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    Clinical Trial Results:
    A Phase 2, Multicenter, Open-label, Study to Determine the Safety and Efficacy for the Combination of Durvalumab (DURVA) and Daratumumab (DARA) (D2) in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM) (FUSION MM-003)

    Summary
    EudraCT number
    		 2016-001209-17
    Trial protocol
    		 DE   SE   DK   ES   BE   GB   IT  
    Global end of trial date
    03 Jan 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Jan 2023
    First version publication date
    20 Jan 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MEDI4736-MM-003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02807454
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bristol-Myers Squibb
    Sponsor organisation address
    Chaussee de la Hulpe 185, Brussels, Belgium, 1170
    Public contact
    EU Study Start-Up Unit, Bristol-Myers Squibb International Corporation, Clinical.Trials@bms.com
    Scientific contact
    Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, Clinical.Trials@bms.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    30 Mar 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Jan 2022
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To assess the safety and efficacy for the combination of Durvalumab (DURVA) and Daratumumab (DARA) (D2) in participants with relapsed and refractory multiple myeloma (RRMM).
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization Good Clinical Practice Guidelines. All the local regulatory requirements pertinent to safety of trial participants were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    08 Jul 2016
    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
    Canada: 5
    Country: Number of subjects enrolled
    Germany: 5
    Country: Number of subjects enrolled
    Denmark: 4
    Country: Number of subjects enrolled
    Spain: 6
    Country: Number of subjects enrolled
    United Kingdom: 6
    Country: Number of subjects enrolled
    Italy: 2
    Country: Number of subjects enrolled
    Sweden: 2
    Country: Number of subjects enrolled
    United States: 7
    Worldwide total number of subjects
    37
    EEA total number of subjects
    19
    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)
    19
    From 65 to 84 years
    18
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Participants were randomized in a 1:1 ratio to receive either Durvalumab + Daratumumab (D2) or Durvalumab + Daratumumab + Pomalidomide + Dexamethasone (PD3). 32 participants were treated in the Simon Stage 1: D2 arm. No participants enrolled in the Simon Stage 2: D2 arm. 5 participants treated in the PD3 arm.

    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
    		 Simon Stage 1: D2 Arm
    Arm description
    		 Durvalumab 1500 mg + Daratumumab 16 mg/kg were administered intravenously within a 28-day cycle for a maximum of 60 cycles. POM + DEX could be added to the D2 regimen, at the investigator’s discretion, upon confirmed progressive disease for participants who had at least 2 cycles of D2.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Daratumumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Daratumumab 16 mg/kg administered intravenously within a 28-day cycle for a maximum of 60 cycles

    Investigational medicinal product name
    Durvalumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Durvalumab 1500 mg administered intravenously within a 28-day cycle for a maximum of 60 cycles

    Arm title
    		 PD3 Arm
    Arm description
    		 Durvalumab 1500 mg IV + Daratumumab 16 mg/kg IV + Pomalidomide 4 mg/day Oral + Dexamethasone 40 mg Oral (20 mg for > 75 Years Old) administered within a 28-day cycle for a maximum of 22 cycles
    Arm type
    		 Experimental

    Investigational medicinal product name
    Durvalumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Durvalumab 1500 mg administered intravenously within a 28-day cycle for a maximum of 22 cycles

    Investigational medicinal product name
    Pomalidomide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Pomalidomide 4 mb/day administered orally within a 28-day cycle for a maximum of 22 cycles

    Investigational medicinal product name
    Dexamethasone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dexamethasone 40 mg (20 mg for > 75 Years Old) administered orally within a 28-day cycle for a maximum of 22 cycles

    Investigational medicinal product name
    Daratumumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Daratumumab 16 mg/kg administered intravenously within a 28-day cycle for a maximum of 22 cycles

    Number of subjects in period 1
    		Simon Stage 1: D2 Arm PD3 Arm
    Started
    32
    5
    D2 participants who received POM+DEX
    7
    0
    Completed
    0
    0
    Not completed
    32
    5
         Consent withdrawn by subject
    -
    1
         Adverse event, non-fatal
    1
    -
         Other Reasons
    1
    1
         Progressive Disease
    30
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Simon Stage 1: D2 Arm
    Reporting group description
    		 Durvalumab 1500 mg + Daratumumab 16 mg/kg were administered intravenously within a 28-day cycle for a maximum of 60 cycles. POM + DEX could be added to the D2 regimen, at the investigator’s discretion, upon confirmed progressive disease for participants who had at least 2 cycles of D2.

