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    Clinical Trial Results:
    A Phase 3, Randomized, Open Label Trial of Lenalidomide/dexamethasone With or Without Elotuzumab in Relapsed or Refractory Multiple Myeloma

    Summary
    EudraCT number
    		 2010-020347-12
    Trial protocol
    		 HU   DE   BE   FR   CZ   DK   IE   AT   GB   GR   ES   PL   IT  
    Global end of trial date
    21 Apr 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Apr 2022
    First version publication date
    06 Apr 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CA204-004
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01239797
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bristol-Myers Squibb
    Sponsor organisation address
    Chaussée de la Hulpe 185, Brussels, Belgium, 1170
    Public contact
    EU Study Start-Up Unit, Bristol-Myers Squibb International Corporation, Clinical.Trials@bms.com
    Scientific contact
    Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, Clinical.Trials@bms.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Interim
    Date of interim/final analysis
    09 Aug 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Apr 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare PFS of lenalidomide/low-dose dexamethasone + elotuzumab (LdE) versus lenalidomide/low-dose dexamethasone (Ld) in subjects with relapsed or refractory multiple myeloma (MM) and to compare the ORR of LdE versus Ld.
    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
    20 Jun 2011
    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: 28
    Country: Number of subjects enrolled
    Austria: 3
    Country: Number of subjects enrolled
    Belgium: 17
    Country: Number of subjects enrolled
    Canada: 67
    Country: Number of subjects enrolled
    Czechia: 24
    Country: Number of subjects enrolled
    Denmark: 13
    Country: Number of subjects enrolled
    France: 50
    Country: Number of subjects enrolled
    Germany: 46
    Country: Number of subjects enrolled
    Greece: 43
    Country: Number of subjects enrolled
    Hungary: 7
    Country: Number of subjects enrolled
    Ireland: 2
    Country: Number of subjects enrolled
    Israel: 22
    Country: Number of subjects enrolled
    Italy: 41
    Country: Number of subjects enrolled
    Japan: 60
    Country: Number of subjects enrolled
    Poland: 48
    Country: Number of subjects enrolled
    Romania: 24
    Country: Number of subjects enrolled
    Spain: 36
    Country: Number of subjects enrolled
    Switzerland: 1
    Country: Number of subjects enrolled
    Turkey: 12
    Country: Number of subjects enrolled
    United Kingdom: 35
    Country: Number of subjects enrolled
    United States: 67
    Worldwide total number of subjects
    646
    EEA total number of subjects
    354
    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)
    276
    From 65 to 84 years
    363
    85 years and over
    7

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 646 participants were randomized and 635 were treated. 1 participant was randomized to treatment E-Ld but received treatment Ld.

    Period 1
    Period 1 title
    Randomized Participants
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Lenalidomide + Dexamethasone + Elotuzumab
    Arm description
    		 Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (Oral): On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (IV): On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug
    Arm type
    		 Experimental

    Investigational medicinal product name
    Elotuzumab
    Investigational medicinal product code
    Other name
    BMS-901608
    Pharmaceutical forms
    Powder and solvent for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days.

    Investigational medicinal product name
    Lenalidomide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    25 mg, once daily, on Days 1-21 Repeat every 28 days

    Investigational medicinal product name
    Dexamethasone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days. On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days.

    Investigational medicinal product name
    Dexamethasone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days

    Arm title
    		 Lenalidomide + Dexamethasone
    Arm description
    		 Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dexamethasone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days

    Investigational medicinal product name
    Lenalidomide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    25 mg, once daily, on Days 1-21 Repeat every 28 days

    Number of subjects in period 1
    		Lenalidomide + Dexamethasone + Elotuzumab Lenalidomide + Dexamethasone
    Started
    321
    325
    Completed
    319
    316
    Not completed
    2
    9
         Participant withdrew consent
    1
    7
         Participant no longer meets study criteria
    1
    1
         Adverse event unrelated to study drug
    -
    1
    Period 2
    Period 2 title
    Treated Participants
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Lenalidomide + Dexamethasone + Elotuzumab
    Arm description
    		 Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (Oral): On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (IV): On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug
    Arm type
    		 Experimental

    Investigational medicinal product name
    Elotuzumab
    Investigational medicinal product code
    Other name
    BMS-901608
    Pharmaceutical forms
    Powder and solvent for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days.

    Investigational medicinal product name
    Lenalidomide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    25 mg, once daily, on Days 1-21 Repeat every 28 days

    Investigational medicinal product name
    Dexamethasone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days. On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days.

    Investigational medicinal product name
    Dexamethasone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days.

    Arm title
    		 Lenalidomide + Dexamethasone
    Arm description
    		 Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dexamethasone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days

    Investigational medicinal product name
    Lenalidomide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    25 mg, once daily, on Days 1-21 Repeat every 28 days

    Number of subjects in period 2
    		Lenalidomide + Dexamethasone + Elotuzumab Lenalidomide + Dexamethasone
    Started
    319
    316
    Completed
    0
    0
    Not completed
    319
    316
         Adverse event, serious fatal
    1
    1
         Disease progression
    185
    185
         Participant withdrew consent
    6
    11
         Study drug toxicity
    39
    45
         Participant no longer meets study criteria
    2
    -
         Adverse event unrelated to study drug
    31
    37
         Other reasons
    14
    14
         Participants request to discontinue treatment
    28
    18
         Poor/non-compliance
    -
    1
         Administrative reason by sponsor
    13
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Lenalidomide + Dexamethasone + Elotuzumab
    Reporting group description
    		 Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (Oral): On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (IV): On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug

    Reporting group title
    Lenalidomide + Dexamethasone
    Reporting group description
    		 Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug

    Reporting group values
    		 Lenalidomide + Dexamethasone + Elotuzumab Lenalidomide + Dexamethasone Total
    Number of subjects
    		 321 325 646
    Age Categorical
    Units:
        < 65 years old
    		 134 142 276
        >= 65 and < 75 years old
    		 119 122 241
        >= 75 years old
    		 68 61 129
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 66.2 ( 9.34 ) 65.3 ( 10.26 ) -
    Sex: Female, Male
    Units:
        Female
    		 129 132 261
        Male
    		 192 193 385
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 5 1 6
        Not Hispanic or Latino
    		 28 33 61
        Unknown or Not Reported
    		 288 291 579
    Race/Ethnicity, Customized
    Units: Subjects
        White
    		 264 280 544
        Black or African American
    		 13 10 23
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 33 31 64
        Native Hawaiian or Other Pacific Islander
    		 1 0 1
        Other
    		 9 4 13
        Not Reported
    		 1 0 1

    End points

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    End points reporting groups
    Reporting group title
    Lenalidomide + Dexamethasone + Elotuzumab
    Reporting group description
    		 Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (Oral): On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (IV): On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug

    Reporting group title
    Lenalidomide + Dexamethasone
    Reporting group description
    		 Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug
    Reporting group title
    Lenalidomide + Dexamethasone + Elotuzumab
    Reporting group description
    		 Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (Oral): On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (IV): On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug

    Reporting group title
    Lenalidomide + Dexamethasone
    Reporting group description
    		 Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug

    Primary: Median Progression Free Survival (PFS)

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    End point title
    		 Median Progression Free Survival (PFS)
    End point description
    Primary definition of Progression-free survival (PFS) defined as the time from randomization to the date of first documented tumor progression or death due to any cause. Participants were censored at the last adequate assessment prior to the start of any subsequent systemic-therapy or at the last adequate assessment prior to 2 missing assessments (> 10 weeks). Participants who died more than 10 weeks after the randomization date and had no on-treatment assessment were censored at the randomization date. Clinical deterioration was not considered progression. The primary analysis of PFS was based on the primary definition using the Independent Review Committee (IRC) tumor assessment using the European Group for Blood and Bone Marrow Transplant (EBMT) criteria. Tumor assessments were made every 4 weeks (±1 week) relative to the first dose of study medication.
    End point type
    Primary
    End point timeframe
    From randomization up to to the date of first documented tumor progression or death (approximately 85 months)
    End point values
    		 Lenalidomide + Dexamethasone + Elotuzumab Lenalidomide + Dexamethasone
    Number of subjects analysed
    321
    325
    Units: Months
        median (confidence interval 95%)
    19.42 (16.62 to 22.31)
    14.92 (12.25 to 17.31)
    Statistical analysis title
    		 LdE versus Ld
    Statistical analysis description
    Hazard Ratio of Lenalidomide + Dexamethasone + Elotuzumab to Lenalidomide + Dexamethasone
    Comparison groups
    Lenalidomide + Dexamethasone + Elotuzumab v Lenalidomide + Dexamethasone
    Number of subjects included in analysis
    646
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0005
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 0.87

    Primary: Objective Response Rate (ORR)

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    End point title
    		 Objective Response Rate (ORR)
    End point description
    Objective response rate (ORR) defined as the number of participants with a best response on-study of partial response (PR) or better (stringent CR [sCR], complete response [CR], very good partial response [VGPR], and partial response [PR]) based on the Independent Review Committee (IRC) assessment of best response using the European Group for Blood and Bone Marrow Transplant (EBMT) assessment criteria. Participants were censored at the last adequate assessment prior to the start of any subsequent systemic-therapy or at the last adequate assessment prior to 2 missing assessments (> 10 weeks). Participants who died more than 10 weeks after the randomization date and had no on-treatment assessment were censored at the randomization date. Clinical deterioration was not considered progression. Assessments were made every 4 weeks.
    End point type
    Primary
    End point timeframe
    Randomization up to approximately 52 months
    End point values
    		 Lenalidomide + Dexamethasone + Elotuzumab Lenalidomide + Dexamethasone
    Number of subjects analysed
    321
    325
    Units: Participants
    272
    239
    Statistical analysis title
    		 Ratio of LdE Ld
    Comparison groups
    Lenalidomide + Dexamethasone + Elotuzumab v Lenalidomide + Dexamethasone
    Number of subjects included in analysis
    646
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0004
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.37
         upper limit
    		 3
    Statistical analysis title
    		 LdE versus Ld
    Statistical analysis description
    Difference of Lenalidomide + Dexamethasone + Elotuzumab minus Lenalidomide + Dexamethasone computed using the method of DerSimonian and Laird (weighted average over the strata)
    Comparison groups
    Lenalidomide + Dexamethasone + Elotuzumab v Lenalidomide + Dexamethasone
    Number of subjects included in analysis
    646
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Difference in ORR
    Point estimate
    10.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.4
         upper limit
    		 16.4

    Secondary: Median Overall Survival (OS)

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    End point title
    		 Median Overall Survival (OS)
    End point description
    Overall survival is defined as the time from randomization to the date of death from any cause. If a subject has not died, their survival time will be censored at the date of last contact (“last known alive date”). A subject will be censored at the date of randomization if they were randomized but had no follow-up. (Based on Kaplan Meier estimates)
    End point type
    Secondary
    End point timeframe
    Randomization to the date of death from any cause (up to approximately 9 years)
    End point values
    		 Lenalidomide + Dexamethasone + Elotuzumab Lenalidomide + Dexamethasone
    Number of subjects analysed
    321
    325
    Units: Months
        median (confidence interval 95%)
    48.30 (40.34 to 51.94)
    39.62 (33.25 to 45.27)
    No statistical analyses for this end point

    Secondary: Change from baseline of mean score pain severity (BPI-SF)

