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    Clinical Trial Results:
    A global randomized multicenter Phase 3 trial to compare the efficacy and safety of JCAR017 to standard of care in adult subjects with high-risk, transplant-eligible relapsed or refractory aggressive B-cell non-Hodgkin lymphomas (TRANSFORM).

    Summary
    EudraCT number
    		 2018-000929-32
    Trial protocol
    		 FR   BE   ES   GB   SE   NL   IT  
    Global end of trial date
    23 Oct 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Nov 2024
    First version publication date
    08 Nov 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    JCAR017-BCM-003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bristol-Myers Squibb
    Sponsor organisation address
    Chaussee de la Hulpe 185, Brussels, Belgium, 1170
    Public contact
    EU Study Start-Up Unit, Bristol-Myers Squibb International Corporation, Clinical.Trials@bms.com
    Scientific contact
    Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, Clinical.Trials@bms.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    13 Dec 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Oct 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    compare the efficacy in subjects treated with JCAR017 versus subjects treated according to standard of care (SOC) defined as event-free survival (EFS)
    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
    23 Oct 2018
    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
    United States: 115
    Country: Number of subjects enrolled
    France: 14
    Country: Number of subjects enrolled
    Germany: 12
    Country: Number of subjects enrolled
    Japan: 9
    Country: Number of subjects enrolled
    Spain: 8
    Country: Number of subjects enrolled
    Netherlands: 6
    Country: Number of subjects enrolled
    Sweden: 6
    Country: Number of subjects enrolled
    United Kingdom: 6
    Country: Number of subjects enrolled
    Switzerland: 4
    Country: Number of subjects enrolled
    Belgium: 2
    Country: Number of subjects enrolled
    Italy: 2
    Worldwide total number of subjects
    184
    EEA total number of subjects
    50
    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)
    123
    From 65 to 84 years
    61
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 184 subjects randomized

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Standard of Care Arm
    Arm description
    		 3 cycles of standard of care (SOC) salvage therapy (rituximab, dexamethasone, cytarabine and cisplatin [R-DHAP], rituximab, ifosfamide, carboplatin and etoposide [R-ICE], rituximab, gemcitabine, dexamethasone, and cisplatin [R-GDP]) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Etoposide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Etoposide 200 mg/m² - Days 2 to 5

    Investigational medicinal product name
    Rituximab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    375 mg/m² - Day 1

    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
    Dexamethasone 40 mg – Days 1 to 4

    Investigational medicinal product name
    Cytarabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Cytarabine 2 x 2000 mg/m² - Day 2

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Cisplatin 100 mg/m² - Day 1

    Investigational medicinal product name
    Ifosfamide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Ifosfamide 5000 mg/m² - Day 2

    Investigational medicinal product name
    Etoposide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Etoposide 100 mg/m² - Days 1 to 3

    Investigational medicinal product name
    Carboplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Carboplatin area under the curve (AUC) 5 (maximum dose 800 mg) – Day 2

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Gemcitabine 1000 mg/m² - Days 1 and 8

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Cisplatin 75 mg/m² - Day 1

    Investigational medicinal product name
    Carmustine
    Investigational medicinal product code
    Other name
    BCNU
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Carmustine (BCNU) 300 mg/m² - Day 1

    Investigational medicinal product name
    Cytarabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Cytarabine 200 mg/m² - Days 2 to 5

    Investigational medicinal product name
    Melphalan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Melphalan 140 mg/m² - Day 6

    Arm title
    		 Liso-cel Arm
    Arm description
    		 [Lymphodepleting chemotherapy (LDC)] Fludarabine IV (30 mg/m^2/day for 3 days) and cyclophosphamide IV (300 mg/m^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)
    Arm type
    		 Experimental

    Investigational medicinal product name
    JCAR017
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    dose of 100 x 106 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29

    Investigational medicinal product name
    Cyclophosphamide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Cyclophosphamide IV (300 mg/m2/day for 3 days)

    Investigational medicinal product name
    Fludarabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Fludarabine IV (30 mg/m2/day for 3 days)

    Number of subjects in period 1
    		Standard of Care Arm Liso-cel Arm
    Started
    92
    92
    Treated
    91
    90
    Crossover
    61
    0 [1]
    JCAR017 conforming cell product
    57
    89
    JCAR017 nonconforming cell product
    1 [2]
    1 [3]
    Completed
    37
    81
    Not completed
    55
    11
         Adverse event, serious fatal
    2
    2
         Consent withdrawn by subject
    1
    1
         Physician decision
    3
    -
         other reasons
    5
    -
         Adverse event, non-fatal
    1
    -
         Study drug manufacturing failure
    -
    1
         Disease relapse
    15
    6
         Death due to the COVID-19 pandemic
    -
    1
         Lack of efficacy
    28
    -
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Number of subjects at this milestone only
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Number of subjects at this milestone only
    [3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Number of subjects at this milestone only

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Standard of Care Arm
    Reporting group description
    		 3 cycles of standard of care (SOC) salvage therapy (rituximab, dexamethasone, cytarabine and cisplatin [R-DHAP], rituximab, ifosfamide, carboplatin and etoposide [R-ICE], rituximab, gemcitabine, dexamethasone, and cisplatin [R-GDP]) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks

    Reporting group title
    Liso-cel Arm
    Reporting group description
    		 [Lymphodepleting chemotherapy (LDC)] Fludarabine IV (30 mg/m^2/day for 3 days) and cyclophosphamide IV (300 mg/m^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)

    Reporting group values
    		 Standard of Care Arm Liso-cel Arm Total
    Number of subjects
    		 92 92 184
    Age categorical
    Units:
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 54.2 ( 13.94 ) 58.3 ( 12.61 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 31 48 79
        Male
    		 61 44 105
    Race/Ethnicity, Customized
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 8 10 18
        Black or African American
    		 3 4 7
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        White
    		 55 54 109
        Not Collected or Reported
    		 25 22 47
        Other
    		 1 2 3
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 3 3 6
        Not Hispanic or Latino
    		 62 65 127
        Unknown or Not Reported
    		 27 24 51

    End points

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    End points reporting groups
    Reporting group title
    Standard of Care Arm
    Reporting group description
    		 3 cycles of standard of care (SOC) salvage therapy (rituximab, dexamethasone, cytarabine and cisplatin [R-DHAP], rituximab, ifosfamide, carboplatin and etoposide [R-ICE], rituximab, gemcitabine, dexamethasone, and cisplatin [R-GDP]) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks

    Reporting group title
    Liso-cel Arm
    Reporting group description
    		 [Lymphodepleting chemotherapy (LDC)] Fludarabine IV (30 mg/m^2/day for 3 days) and cyclophosphamide IV (300 mg/m^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)

    Primary: Event-free Survival (EFS) Per Independent Review Committee (IRC)

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    End point title
    		 Event-free Survival (EFS) Per Independent Review Committee (IRC) [1]
    End point description
    Time from randomization to death, progressive disease (PD), failure to achieve complete response (CR) or partial response (PR) by 9 weeks or start of new antineoplastic therapy, whichever occurs first. CR: Target nodes masses must regress to ≤ 1.5cm in LDi, no extralymphatic sites, no new lesions. PR: ≥ 50% decrease in sum of diameters of up to 6 target nodes and extranodal sites, no new lesions, spleen must have regressed > 50% in length. PD: LDi > 1.5cm, increase by ≥ 50% from PPD nadir, an increase in LDi or SDi from nadir, 0.5 cm for lesions ≤ 2cm, 1.0cm for lesions > 2cm. Complete metabolic response: Lymph nodes score 1, 2, 3 with/without residual mass on 5-point scale, no new lesions, no FDG-avid disease. Partial metabolic response: Lymph nodes score 4 or 5, reduced uptake from baseline, no new lesions, residual uptake higher than normal, reduced from baseline. Progressive metabolic disease: Score 4 or 5 with an increase in uptake intensity from baseline and/or new FDG-avid.
    End point type
    Primary
    End point timeframe
    From randomization to death from any cause, PD, failure to achieve CR or PR by 9 weeks post randomization, or start of new antineoplastic therapy due to efficacy concerns, whichever occurs first (Up to 36 months)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only summary statistics planned for this endpoint
    End point values
    		 Standard of Care Arm Liso-cel Arm
    Number of subjects analysed
    92
    92
    Units: Months
        median (confidence interval 95%)
    2.4 (2.2 to 4.9)
    29.5 (9.5 to 99999)
    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
    Progression-free survival is defined as the time from randomization to progressive disease (PD) or death from any cause, whichever occurs first. Estimates of time to event are from Kaplan-Meier product-limit estimates. PD: LDi > 1.5 cm, increase by ≥ 50% from PPD nadir, an increase in LDi or SDi from nadir, 0.5 cm for lesions ≤ 2 cm, 1.0 cm for lesions > 2 cm. Progressive metabolic disease: Score 4 or 5 with an increase in the intensity of uptake from baseline and/or new FDG-avid. 99999=NA
    End point type
    Secondary
    End point timeframe
    From randomization to progression, or death from any cause, whichever occurs first (Up to 36 months)
    End point values
    		 Standard of Care Arm Liso-cel Arm
    Number of subjects analysed
    92
    92
    Units: Months
        median (confidence interval 95%)
    6.2 (4.3 to 8.6)
    99999 (12.6 to 99999)
    No statistical analyses for this end point

    Secondary: Complete Response Rate (CRR)

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    End point title
    		 Complete Response Rate (CRR)
    End point description
    Complete response rate (CRR) is defined as the percentage of participants achieving a best overall response of complete response (CR). Participants with unknown or missing response will be counted as non-evaluable in the analysis. CR: Target nodes/nodal masses must regress to ≤ 1.5 cm in LDi, no extralymphatic sites, no new lesions. Complete metabolic response: Lymph nodes/extralymphatic sites score 1, 2, 3 with/without residual mass on 5-point scale, no new lesions, no FDG-avid disease.
    End point type
    Secondary
    End point timeframe
    From randomization up to 3 years post randomization (Up to 36 months)
    End point values
    		 Standard of Care Arm Liso-cel Arm
    Number of subjects analysed
    92
    92
    Units: Percentage of participants
        number (confidence interval 95%)
    43.5 (33.2 to 54.2)
    73.9 (63.7 to 82.5)
    No statistical analyses for this end point

    Secondary: Number of Participants with Complete Response (CR)

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    End point title
    		 Number of Participants with Complete Response (CR)
    End point description
    The number of participants achieving a best overall response of complete response (CR). Participants with unknown or missing response will be counted as non-evaluable in the analysis. CR: Target nodes/nodal masses must regress to ≤ 1.5 cm in LDi, no extralymphatic sites, no new lesions. Complete metabolic response: Lymph nodes/extralymphatic sites score 1, 2, 3 with/without residual mass on 5-point scale, no new lesions, no FDG-avid disease.
    End point type
    Secondary
    End point timeframe
    From randomization up to 3 years post randomization (Up to 36 months)
    End point values
    		 Standard of Care Arm Liso-cel Arm
    Number of subjects analysed
    92
    92
    Units: Participants
    40
    68
    No statistical analyses for this end point

    Secondary: Overall Survival (OS)

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    End point title
    		 Overall Survival (OS)
    End point description
    Overall Survival (OS) is defined as the time from randomization to death due to any cause. Estimates of time to event are from Kaplan-Meier product-limit estimates. 99999=NA
    End point type
    Secondary
    End point timeframe
    From randomization to time of death due to any cause (Up to 36 months)
    End point values
    		 Standard of Care Arm Liso-cel Arm
    Number of subjects analysed
    92
    92
    Units: Months
        median (confidence interval 95%)
    99999 (18.2 to 99999)
    99999 (42.8 to 99999)
    No statistical analyses for this end point