    Reporting group title
    PD3 Arm
    Reporting group description
    		 Durvalumab 1500 mg IV + Daratumumab 16 mg/kg IV + Pomalidomide 4 mg/day Oral + Dexamethasone 40 mg Oral (20 mg for > 75 Years Old) administered within a 28-day cycle for a maximum of 22 cycles

    Reporting group values
    		 Simon Stage 1: D2 Arm PD3 Arm Total
    Number of subjects
    		 32 5 37
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 17 2 19
        From 65-84 years
    		 15 3 18
        85 years and over
    		 0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 63.2 ( 7.58 ) 63 ( 5.66 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 13 1 14
        Male
    		 19 4 23
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 0 0 0
        Not Hispanic or Latino
    		 32 5 37
        Unknown or Not Reported
    		 0 0 0
    Race/Ethnicity, Customized
    Race
    Units: Subjects
        White
    		 31 5 36
        Other
    		 1 0 1
    Subject analysis sets

    Subject analysis set title
    Simon Stage 1: D2 + Pomalidomide + Dexamethasone
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Durvalumab 1500 mg IV + Daratumumab 16 mg/kg IV + Pomalidomide 4 mg/day Oral + Dexamethasone 40 mg Oral (20 mg for > 75 Years Old) were administered within a 28-day cycle for a maximum of 60 cycles

    Subject analysis sets values
    		 Simon Stage 1: D2 + Pomalidomide + Dexamethasone
    Number of subjects
    7
    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)
    4
        From 65-84 years
    3
        85 years and over
    0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    63.4 ( 8.26 )
    Sex: Female, Male
    Units: Participants
        Female
    4
        Male
    3
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    0
        Not Hispanic or Latino
    7
        Unknown or Not Reported
    0
    Race/Ethnicity, Customized
    Race
    Units: Subjects
        White
    7
        Other
    0

    End points

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    End points reporting groups
    Reporting group title
    Simon Stage 1: D2 Arm
    Reporting group description
    		 Durvalumab 1500 mg + Daratumumab 16 mg/kg were administered intravenously within a 28-day cycle for a maximum of 60 cycles. POM + DEX could be added to the D2 regimen, at the investigator’s discretion, upon confirmed progressive disease for participants who had at least 2 cycles of D2.

    Reporting group title
    PD3 Arm
    Reporting group description
    		 Durvalumab 1500 mg IV + Daratumumab 16 mg/kg IV + Pomalidomide 4 mg/day Oral + Dexamethasone 40 mg Oral (20 mg for > 75 Years Old) administered within a 28-day cycle for a maximum of 22 cycles

    Subject analysis set title
    Simon Stage 1: D2 + Pomalidomide + Dexamethasone
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Durvalumab 1500 mg IV + Daratumumab 16 mg/kg IV + Pomalidomide 4 mg/day Oral + Dexamethasone 40 mg Oral (20 mg for > 75 Years Old) were administered within a 28-day cycle for a maximum of 60 cycles

    Primary: Overall Response Rate (ORR)

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    End point title
    		 Overall Response Rate (ORR) [1]
    End point description
    Tumor response of partial response (PR) or better was assessed using the International Myeloma Working Group (IMWG) Uniform Response Criteria. ORR was calculated as the percent of responders (multiplied by 100). Partial response required ≥ 50% reduction of serum M-Protein and reduction in 24-hour urinary M protein by ≥ 90% or to < 200 mg per 24 hours.
    End point type
    Primary
    End point timeframe
    From first dose to up to approximately 66 months
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only summary statistics planned for this endpoint.
    End point values
    		 Simon Stage 1: D2 Arm PD3 Arm
    Number of subjects analysed
    32
    4
    Units: Percentage of participants
        number (not applicable)
    53.1
    75.0
    No statistical analyses for this end point

    Primary: Number of Participants with Adverse Events (AEs)

