframe
    per cycle
    End point values
    		 NEPA Standard of care
    Number of subjects analysed
    0 [1]
    2
    Units: mean of days of delay
        arithmetic mean (standard deviation)
    ( )
    7 ( 0 )
    Notes
    [1] - no patients discontinued from CINV
    No statistical analyses for this end point

    Other pre-specified: Days of absence from work

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    End point title
    		 Days of absence from work
    End point description
    End point type
    Other pre-specified
    End point timeframe
    per cycle
    End point values
    		 NEPA Standard of care
    Number of subjects analysed
    5
    3
    Units: mean of days of absence
        arithmetic mean (standard deviation)
    3 ( 3.08 )
    5.7 ( 4.16 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From a dose of antiemetic drug is administration to the end of the study, the day of Visit 4. Visit 4 is a visit on Day 5 of Cycle 3 or before the start of the next programmed chemotherapy cycle.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.1
    Reporting groups
    Reporting group title
    NEPA
    Reporting group description
    		 -

    Reporting group title
    Standard of care
    Reporting group description
    		 -

    Serious adverse events
    		 NEPA Standard of care
    Total subjects affected by serious adverse events
         subjects affected / exposed
    22 / 196 (11.22%)
    23 / 205 (11.22%)
         number of deaths (all causes)
    2
    2
         number of deaths resulting from adverse events
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 196 (0.51%)
    0 / 205 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombosis
         subjects affected / exposed
    0 / 196 (0.00%)
    1 / 205 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Antibiotic therapy
         subjects affected / exposed
    0 / 196 (0.00%)
    1 / 205 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    2 / 196 (1.02%)
    2 / 205 (0.98%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    Pyrexia
         subjects affected / exposed
    3 / 196 (1.53%)
    1 / 205 (0.49%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    1 / 196 (0.51%)
    1 / 205 (0.49%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chills
         subjects affected / exposed
    1 / 196 (0.51%)
    0 / 205 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    1 / 196 (0.51%)
    0 / 205 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    1 / 196 (0.51%)
    0 / 205 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 196 (0.51%)
    2 / 205 (0.98%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cough
         subjects affected / exposed
    1 / 196 (0.51%)
    0 / 205 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    0 / 196 (0.00%)
    1 / 205 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngospasm
         subjects affected / exposed
    1 / 196 (0.51%)
    0 / 205 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    0 / 196 (0.00%)
    1 / 205 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Throat irritation
         subjects affected / exposed
    1 / 196 (0.51%)
    0 / 205 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Oxygen saturation decreased
         subjects affected / exposed
    0 / 196 (0.00%)
    1 / 205 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Platelet count decreased
         subjects affected / exposed
    1 / 196 (0.51%)
    0 / 205 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    1 / 196 (0.51%)
    0 / 205 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    2 / 196 (1.02%)
    1 / 205 (0.49%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aphasia
         subjects affected / exposed
    0 / 196 (0.00%)
    1 / 205 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral artery occlusion
         subjects affected / exposed
    1 / 196 (0.51%)
    0 / 205 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemianopia
         subjects affected / exposed
    0 / 196 (0.00%)
    1 / 205 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    6 / 196 (3.06%)
    5 / 205 (2.44%)
         occurrences causally related to treatment / all
    0 / 6
    2 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    1 / 196 (0.51%)
    0 / 205 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    2 / 196 (1.02%)
    5 / 205 (2.44%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    3 / 196 (1.53%)
    1 / 205 (0.49%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 196 (0.51%)
    3 / 205 (1.46%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    1 / 196 (0.51%)
    1 / 205 (0.49%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholangitis
         subjects affected / exposed
    1 / 196 (0.51%)
    0 / 205 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis acute
         subjects affected / exposed
    0 / 196 (0.00%)
    1 / 205 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholestasis
         subjects affected / exposed
    0 / 196 (0.00%)
    1 / 205 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyper-transaminasaemia
         subjects affected / exposed
    1 / 196 (0.51%)
    0 / 205 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 196 (0.51%)
    0 / 205 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Renal failure
         subjects affected / exposed
    0 / 196 (0.00%)
    1 / 205 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 196 (0.00%)
    1 / 205 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Infection
