Trial Outcomes & Findings for Study of Effectiveness of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Patients With Relapsed/Refractory Diffuse Large B Cell Lymphoma (NCT NCT03391466)
NCT ID: NCT03391466
Last Updated: 2025-12-01
Results Overview
EFS:Time from randomization to disease progression (PD), best response of stable disease (SD) up to Day 150, start of new anti-lymphoma therapy including stem cell transplant, or death from any cause. PD=Score 4 (uptake moderately \> liver) or 5 (uptake markedly \> liver and/or new lesions) with increased uptake from baseline; New fluorodeoxyglucose (FDG)-avid foci consistent with lymphoma rather than another etiology or in bone marrow; Individual node/lesion abnormal with longest diameter \> 1.5 cm, ≥ 50% increase from nadir; Splenic length increase \> 50% of prior increase beyond baseline or ≥ 2 cm increase if no prior splenomegaly; New/recurrent splenomegaly, progression of non-measurable lesions, new lesion, or new/recurrent bone marrow involvement. KM estimates was used for analysis.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
359 participants
Primary outcome timeframe
From randomization date up to a median follow-up: 24.9 months
Results posted on
2025-12-01
Participant Flow
Participants were enrolled at study sites in North America, Middle East, Europe, and Australia.
437 participants were screened.
Participant milestones
| Measure |
Axicabtagene Ciloleucel
Participants received cyclophosphamide 500 mg/m\^2/day intravenous (IV) infusion and fludarabine 30 mg/m\^2/day IV infusion conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10\^6 anti-cluster of differentiation antigen (CD) 19 chimeric antigen receptor (CAR) transduced autologous T cells/kg on Day 0.
|
Standard of Care Therapy
Participants received 2 or 3, 21-day cycles of second-line chemotherapy regimen:
R-ICE: rituximab 375mg/m\^2 before chemotherapy, ifosfamide 5g/m\^2 24 hours continuous infusion (CI) on Day 2 + mesna, carboplatin area under the curve (AUC) 5 Day 2, maximum dose 800mg, etoposide 100mg/m\^2/day on Days 1-3; R-ESHAP: rituximab 375mg/m\^2 Day 1, etoposide 40mg/m\^2/day IV on Days 1-4, methylprednisolone 500mg/day IV on Days 1-4 or 5, cisplatin at 25mg/m\^2/day CI Days 1-4, cytarabine 2g/m\^2 on Day 5; R-GDP: rituximab 375mg/m\^2 Day 1 (or Day 8), gemcitabine 1g/m\^2 on Days 1 and 8, dexamethasone 40mg on Days 1-4, cisplatin 75mg/m\^2 Day 1 or carboplatin AUC=5; or R-DHAP: rituximab 375mg/m\^2 before chemotherapy, dexamethasone 40mg/day on Days 1-4, high dose cytarabine 2g/m\^2 every 12 hours for 2 doses on Day 2 following platinum, cisplatin 100mg/m\^2 24 hours CI on Day 1 or oxaliplatin 100mg/m\^2.
Participants who responded to second-line chemotherapy got high dose therapy and autologous stem cell transplant.
|
|---|---|---|
|
Overall Study
STARTED
|
180
|
179
|
|
Overall Study
COMPLETED
|
2
|
67
|
|
Overall Study
NOT COMPLETED
|
178
|
112
|
Reasons for withdrawal
| Measure |
Axicabtagene Ciloleucel
Participants received cyclophosphamide 500 mg/m\^2/day intravenous (IV) infusion and fludarabine 30 mg/m\^2/day IV infusion conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10\^6 anti-cluster of differentiation antigen (CD) 19 chimeric antigen receptor (CAR) transduced autologous T cells/kg on Day 0.
|
Standard of Care Therapy
Participants received 2 or 3, 21-day cycles of second-line chemotherapy regimen:
R-ICE: rituximab 375mg/m\^2 before chemotherapy, ifosfamide 5g/m\^2 24 hours continuous infusion (CI) on Day 2 + mesna, carboplatin area under the curve (AUC) 5 Day 2, maximum dose 800mg, etoposide 100mg/m\^2/day on Days 1-3; R-ESHAP: rituximab 375mg/m\^2 Day 1, etoposide 40mg/m\^2/day IV on Days 1-4, methylprednisolone 500mg/day IV on Days 1-4 or 5, cisplatin at 25mg/m\^2/day CI Days 1-4, cytarabine 2g/m\^2 on Day 5; R-GDP: rituximab 375mg/m\^2 Day 1 (or Day 8), gemcitabine 1g/m\^2 on Days 1 and 8, dexamethasone 40mg on Days 1-4, cisplatin 75mg/m\^2 Day 1 or carboplatin AUC=5; or R-DHAP: rituximab 375mg/m\^2 before chemotherapy, dexamethasone 40mg/day on Days 1-4, high dose cytarabine 2g/m\^2 every 12 hours for 2 doses on Day 2 following platinum, cisplatin 100mg/m\^2 24 hours CI on Day 1 or oxaliplatin 100mg/m\^2.
Participants who responded to second-line chemotherapy got high dose therapy and autologous stem cell transplant.
|
|---|---|---|
|
Overall Study
Death
|
84
|
91
|
|
Overall Study
Rollover to Long-term Follow-up Study Criteria
|
80
|
0
|
|
Overall Study
Subject Withdrawal of Consent from Further Follow-up
|
3
|
13
|
|
Overall Study
Lost to Follow-up
|
9
|
5
|
|
Overall Study
Reason Not Specified
|
2
|
2
|
|
Overall Study
Investigator Decision
|
0
|
1
|
Baseline Characteristics
Study of Effectiveness of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Patients With Relapsed/Refractory Diffuse Large B Cell Lymphoma
Baseline characteristics by cohort
| Measure |
Axicabtagene Ciloleucel
n=180 Participants
Participants received cyclophosphamide 500 mg/m\^2/day IV infusion and fludarabine 30 mg/m\^2/day IV infusion conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10\^6 anti-CD 19 CAR transduced autologous T cells/kg on Day 0.
|
Standard of Care Therapy
n=179 Participants
Participants received 2 or 3, 21-day cycles of second-line chemotherapy regimen:
* R-ICE: rituximab 375mg/m\^2 before chemotherapy, ifosfamide 5g/m\^2 24 hours CI on Day 2 + mesna, carboplatin AUC 5 Day 2, maximum dose 800mg, etoposide 100mg/m\^2/day on Days 1-3;
* R-ESHAP: rituximab 375mg/m\^2 Day 1, etoposide 40mg/m\^2/day IV on Days 1-4, methylprednisolone 500mg/day IV on Days 1-4 or 5, cisplatin at 25mg/m\^2/day CI Days 1-4, cytarabine 2g/m\^2 on Day 5;
* R-GDP: rituximab 375mg/m\^2 Day 1 (or Day 8), gemcitabine 1g/m\^2 on Days 1 and 8, dexamethasone 40mg on Days 1-4, cisplatin 75mg/m\^2 Day 1 or carboplatin AUC=5; or
* R-DHAP: rituximab 375mg/m\^2 before chemotherapy, dexamethasone 40mg/day on Days 1-4, high dose cytarabine 2g/m\^2 every 12 hours for 2 doses on Day 2 following platinum, cisplatin 100mg/m\^2 24 hours CI on Day 1 or oxaliplatin 100mg/m\^2.
Participants who responded to second-line chemotherapy got high dose therapy and autologous stem cell transplant.
|
Total
n=359 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
129 Participants
n=121 Participants
|
121 Participants
n=122 Participants
|
250 Participants
n=243 Participants
|
|
Age, Categorical
>=65 years
|
51 Participants
n=121 Participants
|
58 Participants
n=122 Participants
|
109 Participants
n=243 Participants
|
|
Age, Continuous
|
57.1 years
STANDARD_DEVIATION 12.0 • n=121 Participants
|
57.4 years
STANDARD_DEVIATION 12.2 • n=122 Participants
|
57.2 years
STANDARD_DEVIATION 12.1 • n=243 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=121 Participants
|
52 Participants
n=122 Participants
|
122 Participants
n=243 Participants
|
|
Sex: Female, Male
Male
|
110 Participants
n=121 Participants
|
127 Participants
n=122 Participants
|
237 Participants
n=243 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=121 Participants
|
8 Participants
n=122 Participants
|
18 Participants
n=243 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
167 Participants
n=121 Participants
|
169 Participants
n=122 Participants
|
336 Participants
n=243 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=121 Participants
|
2 Participants
n=122 Participants
|
5 Participants
n=243 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=121 Participants
|
1 Participants
n=122 Participants
|
1 Participants
n=243 Participants
|
|
Race (NIH/OMB)
Asian
|
12 Participants
n=121 Participants
|
10 Participants
n=122 Participants
|
22 Participants
n=243 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=121 Participants
|
1 Participants
n=122 Participants
|
3 Participants
n=243 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=121 Participants
|
7 Participants
n=122 Participants
|
18 Participants
n=243 Participants
|
|
Race (NIH/OMB)
White
|
145 Participants
n=121 Participants
|
152 Participants
n=122 Participants
|
297 Participants
n=243 Participants
|
|
Race (NIH/OMB)
More than one race
|
10 Participants
n=121 Participants
|
8 Participants
n=122 Participants
|
18 Participants
n=243 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
|
Region of Enrollment
United States
|
130 Participants
n=121 Participants
|
120 Participants
n=122 Participants
|
250 Participants
n=243 Participants
|
|
Region of Enrollment
United Kingdom
|
4 Participants
n=121 Participants
|
8 Participants
n=122 Participants
|
12 Participants
n=243 Participants
|
|
Region of Enrollment
Switzerland
|
1 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
1 Participants
n=243 Participants
|
|
Region of Enrollment
Spain
|
6 Participants
n=121 Participants
|
9 Participants
n=122 Participants
|
15 Participants
n=243 Participants
|
|
Region of Enrollment
Canada
|
10 Participants
n=121 Participants
|
10 Participants
n=122 Participants
|
20 Participants
n=243 Participants
|
|
Region of Enrollment
Belgium
|
4 Participants
n=121 Participants
|
3 Participants
n=122 Participants
|
7 Participants
n=243 Participants
|
|
Region of Enrollment
Netherlands
|
11 Participants
n=121 Participants
|
14 Participants
n=122 Participants
|
25 Participants
n=243 Participants
|
|
Region of Enrollment
Sweden
|
0 Participants
n=121 Participants
|
1 Participants
n=122 Participants
|
1 Participants
n=243 Participants
|
|
Region of Enrollment
Italy
|
2 Participants
n=121 Participants
|
1 Participants
n=122 Participants
|
3 Participants
n=243 Participants
|
|
Region of Enrollment
Israel
|
4 Participants
n=121 Participants
|
2 Participants
n=122 Participants
|
6 Participants
n=243 Participants
|
|
Region of Enrollment
Australia
|
2 Participants
n=121 Participants
|
2 Participants
n=122 Participants
|
4 Participants
n=243 Participants
|
|
Region of Enrollment
France
|
4 Participants
n=121 Participants
|
2 Participants
n=122 Participants
|
6 Participants
n=243 Participants
|
|
Region of Enrollment
Germany
|
1 Participants
n=121 Participants
|
5 Participants
n=122 Participants
|
6 Participants
n=243 Participants
|
|
Region of Enrollment
Austria
|
1 Participants
n=121 Participants
|
2 Participants
n=122 Participants
|
3 Participants
n=243 Participants
|
PRIMARY outcome
Timeframe: From randomization date up to a median follow-up: 24.9 monthsPopulation: Participants in Full Analysis Set were analyzed.
