Trial Outcomes & Findings for A Study Evaluating the Safety and Efficacy of Brexucabtagene Autoleucel (KTE-X19) in Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ZUMA-3) (NCT NCT02614066)
NCT ID: NCT02614066
Last Updated: 2024-11-19
Results Overview
DLT is drug-related events with onset within first 28 days following infusion: * Grade (GR) 4 hematologic toxicity lasting more than 30 days (except lymphopenia) if not attributable to underlying disease * All drug-related GR 3 lasting for \> 7 days or 4 non-hematologic toxicities regardless of duration (except: aphasia/dysphasia or confusion/cognitive disturbance which resolves to at least GR 1/baseline within 2 weeks or baseline within 4 weeks, fever GR 3/ 4, immediate hypersensitivity reactions within 2 hours of drug infusion that are reversible ≤ GR 2 within 24 hours, renal toxicity which requires dialysis for ≤ 7 days, intubation for airway protection if ≤ 7 days, tumor lysis syndrome, GR 3 liver function test elevation, provided there is resolution to ≤ GR 2 within 14 days, GR 4 transient serum hepatic enzyme abnormalities provided there is resolution to ≤ GR 3 within \< 72 hours, hypogammaglobulinemia GR 3/ 4 and GR 3 nausea and/or anorexia).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
125 participants
Primary outcome timeframe
First infusion date of brexucabtagene autoleucel up to 28 days. Participants were evaluated in specified period but GR4 hematologic toxicity (specified in description) having onset in this period were further observed for 30 days for confirmation
Results posted on
2024-11-19
Participant Flow
Participants were enrolled at study sites in France, Germany, the Netherlands, and the United States.
173 participants were screened. Bridging therapy was recommended for all participants particularly those participants with high disease burden at baseline (M3 marrow \[\> 25% leukemic blasts\] or ≥ 1,000 blasts/mm\^3 in the peripheral circulation) to control participant's disease post apheresis/enrollment and prior to conditioning chemotherapy.
Participant milestones
| Measure |
Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg
Participants with relapsed or refractory B-precursor acute lymphoblastic leukemia (r/r B-ALL) received conditioning chemotherapy (fludarabine 25 mg/m\^2 intravenously \[IV\] over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m\^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel (KTE-X19) chimeric antigen receptor (CAR) transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing \> 100 kg, a maximum flat dose of 2 x 10\^8 anti-CD19 CAR T cells/kg of body weight was administered.
|
Phase 1: 1 x 10^6 Anti-CD19 CAR T Cells/kg
Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m\^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m\^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 1 x 10\^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing \> 100 kg, a maximum flat dose of 1 x 10\^8 anti-CD19 CAR T cells/kg of body weight was administered.
|
Phase 1: 0.5 x 10^6 Anti-CD19 CAR T Cells/kg
Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m\^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m\^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 0.5 x 10\^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing \> 100 kg, a maximum flat dose of 0.5 x 10\^8 anti-CD19 CAR T cells/kg of body weight was administered.
|
Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg
Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m\^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m\^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 1 x 10\^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing \> 100 kg, a maximum flat dose of 1 x 10\^8 anti-CD19 CAR T cells/kg of body weight was administered.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
28
|
20
|
71
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
28
|
20
|
71
|
Reasons for withdrawal
| Measure |
Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg
Participants with relapsed or refractory B-precursor acute lymphoblastic leukemia (r/r B-ALL) received conditioning chemotherapy (fludarabine 25 mg/m\^2 intravenously \[IV\] over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m\^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel (KTE-X19) chimeric antigen receptor (CAR) transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing \> 100 kg, a maximum flat dose of 2 x 10\^8 anti-CD19 CAR T cells/kg of body weight was administered.
|
Phase 1: 1 x 10^6 Anti-CD19 CAR T Cells/kg
Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m\^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m\^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 1 x 10\^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing \> 100 kg, a maximum flat dose of 1 x 10\^8 anti-CD19 CAR T cells/kg of body weight was administered.
|
Phase 1: 0.5 x 10^6 Anti-CD19 CAR T Cells/kg
Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m\^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m\^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 0.5 x 10\^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing \> 100 kg, a maximum flat dose of 0.5 x 10\^8 anti-CD19 CAR T cells/kg of body weight was administered.
|
Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg
Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m\^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m\^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 1 x 10\^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing \> 100 kg, a maximum flat dose of 1 x 10\^8 anti-CD19 CAR T cells/kg of body weight was administered.
|
|---|---|---|---|---|
|
Overall Study
Death
|
6
|
14
|
11
|
29
|
|
Overall Study
Full consent withdrawn
|
0
|
1
|
0
|
8
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
2
|
2
|
|
Overall Study
Enrolled but did not Initiate KTE-X19
|
0
|
5
|
4
|
16
|
|
Overall Study
Rolled over or consented to a long term follow-up (LFTU) study
|
0
|
4
|
2
|
15
|
|
Overall Study
Reason not specified
|
0
|
2
|
1
|
1
|
Baseline Characteristics
A Study Evaluating the Safety and Efficacy of Brexucabtagene Autoleucel (KTE-X19) in Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ZUMA-3)
Baseline characteristics by cohort
| Measure |
Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg
n=6 Participants
Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m\^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m\^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing \> 100 kg, a maximum flat dose of 2 x 10\^8 anti-CD19 CAR T cells/kg of body weight was administered.
|
Phase 1: 1 x 10^6 Anti-CD19 CAR T Cells/kg
n=23 Participants
Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m\^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m\^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 1 x 10\^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing \> 100 kg, a maximum flat dose of 1 x 10\^8 anti-CD19 CAR T cells/kg of body weight was administered.
|
Phase 1: 0.5 x 10^6 Anti-CD19 CAR T Cells/kg
n=16 Participants
Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m\^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m\^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 0.5 x 10\^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing \> 100 kg, a maximum flat dose of 0.5 x 10\^8 anti-CD19 CAR T cells/kg of body weight was administered.
|
Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg
n=55 Participants
Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m\^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m\^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 1 x 10\^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing \> 100 kg, a maximum flat dose of 1 x 10\^8 anti-CD19 CAR T cells/kg of body weight was administered.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
38 years
STANDARD_DEVIATION 13.8 • n=5 Participants
|
46 years
STANDARD_DEVIATION 17.6 • n=7 Participants
|
46 years
STANDARD_DEVIATION 16.7 • n=5 Participants
|
42 years
STANDARD_DEVIATION 16.1 • n=4 Participants
|
43 years
STANDARD_DEVIATION 16.3 • n=21 Participants
|
|
Age, Customized
<=18 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Age, Customized
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
84 Participants
n=21 Participants
|
|
Age, Customized
>=65 years
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
45 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
55 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic or Latino
|
3 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
70 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not collected
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
4 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
76 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Other or More Than One Race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Not collected
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
France
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Region of Enrollment
Germany
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Region of Enrollment
Netherlands
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
86 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: First infusion date of brexucabtagene autoleucel up to 28 days. Participants were evaluated in specified period but GR4 hematologic toxicity (specified in description) having onset in this period were further observed for 30 days for confirmationPopulation: DLT-Evaluable Analysis Set included first 3 participants in Phase 1 treated with target brexucabtagene autoleucel dose and followed for at least 28 days. Only participants from Phase 1: 2 X 10\^6 Anti-CD19 CAR T Cells/kg were pre-specified to be assessed for this Outcome Measure.