         subjects affected / exposed
    1 / 196 (0.51%)
    2 / 205 (0.98%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 196 (0.51%)
    1 / 205 (0.49%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Abscess oral
         subjects affected / exposed
    0 / 196 (0.00%)
    1 / 205 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    1 / 196 (0.51%)
    0 / 205 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Catheter site infection
         subjects affected / exposed
    0 / 196 (0.00%)
    1 / 205 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    0 / 196 (0.00%)
    1 / 205 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis salmonella
         subjects affected / exposed
    1 / 196 (0.51%)
    0 / 205 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 196 (0.00%)
    1 / 205 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ludwig angina
         subjects affected / exposed
    0 / 196 (0.00%)
    1 / 205 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 196 (0.00%)
    1 / 205 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    0 / 196 (0.00%)
    1 / 205 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Tumour lysis syndrome
         subjects affected / exposed
    0 / 196 (0.00%)
    1 / 205 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 NEPA Standard of care
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    174 / 196 (88.78%)
    183 / 205 (89.27%)
    Vascular disorders
    Peripheral coldness
         subjects affected / exposed
    5 / 196 (2.55%)
    4 / 205 (1.95%)
         occurrences all number
    7
    6
    Hypotension
         subjects affected / exposed
    2 / 196 (1.02%)
    5 / 205 (2.44%)
         occurrences all number
    2
    5
    Nervous system disorders
    Paraesthesia
         subjects affected / exposed
    33 / 196 (16.84%)
    26 / 205 (12.68%)
         occurrences all number
    49
    43
    Dizziness
         subjects affected / exposed
    24 / 196 (12.24%)
    15 / 205 (7.32%)
         occurrences all number
    31
    16
    Neuropathy peripheral
         subjects affected / exposed
    15 / 196 (7.65%)
    20 / 205 (9.76%)
         occurrences all number
    24
    28
    Headache
         subjects affected / exposed
    18 / 196 (9.18%)
    15 / 205 (7.32%)
         occurrences all number
    25
    22
    Hypoaesthesia
         subjects affected / exposed
    11 / 196 (5.61%)
    20 / 205 (9.76%)
         occurrences all number
    14
    24
    Neurotoxicity
         subjects affected / exposed
    10 / 196 (5.10%)
    8 / 205 (3.90%)
         occurrences all number
    11
    8
    Dysgeusia
         subjects affected / exposed
    8 / 196 (4.08%)
    7 / 205 (3.41%)
         occurrences all number
    8
    10
    Polyneuropathy
         subjects affected / exposed
    6 / 196 (3.06%)
    7 / 205 (3.41%)
         occurrences all number
    9
    7
    Somnolence
         subjects affected / exposed
    7 / 196 (3.57%)
    5 / 205 (2.44%)
         occurrences all number
    10
    10
    Cold dysaesthesia
         subjects affected / exposed
    4 / 196 (2.04%)
    3 / 205 (1.46%)
         occurrences all number
    4
    4
    Peripheral sensory neuropathy
         subjects affected / exposed
    5 / 196 (2.55%)
    2 / 205 (0.98%)
         occurrences all number
    8
    2
    Taste disorder
         subjects affected / exposed
    2 / 196 (1.02%)
    4 / 205 (1.95%)
         occurrences all number
    2
    5
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    8 / 196 (4.08%)
    7 / 205 (3.41%)
         occurrences all number
    8
    8
    Anaemia
         subjects affected / exposed
    3 / 196 (1.53%)
    8 / 205 (3.90%)
         occurrences all number
    3
    8
    Leukocytosis
         subjects affected / exposed
    1 / 196 (0.51%)
    4 / 205 (1.95%)
         occurrences all number
    1
    4
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    54 / 196 (27.55%)
    46 / 205 (22.44%)
         occurrences all number
    83
    78
    Asthenia
         subjects affected / exposed
    25 / 196 (12.76%)
    21 / 205 (10.24%)
         occurrences all number
    33
    27
    General physical health deterioration
         subjects affected / exposed
    3 / 196 (1.53%)
    12 / 205 (5.85%)
         occurrences all number
    3
    12
    Pain
         subjects affected / exposed
    6 / 196 (3.06%)
    7 / 205 (3.41%)
         occurrences all number
    9
    10
    Pyrexia
         subjects affected / exposed
    4 / 196 (2.04%)
    7 / 205 (3.41%)
         occurrences all number
    4
    10
    Oedema peripheral
         subjects affected / exposed
    1 / 196 (0.51%)
    8 / 205 (3.90%)
         occurrences all number
    1
    8
    Chest pain
         subjects affected / exposed
    2 / 196 (1.02%)
    4 / 205 (1.95%)
         occurrences all number
    2
    4
    Chills
         subjects affected / exposed
    1 / 196 (0.51%)
    4 / 205 (1.95%)
         occurrences all number
    1
    4
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    4 / 196 (2.04%)
    7 / 205 (3.41%)
         occurrences all number
    4
    7
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    40 / 196 (20.41%)
    48 / 205 (23.41%)
         occurrences all number
    63
    66
    Constipation
         subjects affected / exposed
    41 / 196 (20.92%)
    29 / 205 (14.15%)
         occurrences all number
    52
    42
    Abdominal pain
         subjects affected / exposed
    19 / 196 (9.69%)