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    End point title
    		 Change from baseline of mean score pain severity (BPI-SF)
    End point description
    The change from baseline of the mean score of pain severity at the end of treatment using the Brief Pain Inventory-Short Form (BPI-SF). The BPI-SF is a self administered questionnaire developed to assess the severity of pain (the sensory dimension) as well as the degree to which pain interferes with function (the reactive dimension). The BPI-SF uses 0 ("No pain", "No interference") to 10 ("Pain as bad as you can imagine", "Highest imaginable interference") numeric rating scale.
    End point type
    Secondary
    End point timeframe
    From baseline up to approximately 38 months
    End point values
    		 Lenalidomide + Dexamethasone + Elotuzumab Lenalidomide + Dexamethasone
    Number of subjects analysed
    114
    152
    Units: Score on a scale
        arithmetic mean (standard deviation)
    0.52 ( 2.237 )
    -0.04 ( 2.408 )
    No statistical analyses for this end point

    Secondary: Change from baseline of mean score pain Interference (BPI-SF)

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    End point title
    		 Change from baseline of mean score pain Interference (BPI-SF)
    End point description
    The change from baseline of the mean score of pain interference at the end of treatment using the Brief Pain Inventory-Short Form (BPI-SF). The BPI-SF is a self administered questionnaire developed to assess the severity of pain (the sensory dimension) as well as the degree to which pain interferes with function (the reactive dimension). The BPI-SF uses 0 ("No pain", "No interference") to 10 ("Pain as bad as you can imagine", "Highest imaginable interference") numeric rating scale.
    End point type
    Secondary
    End point timeframe
    From baseline up to approximately 38 months
    End point values
    		 Lenalidomide + Dexamethasone + Elotuzumab Lenalidomide + Dexamethasone
    Number of subjects analysed
    113
    150
    Units: Score on a scale
        arithmetic mean (standard deviation)
    0.95 ( 2.466 )
    0.48 ( 2.868 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Lenalidomide + Dexamethasone
    Reporting group description
    		 Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug

    Reporting group title
    Lenalidomide + Dexamethasone + Elotuzumab
    Reporting group description
    		 Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (Oral): On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (IV): On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug

    Serious adverse events
    		 Lenalidomide + Dexamethasone Lenalidomide + Dexamethasone + Elotuzumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    194 / 317 (61.20%)
    238 / 318 (74.84%)
         number of deaths (all causes)
    249
    226
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma of colon
         subjects affected / exposed
    1 / 317 (0.32%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Bladder transitional cell carcinoma
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemangioma of bone
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant melanoma in situ
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant neoplasm of unknown primary site
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Squamous cell carcinoma
         subjects affected / exposed
    3 / 317 (0.95%)
    2 / 318 (0.63%)
         occurrences causally related to treatment / all
    1 / 6
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung neoplasm malignant
         subjects affected / exposed
    0 / 317 (0.00%)
    4 / 318 (1.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 3
    Malignant neoplasm progression
         subjects affected / exposed
    4 / 317 (1.26%)
    5 / 318 (1.57%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 4
    0 / 3
    Myelodysplastic syndrome
         subjects affected / exposed
    3 / 317 (0.95%)
    2 / 318 (0.63%)
         occurrences causally related to treatment / all
    2 / 3
    2 / 2
         deaths causally related to treatment / all
    0 / 1
    1 / 1
    Prostatic adenoma
         subjects affected / exposed
    1 / 317 (0.32%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Plasmacytoma
         subjects affected / exposed
    3 / 317 (0.95%)
    2 / 318 (0.63%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Tumour associated fever
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basal cell carcinoma
         subjects affected / exposed
    4 / 317 (1.26%)
    10 / 318 (3.14%)
         occurrences causally related to treatment / all
    1 / 4
    5 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometrial cancer
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal neoplasm
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Meningioma
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    2 / 317 (0.63%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Plasma cell myeloma
         subjects affected / exposed
    5 / 317 (1.58%)
    6 / 318 (1.89%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 6
         deaths causally related to treatment / all
    0 / 3
    0 / 2
    Haemangioma
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (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 of skin
         subjects affected / exposed
    3 / 317 (0.95%)
    12 / 318 (3.77%)
         occurrences causally related to treatment / all
    0 / 8
    4 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsil cancer
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Chronic lymphocytic leukaemia
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant pleural effusion
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mesothelioma
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung cancer metastatic
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute erythroid leukaemia
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute myeloid leukaemia
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atypical fibroxanthoma
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer stage I
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervix carcinoma
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colorectal adenocarcinoma
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    External ear neoplasm malignant
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lip squamous cell carcinoma
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasm malignant
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Non-small cell lung cancer
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Plasma cell myeloma recurrent
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Rectal adenocarcinoma
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sarcoma
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vulval cancer
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Aortic aneurysm rupture
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Orthostatic hypotension
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombosis
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    4 / 317 (1.26%)
    10 / 318 (3.14%)
         occurrences causally related to treatment / all
    3 / 4
    10 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subclavian vein thrombosis
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombophlebitis
         subjects affected / exposed
    2 / 317 (0.63%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral ischaemia
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombophlebitis superficial
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Embolism
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    1 / 317 (0.32%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery thrombosis
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Venous thrombosis
         subjects affected / exposed
    2 / 317 (0.63%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic venous thrombosis
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Venous thrombosis limb
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypovolaemic shock
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Surgical and medical procedures
    Hip arthroplasty
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         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
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    17 / 317 (5.36%)
    25 / 318 (7.86%)
         occurrences causally related to treatment / all
    5 / 24
    9 / 26
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthenia
         subjects affected / exposed
    0 / 317 (0.00%)
    4 / 318 (1.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chills
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    1 / 317 (0.32%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Disease progression
         subjects affected / exposed
    10 / 317 (3.15%)
    15 / 318 (4.72%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 15
         deaths causally related to treatment / all
    0 / 8
    0 / 11
    Malaise
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    4 / 317 (1.26%)
    5 / 318 (1.57%)
         occurrences causally related to treatment / all
    1 / 4
    1 / 5
         deaths causally related to treatment / all
    1 / 4
    0 / 2
    Hernia
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Haemophagocytic lymphohistiocytosis
         subjects affected / exposed
    1 / 317 (0.32%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian cyst
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary alveolar haemorrhage
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obliterative bronchiolitis
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cough
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    4 / 317 (1.26%)
    4 / 318 (1.26%)
         occurrences causally related to treatment / all
    0 / 4
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Organising pneumonia
         subjects affected / exposed
    0 / 317 (0.00%)
    2 / 318 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    1 / 317 (0.32%)
    2 / 318 (0.63%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 317 (0.32%)
    2 / 318 (0.63%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchial disorder
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    3 / 317 (0.95%)
    5 / 318 (1.57%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 7
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Lung disorder
         subjects affected / exposed
    1 / 317 (0.32%)
    4 / 318 (1.26%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Bronchial hyperreactivity
         subjects affected / exposed
    0 / 317 (0.00%)
    2 / 318 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonitis
         subjects affected / exposed
    2 / 317 (0.63%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    8 / 317 (2.52%)
    11 / 318 (3.46%)
         occurrences causally related to treatment / all
    6 / 9
    10 / 11
         deaths causally related to treatment / all
    1 / 1
    1 / 1
    Hypoxia
         subjects affected / exposed
    1 / 317 (0.32%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Interstitial lung disease
         subjects affected / exposed
    3 / 317 (0.95%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute pulmonary oedema
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthma
         subjects affected / exposed
    1 / 317 (0.32%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute respiratory distress syndrome
         subjects affected / exposed
    1 / 317 (0.32%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pulmonary artery thrombosis
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary fibrosis
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Completed suicide
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Depression
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mental status changes
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Confusional state
         subjects affected / exposed
    1 / 317 (0.32%)
    4 / 318 (1.26%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Delirium