EFS:Time from randomization to disease progression (PD), best response of stable disease (SD) up to Day 150, start of new anti-lymphoma therapy including stem cell transplant, or death from any cause. PD=Score 4 (uptake moderately \> liver) or 5 (uptake markedly \> liver and/or new lesions) with increased uptake from baseline; New fluorodeoxyglucose (FDG)-avid foci consistent with lymphoma rather than another etiology or in bone marrow; Individual node/lesion abnormal with longest diameter \> 1.5 cm, ≥ 50% increase from nadir; Splenic length increase \> 50% of prior increase beyond baseline or ≥ 2 cm increase if no prior splenomegaly; New/recurrent splenomegaly, progression of non-measurable lesions, new lesion, or new/recurrent bone marrow involvement. KM estimates was used for analysis.
Outcome measures
| Measure |
Axicabtagene Ciloleucel
n=180 Participants
Participants received cyclophosphamide 500 mg/m\^2/day IV infusion and fludarabine 30 mg/m\^2/day IV infusion conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
|
Standard of Care Therapy
n=179 Participants
Participants received 2 or 3, 21-day cycles of second-line chemotherapy regimen:
* R-ICE: rituximab 375mg/m\^2 before chemotherapy, ifosfamide 5g/m\^2 24 hours CI on Day 2 + mesna, carboplatin AUC 5 Day 2, maximum dose 800mg, etoposide 100mg/m\^2/day on Days 1-3;
* R-ESHAP: rituximab 375mg/m\^2 Day 1, etoposide 40mg/m\^2/day IV on Days 1-4, methylprednisolone 500mg/day IV on Days 1-4 or 5, cisplatin at 25mg/m\^2/day CI Days 1-4, cytarabine 2g/m\^2 on Day 5;
* R-GDP: rituximab 375mg/m\^2 Day 1 (or Day 8), gemcitabine 1g/m\^2 on Days 1 and 8, dexamethasone 40mg on Days 1-4, cisplatin 75mg/m\^2 Day 1 or carboplatin AUC=5; or
* R-DHAP: rituximab 375mg/m\^2 before chemotherapy, dexamethasone 40mg/day on Days 1-4, high dose cytarabine 2g/m\^2 every 12 hours for 2 doses on Day 2 following platinum, cisplatin 100mg/m\^2 24 hours CI on Day 1 or oxaliplatin 100mg/m\^2.
Participants who responded to second-line chemotherapy got high dose therapy and autologous stem cell transplant.
|
|---|---|---|
|
Event Free Survival (EFS) Per Blinded Central Assessment
|
8.3 months
Interval 4.5 to 15.8
|
2.0 months
Interval 1.6 to 2.8
|
SECONDARY outcome
Timeframe: From randomization date up to a median follow-up: 24.9 monthsPopulation: Participants in the Full Analysis Set were analyzed.
ORR: Percentage of participants with CR (Complete Metabolic Response (CMR);Complete Radiologic Response (CRR)) or PR (partial metabolic response (PMR); partial radiologic response (PRR)).CMR: Positron emission tomography (PET) 5-point scale scores: 1-No uptake above background; 2-Uptake ≤mediastinum; 3-Uptake \>mediastinum but ≤liver, with/without residual mass; no new lesions, no FDG-avid disease in bone marrow. CRR: Target nodes/nodal masses regressed ≤1.5 cm in longest diameter, no extralymphatic sites, no non-measured lesions, normal organ size, no new sites, normal bone marrow morphology. PMR: Scores 4 (uptake moderately \>liver), 5 (uptake markedly \>liver, new lesions) with reduced uptake from baseline and residual mass, no new lesions. Responding at interim/residual disease at end of treatment. PRR: ≥50% decrease in sum of diameters of up to 6 target measurable lesions, no increase in non-measured lesions, spleen length decreased \>50% if previously enlarged, no new lesion sites.
Outcome measures
| Measure |
Axicabtagene Ciloleucel
n=180 Participants
Participants received cyclophosphamide 500 mg/m\^2/day IV infusion and fludarabine 30 mg/m\^2/day IV infusion conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
|
Standard of Care Therapy
n=179 Participants
Participants received 2 or 3, 21-day cycles of second-line chemotherapy regimen:
* R-ICE: rituximab 375mg/m\^2 before chemotherapy, ifosfamide 5g/m\^2 24 hours CI on Day 2 + mesna, carboplatin AUC 5 Day 2, maximum dose 800mg, etoposide 100mg/m\^2/day on Days 1-3;
* R-ESHAP: rituximab 375mg/m\^2 Day 1, etoposide 40mg/m\^2/day IV on Days 1-4, methylprednisolone 500mg/day IV on Days 1-4 or 5, cisplatin at 25mg/m\^2/day CI Days 1-4, cytarabine 2g/m\^2 on Day 5;
* R-GDP: rituximab 375mg/m\^2 Day 1 (or Day 8), gemcitabine 1g/m\^2 on Days 1 and 8, dexamethasone 40mg on Days 1-4, cisplatin 75mg/m\^2 Day 1 or carboplatin AUC=5; or
* R-DHAP: rituximab 375mg/m\^2 before chemotherapy, dexamethasone 40mg/day on Days 1-4, high dose cytarabine 2g/m\^2 every 12 hours for 2 doses on Day 2 following platinum, cisplatin 100mg/m\^2 24 hours CI on Day 1 or oxaliplatin 100mg/m\^2.
Participants who responded to second-line chemotherapy got high dose therapy and autologous stem cell transplant.
|
|---|---|---|
|
Objective Response Rate (ORR) Per Blinded Central Assessment
|
83 percentage of participants
Interval 77.1 to 88.5
|
50 percentage of participants
Interval 42.7 to 57.8
|
SECONDARY outcome
Timeframe: Up to 74.9 monthsPopulation: Participants in the Full Analysis Set were analyzed.
Overall survival is defined as the time from randomization to death from any cause. Kaplan-Meier (KM) estimates were used for analysis.
Outcome measures
| Measure |
Axicabtagene Ciloleucel
n=180 Participants
Participants received cyclophosphamide 500 mg/m\^2/day IV infusion and fludarabine 30 mg/m\^2/day IV infusion conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
|
Standard of Care Therapy
n=179 Participants
Participants received 2 or 3, 21-day cycles of second-line chemotherapy regimen:
* R-ICE: rituximab 375mg/m\^2 before chemotherapy, ifosfamide 5g/m\^2 24 hours CI on Day 2 + mesna, carboplatin AUC 5 Day 2, maximum dose 800mg, etoposide 100mg/m\^2/day on Days 1-3;
* R-ESHAP: rituximab 375mg/m\^2 Day 1, etoposide 40mg/m\^2/day IV on Days 1-4, methylprednisolone 500mg/day IV on Days 1-4 or 5, cisplatin at 25mg/m\^2/day CI Days 1-4, cytarabine 2g/m\^2 on Day 5;
* R-GDP: rituximab 375mg/m\^2 Day 1 (or Day 8), gemcitabine 1g/m\^2 on Days 1 and 8, dexamethasone 40mg on Days 1-4, cisplatin 75mg/m\^2 Day 1 or carboplatin AUC=5; or
* R-DHAP: rituximab 375mg/m\^2 before chemotherapy, dexamethasone 40mg/day on Days 1-4, high dose cytarabine 2g/m\^2 every 12 hours for 2 doses on Day 2 following platinum, cisplatin 100mg/m\^2 24 hours CI on Day 1 or oxaliplatin 100mg/m\^2.
Participants who responded to second-line chemotherapy got high dose therapy and autologous stem cell transplant.
|
|---|---|---|
|
Overall Survival (OS)
|
NA months
Interval 28.3 to
Median and upper limit of CI were not reached due to insufficient number of events.
|
35.1 months
Interval 18.5 to
Upper limit of CI was not reached due to insufficient number of events.
|
SECONDARY outcome
Timeframe: From the date of first confirmed objective response (CR or PR) to disease progression or death regardless of cause (Up to 37.8 months)Population: Participants in the Full Analysis Set with objective response were analyzed. Participants not meeting the criteria by the analysis data cut-off date were censored at their last evaluable disease assessment date prior to the data cut-off date or new lymphoma therapy start date (including stem cell transplant in the axicabtagene ciloleucel arm or retreatment of axicabtagene ciloleucel), whichever was earlier.