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    End point title
    		 Number of Participants with Adverse Events (AEs) [2]
    End point description
    Number of participants who experienced at least one adverse event. An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant’s health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition should be considered an AE.
    End point type
    Primary
    End point timeframe
    From first dose to 90 days after last dose (up to approximately 58 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: Only summary statistics planned for this endpoint.
    End point values
    		 Simon Stage 1: D2 Arm PD3 Arm
    Number of subjects analysed
    32
    5
    Units: Participants
    31
    5
    No statistical analyses for this end point

    Primary: Number of Participants with Serious Adverse Events (SAEs)

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    End point title
    		 Number of Participants with Serious Adverse Events (SAEs) [3]
    End point description
    Number of participants who experienced at least one serious adverse event. An SAE is any AE occurring at any dose that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, constitutes an important medical event.
    End point type
    Primary
    End point timeframe
    From first dose to 90 days after last dose (up to approximately 58 months)
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only summary statistics planned for this endpoint.
    End point values
    		 Simon Stage 1: D2 Arm PD3 Arm
    Number of subjects analysed
    32
    5
    Units: Participants
    17
    2
    No statistical analyses for this end point

    Secondary: Time-To-Response (TTR)

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    End point title
    		 Time-To-Response (TTR)
    End point description
    Time-to-response is calculated as the time from enrollment to the first date of documented response (partial response or better). Tumor response of partial response (PR) or better was assessed using the International Myeloma Working Group (IMWG) Uniform Response Criteria. Partial response required ≥ 50% reduction of serum M-Protein and reduction in 24-hour urinary M protein by ≥ 90% or to < 200 mg per 24 hours. For those participants where POM + DEX were added, time-to-response was calculated from the date POM and DEX were added to the first date of documented response (PR or better).
    End point type
    Secondary
    End point timeframe
    From enrollment to earliest documented response (up to approximately 66 months)
    End point values
    		 Simon Stage 1: D2 Arm PD3 Arm Simon Stage 1: D2 + Pomalidomide + Dexamethasone
    Number of subjects analysed
    32
    4
    7
    Units: Weeks
        median (full range (min-max))
    4.29 (4.0 to 12.0)
    8.14 (4.3 to 8.3)
    5.07 (4.1 to 8.1)
    No statistical analyses for this end point

    Secondary: Kaplan-Meier Estimate of Duration of Response (DOR) - Simon Stage 1: D2 Arm

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    End point title
    		 Kaplan-Meier Estimate of Duration of Response (DOR) - Simon Stage 1: D2 Arm [4]
    End point description
    Duration of response was calculated as the time from the earliest date of documented response (PR or better) to the earliest date of disease progression as determined by the investigator. For those participants where POM + DEX was added, duration of response was calculated as the time from the earliest date of documented response after POM + DEX was added (PR or better) to the earliest date of disease. Tumor response of partial response (PR) or better was assessed using the International Myeloma Working Group (IMWG) Uniform Response Criteria. Partial response required ≥ 50% reduction of serum M-Protein and reduction in 24-hour urinary M protein by ≥ 90% or to < 200 mg per 24 hours. Progressive Disease required increase of 25% from lowest response value in the serum M-component (absolute increase must be ≥ 0.5 g/dL) and/or urine M-component (absolute increase must be ≥ 200 mg/24 h).
    End point type
    Secondary
    End point timeframe
    From the earliest date of documented response (PR or better) to earliest date of progressive disease (up to approximately 66 months)
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoints are cohort specific and do not report for all arms.
    End point values
    		 Simon Stage 1: D2 Arm Simon Stage 1: D2 + Pomalidomide + Dexamethasone
    Number of subjects analysed
    32
    7
    Units: Months
        median (confidence interval 95%)
    8.31 (3.7 to 11.1)
    8.41 (3.7 to 12.0)
    No statistical analyses for this end point

    Secondary: Kaplan-Meier Estimate of Duration of Response (DOR) - PD3 Arm

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    End point title
    		 Kaplan-Meier Estimate of Duration of Response (DOR) - PD3 Arm [5]
    End point description
    Duration of response was calculated as the time from the earliest date of documented response (PR or better) to the earliest date of disease progression as determined by the investigator. For those participants where POM + DEX was added, duration of response was calculated as the time from the earliest date of documented response after POM + DEX was added (PR or better) to the earliest date of disease progression as determined by the investigator. Participants who are alive or lost to follow-up will be censored on the last-known-to-be-alive date. Tumor response of partial response (PR) or better was assessed using the International Myeloma Working Group (IMWG) Uniform Response Criteria. Partial response required ≥ 50% reduction of serum M-Protein and reduction in 24-hour urinary M protein by ≥ 90% or to < 200 mg per 24 hours.
    End point type
    Secondary
    End point timeframe
    From the earliest date of documented response (PR or better) to earliest date of progressive disease (up to approximately 66 months)
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoints are cohort specific and do not report for all arms.
    End point values
    		 PD3 Arm
    Number of subjects analysed
    4
    Units: Months
        median (confidence interval 80%)
    7.62 (6.7 to 17.5)
    No statistical analyses for this end point

    Secondary: Kaplan-Meier Estimate of Progression-Free Survival (PFS) - Simon Stage 1: D2 Arm

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    End point title
    		 Kaplan-Meier Estimate of Progression-Free Survival (PFS) - Simon Stage 1: D2 Arm [6]
    End point description
    Progression-free survival was calculated as the time between the enrollment to the first documentation of progressive disease or death from any cause during study, whichever occurs earlier using the International Myeloma Working Group (IMWG) Uniform Response Criteria. Progressive Disease required increase of 25% from lowest response value in the serum M-component (absolute increase must be ≥ 0.5 g/dL) and/or urine M-component (absolute increase must be ≥ 200 mg/24 h).
    End point type
    Secondary
    End point timeframe
    From enrollment to first documentation of progressive disease or death from any cause during study, whichever occurs earlier (up to approximately 66 months)
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoints are cohort specific and do not report for all arms.
    End point values
    		 Simon Stage 1: D2 Arm Simon Stage 1: D2 + Pomalidomide + Dexamethasone
    Number of subjects analysed
    32
    7
    Units: Months
        median (confidence interval 95%)
    5.74 (2.0 to 6.5)
    8.05 (3.7 to 12.9)
    No statistical analyses for this end point

    Secondary: Kaplan-Meier Estimate of Progression-Free Survival (PFS) - PD3 Arm

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    End point title
    		 Kaplan-Meier Estimate of Progression-Free Survival (PFS) - PD3 Arm [7]
    End point description
    Progression-free survival was calculated as the time between the enrollment to the first documentation of progressive disease or death from any cause during study, whichever occurs earlier using the International Myeloma Working Group (IMWG) Uniform Response Criteria. Progressive Disease required increase of 25% from lowest response value in the serum M-component (absolute increase must be ≥ 0.5 g/dL) and/or urine M-component (absolute increase must be ≥ 200 mg/24 h).
    End point type
    Secondary
    End point timeframe
    From enrollment to first documentation of progressive disease or death from any cause during study, whichever occurs earlier (up to approximately 66 months)
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoints are cohort specific and do not report for all arms.
    End point values
    		 PD3 Arm
    Number of subjects analysed
    5
    Units: Months
        median (confidence interval 80%)
    9.02 (6.9 to 18.5)
    No statistical analyses for this end point

    Secondary: Maximum Observed Plasma Concentration (Cmax) - Simon Stage 1: D2 Arm

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    End point title
    		 Maximum Observed Plasma Concentration (Cmax) - Simon Stage 1: D2 Arm [8]
    End point description
    Pharmacokinetics of Durvalumab derived from serum concentration versus time data.
    End point type
    Secondary
    End point timeframe
    Cycle 1 - Days 2, 8, 15, 22
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoints are cohort specific and do not report for all arms.
    End point values
    		 Simon Stage 1: D2 Arm
    Number of subjects analysed
    30
    Units: ug/mL
        geometric mean (geometric coefficient of variation)
    315.806 ( 34.832 )
    No statistical analyses for this end point

    Secondary: Time of Maximum Observed Concentration (Tmax) - Simon Stage 1: D2 Arm

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    End point title
    		 Time of Maximum Observed Concentration (Tmax) - Simon Stage 1: D2 Arm [9]
    End point description
    Pharmacokinetics of Durvalumab derived from serum concentration versus time data.
    End point type
    Secondary
    End point timeframe
    Cycle 1 - Days 2, 8, 15, 22
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoints are cohort specific and do not report for all arms.
    End point values
    		 Simon Stage 1: D2 Arm
    Number of subjects analysed
    30
    Units: Hour
        median (full range (min-max))
    1.150 (1.03 to 1.83)
    No statistical analyses for this end point

    Secondary: Area Under the Plasma Concentration-Time Curve to the Last Measurable Plasma Concentration [AUC(0-Last)] - Simon Stage 1: D2 Arm

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    End point title
    		 Area Under the Plasma Concentration-Time Curve to the Last Measurable Plasma Concentration [AUC(0-Last)] - Simon Stage 1: D2 Arm [10]
    End point description
    Pharmacokinetics of Durvalumab derived from serum concentration versus time data.
    End point type
    Secondary
    End point timeframe
    Cycle 1 - Days 2, 8, 15, 22
    Notes
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoints are cohort specific and do not report for all arms.
    End point values
    		 Simon Stage 1: D2 Arm
    Number of subjects analysed
    30
    Units: Hour*ug/mL
        geometric mean (geometric coefficient of variation)
    77831.751 ( 48.535 )
    No statistical analyses for this end point

    Secondary: Area Under the Plasma Concentration-Time Curve in 1 Dosing Interval [AUC(TAU)] - Simon Stage 1: D2 Arm

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    End point title
    		 Area Under the Plasma Concentration-Time Curve in 1 Dosing Interval [AUC(TAU)] - Simon Stage 1: D2 Arm [11]
    End point description
    Pharmacokinetics of Durvalumab derived from serum concentration versus time data.
    End point type
    Secondary
    End point timeframe
    Cycle 1 - Days 2, 8, 15, 22
    Notes
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoints are cohort specific and do not report for all arms.
    End point values
    		 Simon Stage 1: D2 Arm
    Number of subjects analysed
    28
    Units: Hour*ug/mL
        geometric mean (geometric coefficient of variation)
    83966.099 ( 46.115 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All-cause mortality was assessed from the participant's first dose to their study completion (up to approximately 66 months). SAEs and Other AEs were assessed from first dose to 90 days after last dose of study therapy (up to approximately 58 months).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    Simon Stage 1: D2 Arm
    Reporting group description
    		 Durvalumab 1500 mg + Daratumumab 16 mg/kg were administered intravenously within a 28-day cycle for a maximum of 60 cycles. POM + DEX could be added to the D2 regimen, at the investigator’s discretion, upon confirmed progressive disease for participants who had at least 2 cycles of D2.

    Reporting group title
    PD3 Arm
    Reporting group description
    		 Durvalumab 1500 mg IV + Daratumumab 16 mg/kg IV + Pomalidomide 4 mg/day Oral + Dexamethasone 40 mg Oral (20 mg for > 75 Years Old) administered within a 28-day cycle for a maximum of 22 cycles

    Serious adverse events
    		 Simon Stage 1: D2 Arm PD3 Arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    17 / 32 (53.13%)
    2 / 5 (40.00%)
         number of deaths (all causes)
    11
    4
         number of deaths resulting from adverse events
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Weight decreased
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Plasmacytoma
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    1 / 32 (3.13%)
    1 / 5 (20.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Fatigue
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    3 / 32 (9.38%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 3
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatitis
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 5 (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 / 32 (3.13%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Cellulitis streptococcal
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Corynebacterium infection
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenic sepsis
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumocystis jirovecii pneumonia
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    7 / 32 (21.88%)
    1 / 5 (20.00%)
         occurrences causally related to treatment / all
    2 / 9
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia respiratory syncytial viral
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory syncytial virus infection
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 32 (0.00%)
    2 / 5 (40.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin infection
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular device infection
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyponatraemia
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tumour lysis syndrome
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 5 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Simon Stage 1: D2 Arm PD3 Arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    31 / 32 (96.88%)
    5 / 5 (100.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    2
    0
    Hypotension
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    2
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    3 / 32 (9.38%)
    1 / 5 (20.00%)
         occurrences all number
    3
    1
    Chills
         subjects affected / exposed
    2 / 32 (6.25%)
    1 / 5 (20.00%)
         occurrences all number
    2
    1
    Fatigue
         subjects affected / exposed
    4 / 32 (12.50%)
    2 / 5 (40.00%)
         occurrences all number
    6
    2
    Gait disturbance
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    Influenza like illness
         subjects affected / exposed
    4 / 32 (12.50%)
    0 / 5 (0.00%)
         occurrences all number
    4
    0
    Mucosal inflammation
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    2
    0
    Non-cardiac chest pain
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    2
    0
    Oedema
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    2
    0
    Oedema peripheral
         subjects affected / exposed
    3 / 32 (9.38%)
    1 / 5 (20.00%)
         occurrences all number
    3
    1
    Pyrexia
         subjects affected / exposed
    9 / 32 (28.13%)
    0 / 5 (0.00%)
         occurrences all number
    12
    0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    Cough
         subjects affected / exposed
    7 / 32 (21.88%)
    2 / 5 (40.00%)
         occurrences all number
    9
    3
    Dyspnoea
         subjects affected / exposed
    4 / 32 (12.50%)
    2 / 5 (40.00%)
         occurrences all number
    5
    2
    Epistaxis
         subjects affected / exposed
    3 / 32 (9.38%)
    0 / 5 (0.00%)
         occurrences all number
    3
    0
    Nasal congestion
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    2
    0
    Oropharyngeal pain
         subjects affected / exposed
    3 / 32 (9.38%)
    1 / 5 (20.00%)
         occurrences all number
    8
    1
    Productive cough
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    2
    0
    Rhinorrhoea
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    Sinus congestion
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    2
    0
    Stridor
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    Insomnia
         subjects affected / exposed
    5 / 32 (15.63%)
    1 / 5 (20.00%)
         occurrences all number
    6
    1
    Restlessness
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    2
    0
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    1 / 32 (3.13%)
    1 / 5 (20.00%)
         occurrences all number
    1
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    2
    0
    International normalised ratio increased
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    2
    0
    Neutrophil count decreased
         subjects affected / exposed
    0 / 32 (0.00%)
    2 / 5 (40.00%)
         occurrences all number
    0
    2
    Platelet count decreased
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    Weight decreased
         subjects affected / exposed
    3 / 32 (9.38%)
    0 / 5 (0.00%)
         occurrences all number
    4
    0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    3
    0
    Infusion related reaction
         subjects affected / exposed
    8 / 32 (25.00%)
    0 / 5 (0.00%)
         occurrences all number
    8
    0
    Jaw fracture
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    2
    0
    Cardiac disorders
    Sinus tachycardia
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    2
    Tachycardia
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    2
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    2
    0
    Headache
         subjects affected / exposed
    4 / 32 (12.50%)
    0 / 5 (0.00%)
         occurrences all number
    5
    0
    Peripheral sensory neuropathy
         subjects affected / exposed
    4 / 32 (12.50%)
    0 / 5 (0.00%)
         occurrences all number
    4
    0
    Sciatica
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    2
    0
    Somnolence
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    2
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    16 / 32 (50.00%)
    3 / 5 (60.00%)
         occurrences all number
    26
    3
    Febrile neutropenia
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    2
    0
    Leukopenia
         subjects affected / exposed
    3 / 32 (9.38%)
    1 / 5 (20.00%)
         occurrences all number
    6
    7
    Lymphopenia
         subjects affected / exposed
    8 / 32 (25.00%)
    1 / 5 (20.00%)
         occurrences all number
    8
    1
    Neutropenia
         subjects affected / exposed
    15 / 32 (46.88%)
    3 / 5 (60.00%)
         occurrences all number
    33
    4
    Thrombocytopenia
         subjects affected / exposed
    7 / 32 (21.88%)
    2 / 5 (40.00%)
         occurrences all number
    8
    2
    Eye disorders
    Cataract
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    2
    0
    Conjunctival irritation
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    Ophthalmic vein thrombosis
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    2
    0
    Anal incontinence
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    Constipation
         subjects affected / exposed
    5 / 32 (15.63%)
    0 / 5 (0.00%)
         occurrences all number
    5
    0
    Diarrhoea
         subjects affected / exposed
    9 / 32 (28.13%)
    3 / 5 (60.00%)
         occurrences all number
    20
    3
    Dry mouth
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    2
    0
    Dyspepsia
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    Dysphagia
         subjects affected / exposed
    1 / 32 (3.13%)
    1 / 5 (20.00%)
         occurrences all number
    1
    1
    Nausea
         subjects affected / exposed
    8 / 32 (25.00%)
    2 / 5 (40.00%)
         occurrences all number
    8
    2
    Stomatitis
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    2
    0
    Vomiting
         subjects affected / exposed
    4 / 32 (12.50%)
    1 / 5 (20.00%)
         occurrences all number
    6
    1
    Hepatobiliary disorders
    Hepatomegaly
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Dry skin
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    Erythema
         subjects affected / exposed
    4 / 32 (12.50%)
    0 / 5 (0.00%)
         occurrences all number
    4
    0
    Hyperhidrosis
         subjects affected / exposed
    1 / 32 (3.13%)
    1 / 5 (20.00%)
         occurrences all number
    1
    1
    Pruritus
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    2
    0
    Rash
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    Skin ulcer
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    2
    0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    1 / 32 (3.13%)
    1 / 5 (20.00%)
         occurrences all number
    1
    1
    Pollakiuria
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    Urinary incontinence
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    Urinary retention
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    8 / 32 (25.00%)
    2 / 5 (40.00%)
         occurrences all number
    8
    2
    Back pain
         subjects affected / exposed
    7 / 32 (21.88%)
    4 / 5 (80.00%)
         occurrences all number
    8
    4
    Bone pain
         subjects affected / exposed
    1 / 32 (3.13%)
    1 / 5 (20.00%)
         occurrences all number
    2
    1
    Groin pain
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    Muscular weakness
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    2
    0
    Musculoskeletal chest pain
         subjects affected / exposed
    3 / 32 (9.38%)
    0 / 5 (0.00%)
         occurrences all number
    3
    0
    Myalgia
         subjects affected / exposed
    5 / 32 (15.63%)
    0 / 5 (0.00%)
         occurrences all number
    7
    0
    Pain in extremity
         subjects affected / exposed
    5 / 32 (15.63%)
    1 / 5 (20.00%)
         occurrences all number
    6
    1
    Pathological fracture
         subjects affected / exposed
    1 / 32 (3.13%)
    1 / 5 (20.00%)
         occurrences all number
    1
    1
    Spinal pain
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    2
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    2
    0
    Cellulitis
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    2
    0
    Influenza
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    2
    0
    Nasopharyngitis
         subjects affected / exposed
    2 / 32 (6.25%)
    1 / 5 (20.00%)
         occurrences all number
    2
    1
    Oral candidiasis
         subjects affected / exposed
    1 / 32 (3.13%)
    1 / 5 (20.00%)
         occurrences all number
    1
    1
    Pneumococcal infection
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    Pneumonia
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    Respiratory tract infection
         subjects affected / exposed
    6 / 32 (18.75%)
    2 / 5 (40.00%)
         occurrences all number
    8
    5
    Sinusitis
         subjects affected / exposed
    1 / 32 (3.13%)
    1 / 5 (20.00%)
         occurrences all number
    1
    1
    Skin infection
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 32 (9.38%)
    3 / 5 (60.00%)
         occurrences all number
    6
    5
    Urinary tract infection
         subjects affected / exposed
    1 / 32 (3.13%)
    1 / 5 (20.00%)
         occurrences all number
    1
    5
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    3 / 32 (9.38%)
    1 / 5 (20.00%)
         occurrences all number
    3
    1
    Fluid retention
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    Hypercalcaemia
         subjects affected / exposed
    1 / 32 (3.13%)
    1 / 5 (20.00%)
         occurrences all number
    1
    1
    Hypertriglyceridaemia
         subjects affected / exposed
    3 / 32 (9.38%)
    0 / 5 (0.00%)
         occurrences all number
    3
    0
    Hypokalaemia
         subjects affected / exposed
    3 / 32 (9.38%)
    1 / 5 (20.00%)
         occurrences all number
    4
    1
    Hypomagnesaemia
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    3
    0
    Hyponatraemia
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 5 (0.00%)
         occurrences all number
    2
    0
    Increased appetite
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1

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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.
    Study stopped enrolling participants on 05-Sep-2017 and terminated on 03-Jan-2022. This results disclosure report provides outputs from the Simon Stage 1: D2 and PD3 arms. Simon Stage 2: D2 did not enroll any participants.
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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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