    25 / 205 (12.20%)
         occurrences all number
    26
    31
    Nausea
         subjects affected / exposed
    15 / 196 (7.65%)
    17 / 205 (8.29%)
         occurrences all number
    22
    32
    Dyspepsia
         subjects affected / exposed
    9 / 196 (4.59%)
    6 / 205 (2.93%)
         occurrences all number
    12
    10
    Dry mouth
         subjects affected / exposed
    8 / 196 (4.08%)
    6 / 205 (2.93%)
         occurrences all number
    10
    8
    Abdominal discomfort
         subjects affected / exposed
    3 / 196 (1.53%)
    10 / 205 (4.88%)
         occurrences all number
    4
    11
    Abdominal pain upper
         subjects affected / exposed
    6 / 196 (3.06%)
    2 / 205 (0.98%)
         occurrences all number
    6
    2
    Stomatitis
         subjects affected / exposed
    4 / 196 (2.04%)
    4 / 205 (1.95%)
         occurrences all number
    5
    4
    Dysphagia
         subjects affected / exposed
    1 / 196 (0.51%)
    6 / 205 (2.93%)
         occurrences all number
    3
    9
    Eructation
         subjects affected / exposed
    5 / 196 (2.55%)
    2 / 205 (0.98%)
         occurrences all number
    6
    2
    Gastrooesophageal reflux disease
         subjects affected / exposed
    5 / 196 (2.55%)
    1 / 205 (0.49%)
         occurrences all number
    5
    1
    Hypoaesthesia oral
         subjects affected / exposed
    2 / 196 (1.02%)
    4 / 205 (1.95%)
         occurrences all number
    2
    5
    Vomiting
         subjects affected / exposed
    2 / 196 (1.02%)
    4 / 205 (1.95%)
         occurrences all number
    2
    5
    Abdominal distension
         subjects affected / exposed
    4 / 196 (2.04%)
    1 / 205 (0.49%)
         occurrences all number
    4
    2
    Flatulence
         subjects affected / exposed
    0 / 196 (0.00%)
    4 / 205 (1.95%)
         occurrences all number
    0
    7
    Oral pain
         subjects affected / exposed
    0 / 196 (0.00%)
    4 / 205 (1.95%)
         occurrences all number
    0
    4
    Paraesthesia oral
         subjects affected / exposed
    0 / 196 (0.00%)
    4 / 205 (1.95%)
         occurrences all number
    0
    5
    Respiratory, thoracic and mediastinal disorders
    Hiccups
         subjects affected / exposed
    10 / 196 (5.10%)
    4 / 205 (1.95%)
         occurrences all number
    11
    5
    Epistaxis
         subjects affected / exposed
    5 / 196 (2.55%)
    8 / 205 (3.90%)
         occurrences all number
    5
    10
    Dyspnoea
         subjects affected / exposed
    4 / 196 (2.04%)
    6 / 205 (2.93%)
         occurrences all number
    4
    7
    Cough
         subjects affected / exposed
    5 / 196 (2.55%)
    1 / 205 (0.49%)
         occurrences all number
    5
    1
    Oropharyngeal pain
         subjects affected / exposed
    5 / 196 (2.55%)
    1 / 205 (0.49%)
         occurrences all number
    5
    1
    Throat irritation
         subjects affected / exposed
    1 / 196 (0.51%)
    4 / 205 (1.95%)
         occurrences all number
    2
    7
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    9 / 196 (4.59%)
    12 / 205 (5.85%)
         occurrences all number
    10
    15
    Erythema
         subjects affected / exposed
    5 / 196 (2.55%)
    7 / 205 (3.41%)
         occurrences all number
    5
    13
    Rash
         subjects affected / exposed
    9 / 196 (4.59%)
    2 / 205 (0.98%)
         occurrences all number
    10
    2
    Pruritus
         subjects affected / exposed
    3 / 196 (1.53%)
    5 / 205 (2.44%)
         occurrences all number
    3
    6
    Dry skin
         subjects affected / exposed
    1 / 196 (0.51%)
    5 / 205 (2.44%)
         occurrences all number
    1
    6
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    4 / 196 (2.04%)
    8 / 205 (3.90%)
         occurrences all number
    5
    10
    Restlessness
         subjects affected / exposed
    2 / 196 (1.02%)
    4 / 205 (1.95%)
         occurrences all number
    2
    6
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    11 / 196 (5.61%)
    16 / 205 (7.80%)
         occurrences all number
    13
    26
    Arthralgia
         subjects affected / exposed
    6 / 196 (3.06%)
    7 / 205 (3.41%)
         occurrences all number
    6
    7
    Muscle spasms
         subjects affected / exposed
    4 / 196 (2.04%)
    7 / 205 (3.41%)
         occurrences all number
    6
    12
    Bone pain
         subjects affected / exposed
    7 / 196 (3.57%)
    3 / 205 (1.46%)
         occurrences all number
    7
    3
    Limb discomfort
         subjects affected / exposed
    6 / 196 (3.06%)
    2 / 205 (0.98%)
         occurrences all number
    7
    2
    Back pain
         subjects affected / exposed
    3 / 196 (1.53%)
    4 / 205 (1.95%)
         occurrences all number
    3
    7
    Muscular weakness
         subjects affected / exposed
    4 / 196 (2.04%)
    2 / 205 (0.98%)
         occurrences all number
    4
    2
    Myalgia
         subjects affected / exposed
    2 / 196 (1.02%)
    4 / 205 (1.95%)
         occurrences all number
    3
    6
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    23 / 196 (11.73%)
    30 / 205 (14.63%)
         occurrences all number
    33
    47
    Hypokalaemia
         subjects affected / exposed
    5 / 196 (2.55%)
    3 / 205 (1.46%)
         occurrences all number
    5
    3

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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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