DOR was defined only for participants who experience an objective response after axicabtagene ciloleucel infusion and was the time from the first objective response per Lugano classification to disease progression or death from any cause. Objective response was defined in outcome measure 2 and disease progression was defined in outcome measure 1. KM estimates were used for analysis.
Outcome measures
| Measure |
Axicabtagene Ciloleucel
n=150 Participants
Participants received cyclophosphamide 500 mg/m\^2/day IV infusion and fludarabine 30 mg/m\^2/day IV infusion conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
|
Standard of Care Therapy
n=90 Participants
Participants received 2 or 3, 21-day cycles of second-line chemotherapy regimen:
* R-ICE: rituximab 375mg/m\^2 before chemotherapy, ifosfamide 5g/m\^2 24 hours CI on Day 2 + mesna, carboplatin AUC 5 Day 2, maximum dose 800mg, etoposide 100mg/m\^2/day on Days 1-3;
* R-ESHAP: rituximab 375mg/m\^2 Day 1, etoposide 40mg/m\^2/day IV on Days 1-4, methylprednisolone 500mg/day IV on Days 1-4 or 5, cisplatin at 25mg/m\^2/day CI Days 1-4, cytarabine 2g/m\^2 on Day 5;
* R-GDP: rituximab 375mg/m\^2 Day 1 (or Day 8), gemcitabine 1g/m\^2 on Days 1 and 8, dexamethasone 40mg on Days 1-4, cisplatin 75mg/m\^2 Day 1 or carboplatin AUC=5; or
* R-DHAP: rituximab 375mg/m\^2 before chemotherapy, dexamethasone 40mg/day on Days 1-4, high dose cytarabine 2g/m\^2 every 12 hours for 2 doses on Day 2 following platinum, cisplatin 100mg/m\^2 24 hours CI on Day 1 or oxaliplatin 100mg/m\^2.
Participants who responded to second-line chemotherapy got high dose therapy and autologous stem cell transplant.
|
|---|---|---|
|
Duration of Response (DOR) Per Blinded Central Assessments
|
26.9 months
Interval 13.6 to
Upper limit of CI was not reached due to insufficient number of events.
|
8.9 months
Interval 5.7 to
Upper limit of CI was not reached due to insufficient number of events.
|
SECONDARY outcome
Timeframe: From randomization date up to a median follow-up: 24.9 monthsPopulation: Participants in the Full Analysis Set were analyzed.
Modified event free survival is defined the same way as EFS, except that a best response of SD up to and including Day 150 assessment post randomization was not considered an event. KM estimates were used for analysis.
Outcome measures
| Measure |
Axicabtagene Ciloleucel
n=180 Participants
Participants received cyclophosphamide 500 mg/m\^2/day IV infusion and fludarabine 30 mg/m\^2/day IV infusion conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
|
Standard of Care Therapy
n=179 Participants
Participants received 2 or 3, 21-day cycles of second-line chemotherapy regimen:
* R-ICE: rituximab 375mg/m\^2 before chemotherapy, ifosfamide 5g/m\^2 24 hours CI on Day 2 + mesna, carboplatin AUC 5 Day 2, maximum dose 800mg, etoposide 100mg/m\^2/day on Days 1-3;
* R-ESHAP: rituximab 375mg/m\^2 Day 1, etoposide 40mg/m\^2/day IV on Days 1-4, methylprednisolone 500mg/day IV on Days 1-4 or 5, cisplatin at 25mg/m\^2/day CI Days 1-4, cytarabine 2g/m\^2 on Day 5;
* R-GDP: rituximab 375mg/m\^2 Day 1 (or Day 8), gemcitabine 1g/m\^2 on Days 1 and 8, dexamethasone 40mg on Days 1-4, cisplatin 75mg/m\^2 Day 1 or carboplatin AUC=5; or
* R-DHAP: rituximab 375mg/m\^2 before chemotherapy, dexamethasone 40mg/day on Days 1-4, high dose cytarabine 2g/m\^2 every 12 hours for 2 doses on Day 2 following platinum, cisplatin 100mg/m\^2 24 hours CI on Day 1 or oxaliplatin 100mg/m\^2.
Participants who responded to second-line chemotherapy got high dose therapy and autologous stem cell transplant.
|
|---|---|---|
|
Modified Event Free Survival (mEFS) Per Blinded Central Assessment
|
10.3 months
Interval 5.0 to 21.5
|
2.0 months
Interval 1.6 to 2.8
|
SECONDARY outcome
Timeframe: From randomization date up to a median follow-up: 47.2 monthsPopulation: Participants in the Full Analysis Set were analyzed.
EFS was defined as the time from randomization to the earliest date of disease progression per the Lugano Classification, best response of stable disease (SD) up to and including Day 150, commencement of new lymphoma therapy, or death from any cause. Disease progression is defined in outcome measure 1.
Outcome measures
| Measure |
Axicabtagene Ciloleucel
n=180 Participants
Participants received cyclophosphamide 500 mg/m\^2/day IV infusion and fludarabine 30 mg/m\^2/day IV infusion conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
|
Standard of Care Therapy
n=179 Participants
Participants received 2 or 3, 21-day cycles of second-line chemotherapy regimen:
* R-ICE: rituximab 375mg/m\^2 before chemotherapy, ifosfamide 5g/m\^2 24 hours CI on Day 2 + mesna, carboplatin AUC 5 Day 2, maximum dose 800mg, etoposide 100mg/m\^2/day on Days 1-3;
* R-ESHAP: rituximab 375mg/m\^2 Day 1, etoposide 40mg/m\^2/day IV on Days 1-4, methylprednisolone 500mg/day IV on Days 1-4 or 5, cisplatin at 25mg/m\^2/day CI Days 1-4, cytarabine 2g/m\^2 on Day 5;
* R-GDP: rituximab 375mg/m\^2 Day 1 (or Day 8), gemcitabine 1g/m\^2 on Days 1 and 8, dexamethasone 40mg on Days 1-4, cisplatin 75mg/m\^2 Day 1 or carboplatin AUC=5; or
* R-DHAP: rituximab 375mg/m\^2 before chemotherapy, dexamethasone 40mg/day on Days 1-4, high dose cytarabine 2g/m\^2 every 12 hours for 2 doses on Day 2 following platinum, cisplatin 100mg/m\^2 24 hours CI on Day 1 or oxaliplatin 100mg/m\^2.
Participants who responded to second-line chemotherapy got high dose therapy and autologous stem cell transplant.
|
|---|---|---|
|
EFS Per Investigator Disease Assessments
|
10.8 months
Interval 5.0 to 25.5
|
2.3 months
Interval 1.7 to 3.1
|
SECONDARY outcome
Timeframe: From randomization date up to a median follow-up: 47.2 monthsPopulation: Participants in the Full Analysis Set were analyzed.
PFS is defined as the time from the randomization date to the date of disease progression per Lugano classification or death from any cause. Disease progression is defined in outcome measure 1. KM estimates were used for analysis.
Outcome measures
| Measure |
Axicabtagene Ciloleucel
n=180 Participants
Participants received cyclophosphamide 500 mg/m\^2/day IV infusion and fludarabine 30 mg/m\^2/day IV infusion conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
|
Standard of Care Therapy
n=179 Participants
Participants received 2 or 3, 21-day cycles of second-line chemotherapy regimen:
* R-ICE: rituximab 375mg/m\^2 before chemotherapy, ifosfamide 5g/m\^2 24 hours CI on Day 2 + mesna, carboplatin AUC 5 Day 2, maximum dose 800mg, etoposide 100mg/m\^2/day on Days 1-3;
* R-ESHAP: rituximab 375mg/m\^2 Day 1, etoposide 40mg/m\^2/day IV on Days 1-4, methylprednisolone 500mg/day IV on Days 1-4 or 5, cisplatin at 25mg/m\^2/day CI Days 1-4, cytarabine 2g/m\^2 on Day 5;
* R-GDP: rituximab 375mg/m\^2 Day 1 (or Day 8), gemcitabine 1g/m\^2 on Days 1 and 8, dexamethasone 40mg on Days 1-4, cisplatin 75mg/m\^2 Day 1 or carboplatin AUC=5; or
* R-DHAP: rituximab 375mg/m\^2 before chemotherapy, dexamethasone 40mg/day on Days 1-4, high dose cytarabine 2g/m\^2 every 12 hours for 2 doses on Day 2 following platinum, cisplatin 100mg/m\^2 24 hours CI on Day 1 or oxaliplatin 100mg/m\^2.
Participants who responded to second-line chemotherapy got high dose therapy and autologous stem cell transplant.
|
|---|---|---|
|
Progression-Free Survival (PFS) Per Investigator Disease Assessments
|
14.7 months
Interval 5.4 to 43.5
|
3.7 months
Interval 2.9 to 5.3
|
SECONDARY outcome
Timeframe: From randomization date up to a median follow-up: 47.2 monthsPopulation: Participants in the Full Analysis Set were analyzed.
mEFS is defined the same way as EFS, except that a best response of SD up to and including Day 150 assessment post randomization was not considered an event. KM estimates were used for analysis.
