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    Clinical Trial Results:
    A PHASE 2, MULTICENTER STUDY TO DETERMINE THE EFFICACY AND SAFETY OF BB2121 IN SUBJECTS WITH RELAPSED AND REFRACTORY MULTIPLE MYELOMA.

    Summary
    EudraCT number
    		 2017-002245-29
    Trial protocol
    		 DE   BE   FR   ES   IT  
    Global end of trial date
    20 Dec 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Dec 2024
    First version publication date
    28 Dec 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BB2121-MM-001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    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
    Final
    Date of interim/final analysis
    20 Dec 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Dec 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study is to evaluate the efficacy, as defined as overall response rate (ORR), of bb2121 in subjects with relapsed and refractory multiple myeloma (RRMM)
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization Good Clinical Practice Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Dec 2017
    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
    Belgium: 3
    Country: Number of subjects enrolled
    Canada: 1
    Country: Number of subjects enrolled
    France: 8
    Country: Number of subjects enrolled
    Germany: 6
    Country: Number of subjects enrolled
    Italy: 3
    Country: Number of subjects enrolled
    Japan: 9
    Country: Number of subjects enrolled
    Spain: 13
    Country: Number of subjects enrolled
    United States: 94
    Worldwide total number of subjects
    137
    EEA total number of subjects
    33
    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)
    91
    From 65 to 84 years
    46
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 137 participants treated

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

    Arms
    Arm title
    		 BB2121
    Arm description
    		 BB2121
    Arm type
    		 Experimental

    Investigational medicinal product name
    BB2121
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Dispersion for infusion
    Routes of administration
    Intravascular use
    Dosage and administration details
    dose ranging from 150 to 450 × 106 CAR+ T cells/infusion.

    Number of subjects in period 1
    		BB2121
    Started
    137
    Completed
    36
    Not completed
    101
         Adverse event, serious fatal
    77
         Consent withdrawn by subject
    20
         Lost to follow-up
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    BB2121
    Reporting group description
    		 BB2121

    Reporting group values
    		 BB2121 Total
    Number of subjects
    		 137 137
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 91 91
        From 65-84 years
    		 46 46
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 59.4 ( 9.53 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 54 54
        Male
    		 83 83
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0
        Asian
    		 12 12
        Native Hawaiian or Other Pacific Islander
    		 0 0
        Black or African American
    		 6 6
        White
    		 103 103
        More than one race
    		 0 0
        Unknown or Not Reported
    		 16 16
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 11 11
        Not Hispanic or Latino
    		 112 112
        Unknown or Not Reported
    		 14 14

    End points

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    End points reporting groups
    Reporting group title
    BB2121
    Reporting group description
    		 BB2121

    Primary: Overall Response Rate

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    End point title
    		 Overall Response Rate [1]
    End point description
    Number of participants who achieved partial response (PR) or better according to IMWG Uniform Response Criteria for Multiple Myeloma as assessed by an independent response committee (IRC).
    End point type
    Primary
    End point timeframe
    From first dose to 24 Months
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis done for this endpoint
    End point values
    		 BB2121
    Number of subjects analysed
    102
    Units: Percentage of Participants
        number (confidence interval 95%)
    74.5 (67.1 to 81.8)
    No statistical analyses for this end point

    Secondary: Complete Response Rate

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    End point title
    		 Complete Response Rate
    End point description
    Percentage of participants who achieved CR or sCR according to IMWG Uniform Response Criteria for Multiple Myeloma as assessed by an IRC.
    End point type
    Secondary
    End point timeframe
    From first dose to 24 Months
    End point values
    		 BB2121
    Number of subjects analysed
    47
    Units: Percentage of participants
        number (confidence interval 95%)
    34.3 (26.4 to 42.3)
    No statistical analyses for this end point

    Secondary: Duration of Response

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    End point title
    		 Duration of Response
    End point description
    Time from first documentation of response or PR or better to first documentation of disease progression or death from any cause, whichever occurs first.
    End point type
    Secondary
    End point timeframe
    From first dose to 24 months after first dose
    End point values
    		 BB2121
    Number of subjects analysed
    102
    Units: Months
        median (confidence interval 95%)
    11.04 (9.92 to 12.52)
    No statistical analyses for this end point

    Secondary: Time to response

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    End point title
    		 Time to response
    End point description
    Time from first bb2121 infusion to first documentation of response of PR or better.
    End point type
    Secondary
    End point timeframe
    From first dose to initial response (approximately on average 1.2 months, max of 8.8 months)
    End point values
    		 BB2121
    Number of subjects analysed
    102
    Units: Months
        median (full range (min-max))
    1.0 (0.5 to 8.8)
    No statistical analyses for this end point

    Secondary: Progression Free Survival (PFS)