    Secondary: Overall Response Rate (ORR)

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    End point title
    		 Overall Response Rate (ORR)
    End point description
    ORR is defined as the percentage of participants achieving a best overall response of partial response (PR) or complete response (CR). CR: Target nodes masses must regress to ≤ 1.5cm in LDi, no extralymphatic sites, no new lesions. PR: ≥ 50% decrease in sum of diameters of up to 6 target nodes and extranodal sites, no new lesions, spleen must have regressed > 50% in length. Complete metabolic response: Lymph nodes score 1, 2, 3 with/without residual mass on 5-point scale, no new lesions, no FDG-avid disease. Partial metabolic response: Lymph nodes score 4 or 5, reduced uptake from baseline, no new lesions, residual uptake higher than normal, reduced from baseline.
    End point type
    Secondary
    End point timeframe
    From randomization to PR or CR (Up to 36 months)
    End point values
    		 Standard of Care Arm Liso-cel Arm
    Number of subjects analysed
    92
    92
    Units: Percentage of participants
        number (confidence interval 95%)
    48.9 (38.3 to 59.6)
    87.0 (78.3 to 93.1)
    No statistical analyses for this end point

    Secondary: Duration of Response (DoR) Per Independent Review Committee (IRC)

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    End point title
    		 Duration of Response (DoR) Per Independent Review Committee (IRC)
    End point description
    The time from first partial or complete response (CR or PR) to disease progression, start of new antineoplastic therapy due to efficacy concerns or death, whichever occurs first. CR: Target nodes masses must regress to ≤ 1.5cm in LDi, no extralymphatic sites, no new lesions. PR: ≥ 50% decrease in sum of diameters of up to 6 target nodes and extranodal sites, no new lesions, spleen must have regressed > 50% in length. PD: LDi > 1.5cm, increase by ≥ 50% from PPD nadir, an increase in LDi or SDi from nadir, 0.5 cm for lesions ≤ 2cm, 1.0cm for lesions > 2cm. Complete metabolic response: Lymph nodes score 1, 2, 3 with/without residual mass on 5-point scale, no new lesions, no FDG-avid disease. Partial metabolic response: Lymph nodes score 4 or 5, reduced uptake from baseline, no new lesions, residual uptake higher than normal, reduced from baseline. Progressive metabolic disease: Score 4 or 5 with an increase in uptake intensity from baseline and/or new FDG-avid. 99999=NA
    End point type
    Secondary
    End point timeframe
    From randomization to to disease progression, start of new antineoplastic therapy due to efficacy concerns or death, whichever occurs first (Up to 36 months)
    End point values
    		 Standard of Care Arm Liso-cel Arm
    Number of subjects analysed
    45
    80
    Units: Months
        median (confidence interval 95%)
    9.1 (5.1 to 999999)
    99999 (16.9 to 99999)
    No statistical analyses for this end point

    Secondary: Progression-free Survival on Next Line of Treatment (PFS-2)

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    End point title
    		 Progression-free Survival on Next Line of Treatment (PFS-2)
    End point description
    Progression-free Survival (PFS)-2 based on investigator's assessment is defined as time from randomization to second objective progressive disease (PD) or death from any cause, whichever occurs first. Estimates of time to event are from Kaplan-Meier product-limit estimates. PD: LDi > 1.5 cm, increase by ≥ 50% from PPD nadir, an increase in LDi or SDi from nadir, 0.5 cm for lesions ≤ 2 cm, 1.0 cm for lesions > 2 cm. Progressive metabolic disease: Score 4 or 5 with an increase in the intensity of uptake from baseline and/or new FDG-avid.
    End point type
    Secondary
    End point timeframe
    From randomization to second objective progression, or death from any cause, whichever occurs first (Up to 36 months)
    End point values
    		 Standard of Care Arm Liso-cel Arm
    Number of subjects analysed
    92
    92
    Units: Participants
        Number of patients who died
    15
    10
        Number of patients with first progression
    60
    40
        Number of patients with second progression
    8
    8
    No statistical analyses for this end point

    Secondary: Event-free Survival (EFS) Rate

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    End point title
    		 Event-free Survival (EFS) Rate
    End point description
    EFS rate is defined as the percentage of participants free of any EFS event at fixed timepoints. Complete response: Target nodes masses must regress to ≤ 1.5cm in LDi, no extralymphatic sites, no new lesions. Partial response: ≥ 50% decrease in sum of diameters of up to 6 target nodes and extranodal sites, no new lesions, spleen must have regressed > 50% in length. Progression: LDi > 1.5cm, increase by ≥ 50% from PPD nadir, an increase in LDi or SDi from nadir, 0.5 cm for lesions ≤ 2cm, 1.0cm for lesions > 2cm. Complete metabolic response: Lymph nodes score 1, 2, 3 with/without residual mass on 5-point scale, no new lesions, no FDG-avid disease. Partial metabolic response: Lymph nodes score 4 or 5, reduced uptake from baseline, no new lesions, residual uptake higher than normal, reduced from baseline. Metabolic progression: Score 4 or 5 with an increase in uptake intensity from baseline and/or new FDG-avid.
    End point type
    Secondary
    End point timeframe
    Months 6, 12, 18, 24, 36
    End point values
    		 Standard of Care Arm Liso-cel Arm
    Number of subjects analysed
    92
    92
    Units: Percentage of participants
    number (confidence interval 95%)
        EFS Rate at 6 months
    36.2 (26.3 to 46.1)
    68.1 (58.6 to 77.7)
        EFS Rate at 12 months
    22.6 (13.9 to 31.3)
    57.0 (46.8 to 67.2)
        EFS Rate at 18 months
    22.6 (13.9 to 31.3)
    52.6 (42.3 to 62.8)
        EFS Rate at 24 months
    21.5 (13.0 to 30.0)
    51.4 (41.1 to 61.7)
        EFS Rate at 36 months
    19.1 (11.0 to 27.3)
    45.8 (35.2 to 56.5)
    No statistical analyses for this end point

    Secondary: Overall Survival (OS) Rate

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    End point title
    		 Overall Survival (OS) Rate
    End point description
    Overall Survival (OS) rate is defined as the percentage of participants alive at fixed timepoints. OS is defined as the time from randomization to death due to any cause.
    End point type
    Secondary
    End point timeframe
    Months 6, 12, 18, 24, 36
    End point values
    		 Standard of Care Arm Liso-cel Arm
    Number of subjects analysed
    92
    92
    Units: Percentage of participants
    number (confidence interval 95%)
        OS Rate at 6 months
    88.9 (82.4 to 95.4)
    93.4 (88.4 to 98.5)
        OS Rate at 12 months
    72.0 (62.7 to 81.3)
    83.5 (75.8 to 91.1)
        OS Rate at 18 months
    61.7 (51.5 to 71.8)
    73.3 (64.2 to 82.5)
        OS Rate at 24 months
    58.2 (47.9 to 68.5)
    67.5 (57.8 to 77.2)
        OS Rate at 36 months
    51.8 (41.2 to 62.4)
    62.8 (52.7 to 72.9)
    No statistical analyses for this end point

    Secondary: Progression-free Survival (PFS) Rate

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    End point title
    		 Progression-free Survival (PFS) Rate
    End point description
    Progression-free Survival (PFS) rate is defined as the percentage of participants free of any PFS event at fixed timepoints. Progression-free survival is defined as the time from randomization to progressive disease (PD) or death from any cause, whichever occurs first. Estimates of time to event are from Kaplan-Meier product-limit estimates. PD: LDi > 1.5 cm, increase by ≥ 50% from PPD nadir, an increase in LDi or SDi from nadir, 0.5 cm for lesions ≤ 2 cm, 1.0 cm for lesions > 2 cm. Progressive metabolic disease: Score 4 or 5 with an increase in the intensity of uptake from baseline and/or new FDG-avid.
    End point type
    Secondary
    End point timeframe
    Months 6, 12, 18, 24, 36
    End point values
    		 Standard of Care Arm Liso-cel Arm
    Number of subjects analysed
    92
    92
    Units: Percentage of participants
    number (confidence interval 95%)
        PFS Rate at 6 months
    51.7 (40.2 to 63.1)
    73.7 (64.5 to 83.0)
        PFS Rate at 12 months
    31.3 (20.3 to 42.4)
    63.0 (52.8 to 73.2)
        PFS Rate at 18 months
    31.3 (20.3 to 42.4)
    58.2 (47.7 to 68.7)
        PFS Rate at 24 months
    29.7 (18.8 to 40.7)
    57.0 (46.4 to 67.5)
        PFS Rate at 36 months
    26.5 (15.9 to 37.1)
    50.9 (39.9 to 62.0)
    No statistical analyses for this end point

    Secondary: Number of Participants with Serious Treatment-Emergent Adverse Events (TEAEs)

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    End point title
    		 Number of Participants with Serious Treatment-Emergent Adverse Events (TEAEs)
    End point description
    A serious adverse event is defined as any adverse event occurring at any dose that results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or constitutes an important medical event. Treatment emergent adverse events are adverse events occurring or worsening on or after the date of randomization and within 90 days after last dose of chemotherapy (Arm A), or within 90 days after the infusion of JCAR017 (Arm B) or start of new antineoplastic therapy, whichever occurs first as well as those AEs made known to the investigator at any time thereafter that are suspected of being related to study treatment. Graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. 99999=NA
    End point type
    Secondary
    End point timeframe
    From randomization to 90 days after last dose or start of new antineoplastic therapy, whichever occurs first (Up to 39 months)
    End point values
    		 Standard of Care Arm Liso-cel Arm
    Number of subjects analysed
    91
    92
    Units: Participants
        Overall
    45
    43
        NHL: Diffuse Large B-cell Lymphoma (DLBCL)
    29
    23
        NIH: Follicular Lymphoma Grade 3B
    99999
    0
        NIH: HGBCL with DLBCL Histology
    9
    17
        NIH: PMLBCL
    4
    2
        NIH: T Cell/Histiocyte-Rich Large B-Cell Lymphoma
    3
    1
        DLBCL: DLBCL NOS de novo
    25
    20
        DLBCL: DLBCL from Transformed Indolent NHL
    4
    3
    No statistical analyses for this end point

    Secondary: Number of Participants with Treatment Emergent Adverse Events (TEAEs)

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    End point title
    		 Number of Participants with Treatment Emergent Adverse Events (TEAEs)
    End point description
    Treatment emergent adverse events are adverse events occurring or worsening on or after the date of randomization and within 90 days after last dose of chemotherapy (Arm A), or within 90 days after the infusion of JCAR017 (Arm B) or start of new antineoplastic therapy, whichever occurs first as well as those AEs made known to the investigator at any time thereafter that are suspected of being related to study treatment. Graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. 99999=NA
    End point type
    Secondary
    End point timeframe
    From randomization to 90 days after last dose or start of new antineoplastic therapy, whichever occurs first (Up to 39 months)
    End point values
    		 Standard of Care Arm Liso-cel Arm
    Number of subjects analysed
    91
    92
    Units: Participants
        Overall
    90
    92
        (NHL): Diffuse Large B-cell Lymphoma (DLBCL)
    57
    60
        NIH: Follicular Lymphoma Grade 3B
    99999
    1
        NIH: HGBCL with DLBCL Histology
    20
    22
        NIH: PMLBL
    9
    8
        NIH: T Cell/Histiocyte-Rich Large B-Cell Lymphoma
    4
    1
        DLBCL: DLBCL NOS de novo
    49
    53
        DLBCL: DLBCL from Transformed Indolent NHL
    8
    7
    No statistical analyses for this end point

    Secondary: Change from Baseline in Hematology Parameters 1: Hemoglobin

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    End point title
    		 Change from Baseline in Hematology Parameters 1: Hemoglobin
    End point description
    Change from baseline in hemoglobin. Baseline value will be defined as the last value on the randomization date (+3 days) or before the date/time of randomization (date if date/time not collected). 99999=NA
    End point type
    Secondary
    End point timeframe
    baseline, months 1, 2, 3, 4, 6, 9, 12, 18, 24, 36
    End point values
    		 Standard of Care Arm Liso-cel Arm
    Number of subjects analysed
    73
    84
    Units: g/L
    arithmetic mean (standard deviation)
        Hemoglobin Month 1
    -16.98 ( 13.408 )
    -14.94 ( 14.628 )
        Hemoglobin Month 2
    -25.00 ( 99999 )
    99999 ( 99999 )
        Hemoglobin Month 3
    -30.83 ( 19.013 )
    -15.78 ( 19.410 )
        Hemoglobin Month 4
    -22.00 ( 99999 )
    99999 ( 99999 )
        Hemoglobin Month 6
    -6.80 ( 14.935 )
    -3.16 ( 19.755 )
        Hemoglobin Month 9
    0.36 ( 19.242 )
    -0.52 ( 15.632 )
        Hemoglobin Month 12
    6.17 ( 14.598 )
    3.32 ( 15.417 )
        Hemoglobin Month 18
    11.37 ( 14.592 )
    7.38 ( 12.854 )
        Hemoglobin Month 24
    13.88 ( 18.996 )
    7.38 ( 16.986 )
        Hemoglobin Month 36
    14.41 ( 16.978 )
    13.63 ( 12.417 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Selected Hematology Parameters 2

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    End point title
    		 Change from Baseline in Selected Hematology Parameters 2
    End point description
    Change from baseline in selected hematology parameters such as leukocytes, lymphocytes, neutrophils, and platelets. Baseline value will be defined as the last value on the randomization date (+3 days) or before the date/time of randomization (date if date/time not collected). 99999=NA
    End point type
    Secondary
    End point timeframe
    baseline, months 1, 2, 3, 4, 6, 9, 12, 18, 24, 36
    End point values
    		 Standard of Care Arm Liso-cel Arm
    Number of subjects analysed
    73
    84
    Units: 10^9/L
    arithmetic mean (standard deviation)
        Month 1 leukocytes
    0.815 ( 6.9413 )
    -3.219 ( 2.4688 )
        Month 2 leukocytes
    -0.870 ( 99999 )
    99999 ( 99999 )
        Month 3 leukocytes
    -3.445 ( 5.8845 )
    -2.234 ( 2.3520 )
        Month 4 leukocytes
    -1.180 ( 99999 )
    99999 ( 99999 )
        Month 6 leukocytes
    -1.699 ( 1.9099 )
    -1.853 ( 2.5876 )
        Month 9 leukocytes
    -0.710 ( 3.0670 )
    -1.156 ( 3.3604 )
        Month 12 leukocytes
    -0.427 ( 1.4093 )
    -1.138 ( 2.3772 )
        Month 18 leukocytes
    -0.598 ( 1.6136 )
    -1.088 ( 2.8028 )
        Month 24 leukocytes
    0.694 ( 3.0465 )
    -0.806 ( 2.5709 )
        Month 36 leukocytes
    0.761 ( 2.3637 )
    -0.970 ( 3.0158 )
        Month 1 lymphocytes
    -0.2824 ( 0.43519 )
    -0.7380 ( 0.43499 )
        Month 2 lymphocytes
    -0.2100 ( 99999 )
    99999 ( 99999 )
        Month 3 lymphocytes
    -0.4216 ( 0.55872 )
    -0.1318 ( 0.43385 )
        Month 4 lymphocytes
    -0.1700 ( 99999 )
    99999 ( 99999 )
        Month 6 lymphocytes
    0.1343 ( 0.38219 )
    -0.0845 ( 0.48047 )
        Month 9 lymphocytes
    0.3264 ( 0.66121 )
    -0.0442 ( 0.39684 )
        Month 12 lymphocytes
    0.5089 ( 0.71831 )
    0.0097 ( 0.37252 )
        Month 18 lymphocytes
    0.6942 ( 0.98993 )
    0.2283 ( 0.55421 )
        Month 24 lymphocytes
    0.8688 ( 1.12695 )
    0.3298 ( 0.51386 )
        Month 36 lymphocytes
    1.2253 ( 1.20268 )
    0.3550 ( 0.55387 )
        Month 1 neutrophils
    1.368 ( 6.5393 )
    -2.065 ( 2.3479 )
        Month 2 neutrophils
    -0.590 ( 99999 )
    99999 ( 99999 )
        Month 3 neutrophils
    -0.621 ( 6.8377 )
    -1.909 ( 2.1727 )
        Month 4 neutrophils
    -1.160 ( 99999 )
    99999 ( 99999 )
        Month 6 neutrophils
    -1.648 ( 1.7635 )
    -1.584 ( 2.4539 )
        Month 9 neutrophils
    -0.879 ( 2.9777 )
    -1.001 ( 3.1318 )
        Month 12 neutrophils
    -0.822 ( 1.5780 )
    -1.035 ( 2.2898 )
        Month 18 neutrophils
    -1.167 ( 1.3772 )
    -1.189 ( 2.6342 )
        Month 24 neutrophils
    -0.124 ( 2.5434 )
    -0.998 ( 2.5506 )
        Month 36 neutrophils
    -0.404 ( 1.8392 )
    -0.998 ( 2.5222 )
        Month 1 platelets
    13.9 ( 140.94 )
    29.4 ( 115.53 )
        Month 2 platelets
    13.0 ( 99999 )
    99999 ( 99999 )
        Month 3 platelets
    -189.5 ( 132.93 )
    -65.7 ( 100.52 )
        Month 4 platelets
    -74.0 ( 99999 )
    99999 ( 99999 )
        Month 6 platelets
    -45.5 ( 94.13 )
    -48.2 ( 89.04 )
        Month 9 platelets
    -57.0 ( 110.48 )
    -48.9 ( 89.29 )
        Month 12 platelets
    -66.5 ( 85.82 )
    -42.4 ( 92.65 )
        Month 18 platelets
    -68.0 ( 84.69 )
    -32.6 ( 81.68 )
        Month 24 platelets
    -29.4 ( 103.87 )
    -28.7 ( 79.70 )
        Month 36 platelets
    -45.2 ( 123.28 )
    -10.5 ( 72.79 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Selected Chemistry Parameters 1

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    End point title
    		 Change from Baseline in Selected Chemistry Parameters 1
    End point description
    Change from baseline in selected chemistry parameters such as alanine aminotransferase, aspartate aminotransferase, and lactate dehydrogenase. Baseline value will be defined as the last value on the randomization date (+3 days) or before the date/time of randomization (date if date/time not collected). 99999=NA
    End point type
    Secondary
    End point timeframe
    baseline, months 1, 2, 3, 4, 6, 9, 12, 18, 24, 36
    End point values
    		 Standard of Care Arm Liso-cel Arm
    Number of subjects analysed
    76
    88
    Units: U/L
    arithmetic mean (standard deviation)
        Month 1 Alanine Aminotransferase
    17.22 ( 25.997 )
    -0.52 ( 18.337 )
        Month 2 Alanine Aminotransferase
    4.00 ( 99999 )
    99999 ( 99999 )
        Month 3 Alanine Aminotransferase
    -3.40 ( 22.295 )
    2.53 ( 13.246 )
        Month 4 Alanine Aminotransferase
    -3.00 ( 99999 )
    99999 ( 99999 )
        Month 6 Alanine Aminotransferase
    2.81 ( 21.067 )
    3.08 ( 14.813 )
        Month 9 Alanine Aminotransferase
    2.43 ( 20.165 )
    5.23 ( 16.660 )
        Month 12 Alanine Aminotransferase
    0.72 ( 23.542 )
    4.19 ( 19.653 )
        Month 18 Alanine Aminotransferase
    10.40 ( 15.892 )
    -0.45 ( 10.943 )
        Month 24 Alanine Aminotransferase
    7.69 ( 15.134 )
    1.88 ( 13.211 )
        Month 36 Alanine Aminotransferase
    12.41 ( 17.429 )
    13.98 ( 104.054 )
        Month 1 Aspartate Aminotransferase
    3.38 ( 16.624 )
    2.03 ( 17.526 )
        Month 2 Aspartate Aminotransferase
    5.00 ( 99999 )
    99999 ( 99999 )
        Month 3 Aspartate Aminotransferase
    -6.47 ( 17.248 )
    -1.24 ( 8.800 )
        Month 4 Aspartate Aminotransferase
    3.00 ( 99999 )
    99999 ( 99999 )
        Month 6 Aspartate Aminotransferase
    1.23 ( 15.911 )
    1.78 ( 8.550 )
        Month 9 Aspartate Aminotransferase
    3.68 ( 12.549 )
    2.12 ( 10.355 )
        Month 12 Aspartate Aminotransferase
    -1.44 ( 16.180 )
    1.88 ( 13.200 )
        Month 18 Aspartate Aminotransferase
    4.90 ( 7.663 )
    -1.22 ( 7.452 )
        Month 24 Aspartate Aminotransferase
    4.63 ( 9.172 )
    0.90 ( 10.757 )
        Month 36 Aspartate Aminotransferase
    9.06 ( 15.117 )
    14.95 ( 94.651 )
        Month 1 Lactate Dehydrogenase
    -66.7 ( 222.79 )
    -14.0 ( 203.18 )
        Month 2 Lactate Dehydrogenase
    27.0 ( 99999 )
    99999 ( 99999 )
        Month 3 Lactate Dehydrogenase
    -57.2 ( 377.22 )
    -84.1 ( 183.29 )
        Month 4 Lactate Dehydrogenase
    117.0 ( 99999 )
    99999 ( 99999 )
        Month 6 Lactate Dehydrogenase
    -85.5 ( 310.71 )
    -53.7 ( 183.53 )
        Month 9 Lactate Dehydrogenase
    -85.0 ( 362.52 )
    -62.0 ( 186.25 )
        Month 12 Lactate Dehydrogenase
    -52.9 ( 74.56 )
    -41.9 ( 207.30 )
        Month 18 Lactate Dehydrogenase
    -44.1 ( 71.19 )
    -50.8 ( 133.31 )
        Month 24 Lactate Dehydrogenase
    -45.6 ( 75.04 )
    -63.3 ( 148.25 )
        Month 36 Lactate Dehydrogenase
    -46.0 ( 85.14 )
    -59.9 ( 124.62 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Selected Chemistry Parameters 2

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    End point title
    		 Change from Baseline in Selected Chemistry Parameters 2
    End point description
    Change from baseline in selected chemistry parameters such as magnesium, phosphate, potassium, and sodium. Baseline value will be defined as the last value on the randomization date (+3 days) or before the date/time of randomization (date if date/time not collected). 99999=NA
    End point type
    Secondary
    End point timeframe
    baseline, months 1, 2, 3, 4, 6, 9, 12, 18, 24, 36
    End point values
    		 Standard of Care Arm Liso-cel Arm
    Number of subjects analysed
    76
    88
    Units: mmol/L
    arithmetic mean (standard deviation)
        Month 1 magnesium
    -0.023 ( 0.1145 )
    0.009 ( 0.0933 )
        Month 2 magnesium
    -0.080 ( 99999 )
    99999 ( 99999 )
        Month 3 magnesium
    -0.063 ( 0.1210 )
    0.007 ( 0.1010 )
        Month 4 magnesium
    -0.200 ( 99999 )
    99999 ( 99999 )
        Month 6 magnesium
    -0.041 ( 0.1452 )
    0.015 ( 0.1090 )
        Month 9 magnesium
    -0.027 ( 0.1459 )
    0.025 ( 0.1079 )
        Month 12 magnesium
    0.012 ( 0.1047 )
    0.031 ( 0.1054 )
        Month 18 magnesium
    0.033 ( 0.0639 )
    0.032 ( 0.1065 )
        Month 24 magnesium
    0.040 ( 0.1145 )
    0.015 ( 0.1027 )
        Month 36 magnesium
    0.039 ( 0.0920 )
    0.011 ( 0.0751 )
        Month 1 phosphate
    -0.061 ( 0.2643 )
    -0.038 ( 0.2498 )
        Month 2 phosphate
    0.030 ( 99999 )
    99999 ( 99999 )
        Month 3 phosphate
    -0.128 ( 0.3299 )
    0.039 ( 0.2316 )
        Month 4 phosphate
    0.130 ( 99999 )
    99999 ( 99999 )
        Month 6 phosphate
    0.140 ( 0.2166 )
    -0.020 ( 0.2276 )
        Month 9 phosphate
    0.025 ( 0.2020 )
    -0.028 ( 0.2098 )
        Month 12 phosphate
    -0.021 ( 0.1578 )
    -0.090 ( 0.2051 )
        Month 18 phosphate
    -0.025 ( 0.2666 )
    -0.059 ( 0.2224 )
        Month 24 phosphate
    -0.064 ( 0.2469 )
    -0.061 ( 0.2549 )
        Month 36 phosphate
    -0.044 ( 0.2464 )
    -0.061 ( 0.2053 )
        Month 1 potassium
    -0.08 ( 0.400 )
    -0.05 ( 0.460 )
        Month 2 potassium
    0.30 ( 99999 )
    99999 ( 99999 )
        Month 3 potassium
    -0.33 ( 0.604 )
    0.00 ( 0.428 )
        Month 4 potassium
    0.80 ( 99999 )
    99999 ( 99999 )
        Month 6 potassium
    0.11 ( 0.337 )
    0.08 ( 0.359 )
        Month 9 potassium
    -0.06 ( 0.447 )
    0.12 ( 0.391 )
        Month 12 potassium
    0.01 ( 0.445 )
    0.06 ( 0.491 )
        Month 18 potassium
    0.06 ( 0.380 )
    0.15 ( 0.411 )
        Month 24 potassium
    0.09 ( 0.516 )
    0.09 ( 0.435 )
        Month 36 potassium
    0.07 ( 0.549 )
    0.11 ( 0.430 )
        month 1 sodium
    -2.75 ( 3.493 )
    -1.09 ( 2.875 )
        month 2 sodium
    -1.00 ( 99999 )
    99999 ( 99999 )
        month 3 sodium
    -1.86 ( 4.496 )
    0.59 ( 3.054 )
        month 4 sodium
    -2.00 ( 99999 )
    99999 ( 99999 )
        month 6 sodium
    -0.42 ( 2.514 )
    0.33 ( 3.222 )
        month 9 sodium
    0.52 ( 2.108 )
    -0.08 ( 3.111 )
        month 12 sodium
    0.33 ( 2.114 )
    -0.34 ( 4.046 )
        month 18 sodium
    0.45 ( 2.964 )
    0.74 ( 3.572 )
        month 24 sodium
    -1.00 ( 3.246 )
    1.02 ( 3.795 )
        month 36 sodium
    -0.44 ( 2.229 )
    0.25 ( 3.432 )
    No statistical analyses for this end point

    Secondary: Overall Response Rate (ORR) by Subgroups

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    End point title
    		 Overall Response Rate (ORR) by Subgroups
    End point description
    ORR is defined as the percentage of participants achieving a best overall response of partial response (PR) or complete response (CR). CR: Target nodes masses must regress to ≤ 1.5cm in LDi, no extralymphatic sites, no new lesions. PR: ≥ 50% decrease in sum of diameters of up to 6 target nodes and extranodal sites, no new lesions, spleen must have regressed > 50% in length. Complete metabolic response: Lymph nodes score 1, 2, 3 with/without residual mass on 5-point scale, no new lesions, no FDG-avid disease. Partial metabolic response: Lymph nodes score 4 or 5, reduced uptake from baseline, no new lesions, residual uptake higher than normal, reduced from baseline. 99999=NA
    End point type
    Secondary
    End point timeframe
    From randomization to PR or CR (Up to 36 months)
    End point values
    		 Standard of Care Arm Liso-cel Arm
    Number of subjects analysed
    92
    92
    Units: Percentage of participants
    number (confidence interval 95%)
        NHL: Diffuse Large B-cell Lymphoma (DLBCL)
    51.7 (38.2 to 65.0)
    86.7 (75.4 to 94.1)
        NIH: Follicular Lymphoma Grade 3B
    99999 (99999 to 99999)
    100 (2.5 to 100.0)
        NIH: HGBCL with DLBCL Histology
    42.9 (21.8 to 66.0)
    81.8 (59.7 to 94.8)
        NIH: PMLBCL
    33.3 (7.5 to 70.1)
    100 (63.1 to 100.0)
        NIH: T Cell/Histiocyte-Rich Large B-Cell Lymphoma
    75.0 (19.4 to 99.4)
    100 (2.5 to 100.0)
        DLBCL: DLBCL NOS de novo
    54.0 (39.3 to 68.2)
    86.8 (74.7 to 94.5)
        DLBCL: DLBCL from Transformed Indolent NHL
    37.5 (8.5 to 75.5)
    85.7 (42.1 to 99.6)
        DLBCL: Germinal Center B-cell like (GCB)
    50.0 (33.8 to 66.2)
    91.1 (78.8 to 97.5)
        DLBCL: Activated B-cell-like, non-GCB
    44.8 (26.4 to 64.3)
    85.7 (63.7 to 97.0)
        NHL: DBL/THL
    40.0 (19.1 to 63.9)
    81.8 (59.7 to 94.8)
        NHL: Non-DHL/THL
    51.4 (39.3 to 63.3)
    88.6 (78.7 to 94.9)
    No statistical analyses for this end point

    Secondary: Event-free Survival (EFS) by Subgroups

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    End point title
    		 Event-free Survival (EFS) by Subgroups
    End point description
    Time from randomization to death, progressive disease (PD), failure to achieve complete response (CR) or partial response (PR) by 9 weeks or start of new antineoplastic therapy, whichever occurs first. CR: Target nodes masses must regress to ≤ 1.5cm in LDi, no extralymphatic sites, no new lesions. PR: ≥ 50% decrease in sum of diameters of up to 6 target nodes and extranodal sites, no new lesions, spleen must have regressed > 50% in length. PD: LDi > 1.5cm, increase by ≥ 50% from PPD nadir, an increase in LDi or SDi from nadir, 0.5cm for lesions ≤ 2cm, 1.0cm for lesions > 2cm. Complete metabolic response: Lymph nodes score 1, 2, 3 with/without residual mass on 5-point scale, no new lesions, no FDG-avid disease. Partial metabolic response: Lymph nodes score 4 or 5, reduced uptake, no new lesions, residual uptake higher than normal, reduced from baseline. Progressive metabolic disease: Score 4 or 5 with an increase in uptake intensity from baseline and/or new FDG-avid. 99999=NA
    End point type
    Secondary
    End point timeframe
    From randomization to death from any cause, PD, failure to achieve CR or PR by 9 weeks post randomization, or start of new antineoplastic therapy due to efficacy concerns, whichever occurs first (Up to 36 months)
    End point values
    		 Standard of Care Arm Liso-cel Arm
    Number of subjects analysed
    92
    92
    Units: Months
    median (confidence interval 95%)
        NHL: Diffuse Large B-cell Lymphoma (DLBCL)
    3.0 (2.2 to 6.4)
    99999 (9.5 to 99999)
        NIH: Follicular Lymphoma Grade 3B
    99999 (99999 to 99999)
    99999 (99999 to 99999)
        NIH: HGBCL with DLBCL Histology
    2.2 (0.9 to 3.9)
    4.6 (4.1 to 12.6)
        NIH: PMLBCL
    2.2 (1.0 to 99999)
    99999 (11.0 to 99999)
        NIH: T Cell/Histiocyte-Rich Large B-Cell Lymphoma
    99999 (2.3 to 99999)
    99999 (99999 to 99999)
        DLBCL: DLBCL NOS de novo
    4.4 (2.2 to 7.5)
    33.2 (9.4 to 99999)
        DLBCL: DLBCL from Transformed Indolent NHL
    2.1 (1.2 to 11.2)
    99999 (1.9 to 99999)
        DLBCL: Germinal Center B-cell like (GCB)
    2.1 (1.6 to 4.9)
    11.7 (6.0 to 99999)
        DLBCL: Activated B-cell-like, non-GCB
    2.3 (2.1 to 7.5)
    33.2 (4.9 to 99999)
        NHL: DBL/THL
    2.1 (0.9 to 3.9)
    4.6 (4.1 to 12.6)
        NHL: Non-DHL/THL
    2.8 (2.2 to 6.4)
    99999 (15.6 to 99999)
    No statistical analyses for this end point

    Secondary: Progression-free Survival (PFS) by Subgroups

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    End point title
    		 Progression-free Survival (PFS) by Subgroups
    End point description
    Progression-free survival is defined as the time from randomization to progressive disease (PD) or death from any cause, whichever occurs first. Estimates of time to event are from Kaplan-Meier product-limit estimates. PD: LDi > 1.5 cm, increase by ≥ 50% from PPD nadir, an increase in LDi or SDi from nadir, 0.5 cm for lesions ≤ 2 cm, 1.0 cm for lesions > 2 cm. Progressive metabolic disease: Score 4 or 5 with an increase in the intensity of uptake from baseline and/or new FDG-avid. 99999=NA
    End point type
    Secondary
    End point timeframe
    From randomization to progression, or death from any cause, whichever occurs first (Up to 36 months)
    End point values
    		 Standard of Care Arm Liso-cel Arm
    Number of subjects analysed
    92
    92
    Units: Months
    median (confidence interval 95%)
        NHL: Diffuse Large B-cell Lymphoma (DLBCL)
    6.0 (2.9 to 8.6)
    99999 (30.9 to 99999)
        NIH: Follicular Lymphoma Grade 3B
    99999 (99999 to 99999)
    99999 (99999 to 99999)
        NIH: HGBCL with DLBCL Histology
    4.3 (1.4 to 6.5)
    5.8 (4.3 to 14.8)
        NIH: PMLBCL
    99999 (1.0 to 99999)
    99999 (11.0 to 99999)
        NIH: T Cell/Histiocyte-Rich Large B-Cell Lymphoma
    99999 (28.2 to 99999)
    99999 (99999 to 99999)
        DLBCL: DLBCL NOS de novo
    6.4 (3.1 to 8.6)
    99999 (12.2 to 99999)
        DLBCL: DLBCL from Transformed Indolent NHL
    3.4 (1.2 to 99999)
    99999 (2.3 to 99999)
        DLBCL: Germinal Center B-cell like (GCB)
    4.6 (2.0 to 6.4)
    14.8 (6.2 to 99999)
        DLBCL: Activated B-cell-like, non-GCB
    7.5 (2.3 to 9.4)
    33.2 (6.6 to 99999)
        NHL: DBL/THL
    4.3 (1.4 to 6.5)
    5.8 (4.3 to 14.8)
        NHL: Non-DHL/THL
    6.4 (4.6 to 9.4)
    99999 (33.2 to 99999)
    No statistical analyses for this end point

    Secondary: Overall Survival (OS) by Subgroups

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    End point title
    		 Overall Survival (OS) by Subgroups
    End point description
    Overall Survival (OS) is defined as the time from randomization to death due to any cause. Estimates of time to event are from Kaplan-Meier product-limit estimates. 99999=NA
    End point type
    Secondary
    End point timeframe
    From randomization to time of death due to any cause (Up to 36 months)
    End point values
    		 Standard of Care Arm Liso-cel Arm
    Number of subjects analysed
    92
    92
    Units: Months
    median (confidence interval 95%)
        NHL: Diffuse Large B-cell Lymphoma (DLBCL)
    99999 (17.0 to 99999)
    99999 (42.8 to 99999)
        NIH: Follicular Lymphoma Grade 3B
    99999 (99999 to 99999)
    99999 (99999 to 99999)
        NIH: HGBCL with DLBCL Histology
    16.3 (5.3 to 99999)
    13.3 (7.9 to 99999)
        NIH: PMLBCL
    99999 (17.9 to 99999)
    99999 (11.0 to 99999)
        NIH: T Cell/Histiocyte-Rich Large B-Cell Lymphoma
    99999 (8.9 to 99999)
    99999 (99999 to 99999)
        DLBCL: DLBCL NOS de novo
    99999 (16.7 to 99999)
    99999 (42.8 to 99999)
        DLBCL: DLBCL from Transformed Indolent NHL
    28.2 (2.0 to 99999)
    99999 (14.2 to 99999)
        DLBCL: Germinal Center B-cell like (GCB)
    99999 (18.2 to 99999)
    99999 (15.8 to 99999)
        DLBCL: Activated B-cell-like, non-GCB
    16.3 (9.7 to 99999)
    99999 (32.4 to 99999)
        NHL: DBL/THL
    16.3 (5.3 to 30.7)
    13.3 (7.9 to 99999)
        NHL: Non-DHL/THL
    99999 (27.5 to 99999)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Secondary: Change from Baseline in the European Organization for Research and Treatment of Cancer – Quality of Life C30 Questionnaire (EORTC QLQ-C30)

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    End point title
    		 Change from Baseline in the European Organization for Research and Treatment of Cancer – Quality of Life C30 Questionnaire (EORTC QLQ-C30)
    End point description
    Change from baseline in EORTC QLQ-C30 specified parameters including global health/quality of life, cognitive functioning, physical functioning, and fatigue. It is composed of both multi-item scales and single item measures. All of the scales and single-item measures range in score from 0 to 100. A 10-point change in the scoring is considered to be a meaningful change in HRQoL. Functional scale and global health status/HRQoL higher scale score represents a higher level of well-being and better ability of daily functioning. Symptom scale/item higher score represents a high level of symptomatic problem. Baseline value will be defined as the last value on the randomization date (+3 days) or before the date/time of randomization (date if date/time not collected).
    End point type
    Secondary
    End point timeframe
    baseline, months 1, 6, 9, 12, 18, 24, 36
    End point values
    		 Standard of Care Arm Liso-cel Arm
    Number of subjects analysed
    41
    43
    Units: score on a scale
    arithmetic mean (standard deviation)
        Global Health/Quality of Life Month 1
    -9.55 ( 25.655 )
    -5.23 ( 18.004 )
        Global Health/Quality of Life Month 6
    -2.78 ( 24.734 )
    12.36 ( 23.635 )
        Global Health/Quality of Life Month 9
    5.30 ( 24.516 )
    12.50 ( 22.252 )
        Global Health/Quality of Life Month 12
    15.63 ( 32.865 )
    8.93 ( 24.525 )
        Global Health/Quality of Life Month 18
    14.81 ( 29.397 )
    8.33 ( 23.442 )
        Global Health/Quality of Life Month 24
    12.50 ( 28.934 )
    7.29 ( 23.093 )
        Global Health/Quality of Life Month 36
    15.00 ( 21.802 )
    2.67 ( 21.071 )
        Physical Functioning Month 1
    -8.94 ( 19.867 )
    -4.03 ( 16.339 )
        Physical Functioning Month 6
    -2.08 ( 11.081 )
    2.24 ( 17.470 )
        Physical Functioning Month 9
    0.61 ( 9.167 )
    5.00 ( 21.825 )
        Physical Functioning Month 12
    10.00 ( 17.817 )
    4.52 ( 17.875 )
        Physical Functioning Month 18
    13.33 ( 22.608 )
    1.73 ( 17.027 )
        Physical Functioning Month 24
    10.67 ( 18.645 )
    2.78 ( 22.147 )
        Physical Functioning Month 36
    7.33 ( 15.540 )
    -1.87 ( 16.613 )
        Cognitive Functioning Month 1
    -8.54 ( 19.047 )
    -0.39 ( 16.462 )
        Cognitive Functioning Month 6
    -3.33 ( 14.365 )
    3.45 ( 20.596 )
        Cognitive Functioning Month 9
    -3.03 ( 16.361 )
    9.72 ( 23.008 )
        Cognitive Functioning Month 12
    -4.17 ( 7.715 )
    4.17 ( 27.074 )
        Cognitive Functioning Month 18
    0.00 ( 18.634 )
    4.17 ( 26.580 )
        Cognitive Functioning Month 24
    0.00 ( 13.608 )
    0.00 ( 26.919 )
        Cognitive Functioning Month 36
    -1.67 ( 9.461 )
    2.67 ( 17.795 )
        Fatigue Month 1
    19.24 ( 24.848 )
    0.26 ( 20.501 )
        Fatigue Month 6
    0.69 ( 27.657 )
    -12.84 ( 29.811 )
        Fatigue Month 9
    -4.04 ( 29.090 )
    -10.65 ( 36.702 )
        Fatigue Month 12
    -6.94 ( 8.267 )
    -9.52 ( 33.363 )
        Fatigue Month 18
    -6.17 ( 22.299 )
    -10.22 ( 30.919 )
        Fatigue Month 24
    -6.67 ( 19.030 )
    -8.80 ( 30.557 )
        Fatigue Month 36
    -3.33 ( 16.605 )
    -5.33 ( 25.884 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in the Functional Assessment of Cancer Therapy-Lymphoma Subscale (FACT-Lym)

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    End point title
    		 Change from Baseline in the Functional Assessment of Cancer Therapy-Lymphoma Subscale (FACT-Lym)
    End point description
    Change from Baseline in the Functional Assessment of Cancer Therapy-Lymphoma 15-item lymphoma-specific “Additional concerns” subscale (FACT-Lym). The LYM items are scored on a 0 (“Not at all”) to 4 (“Very much”) response scale. Items are aggregated to a single score on a 0-60 scale. Baseline value will be defined as the last value on the randomization date (+3 days) or before the date/time of randomization (date if date/time not collected). A meaningful change from baseline in the FACT-Lym score, often referred to as the minimally important difference (MID), typically ranges between 6.5 and 11.2 points for the total score. This range indicates a clinically significant improvement or deterioration in a patient’s health-related quality of life.
    End point type
    Secondary
    End point timeframe
    baseline, months 1, 6, 9, 12, 18, 24, 36
    End point values
    		 Standard of Care Arm Liso-cel Arm
    Number of subjects analysed
    38
    40
    Units: score on a scale
    arithmetic mean (standard deviation)
        Month 1
    -0.76 ( 5.558 )
    0.35 ( 7.329 )
        Month 6
    2.19 ( 9.474 )
    3.52 ( 10.805 )
        Month 9
    0.11 ( 9.597 )
    5.48 ( 14.330 )
        Month 12
    5.43 ( 3.645 )
    3.93 ( 13.485 )
        Month 18
    3.50 ( 5.632 )
    2.56 ( 12.149 )
        Month 24
    5.20 ( 5.789 )
    2.18 ( 12.374 )
        Month 36
    4.90 ( 5.152 )
    0.50 ( 9.478 )
    No statistical analyses for this end point

    Secondary: Percentage of Participants Completing High Dose Chemotherapy (HDCT)

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    End point title
    		 Percentage of Participants Completing High Dose Chemotherapy (HDCT)
    End point description
    Percentage of Participants Completing High Dose Chemotherapy (HDCT).
    End point type
    Secondary
    End point timeframe
    Up to 5 months after first dose
    End point values
    		 Standard of Care Arm Liso-cel Arm
    Number of subjects analysed
    91
    0 [2]
    Units: Percentage of participants
        number (not applicable)
    47.3
    Notes
    [2] - 0 subjects analyzed
    No statistical analyses for this end point

    Secondary: Hospital Resource Utilization (HRU) Results

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    End point title
    		 Hospital Resource Utilization (HRU) Results
    End point description
    Hospital resource utilization (HRU) results including hospitalized, reasons for hospitalizations, and admitted to intensive care unit (ICU)
    End point type
    Secondary
    End point timeframe
    Up to 36 months
    End point values
    		 Standard of Care Arm Liso-cel Arm
    Number of subjects analysed
    91
    92
    Units: Number of participants
        Hospitalized
    74
    87
        Hospitalized due to Adverse Event (AE)
    42
    44
        Hospitalized due to Progression of Disease
    2
    6
        Hospitalized per protocol
    11
    22
        Hospitalized due to other reasons
    56
    71
        Admitted to Intensive Care Unit (ICU)
    4
    5
    No statistical analyses for this end point

    Secondary: Percentage of Participants Completing Hematopoietic Stem Cell Transplant (HSCT)

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    End point title
    		 Percentage of Participants Completing Hematopoietic Stem Cell Transplant (HSCT)
    End point description
    Percentage of Participants Completing Hematopoietic Stem Cell Transplant (HSCT).
    End point type
    Secondary
    End point timeframe
    Up to 5 months after first dose
    End point values
    		 Standard of Care Arm Liso-cel Arm
    Number of subjects analysed
    91
    0 [3]
    Units: Percentage of participants
        number (not applicable)
    47.3
    Notes
    [3] - 0 subject analyzed
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 60 months). SAEs and non-serious AEs were assessed from first dose to 90 days after last dose of study therapy (Up to 39 months).
    Adverse event reporting additional description
    The number at Risk for All-Cause Mortality=All randomized participants. The number at Risk for SAEs and non-serious AEs=All treated participants.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    SOC Arm only
    Reporting group description
    		 3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). 1 cycle = 3 weeks

    Reporting group title
    SOC-JCAR017 Arm Post-Crossover (All Crossed)
    Reporting group description
    		 Participants who crossed over to JCAR017 regardless of if they received CAR T therapy or not. 3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT)

    Reporting group title
    SOC-JCAR017 Arm Post-Crossover (All Treated)
    Reporting group description
    		 Participants who crossed over to JCAR017 and received CAR T therapy. 3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). As requested by the investigator, participants were allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks

    Reporting group title
    Liso-cel Arm only
    Reporting group description
    		 [Lymphodepleting chemotherapy (LDC)] Fludarabine IV (30 mg/m^2/day for 3 days) and cyclophosphamide IV (300 mg/m^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)

    Serious adverse events
    		 SOC Arm only SOC-JCAR017 Arm Post-Crossover (All Crossed) SOC-JCAR017 Arm Post-Crossover (All Treated) Liso-cel Arm only
    Total subjects affected by serious adverse events
         subjects affected / exposed
    21 / 30 (70.00%)
    19 / 61 (31.15%)
    24 / 58 (41.38%)
    43 / 92 (46.74%)
         number of deaths (all causes)
    9
    33
    0
    34
         number of deaths resulting from adverse events
    2
    2
    0
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Myelodysplastic syndrome
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 61 (1.64%)
    0 / 58 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    Bowen's disease
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 61 (1.64%)
    0 / 58 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Basal cell carcinoma
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 61 (0.00%)
    1 / 58 (1.72%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thyroid cancer metastatic
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 61 (1.64%)
    0 / 58 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 61 (1.64%)
    0 / 58 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertensive emergency
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 61 (0.00%)
    0 / 58 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vasculitis
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 61 (0.00%)
    0 / 58 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Peripheral swelling
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 61 (0.00%)
    0 / 58 (0.00%)
    2 / 92 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 61 (0.00%)
    0 / 58 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 61 (0.00%)
    0 / 58 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mucosal inflammation
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 61 (0.00%)
    0 / 58 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 61 (1.64%)
    0 / 58 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 61 (0.00%)
    0 / 58 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Face oedema
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 61 (1.64%)
    0 / 58 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chills
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 61 (0.00%)
    0 / 58 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 61 (0.00%)
    5 / 58 (8.62%)
    6 / 92 (6.52%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    5 / 5
    4 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Engraftment syndrome
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 61 (0.00%)
    0 / 58 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cytokine release syndrome
         subjects affected / exposed
    0 / 30 (0.00%)
    5 / 61 (8.20%)
    0 / 58 (0.00%)
    12 / 92 (13.04%)
         occurrences causally related to treatment / all
    0 / 0
    6 / 6
    0 / 0
    13 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anaphylactic reaction
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 61 (0.00%)
    0 / 58 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemophagocytic lymphohistiocytosis
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 61 (1.64%)
    0 / 58 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 61 (0.00%)
    0 / 58 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 61 (0.00%)
    0 / 58 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 61 (0.00%)
    0 / 58 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute respiratory distress syndrome
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 61 (0.00%)
    0 / 58 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 61 (0.00%)
    0 / 58 (0.00%)
    2 / 92 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 61 (1.64%)
    0 / 58 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 61 (1.64%)
    0 / 58 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 61 (1.64%)
    0 / 58 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 61 (0.00%)
    1 / 58 (1.72%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Confusional state
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 61 (1.64%)
    0 / 58 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anxiety
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 61 (1.64%)
    0 / 58 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mental status changes
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 61 (1.64%)
    0 / 58 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    White blood cell count decreased
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 61 (0.00%)
    0 / 58 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Platelet count decreased
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 61 (0.00%)
    0 / 58 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    C-reactive protein increased
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 61 (0.00%)
    0 / 58 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 61 (0.00%)
    0 / 58 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 61 (0.00%)
    0 / 58 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Myocardial infarction
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 61 (0.00%)
    0 / 58 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 61 (0.00%)
    0 / 58 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Postural orthostatic tachycardia syndrome
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 61 (0.00%)
    0 / 58 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sinus tachycardia
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 61 (1.64%)
    0 / 58 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 61 (0.00%)
    1 / 58 (1.72%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 61 (0.00%)
    0 / 58 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial flutter
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 61 (0.00%)
    0 / 58 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Aphasia
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 61 (1.64%)
    0 / 58 (0.00%)
    2 / 92 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cognitive disorder
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 61 (1.64%)
    0 / 58 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tremor
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 61 (0.00%)
    0 / 58 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Somnolence
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 61 (0.00%)
    1 / 58 (1.72%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 61 (1.64%)
    0 / 58 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Migraine
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 61 (0.00%)
    0 / 58 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 61 (0.00%)
    1 / 58 (1.72%)
    2 / 92 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Encephalopathy
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 61 (3.28%)
    0 / 58 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Lymphopenia
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 61 (0.00%)
    0 / 58 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anaemia
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 61 (1.64%)
    1 / 58 (1.72%)
    2 / 92 (2.17%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cytopenia
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 61 (0.00%)
    0 / 58 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    4 / 30 (13.33%)
    3 / 61 (4.92%)
    5 / 58 (8.62%)
    7 / 92 (7.61%)
         occurrences causally related to treatment / all
    4 / 4
    3 / 3
    6 / 6
    7 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    3 / 30 (10.00%)
    1 / 61 (1.64%)
    1 / 58 (1.72%)
    7 / 92 (7.61%)
         occurrences causally related to treatment / all
    3 / 3
    1 / 1
    1 / 1
    7 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 61 (1.64%)
    0 / 58 (0.00%)
    4 / 92 (4.35%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Diplopia
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 61 (0.00%)
    0 / 58 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Photophobia
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 61 (0.00%)
    0 / 58 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Ileus
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 61 (0.00%)
    0 / 58 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal toxicity
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 61 (0.00%)
    0 / 58 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 61 (0.00%)
    0 / 58 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 61 (0.00%)
    0 / 58 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Duodenal stenosis
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 61 (0.00%)
    0 / 58 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 61 (0.00%)
    0 / 58 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 61 (3.28%)
    0 / 58 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 61 (1.64%)
    0 / 58 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 61 (0.00%)
    1 / 58 (1.72%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 61 (0.00%)
    0 / 58 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 61 (0.00%)
    1 / 58 (1.72%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 61 (0.00%)
    0 / 58 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retroperitoneal haemorrhage
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 61 (1.64%)
    0 / 58 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 61 (0.00%)
    1 / 58 (1.72%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stomatitis
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 61 (0.00%)
    1 / 58 (1.72%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    4 / 30 (13.33%)
    1 / 61 (1.64%)
    1 / 58 (1.72%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    3 / 5
    0 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 61 (0.00%)
    1 / 58 (1.72%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 61 (0.00%)
    1 / 58 (1.72%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract obstruction
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 61 (0.00%)
    0 / 58 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 61 (0.00%)
    1 / 58 (1.72%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myalgia
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 61 (0.00%)
    0 / 58 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal pain
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 61 (0.00%)
    1 / 58 (1.72%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Muscular weakness
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 61 (0.00%)
    0 / 58 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 61 (1.64%)
    1 / 58 (1.72%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Catheter site infection
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 61 (0.00%)
    1 / 58 (1.72%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 61 (0.00%)
    0 / 58 (0.00%)
    2 / 92 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchopulmonary aspergillosis
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 61 (0.00%)
    0 / 58 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bacterial sepsis
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 61 (0.00%)
    0 / 58 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 61 (1.64%)
    0 / 58 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 61 (0.00%)
    0 / 58 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Clostridium difficile infection
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 61 (0.00%)
    0 / 58 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device related bacteraemia
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 61 (0.00%)
    1 / 58 (1.72%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enterococcal bacteraemia
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 61 (0.00%)
    0 / 58 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enterocolitis infectious
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 61 (0.00%)
    0 / 58 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Escherichia bacteraemia
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 61 (0.00%)
    0 / 58 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Escherichia sepsis
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 61 (0.00%)
    1 / 58 (1.72%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fungal infection
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 61 (1.64%)
    0 / 58 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 61 (0.00%)
    1 / 58 (1.72%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infectious pleural effusion
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 61 (1.64%)
    0 / 58 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Klebsiella sepsis
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 61 (0.00%)
    0 / 58 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 61 (1.64%)
    1 / 58 (1.72%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia pseudomonal
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 61 (0.00%)
    0 / 58 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 61 (0.00%)
    0 / 58 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 61 (1.64%)
    0 / 58 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 61 (0.00%)
    0 / 58 (0.00%)
    2 / 92 (2.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Pseudomonal sepsis
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 61 (0.00%)
    0 / 58 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 61 (1.64%)
    0 / 58 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 61 (0.00%)
    0 / 58 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypercalcaemia
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 61 (1.64%)
    0 / 58 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Electrolyte imbalance
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 61 (0.00%)
    0 / 58 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 SOC Arm only SOC-JCAR017 Arm Post-Crossover (All Crossed) SOC-JCAR017 Arm Post-Crossover (All Treated) Liso-cel Arm only
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    30 / 30 (100.00%)
    57 / 61 (93.44%)
    55 / 58 (94.83%)
    92 / 92 (100.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    3 / 30 (10.00%)
    4 / 61 (6.56%)
    5 / 58 (8.62%)
    8 / 92 (8.70%)
         occurrences all number
    6
    7
    10
    10
    Deep vein thrombosis
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 61 (0.00%)
    4 / 58 (6.90%)
    4 / 92 (4.35%)
         occurrences all number
    1
    0
    4
    4
    Orthostatic hypotension
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 61 (3.28%)
    0 / 58 (0.00%)
    5 / 92 (5.43%)
         occurrences all number
    0
    2
    0
    6
    Jugular vein thrombosis
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 61 (1.64%)
    1 / 58 (1.72%)
    1 / 92 (1.09%)
         occurrences all number
    2
    1
    1
    1
    Hypotension
         subjects affected / exposed
    2 / 30 (6.67%)
    10 / 61 (16.39%)
    4 / 58 (6.90%)
    19 / 92 (20.65%)
         occurrences all number
    6
    18
    5
    37
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    3 / 30 (10.00%)
    3 / 61 (4.92%)
    5 / 58 (8.62%)
    11 / 92 (11.96%)
         occurrences all number
    5
    3
    6
    11
    Chills
         subjects affected / exposed
    0 / 30 (0.00%)
    4 / 61 (6.56%)
    3 / 58 (5.17%)
    8 / 92 (8.70%)
         occurrences all number
    0
    6
    4
    8
    Pyrexia
         subjects affected / exposed
    6 / 30 (20.00%)
    6 / 61 (9.84%)
    11 / 58 (18.97%)
    22 / 92 (23.91%)
         occurrences all number
    9
    9
    12
    24
    Pain
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 61 (1.64%)
    5 / 58 (8.62%)
    4 / 92 (4.35%)
         occurrences all number
    1
    1
    5
    5
    Oedema peripheral
         subjects affected / exposed
    4 / 30 (13.33%)
    7 / 61 (11.48%)
    13 / 58 (22.41%)
    15 / 92 (16.30%)
         occurrences all number
    7
    11
    15
    19
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 30 (3.33%)
    2 / 61 (3.28%)
    1 / 58 (1.72%)
    5 / 92 (5.43%)
         occurrences all number
    1
    2
    1
    5
    Mucosal inflammation
         subjects affected / exposed
    5 / 30 (16.67%)
    0 / 61 (0.00%)
    8 / 58 (13.79%)
    5 / 92 (5.43%)
         occurrences all number
    5
    0
    11
    5
    Malaise
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 61 (3.28%)
    4 / 58 (6.90%)
    3 / 92 (3.26%)
         occurrences all number
    0
    2
    4
    3
    Fatigue
         subjects affected / exposed
    10 / 30 (33.33%)
    12 / 61 (19.67%)
    28 / 58 (48.28%)
    37 / 92 (40.22%)
         occurrences all number
    19
    15
    36
    45
    Immune system disorders
    Hypogammaglobulinaemia
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 61 (3.28%)
    2 / 58 (3.45%)
    9 / 92 (9.78%)
         occurrences all number
    0
    2
    3
    11
    Cytokine release syndrome
         subjects affected / exposed
    0 / 30 (0.00%)
    24 / 61 (39.34%)
    0 / 58 (0.00%)
    33 / 92 (35.87%)
         occurrences all number
    0
    26
    0
    34
    Respiratory, thoracic and mediastinal disorders
    Dysphonia
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 61 (1.64%)
    4 / 58 (6.90%)
    1 / 92 (1.09%)
         occurrences all number
    1
    1
    4
    1
    Cough
         subjects affected / exposed
    3 / 30 (10.00%)
    3 / 61 (4.92%)
    7 / 58 (12.07%)
    13 / 92 (14.13%)
         occurrences all number
    6
    3
    7
    14
    Dyspnoea
         subjects affected / exposed
    4 / 30 (13.33%)
    5 / 61 (8.20%)
    6 / 58 (10.34%)
    13 / 92 (14.13%)
         occurrences all number
    4
    9
    9
    13
    Rhinorrhoea
         subjects affected / exposed
    2 / 30 (6.67%)
    2 / 61 (3.28%)
    4 / 58 (6.90%)
    0 / 92 (0.00%)
         occurrences all number
    2
    2
    5
    0
    Pulmonary embolism
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 61 (0.00%)
    3 / 58 (5.17%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    3
    0
    Pleural effusion
         subjects affected / exposed
    3 / 30 (10.00%)
    3 / 61 (4.92%)
    3 / 58 (5.17%)
    3 / 92 (3.26%)
         occurrences all number
    3
    3
    3
    3
    Oropharyngeal pain
         subjects affected / exposed
    0 / 30 (0.00%)
    3 / 61 (4.92%)
    8 / 58 (13.79%)
    2 / 92 (2.17%)
         occurrences all number
    0
    4
    8
    3
    Nasal congestion
         subjects affected / exposed
    2 / 30 (6.67%)
    3 / 61 (4.92%)
    0 / 58 (0.00%)
    5 / 92 (5.43%)
         occurrences all number
    2
    3
    0
    5
    Epistaxis
         subjects affected / exposed
    2 / 30 (6.67%)
    2 / 61 (3.28%)
    3 / 58 (5.17%)
    7 / 92 (7.61%)
         occurrences all number
    2
    6
    3
    9
    Hiccups
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 61 (1.64%)
    5 / 58 (8.62%)
    6 / 92 (6.52%)
         occurrences all number
    2
    1
    8
    6
    Psychiatric disorders
    Depression
         subjects affected / exposed
    2 / 30 (6.67%)
    2 / 61 (3.28%)
    2 / 58 (3.45%)
    4 / 92 (4.35%)
         occurrences all number
    2
    2
    3
    4
    Anxiety
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 61 (1.64%)
    4 / 58 (6.90%)
    5 / 92 (5.43%)
         occurrences all number
    1
    1
    5
    5
    Confusional state
         subjects affected / exposed
    0 / 30 (0.00%)
    6 / 61 (9.84%)
    0 / 58 (0.00%)
    5 / 92 (5.43%)
         occurrences all number
    0
    7
    0
    5
    Insomnia
         subjects affected / exposed
    5 / 30 (16.67%)
    4 / 61 (6.56%)
    5 / 58 (8.62%)
    19 / 92 (20.65%)
         occurrences all number
    7
    5
    6
    22
    Hallucination
         subjects affected / exposed
    1 / 30 (3.33%)
    3 / 61 (4.92%)
    1 / 58 (1.72%)
    1 / 92 (1.09%)
         occurrences all number
    1
    3
    1
    1
    Investigations
    Weight increased
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 61 (1.64%)
    5 / 58 (8.62%)
    2 / 92 (2.17%)
         occurrences all number
    0
    1
    10
    4
    Weight decreased
         subjects affected / exposed
    1 / 30 (3.33%)
    3 / 61 (4.92%)
    2 / 58 (3.45%)
    3 / 92 (3.26%)
         occurrences all number
    1
    4
    2
    3
    Platelet count decreased
         subjects affected / exposed
    1 / 30 (3.33%)
    2 / 61 (3.28%)
    1 / 58 (1.72%)
    6 / 92 (6.52%)
         occurrences all number
    1
    3
    3
    11
    Neutrophil count decreased
         subjects affected / exposed
    0 / 30 (0.00%)
    3 / 61 (4.92%)
    0 / 58 (0.00%)
    7 / 92 (7.61%)
         occurrences all number
    0
    10
    0
    13
    International normalised ratio increased
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 61 (1.64%)
    1 / 58 (1.72%)
    4 / 92 (4.35%)
         occurrences all number
    3
    2
    1
    8
    C-reactive protein increased
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 61 (1.64%)
    0 / 58 (0.00%)
    1 / 92 (1.09%)
         occurrences all number
    2
    1
    0
    1
    Blood creatinine increased
         subjects affected / exposed
    2 / 30 (6.67%)
    3 / 61 (4.92%)
    2 / 58 (3.45%)
    6 / 92 (6.52%)
         occurrences all number
    4
    3
    3
    10
    Blood alkaline phosphatase increased
         subjects affected / exposed
    1 / 30 (3.33%)
    4 / 61 (6.56%)
    5 / 58 (8.62%)
    8 / 92 (8.70%)
         occurrences all number
    3
    4
    9
    10
    Aspartate aminotransferase increased
         subjects affected / exposed
    3 / 30 (10.00%)
    2 / 61 (3.28%)
    3 / 58 (5.17%)
    6 / 92 (6.52%)
         occurrences all number
    3
    3
    4
    12
    Alanine aminotransferase increased
         subjects affected / exposed
    3 / 30 (10.00%)
    2 / 61 (3.28%)
    5 / 58 (8.62%)
    6 / 92 (6.52%)
         occurrences all number
    3
    4
    8
    7
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 61 (1.64%)
    3 / 58 (5.17%)
    1 / 92 (1.09%)
         occurrences all number
    0
    2
    3
    1
    Fall
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 61 (0.00%)
    1 / 58 (1.72%)
    4 / 92 (4.35%)
         occurrences all number
    2
    0
    1
    5
    Vascular access site pain
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 61 (0.00%)
    0 / 58 (0.00%)
    6 / 92 (6.52%)
         occurrences all number
    0
    0
    0
    6
    Infusion related reaction
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 61 (1.64%)
    4 / 58 (6.90%)
    8 / 92 (8.70%)
         occurrences all number
    0
    1
    5
    8
    Allergic transfusion reaction
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 61 (0.00%)
    3 / 58 (5.17%)
    1 / 92 (1.09%)
         occurrences all number
    0
    0
    3
    1
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    5 / 30 (16.67%)
    4 / 61 (6.56%)
    6 / 58 (10.34%)
    9 / 92 (9.78%)
         occurrences all number
    7
    9
    7
    12
    Sinus tachycardia
         subjects affected / exposed
    2 / 30 (6.67%)
    2 / 61 (3.28%)
    3 / 58 (5.17%)
    7 / 92 (7.61%)
         occurrences all number
    5
    2
    4
    27
    Palpitations
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 61 (1.64%)
    3 / 58 (5.17%)
    3 / 92 (3.26%)
         occurrences all number
    0
    1
    3
    3
    Nervous system disorders
    Aphasia
         subjects affected / exposed
    0 / 30 (0.00%)
    3 / 61 (4.92%)
    0 / 58 (0.00%)
    4 / 92 (4.35%)
         occurrences all number
    0
    4
    0
    4
    Dizziness
         subjects affected / exposed
    1 / 30 (3.33%)
    10 / 61 (16.39%)
    12 / 58 (20.69%)
    22 / 92 (23.91%)
         occurrences all number
    1
    11
    15
    29
    Dysgeusia
         subjects affected / exposed
    3 / 30 (10.00%)
    0 / 61 (0.00%)
    8 / 58 (13.79%)
    3 / 92 (3.26%)
         occurrences all number
    3
    0
    8
    3
    Headache
         subjects affected / exposed
    8 / 30 (26.67%)
    16 / 61 (26.23%)
    12 / 58 (20.69%)
    40 / 92 (43.48%)
         occurrences all number
    9
    20
    17
    61
    Paraesthesia
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 61 (1.64%)
    0 / 58 (0.00%)
    1 / 92 (1.09%)
         occurrences all number
    2
    1
    0
    1
    Peripheral sensory neuropathy
         subjects affected / exposed
    3 / 30 (10.00%)
    2 / 61 (3.28%)
    7 / 58 (12.07%)
    7 / 92 (7.61%)
         occurrences all number
    5
    2
    7
    8
    Tremor
         subjects affected / exposed
    0 / 30 (0.00%)
    10 / 61 (16.39%)
    1 / 58 (1.72%)
    11 / 92 (11.96%)
         occurrences all number
    0
    10
    1
    12
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    8 / 30 (26.67%)
    1 / 61 (1.64%)
    8 / 58 (13.79%)
    10 / 92 (10.87%)
         occurrences all number
    10
    1
    8
    14
    Thrombocytopenia
         subjects affected / exposed
    25 / 30 (83.33%)
    21 / 61 (34.43%)
    40 / 58 (68.97%)
    54 / 92 (58.70%)
         occurrences all number
    45
    26
    89
    125
    Neutropenia
         subjects affected / exposed
    14 / 30 (46.67%)
    31 / 61 (50.82%)
    36 / 58 (62.07%)
    75 / 92 (81.52%)
         occurrences all number
    33
    65
    85
    196
    Lymphopenia
         subjects affected / exposed
    4 / 30 (13.33%)
    9 / 61 (14.75%)
    7 / 58 (12.07%)
    25 / 92 (27.17%)
         occurrences all number
    10
    13
    18
    41
    Leukopenia
         subjects affected / exposed
    7 / 30 (23.33%)
    5 / 61 (8.20%)
    6 / 58 (10.34%)
    17 / 92 (18.48%)
         occurrences all number
    13
    8
    9
    39
    Anaemia
         subjects affected / exposed
    20 / 30 (66.67%)
    24 / 61 (39.34%)
    41 / 58 (70.69%)
    62 / 92 (67.39%)
         occurrences all number
    33
    46
    73
    133
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 61 (0.00%)
    5 / 58 (8.62%)
    4 / 92 (4.35%)
         occurrences all number
    1
    0
    5
    4
    Ear pain
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 61 (3.28%)
    0 / 58 (0.00%)
    6 / 92 (6.52%)
         occurrences all number
    0
    2
    0
    7
    Eye disorders
    Vision blurred
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 61 (1.64%)
    3 / 58 (5.17%)
    6 / 92 (6.52%)
         occurrences all number
    1
    1
    4
    7
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    2 / 30 (6.67%)
    2 / 61 (3.28%)
    4 / 58 (6.90%)
    6 / 92 (6.52%)
         occurrences all number
    4
    3
    5
    6
    Oral pain
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 61 (1.64%)
    6 / 58 (10.34%)
    3 / 92 (3.26%)
         occurrences all number
    2
    1
    6
    3
    Oesophagitis
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 61 (0.00%)
    2 / 58 (3.45%)
    0 / 92 (0.00%)
         occurrences all number
    2
    0
    2
    0
    Nausea
         subjects affected / exposed
    17 / 30 (56.67%)
    14 / 61 (22.95%)
    36 / 58 (62.07%)
    49 / 92 (53.26%)
         occurrences all number
    31
    15
    60
    80
    Haemorrhoids
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 61 (1.64%)
    4 / 58 (6.90%)
    2 / 92 (2.17%)
         occurrences all number
    2
    1
    4
    2
    Haematochezia
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 61 (0.00%)
    0 / 58 (0.00%)
    1 / 92 (1.09%)
         occurrences all number
    2
    0
    0
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 61 (1.64%)
    5 / 58 (8.62%)
    3 / 92 (3.26%)
         occurrences all number
    2
    1
    5
    3
    Dyspepsia
         subjects affected / exposed
    3 / 30 (10.00%)
    3 / 61 (4.92%)
    8 / 58 (13.79%)
    5 / 92 (5.43%)
         occurrences all number
    3
    3
    9
    5
    Dry mouth
         subjects affected / exposed
    3 / 30 (10.00%)
    2 / 61 (3.28%)
    5 / 58 (8.62%)
    7 / 92 (7.61%)
         occurrences all number
    3
    2
    6
    7
    Diarrhoea
         subjects affected / exposed
    14 / 30 (46.67%)
    9 / 61 (14.75%)
    24 / 58 (41.38%)
    23 / 92 (25.00%)
         occurrences all number
    20
    10
    34
    33
    Constipation
         subjects affected / exposed
    5 / 30 (16.67%)
    10 / 61 (16.39%)
    19 / 58 (32.76%)
    30 / 92 (32.61%)
         occurrences all number
    5
    10
    23
    43
    Abdominal pain upper
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 61 (0.00%)
    3 / 58 (5.17%)
    1 / 92 (1.09%)
         occurrences all number
    2
    0
    3
    1
    Abdominal pain lower
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 61 (0.00%)
    3 / 58 (5.17%)
    1 / 92 (1.09%)
         occurrences all number
    0
    0
    3
    3
    Stomatitis
         subjects affected / exposed
    4 / 30 (13.33%)
    1 / 61 (1.64%)
    5 / 58 (8.62%)
    6 / 92 (6.52%)
         occurrences all number
    4
    1
    6
    6
    Abdominal pain
         subjects affected / exposed
    5 / 30 (16.67%)
    4 / 61 (6.56%)
    8 / 58 (13.79%)
    13 / 92 (14.13%)
         occurrences all number
    6
    4
    9
    15
    Vomiting
         subjects affected / exposed
    10 / 30 (33.33%)
    6 / 61 (9.84%)
    16 / 58 (27.59%)
    18 / 92 (19.57%)
         occurrences all number
    11
    6
    21
    30
    Skin and subcutaneous tissue disorders
    Night sweats
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 61 (1.64%)
    4 / 58 (6.90%)
    2 / 92 (2.17%)
         occurrences all number
    1
    1
    5
    2
    Hyperhidrosis
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 61 (0.00%)
    3 / 58 (5.17%)
    1 / 92 (1.09%)
         occurrences all number
    0
    0
    3
    1
    Erythema
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 61 (1.64%)
    3 / 58 (5.17%)
    2 / 92 (2.17%)
         occurrences all number
    0
    1
    3
    2
    Dry skin
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 61 (0.00%)
    3 / 58 (5.17%)
    5 / 92 (5.43%)
         occurrences all number
    1
    0
    3
    5
    Alopecia
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 61 (0.00%)
    4 / 58 (6.90%)
    2 / 92 (2.17%)
         occurrences all number
    1
    0
    4
    2
    Skin mass
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 61 (0.00%)
    1 / 58 (1.72%)
    0 / 92 (0.00%)
         occurrences all number
    2
    0
    1
    0
    Skin lesion
         subjects affected / exposed
    0 / 30 (0.00%)
    3 / 61 (4.92%)
    0 / 58 (0.00%)
    1 / 92 (1.09%)
         occurrences all number
    0
    3
    0
    1
    Rash maculo-papular
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 61 (1.64%)
    1 / 58 (1.72%)
    2 / 92 (2.17%)
         occurrences all number
    3
    1
    1
    3
    Pruritus
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 61 (1.64%)
    1 / 58 (1.72%)
    7 / 92 (7.61%)
         occurrences all number
    1
    1
    1
    9
    Petechiae
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 61 (0.00%)
    3 / 58 (5.17%)
    1 / 92 (1.09%)
         occurrences all number
    0
    0
    3
    1
    Rash
         subjects affected / exposed
    1 / 30 (3.33%)
    5 / 61 (8.20%)
    0 / 58 (0.00%)
    9 / 92 (9.78%)
         occurrences all number
    1
    5
    0
    9
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    2 / 30 (6.67%)
    2 / 61 (3.28%)
    4 / 58 (6.90%)
    4 / 92 (4.35%)
         occurrences all number
    3
    5
    7
    4
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 30 (10.00%)
    7 / 61 (11.48%)
    8 / 58 (13.79%)
    17 / 92 (18.48%)
         occurrences all number
    4
    10
    9
    17
    Back pain
         subjects affected / exposed
    3 / 30 (10.00%)
    3 / 61 (4.92%)
    12 / 58 (20.69%)
    14 / 92 (15.22%)
         occurrences all number
    3
    3
    13
    16
    Musculoskeletal chest pain
         subjects affected / exposed
    2 / 30 (6.67%)
    4 / 61 (6.56%)
    0 / 58 (0.00%)
    3 / 92 (3.26%)
         occurrences all number
    2
    4
    0
    3
    Muscle spasms
         subjects affected / exposed
    2 / 30 (6.67%)
    2 / 61 (3.28%)
    1 / 58 (1.72%)
    5 / 92 (5.43%)
         occurrences all number
    2
    2
    2
    6
    Flank pain
         subjects affected / exposed
    2 / 30 (6.67%)
    2 / 61 (3.28%)
    3 / 58 (5.17%)
    3 / 92 (3.26%)
         occurrences all number
    3
    2
    3
    4
    Bone pain
         subjects affected / exposed
    3 / 30 (10.00%)
    3 / 61 (4.92%)
    6 / 58 (10.34%)
    12 / 92 (13.04%)
         occurrences all number
    3
    3
    6
    15
    Myalgia
         subjects affected / exposed
    2 / 30 (6.67%)
    5 / 61 (8.20%)
    3 / 58 (5.17%)
    11 / 92 (11.96%)
         occurrences all number
    2
    5
    3
    13
    Neck pain
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 61 (3.28%)
    3 / 58 (5.17%)
    7 / 92 (7.61%)
         occurrences all number
    0
    2
    3
    8
    Pain in extremity
         subjects affected / exposed
    2 / 30 (6.67%)
    4 / 61 (6.56%)
    6 / 58 (10.34%)
    8 / 92 (8.70%)
         occurrences all number
    4
    4
    7
    8
    Muscular weakness
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 61 (3.28%)
    3 / 58 (5.17%)
    5 / 92 (5.43%)
         occurrences all number
    0
    2
    4
    6
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    2 / 30 (6.67%)
    2 / 61 (3.28%)
    1 / 58 (1.72%)
    2 / 92 (2.17%)
         occurrences all number
    2
    2
    1
    2
    Oral candidiasis
         subjects affected / exposed
    3 / 30 (10.00%)
    0 / 61 (0.00%)
    1 / 58 (1.72%)
    2 / 92 (2.17%)
         occurrences all number
    3
    0
    1
    2
    COVID-19
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 61 (0.00%)
    0 / 58 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Urinary tract infection
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 61 (1.64%)
    3 / 58 (5.17%)
    6 / 92 (6.52%)
         occurrences all number
    1
    1
    3
    7
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    12 / 30 (40.00%)
    8 / 61 (13.11%)
    20 / 58 (34.48%)
    21 / 92 (22.83%)
         occurrences all number
    16
    11
    25
    29
    Dehydration
         subjects affected / exposed
    1 / 30 (3.33%)
    2 / 61 (3.28%)
    3 / 58 (5.17%)
    2 / 92 (2.17%)
         occurrences all number
    1
    2
    3
    3
    Hypercalcaemia
         subjects affected / exposed
    3 / 30 (10.00%)
    1 / 61 (1.64%)
    2 / 58 (3.45%)
    2 / 92 (2.17%)
         occurrences all number
    3
    3
    2
    3
    Hyperglycaemia
         subjects affected / exposed
    4 / 30 (13.33%)
    4 / 61 (6.56%)
    5 / 58 (8.62%)
    6 / 92 (6.52%)
         occurrences all number
    8
    14
    8
    13
    Hyperkalaemia
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 61 (1.64%)
    4 / 58 (6.90%)
    0 / 92 (0.00%)
         occurrences all number
    0
    1
    4
    0
    Hypernatraemia
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 61 (1.64%)
    1 / 58 (1.72%)
    1 / 92 (1.09%)
         occurrences all number
    2
    1
    1
    2
    Hyperphosphataemia
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 61 (0.00%)
    0 / 58 (0.00%)
    2 / 92 (2.17%)
         occurrences all number
    2
    0
    0
    4
    Hypertriglyceridaemia
         subjects affected / exposed
    2 / 30 (6.67%)
    2 / 61 (3.28%)
    4 / 58 (6.90%)
    6 / 92 (6.52%)
         occurrences all number
    3
    4
    6
    8
    Hyperuricaemia
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 61 (1.64%)
    3 / 58 (5.17%)
    3 / 92 (3.26%)
         occurrences all number
    2
    1
    4
    4
    Hypoalbuminaemia
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 61 (1.64%)
    2 / 58 (3.45%)
    4 / 92 (4.35%)
         occurrences all number
    3
    4
    2
    9
    Hypocalcaemia
         subjects affected / exposed
    1 / 30 (3.33%)
    6 / 61 (9.84%)
    5 / 58 (8.62%)
    7 / 92 (7.61%)
         occurrences all number
    3
    12
    5
    12
    Hypokalaemia
         subjects affected / exposed
    8 / 30 (26.67%)
    10 / 61 (16.39%)
    14 / 58 (24.14%)
    21 / 92 (22.83%)
         occurrences all number
    13
    13
    28
    28
    Hypomagnesaemia
         subjects affected / exposed
    8 / 30 (26.67%)
    5 / 61 (8.20%)
    13 / 58 (22.41%)
    15 / 92 (16.30%)
         occurrences all number
    21
    9
    27
    26
    Hyponatraemia
         subjects affected / exposed
    2 / 30 (6.67%)
    2 / 61 (3.28%)
    5 / 58 (8.62%)
    9 / 92 (9.78%)
         occurrences all number
    6
    6
    7
    14
    Hypophosphataemia
         subjects affected / exposed
    7 / 30 (23.33%)
    5 / 61 (8.20%)
    10 / 58 (17.24%)
    7 / 92 (7.61%)
         occurrences all number
    11
    6
    14
    11
    Malnutrition
         subjects affected / exposed
    4 / 30 (13.33%)
    2 / 61 (3.28%)
    0 / 58 (0.00%)
    1 / 92 (1.09%)
         occurrences all number
    5
    2
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Feb 2019
    Eligibility criteria, study design, endpoints, concomitant medication and procedures, prohibited concomitant medication and procedures updated.
    09 Dec 2019
    Toxicity management guidelines update for MAS/HLH

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    13 Mar 2020
    Temporary suspension of screening, enrollment, and apheresis due to COVID-19 pandemic
    27 Apr 2020

    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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