Outcome measures
| Measure |
Axicabtagene Ciloleucel
n=180 Participants
Participants received cyclophosphamide 500 mg/m\^2/day IV infusion and fludarabine 30 mg/m\^2/day IV infusion conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
|
Standard of Care Therapy
n=179 Participants
Participants received 2 or 3, 21-day cycles of second-line chemotherapy regimen:
* R-ICE: rituximab 375mg/m\^2 before chemotherapy, ifosfamide 5g/m\^2 24 hours CI on Day 2 + mesna, carboplatin AUC 5 Day 2, maximum dose 800mg, etoposide 100mg/m\^2/day on Days 1-3;
* R-ESHAP: rituximab 375mg/m\^2 Day 1, etoposide 40mg/m\^2/day IV on Days 1-4, methylprednisolone 500mg/day IV on Days 1-4 or 5, cisplatin at 25mg/m\^2/day CI Days 1-4, cytarabine 2g/m\^2 on Day 5;
* R-GDP: rituximab 375mg/m\^2 Day 1 (or Day 8), gemcitabine 1g/m\^2 on Days 1 and 8, dexamethasone 40mg on Days 1-4, cisplatin 75mg/m\^2 Day 1 or carboplatin AUC=5; or
* R-DHAP: rituximab 375mg/m\^2 before chemotherapy, dexamethasone 40mg/day on Days 1-4, high dose cytarabine 2g/m\^2 every 12 hours for 2 doses on Day 2 following platinum, cisplatin 100mg/m\^2 24 hours CI on Day 1 or oxaliplatin 100mg/m\^2.
Participants who responded to second-line chemotherapy got high dose therapy and autologous stem cell transplant.
|
|---|---|---|
|
Modified Event Free Survival (mEFS) Per Investigator Assessment
|
12.6 months
Interval 5.0 to 29.1
|
2.3 months
Interval 1.7 to 3.1
|
SECONDARY outcome
Timeframe: Baseline, Days 50, 100, and 150; Months 9, 12, 15, 18, 21 and 24Population: Participants in Quality of Life (QoL) Analysis Set with data available at given timepoint were analyzed. The QoL Analysis Set was defined as the subset of participants in the Full Analysis Set who have a baseline and Day 150 post-randomization QoL assessment.
Global health status was measured using European Organization for Research and Treatment of Cancer (EORTC) Quality Life Questionnaire (QLQ) C-30. This health related quality of life (HRQoL) questionnaire was comprised of 15 questions on functional scales, 13 questions on symptom scales and 2 on global health status scale. Global Health Status used a 7 point Likert-type scale of 1 (Very poor) to 7 (Excellent). All scores were transformed to 0-100. Higher scores for Global Health Status indicated better HRQoL.
Outcome measures
| Measure |
Axicabtagene Ciloleucel
n=165 Participants
Participants received cyclophosphamide 500 mg/m\^2/day IV infusion and fludarabine 30 mg/m\^2/day IV infusion conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
|
Standard of Care Therapy
n=130 Participants
Participants received 2 or 3, 21-day cycles of second-line chemotherapy regimen:
* R-ICE: rituximab 375mg/m\^2 before chemotherapy, ifosfamide 5g/m\^2 24 hours CI on Day 2 + mesna, carboplatin AUC 5 Day 2, maximum dose 800mg, etoposide 100mg/m\^2/day on Days 1-3;
* R-ESHAP: rituximab 375mg/m\^2 Day 1, etoposide 40mg/m\^2/day IV on Days 1-4, methylprednisolone 500mg/day IV on Days 1-4 or 5, cisplatin at 25mg/m\^2/day CI Days 1-4, cytarabine 2g/m\^2 on Day 5;
* R-GDP: rituximab 375mg/m\^2 Day 1 (or Day 8), gemcitabine 1g/m\^2 on Days 1 and 8, dexamethasone 40mg on Days 1-4, cisplatin 75mg/m\^2 Day 1 or carboplatin AUC=5; or
* R-DHAP: rituximab 375mg/m\^2 before chemotherapy, dexamethasone 40mg/day on Days 1-4, high dose cytarabine 2g/m\^2 every 12 hours for 2 doses on Day 2 following platinum, cisplatin 100mg/m\^2 24 hours CI on Day 1 or oxaliplatin 100mg/m\^2.
Participants who responded to second-line chemotherapy got high dose therapy and autologous stem cell transplant.
|
|---|---|---|
|
Change From Baseline in Global Health Status Scores
Score at Baseline
|
68.6 Score on scale
Standard Deviation 19.9
|
70.1 Score on scale
Standard Deviation 23.1
|
|
Change From Baseline in Global Health Status Scores
Change from Baseline at Study Day 50
|
-7.4 Score on scale
Standard Deviation 20.2
|
-8.5 Score on scale
Standard Deviation 22.7
|
|
Change From Baseline in Global Health Status Scores
Change from Baseline at Study Day 100
|
1.3 Score on scale
Standard Deviation 19.6
|
-15.3 Score on scale
Standard Deviation 22.7
|
|
Change From Baseline in Global Health Status Scores
Change from Baseline at Study Day 150
|
5.9 Score on scale
Standard Deviation 24.9
|
-4.2 Score on scale
Standard Deviation 23.7
|
|
Change From Baseline in Global Health Status Scores
Change from Baseline at Study Month 9
|
8.0 Score on scale
Standard Deviation 22.7
|
3.5 Score on scale
Standard Deviation 23.7
|
|
Change From Baseline in Global Health Status Scores
Change from Baseline at Study Month 12
|
8.6 Score on scale
Standard Deviation 24.9
|
9.1 Score on scale
Standard Deviation 20.2
|
|
Change From Baseline in Global Health Status Scores
Change from Baseline at Study Month 15
|
9.0 Score on scale
Standard Deviation 22.3
|
9.9 Score on scale
Standard Deviation 18.9
|
|
Change From Baseline in Global Health Status Scores
Change from Baseline at Study Month 18
|
10.2 Score on scale
Standard Deviation 20.9
|
6.5 Score on scale
Standard Deviation 21.3
|
|
Change From Baseline in Global Health Status Scores
Change from Baseline at Study Month 21
|
10.0 Score on scale
Standard Deviation 21.5
|
15.0 Score on scale
Standard Deviation 19.6
|
|
Change From Baseline in Global Health Status Scores
Change from Baseline at Study Month 24
|
8.6 Score on scale
Standard Deviation 21.0
|
13.2 Score on scale
Standard Deviation 17.2
|
SECONDARY outcome
Timeframe: Baseline, Days 50, 100, 150, Months 9, 12, 15, 18, 21 and 24Population: Participants in QoL analysis set with data available at given timepoint were analyzed.
The EORTC QLQ-C30 is composed of global health status/QoL scale; five functional domains (physical, role, emotional, cognitive, and social); three symptom domains (fatigue, nausea and vomiting, and pain); and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The Physical Functioning domain includes 5 questions in which participants were asked to rate their overall health and overall quality of life as it relates to physical functioning during the past week on a scale from 1 (very poor) to 7 (excellent). The 5 scores were transformed to a scale from 0 to 100, where a high score indicated better QoL. A positive change from baseline indicates better QoL.
Outcome measures
| Measure |
Axicabtagene Ciloleucel
n=164 Participants
Participants received cyclophosphamide 500 mg/m\^2/day IV infusion and fludarabine 30 mg/m\^2/day IV infusion conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
|
Standard of Care Therapy
n=131 Participants
Participants received 2 or 3, 21-day cycles of second-line chemotherapy regimen:
* R-ICE: rituximab 375mg/m\^2 before chemotherapy, ifosfamide 5g/m\^2 24 hours CI on Day 2 + mesna, carboplatin AUC 5 Day 2, maximum dose 800mg, etoposide 100mg/m\^2/day on Days 1-3;
* R-ESHAP: rituximab 375mg/m\^2 Day 1, etoposide 40mg/m\^2/day IV on Days 1-4, methylprednisolone 500mg/day IV on Days 1-4 or 5, cisplatin at 25mg/m\^2/day CI Days 1-4, cytarabine 2g/m\^2 on Day 5;
* R-GDP: rituximab 375mg/m\^2 Day 1 (or Day 8), gemcitabine 1g/m\^2 on Days 1 and 8, dexamethasone 40mg on Days 1-4, cisplatin 75mg/m\^2 Day 1 or carboplatin AUC=5; or
* R-DHAP: rituximab 375mg/m\^2 before chemotherapy, dexamethasone 40mg/day on Days 1-4, high dose cytarabine 2g/m\^2 every 12 hours for 2 doses on Day 2 following platinum, cisplatin 100mg/m\^2 24 hours CI on Day 1 or oxaliplatin 100mg/m\^2.
Participants who responded to second-line chemotherapy got high dose therapy and autologous stem cell transplant.
|
|---|---|---|
|
Change From Baseline in EORTC QLQ-C30 Physical Functioning Score
Score at Baseline
|
83.5 Score on scale
Standard Deviation 17.7
|
85.3 Score on scale
Standard Deviation 18.9
|
|
Change From Baseline in EORTC QLQ-C30 Physical Functioning Score
Change from Baseline at Study Day 50
|
-12.9 Score on scale
Standard Deviation 21.7
|
-8.3 Score on scale
Standard Deviation 17.5
|
|
Change From Baseline in EORTC QLQ-C30 Physical Functioning Score
Change from Baseline at Study Day 100
|
-1.8 Score on scale
Standard Deviation 17.8
|
-15.0 Score on scale
Standard Deviation 19.1
|
|
Change From Baseline in EORTC QLQ-C30 Physical Functioning Score
Change from Baseline at Study Day 150
|
1.3 Score on scale
Standard Deviation 18.9
|
-5.2 Score on scale
Standard Deviation 21.3
|
|
Change From Baseline in EORTC QLQ-C30 Physical Functioning Score
Change from Baseline at Study Month 9
|
4.1 Score on scale
Standard Deviation 17.1
|
-2.4 Score on scale
Standard Deviation 23.5
|
|
Change From Baseline in EORTC QLQ-C30 Physical Functioning Score
Change from Baseline at Study Month 12
|
3.4 Score on scale
Standard Deviation 20.8
|
0.4 Score on scale
Standard Deviation 20.3
|
|
Change From Baseline in EORTC QLQ-C30 Physical Functioning Score
Change from Baseline at Study Month 15
|
3.9 Score on scale
Standard Deviation 19.3
|
1.6 Score on scale
Standard Deviation 16.1
|
|
Change From Baseline in EORTC QLQ-C30 Physical Functioning Score
Change from Baseline at Study Month 18
|
5.0 Score on scale
Standard Deviation 15.1
|
3.2 Score on scale
Standard Deviation 17.9
|
|
Change From Baseline in EORTC QLQ-C30 Physical Functioning Score
Change from Baseline at Study Month 21
|
6.0 Score on scale
Standard Deviation 16.1
|
4.3 Score on scale
Standard Deviation 21.4
|
|
Change From Baseline in EORTC QLQ-C30 Physical Functioning Score
Change from Baseline at Study Month 24
|
3.7 Score on scale
Standard Deviation 16.5
|
5.6 Score on scale
Standard Deviation 8.0
|
SECONDARY outcome
Timeframe: Baseline, Days 50, 100, 150; Months 9, 12, 15, 18, 21 and 24Population: Participants in QoL analysis set with data available at given timepoint were analyzed.