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Product issues
    Device dislocation
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    International normalised ratio increased
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood creatinine increased
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Viral test positive
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver function test abnormal
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia test positive
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoglobin decreased
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium test positive
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic enzyme increased
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza A virus test positive
         subjects affected / exposed
    1 / 317 (0.32%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical condition abnormal
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza B virus test positive
         subjects affected / exposed
    1 / 317 (0.32%)
    2 / 318 (0.63%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polymerase chain reaction positive
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Femoral neck fracture
         subjects affected / exposed
    1 / 317 (0.32%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    2 / 317 (0.63%)
    2 / 318 (0.63%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    0 / 317 (0.00%)
    2 / 318 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    0 / 317 (0.00%)
    2 / 318 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Compression fracture
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    1 / 317 (0.32%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ilium fracture
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar vertebral fracture
         subjects affected / exposed
    1 / 317 (0.32%)
    2 / 318 (0.63%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stenosis of vesicourethral anastomosis
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ankle fracture
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic fracture
         subjects affected / exposed
    2 / 317 (0.63%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seroma
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    1 / 317 (0.32%)
    3 / 318 (0.94%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    1 / 317 (0.32%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Craniocerebral injury
         subjects affected / exposed
    2 / 317 (0.63%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Soft tissue injury
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thoracic vertebral fracture
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lip injury
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    2 / 317 (0.63%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon rupture
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic fracture
         subjects affected / exposed
    2 / 317 (0.63%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Accidental overdose
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chemical burn
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint dislocation
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb injury
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    1 / 317 (0.32%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural pain
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin laceration
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal fracture
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    2 / 317 (0.63%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Myocardial infarction
         subjects affected / exposed
    3 / 317 (0.95%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Left ventricular failure
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    1 / 317 (0.32%)
    2 / 318 (0.63%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    2 / 317 (0.63%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    9 / 317 (2.84%)
    6 / 318 (1.89%)
         occurrences causally related to treatment / all
    1 / 9
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    3 / 317 (0.95%)
    3 / 318 (0.94%)
         occurrences causally related to treatment / all
    2 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Atrioventricular block complete
         subjects affected / exposed
    0 / 317 (0.00%)
    2 / 318 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    1 / 317 (0.32%)
    3 / 318 (0.94%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Myocardial ischaemia
         subjects affected / exposed
    2 / 317 (0.63%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute left ventricular failure
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brugada syndrome
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac aneurysm
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    1 / 317 (0.32%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiogenic shock
         subjects affected / exposed
    0 / 317 (0.00%)
    2 / 318 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus node dysfunction
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    3 / 317 (0.95%)
    2 / 318 (0.63%)
         occurrences causally related to treatment / all
    1 / 4
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hemiparesis
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoaesthesia
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    2 / 317 (0.63%)
    3 / 318 (0.94%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paraesthesia
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Somnolence
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    1 / 317 (0.32%)
    2 / 318 (0.63%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral ischaemia
         subjects affected / exposed
    1 / 317 (0.32%)
    2 / 318 (0.63%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dementia
         subjects affected / exposed
    0 / 317 (0.00%)
    2 / 318 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    0 / 317 (0.00%)
    2 / 318 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Status epilepticus
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Optic neuritis
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Encephalopathy
         subjects affected / exposed
    2 / 317 (0.63%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Paraparesis
         subjects affected / exposed
    1 / 317 (0.32%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral infarction
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuropathy peripheral
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal cord disorder
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral haemorrhage
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Spinal cord compression
         subjects affected / exposed
    2 / 317 (0.63%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrospinal fluid leakage
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic encephalopathy
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorder
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sciatica
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    4 / 317 (1.26%)
    5 / 318 (1.57%)
         occurrences causally related to treatment / all
    2 / 5
    4 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Neutropenia
         subjects affected / exposed
    4 / 317 (1.26%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    4 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    0 / 317 (0.00%)
    2 / 318 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Splenic infarction
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eosinophilia
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia
         subjects affected / exposed
    8 / 317 (2.52%)
    11 / 318 (3.46%)
         occurrences causally related to treatment / all
    2 / 9
    2 / 17
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone marrow failure
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    2 / 317 (0.63%)
    5 / 318 (1.57%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Microangiopathic haemolytic anaemia
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Visual impairment
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cataract nuclear
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cataract
         subjects affected / exposed
    6 / 317 (1.89%)
    6 / 318 (1.89%)
         occurrences causally related to treatment / all
    4 / 7
    4 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Ileus
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus paralytic
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestinal ulcer
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    0 / 317 (0.00%)
    3 / 318 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    2 / 317 (0.63%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 317 (0.32%)
    2 / 318 (0.63%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestine perforation
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    0 / 317 (0.00%)
    2 / 318 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    2 / 317 (0.63%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enteritis
         subjects affected / exposed
    0 / 317 (0.00%)
    2 / 318 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal haemorrhage
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Mouth haemorrhage
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    1 / 317 (0.32%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    4 / 317 (1.26%)
    2 / 318 (0.63%)
         occurrences causally related to treatment / all
    3 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 317 (0.32%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia, obstructive
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subileus
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    0 / 317 (0.00%)
    2 / 318 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Diarrhoea
         subjects affected / exposed
    12 / 317 (3.79%)
    7 / 318 (2.20%)
         occurrences causally related to treatment / all
    2 / 13
    5 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulum
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterocolitis
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterocutaneous fistula
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hiatus hernia
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric haemorrhage
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal ischaemia
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Inguinal hernia
         subjects affected / exposed
    1 / 317 (0.32%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Irritable bowel syndrome
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic failure
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic function abnormal
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperbilirubinaemia
         subjects affected / exposed
    0 / 317 (0.00%)
    2 / 318 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    0 / 317 (0.00%)
    4 / 318 (1.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis chronic
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Pustular psoriasis
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin haemorrhage
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash maculo-papular
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin ulcer
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermal cyst
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Haemorrhage urinary tract
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    3 / 317 (0.95%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neurogenic bladder
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal tubular acidosis
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prerenal failure
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Renal failure
         subjects affected / exposed
    5 / 317 (1.58%)
    4 / 318 (1.26%)
         occurrences causally related to treatment / all
    1 / 7
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal impairment
         subjects affected / exposed
    0 / 317 (0.00%)
    3 / 318 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract obstruction
         subjects affected / exposed
    1 / 317 (0.32%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute kidney injury
         subjects affected / exposed
    8 / 317 (2.52%)
    11 / 318 (3.46%)
         occurrences causally related to treatment / all
    2 / 8
    2 / 12
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Haematuria
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myeloma cast nephropathy
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (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
    Arthralgia
         subjects affected / exposed
    2 / 317 (0.63%)
    2 / 318 (0.63%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone pain
         subjects affected / exposed
    0 / 317 (0.00%)
    3 / 318 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal pain
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pathological fracture
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical spinal stenosis
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle mass
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscular weakness
         subjects affected / exposed
    0 / 317 (0.00%)
    2 / 318 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 317 (0.32%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhabdomyolysis
         subjects affected / exposed
    3 / 317 (0.95%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    5 / 317 (1.58%)
    7 / 318 (2.20%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone lesion
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteonecrosis of jaw
         subjects affected / exposed
    6 / 317 (1.89%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Exostosis
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteonecrosis
         subjects affected / exposed
    1 / 317 (0.32%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone cyst
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal stenosis
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendonitis
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Diverticulitis
         subjects affected / exposed
    0 / 317 (0.00%)
    2 / 318 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory syncytial virus infection
         subjects affected / exposed
    1 / 317 (0.32%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin infection
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Streptococcal bacteraemia
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    8 / 317 (2.52%)
    8 / 318 (2.52%)
         occurrences causally related to treatment / all
    3 / 8
    2 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile infection
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cytomegalovirus infection
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocarditis
         subjects affected / exposed
    2 / 317 (0.63%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enteritis infectious
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis staphylococcal
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Neutropenic sepsis
         subjects affected / exposed
    1 / 317 (0.32%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal sepsis
         subjects affected / exposed
    1 / 317 (0.32%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    5 / 317 (1.58%)
    3 / 318 (0.94%)
         occurrences causally related to treatment / all
    1 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess oral
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral aspergillosis
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    1 / 317 (0.32%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia pneumococcal
         subjects affected / exposed
    1 / 317 (0.32%)
    3 / 318 (0.94%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal bacteraemia
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tooth abscess
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial sepsis
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 317 (0.32%)
    8 / 318 (2.52%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterocolitis viral
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    2 / 317 (0.63%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia fungal
         subjects affected / exposed
    0 / 317 (0.00%)
    2 / 318 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Viral diarrhoea
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atypical pneumonia
         subjects affected / exposed
    0 / 317 (0.00%)
    3 / 318 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    1 / 317 (0.32%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related sepsis
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile infection
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    1 / 317 (0.32%)
    4 / 318 (1.26%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    1 / 317 (0.32%)
    3 / 318 (0.94%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Listeriosis
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    4 / 317 (1.26%)
    8 / 318 (2.52%)
         occurrences causally related to treatment / all
    1 / 5
    4 / 9
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Periodontitis
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Pharyngitis
         subjects affected / exposed
    2 / 317 (0.63%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    40 / 317 (12.62%)
    56 / 318 (17.61%)
         occurrences causally related to treatment / all
    14 / 49
    30 / 74
         deaths causally related to treatment / all
    0 / 3
    0 / 3
    Septic shock
         subjects affected / exposed
    5 / 317 (1.58%)
    2 / 318 (0.63%)
         occurrences causally related to treatment / all
    3 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Sinusitis
         subjects affected / exposed
    1 / 317 (0.32%)
    2 / 318 (0.63%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    4 / 317 (1.26%)
    3 / 318 (0.94%)
         occurrences causally related to treatment / all
    0 / 4
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Pneumocystis jirovecii pneumonia
         subjects affected / exposed
    1 / 317 (0.32%)
    2 / 318 (0.63%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 2
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia influenzal
         subjects affected / exposed
    2 / 317 (0.63%)
    2 / 318 (0.63%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    4 / 317 (1.26%)
    11 / 318 (3.46%)
         occurrences causally related to treatment / all
    2 / 4
    6 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    8 / 317 (2.52%)
    5 / 318 (1.57%)
         occurrences causally related to treatment / all
    3 / 8
    1 / 5
         deaths causally related to treatment / all
    2 / 5
    0 / 2
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 317 (0.32%)
    2 / 318 (0.63%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchopulmonary aspergillosis
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung abscess
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumococcal sepsis
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute sinusitis
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis bacterial
         subjects affected / exposed
    2 / 317 (0.63%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Campylobacter gastroenteritis
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    4 / 317 (1.26%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    2 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    H1N1 influenza
         subjects affected / exposed
    1 / 317 (0.32%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ophthalmic herpes zoster
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection enterococcal
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal abscess
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary sepsis
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain abscess
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Bursitis infective
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Catheter site abscess
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium colitis
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cytomegalovirus chorioretinitis
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epididymitis
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia urinary tract infection
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis clostridial
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis norovirus
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis B
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Genital abscess
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes zoster reactivation
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infective exacerbation of chronic obstructive airways disease
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral discitis
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestine infection
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metapneumovirus infection
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Localised infection
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis media chronic
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parvovirus B19 infection
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural infection
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pseudomonal sepsis
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pseudomonas infection
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary sepsis
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinitis
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rotavirus infection
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Systemic infection
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Varicella zoster virus infection
         subjects affected / exposed
    0 / 317 (0.00%)
    2 / 318 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 317 (0.32%)
    2 / 318 (0.63%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Failure to thrive
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypocalcaemia
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    2 / 317 (0.63%)
    3 / 318 (0.94%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypercalcaemia
         subjects affected / exposed
    2 / 317 (0.63%)
    3 / 318 (0.94%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tumour lysis syndrome
         subjects affected / exposed
    1 / 317 (0.32%)
    0 / 318 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Decreased appetite
         subjects affected / exposed
    1 / 317 (0.32%)
    2 / 318 (0.63%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes mellitus
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    1 / 317 (0.32%)
    3 / 318 (0.94%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fluid retention
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ketoacidosis
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Type 2 diabetes mellitus
         subjects affected / exposed
    0 / 317 (0.00%)
    1 / 318 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Lenalidomide + Dexamethasone Lenalidomide + Dexamethasone + Elotuzumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    309 / 317 (97.48%)
    314 / 318 (98.74%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    23 / 317 (7.26%)
    40 / 318 (12.58%)
         occurrences all number
    33
    62
    Deep vein thrombosis
         subjects affected / exposed
    10 / 317 (3.15%)
    19 / 318 (5.97%)
         occurrences all number
    10
    21
    Hypotension
         subjects affected / exposed
    12 / 317 (3.79%)
    33 / 318 (10.38%)
         occurrences all number
    13
    44
    Flushing
         subjects affected / exposed
    6 / 317 (1.89%)
    16 / 318 (5.03%)
         occurrences all number
    6
    21
    Haematoma
         subjects affected / exposed
    8 / 317 (2.52%)
    17 / 318 (5.35%)
         occurrences all number
    9
    18
    General disorders and administration site conditions
    Oedema peripheral
         subjects affected / exposed
    78 / 317 (24.61%)
    97 / 318 (30.50%)
         occurrences all number
    100
    172
    Chest pain
         subjects affected / exposed
    14 / 317 (4.42%)
    28 / 318 (8.81%)
         occurrences all number
    14
    32
    Influenza like illness
         subjects affected / exposed
    16 / 317 (5.05%)
    27 / 318 (8.49%)
         occurrences all number
    24
    38
    Pyrexia
         subjects affected / exposed
    74 / 317 (23.34%)
    121 / 318 (38.05%)
         occurrences all number
    106
    235
    Asthenia
         subjects affected / exposed
    54 / 317 (17.03%)
    80 / 318 (25.16%)
         occurrences all number
    85
    128
    Chills
         subjects affected / exposed
    12 / 317 (3.79%)
    31 / 318 (9.75%)
         occurrences all number
    12
    38
    Fatigue
         subjects affected / exposed
    131 / 317 (41.32%)
    154 / 318 (48.43%)
         occurrences all number
    159
    229
    Malaise
         subjects affected / exposed
    12 / 317 (3.79%)
    19 / 318 (5.97%)
         occurrences all number
    12
    24
    Pain
         subjects affected / exposed
    7 / 317 (2.21%)
    17 / 318 (5.35%)
         occurrences all number
    8
    19
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea exertional
         subjects affected / exposed
    15 / 317 (4.73%)
    20 / 318 (6.29%)
         occurrences all number
    15
    21
    Epistaxis
         subjects affected / exposed
    19 / 317 (5.99%)
    22 / 318 (6.92%)
         occurrences all number
    22
    24
    Oropharyngeal pain
         subjects affected / exposed
    15 / 317 (4.73%)
    32 / 318 (10.06%)
         occurrences all number
    20
    48
    Cough
         subjects affected / exposed
    62 / 317 (19.56%)
    109 / 318 (34.28%)
         occurrences all number
    95
    188
    Dyspnoea
         subjects affected / exposed
    60 / 317 (18.93%)
    72 / 318 (22.64%)
         occurrences all number
    74
    108
    Productive cough
         subjects affected / exposed
    5 / 317 (1.58%)
    25 / 318 (7.86%)
         occurrences all number
    5
    32
    Dysphonia
         subjects affected / exposed
    32 / 317 (10.09%)
    25 / 318 (7.86%)
         occurrences all number
    33
    28
    Psychiatric disorders
    Mood altered
         subjects affected / exposed
    8 / 317 (2.52%)
    23 / 318 (7.23%)
         occurrences all number
    8
    25
    Depression
         subjects affected / exposed
    14 / 317 (4.42%)
    18 / 318 (5.66%)
         occurrences all number
    15
    19
    Insomnia
         subjects affected / exposed
    83 / 317 (26.18%)
    79 / 318 (24.84%)
         occurrences all number
    112
    90
    Anxiety
         subjects affected / exposed
    24 / 317 (7.57%)
    26 / 318 (8.18%)
         occurrences all number
    26
    27
    Confusional state
         subjects affected / exposed
    10 / 317 (3.15%)
    18 / 318 (5.66%)
         occurrences all number
    10
    28
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    27 / 317 (8.52%)
    36 / 318 (11.32%)
         occurrences all number
    38
    76
    Aspartate aminotransferase increased
         subjects affected / exposed
    31 / 317 (9.78%)
    21 / 318 (6.60%)
         occurrences all number
    49
    26
    Weight decreased
         subjects affected / exposed
    20 / 317 (6.31%)
    52 / 318 (16.35%)
         occurrences all number
    21
    54
    Alanine aminotransferase increased
         subjects affected / exposed
    33 / 317 (10.41%)
    25 / 318 (7.86%)
         occurrences all number
    70
    37
    Platelet count decreased
         subjects affected / exposed
    5 / 317 (1.58%)
    16 / 318 (5.03%)
         occurrences all number
    8
    28
    C-reactive protein increased
         subjects affected / exposed
    16 / 317 (5.05%)
    13 / 318 (4.09%)
         occurrences all number
    25
    25
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    28 / 317 (8.83%)
    44 / 318 (13.84%)
         occurrences all number
    33
    54
    Fall
         subjects affected / exposed
    14 / 317 (4.42%)
    21 / 318 (6.60%)
         occurrences all number
    21
    27
    Nervous system disorders
    Hypoaesthesia
         subjects affected / exposed
    12 / 317 (3.79%)
    28 / 318 (8.81%)
         occurrences all number
    12
    31
    Headache
         subjects affected / exposed
    29 / 317 (9.15%)
    54 / 318 (16.98%)
         occurrences all number
    53
    104
    Paraesthesia
         subjects affected / exposed
    29 / 317 (9.15%)
    35 / 318 (11.01%)
         occurrences all number
    35
    40
    Peripheral sensory neuropathy
         subjects affected / exposed
    39 / 317 (12.30%)
    33 / 318 (10.38%)
         occurrences all number
    47
    37
    Dizziness
         subjects affected / exposed
    38 / 317 (11.99%)
    48 / 318 (15.09%)
         occurrences all number
    45
    76
    Tremor
         subjects affected / exposed
    29 / 317 (9.15%)
    30 / 318 (9.43%)
         occurrences all number
    35
    34
    Neuropathy peripheral
         subjects affected / exposed
    31 / 317 (9.78%)
    51 / 318 (16.04%)
         occurrences all number
    34
    56
    Taste disorder
         subjects affected / exposed
    14 / 317 (4.42%)
    18 / 318 (5.66%)
         occurrences all number
    14
    19
    Blood and lymphatic system disorders
    Leukopenia
         subjects affected / exposed
    26 / 317 (8.20%)
    26 / 318 (8.18%)
         occurrences all number
    73
    72
    Neutropenia
         subjects affected / exposed
    137 / 317 (43.22%)
    114 / 318 (35.85%)
         occurrences all number
    476
    365
    Anaemia
         subjects affected / exposed
    118 / 317 (37.22%)
    135 / 318 (42.45%)
         occurrences all number
    229
    289
    Thrombocytopenia
         subjects affected / exposed
    72 / 317 (22.71%)
    91 / 318 (28.62%)
         occurrences all number
    173
    215
    Lymphopenia
         subjects affected / exposed
    23 / 317 (7.26%)
    41 / 318 (12.89%)
         occurrences all number
    60
    92
    Eye disorders
    Vision blurred
         subjects affected / exposed
    18 / 317 (5.68%)
    31 / 318 (9.75%)
         occurrences all number
    21
    33
    Cataract
         subjects affected / exposed
    36 / 317 (11.36%)
    58 / 318 (18.24%)
         occurrences all number
    37
    65
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    31 / 317 (9.78%)
    44 / 318 (13.84%)
         occurrences all number
    39
    49
    Constipation
         subjects affected / exposed
    89 / 317 (28.08%)
    115 / 318 (36.16%)
         occurrences all number
    117
    184
    Dyspepsia
         subjects affected / exposed
    19 / 317 (5.99%)
    36 / 318 (11.32%)
         occurrences all number
    26
    50
    Vomiting
         subjects affected / exposed
    32 / 317 (10.09%)
    58 / 318 (18.24%)
         occurrences all number
    42
    88
    Stomatitis
         subjects affected / exposed
    14 / 317 (4.42%)
    30 / 318 (9.43%)
         occurrences all number
    16
    36
    Nausea
         subjects affected / exposed
    73 / 317 (23.03%)
    82 / 318 (25.79%)
         occurrences all number
    99
    129
    Abdominal pain upper
         subjects affected / exposed
    20 / 317 (6.31%)
    30 / 318 (9.43%)
         occurrences all number
    25
    33
    Diarrhoea
         subjects affected / exposed
    122 / 317 (38.49%)
    159 / 318 (50.00%)
         occurrences all number
    247
    451
    Dry mouth
         subjects affected / exposed
    10 / 317 (3.15%)
    16 / 318 (5.03%)
         occurrences all number
    10
    16
    Toothache
         subjects affected / exposed
    11 / 317 (3.47%)
    18 / 318 (5.66%)
         occurrences all number
    12
    23
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    29 / 317 (9.15%)
    36 / 318 (11.32%)
         occurrences all number
    31
    47
    Rash
         subjects affected / exposed
    58 / 317 (18.30%)
    63 / 318 (19.81%)
         occurrences all number
    93
    105
    Hyperhidrosis
         subjects affected / exposed
    25 / 317 (7.89%)
    38 / 318 (11.95%)
         occurrences all number
    33
    46
    Erythema
         subjects affected / exposed
    16 / 317 (5.05%)
    26 / 318 (8.18%)
         occurrences all number
    22
    28
    Night sweats
         subjects affected / exposed
    10 / 317 (3.15%)
    24 / 318 (7.55%)
         occurrences all number
    13
    34
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    9 / 317 (2.84%)
    16 / 318 (5.03%)
         occurrences all number
    9
    19
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    63 / 317 (19.87%)
    98 / 318 (30.82%)
         occurrences all number
    78
    135
    Bone pain
         subjects affected / exposed
    43 / 317 (13.56%)
    33 / 318 (10.38%)
         occurrences all number
    54
    42
    Myalgia
         subjects affected / exposed
    22 / 317 (6.94%)
    26 / 318 (8.18%)
         occurrences all number
    25
    29
    Muscle spasms
         subjects affected / exposed
    85 / 317 (26.81%)
    99 / 318 (31.13%)
         occurrences all number
    112
    145
    Neck pain
         subjects affected / exposed
    13 / 317 (4.10%)
    23 / 318 (7.23%)
         occurrences all number
    14
    27
    Muscular weakness
         subjects affected / exposed
    28 / 317 (8.83%)
    42 / 318 (13.21%)
         occurrences all number
    31
    45
    Musculoskeletal chest pain
         subjects affected / exposed
    30 / 317 (9.46%)
    39 / 318 (12.26%)
         occurrences all number
    31
    47
    Pain in extremity
         subjects affected / exposed
    35 / 317 (11.04%)
    64 / 318 (20.13%)
         occurrences all number
    43
    88
    Back pain
         subjects affected / exposed
    97 / 317 (30.60%)
    105 / 318 (33.02%)
         occurrences all number
    122
    144
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    52 / 317 (16.40%)
    66 / 318 (20.75%)
         occurrences all number
    81
    124
    Nasopharyngitis
         subjects affected / exposed
    60 / 317 (18.93%)
    83 / 318 (26.10%)
         occurrences all number
    128
    236
    Urinary tract infection
         subjects affected / exposed
    31 / 317 (9.78%)
    36 / 318 (11.32%)
         occurrences all number
    64
    65
    Rhinitis
         subjects affected / exposed
    13 / 317 (4.10%)
    30 / 318 (9.43%)
         occurrences all number
    17
    34
    Herpes zoster
         subjects affected / exposed
    5 / 317 (1.58%)
    18 / 318 (5.66%)
         occurrences all number
    5
    19
    Lower respiratory tract infection
         subjects affected / exposed
    16 / 317 (5.05%)
    32 / 318 (10.06%)
         occurrences all number
    21
    70
    Pharyngitis
         subjects affected / exposed
    16 / 317 (5.05%)
    17 / 318 (5.35%)
         occurrences all number
    29
    18
    Pneumonia
         subjects affected / exposed
    23 / 317 (7.26%)
    30 / 318 (9.43%)
         occurrences all number
    29
    36
    Sinusitis
         subjects affected / exposed
    15 / 317 (4.73%)
    23 / 318 (7.23%)
         occurrences all number
    37
    52
    Influenza
         subjects affected / exposed
    17 / 317 (5.36%)
    25 / 318 (7.86%)
         occurrences all number
    26
    32
    Respiratory tract infection
         subjects affected / exposed
    32 / 317 (10.09%)
    36 / 318 (11.32%)
         occurrences all number
    63
    67
    Upper respiratory tract infection
         subjects affected / exposed
    62 / 317 (19.56%)
    86 / 318 (27.04%)
         occurrences all number
    146
    209
    Oral herpes
         subjects affected / exposed
    13 / 317 (4.10%)
    20 / 318 (6.29%)
         occurrences all number
    16
    30
    Gastroenteritis
         subjects affected / exposed
    9 / 317 (2.84%)
    18 / 318 (5.66%)
         occurrences all number
    13
    20
    Viral infection
         subjects affected / exposed
    10 / 317 (3.15%)
    18 / 318 (5.66%)
         occurrences all number
    16
    36
    Metabolism and nutrition disorders
    Hyponatraemia
         subjects affected / exposed
    10 / 317 (3.15%)
    18 / 318 (5.66%)
         occurrences all number
    17
    41
    Hypomagnesaemia
         subjects affected / exposed
    5 / 317 (1.58%)
    22 / 318 (6.92%)
         occurrences all number
    5
    46
    Hypocalcaemia
         subjects affected / exposed
    28 / 317 (8.83%)
    48 / 318 (15.09%)
         occurrences all number
    71
    135
    Hypokalaemia
         subjects affected / exposed
    47 / 317 (14.83%)
    67 / 318 (21.07%)
         occurrences all number
    103
    124
    Decreased appetite
         subjects affected / exposed
    42 / 317 (13.25%)
    71 / 318 (22.33%)
         occurrences all number
    48
    93
    Hyperglycaemia
         subjects affected / exposed
    45 / 317 (14.20%)
    61 / 318 (19.18%)
         occurrences all number
    87
    129
    Hypoalbuminaemia
         subjects affected / exposed
    11 / 317 (3.47%)
    17 / 318 (5.35%)
         occurrences all number
    21
    22
    Hypophosphataemia
         subjects affected / exposed
    10 / 317 (3.15%)
    19 / 318 (5.97%)
         occurrences all number
    33
    45

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Mar 2012
    Clarification of subject eligibility or study procedures
    14 Apr 2014
    Addition of formal interim analyses.
    14 Apr 2014
    The addition of a secondary and exploratory objectives and the removal Brief Pain Inventory assessment as exploratory endpoint.

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

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