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    End point title
    		 Progression Free Survival (PFS)
    End point description
    Time from first bb2121 infusion to first documentation of progressive disease (PD), or death due to any cause, whichever occurs first.
    End point type
    Secondary
    End point timeframe
    From first dose to 24 months after first dose
    End point values
    		 BB2121
    Number of subjects analysed
    137
    Units: Months
        median (confidence interval 95%)
    8.90 (6.01 to 11.86)
    No statistical analyses for this end point

    Secondary: Number of participants with safety related events

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    End point title
    		 Number of participants with safety related events
    End point description
    Number of participants with adverse events (AEs), adverse events of special interest (AESI), serious adverse events (SAEs), cytokine release syndrome, neurotoxicity, infection and clinically significantt laboratory abnormalities.
    End point type
    Secondary
    End point timeframe
    From screening to the end of follow up (approximately 5 years and 2 months)
    End point values
    		 BB2121
    Number of subjects analysed
    137
    Units: Participants
        Any Grade AE
    137
        Grade 3 or 4 AE
    136
        SAEs
    98
        AEs of Special Interest
    136
        Cytokine Release Syndrome
    116
        Neurotoxicity
    53
        Infections
    95
        Clinically Significant Laboratory Abnormalities
    0
    No statistical analyses for this end point

    Secondary: Time to Progression (TTP)

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    End point title
    		 Time to Progression (TTP)
    End point description
    Time from first bb2121 infusion to first documentation of progressive disease (PD), or death due to any cause, whichever occurs first.
    End point type
    Secondary
    End point timeframe
    From first dose to 24 months after first dose
    End point values
    		 BB2121
    Number of subjects analysed
    137
    Units: Months
        median (confidence interval 95%)
    10.38 (6.11 to 12.06)
    No statistical analyses for this end point

    Secondary: Overall Survival

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    End point title
    		 Overall Survival
    End point description
    Time from first bb2121 infusion to time of death due to any cause.
    End point type
    Secondary
    End point timeframe
    From screening to the end of follow up (approximately 5 years and 2 months)
    End point values
    		 BB2121
    Number of subjects analysed
    137
    Units: Months
        median (confidence interval 95%)
    28.25 (20.21 to 38.08)
    No statistical analyses for this end point

    Secondary: Cmax

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    End point title
    		 Cmax
    End point description
    Cmax
    End point type
    Secondary
    End point timeframe
    From first dose to the end of follow up (Approximately 5 years)
    End point values
    		 BB2121
    Number of subjects analysed
    136
    Units: copies/ug
    arithmetic mean (standard deviation)
        Total
    388150.65 ( 372280.64 )
        450x10^6 cells
    449826.92 ( 375293.18 )
        300x10^6 cells
    335916.20 ( 369546.39 )
        150x10^6 cells
    317793.50 ( 284926.30 )
    No statistical analyses for this end point

    Secondary: AUC 0-9M

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    End point title
    		 AUC 0-9M
    End point description
    Cmax
    End point type
    Secondary
    End point timeframe
    From first dose to the end of follow up (Approximately 5 years)
    End point values
    		 BB2121
    Number of subjects analysed
    136
    Units: copies*days/ug
    arithmetic mean (standard deviation)
        Total
    8634034.70 ( 9909488.82 )
        450x10^6 cells
    10599751.18 ( 10833877.42 )
        300x10^6 cells
    6604279.35 ( 8523928.48 )
        150x10^6 cells
    10555200.59 ( 13555457.13 )
    No statistical analyses for this end point

    Secondary: Tmax

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    End point title
    		 Tmax
    End point description
    Tmax
    End point type
    Secondary
    End point timeframe
    From first dose to the end of follow up (Approximately 5 years)
    End point values
    		 BB2121
    Number of subjects analysed
    136
    Units: Days
    arithmetic mean (standard deviation)
        Total
    12.07 ( 4.114 )
        450x10^6 cells
    12.37 ( 4.513 )
        300x10^6 cells
    11.74 ( 3.830 )
        150x10^6 cells
    13.25 ( 1.500 )
    No statistical analyses for this end point

    Secondary: Number of Participants with Anti-CAR-Antibodies

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    End point title
    		 Number of Participants with Anti-CAR-Antibodies
    End point description
    Number of Participants with Anti-CAR-Antibodies. Pre-positive is defined by last value before or on bb2121 infusion date is positive Post-positive is defined by at least one positive value post bb2121 infusion.
    End point type
    Secondary
    End point timeframe
    From first dose to the end of follow up (Approximately 5 years)
    End point values
    		 BB2121
    Number of subjects analysed
    137
    Units: Participants
        Pre-Positive (pre-positive and post-positive)
    6
        Pre-Positive (pre-positive and post-negative)
    0
        Pre-Positive (missing post data)
    0
        Pre-Negative (pre-negative and post-positive)
    69
        Pre-Negative (pre-negative and post-negative)
    60
        Pre-Negative (missing post data)
    1
        Missing Pre data (post-positive)
    1
        Missing Pre data (post-negative)
    0
        Missing Pre Data (missing post data)
    0
    No statistical analyses for this end point