The Euro-QOL (EQ) Five Dimensions (5D) Five Levels (5L), EQ-5D-5L questionnaire was a generic measure of health status that provided a simple descriptive profile and a single index value. The EQ-5D-5L comprised 2 components: a questionnaire covering 5 dimensions and a tariff of values based upon direct valuations of health stated using a visual analog scale (VAS). The total score for EQ-5D-5L index was presented on a range from 0 to 1 where higher scores indicated better outcome. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Axicabtagene Ciloleucel
n=165 Participants
Participants received cyclophosphamide 500 mg/m\^2/day IV infusion and fludarabine 30 mg/m\^2/day IV infusion conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
|
Standard of Care Therapy
n=131 Participants
Participants received 2 or 3, 21-day cycles of second-line chemotherapy regimen:
* R-ICE: rituximab 375mg/m\^2 before chemotherapy, ifosfamide 5g/m\^2 24 hours CI on Day 2 + mesna, carboplatin AUC 5 Day 2, maximum dose 800mg, etoposide 100mg/m\^2/day on Days 1-3;
* R-ESHAP: rituximab 375mg/m\^2 Day 1, etoposide 40mg/m\^2/day IV on Days 1-4, methylprednisolone 500mg/day IV on Days 1-4 or 5, cisplatin at 25mg/m\^2/day CI Days 1-4, cytarabine 2g/m\^2 on Day 5;
* R-GDP: rituximab 375mg/m\^2 Day 1 (or Day 8), gemcitabine 1g/m\^2 on Days 1 and 8, dexamethasone 40mg on Days 1-4, cisplatin 75mg/m\^2 Day 1 or carboplatin AUC=5; or
* R-DHAP: rituximab 375mg/m\^2 before chemotherapy, dexamethasone 40mg/day on Days 1-4, high dose cytarabine 2g/m\^2 every 12 hours for 2 doses on Day 2 following platinum, cisplatin 100mg/m\^2 24 hours CI on Day 1 or oxaliplatin 100mg/m\^2.
Participants who responded to second-line chemotherapy got high dose therapy and autologous stem cell transplant.
|
|---|---|---|
|
Changes From Baseline in the European Quality of Life Five Dimensions Five Levels Scale Index Score
Score at Baseline
|
0.803 Score on scale
Standard Deviation 0.210
|
0.799 Score on scale
Standard Deviation 0.250
|
|
Changes From Baseline in the European Quality of Life Five Dimensions Five Levels Scale Index Score
Change from Baseline at Study Day 50
|
-0.049 Score on scale
Standard Deviation 0.205
|
-0.003 Score on scale
Standard Deviation 0.198
|
|
Changes From Baseline in the European Quality of Life Five Dimensions Five Levels Scale Index Score
Change from Baseline at Study Day 100
|
0.012 Score on scale
Standard Deviation 0.191
|
-0.068 Score on scale
Standard Deviation 0.246
|
|
Changes From Baseline in the European Quality of Life Five Dimensions Five Levels Scale Index Score
Change from Baseline at Study Day 150
|
0.050 Score on scale
Standard Deviation 0.212
|
0.014 Score on scale
Standard Deviation 0.208
|
|
Changes From Baseline in the European Quality of Life Five Dimensions Five Levels Scale Index Score
Change from Baseline at Study Month 9
|
0.064 Score on scale
Standard Deviation 0.190
|
0.015 Score on scale
Standard Deviation 0.197
|
|
Changes From Baseline in the European Quality of Life Five Dimensions Five Levels Scale Index Score
Change from Baseline at Study Month 12
|
0.072 Score on scale
Standard Deviation 0.241
|
0.051 Score on scale
Standard Deviation 0.200
|
|
Changes From Baseline in the European Quality of Life Five Dimensions Five Levels Scale Index Score
Change from Baseline at Study Month 15
|
0.051 Score on scale
Standard Deviation 0.209
|
0.080 Score on scale
Standard Deviation 0.125
|
|
Changes From Baseline in the European Quality of Life Five Dimensions Five Levels Scale Index Score
Change from Baseline at Study Month 18
|
0.094 Score on scale
Standard Deviation 0.180
|
0.072 Score on scale
Standard Deviation 0.188
|
|
Changes From Baseline in the European Quality of Life Five Dimensions Five Levels Scale Index Score
Change from Baseline at Study Month 21
|
0.089 Score on scale
Standard Deviation 0.235
|
0.110 Score on scale
Standard Deviation 0.177
|
|
Changes From Baseline in the European Quality of Life Five Dimensions Five Levels Scale Index Score
Change from Baseline at Study Month 24
|
0.051 Score on scale
Standard Deviation 0.239
|
0.117 Score on scale
Standard Deviation 0.138
|
SECONDARY outcome
Timeframe: Baseline, Days 50, 100, 150; Months 9, 12, 15, 18, 21 and 24Population: Participants in QoL analysis set with data available at given timepoint were analyzed.
The EQ-5D-5L VAS is a 20-cm VAS for recording self-rated current HRQoL state and is used to describe the participants' health status on the day of the assessment. The EQ-5D-5L VAS score is recorded by each participant for his or her current HRQoL state and scored 0 ("the worst health you can imagine") to 100 ("the best health you can imagine"). The value 100 indicates improvement.
Outcome measures
| Measure |
Axicabtagene Ciloleucel
n=165 Participants
Participants received cyclophosphamide 500 mg/m\^2/day IV infusion and fludarabine 30 mg/m\^2/day IV infusion conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
|
Standard of Care Therapy
n=129 Participants
Participants received 2 or 3, 21-day cycles of second-line chemotherapy regimen:
* R-ICE: rituximab 375mg/m\^2 before chemotherapy, ifosfamide 5g/m\^2 24 hours CI on Day 2 + mesna, carboplatin AUC 5 Day 2, maximum dose 800mg, etoposide 100mg/m\^2/day on Days 1-3;
* R-ESHAP: rituximab 375mg/m\^2 Day 1, etoposide 40mg/m\^2/day IV on Days 1-4, methylprednisolone 500mg/day IV on Days 1-4 or 5, cisplatin at 25mg/m\^2/day CI Days 1-4, cytarabine 2g/m\^2 on Day 5;
* R-GDP: rituximab 375mg/m\^2 Day 1 (or Day 8), gemcitabine 1g/m\^2 on Days 1 and 8, dexamethasone 40mg on Days 1-4, cisplatin 75mg/m\^2 Day 1 or carboplatin AUC=5; or
* R-DHAP: rituximab 375mg/m\^2 before chemotherapy, dexamethasone 40mg/day on Days 1-4, high dose cytarabine 2g/m\^2 every 12 hours for 2 doses on Day 2 following platinum, cisplatin 100mg/m\^2 24 hours CI on Day 1 or oxaliplatin 100mg/m\^2.
Participants who responded to second-line chemotherapy got high dose therapy and autologous stem cell transplant.
|
|---|---|---|
|
Change From Baseline in EQ-5D-5L VAS Scale Score
Change from Baseline at Study Month 9
|
11.4 Score on scale
Standard Deviation 19.9
|
4.4 Score on scale
Standard Deviation 19.0
|
|
Change From Baseline in EQ-5D-5L VAS Scale Score
Change from Baseline at Study Month 12
|
10.1 Score on scale
Standard Deviation 19.9
|
6.6 Score on scale
Standard Deviation 17.8
|
|
Change From Baseline in EQ-5D-5L VAS Scale Score
Change from Baseline at Study Month 15
|
10.7 Score on scale
Standard Deviation 20.7
|
8.2 Score on scale
Standard Deviation 13.7
|
|
Change From Baseline in EQ-5D-5L VAS Scale Score
Change from Baseline at Study Month 18
|
15.1 Score on scale
Standard Deviation 17.1
|
9.3 Score on scale
Standard Deviation 13.6
|
|
Change From Baseline in EQ-5D-5L VAS Scale Score
Change from Baseline at Study Month 21
|
14.0 Score on scale
Standard Deviation 17.2
|
10.1 Score on scale
Standard Deviation 14.3
|
|
Change From Baseline in EQ-5D-5L VAS Scale Score
Change from Baseline at Study Month 24
|
10.9 Score on scale
Standard Deviation 18.8
|
12.2 Score on scale
Standard Deviation 15.3
|
|
Change From Baseline in EQ-5D-5L VAS Scale Score
Score at Baseline
|
72.4 Score on scale
Standard Deviation 18.7
|
74.4 Score on scale
Standard Deviation 20.1
|
|
Change From Baseline in EQ-5D-5L VAS Scale Score
Change from Baseline at Study Day 50
|
-1.9 Score on scale
Standard Deviation 18.7
|
-4.4 Score on scale
Standard Deviation 16.7
|
|
Change From Baseline in EQ-5D-5L VAS Scale Score
Change from Baseline at Study Day 100
|
4.0 Score on scale
Standard Deviation 18.4
|
-8.2 Score on scale
Standard Deviation 19.8
|
|
Change From Baseline in EQ-5D-5L VAS Scale Score
Change from Baseline at Study Day 150
|
9.1 Score on scale
Standard Deviation 19.4
|
-2.2 Score on scale
Standard Deviation 22.2
|
SECONDARY outcome
Timeframe: Up to 74.9 monthsPopulation: Participants in the Safety Analysis Set were analyzed. The Safety Analysis Set was defined as the subset of all randomized participants who received at least 1 dose of axicabtagene ciloleucel as protocol therapy or SOC chemotherapy as protocol therapy.