DLT is drug-related events with onset within first 28 days following infusion: * Grade (GR) 4 hematologic toxicity lasting more than 30 days (except lymphopenia) if not attributable to underlying disease * All drug-related GR 3 lasting for \> 7 days or 4 non-hematologic toxicities regardless of duration (except: aphasia/dysphasia or confusion/cognitive disturbance which resolves to at least GR 1/baseline within 2 weeks or baseline within 4 weeks, fever GR 3/ 4, immediate hypersensitivity reactions within 2 hours of drug infusion that are reversible ≤ GR 2 within 24 hours, renal toxicity which requires dialysis for ≤ 7 days, intubation for airway protection if ≤ 7 days, tumor lysis syndrome, GR 3 liver function test elevation, provided there is resolution to ≤ GR 2 within 14 days, GR 4 transient serum hepatic enzyme abnormalities provided there is resolution to ≤ GR 3 within \< 72 hours, hypogammaglobulinemia GR 3/ 4 and GR 3 nausea and/or anorexia).
Outcome measures
| Measure |
Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg
n=3 Participants
Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m\^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m\^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing \> 100 kg, a maximum flat dose of 2 x 10\^8 anti-CD19 CAR T cells/kg of body weight was administered.
|
|---|---|
|
Phase 1: Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs)
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: First infusion date of brexucabtagene autoleucel (Phase 2) up to 3.7 yearsPopulation: The modified Intent-to-Treat (mITT) Analysis Set included all enrolled participants treated with brexucabtagene autoleucel in Phase 2.
OCR rate:percentage of participants achieving CR+CRi.CR: ≤5% blasts by morphology in bone marrow(BM);absolute neutrophil count(ANC)≥1000/microliters (μL) and platelets(Plt) ≥100000/μL in peripheral blood(PB);central nervous system extramedullary disease(CNS EMD) of CNS-1(no detectable leukemia in cerebrospinal fluid\[CSF\]);Non-CNS baselineEMD:if present(images shows CR),if no(images not needed),if performed shows negative positron emission tomography(PET) baseline,baseline lesions shows CR as disappearance of measurable and nonmeasurable nodal lesions(Nodal masses \>1.5 cm in greatest transverse diameter\[GTD\] at baseline have regressed to ≤l.5 cm GTD,nodes that were 1.1 to 1.5 cm\[long axis\] and \>1.0 cm\[short axis\] have decreased to 1.0 cm in their short axis, spleen and/or liver must be normal size) and no new lesions.CRi:all CR criteria except in PB ANC≥1000/μL and Plt\<100000/μL or ANC\<1000/μL and Plt ≥100000/μL.95% confidence interval (CI) was calculated by Clopper-Pearson method.
Outcome measures
| Measure |
Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg
n=55 Participants
Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m\^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m\^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing \> 100 kg, a maximum flat dose of 2 x 10\^8 anti-CD19 CAR T cells/kg of body weight was administered.
|
|---|---|
|
Phase 2: Overall Complete Remission (OCR) Rate (Complete Remission [CR]+ Complete Remission With Incomplete Hematologic Recovery [CRi]) as Assessed Per Independent Review
|
70.9 percentage of participants
Interval 57.0 to 82.0
|
SECONDARY outcome
Timeframe: First infusion date of brexucabtagene autoleucel (Phase 2) up to 3.7 yearsPopulation: Participants in mITT Analysis Set were analyzed.
MRD was assessed utilizing multicolor flow cytometry to detect residual cancerous cells with a sensitivity of 10\^-4. MRD negative remission was defined as MRD \< 10\^-4 threshold. Percentage of participants with MRD negative remission was reported. 95% CI was calculated by Clopper-Pearson method.
Outcome measures
| Measure |
Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg
n=55 Participants
Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m\^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m\^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing \> 100 kg, a maximum flat dose of 2 x 10\^8 anti-CD19 CAR T cells/kg of body weight was administered.
|
|---|---|
|
Phase 2: Minimum Residual Disease (MRD) Negative Remission Rate
|
76 percentage of participants
Interval 63.0 to 87.0
|
SECONDARY outcome
Timeframe: First infusion date of brexucabtagene autoleucel (Phase 2) up to 3.7 yearsPopulation: Participants in mITT Analysis Set were analyzed.
CR: ≤ 5% blasts by morphology in BM; ANC ≥ 1000/µL and Plt ≥ 100000/µL in PB; CNS EMD of CNS-1 (no detectable leukemia in CSF); Non-CNS EMD: if baseline EMD present (images must show CR), if no baseline EMD (then images not required), but if performed should show negative PET baseline, baseline lesions must show CR as disappearance of measurable and nonmeasurable nodal lesions (Nodal masses \> 1.5 cm in GTD at baseline must have regressed to ≤ l.5 cm GTD, nodes that were 1.1 to 1.5 cm \[long axis\] and \> 1.0 cm \[short axis\] must have decreased to 1.0 cm in their short axis, spleen and/or liver must be normal size) and no new lesions. Percentage of participants with CR was reported. 95% CI was calculated by Clopper-Pearson method.
Outcome measures
| Measure |
Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg
n=55 Participants
Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m\^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m\^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing \> 100 kg, a maximum flat dose of 2 x 10\^8 anti-CD19 CAR T cells/kg of body weight was administered.
|
|---|---|
|
Phase 2: Complete Remission (CR) Rate Per Independent Review
|
56.4 percentage of participants
Interval 42.0 to 70.0
|
SECONDARY outcome
Timeframe: First infusion date of brexucabtagene autoleucel (Phase 2) up to 3.7 yearsPopulation: Participants in mITT Analysis Set were analyzed.
CRi: ≤ 5% blasts by morphology in BM; ANC ≥ 1000/µL and Plt \< 100000/µL or ANC \< 1000/µL and Plt ≥ 100000/µL in PB; CNS EMD of CNS-1 (no detectable leukemia in CSF); Non-CNS EMD: if baseline EMD present (images must show CR), if no baseline EMD (then images not required), but if performed should show negative PET baseline, baseline lesions must show CR as disappearance of measurable and nonmeasurable nodal lesions (Nodal masses \> 1.5 cm in GTD at baseline must have regressed to ≤ l.5 cm GTD, nodes that were 1.1 to 1.5 cm \[long axis\] and \> 1.0 cm \[short axis\] must have decreased to 1.0 cm in their short axis, spleen and/or liver must be normal size, if tested) and no new lesions. Percentage of participants with CRi was reported. 95% CI was calculated by Clopper-Pearson method.
Outcome measures
| Measure |
Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg
n=55 Participants
Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m\^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m\^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing \> 100 kg, a maximum flat dose of 2 x 10\^8 anti-CD19 CAR T cells/kg of body weight was administered.
|
|---|---|
|
Phase 2: Complete Remission With Incomplete Hematologic Recovery (CRi) Rate Per Independent Review
|
14.5 percentage of participants
Interval 6.0 to 27.0
|
SECONDARY outcome
Timeframe: From first CR or CRi (Phase 2) up to 3.7 yearsPopulation: Participants in mITT Analysis Set with overall complete remission (CR or CRi ) were analyzed.
DOR was defined as the time from first CR or CRi to relapse or any death in the absence of documented relapse. CR and CRi are defined in Outcome Measures 4 and 5. Relapse: ≤ 5% blasts by morphology in BM; or circulating leukemia present in PB; or CNS EMD of CNS-2 (detectable CSF blast cells in a sample of CSF with \< 5 white blood cells \[WBCs\] per mm\^3 with neurological changes) or CNS-3 (detectable CSF blast cells in a sample of CSF with ≥ 5 WBCs per mm\^3 with or without neurological changes); or progressive disease (PD): at least one of the following (≥ 50% increase from nadir in the sum of the products of at least two lymph nodes, or if a single node is involved at least a 50% increase in the product of the diameters of this one node; at least a 50% increase in the longest diameter of any single previously identified node more than 1 cm in its short axis; ≥ 50% increase in size of splenic, hepatic or any other non-nodal lesion). Kaplan-Meier (KM) estimates was used for analyses.
Outcome measures
| Measure |
Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg
n=39 Participants
Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m\^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m\^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing \> 100 kg, a maximum flat dose of 2 x 10\^8 anti-CD19 CAR T cells/kg of body weight was administered.
|
|---|---|
|
Phase 2: Duration of Remission (DOR) Per Independent Review
|
14.6 months
Interval 9.4 to 24.1
|
SECONDARY outcome
Timeframe: First infusion date of brexucabtagene autoleucel (Phase 2) up to 5 yearsPopulation: Participants in mITT Analysis Set were analyzed.
OCR rate: percentage of participants achieving CR+CRi. CR: ≤ 5% blasts by morphology in BM; ANC ≥1000/µL and Plt ≥ 100000/µL in PB; CNS EMD of CNS-1 (no detectable leukemia in CSF); Non-CNS EMD: if baseline EMD present (images must show CR), if no baseline EMD (then images not required), but if performed should show negative PET baseline, baseline lesions must show CR as disappearance of measurable and nonmeasurable nodal lesions (Nodal masses \>1.5 cm in GTD at baseline must have regressed to ≤l.5 cm GTD, nodes that were 1.1 to 1.5 cm \[long axis\] and \>1.0 cm \[short axis\] must have decreased to 1.0 cm in their short axis, spleen and/or liver must be normal size, if tested) and no new lesions. CRi: all CR criteria except in PB ANC ≥1000/µL and Plt \<100000/µL or ANC \<1000/µL and Plt ≥100000/µL. 95% CI was calculated by Clopper-Pearson method.
Outcome measures
| Measure |
Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg
n=55 Participants
Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m\^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m\^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing \> 100 kg, a maximum flat dose of 2 x 10\^8 anti-CD19 CAR T cells/kg of body weight was administered.
|
|---|---|
|
Phase 2: OCR Rate (CR + CRi) Per Investigator Review
|
72.7 percentage of participants
Interval 59.0 to 84.0
|
SECONDARY outcome
Timeframe: First infusion date of brexucabtagene autoleucel (Phase 2) up to 5 yearsPopulation: Participants in mITT Analysis Set were analyzed.
Outcome measures
| Measure |
Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg
n=55 Participants
Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m\^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m\^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing \> 100 kg, a maximum flat dose of 2 x 10\^8 anti-CD19 CAR T cells/kg of body weight was administered.
|
|---|---|
|
Phase 2: Percentage of Participants With Allogeneic Stem Cell Transplant (Allo-SCT)
|
20 percentage of participants
|
SECONDARY outcome
Timeframe: First infusion date of brexucabtagene autoleucel (Phase 2) up to 3.7 yearsPopulation: Participants in mITT Analysis Set with CR were analyzed.
Percentage of participants with MRD negative remission among CR participants was reported. MRD was assessed utilizing multicolor flow cytometry to detect residual cancerous cells with a sensitivity of 10\^-4. MRD negative remission was defined as MRD \< 10\^-4 threshold. CR: ≤5% blasts by morphology in BM; ANC ≥ 1000/µL and Plt ≥ 100000/µL in PB; CNS EMD of CNS-1 (no detectable leukemia in CSF); Non-CNS EMD: if baseline EMD present (images must show CR), if no baseline EMD (then images not required), but if performed should show negative PET baseline, baseline lesions must show CR as disappearance of measurable and nonmeasurable nodal lesions (Nodal masses \> 1.5 cm in GTD at baseline must have regressed to ≤ l.5 cm GTD, nodes that were 1.1 to 1.5 cm \[long axis\] and \> 1.0 cm \[short axis\] must have decreased to 1.0 cm in their short axis, spleen and/or liver must be normal size) and no new lesions. 95% CI was calculated by Clopper-Pearson method.
Outcome measures
| Measure |
Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg
n=31 Participants
Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m\^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m\^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing \> 100 kg, a maximum flat dose of 2 x 10\^8 anti-CD19 CAR T cells/kg of body weight was administered.
|
|---|---|
|
Phase 2: MRD Negative Remission Rate Among Complete Remission (CR) Participants
|
97 percentage of participants
Interval 83.0 to 100.0
|
SECONDARY outcome
Timeframe: First infusion date of brexucabtagene autoleucel (Phase 2) up to 3.7 yearsPopulation: Participants in mITT Analysis Set with CRi were analyzed.
Percentage of participants with MRD negative remission among CRi participants was reported. MRD was assessed utilizing multicolor flow cytometry to detect residual cancerous cells with a sensitivity of 10\^-4. MRD negative remission was defined as MRD \< 10\^-4 threshold. CRi: ≤ 5% blasts by morphology in BM; ANC ≥ 1000/µL and Plt \< 100000/µL or ANC \< 1000/µL and Plt ≥ 100000/µL in PB; CNS EMD of CNS-1 (no detectable leukemia in CSF); Non-CNS EMD: if baseline EMD present (images must show CR), if no baseline EMD (then images not required), but if performed should show negative PET baseline, baseline lesions must show CR as disappearance of measurable and nonmeasurable nodal lesions (Nodal masses \>1.5 cm in GTD at baseline must have regressed to ≤l.5 cm GTD, nodes that were 1.1 to 1.5 cm \[long axis\] and \>1.0 cm \[short axis\] must have decreased to 1.0 cm in their short axis, spleen and/or liver must be normal size) and no new lesions. 95% CI was calculated by Clopper-Pearson method.
Outcome measures
| Measure |
Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg
n=8 Participants
Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m\^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m\^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing \> 100 kg, a maximum flat dose of 2 x 10\^8 anti-CD19 CAR T cells/kg of body weight was administered.
|
|---|---|
|
Phase 2: MRD Negative Remission Rate Among Complete Remission With Incomplete Hematologic Recovery (CRi) Participants
|
100 percentage of participants
Interval 63.0 to 100.0
|
SECONDARY outcome
Timeframe: First infusion date of brexucabtagene autoleucel (Phase 2) up to 5 yearsPopulation: Participants in mITT Analysis Set were analyzed.
OS was defined as the time from brexucabtagene autoleucel infusion to the date of death from any cause. Participants who had not died by the analysis data cutoff date were censored at their last contact date. KM estimates was used for analyses.
Outcome measures
| Measure |
Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg
n=55 Participants
Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m\^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m\^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing \> 100 kg, a maximum flat dose of 2 x 10\^8 anti-CD19 CAR T cells/kg of body weight was administered.
|
|---|---|
|
Phase 2: Overall Survival (OS)
|
26.0 months
Interval 16.2 to
Upper limit of confidence interval was not estimable due to insufficient number of events.
|
SECONDARY outcome
Timeframe: First infusion date of brexucabtagene autoleucel (Phase 2) up to 3.7 yearsPopulation: Participants in mITT Analysis Set were analyzed.
RFS: time from brexucabtagene autoleucel infusion to date of disease relapse or death from any cause. Participants not meeting criteria for relapse by the analysis data cutoff date were censored at their last evaluable disease assessment date. Participants who had not achieved a CR or CRi at analysis data cutoff were evaluated as an RFS event at Day 0. CR and CRi are defined in Outcome Measures 4 and 5. Relapse is defined in Outcome Measure 6. KM estimates was used for analyses.
Outcome measures
| Measure |
Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg
n=55 Participants
Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m\^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m\^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing \> 100 kg, a maximum flat dose of 2 x 10\^8 anti-CD19 CAR T cells/kg of body weight was administered.
|
|---|---|
|
Phase 2: Relapse-free Survival (RFS)
|
11.6 months
Interval 2.7 to 20.5
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel.
An AE was any untoward medical occurrence in a participant after brexucabtagene autoleucel infusion, which did not necessarily have a causal relationship with the treatment. An AE could therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. TEAEs included all AEs with onset on or after initiation of the brexucabtagene autoleucel infusion.
Outcome measures
| Measure |
Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg
n=55 Participants
Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m\^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m\^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing \> 100 kg, a maximum flat dose of 2 x 10\^8 anti-CD19 CAR T cells/kg of body weight was administered.
|
|---|---|
|
Phase 2: Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs)
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Participants in Safety Analysis Set were analyzed.
Grading categories are 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.
Outcome measures
| Measure |
Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg
n=55 Participants
Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m\^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m\^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing \> 100 kg, a maximum flat dose of 2 x 10\^8 anti-CD19 CAR T cells/kg of body weight was administered.
|
|---|---|
|
Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Increased Parameter Value
Hematology: Lymphocytes
|
1 Participants
|
|
Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Increased Parameter Value
Hematology: Leukocytes
|
4 Participants
|
|
Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Increased Parameter Value
Hematology: Hemoglobin
|
0 Participants
|
|
Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Increased Parameter Value
Hematology: Neutrophils
|
0 Participants
|
|
Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Increased Parameter Value
Hematology: Platelets
|
0 Participants
|
|
Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Increased Parameter Value
Chemistry: Creatinine
|
4 Participants
|
|
Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Increased Parameter Value
Chemistry: Glucose
|
13 Participants
|
|
Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Increased Parameter Value
Chemistry: Aspartate Aminotransferase
|
14 Participants
|
|
Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Increased Parameter Value
Chemistry: Alanine Aminotransferase
|
17 Participants
|
|
Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Increased Parameter Value
Chemistry: Bilirubin
|
5 Participants
|
|
Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Increased Parameter Value
Chemistry: Alkaline Phosphatase
|
3 Participants
|
|
Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Increased Parameter Value
Chemistry: Direct Bilirubin
|
8 Participants
|
|
Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Increased Parameter Value
Chemistry: Urate
|
12 Participants
|
|
Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Increased Parameter Value
Chemistry: Sodium
|
1 Participants
|
|
Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Increased Parameter Value
Chemistry: Potassium
|
2 Participants
|
|
Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Increased Parameter Value
Chemistry: Magnesium
|
3 Participants
|
|
Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Increased Parameter Value
Chemistry: Calcium
|
0 Participants
|
|
Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Increased Parameter Value
Chemistry: Albumin
|
0 Participants
|
|
Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Increased Parameter Value
Chemistry: Phosphate
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Participants in Safety Analysis Set were analyzed.
Grading categories are determined by CTCAE version 4.03. Grade 1: mild, Grade 2: moderate, Grade 3: severe or medically significant, Grade 4: life-threatening.
Outcome measures
| Measure |
Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg
n=55 Participants
Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m\^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m\^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing \> 100 kg, a maximum flat dose of 2 x 10\^8 anti-CD19 CAR T cells/kg of body weight was administered.
|
|---|---|
|
Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Decreased Parameter Value
Chemistry: Alkaline Phosphatase
|
0 Participants
|
|
Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Decreased Parameter Value
Hematology: Hemoglobin
|
42 Participants
|
|
Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Decreased Parameter Value
Hematology: Leukocytes
|
54 Participants
|
|
Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Decreased Parameter Value
Hematology: Platelets
|
46 Participants
|
|
Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Decreased Parameter Value
Hematology: Lymphocytes
|
52 Participants
|
|
Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Decreased Parameter Value
Hematology: Neutrophils
|
53 Participants
|
|
Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Decreased Parameter Value
Chemistry: Calcium
|
9 Participants
|
|
Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Decreased Parameter Value
Chemistry: Albumin
|
5 Participants
|
|
Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Decreased Parameter Value
Chemistry: Phosphate
|
27 Participants
|
|
Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Decreased Parameter Value
Chemistry: Magnesium
|
0 Participants
|
|
Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Decreased Parameter Value
Chemistry: Sodium
|
11 Participants
|
|
Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Decreased Parameter Value
Chemistry: Potassium
|
7 Participants
|
|
Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Decreased Parameter Value
Chemistry: Glucose
|
0 Participants
|
|
Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Decreased Parameter Value
Chemistry: Alanine Aminotransferase
|
0 Participants
|
|
Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Decreased Parameter Value
Chemistry: Aspartate Aminotransferase
|
0 Participants
|
|
Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Decreased Parameter Value
Chemistry: Bilirubin
|
0 Participants
|
|
Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Decreased Parameter Value
Chemistry: Creatinine
|
0 Participants
|
|
Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Decreased Parameter Value
Chemistry: Direct Bilirubin
|
0 Participants
|
|
Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Decreased Parameter Value
Chemistry: Urate
|
0 Participants
|
SECONDARY outcome
Timeframe: First infusion date of brexucabtagene autoleucel (Phase 2) up to 2.7 yearsPopulation: Participants in Safety Analysis Set were analyzed.
Outcome measures
| Measure |
Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg
n=55 Participants
Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m\^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m\^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing \> 100 kg, a maximum flat dose of 2 x 10\^8 anti-CD19 CAR T cells/kg of body weight was administered.
|
|---|---|
|
Phase 2: Percentage of Participants With Anti-KTE-X19 Antibodies
|
7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Day 28, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, and Month 24Population: Participants in Safety Analysis Set with available data were analyzed.
The EQ-5D-5 levels(EQ-5D-5L)is a standardized measure of health status of the participant that provides a simple, generic measure of health for clinical and economic appraisal.It is a self-reported questionnaire used to assess the overall health status of participant scoring 5 dimensions of health: mobility,self-care,usual activities,pain/discomfort and anxiety/depression.Each dimension has 5 levels:no problems,slight problems,moderate problems,severe problems,and extreme problems.EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by a formula that attaches values (called QOL utilities)to each of the levels in each dimension.EQ-5D Summary Index values range from -0.11(worst health) to 1.00(perfect health).This decision results in a 1-digit number that shows the level for that dimension. The digits for 5 dimensions can be combined to 5-digit number that show the participant's health.Higher scores of EQ-5D-5L indicate better health.
Outcome measures
| Measure |
Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg
n=51 Participants
Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m\^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m\^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing \> 100 kg, a maximum flat dose of 2 x 10\^8 anti-CD19 CAR T cells/kg of body weight was administered.
|
|---|---|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 6: Anxiety/Depression (Severe problem)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 6: Anxiety/Depression (Extreme Anxious or Depressed)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 9: Anxiety/Depression (No problem)
|
9 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 9: Anxiety/Depression (Slight problem)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 9: Anxiety/Depression (Moderate problem)
|
1 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 9: Anxiety/Depression (Severe problem)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 9: Anxiety/Depression (Extreme Anxious or Depressed)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 12: Anxiety/Depression (No problem)
|
10 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 12: Anxiety/Depression (Slight problem)
|
2 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 12: Anxiety/Depression (Moderate problem)
|
2 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 12: Anxiety/Depression (Severe problem)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 12: Anxiety/Depression (Extreme Anxious or Depressed)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 15: Anxiety/Depression (No problem)
|
7 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 15: Anxiety/Depression (Slight problem)
|
2 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 15: Anxiety/Depression (Moderate problem)
|
1 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 15: Anxiety/Depression (Severe problem)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 15: Anxiety/Depression (Extreme Anxious or Depressed)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 18: Anxiety/Depression (No problem)
|
3 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 18: Anxiety/Depression (Slight problem)
|
1 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 18: Anxiety/Depression (Moderate problem)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 18: Anxiety/Depression (Severe problem)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 18: Anxiety/Depression (Extreme Anxious or Depressed)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 24: Anxiety/Depression (No problem)
|
4 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 24: Anxiety/Depression (Slight problem)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 24: Anxiety/Depression (Moderate problem)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 24: Anxiety/Depression (Severe problem)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 24: Anxiety/Depression (Extreme Anxious or Depressed)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Baseline: Mobility (No problem)
|
39 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Baseline: Mobility (Slight problem)
|
7 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Baseline: Mobility (Moderate problem)
|
4 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Baseline: Mobility (Severe problem)
|
1 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Baseline: Mobility (Unable to walk)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Day 28: Mobility (No problem)
|
19 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Day 28: Mobility (Slight problem)
|
10 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Day 28: Mobility (Moderate problem)
|
9 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Day 28: Mobility (Severe problem)
|
1 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Day 28: Mobility (Unable to walk)
|
3 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 3: Mobility (No problem)
|
19 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 3: Mobility (Slight problem)
|
5 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 3: Mobility (Moderate problem)
|
1 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 3: Mobility (Severe problem)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 3: Mobility (Unable to walk)
|
1 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 6: Mobility (No problem)
|
16 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 6: Mobility (Slight problem)
|
6 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 6: Mobility (Moderate problem)
|
2 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 6: Mobility (Severe problem)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 6: Mobility (Unable to walk)
|
1 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 9: Mobility (No problem)
|
8 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 9: Mobility (Slight problem)
|
1 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 9: Mobility (Moderate problem)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 9: Mobility (Severe problem)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 9: Mobility (Unable to walk)
|
1 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 12: Mobility (No problem)
|
11 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 12: Mobility (Slight problem)
|
3 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 12: Mobility (Moderate problem)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 12: Mobility (Severe problem)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 12: Mobility (Unable to walk)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 15: Mobility (No problem)
|
7 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 15: Mobility (Slight problem)
|
2 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 15: Mobility (Moderate problem)
|
1 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 15: Mobility (Severity problem)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 15: Mobility (Unable to walk)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 18: Mobility (No problem)
|
3 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 18: Mobility (Slight problem)
|
1 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 18: Mobility (Moderate problem)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 18: Mobility (Severe problem)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 18: Mobility (Unable to walk)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 24: Mobility (No problem)
|
3 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 24: Mobility (Slight problem)
|
1 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 24: Mobility (Moderate problem)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 24: Mobility (Severe problem)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 24: Mobility (Unable to Walk)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Baseline: Self-care (No problem)
|
44 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Baseline: Self-care (Slight problem)
|
5 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Baseline: Self-care (Moderate problem)
|
1 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Baseline: Self-care (Severe problem)
|
1 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Baseline: Self-care (Unable to wash or dress)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Day 28: Self-care (No problem)
|
31 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Day 28: Self-care (Slight problem)
|
6 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Day 28: Self-care (Moderate problem)
|
1 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Day 28: Self-care (Severe problem)
|
2 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Day 28: Self-care (Unable to wash or dress)
|
2 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 3: Self-care (No problem)
|
23 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 3: Self-care (Slight problem)
|
1 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 3: Self-care (Moderate problem)
|
1 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 3: Self-care (Severe problem)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 3: Self-care (Unable to wash or dress)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 6: Self-care (No problem)
|
23 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 6: Self-care (Slight problem)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 6: Self-care (Moderate problem)
|
1 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 6: Self-care (Severe problem)
|
1 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 6: Self-care (Unable to wash or dress)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 9: Self-care (No problem)
|
9 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 9: Self-care (Slight problem)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 9: Self-care (Moderate problem)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 9: Self-care (Severe problem)
|
1 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 9: Self-care (Unable to wash or dress)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 12: Self-care (No problem)
|
14 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 12: Self-care (Slight problem)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 12: Self-care (Moderate problem)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 12: Self-care (Severe problem)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 12: Self-care (Unable to wash or dress)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 15: Self-care (No problem)
|
10 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 15: Self-care (Slight problem)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 15: Self-care (Moderate problem)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 15: Self-care (Severe problem)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 15: Self-care (Unable to wash or dress)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 18: Self-care (No problem)
|
4 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 18: Self-care (Slight problem)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 18: Self-care (Moderate problem)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 18: Self-care (Severe problem)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 18: Self-care (Unable to wash or dress)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 24: Self-care (No problem)
|
4 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 24: Self-care (Slight problem)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 24: Self-care (Moderate problem)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 24: Self-care (Severe problem)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 24: Self-care (Unable to wash or dress)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Baseline: Usual activities (No problem)
|
24 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Baseline: Usual activities (Slight problem)
|
14 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Baseline: Usual activities (Moderate problem)
|
9 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Baseline: Usual activities (Severe problem)
|
3 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Baseline: Usual activities (Unable to do usual activities)
|
1 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Day 28: Usual activities (No problem)
|
17 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Day 28: Usual activities (Slight problem)
|
13 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Day 28: Usual activities (Moderate problem)
|
8 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Day 28: Usual activities (Severe problem)
|
3 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Day 28: Usual activities (Unable to do usual activities)
|
1 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 3: Usual activities (No problem)
|
14 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 3: Usual activities (Slight problem)
|
9 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 3: Usual activities (Moderate problem)
|
1 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 3: Usual activities (Severe problem)
|
1 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 3: Usual activities (Unable to do usual activities)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 6: Usual activities (No problem)
|
17 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 6: Usual activities (Slight problem)
|
4 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 6: Usual activities (Moderate problem)
|
2 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 6: Usual activities (Severe problem)
|
2 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 6: Usual activities (Unable to do usual activities)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 9: Usual activities (No problem)
|
9 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 9: Usual activities (Slight problem)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 9: Usual activities (Moderate problem)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 9: Usual activities (Severe problem)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 9: Usual activities (Unable to do usual activities)
|
1 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 12: Usual activities (No problem)
|
11 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 12: Usual activities (Slight problem)
|
3 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 12: Usual activities (Moderate problem)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 12: Usual activities (Severe problem)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 12: Usual activities (Unable to do usual activities)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 15: Usual activities (No problem)
|
8 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 15: Usual activities (Slight problem)
|
2 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 15: Usual activities (Moderate problem)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 15: Usual activities (Severe problem)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 15: Usual activities (Unable to do usual activities)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 18: Usual activities (No problem)
|
1 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 18: Usual activities (Slight problem)
|
3 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 18: Usual activities (Moderate problem)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 18: Usual activities (Severe problem)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 18: Usual activities (Unable to do usual activities)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 24: Usual activities (No problem)
|
4 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 24: Usual activities (Slight problem)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 24: Usual activities (Moderate problem)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 24: Usual activities (Severe problem)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 24: Usual activities (Unable to do usual activities)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Baseline: Pain/Discomfort (No Problem)
|
23 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Baseline: Pain/Discomfort (Slight Problem)
|
16 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Baseline: Pain/Discomfort (Moderate Problem)
|
12 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Baseline: Pain/Discomfort (Severe Problem)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Baseline: Pain/Discomfort (Extreme Pain or discomfort)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Day 28: Pain/Discomfort (No Problem)
|
19 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Day 28: Pain/Discomfort (Slight Problem)
|
14 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Day 28: Pain/Discomfort (Moderate Problem)
|
9 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Day 28: Pain/Discomfort (Severe Problem)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Day 28: Pain/Discomfort (Extreme Pain or discomfort)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 3: Pain/Discomfort (No Problem)
|
11 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 3: Pain/Discomfort (Slight Problem)
|
9 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 3: Pain/Discomfort (Moderate Problem)
|
6 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 3: Pain/Discomfort (Severe Problem)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 3: Pain/Discomfort (Extreme Pain or discomfort)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 6: Pain/Discomfort (No Problem)
|
11 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 6: Pain/Discomfort (Slight Problem)
|
5 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 6: Pain/Discomfort (Moderate Problem)
|
7 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 6: Pain/Discomfort (Severe Problem)
|
2 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 6: Pain/Discomfort (Extreme Pain or discomfort)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 9: Pain/Discomfort (No Problem)
|
7 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 9: Pain/Discomfort (Slight Problem)
|
1 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 9: Pain/Discomfort (Moderate Problem)
|
2 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 9: Pain/Discomfort (Severe Problem)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 9: Pain/Discomfort (Extreme Pain or discomfort)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 12: Pain/Discomfort (No Problem)
|
7 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 12: Pain/Discomfort (Slight Problem)
|
6 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 12: Pain/Discomfort (Moderate Problem)
|
1 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 12: Pain/Discomfort (Severe Problem)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 12: Pain/Discomfort (Extreme Pain or discomfort)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 15: Pain/Discomfort (No Problem)
|
6 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 15: Pain/Discomfort (Slight Problem)
|
4 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 15: Pain/Discomfort (Moderate Problem)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 15: Pain/Discomfort (Severe Problem)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 15: Pain/Discomfort (Extreme Pain or discomfort)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 18: Pain/Discomfort (No Problem)
|
1 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 18: Pain/Discomfort (Slight Problem)
|
3 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 18: Pain/Discomfort (Moderate Problem)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 18: Pain/Discomfort (Severe Problem)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 18: Pain/Discomfort (Extreme Pain or discomfort)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 24: Pain/Discomfort (No Problem)
|
3 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 24: Pain/Discomfort (Slight Problem)
|
1 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 24: Pain/Discomfort (Moderate Problem)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 24: Pain/Discomfort (Severe Problem)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 24: Pain/Discomfort (Extreme Pain or discomfort)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Baseline: Anxiety/Depression (No problem)
|
30 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Baseline: Anxiety/Depression (Slight problem)
|
12 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Baseline: Anxiety/Depression (Moderate problem)
|
7 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Baseline: Anxiety/Depression (Severe problem)
|
2 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Baseline: Anxiety/Depression (Extreme Anxious or Depressed)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Day 28: Anxiety/Depression (No problem)
|
28 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Day 28: Anxiety/Depression (Slight problem)
|
11 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Day 28: Anxiety/Depression (Moderate problem)
|
3 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Day 28: Anxiety/Depression (Severe problem)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Day 28: Anxiety/Depression (Extreme Anxious or Depressed)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 3: Anxiety/Depression (No problem)
|
17 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 3: Anxiety/Depression (Slight problem)
|
6 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 3: Anxiety/Depression (Moderate problem)
|
3 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 3: Anxiety/Depression (Severe problem)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 3: Anxiety/Depression (Extreme Anxious or Depressed)
|
0 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 6: Anxiety/Depression (No problem)
|
18 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 6: Anxiety/Depression (Slight problem)
|
4 Participants
|
|
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
Month 6: Anxiety/Depression (Moderate problem)
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline, Day 28, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, and Month 24Population: Participants in Safety Analysis Set with available data were analyzed.
EQ-5D is a self-reported questionnaire used for assessing the overall health status of a participant. The EQ-5D is a participant rated questionnaire to assess health-related quality of life in terms of a single index value. The EQ-5D-VAS records the participant's self-rated health on a 20-cm vertical visual analogue scale and is asked to make a global assessment of their current state of health with 0 indicating the worst health they can imagine and 100 indicating the best health they can imagine. Higher scores indicated a better health state.
Outcome measures
| Measure |
Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg
n=51 Participants
Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m\^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m\^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing \> 100 kg, a maximum flat dose of 2 x 10\^8 anti-CD19 CAR T cells/kg of body weight was administered.
|
|---|---|
|
Phase 2: EQ-5D Visual Analogue Scale (VAS) Score
Baseline
|
68.2 score on a scale
Standard Deviation 21.8
|
|
Phase 2: EQ-5D Visual Analogue Scale (VAS) Score
Day 28
|
74.7 score on a scale
Standard Deviation 17.9
|
|
Phase 2: EQ-5D Visual Analogue Scale (VAS) Score
Month 3
|
79.7 score on a scale
Standard Deviation 12.2
|
|
Phase 2: EQ-5D Visual Analogue Scale (VAS) Score
Month 6
|
81.0 score on a scale
Standard Deviation 17.6
|
|
Phase 2: EQ-5D Visual Analogue Scale (VAS) Score
Month 9
|
81.7 score on a scale
Standard Deviation 23.1
|
|
Phase 2: EQ-5D Visual Analogue Scale (VAS) Score
Month 12
|
86.9 score on a scale
Standard Deviation 10.0
|
|
Phase 2: EQ-5D Visual Analogue Scale (VAS) Score
Month 15
|
87.8 score on a scale
Standard Deviation 11.6
|
|
Phase 2: EQ-5D Visual Analogue Scale (VAS) Score
Month 18
|
93.3 score on a scale
Standard Deviation 5.9
|
|
Phase 2: EQ-5D Visual Analogue Scale (VAS) Score
Month 24
|
97.5 score on a scale
Standard Deviation 2.9
|
Adverse Events
Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg
Serious events: 6 serious events
Other events: 6 other events
Deaths: 6 deaths
Phase 1: 1 x 10^6 Anti-CD19 CAR T Cells/kg
Serious events: 21 serious events
Other events: 23 other events
Deaths: 17 deaths
Phase 1: 0.5 x 10^6 Anti-CD19 CAR T Cells/kg
Serious events: 12 serious events
Other events: 16 other events
Deaths: 15 deaths
Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg
Serious events: 41 serious events
Other events: 55 other events
Deaths: 39 deaths
Serious adverse events
| Measure |
Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg
n=6 participants at risk
Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m\^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m\^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing \> 100 kg, a maximum flat dose of 2 x 10\^8 anti-CD19 CAR T cells/kg of body weight was administered.
|
Phase 1: 1 x 10^6 Anti-CD19 CAR T Cells/kg
n=23 participants at risk
Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m\^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m\^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 1 x 10\^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing \> 100 kg, a maximum flat dose of 1 x 10\^8 anti-CD19 CAR T cells/kg of body weight was administered.
|
Phase 1: 0.5 x 10^6 Anti-CD19 CAR T Cells/kg
n=16 participants at risk
Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m\^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m\^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 0.5 x 10\^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing \> 100 kg, a maximum flat dose of 0.5 x 10\^8 anti-CD19 CAR T cells/kg of body weight was administered.
|
Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg
n=55 participants at risk
Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m\^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m\^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 1 x 10\^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing \> 100 kg, a maximum flat dose of 1 x 10\^8 anti-CD19 CAR T cells/kg of body weight was administered.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Cytopenia
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
1.8%
1/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
4.3%
1/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
1.8%
1/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
25.0%
4/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
3.6%
2/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
1.8%
1/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
1.8%
1/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Cardiac disorders
Pulseless electrical activity
|
16.7%
1/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
8.7%
2/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
3.6%
2/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
8.7%
2/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
5.5%
3/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
4.3%
1/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
1.8%
1/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
1.8%
1/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
1.8%
1/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
1.8%
1/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
4.3%
1/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Gastrointestinal disorders
Tongue oedema
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
1.8%
1/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
General disorders
Chills
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
4.3%
1/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
General disorders
Face oedema
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
1.8%
1/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
General disorders
Fatigue
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
3.6%
2/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
General disorders
Multiple organ dysfunction syndrome
|
16.7%
1/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
General disorders
Pyrexia
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
17.4%
4/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
27.3%
15/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
1.8%
1/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Immune system disorders
Graft versus host disease
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
4.3%
1/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
1.8%
1/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Immune system disorders
Haemophagocytic lymphohistiocytosis
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
3.6%
2/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Immune system disorders
Hypogammaglobulinaemia
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
1.8%
1/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
4.3%
1/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
1.8%
1/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
4.3%
1/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Infections and infestations
Device related bacteraemia
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
4.3%
1/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
12.5%
2/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
4.3%
1/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
1.8%
1/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
1.8%
1/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Infections and infestations
Herpes simplex viraemia
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
4.3%
1/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Infections and infestations
Influenza
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
1.8%
1/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Infections and infestations
Osteomyelitis fungal
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
1.8%
1/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Infections and infestations
Peritonitis
|
16.7%
1/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
1.8%
1/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
4.3%
1/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
5.5%
3/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Infections and infestations
Pneumonia fungal
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
1.8%
1/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
1.8%
1/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Infections and infestations
Sepsis
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
17.4%
4/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
18.8%
3/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
3.6%
2/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Infections and infestations
Septic shock
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
3.6%
2/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
1.8%
1/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
4.3%
1/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
4.3%
1/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Injury, poisoning and procedural complications
Brain herniation
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
1.8%
1/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
1.8%
1/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Investigations
Platelet count decreased
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
1.8%
1/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
4.3%
1/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
4.3%
1/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
1.8%
1/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
16.7%
1/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
33.3%
2/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
4.3%
1/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
25.0%
4/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
7.3%
4/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoma in situ
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
4.3%
1/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
13.0%
3/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
5.5%
3/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
1.8%
1/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Nervous system disorders
Cauda equina syndrome
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
1.8%
1/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
12.5%
2/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Nervous system disorders
Encephalopathy
|
33.3%
2/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
34.8%
8/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
7.3%
4/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
1.8%
1/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
4.3%
1/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Nervous system disorders
Immune effector cell-associated neurotoxicity syndrome
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
1.8%
1/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Nervous system disorders
Monoplegia
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
1.8%
1/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Nervous system disorders
Paraparesis
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
3.6%
2/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Nervous system disorders
Seizure
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
4.3%
1/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
5.5%
3/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Nervous system disorders
Status epilepticus
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Nervous system disorders
Syncope
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
4.3%
1/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
4.3%
1/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
8.7%
2/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
5.5%
3/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
1.8%
1/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
4.3%
1/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
4.3%
1/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
4.3%
1/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
4.3%
1/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
12.5%
2/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
1.8%
1/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
5.5%
3/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
16.7%
1/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
13.0%
3/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
12.5%
2/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
12.7%
7/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary alveolar haemorrhage
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
4.3%
1/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
16.7%
1/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
3.6%
2/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
4.3%
1/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
1.8%
1/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
4.3%
1/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Vascular disorders
Hypotension
|
50.0%
3/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
39.1%
9/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
18.8%
3/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
29.1%
16/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Vascular disorders
Shock
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
Other adverse events
| Measure |
Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg
n=6 participants at risk
Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m\^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m\^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing \> 100 kg, a maximum flat dose of 2 x 10\^8 anti-CD19 CAR T cells/kg of body weight was administered.
|
Phase 1: 1 x 10^6 Anti-CD19 CAR T Cells/kg
n=23 participants at risk
Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m\^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m\^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 1 x 10\^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing \> 100 kg, a maximum flat dose of 1 x 10\^8 anti-CD19 CAR T cells/kg of body weight was administered.
|
Phase 1: 0.5 x 10^6 Anti-CD19 CAR T Cells/kg
n=16 participants at risk
Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m\^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m\^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 0.5 x 10\^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing \> 100 kg, a maximum flat dose of 0.5 x 10\^8 anti-CD19 CAR T cells/kg of body weight was administered.
|
Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg
n=55 participants at risk
Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m\^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m\^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 1 x 10\^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing \> 100 kg, a maximum flat dose of 1 x 10\^8 anti-CD19 CAR T cells/kg of body weight was administered.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
50.0%
3/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
60.9%
14/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
25.0%
4/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
52.7%
29/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
1.8%
1/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Blood and lymphatic system disorders
Bone marrow reticulin fibrosis
|
16.7%
1/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
8.7%
2/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
1.8%
1/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
16.7%
1/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
17.4%
4/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
12.5%
2/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
9.1%
5/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Blood and lymphatic system disorders
Hypofibrinogenaemia
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
5.5%
3/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
3.6%
2/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Blood and lymphatic system disorders
Neutropenia
|
16.7%
1/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
30.4%
7/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
14.5%
8/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
16.7%
1/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
13.0%
3/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
16.4%
9/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Cardiac disorders
Angina pectoris
|
16.7%
1/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
12.5%
2/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
9.1%
5/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
3.6%
2/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Cardiac disorders
Sinus bradycardia
|
16.7%
1/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
17.4%
4/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
3.6%
2/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Cardiac disorders
Sinus tachycardia
|
33.3%
2/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
34.8%
8/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
12.5%
2/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
34.5%
19/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Cardiac disorders
Tachycardia
|
33.3%
2/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
17.4%
4/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
37.5%
6/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
23.6%
13/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Cardiac disorders
Ventricular tachycardia
|
16.7%
1/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
8.7%
2/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Eye disorders
Dry eye
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
5.5%
3/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Eye disorders
Eye pain
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
1.8%
1/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Eye disorders
Photophobia
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
4.3%
1/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
3.6%
2/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Eye disorders
Vision blurred
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
13.0%
3/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
12.5%
2/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
7.3%
4/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Eye disorders
Visual impairment
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
1.8%
1/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Gastrointestinal disorders
Abdominal distension
|
16.7%
1/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
8.7%
2/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
7.3%
4/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
50.0%
3/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
21.7%
5/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
12.5%
2/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
18.2%
10/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
1.8%
1/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Gastrointestinal disorders
Ascites
|
16.7%
1/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
4.3%
1/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
47.8%
11/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
12.5%
2/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
14.5%
8/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
3/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
47.8%
11/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
37.5%
6/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
20.0%
11/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Gastrointestinal disorders
Dry mouth
|
33.3%
2/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
8.7%
2/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
5.5%
3/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
8.7%
2/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
5.5%
3/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
8.7%
2/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
1.8%
1/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
4.3%
1/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
5.5%
3/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
4.3%
1/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Gastrointestinal disorders
Mucous stools
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
47.8%
11/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
18.8%
3/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
38.2%
21/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
4.3%
1/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
1.8%
1/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Gastrointestinal disorders
Toothache
|
16.7%
1/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
30.4%
7/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
12.5%
2/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
16.4%
9/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
General disorders
Asthenia
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
13.0%
3/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
5.5%
3/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
General disorders
Catheter site pain
|
16.7%
1/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
1.8%
1/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
General disorders
Chills
|
50.0%
3/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
52.2%
12/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
18.8%
3/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
32.7%
18/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
General disorders
Face oedema
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
5.5%
3/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
General disorders
Fatigue
|
16.7%
1/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
30.4%
7/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
37.5%
6/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
23.6%
13/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
General disorders
Gravitational oedema
|
16.7%
1/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
General disorders
Hypothermia
|
16.7%
1/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
General disorders
Malaise
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
9.1%
5/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
8.7%
2/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
3.6%
2/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
General disorders
Oedema
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
1.8%
1/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
General disorders
Oedema peripheral
|
16.7%
1/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
30.4%
7/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
25.0%
4/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
18.2%
10/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
General disorders
Pain
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
13.0%
3/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
12.7%
7/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
General disorders
Peripheral swelling
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
General disorders
Pyrexia
|
100.0%
6/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
91.3%
21/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
68.8%
11/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
89.1%
49/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
8.7%
2/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
5.5%
3/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
16.7%
1/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
4.3%
1/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
18.8%
3/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
1.8%
1/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Immune system disorders
Drug hypersensitivity
|
16.7%
1/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
4.3%
1/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Immune system disorders
Hypogammaglobulinaemia
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
13.0%
3/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
5.5%
3/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Infections and infestations
Bacteraemia
|
16.7%
1/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
4.3%
1/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
1.8%
1/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
1.8%
1/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Infections and infestations
Infection
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
8.7%
2/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
1.8%
1/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Infections and infestations
Skin infection
|
16.7%
1/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
16.7%
1/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
4.3%
1/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
3.6%
2/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
8.7%
2/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
12.5%
2/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
5.5%
3/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
16.7%
1/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
8.7%
2/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
3.6%
2/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
1/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
34.8%
8/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
21.8%
12/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
1/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
39.1%
9/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
18.2%
10/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
4.3%
1/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
7.3%
4/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Investigations
Blood bilirubin increased
|
33.3%
2/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
17.4%
4/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
5.5%
3/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Investigations
Blood creatinine increased
|
33.3%
2/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
3.6%
2/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Investigations
Blood fibrinogen decreased
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
17.4%
4/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
3.6%
2/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
5.5%
3/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
7.3%
4/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
34.8%
8/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
25.0%
4/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
27.3%
15/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Investigations
Platelet count decreased
|
16.7%
1/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
43.5%
10/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
31.2%
5/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
32.7%
18/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Investigations
Weight decreased
|
50.0%
3/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
13.0%
3/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
1.8%
1/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Investigations
Weight increased
|
33.3%
2/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
8.7%
2/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
8.7%
2/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
25.0%
4/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
25.5%
14/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Metabolism and nutrition disorders
Acidosis hyperchloraemic
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
39.1%
9/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
25.0%
4/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
14.5%
8/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
33.3%
2/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
4.3%
1/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
1.8%
1/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
8.7%
2/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
1.8%
1/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
16.7%
1/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
34.8%
8/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
31.2%
5/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
14.5%
8/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
33.3%
2/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
4.3%
1/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
50.0%
3/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
8.7%
2/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
1.8%
1/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
16.7%
1/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
4.3%
1/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
3.6%
2/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
1.8%
1/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
50.0%
3/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
21.7%
5/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
1.8%
1/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
33.3%
2/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
34.8%
8/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
16.4%
9/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
16.7%
1/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
47.8%
11/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
12.5%
2/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
27.3%
15/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
16.7%
1/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
34.8%
8/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
21.8%
12/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
50.0%
3/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
30.4%
7/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
12.5%
2/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
7.3%
4/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
33.3%
2/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
56.5%
13/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
18.8%
3/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
27.3%
15/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Metabolism and nutrition disorders
Iron overload
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Metabolism and nutrition disorders
Metabolic alkalosis
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
4.3%
1/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
5.5%
3/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
17.4%
4/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
3.6%
2/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Musculoskeletal and connective tissue disorders
Bone lesion
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
16.7%
1/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
4.3%
1/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
12.5%
2/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
5.5%
3/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
33.3%
2/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
4.3%
1/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
33.3%
2/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
21.7%
5/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
10.9%
6/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
8.7%
2/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
4.3%
1/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
10.9%
6/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
8.7%
2/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
5.5%
3/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
1/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
8.7%
2/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
3.6%
2/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
34.8%
8/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
18.8%
3/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
10.9%
6/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
8.7%
2/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Nervous system disorders
Brain fog
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Nervous system disorders
Cerebral ischaemia
|
16.7%
1/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
4.3%
1/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
5.5%
3/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
8.7%
2/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
12.5%
2/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
14.5%
8/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Nervous system disorders
Encephalopathy
|
66.7%
4/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
26.1%
6/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
16.4%
9/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
43.5%
10/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
50.0%
8/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
36.4%
20/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
13.0%
3/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
12.5%
2/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
1.8%
1/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Nervous system disorders
Neuropathy peripheral
|
16.7%
1/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
12.5%
2/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
16.7%
1/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Nervous system disorders
Seizure
|
16.7%
1/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
8.7%
2/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
8.7%
2/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
5.5%
3/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Nervous system disorders
Tremor
|
16.7%
1/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
34.8%
8/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
25.0%
4/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
27.3%
15/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Psychiatric disorders
Abnormal dreams
|
16.7%
1/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
17.4%
4/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
12.5%
2/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
12.7%
7/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Psychiatric disorders
Anxiety
|
16.7%
1/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
21.7%
5/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
12.5%
2/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
7.3%
4/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Psychiatric disorders
Confusional state
|
33.3%
2/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
26.1%
6/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
37.5%
6/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
20.0%
11/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Psychiatric disorders
Delirium
|
33.3%
2/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
12.5%
2/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
1.8%
1/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Psychiatric disorders
Depression
|
16.7%
1/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
3.6%
2/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Psychiatric disorders
Insomnia
|
16.7%
1/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
13.0%
3/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
12.7%
7/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
8.7%
2/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
3.6%
2/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Renal and urinary disorders
Acute kidney injury
|
16.7%
1/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
4.3%
1/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
1.8%
1/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Renal and urinary disorders
Dysuria
|
16.7%
1/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
4.3%
1/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
4.3%
1/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
8.7%
2/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
4.3%
1/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
12.5%
2/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
5.5%
3/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Renal and urinary disorders
Urinary retention
|
16.7%
1/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
13.0%
3/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
12.5%
2/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
3.6%
2/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
16.7%
1/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Reproductive system and breast disorders
Pelvic pain
|
16.7%
1/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
1.8%
1/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
4.3%
1/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
4.3%
1/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
8.7%
2/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
12.5%
2/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
12.7%
7/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.7%
1/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
13.0%
3/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
18.8%
3/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
7.3%
4/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
4.3%
1/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
5.5%
3/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
33.3%
2/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
21.7%
5/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
31.2%
5/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
21.8%
12/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
5.5%
3/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
17.4%
4/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
3.6%
2/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
12.5%
2/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
13.0%
3/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
12.5%
2/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
16.7%
1/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
5.5%
3/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
16.7%
1/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
1.8%
1/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
16.7%
1/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
8.7%
2/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
5.5%
3/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
4.3%
1/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
17.4%
4/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
1.8%
1/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
8.7%
2/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
1.8%
1/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
1.8%
1/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
8.7%
2/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
4.3%
1/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
16.7%
1/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
8.7%
2/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
4.3%
1/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
5.5%
3/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
13.0%
3/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
5.5%
3/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
17.4%
4/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
12.5%
2/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
9.1%
5/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
4.3%
1/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
1.8%
1/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
8.7%
2/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
3.6%
2/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
13.0%
3/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Vascular disorders
Distributive shock
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
1.8%
1/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Vascular disorders
Flushing
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
13.0%
3/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
5.5%
3/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Vascular disorders
Haematoma
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
13.0%
3/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
12.5%
2/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
12.7%
7/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Vascular disorders
Hypotension
|
83.3%
5/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
56.5%
13/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
43.8%
7/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
49.1%
27/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
6.2%
1/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
0.00%
0/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
|
Immune system disorders
CRS
|
100.0%
6/6 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
100.0%
23/23 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
81.2%
13/16 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
89.1%
49/55 • Adverse Event: Up to 5 years; All-Cause mortality: Up to to 7.1 years
Adverse Events: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel. All-cause mortality: All Enrolled Analysis Set included all enrolled participants in the study.
|
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