    Secondary: Percentage of participants who achieved >= VGPR and MRD negative status

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    End point title
    		 Percentage of participants who achieved >= VGPR and MRD negative status
    End point description
    Percentage of Subjects Who Achieved >= VGPR and MRD Negative Status at Any Time Point from within 3 Months prior to Achieving VGPR or above to until Time of Progression/Death (Exclusive) based on IRC Review
    End point type
    Secondary
    End point timeframe
    From screening to the end of follow up (Approximately 5 years and 2 months)
    End point values
    		 BB2121
    Number of subjects analysed
    137
    Units: Percentage of Participants
    number (confidence interval 95%)
        10^(-4) Sensitivity
    41.6 (33.3 to 50.3)
        10^(-5) Sensitivity
    40.9 (32.6 to 49.6)
        10^(-6) Sensitivity
    24.8 (17.8 to 32.9)
    No statistical analyses for this end point

    Secondary: Mean change from baseline on the EORTC QLQ-C30 - Pain

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    End point title
    		 Mean change from baseline on the EORTC QLQ-C30 - Pain
    End point description
    Mean change from baseline on the EORTC QLQ-C30 Mean change from baseline on the EORTC QLQ-C30 The QLQ-C30 employs a week recall period for all items and a 4-point scale for the functional and symptom scales/items with response categories “Not at all”, “A little”, “Quite a bit” and “Very much”. The two items assessing global health status/ HRQoL utilize a 7-point scale ranging from 1(“Very Poor”) to 7 (“Excellent”)
    End point type
    Secondary
    End point timeframe
    At Day 1 and at specific time points up to month 24
    End point values
    		 BB2121
    Number of subjects analysed
    126
    Units: Score on a Scale
    arithmetic mean (standard deviation)
        Day 1
    -3.8 ( 19.46 )
        Month 1
    -8.9 ( 26.02 )
        Month 3
    -12.0 ( 26.65 )
        Month 6
    -14.5 ( 26.15 )
        Month 9
    -17.5 ( 24.26 )
        Month 12
    -17.3 ( 26.05 )
        Month 18
    -16.7 ( 25.39 )
        Month 24
    -13.1 ( 16.25 )
    No statistical analyses for this end point

    Secondary: Mean change from baseline on the EORTC QLQ-C30 - Physical Functioning

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    End point title
    		 Mean change from baseline on the EORTC QLQ-C30 - Physical Functioning
    End point description
    Mean change from baseline on the EORTC QLQ-C30 Mean change from baseline on the EORTC QLQ-C30 The QLQ-C30 employs a week recall period for all items and a 4-point scale for the functional and symptom scales/items with response categories “Not at all”, “A little”, “Quite a bit” and “Very much”. The two items assessing global health status/ HRQoL utilize a 7-point scale ranging from 1(“Very Poor”) to 7 (“Excellent”)
    End point type
    Secondary
    End point timeframe
    At Day 1 and at specific time points up to month 24
    End point values
    		 BB2121
    Number of subjects analysed
    126
    Units: Score on a Scale
    arithmetic mean (standard deviation)
        Day 1
    -0.4 ( 18.13 )
        Month 1
    2.1 ( 22.27 )
        Month 3
    9.8 ( 18.54 )
        Month 6
    13.9 ( 18.47 )
        Month 9
    13.1 ( 19.02 )
        Month 12
    13.3 ( 19.16 )
        Month 18
    12.8 ( 15.99 )
        Month 24
    3.8 ( 13.77 )
    No statistical analyses for this end point

    Secondary: Mean change from baseline on the EORTC QLQ-C30 - Cognitive Functioning

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    End point title
    		 Mean change from baseline on the EORTC QLQ-C30 - Cognitive Functioning
    End point description
    Mean change from baseline on the EORTC QLQ-C30 Mean change from baseline on the EORTC QLQ-C30 The QLQ-C30 employs a week recall period for all items and a 4-point scale for the functional and symptom scales/items with response categories “Not at all”, “A little”, “Quite a bit” and “Very much”. The two items assessing global health status/ HRQoL utilize a 7-point scale ranging from 1(“Very Poor”) to 7 (“Excellent”)
    End point type
    Secondary
    End point timeframe
    At Day 1 and at specific time points up to month 24
    End point values
    		 BB2121
    Number of subjects analysed
    126
    Units: Score on a Scale
    arithmetic mean (standard deviation)
        Day 1
    -0.4 ( 16.66 )
        Month 1
    2.8 ( 20.10 )
        Month 3
    5.4 ( 17.42 )
        Month 6
    6.4 ( 16.55 )
        Month 9
    6.8 ( 14.88 )
        Month 12
    4.2 ( 17.63 )
        Month 18
    3.8 ( 19.61 )
        Month 24
    3.6 ( 16.25 )
    No statistical analyses for this end point

    Secondary: Mean change from baseline on the EORTC QLQ-C30 - Global heath/QoL

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    End point title
    		 Mean change from baseline on the EORTC QLQ-C30 - Global heath/QoL
    End point description
    Mean change from baseline on the EORTC QLQ-C30 Mean change from baseline on the EORTC QLQ-C30 The QLQ-C30 employs a week recall period for all items and a 4-point scale for the functional and symptom scales/items with response categories “Not at all”, “A little”, “Quite a bit” and “Very much”. The two items assessing global health status/ HRQoL utilize a 7-point scale ranging from 1(“Very Poor”) to 7 (“Excellent”)
    End point type
    Secondary
    End point timeframe
    At Day 1 and at specific time points up to month 24
    End point values
    		 BB2121
    Number of subjects analysed
    126
    Units: Score on a Scale
    arithmetic mean (standard deviation)
        Day 1
    -4.7 ( 17.03 )
        Month 1
    4.3 ( 19.95 )
        Month 3
    8.8 ( 20.31 )
        Month 6
    12.5 ( 19.12 )
        Month 9
    15.7 ( 20.88 )
        Month 12
    14.1 ( 21.57 )
        Month 18
    10.6 ( 17.25 )
        Month 24
    7.1 ( 14.93 )
    No statistical analyses for this end point

    Secondary: Mean change from baseline on the EORTC QLQ-MY20 - Disease Symptoms

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    End point title
    		 Mean change from baseline on the EORTC QLQ-MY20 - Disease Symptoms
    End point description
    Mean change from baseline on the EORTC QLQ-MY20 The EORTC has developed a myeloma module referred to as QLQ- MY20, to be administered alongside the core QLQ-C30. The QLQ-MY20 is a 20-item myeloma module intended for use among patients varying in disease stage and treatment modality. The QLQ-C30 employs a week recall period for all items and a 4-point scale for the functional and symptom scales/items with response categories “Not at all”, “A little”, “Quite a bit” and “Very much”. The two items assessing global health status/ HRQoL utilize a 7-point scale ranging from 1(“Very Poor”) to 7 (“Excellent”)
    End point type
    Secondary
    End point timeframe
    At Day 1 and at specific time points up to month 24
    End point values
    		 BB2121
    Number of subjects analysed
    126
    Units: Score on a Scale
    arithmetic mean (standard deviation)
        Day 1
    -0.8 ( 14.11 )
        Month 1
    -10.2 ( 18.54 )
        Month 3
    -10.8 ( 20.32 )
        Month 6
    -12.6 ( 20.81 )
        Month 9
    -14.4 ( 20.29 )
        Month 12
    -15.7 ( 23.28 )
        Month 18
    -12.0 ( 20.47 )
        Month 24
    -13.1 ( 19.07 )
    No statistical analyses for this end point

    Secondary: Mean change from baseline on the EORTC QLQ-MY20 - Side Effects

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    End point title
    		 Mean change from baseline on the EORTC QLQ-MY20 - Side Effects
    End point description
    Mean change from baseline on the EORTC QLQ-MY20 The EORTC has developed a myeloma module referred to as QLQ- MY20, to be administered alongside the core QLQ-C30. The QLQ-MY20 is a 20-item myeloma module intended for use among patients varying in disease stage and treatment modality. The QLQ-C30 employs a week recall period for all items and a 4-point scale for the functional and symptom scales/items with response categories “Not at all”, “A little”, “Quite a bit” and “Very much”. The two items assessing global health status/ HRQoL utilize a 7-point scale ranging from 1(“Very Poor”) to 7 (“Excellent”)
    End point type
    Secondary
    End point timeframe
    At Day 1 and at specific time points up to month 24
    End point values
    		 BB2121
    Number of subjects analysed
    126
    Units: Score on a Scale
    arithmetic mean (standard deviation)
        Day 1
    2.5 ( 9.51 )
        Month 1
    0.0 ( 11.95 )
        Month 3
    -2.6 ( 11.45 )
        Month 6
    -4.7 ( 10.16 )
        Month 9
    -6.5 ( 10.28 )
        Month 12
    -4.0 ( 11.87 )
        Month 18
    -3.4 ( 9.96 )
        Month 24
    -3.2 ( 7.98 )
    No statistical analyses for this end point

    Secondary: Mean change from baseline on the EQ-5D-5L Index

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    End point title
    		 Mean change from baseline on the EQ-5D-5L Index
    End point description
    Mean change from baseline on the EQ-5D-5L Index EQ-5D is a standardized measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. The descriptive system comprises dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels (no problems, slight problems, moderate problems, severe problems, extreme problems). The lower the score the the better.
    End point type
    Secondary
    End point timeframe
    At Day 1 and at specific time points up to month 24
    End point values
    		 BB2121
    Number of subjects analysed
    126
    Units: Score on a Scale
    arithmetic mean (standard deviation)
        Day 1
    0.0314 ( 0.1760 )
        Month 1
    0.0528 ( 0.2473 )
        Month 3
    0.0998 ( 0.1956 )
        Month 6
    0.0974 ( 0.1798 )
        Month 9
    0.1067 ( 0.2334 )
        Month 12
    0.1097 ( 0.2287 )
        Month 18
    0.1101 ( 0.2027 )
        Month 24
    0.0383 ( 0.1604 )
    No statistical analyses for this end point

    Secondary: Mean change from baseline on the EORTC QLQ-C30 - Fatigue.

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    End point title
    		 Mean change from baseline on the EORTC QLQ-C30 - Fatigue.
    End point description
    Mean change from baseline on the EORTC QLQ-C30 The QLQ-C30 employs a week recall period for all items and a 4-point scale for the functional and symptom scales/items with response categories “Not at all”, “A little”, “Quite a bit” and “Very much”. The two items assessing global health status/ HRQoL utilize a 7-point scale ranging from 1(“Very Poor”) to 7 (“Excellent”)
    End point type
    Secondary
    End point timeframe
    At Day 1 and at specific time points up to month 24
    End point values
    		 BB2121
    Number of subjects analysed
    126
    Units: Score on a Scale
    arithmetic mean (standard deviation)
        Day 1
    4.4 ( 18.56 )
        Month 1
    1.1 ( 24.38 )
        Month 3
    -10.1 ( 24.32 )
        Month 6
    -15.1 ( 24.39 )
        Month 9
    -21.5 ( 24.58 )
        Month 12
    -16.4 ( 25.02 )
        Month 18
    -18.4 ( 19.10 )
        Month 24
    -7.9 ( 15.97 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From screening to the end of follow up (approximately 5 years and 2 months)
    Adverse event reporting additional description
    The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    BB2121
    Reporting group description
    		 BB2121

    Serious adverse events
    		 BB2121
    Total subjects affected by serious adverse events
         subjects affected / exposed
    108 / 137 (78.83%)
         number of deaths (all causes)
    82
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Squamous cell carcinoma
         subjects affected / exposed
    2 / 137 (1.46%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Plasmablastic lymphoma
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Plasma cell leukaemia
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Anal cancer
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Basal cell carcinoma
         subjects affected / exposed
    5 / 137 (3.65%)
         occurrences causally related to treatment / all
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    Lung adenocarcinoma
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    Myelodysplastic syndrome
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    Pelvic venous thrombosis
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypotension
         subjects affected / exposed
    2 / 137 (1.46%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Distributive shock
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    2 / 137 (1.46%)
         occurrences causally related to treatment / all
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    Chills
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Fatigue
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    30 / 137 (21.90%)
         occurrences causally related to treatment / all
    0 / 33
         deaths causally related to treatment / all
    0 / 28
    Localised oedema
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Mucosal inflammation
         subjects affected / exposed
    2 / 137 (1.46%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Pain
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Pyrexia
         subjects affected / exposed
    8 / 137 (5.84%)
         occurrences causally related to treatment / all
    2 / 11
         deaths causally related to treatment / all
    0 / 0
    Immune system disorders
    Acute graft versus host disease
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Haemophagocytic lymphohistiocytosis
         subjects affected / exposed
    2 / 137 (1.46%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Cytokine release syndrome
         subjects affected / exposed
    22 / 137 (16.06%)
         occurrences causally related to treatment / all
    27 / 27
         deaths causally related to treatment / all
    1 / 1
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Upper airway obstruction
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumothorax
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonitis
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Lung disorder
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypoxia
         subjects affected / exposed
    2 / 137 (1.46%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Dyspnoea
         subjects affected / exposed
    4 / 137 (2.92%)
         occurrences causally related to treatment / all
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    4 / 137 (2.92%)
         occurrences causally related to treatment / all
    4 / 5
         deaths causally related to treatment / all
    0 / 0
    Mood altered
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Mental status changes
         subjects affected / exposed
    3 / 137 (2.19%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    Hallucination
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Disorientation
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Delirium
         subjects affected / exposed
    3 / 137 (2.19%)
         occurrences causally related to treatment / all
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    Blood alkaline phosphatase increased
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    Blood bilirubin increased
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    Blood creatinine increased
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    C-reactive protein increased
         subjects affected / exposed
    3 / 137 (2.19%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    Coronavirus test positive
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Compression fracture
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hyphaema
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Stress fracture
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    Toxicity to various agents
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Vascular access complication
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    2 / 137 (1.46%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Coronary artery disease
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    3 / 137 (2.19%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Pericarditis
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Tachycardia
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    2 / 137 (1.46%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Spinal cord compression
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Seizure
         subjects affected / exposed
    2 / 137 (1.46%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Paraesthesia
         subjects affected / exposed
    2 / 137 (1.46%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Migraine
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolic encephalopathy
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Lethargy
         subjects affected / exposed
    2 / 137 (1.46%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    Hypotonia
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Hemiparesis
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Headache
         subjects affected / exposed
    2 / 137 (1.46%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Encephalopathy
         subjects affected / exposed
    4 / 137 (2.92%)
         occurrences causally related to treatment / all
    5 / 6
         deaths causally related to treatment / all
    0 / 0
    Dysarthria
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Cognitive disorder
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Cerebral haemorrhage
         subjects affected / exposed
    2 / 137 (1.46%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 1
    Cerebral haematoma
         subjects affected / exposed
    2 / 137 (1.46%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 1
    Cauda equina syndrome
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ataxia
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Aphasia
         subjects affected / exposed
    2 / 137 (1.46%)
         occurrences causally related to treatment / all
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    Amnesia
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Disseminated intravascular coagulation
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Anaemia
         subjects affected / exposed
    2 / 137 (1.46%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Hyperviscosity syndrome
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    12 / 137 (8.76%)
         occurrences causally related to treatment / all
    5 / 16
         deaths causally related to treatment / all
    0 / 0
    Thrombotic microangiopathy
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    9 / 137 (6.57%)
         occurrences causally related to treatment / all
    7 / 9
         deaths causally related to treatment / all
    0 / 0
    Pancytopenia
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Neutropenia
         subjects affected / exposed
    6 / 137 (4.38%)
         occurrences causally related to treatment / all
    8 / 9
         deaths causally related to treatment / all
    0 / 0
    Eye disorders
    Diplopia
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Diarrhoea
         subjects affected / exposed
    2 / 137 (1.46%)
         occurrences causally related to treatment / all
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    2 / 137 (1.46%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    1 / 1
    Melaena
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Urticaria
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Rash
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Chronic kidney disease
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Acute kidney injury
         subjects affected / exposed
    5 / 137 (3.65%)
         occurrences causally related to treatment / all
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 137 (1.46%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Back pain
         subjects affected / exposed
    3 / 137 (2.19%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Bone pain
         subjects affected / exposed
    3 / 137 (2.19%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Muscular weakness
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pain in extremity
         subjects affected / exposed
    2 / 137 (1.46%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Pathological fracture
         subjects affected / exposed
    2 / 137 (1.46%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Spinal pain
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Acute sinusitis
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Sepsis
         subjects affected / exposed
    7 / 137 (5.11%)
         occurrences causally related to treatment / all
    0 / 8
         deaths causally related to treatment / all
    0 / 1
    Bacteraemia
         subjects affected / exposed
    2 / 137 (1.46%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Bronchopulmonary aspergillosis
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    1 / 1
    Clostridium difficile colitis
         subjects affected / exposed
    2 / 137 (1.46%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Coronavirus infection
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Device related bacteraemia
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Device related infection
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Enterococcal bacteraemia
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Erysipelas
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Escherichia bacteraemia
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastroenteritis salmonella
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Haemophilus infection
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatitis E
         subjects affected / exposed
    2 / 137 (1.46%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Herpes zoster
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypopyon
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infection
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Influenza
         subjects affected / exposed
    5 / 137 (3.65%)
         occurrences causally related to treatment / all
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    Listeriosis
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lower respiratory tract infection viral
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    15 / 137 (10.95%)
         occurrences causally related to treatment / all
    4 / 19
         deaths causally related to treatment / all
    0 / 2
    Pneumonia aspiration
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia cytomegaloviral
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    1 / 1
    Pneumonia pneumococcal
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia pseudomonal
         subjects affected / exposed
    3 / 137 (2.19%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Rhinovirus infection
         subjects affected / exposed
    2 / 137 (1.46%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    3 / 137 (2.19%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    Arthritis infective
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Septic shock
         subjects affected / exposed
    2 / 137 (1.46%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    Serratia bacteraemia
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Typhoid fever
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Acidosis
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Adult failure to thrive
         subjects affected / exposed
    2 / 137 (1.46%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Diabetic ketoacidosis
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolic acidosis
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Tumour lysis syndrome
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 BB2121
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    137 / 137 (100.00%)
    Vascular disorders
    Hypotension
         subjects affected / exposed
    24 / 137 (17.52%)
         occurrences all number
    35
    Hypertension
         subjects affected / exposed
    19 / 137 (13.87%)
         occurrences all number
    44
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    22 / 137 (16.06%)
         occurrences all number
    32
    Chills
         subjects affected / exposed
    20 / 137 (14.60%)
         occurrences all number
    22
    Fatigue
         subjects affected / exposed
    53 / 137 (38.69%)
         occurrences all number
    91
    Malaise
         subjects affected / exposed
    7 / 137 (5.11%)
         occurrences all number
    9
    Oedema peripheral
         subjects affected / exposed
    27 / 137 (19.71%)
         occurrences all number
    39
    Pain
         subjects affected / exposed
    9 / 137 (6.57%)
         occurrences all number
    9
    Pyrexia
         subjects affected / exposed
    36 / 137 (26.28%)
         occurrences all number
    77
    Immune system disorders
    Cytokine release syndrome
         subjects affected / exposed
    110 / 137 (80.29%)
         occurrences all number
    170
    Hypogammaglobulinaemia
         subjects affected / exposed
    32 / 137 (23.36%)
         occurrences all number
    36
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    34 / 137 (24.82%)
         occurrences all number
    47
    Dyspnoea
         subjects affected / exposed
    14 / 137 (10.22%)
         occurrences all number
    20
    Dyspnoea exertional
         subjects affected / exposed
    8 / 137 (5.84%)
         occurrences all number
    10
    Epistaxis
         subjects affected / exposed
    11 / 137 (8.03%)
         occurrences all number
    12
    Nasal congestion
         subjects affected / exposed
    11 / 137 (8.03%)
         occurrences all number
    11
    Oropharyngeal pain
         subjects affected / exposed
    13 / 137 (9.49%)
         occurrences all number
    14
    Pleural effusion
         subjects affected / exposed
    8 / 137 (5.84%)
         occurrences all number
    10
    Rhinorrhoea
         subjects affected / exposed
    7 / 137 (5.11%)
         occurrences all number
    7
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    19 / 137 (13.87%)
         occurrences all number
    27
    Confusional state
         subjects affected / exposed
    16 / 137 (11.68%)
         occurrences all number
    20
    Insomnia
         subjects affected / exposed
    14 / 137 (10.22%)
         occurrences all number
    15
    Investigations
    Activated partial thromboplastin time prolonged
         subjects affected / exposed
    7 / 137 (5.11%)
         occurrences all number
    14
    Alanine aminotransferase increased
         subjects affected / exposed
    22 / 137 (16.06%)
         occurrences all number