Outcome measures
| Measure |
Axicabtagene Ciloleucel
n=170 Participants
Participants received cyclophosphamide 500 mg/m\^2/day IV infusion and fludarabine 30 mg/m\^2/day IV infusion conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
|
Standard of Care Therapy
Participants received 2 or 3, 21-day cycles of second-line chemotherapy regimen:
* R-ICE: rituximab 375mg/m\^2 before chemotherapy, ifosfamide 5g/m\^2 24 hours CI on Day 2 + mesna, carboplatin AUC 5 Day 2, maximum dose 800mg, etoposide 100mg/m\^2/day on Days 1-3;
* R-ESHAP: rituximab 375mg/m\^2 Day 1, etoposide 40mg/m\^2/day IV on Days 1-4, methylprednisolone 500mg/day IV on Days 1-4 or 5, cisplatin at 25mg/m\^2/day CI Days 1-4, cytarabine 2g/m\^2 on Day 5;
* R-GDP: rituximab 375mg/m\^2 Day 1 (or Day 8), gemcitabine 1g/m\^2 on Days 1 and 8, dexamethasone 40mg on Days 1-4, cisplatin 75mg/m\^2 Day 1 or carboplatin AUC=5; or
* R-DHAP: rituximab 375mg/m\^2 before chemotherapy, dexamethasone 40mg/day on Days 1-4, high dose cytarabine 2g/m\^2 every 12 hours for 2 doses on Day 2 following platinum, cisplatin 100mg/m\^2 24 hours CI on Day 1 or oxaliplatin 100mg/m\^2.
Participants who responded to second-line chemotherapy got high dose therapy and autologous stem cell transplant.
|
|---|---|---|
|
Number of Participants With Post-dose Anti-Axicabtagene Ciloleucel Antibodies
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: From first dose up to 61.8 monthsPopulation: Participants in the Safety Analysis Set were analyzed.
A TEAE was defined as any AE that begins on or after the first dose of study treatment (axicabtagene ciloleucel infusion or SOC), excluding bridging therapy.
Outcome measures
| Measure |
Axicabtagene Ciloleucel
n=170 Participants
Participants received cyclophosphamide 500 mg/m\^2/day IV infusion and fludarabine 30 mg/m\^2/day IV infusion conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
|
Standard of Care Therapy
n=168 Participants
Participants received 2 or 3, 21-day cycles of second-line chemotherapy regimen:
* R-ICE: rituximab 375mg/m\^2 before chemotherapy, ifosfamide 5g/m\^2 24 hours CI on Day 2 + mesna, carboplatin AUC 5 Day 2, maximum dose 800mg, etoposide 100mg/m\^2/day on Days 1-3;
* R-ESHAP: rituximab 375mg/m\^2 Day 1, etoposide 40mg/m\^2/day IV on Days 1-4, methylprednisolone 500mg/day IV on Days 1-4 or 5, cisplatin at 25mg/m\^2/day CI Days 1-4, cytarabine 2g/m\^2 on Day 5;
* R-GDP: rituximab 375mg/m\^2 Day 1 (or Day 8), gemcitabine 1g/m\^2 on Days 1 and 8, dexamethasone 40mg on Days 1-4, cisplatin 75mg/m\^2 Day 1 or carboplatin AUC=5; or
* R-DHAP: rituximab 375mg/m\^2 before chemotherapy, dexamethasone 40mg/day on Days 1-4, high dose cytarabine 2g/m\^2 every 12 hours for 2 doses on Day 2 following platinum, cisplatin 100mg/m\^2 24 hours CI on Day 1 or oxaliplatin 100mg/m\^2.
Participants who responded to second-line chemotherapy got high dose therapy and autologous stem cell transplant.
|
|---|---|---|
|
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
|
100.0 percentage of participants
|
100.0 percentage of participants
|
SECONDARY outcome
Timeframe: From first dose up to 61.8 monthsPopulation: Participants in the Safety Analysis Set with available data were analyzed.
Grading categories were determined by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Grade 1: mild, Grade 2: moderate, Grade 3: severe or medically significant, Grade 4: life-threatening. Percentages were rounded off.
Outcome measures
| Measure |
Axicabtagene Ciloleucel
n=170 Participants
Participants received cyclophosphamide 500 mg/m\^2/day IV infusion and fludarabine 30 mg/m\^2/day IV infusion conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
|
Standard of Care Therapy
n=168 Participants
Participants received 2 or 3, 21-day cycles of second-line chemotherapy regimen:
* R-ICE: rituximab 375mg/m\^2 before chemotherapy, ifosfamide 5g/m\^2 24 hours CI on Day 2 + mesna, carboplatin AUC 5 Day 2, maximum dose 800mg, etoposide 100mg/m\^2/day on Days 1-3;
* R-ESHAP: rituximab 375mg/m\^2 Day 1, etoposide 40mg/m\^2/day IV on Days 1-4, methylprednisolone 500mg/day IV on Days 1-4 or 5, cisplatin at 25mg/m\^2/day CI Days 1-4, cytarabine 2g/m\^2 on Day 5;
* R-GDP: rituximab 375mg/m\^2 Day 1 (or Day 8), gemcitabine 1g/m\^2 on Days 1 and 8, dexamethasone 40mg on Days 1-4, cisplatin 75mg/m\^2 Day 1 or carboplatin AUC=5; or
* R-DHAP: rituximab 375mg/m\^2 before chemotherapy, dexamethasone 40mg/day on Days 1-4, high dose cytarabine 2g/m\^2 every 12 hours for 2 doses on Day 2 following platinum, cisplatin 100mg/m\^2 24 hours CI on Day 1 or oxaliplatin 100mg/m\^2.
Participants who responded to second-line chemotherapy got high dose therapy and autologous stem cell transplant.
|
|---|---|---|
|
Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher
Potassium (mmol/L)
|
0 percentage of participants
|
1 percentage of participants
|
|
Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher
Sodium (mmol/L)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher
Leukocytes (10^9/L)
|
0 percentage of participants
|
1 percentage of participants
|
|
Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher
Hemoglobin (mmol/L)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher
Lymphocytes (10^9/L)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher
Alanine Aminotransferase (U/L)
|
6 percentage of participants
|
4 percentage of participants
|
|
Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher
Alkaline Phosphatase (U/L)
|
1 percentage of participants
|
1 percentage of participants
|
|
Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher
Aspartate Aminotransferase (U/L)
|
6 percentage of participants
|
2 percentage of participants
|
|
Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher
Bilirubin (umol/L)
|
2 percentage of participants
|
1 percentage of participants
|
|
Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher
Calcium (mmol/L)
|
2 percentage of participants
|
1 percentage of participants
|
|
Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher
Creatinine (umol/L)
|
4 percentage of participants
|
1 percentage of participants
|
|
Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher
Glucose (mmol/L)
|
14 percentage of participants
|
5 percentage of participants
|
|
Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher
Magnesium (mmol/L)
|
2 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: From first dose up to 61.8 monthsPopulation: Participants in the Safety Analysis Set were analyzed.
Grading categories were determined by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Grade 1: mild, Grade 2: moderate, Grade 3: severe or medically significant, Grade 4: life-threatening. Percentages were rounded off.
Outcome measures
| Measure |
Axicabtagene Ciloleucel
n=170 Participants
Participants received cyclophosphamide 500 mg/m\^2/day IV infusion and fludarabine 30 mg/m\^2/day IV infusion conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
|
Standard of Care Therapy
n=168 Participants
Participants received 2 or 3, 21-day cycles of second-line chemotherapy regimen:
* R-ICE: rituximab 375mg/m\^2 before chemotherapy, ifosfamide 5g/m\^2 24 hours CI on Day 2 + mesna, carboplatin AUC 5 Day 2, maximum dose 800mg, etoposide 100mg/m\^2/day on Days 1-3;
* R-ESHAP: rituximab 375mg/m\^2 Day 1, etoposide 40mg/m\^2/day IV on Days 1-4, methylprednisolone 500mg/day IV on Days 1-4 or 5, cisplatin at 25mg/m\^2/day CI Days 1-4, cytarabine 2g/m\^2 on Day 5;
* R-GDP: rituximab 375mg/m\^2 Day 1 (or Day 8), gemcitabine 1g/m\^2 on Days 1 and 8, dexamethasone 40mg on Days 1-4, cisplatin 75mg/m\^2 Day 1 or carboplatin AUC=5; or
* R-DHAP: rituximab 375mg/m\^2 before chemotherapy, dexamethasone 40mg/day on Days 1-4, high dose cytarabine 2g/m\^2 every 12 hours for 2 doses on Day 2 following platinum, cisplatin 100mg/m\^2 24 hours CI on Day 1 or oxaliplatin 100mg/m\^2.
