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    Clinical Trial Results:
    A Phase III Study of Pomalidomide and Low Dose Dexamethasone With or Without Pembrolizumab (MK3475) in Refractory or Relapsed and Refractory Multiple Myeloma (rrMM) (KEYNOTE 183)

    Summary
    EudraCT number
    		 2015-002509-13
    Trial protocol
    		 DE   ES   NO   FR   IT  
    Global end of trial date
    16 Jul 2020

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

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    MK-3475-183
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02576977
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Senior Vice President, Global Clinical Development, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.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
    16 Jul 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Jul 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Jul 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The purpose of this study is to compare the efficacy of pomalidomide and low dose dexamethasone with pembrolizumab (MK-3475) to that of pomalidomide and low dose dexamethasone without pembrolizumab in terms of Progression-Free Survival (PFS) in participants with refractory or relapsed and refractory multiple myeloma (rrMM) who have undergone at least 2 lines of prior treatment. The study's 2 primary hypotheses are: 1. Pembrolizumab in combination with pomalidomide and low dose dexamethasone prolongs PFS as assessed by Clinical Adjudication Committee (CAC) blinded central review using International Myeloma Working Group Criteria for Response Assessment in Multiple Myeloma (IMWG criteria) compared to treatment with pomalidomide and low dose dexamethasone standard of care (SOC) alone. 2. Pembrolizumab in combination with pomalidomide and low dose dexamethasone prolongs OS compared to treatment with pomalidomide and low dose dexamethasone (SOC) alone.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Oct 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 5
    Country: Number of subjects enrolled
    Canada: 4
    Country: Number of subjects enrolled
    France: 9
    Country: Number of subjects enrolled
    Germany: 9
    Country: Number of subjects enrolled
    Israel: 23
    Country: Number of subjects enrolled
    Italy: 8
    Country: Number of subjects enrolled
    Japan: 27
    Country: Number of subjects enrolled
    New Zealand: 25
    Country: Number of subjects enrolled
    Norway: 12
    Country: Number of subjects enrolled
    Spain: 21
    Country: Number of subjects enrolled
    United States: 108
    Worldwide total number of subjects
    251
    EEA total number of subjects
    59
    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)
    110
    From 65 to 84 years
    137
    85 years and over
    4

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subject Disposition as per database cutoff date of August 3, 2020. Note: For administrative reasons (a noncompliant site), one participant in the SOC arm was recorded as "Ongoing in Trial" in the CSR Disposition Table and "Final Disposition Unknown" here.

    Pre-assignment
    Screening details
    		 Has a confirmed diagnosis of active multiple myeloma and measurable disease. Must have undergone prior treatment with ≥ 2 treatment lines of anti-myeloma therapy and must have failed their last line of treatment (disease progression during or within 60 days of completing their last anti-myeloma therapy).

    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
    		 Pembrolizumab+Pomalidomide+Dexamethasone
    Arm description
    		 Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 every 3 weeks (Q3W) PLUS pomalidomide 4 mg orally (PO) on Days 1 to 21 of each 28-day cycle PLUS dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pembrolizumab
    Investigational medicinal product code
    Other name
    KEYTRUDA® MK-3475 SCH 9000475
    Pharmaceutical forms
    Concentrate and solvent for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Pembrolizumab 200 mg intravenously (IV) on Day 1 every 3 weeks (Q3W)

    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 PO on Days 1, 8, 15 and 22 of each 28-day cycle.

    Investigational medicinal product name
    Pomalidomide
    Investigational medicinal product code
    Other name
    POMALYST®
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Pomalidomide 4 mg orally (PO) on Days 1 to 21 of each 28-day cycle

    Arm title
    		 Standard of Care (SOC) Pomalidomide+Dexamethasone
    Arm description
    		 Participants receive pomalidomide 4 mg PO on Days 1 to 21 of each 28-day cycle PLUS dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle.
    Arm type
    		 Active comparator

    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 PO on Days 1, 8, 15 and 22 of each 28-day cycle.

    Investigational medicinal product name
    Pomalidomide
    Investigational medicinal product code
    Other name
    POMALYST®
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Pomalidomide 4 mg orally (PO) on Days 1 to 21 of each 28-day cycle

    Number of subjects in period 1
    		Pembrolizumab+Pomalidomide+Dexamethasone Standard of Care (SOC) Pomalidomide+Dexamethasone
    Started
    126
    125
    Treated
    122
    123
    Completed
    0
    0
    Not completed
    126
    125
         Adverse event, serious fatal
    73
    60
         Consent withdrawn by subject
    11
    11
         Adverse event, non-fatal
    13
    2
         Progressive Disease
    -
    1
         Final Disposition Unknown
    -
    1
         Screen failure
    1
    -
         Lost to follow-up
    1
    -
         Study Terminated at Selected Sites
    27
    50

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Pembrolizumab+Pomalidomide+Dexamethasone
    Reporting group description
    		 Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 every 3 weeks (Q3W) PLUS pomalidomide 4 mg orally (PO) on Days 1 to 21 of each 28-day cycle PLUS dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle.

    Reporting group title
    Standard of Care (SOC) Pomalidomide+Dexamethasone
    Reporting group description
    		 Participants receive pomalidomide 4 mg PO on Days 1 to 21 of each 28-day cycle PLUS dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle.

    Reporting group values
    		 Pembrolizumab+Pomalidomide+Dexamethasone Standard of Care (SOC) Pomalidomide+Dexamethasone Total
    Number of subjects
    		 126 125 251
    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)
    		 61 49 110
        From 65-84 years
    		 63 74 137
        85 years and over
    		 2 2 4
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 65.5 ( 9.3 ) 66.4 ( 10.0 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 48 46 94
        Male
    		 78 79 157
    Race (NIH/OMB)
    Units: Subjects
        Asian
    		 17 12 29
        Native Hawaiian or Other Pacific Islander
    		 2 1 3
        Black or African American
    		 10 14 24
        White
    		 92 95 187
        More than one race
    		 1 2 3
        Unknown or Not Reported
    		 4 1 5
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 8 5 13
        Not Hispanic or Latino
    		 110 117 227
        Unknown or Not Reported
    		 8 3 11
    Disease Status (Refractory vs. Sensitive to Lenalidomide)
    Units: Subjects
        Refractory to Lenalidomide
    		 108 108 216
        Sensitive to Lenalidomide
    		 18 17 35

    End points

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    End points reporting groups
    Reporting group title
    Pembrolizumab+Pomalidomide+Dexamethasone
    Reporting group description
    		 Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 every 3 weeks (Q3W) PLUS pomalidomide 4 mg orally (PO) on Days 1 to 21 of each 28-day cycle PLUS dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle.

    Reporting group title
    Standard of Care (SOC) Pomalidomide+Dexamethasone
    Reporting group description
    		 Participants receive pomalidomide 4 mg PO on Days 1 to 21 of each 28-day cycle PLUS dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle.

    Primary: Progression Free Survival (PFS) Assessed by Clinical Adjudication Committee (CAC) Blinded Central Review According to the International Myeloma Working Group (IMWG) Response Criteria

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    End point title
    		 Progression Free Survival (PFS) Assessed by Clinical Adjudication Committee (CAC) Blinded Central Review According to the International Myeloma Working Group (IMWG) Response Criteria
    End point description
    Progression free survival was defined as the time from randomization to the first documented disease progression, or death due to any cause, whichever occurred first. PFS was assessed by CAC blinded central review according to the IMWG criteria based on the development of new bone lesions or soft tissue plasmacytomas or on a definite increase in the size of existing bone lesions or soft tissue plasmacytomas. Median PFS was calculated from the product-limit (Kaplan-Meier) method for censored data. The analysis population included all randomized participants. Participants were included in the treatment group to which they were randomized. The data cutoff date was July 9, 2018.
    End point type
    Primary
    End point timeframe
    Up to approximately 30 months
    End point values
    		 Pembrolizumab+Pomalidomide+Dexamethasone Standard of Care (SOC) Pomalidomide+Dexamethasone
    Number of subjects analysed
    126
    125
    Units: Months
        median (confidence interval 95%)
    5.7 (4.5 to 7.5)
    7.4 (5.6 to 11.5)
    Statistical analysis title
    		 MK-3475 200mg Q3W + SOC vs. Standard of Care
    Statistical analysis description
    Based on Cox regression model with treatment as a covariate stratified by disease status (refractory vs. sensitive to Lenalidomide) and Lines of previous treatments (two vs. three or more).
    Comparison groups
    Pembrolizumab+Pomalidomide+Dexamethasone v Standard of Care (SOC) Pomalidomide+Dexamethasone
    Number of subjects included in analysis
    251
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.99324 [1]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.08
         upper limit
    		 2.08
    Notes
    [1] - One-sided p-value based on Stratified log-rank test.

    Primary: Overall Survival (OS)

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    End point title
    		 Overall Survival (OS)
    End point description
    Overall survival is defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. Median overall survival was calculated from the product-limit (Kaplan-Meier) method for censored data. A value of "9999" indicates that the median, a lower or upper confidence interval were not reached due to an insufficient number of deaths. The analysis population included all randomized participants. Participants were included in the treatment group to which they were randomized. The data cutoff date was August 3, 2020.
    End point type
    Primary
    End point timeframe
    Up to approximately 54 months
    End point values
    		 Pembrolizumab+Pomalidomide+Dexamethasone Standard of Care (SOC) Pomalidomide+Dexamethasone
    Number of subjects analysed
    126
    125
    Units: Months
        median (confidence interval 95%)
    21.0 (14.2 to 29.1)
    39.6 (28.5 to 9999)
    Statistical analysis title
    		 MK-3475 200mg Q3W + SOC vs. Standard of Care
    Statistical analysis description
    The Hazard Ratio and 95% confidence intervals were based on Cox regression model with treatment as a covariate stratified by disease status (refractory vs. sensitive to Lenalidomide) and Lines of previous treatments (two vs. three or more).
    Comparison groups
    Pembrolizumab+Pomalidomide+Dexamethasone v Standard of Care (SOC) Pomalidomide+Dexamethasone
    Number of subjects included in analysis
    251
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.99989 [2]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.84
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.32
         upper limit
    		 2.55
    Notes
    [2] - One-sided p-value based on Stratified log-rank test.

    Secondary: Overall Response Rate (ORR) Evaluated According to the IMWG Response Criteria by CAC Blinded Central Review

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    End point title
    		 Overall Response Rate (ORR) Evaluated According to the IMWG Response Criteria by CAC Blinded Central Review
    End point description
    Disease control rate was based on participants who achieved confirmed sCR, CR, VGPR, PR, minimal response (MR) or have demonstrated stable disease (SD) for at least 12 weeks prior to any evidence of progression. CR = negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND <5% plasmacytomas in the bone marrow; sCR=stringent complete response, CR as above PLUS normal serum FLC assay ratio and absence of clonal cells in bone marrow by immunohistochemistry/fluorescence; VGPR = serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component <100 mg/24 hr; PR = ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24 hours. The analysis population included all randomized participants. Participants were included in the treatment group to which they were randomized. The data cutoff date was July 9, 2018.
    End point type
    Secondary
    End point timeframe
    Up to approximately 30 months
    End point values
    		 Pembrolizumab+Pomalidomide+Dexamethasone Standard of Care (SOC) Pomalidomide+Dexamethasone
    Number of subjects analysed
    126
    125
    Units: Percentage of participants
        number (confidence interval 95%)
    37.3 (28.9 to 46.4)
    42.4 (33.6 to 51.6)
    Statistical analysis title
    		 MK-3475 200mg Q3W + SOC vs. Standard of Care
    Statistical analysis description
    Based on Miettinen & Nurminen method stratified by disease status (refractory vs. sensitive to Lenalidomide) and Lines of previous treatments (two vs. three or more); If there were no participants in one of the treatment groups involved in a comparison for a particular stratum, then that stratum was excluded from the treatment comparison.
    Comparison groups
    Pembrolizumab+Pomalidomide+Dexamethasone v Standard of Care (SOC) Pomalidomide+Dexamethasone
    Number of subjects included in analysis
    251
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.79921
    Method
    		 Miettinen & Nurminen method
    Parameter type
    		 Difference in % vs. SOC
    Point estimate
    -5.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -17.1
         upper limit
    		 6.9

    Secondary: Participants Experiencing One or More Adverse Events (AEs)

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    End point title
    		 Participants Experiencing One or More Adverse Events (AEs)
    End point description
    An adverse event (AE) was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study. The analysis population consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. The data cutoff date was August 3, 2020.
    End point type
    Secondary
    End point timeframe
    Up to approximately 54 months
    End point values
    		 Pembrolizumab+Pomalidomide+Dexamethasone Standard of Care (SOC) Pomalidomide+Dexamethasone
    Number of subjects analysed
    122
    123
    Units: Participants
    122
    119
    No statistical analyses for this end point

    Secondary: Participants Discontinuing Study Investigational Product Due to an AE

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    End point title
    		 Participants Discontinuing Study Investigational Product Due to an AE
    End point description
    An adverse event was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study. The analysis population consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. The data cutoff date was August 3, 2020.
    End point type
    Secondary
    End point timeframe
    Up to approximately 54 months
    End point values
    		 Pembrolizumab+Pomalidomide+Dexamethasone Standard of Care (SOC) Pomalidomide+Dexamethasone
    Number of subjects analysed
    122
    123
    Units: Participants
    26
    10
    No statistical analyses for this end point

    Secondary: Disease Control Rate (DCR) Evaluated According to the IMWG Response Criteria by CAC Blinded Central Review

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    End point title
    		 Disease Control Rate (DCR) Evaluated According to the IMWG Response Criteria by CAC Blinded Central Review
    End point description
    Disease control rate was based on participants who achieved confirmed sCR, CR, VGPR, PR, minimal response (MR) or had demonstrated stable disease (SD) for at least 12 weeks prior to any evidence of progression. CR = negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND <5% plasmacytomas in the bone marrow; sCR=stringent complete response, CR as above PLUS normal serum FLC assay ratio and absence of clonal cells in bone marrow by immunohistochemistry/fluorescence; VGPR = serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component <100 mg/24 hr; PR = ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24 hours. The analysis population included all randomized participants. Participants were included in the treatment group to which they were randomized. The data cutoff date was July 9, 2018.
    End point type
    Secondary
    End point timeframe
    Up to approximately 30 months
    End point values
    		 Pembrolizumab+Pomalidomide+Dexamethasone Standard of Care (SOC) Pomalidomide+Dexamethasone
    Number of subjects analysed
    126
    125
    Units: Percentage of participants
        number (confidence interval 95%)
    88.1 (81.1 to 93.2)
    84.8 (77.3 to 90.6)
    No statistical analyses for this end point

    Secondary: Second Progression Free Survival (PFS2)

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    End point title
    		 Second Progression Free Survival (PFS2)
    End point description
    PFS2 was defined as the time from randomization to subsequent disease progression after initiation of new anti-cancer therapy, or death from any cause, whichever occurred first, by investigator assessment. PFS was assessed by CAC blinded central review according to the IMWG response criteria based on the development of new bone lesions or soft tissue plasmacytomas or on a definite increase in the size of existing bone lesions or soft tissue plasmacytomas. The analysis population included all randomized participants. Participants were included in the treatment group to which they were randomized. PFS2 was not analyzed or reported due to early termination of the study.
    End point type
    Secondary
    End point timeframe
    Up to approximately 30 months
    End point values
    		 Pembrolizumab+Pomalidomide+Dexamethasone Standard of Care (SOC) Pomalidomide+Dexamethasone
    Number of subjects analysed
    0 [3]
    0 [4]
    Units: Months
        median (confidence interval 95%)
    ( to )
    ( to )
    Notes
    [3] - PFS2 was not analyzed or reported due to an early termination of the study.
    [4] - PFS2 was not analyzed or reported due to an early termination of the study.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to approximately 54 months
    Adverse event reporting additional description
    Cancer progression was not considered an adverse event (AE) unless considered related to study treatment. The analysis population for all-cause mortality was all randomized participants and for adverse events was the treated participants. The data cutoff date was August 3, 2020.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    Pembrolizumab+Pomalidomide+Dexamethasone
    Reporting group description
    		 Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 every 3 weeks (Q3W) PLUS pomalidomide 4 mg orally (PO) on Days 1 to 21 of each 28-day cycle PLUS dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle.

    Reporting group title
    Standard of Care (SOC) Pomalidomide+Dexamethasone
    Reporting group description
    		 Participants receive pomalidomide 4 mg PO on Days 1 to 21 of each 28-day cycle PLUS dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle.

    Serious adverse events
    		 Pembrolizumab+Pomalidomide+Dexamethasone Standard of Care (SOC) Pomalidomide+Dexamethasone
    Total subjects affected by serious adverse events
         subjects affected / exposed
    79 / 122 (64.75%)
    57 / 123 (46.34%)
         number of deaths (all causes)
    86
    64
         number of deaths resulting from adverse events
    4
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basosquamous carcinoma of skin
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colorectal adenocarcinoma
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal adenocarcinoma
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant ascites
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    2 / 122 (1.64%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma of skin
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Aortic stenosis
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deep vein thrombosis
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Orthostatic hypotension
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 123 (0.81%)
         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
    Chest pain
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    3 / 122 (2.46%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    1 / 3
    0 / 0
    Fatigue
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    0 / 122 (0.00%)
    2 / 123 (1.63%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema peripheral
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    3 / 122 (2.46%)
    5 / 123 (4.07%)
         occurrences causally related to treatment / all
    1 / 3
    3 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute pulmonary oedema
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute respiratory failure
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthma
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    2 / 122 (1.64%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cough
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    2 / 123 (1.63%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoptysis
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxia
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Interstitial lung disease
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonitis
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    5 / 122 (4.10%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    5 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary congestion
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    0 / 122 (0.00%)
    4 / 123 (3.25%)
         occurrences causally related to treatment / all
    0 / 0
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary haemorrhage
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Delirium
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Alanine aminotransferase increased
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aspartate aminotransferase increased
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutrophil count decreased
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    2 / 122 (1.64%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Accidental overdose
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral neck fracture
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur fracture
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fibula fracture
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip fracture
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infusion related reaction
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle strain
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural fever
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural haematoma
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper limb fracture
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    2 / 122 (1.64%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiogenic shock
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    2 / 122 (1.64%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Myocarditis
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Pericardial haemorrhage
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Supraventricular tachycardia
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 123 (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
    Balance disorder
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Central nervous system lesion
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral haemorrhage
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cerebrovascular accident
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    2 / 122 (1.64%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cognitive disorder
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    IIIrd nerve disorder
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Somnolence
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    4 / 123 (3.25%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia of malignant disease
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Disseminated intravascular coagulation
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile bone marrow aplasia
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile neutropenia
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    4 / 122 (3.28%)
    4 / 123 (3.25%)
         occurrences causally related to treatment / all
    3 / 4
    2 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancytopenia
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertigo positional
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Cataract
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Constipation
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestine perforation
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tooth disorder
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatitis
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Panniculitis
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stevens-Johnson syndrome
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Rash
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    4 / 122 (3.28%)
    4 / 123 (3.25%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic kidney disease
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystitis haemorrhagic
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal failure
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    2 / 122 (1.64%)
    2 / 123 (1.63%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Adrenal insufficiency
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 123 (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
    Fracture pain
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscular weakness
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteonecrosis of jaw
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pathological fracture
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    3 / 123 (2.44%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polyarthritis
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Anal abscess
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis bacterial
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacteraemia
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial infection
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial sepsis
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis bacterial
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    2 / 122 (1.64%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile colitis
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile infection
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia bacteraemia
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Genital herpes simplex
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infective exacerbation of chronic obstructive airways disease
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    3 / 123 (2.44%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenic sepsis
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    2 / 122 (1.64%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Parainfluenzae virus infection
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parotitis
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumocystis jirovecii pneumonia
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    3 / 122 (2.46%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    23 / 122 (18.85%)
    17 / 123 (13.82%)
         occurrences causally related to treatment / all
    13 / 29
    5 / 21
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pneumonia bacterial
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pneumonia influenzal
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia parainfluenzae viral
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary sepsis
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Respiratory tract infection viral
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhinovirus infection
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    3 / 122 (2.46%)
    3 / 123 (2.44%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    2 / 122 (1.64%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Sinusitis
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subcutaneous abscess
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    3 / 123 (2.44%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral infection
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound infection
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    0 / 122 (0.00%)
    2 / 123 (1.63%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gout
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypercalcaemia
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    2 / 122 (1.64%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatraemia
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 123 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypovolaemia
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Steroid Diabetes
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 123 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Pembrolizumab+Pomalidomide+Dexamethasone Standard of Care (SOC) Pomalidomide+Dexamethasone
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    115 / 122 (94.26%)
    114 / 123 (92.68%)
    Investigations
    Alanine aminotransferase increased
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    10 / 122 (8.20%)
    4 / 123 (3.25%)
         occurrences all number
    11
    4
    Blood creatinine increased
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    7 / 122 (5.74%)
    4 / 123 (3.25%)
         occurrences all number
    10
    4
    Neutrophil count decreased
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    16 / 122 (13.11%)
    17 / 123 (13.82%)
         occurrences all number
    28
    26
    Platelet count decreased
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    7 / 122 (5.74%)
    10 / 123 (8.13%)
         occurrences all number
    11
    12
    Weight decreased
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    7 / 122 (5.74%)
    5 / 123 (4.07%)
         occurrences all number
    7
    5
    White blood cell count decreased
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    13 / 122 (10.66%)
    11 / 123 (8.94%)
         occurrences all number
    19
    21
    Nervous system disorders
    Dizziness
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    16 / 122 (13.11%)
    14 / 123 (11.38%)
         occurrences all number
    19
    15
    Headache
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    16 / 122 (13.11%)
    5 / 123 (4.07%)
         occurrences all number
    20
    7
    Neuropathy peripheral
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    8 / 122 (6.56%)
    5 / 123 (4.07%)
         occurrences all number
    8
    5
    Tremor
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    10 / 122 (8.20%)
    10 / 123 (8.13%)
         occurrences all number
    11
    10
    Blood and lymphatic system disorders
    Anaemia
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    34 / 122 (27.87%)
    40 / 123 (32.52%)
         occurrences all number
    53
    57
    Leukopenia
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    10 / 122 (8.20%)
    9 / 123 (7.32%)
         occurrences all number
    21
    16
    Neutropenia
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    49 / 122 (40.16%)
    33 / 123 (26.83%)
         occurrences all number
    120
    63
    Thrombocytopenia
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    26 / 122 (21.31%)
    19 / 123 (15.45%)
         occurrences all number
    49
    27
    General disorders and administration site conditions
    Asthenia
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    15 / 122 (12.30%)
    14 / 123 (11.38%)
         occurrences all number
    21
    17
    Chest pain
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    9 / 122 (7.38%)
    5 / 123 (4.07%)
         occurrences all number
    11
    6
    Fatigue
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    33 / 122 (27.05%)
    37 / 123 (30.08%)
         occurrences all number
    36
    44
    Oedema peripheral
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    22 / 122 (18.03%)
    20 / 123 (16.26%)
         occurrences all number
    26
    23
    Pyrexia
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    26 / 122 (21.31%)
    19 / 123 (15.45%)
         occurrences all number
    35
    23
    Gastrointestinal disorders
    Constipation
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    30 / 122 (24.59%)
    26 / 123 (21.14%)
         occurrences all number
    37
    27
    Diarrhoea
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    21 / 122 (17.21%)
    27 / 123 (21.95%)
         occurrences all number
    30
    35
    Gastrooesophageal reflux disease
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    4 / 122 (3.28%)
    7 / 123 (5.69%)
         occurrences all number
    4
    7
    Nausea
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    23 / 122 (18.85%)
    16 / 123 (13.01%)
         occurrences all number
    26
    19
    Vomiting
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    10 / 122 (8.20%)
    13 / 123 (10.57%)
         occurrences all number
    17
    14
    Respiratory, thoracic and mediastinal disorders
    Cough
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    19 / 122 (15.57%)
    18 / 123 (14.63%)
         occurrences all number
    23
    21
    Dyspnoea
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    21 / 122 (17.21%)
    19 / 123 (15.45%)
         occurrences all number
    26
    25
    Epistaxis
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    9 / 122 (7.38%)
    3 / 123 (2.44%)
         occurrences all number
    9
    5
    Skin and subcutaneous tissue disorders
    Pruritus
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    6 / 122 (4.92%)
    10 / 123 (8.13%)
         occurrences all number
    6
    10
    Rash
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    12 / 122 (9.84%)
    10 / 123 (8.13%)
         occurrences all number
    13
    12
    Psychiatric disorders
    Depression
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    7 / 122 (5.74%)
    3 / 123 (2.44%)
         occurrences all number
    7
    3
    Insomnia
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    10 / 122 (8.20%)
    17 / 123 (13.82%)
         occurrences all number
    11
    18
    Musculoskeletal and connective tissue disorders
    Arthralgia
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    10 / 122 (8.20%)
    16 / 123 (13.01%)
         occurrences all number
    11
    17
    Back pain
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    14 / 122 (11.48%)
    21 / 123 (17.07%)
         occurrences all number
    15
    23
    Muscle spasms
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    15 / 122 (12.30%)
    14 / 123 (11.38%)
         occurrences all number
    16
    15
    Muscular weakness
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    6 / 122 (4.92%)
    11 / 123 (8.94%)
         occurrences all number
    10
    13
    Musculoskeletal chest pain
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    12 / 122 (9.84%)
    6 / 123 (4.88%)
         occurrences all number
    14
    6
    Pain in extremity
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    6 / 122 (4.92%)
    7 / 123 (5.69%)
         occurrences all number
    8
    7
    Infections and infestations
    Nasopharyngitis
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    7 / 122 (5.74%)
    6 / 123 (4.88%)
         occurrences all number
    7
    8
    Upper respiratory tract infection
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    21 / 122 (17.21%)
    25 / 123 (20.33%)
         occurrences all number
    27
    33
    Urinary tract infection
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    1 / 122 (0.82%)
    8 / 123 (6.50%)
         occurrences all number
    1
    9
    Pneumonia
         subjects affected / exposed
    7 / 122 (5.74%)
    2 / 123 (1.63%)
         occurrences all number
    7
    2
    Metabolism and nutrition disorders
    Decreased appetite
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    9 / 122 (7.38%)
    8 / 123 (6.50%)
         occurrences all number
    9
    8
    Hyperglycaemia
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    7 / 122 (5.74%)
    5 / 123 (4.07%)
         occurrences all number
    7
    5
    Hypokalaemia
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    11 / 122 (9.02%)
    8 / 123 (6.50%)
         occurrences all number
    16
    9
    Hypomagnesaemia
    alternative dictionary used: MedDRA 21.0
         subjects affected / exposed
    3 / 122 (2.46%)
    8 / 123 (6.50%)
         occurrences all number
    6
    8

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Apr 2016
    a. Sections 5.7.3, 5.7.4, 6.1, 7.1.5.2 - Addition of Pomalidomide pregnancy prevention plan for subjects in clinical trials. Added row to flowchart for Pomalidomide education and counseling. b. Section 12.9. 12.10, 12.11 - Supplemental information/sheets from the Pomalidomide Adult Pregnancy Risk Minimization Plan for Clinical Trials added as Appendices. c. Section 5.7.5.1 - Removed section
    22 Aug 2016
    Section 5.3 - Clarified the exclusion criteria related to pneumonitis.
    07 Feb 2017
    a. Section 5.2.1.2.1 - Updated Table 4 to permanently discontinue for any recurrent grade 2 pneumonitis. b. Sections 7.1.5.4.1; 7.1.5.5.2; 7.2.3.2.1 - Clarification of follow-up for allogeneic SCT with collect additional information regarding allogeneic Stem Cell Transplants and complications following treatment with pembrolizumab.
    05 Oct 2017
    Sections 1.0, 2.1, 5.2.3, 6.1, 6.1.1, 7.1.5.3, 8.0 - Added treatment discontinuation statement with defined population. The FDA determined that the risks of pembrolizumab plus pomalidomide or lenalidomide outweighed any potential benefit for patients with multiple myeloma. Based on this decision, the treatment phase of KN183 and KN185 is closed effective immediately. All subjects must stop study treatment, complete the Discontinuation Visit and move into the long-term safety and survival follow-up per protocol.
    10 May 2018
    a. Section 4.2.3.4 - Added in the second paragraph: Samples obtained for PK may be used to conduct additional safety analysis, if needed. b. Section 6.1 - Added in footnote #6: Pharmacokinetic/anti-drug antibody (PK/ADA) samples may be used to conduct additional safety analysis, if needed. c. Section 7.1.3.2.1 - Added in the second paragraph: Samples obtained for PK or ADA may be used to conduct additional safety analysis, if needed.
    16 Jul 2020
    a. Section 1.0 - Updated duration of survival follow-up to 12 months following discontinuation visit. b. Section 2.1 - Updated follow-up after stem cell transplant (SCT) to provide for completion of follow-up at the end of the trial. c. Section 5.10 - Updated criteria for end of the trial to include Sponsor decision to close.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    05 Oct 2017
    The FDA determined that the risks of pembrolizumab plus pomalidomide or lenalidomide outweighed any potential benefit for patients with multiple myeloma. Based on this decision, the treatment phase of KN183 and KN185 is closed effective immediately.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The MK-3475-183 study was stopped/terminated early. Endpoint statistics may be biased due to the incomplete treatment and follow-up of subjects after study termination
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