    33
    Aspartate aminotransferase increased
         subjects affected / exposed
    26 / 137 (18.98%)
         occurrences all number
    40
    Blood alkaline phosphatase increased
         subjects affected / exposed
    18 / 137 (13.14%)
         occurrences all number
    36
    Blood creatinine increased
         subjects affected / exposed
    8 / 137 (5.84%)
         occurrences all number
    14
    C-reactive protein increased
         subjects affected / exposed
    15 / 137 (10.95%)
         occurrences all number
    29
    International normalised ratio increased
         subjects affected / exposed
    7 / 137 (5.11%)
         occurrences all number
    9
    Weight decreased
         subjects affected / exposed
    19 / 137 (13.87%)
         occurrences all number
    38
    Weight increased
         subjects affected / exposed
    8 / 137 (5.84%)
         occurrences all number
    16
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    9 / 137 (6.57%)
         occurrences all number
    9
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    22 / 137 (16.06%)
         occurrences all number
    44
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    23 / 137 (16.79%)
         occurrences all number
    27
    Headache
         subjects affected / exposed
    47 / 137 (34.31%)
         occurrences all number
    68
    Somnolence
         subjects affected / exposed
    10 / 137 (7.30%)
         occurrences all number
    11
    Tremor
         subjects affected / exposed
    12 / 137 (8.76%)
         occurrences all number
    14
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    104 / 137 (75.91%)
         occurrences all number
    706
    Leukopenia
         subjects affected / exposed
    70 / 137 (51.09%)
         occurrences all number
    531
    Lymphopenia
         subjects affected / exposed
    49 / 137 (35.77%)
         occurrences all number
    284
    Neutropenia
         subjects affected / exposed
    130 / 137 (94.89%)
         occurrences all number
    1018
    Thrombocytopenia
         subjects affected / exposed
    95 / 137 (69.34%)
         occurrences all number
    719
    Febrile neutropenia
         subjects affected / exposed
    19 / 137 (13.87%)
         occurrences all number
    24
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    45 / 137 (32.85%)
         occurrences all number
    63
    Diarrhoea
         subjects affected / exposed
    61 / 137 (44.53%)
         occurrences all number
    81
    Dry mouth
         subjects affected / exposed
    10 / 137 (7.30%)
         occurrences all number
    11
    Dyspepsia
         subjects affected / exposed
    12 / 137 (8.76%)
         occurrences all number
    15
    Nausea
         subjects affected / exposed
    85 / 137 (62.04%)
         occurrences all number
    123
    Vomiting
         subjects affected / exposed
    34 / 137 (24.82%)
         occurrences all number
    43
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    11 / 137 (8.03%)
         occurrences all number
    11
    Pruritus
         subjects affected / exposed
    9 / 137 (6.57%)
         occurrences all number
    9
    Rash
         subjects affected / exposed
    12 / 137 (8.76%)
         occurrences all number
    21
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    11 / 137 (8.03%)
         occurrences all number
    12
    Pollakiuria
         subjects affected / exposed
    7 / 137 (5.11%)
         occurrences all number
    9
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    32 / 137 (23.36%)
         occurrences all number
    48
    Back pain
         subjects affected / exposed
    29 / 137 (21.17%)
         occurrences all number
    36
    Bone pain
         subjects affected / exposed
    18 / 137 (13.14%)
         occurrences all number
    23
    Muscle spasms
         subjects affected / exposed
    9 / 137 (6.57%)
         occurrences all number
    13
    Musculoskeletal chest pain
         subjects affected / exposed
    11 / 137 (8.03%)
         occurrences all number
    26
    Myalgia
         subjects affected / exposed
    8 / 137 (5.84%)
         occurrences all number
    10
    Pain in extremity
         subjects affected / exposed
    12 / 137 (8.76%)
         occurrences all number
    15
    Infections and infestations
    Influenza
         subjects affected / exposed
    9 / 137 (6.57%)
         occurrences all number
    11
    Candida infection
         subjects affected / exposed
    8 / 137 (5.84%)
         occurrences all number
    9
    Nasopharyngitis
         subjects affected / exposed
    10 / 137 (7.30%)
         occurrences all number
    12
    Pneumonia
         subjects affected / exposed
    9 / 137 (6.57%)
         occurrences all number
    9
    Respiratory tract infection
         subjects affected / exposed
    8 / 137 (5.84%)
         occurrences all number
    10
    Sinusitis
         subjects affected / exposed
    7 / 137 (5.11%)
         occurrences all number
    9
    Upper respiratory tract infection
         subjects affected / exposed
    21 / 137 (15.33%)
         occurrences all number
    37
    Urinary tract infection
         subjects affected / exposed
    8 / 137 (5.84%)
         occurrences all number
    8
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    41 / 137 (29.93%)
         occurrences all number
    58
    Hypercalcaemia
         subjects affected / exposed
    12 / 137 (8.76%)
         occurrences all number
    19
    Hyperglycaemia
         subjects affected / exposed
    15 / 137 (10.95%)
         occurrences all number
    49
    Hyperkalaemia
         subjects affected / exposed
    7 / 137 (5.11%)
         occurrences all number
    7
    Hyperuricaemia
         subjects affected / exposed
    13 / 137 (9.49%)
         occurrences all number
    16
    Hypoalbuminaemia
         subjects affected / exposed
    26 / 137 (18.98%)
         occurrences all number
    60
    Hypocalcaemia
         subjects affected / exposed
    37 / 137 (27.01%)
         occurrences all number
    118
    Hypokalaemia
         subjects affected / exposed
    56 / 137 (40.88%)
         occurrences all number
    93
    Hypomagnesaemia
         subjects affected / exposed
    35 / 137 (25.55%)
         occurrences all number
    59
    Hyponatraemia
         subjects affected / exposed
    30 / 137 (21.90%)
         occurrences all number
    72
    Hypophosphataemia
         subjects affected / exposed
    46 / 137 (33.58%)
         occurrences all number
    106

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Jun 2019
    • Moved minimal residual disease (MRD) assessment by EuroFlow to Exploratory Objectives and Exploratory Endpoints. Updated the term “vector copy number” (VCN). • Separated the secondary objective of characterization of the expansion of CAR+ T cells in the peripheral blood and bone marrow into two objectives. Evaluation of CAR+ T cells in the peripheral blood will remain as a secondary objective while evaluation in the bone marrow will be an exploratory objective. Evaluation in the bone marrow was also added as an exploratory endpoint. • Removed the secondary objective and secondary endpoint, “Evaluate cytokine induction in the blood of subjects after infusion of bb2121”, and removed cytokines as a key safety assessment. • Moved the secondary objective and secondary endpoint, “Evaluate the percentage of B-cell maturation antigen (BCMA)-expressing (BCMA+) cells and levels of BCMA expression in bone marrow, and the level of circulating soluble BCMA” to exploratory objectives and exploratory endpoints. • Clarified the definition of “cellular kinetics”.

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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