Participants who responded to second-line chemotherapy got high dose therapy and autologous stem cell transplant.
|
|---|---|---|
|
Percentage of Participants With Decrease in Laboratory Values Reported as Grade 3 or Higher
Hemoglobin (mmol/L)
|
41 percentage of participants
|
44 percentage of participants
|
|
Percentage of Participants With Decrease in Laboratory Values Reported as Grade 3 or Higher
Leukocytes (10^9/L)
|
95 percentage of participants
|
56 percentage of participants
|
|
Percentage of Participants With Decrease in Laboratory Values Reported as Grade 3 or Higher
Lymphocytes (10^9/L)
|
99 percentage of participants
|
68 percentage of participants
|
|
Percentage of Participants With Decrease in Laboratory Values Reported as Grade 3 or Higher
Neutrophils (10^9/L)
|
94 percentage of participants
|
51 percentage of participants
|
|
Percentage of Participants With Decrease in Laboratory Values Reported as Grade 3 or Higher
Platelets (10^9/L)
|
26 percentage of participants
|
63 percentage of participants
|
|
Percentage of Participants With Decrease in Laboratory Values Reported as Grade 3 or Higher
Albumin (g/L)
|
4 percentage of participants
|
1 percentage of participants
|
|
Percentage of Participants With Decrease in Laboratory Values Reported as Grade 3 or Higher
Calcium (mmol/L)
|
8 percentage of participants
|
2 percentage of participants
|
|
Percentage of Participants With Decrease in Laboratory Values Reported as Grade 3 or Higher
Glucose (mmol/L)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Decrease in Laboratory Values Reported as Grade 3 or Higher
Magnesium (mmol/L)
|
2 percentage of participants
|
3 percentage of participants
|
|
Percentage of Participants With Decrease in Laboratory Values Reported as Grade 3 or Higher
Phosphate (mmol/L)
|
5 percentage of participants
|
5 percentage of participants
|
|
Percentage of Participants With Decrease in Laboratory Values Reported as Grade 3 or Higher
Potassium (mmol/L)
|
6 percentage of participants
|
7 percentage of participants
|
|
Percentage of Participants With Decrease in Laboratory Values Reported as Grade 3 or Higher
Sodium (mmol/L)
|
12 percentage of participants
|
2 percentage of participants
|
Adverse Events
Axicabtagene Ciloleucel Treatment
Serious events: 96 serious events
Other events: 170 other events
Deaths: 81 deaths
Standard of Care Therapy
Serious events: 78 serious events
Other events: 166 other events
Deaths: 101 deaths
Retreatment Axicabtagene Ciloleucel
Serious events: 2 serious events
Other events: 10 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Axicabtagene Ciloleucel Treatment
n=170 participants at risk
Participants received cyclophosphamide 500 mg/m\^2/day IV infusion and fludarabine 30 mg/m\^2/day IV infusion conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
|
Standard of Care Therapy
n=168 participants at risk
Participants received 2 or 3, 21-day cycles of second-line chemotherapy regimen:
* R-ICE: rituximab 375mg/m\^2 before chemotherapy, ifosfamide 5g/m\^2 24 hours CI on Day 2 + mesna, carboplatin AUC 5 Day 2, maximum dose 800mg, etoposide 100mg/m\^2/day on Days 1-3;
* R-ESHAP: rituximab 375mg/m\^2 Day 1, etoposide 40mg/m\^2/day IV on Days 1-4, methylprednisolone 500mg/day IV on Days 1-4 or 5, cisplatin at 25mg/m\^2/day CI Days 1-4, cytarabine 2g/m\^2 on Day 5;
* R-GDP: rituximab 375mg/m\^2 Day 1 (or Day 8), gemcitabine 1g/m\^2 on Days 1 and 8, dexamethasone 40mg on Days 1-4, cisplatin 75mg/m\^2 Day 1 or carboplatin AUC=5; or
* R-DHAP: rituximab 375mg/m\^2 before chemotherapy, dexamethasone 40mg/day on Days 1-4, high dose cytarabine 2g/m\^2 every 12 hours for 2 doses on Day 2 following platinum, cisplatin 100mg/m\^2 24 hours CI on Day 1 or oxaliplatin 100mg/m\^2.
Participants who responded to second-line chemotherapy got high dose therapy and autologous stem cell transplant.
|
Retreatment Axicabtagene Ciloleucel
n=10 participants at risk
Participants who achieved a partial response or complete response and subsequently experienced disease progression received a second course of conditioning chemotherapy (cyclophosphamide 500 mg/m\^2/day IV infusion and fludarabine 30 mg/m\^2/day IV infusion) for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10\^6 anti-CD 19 CAR transduced autologous T cells/kg.
|
|---|---|---|---|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.60%
1/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.60%
1/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Infections and infestations
Furuncle
|
0.00%
0/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
10.0%
1/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Gastrointestinal disorders
Food poisoning
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
0.00%
0/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.60%
1/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.60%
1/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.60%
1/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.60%
1/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.60%
1/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
1.2%
2/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Gastrointestinal disorders
Oesophageal fistula
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Gastrointestinal disorders
Oral disorder
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.60%
1/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.60%
1/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
General disorders
Chest pain
|
0.00%
0/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.60%
1/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
General disorders
Chills
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
General disorders
Fatigue
|
1.8%
3/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
General disorders
Incarcerated hernia
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
General disorders
Influenza like illness
|
0.00%
0/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.60%
1/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
General disorders
Malaise
|
1.2%
2/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.60%
1/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.60%
1/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
General disorders
Pyrexia
|
15.9%
27/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
4.8%
8/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Hepatobiliary disorders
Cholangitis
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.60%
1/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.60%
1/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Infections and infestations
Arthritis infective
|
0.00%
0/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.60%
1/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.60%
1/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.60%
1/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Infections and infestations
Covid-19
|
4.1%
7/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.60%
1/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Infections and infestations
Covid-19 pneumonia
|
1.8%
3/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Infections and infestations
Cytomegalovirus infection
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Infections and infestations
Device related infection
|
0.00%
0/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.60%
1/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Infections and infestations
Fungal cystitis
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.2%
2/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
1.8%
3/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.5%
6/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
13.1%
22/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.60%
1/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.9%
5/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.60%
1/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.60%
1/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.60%
1/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
2.9%
5/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
1.2%
2/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Cardiac disorders
Cardiac arrest
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.60%
1/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.60%
1/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Cardiac disorders
Cardiomyopathy
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Cardiac disorders
Heart failure with reduced ejection fraction
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Cardiac disorders
Myocardial infarction
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Cardiac disorders
Pericardial effusion
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
1.2%
2/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
1.2%
2/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Cardiac disorders
Tachycardia
|
1.2%
2/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Eye disorders
Vision blurred
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.8%
3/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
1.2%
2/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.60%
1/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.60%
1/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Infections and infestations
Gastrointestinal infection
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Infections and infestations
Hepatitis B reactivation
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
1.2%
2/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Infections and infestations
Influenza
|
1.2%
2/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Infections and infestations
Metapneumovirus infection
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.60%
1/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Infections and infestations
Pelvic abscess
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Infections and infestations
Pneumococcal sepsis
|
0.00%
0/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.60%
1/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.60%
1/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Infections and infestations
Pneumonia
|
9.4%
16/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
2.4%
4/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Infections and infestations
Pneumonia legionella
|
0.00%
0/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.60%
1/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Infections and infestations
Progressive multifocal leukoencephalopathy
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Infections and infestations
Pseudomonal sepsis
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Infections and infestations
Pyelonephritis
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.60%
1/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Infections and infestations
Respiratory tract infection
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Infections and infestations
Rhinovirus infection
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Infections and infestations
Salmonella bacteraemia
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Infections and infestations
Sepsis
|
2.9%
5/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
2.4%
4/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Infections and infestations
Sinusitis
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.60%
1/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.2%
2/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Infections and infestations
Urinary tract infection
|
1.8%
3/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
10.0%
1/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Infections and infestations
Urosepsis
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.60%
1/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Infections and infestations
Wound infection
|
1.2%
2/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Injury, poisoning and procedural complications
Blood stem cell harvest failure
|
0.00%
0/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.60%
1/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
1.2%
2/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.60%
1/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.60%
1/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.60%
1/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.60%
1/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Investigations
Blood fibrinogen decreased
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Investigations
Neutrophil count decreased
|
1.8%
3/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
1.8%
3/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
10.0%
1/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Investigations
Platelet count decreased
|
0.00%
0/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
3.0%
5/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Investigations
Troponin I increased
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Investigations
Weight decreased
|
0.00%
0/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.60%
1/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
1.8%
3/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
1.8%
3/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.60%
1/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.60%
1/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
1.2%
2/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.60%
1/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.2%
2/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.60%
1/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
1.2%
2/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.4%
4/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.60%
1/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal squamous cell carcinoma
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
4.1%
7/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
3.0%
5/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.00%
0/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.60%
1/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ductal adenocarcinoma of pancreas
|
0.00%
0/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.60%
1/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large granular lymphocytosis
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
0.00%
0/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.60%
1/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
1.2%
2/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Spindle cell sarcoma
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Nervous system disorders
Aphasia
|
5.3%
9/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Nervous system disorders
Ataxia
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Nervous system disorders
Cognitive disorder
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Nervous system disorders
Dysarthria
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Nervous system disorders
Dyspraxia
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Nervous system disorders
Encephalopathy
|
10.0%
17/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.60%
1/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Nervous system disorders
Facial paralysis
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.00%
0/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.60%
1/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Nervous system disorders
Headache
|
2.4%
4/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.60%
1/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Nervous system disorders
Hemiparesis
|
1.2%
2/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Nervous system disorders
Hypoaesthesia
|
1.2%
2/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.60%
1/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Nervous system disorders
Lethargy
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Nervous system disorders
Memory impairment
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Nervous system disorders
Paraesthesia
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Nervous system disorders
Seizure
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Nervous system disorders
Somnolence
|
2.9%
5/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.60%
1/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Nervous system disorders
Syncope
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
1.8%
3/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Nervous system disorders
Tremor
|
2.9%
5/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Psychiatric disorders
Agitation
|
1.2%
2/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Psychiatric disorders
Bradyphrenia
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Psychiatric disorders
Confusional state
|
4.1%
7/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Psychiatric disorders
Delirium
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Psychiatric disorders
Mental status changes
|
1.8%
3/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.4%
4/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
4.8%
8/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Renal and urinary disorders
Faecaluria
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
1.2%
2/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.2%
2/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.60%
1/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.8%
3/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.60%
1/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.60%
1/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.8%
3/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
1.2%
2/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Lung opacity
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.60%
1/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
1.2%
2/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.60%
1/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Surgical and medical procedures
Haematopoietic stem cell mobilisation
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Vascular disorders
Angiopathy
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Vascular disorders
Embolism
|
1.2%
2/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Vascular disorders
Hypotension
|
8.8%
15/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
1.8%
3/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
10.0%
1/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Vascular disorders
Orthostatic hypotension
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
Other adverse events
| Measure |
Axicabtagene Ciloleucel Treatment
n=170 participants at risk
Participants received cyclophosphamide 500 mg/m\^2/day IV infusion and fludarabine 30 mg/m\^2/day IV infusion conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
|
Standard of Care Therapy
n=168 participants at risk
Participants received 2 or 3, 21-day cycles of second-line chemotherapy regimen:
* R-ICE: rituximab 375mg/m\^2 before chemotherapy, ifosfamide 5g/m\^2 24 hours CI on Day 2 + mesna, carboplatin AUC 5 Day 2, maximum dose 800mg, etoposide 100mg/m\^2/day on Days 1-3;
* R-ESHAP: rituximab 375mg/m\^2 Day 1, etoposide 40mg/m\^2/day IV on Days 1-4, methylprednisolone 500mg/day IV on Days 1-4 or 5, cisplatin at 25mg/m\^2/day CI Days 1-4, cytarabine 2g/m\^2 on Day 5;
* R-GDP: rituximab 375mg/m\^2 Day 1 (or Day 8), gemcitabine 1g/m\^2 on Days 1 and 8, dexamethasone 40mg on Days 1-4, cisplatin 75mg/m\^2 Day 1 or carboplatin AUC=5; or
* R-DHAP: rituximab 375mg/m\^2 before chemotherapy, dexamethasone 40mg/day on Days 1-4, high dose cytarabine 2g/m\^2 every 12 hours for 2 doses on Day 2 following platinum, cisplatin 100mg/m\^2 24 hours CI on Day 1 or oxaliplatin 100mg/m\^2.
Participants who responded to second-line chemotherapy got high dose therapy and autologous stem cell transplant.
|
Retreatment Axicabtagene Ciloleucel
n=10 participants at risk
Participants who achieved a partial response or complete response and subsequently experienced disease progression received a second course of conditioning chemotherapy (cyclophosphamide 500 mg/m\^2/day IV infusion and fludarabine 30 mg/m\^2/day IV infusion) for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10\^6 anti-CD 19 CAR transduced autologous T cells/kg.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
41.8%
71/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
53.6%
90/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
40.0%
4/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
14.3%
24/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
5.3%
9/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
3.6%
6/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
44.1%
75/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
16.7%
28/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
20.0%
2/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
12.9%
22/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
23.8%
40/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
34.1%
58/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
9.5%
16/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
40.0%
4/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Cardiac disorders
Tachycardia
|
7.6%
13/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
6.0%
10/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
6.5%
11/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
2.4%
4/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
6.5%
11/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
12.9%
22/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
13.7%
23/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
10.0%
1/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Gastrointestinal disorders
Constipation
|
20.0%
34/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
34.5%
58/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
30.0%
3/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
41.8%
71/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
39.3%
66/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
20.0%
2/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
9.4%
16/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
4.8%
8/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.9%
5/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
8.3%
14/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Gastrointestinal disorders
Nausea
|
40.0%
68/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
69.0%
116/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
40.0%
4/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
2.4%
4/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
17.3%
29/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Gastrointestinal disorders
Toothache
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
1.8%
3/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
10.0%
1/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Gastrointestinal disorders
Vomiting
|
19.4%
33/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
32.7%
55/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
30.0%
3/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
General disorders
Asthenia
|
7.6%
13/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
8.9%
15/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
General disorders
Chills
|
27.1%
46/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
8.3%
14/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
General disorders
Fatigue
|
40.6%
69/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
51.8%
87/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
20.0%
2/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
General disorders
Malaise
|
8.8%
15/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
5.4%
9/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
10.0%
1/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
General disorders
Mucosal inflammation
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
8.9%
15/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
General disorders
Oedema peripheral
|
11.8%
20/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
16.7%
28/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
General disorders
Pain
|
0.00%
0/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.60%
1/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
10.0%
1/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
General disorders
Pyrexia
|
87.6%
149/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
23.8%
40/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
90.0%
9/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
6.5%
11/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.60%
1/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Immune system disorders
Hypogammaglobulinaemia
|
11.2%
19/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.60%
1/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Infections and infestations
Furuncle
|
0.00%
0/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
10.0%
1/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Infections and infestations
Oral candidiasis
|
8.2%
14/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
3.0%
5/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Infections and infestations
Pneumonia
|
1.2%
2/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
3.0%
5/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
10.0%
1/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Infections and infestations
Pseudomonas infection
|
0.00%
0/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
10.0%
1/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.3%
9/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
3.0%
5/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
7.1%
12/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Investigations
Alanine aminotransferase increased
|
18.2%
31/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
9.5%
16/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
20.0%
2/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
14.1%
24/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
8.9%
15/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
10.0%
1/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
5.9%
10/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
8.3%
14/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Investigations
Blood bilirubin increased
|
2.9%
5/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
1.2%
2/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
10.0%
1/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Investigations
Blood creatinine increased
|
5.9%
10/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
8.9%
15/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Investigations
C-reactive protein increased
|
8.8%
15/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
2.4%
4/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Investigations
Lymphocyte count decreased
|
18.2%
31/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
12.5%
21/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
30.0%
3/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Investigations
Neutrophil count decreased
|
30.0%
51/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
26.8%
45/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
50.0%
5/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Investigations
Platelet count decreased
|
17.6%
30/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
38.1%
64/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
10.0%
1/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Investigations
Serum ferritin increased
|
8.8%
15/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Investigations
Weight decreased
|
6.5%
11/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
3.6%
6/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
10.0%
1/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Investigations
Weight increased
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
7.1%
12/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Investigations
White blood cell count decreased
|
27.1%
46/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
22.0%
37/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
40.0%
4/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
24.7%
42/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
24.4%
41/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
10.0%
1/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.8%
3/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
4.2%
7/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
10.0%
1/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
15.9%
27/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
10.1%
17/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
10.0%
1/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.4%
4/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
1.8%
3/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
10.0%
1/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
12.9%
22/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
7.1%
12/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
20.0%
2/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
15.9%
27/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
10.1%
17/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
10.0%
1/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
25.9%
44/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
28.0%
47/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
10.0%
1/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
11.8%
20/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
20.2%
34/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
10.0%
1/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
11.2%
19/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
4.2%
7/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
30.0%
3/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
26.5%
45/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
17.3%
29/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
20.0%
2/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.8%
20/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
8.3%
14/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
10.0%
1/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.8%
15/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
13.7%
23/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
10.0%
1/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.1%
7/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
8.3%
14/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
10.6%
18/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
6.5%
11/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
10.0%
1/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.2%
14/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
4.2%
7/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
20.0%
2/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.2%
14/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
5.4%
9/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Nervous system disorders
Aphasia
|
18.2%
31/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
10.0%
1/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Nervous system disorders
Dizziness
|
21.2%
36/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
12.5%
21/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Nervous system disorders
Dysgeusia
|
2.4%
4/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
8.3%
14/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Nervous system disorders
Encephalopathy
|
10.6%
18/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.60%
1/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Nervous system disorders
Headache
|
40.6%
69/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
25.6%
43/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
60.0%
6/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
10.0%
1/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Nervous system disorders
Paraesthesia
|
4.1%
7/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
8.3%
14/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
10.0%
1/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
6.0%
10/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Nervous system disorders
Somnolence
|
8.2%
14/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
1.2%
2/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Nervous system disorders
Tremor
|
24.1%
41/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.60%
1/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
10.0%
1/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Psychiatric disorders
Anxiety
|
6.5%
11/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
8.3%
14/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
20.0%
2/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Psychiatric disorders
Confusional state
|
20.0%
34/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
2.4%
4/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Psychiatric disorders
Insomnia
|
12.4%
21/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
15.5%
26/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
7.1%
12/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
9.5%
16/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Renal and urinary disorders
Micturition urgency
|
2.4%
4/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.60%
1/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
10.0%
1/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Renal and urinary disorders
Urinary incontinence
|
7.1%
12/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
3.0%
5/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
10.0%
1/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
24.7%
42/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
10.7%
18/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.1%
12/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
11.9%
20/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
10.0%
1/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
2.9%
5/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
12.5%
21/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
20.0%
34/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
7.7%
13/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.5%
11/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
8.3%
14/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.9%
10/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
1.8%
3/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.2%
2/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
1.2%
2/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
10.0%
1/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.8%
3/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
6.0%
10/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.9%
10/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
1.8%
3/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
2.4%
4/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
2.4%
4/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
10.0%
1/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.1%
7/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
5.4%
9/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
10.0%
1/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Vascular disorders
Embolism
|
0.59%
1/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.60%
1/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
10.0%
1/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Vascular disorders
Hypertension
|
8.8%
15/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
8.9%
15/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
0.00%
0/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
|
Vascular disorders
Hypotension
|
38.8%
66/170 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
13.7%
23/168 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
30.0%
3/10 • All-cause mortality and Adverse events: Up to 74.9 months
All-Cause Mortality: Full Analysis Set consisted of all randomized participants. Adverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel. Data for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.
|
Additional Information
Medical Information
Kite, A Gilead Company
Phone: 844-454-5483 (1-844-454-KITE)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER